Physical Protection of Byproduct Material, 16921-17022 [2013-05895]
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Vol. 78
Tuesday,
No. 53
March 19, 2013
Part II
Nuclear Regulatory Commission
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10 CFR Parts 20, 30, 32, et al.
Physical Protection of Byproduct Material; Rule
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Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Rules and Regulations
NUCLEAR REGULATORY
COMMISSION
10 CFR Parts 20, 30, 32, 33, 34, 35, 36,
37, 39, 51, 71, and 73
[NRC–2008–0120; NRC–2010–0194]
RIN 3150–AI12
Physical Protection of Byproduct
Material
Nuclear Regulatory
Commission.
ACTION: Final rule.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is amending its
regulations to establish security
requirements for the use and transport
of category 1 and category 2 quantities
of radioactive material. The NRC
considers these quantities to be risk
significant and, therefore, to warrant
additional protection. Category 1 and
category 2 thresholds are based on the
quantities established by the
International Atomic Energy Agency
(IAEA) in its Code of Conduct on the
Safety and Security of Radioactive
Sources, which the NRC endorses. The
objective of this final rule is to provide
reasonable assurance of preventing the
theft or diversion of category 1 and
category 2 quantities of radioactive
material. The regulations also include
security requirements for the
transportation of irradiated reactor fuel
that weighs 100 grams or less in net
weight of irradiated fuel. The final rule
affects any licensee that possesses an
aggregated category 1 or category 2
quantity of radioactive material, any
licensee that transports these materials
using ground transportation, and any
licensee that transports small quantities
of irradiated reactor fuel. The rule also
considers a petition for rulemaking
(PRM–71–13) submitted by the State of
Washington that requested that the NRC
adopt the use of global positioning
satellite tracking as a national
requirement for vehicles transporting
highly radioactive mobile or portable
radioactive devices.
DATES: Effective Date: This final rule is
effective on May 20, 2013.
Compliance Date: Compliance with
this final rule is required on March 19,
2014.
ADDRESSES: You can access publicly
available documents related to this
document 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, O1–F21,
One White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
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SUMMARY:
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• NRC’s Agencywide Documents
Access and Management System
(ADAMS): Publicly available documents
created or received at the NRC are
available online in the NRC Library at
https://www.nrc.gov/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’s
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 final rule can be
found at https://www.regulations.gov by
searching on Docket ID NRC–2008–
0120. Public comments on the guidance
document supporting this rule can be
found by searching Docket ID NRC–
2010–0194. Address questions about
NRC dockets to Carol Gallagher,
telephone: 301–492–3668; email:
Carol.Gallagher@nrc.gov.
Availability of Guidance
The NRC is issuing new guidance for
the implementation of the requirements
of 10 CFR part 37. The guidance
document is NUREG–2155,
Implementation Guidance for 10 CFR
part 37, ‘‘Physical Protection of Category
1 and Category 2 Quantities of
Radioactive Material’’ (ADAMS
Accession No. ML13053A061). This
guidance is publicly available as stated
in this ADDRESSES section.
FOR FURTHER INFORMATION CONTACT:
Merri Horn, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 01–415–
8126, email: Merri.Horn@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PRM 71–1
II. Discussion
A. General Applicability
B. Background Investigations and Access
Authorization Program
C. Physical Protection During Use
D. Transportation Security
III. Summary and Analysis of Public
Comments on the Proposed Rule
IV. Discussion of Final Amendments by
Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Writing
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental
Impact: Availability
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
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XIII. Backfit Analysis
XIV. Congressional Review Act
I. Background
The NRC has long participated in
efforts to ensure radioactive source
protection and security. The terrorist
attacks of September 11, 2001,
heightened concerns about the use of
risk-significant radioactive materials in
a malevolent act. Such an attack is of
particular concern because of the
widespread use of radioactive materials
in the United States by industrial,
medical, and academic institutions. The
theft or diversion of risk-significant
quantities of radioactive materials could
lead to their use in a radiological
dispersal device (RDD) or a radiological
exposure device (RED).
The NRC’s current regulations
provide requirements for the safe use,
transportation, and control of licensed
radioactive material. Loss of control of
risk-significant radioactive material,
whether inadvertent or through a
deliberate act, could result in significant
adverse impacts that could reasonably
constitute a threat to the public health
and safety or the common defense and
security of the United States. In the
changed threat environment after the
attacks of September 11, 2001, the
Commission determined that certain
licensed material should be subject to
enhanced security requirements and
safeguarded during transport, and that
individuals with unescorted access to
risk-significant quantities of radioactive
material should be subject to
background investigations.
As part of the development of the
enhanced security measures, the NRC
performed threat and vulnerability
assessments to identify gaps or
vulnerabilities in security and the
effectiveness and costs of certain
physical protection enhancements at
various licensed facilities. The results of
these assessments were used in the
development of security enhancement
orders that were issued to licensees
using a graded approach based on the
relative risk and quantity of material
possessed by the licensee.
The NRC issued the first series of
orders to certain panoramic and
underwater irradiator licensees that
possessed more than 370 Terabequerels
(TBq) (10,000 curies (Ci)) of radioactive
material (EA–02–249; June 6, 2003) (68
FR 35458; June 13, 2003). The next
series of orders were issued to certain
manufacturing and distribution (M&D)
licensees (EA–03–225; January 12, 2004)
(69 FR 5375; February 4, 2004). These
orders require the implementation of
additional security measures and the
protection of the licensee’s physical
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protection information as Safeguards
Information—Modified Handling (SGI–
M). The original orders are not publicly
available because they contain detailed
security requirements that are
designated as SGI–M. However,
redacted versions of these orders have
been made available to the public (73
FR 33859; June 13, 2008, and 73 FR
49714; August 22, 2008). These orders
were issued to both NRC and Agreement
State licensees under the NRC’s
authority to protect the common defense
and security.
Subsequently, the NRC issued
Increased Control Orders (EA–05–090;
November 14, 2005) (70 FR 72128;
December 1, 2005) to other licensees
authorized to possess certain risksignificant quantities of radioactive
material (category 1 and category 2
quantities). The Increased Control
Orders do not contain safeguards
information (SGI) or SGI–M, and are
available on the NRC’s public Web site
at https://www.nrc.gov/security/
byproduct/orders.html. These orders
were issued under the NRC’s authority
to protect public health and safety, and
require licensees to implement
enhanced security measures known as
Increased Controls. To effect nationwide
implementation of the Increased Control
Orders, each Agreement State issued
legally binding requirements to impose
enhanced security measures, identical
to the Increased Controls, for licensees
under that State’s regulatory
jurisdiction.
All of the orders described above
specifically address the security of
byproduct material possessed in
quantities equal to or greater than
category 1 or category 2 quantities. The
orders provide for enhanced security
measures for such things as license
verification before the transfer of these
materials, access control, intrusion
detection and response, and
coordination with local law
enforcement authorities (LLEAs). The
orders also contain requirements for the
licensee to determine the
trustworthiness and reliability of
individuals permitted unescorted access
to risk-significant radioactive materials.
The determination involves a
background investigation of the
individual. The background
investigations were originally limited to
local criminal history records checks
with law enforcement agencies,
verification of employment history,
education, personal references, and
confirmation of employment eligibility
(legal immigration status).
In 2005, Congress passed, and the
President signed, the Energy Policy Act
of 2005 (EPAct). The EPAct amended
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Section 149 of the Atomic Energy Act
(AEA) to authorize the Commission to
require to be fingerprinted any
individual who is permitted unescorted
access to radioactive material or other
property subject to regulation by the
Commission that the Commission
determines to be of such significance to
the public health and safety or the
common defense and security as to
warrant fingerprinting and a Federal
Bureau of Investigation (FBI) criminal
history records check. With this new
authority, the Commission determined
that individuals who have access to
category 1 and category 2 quantities of
radioactive material warrant
fingerprinting and FBI criminal history
records checks.
On October 17, 2006, the NRC issued
orders to panoramic and underwater
irradiator licensees (EA–06–248) (71 FR
63043; October 27, 2006), M&D
licensees (EA–06–250) (71 FR 63046;
October 27, 2006), and licensees making
shipments of category 1 quantities of
radioactive material (EA–06–249) (71 FR
62302; October 24, 2006) to require
fingerprinting and FBI criminal history
records checks for unescorted access to
risk-significant quantities of radioactive
material at their facilities. In issuing
these orders, the NRC noted that a
malevolent act by an individual with
unescorted access to these materials
could result in significant adverse
impacts to the public health and safety
or the common defense and security
and, thus, necessitated expedited
implementation of fingerprinting
requirements. The orders were issued to
both NRC and Agreement State
licensees under the NRC’s authority to
protect the common defense and
security. On December 5, 2007, the NRC
issued orders to all other NRC licensees
that possessed category 1 or category 2
quantities of radioactive material (EA–
07–305) (72 FR 70901; December 13,
2007) to require fingerprinting and FBI
criminal history records checks for
unescorted access to category 1 or
category 2 quantities of radioactive
material. These orders were issued
under the NRC’s authority to protect the
public health and safety and are
available on the NRC’s public Web site
at https://www.nrc.gov/security/
byproduct/orders.html. To effect
nationwide implementation, each
Agreement State issued legally binding
requirements consistent with the
Increased Control Orders to licensees
under their regulatory jurisdiction.
In 2005, the NRC issued two sets of
orders to licensees transporting
radioactive material in quantities of
concern. The first set of transportation
security orders was issued to certain
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licensees that might be expected to
transport radioactive materials in
category 1 quantities (EA–05–006; July
19, 2005) (70 FR 44407; August 2, 2005).
These orders require the
implementation of additional security
measures and the protection of the
licensee’s physical protection
information as SGI–M. The original
orders are not publicly available
because they contain detailed security
requirements that are designated as
SGI–M. However, a redacted version of
the order is publicly available (73 FR
51016; August 29, 2008). These orders
were issued to both NRC and Agreement
State licensees under the NRC’s
authority to protect the common defense
and security.
Subsequently, the NRC issued orders
(EA–05–090; November 14, 2005) (70 FR
72128; December 1, 2005) to specifically
address the transportation security of
byproduct material transported in
quantities equal to or greater than
category 2. The Increased Control
Orders mentioned earlier also contain
requirements for transporting category 2
quantities of radioactive material. The
additional security measures contained
in these two sets of orders provide for
enhanced security measures during
transportation that are beyond the
regulations then applicable, and
include: Enhanced security in
preplanning and coordinating
shipments; advance notification of
shipments to the NRC and States
through which the shipment will pass;
control and monitoring of shipments
that are underway; trustworthiness and
reliability of transport personnel;
information security considerations; and
control of mobile or portable devices
such as radiography cameras and welllogging devices.
In November 2009, the NRC issued
the Increased Control Order and the
Fingerprint Order to power reactor
licensees that are undergoing
decommissioning (EA–09–204 and EA–
09–205; November 23, 2009) (74 FR
66168 and 74 FR 66164; December 14,
2009). The orders required these
licensees to implement the Increased
Controls and to obtain fingerprints and
criminal history records checks for
individuals to have or continue having
unescorted access to aggregated category
1 or category 2 quantities of radioactive
material.
In December 2009, the NRC issued
orders to service provider licensees that
were not manufacturers or distributors
(EA–09–293; December 16, 2009 (75 FR
160; January 4, 2010). The order
required service provider licensees to
implement specific measures to ensure
the trustworthiness and reliability of
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their service representatives that have
unescorted access to category 1 or
category 2 quantities of radioactive
materials.
The requirements put in place by all
these above-described orders
supplement the existing regulatory
requirements. These additional
requirements are primarily intended to
provide reasonable assurance of
preventing the theft or diversion of risksignificant radioactive material. These
requirements provide the Commission
with reasonable assurance that public
health and safety and the common
defense and security continue to be
adequately protected.
It is the Commission’s preference to
implement generically applicable
requirements through rulemaking rather
than by orders. An order is legally
binding only on the licensee or
licensees receiving the order. Further,
the notice-and-comment rulemaking
process allows members of the public to
provide comments on the proposed rule.
This rulemaking promulgates
generically applicable security
requirements for licensees possessing
category 1 and category 2 quantities of
radioactive material in the regulations.
New requirements for background
investigations and an access
authorization program are included to
ensure that individuals who have access
to these materials have gone through
background investigations and are
determined to be trustworthy and
reliable. New requirements are also
included to establish physical
protection systems to detect, assess, and
respond to unauthorized access to
category 1 and category 2 quantities of
radioactive material. For transport of the
radioactive materials, new requirements
for recipient license verification;
preplanning and coordination of
shipments; advance notification of
shipments; notification of shipment
delays, schedule changes, and suspected
loss of a shipment; and control and
monitoring of shipments are included.
The amendments also include security
requirements for shipments of irradiated
reactor fuel that weigh 100 grams (g)
(0.22 pounds (lb)) or less in net weight
of irradiated fuel, exclusive of cladding
or other structural or packaging
material, which has a total external
radiation dose rate in excess of 1 Gray
(100 rad) per hour at a distance of 1
meters (m) (3.3 feet (ft)) from any
accessible surface without intervening
shielding.
In developing this final rule, the NRC
considered, among other things, the
various orders, lessons-learned during
implementation of the orders, the
recommendations of the Independent
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External Review Panel and the Materials
Program Working Group, and
stakeholder comments received on the
proposed rule and the draft
implementation guidance. The
Commission chartered the Independent
External Review Panel to: (1) Identify
vulnerabilities in the NRC’s materials
licensing program with respect to
import, export, specific, and general
licenses; (2) validate the ongoing
byproduct material security efforts; and
(3) evaluate the apparent ‘‘good faith
presumption’’ in the NRC licensing
process that had in the past justified
minimal investigation of new license
applicants or inspection of their
facilities before allowing their
possession of radioactive material. The
Panel’s March 2008 report is available
in ADAMS under Accession No.
ML080700957. The Materials Program
Working Group conducted a
comprehensive evaluation of the
materials program to identify short- and
long-term strategies to mitigate security
vulnerabilities. The Working Group
report contains sensitive information
and is not publicly available. However,
the Group’s comments on the Panel’s
report are publicly available in ADAMS
under Accession No. ML080660424.
PRM–71–13
On July 16, 2008 (73 FR 40767), the
NRC published the resolution and
closure of a petition for rulemaking filed
by Christine O. Gregoire, Governor of
the State of Washington (PRM–71–13).
The NRC indicated that the issues raised
by the petitioner would be considered
in an ongoing rulemaking on security
requirements for the transportation of
radioactive material in quantities of
concern.
The petitioner requested that the NRC
adopt the use of global positioning
system (GPS) tracking as a national
requirement for vehicles transporting
highly radioactive mobile or portable
radioactive devices. As an alternative,
the petitioner stated that the
Commission could grant States the
flexibility to impose more stringent
requirements than those required under
the current Increased Controls Orders.
The petitioner believes that GPS
technology is an effective and relatively
inexpensive tool that would give law
enforcement a significant advantage in
locating a missing source. However, the
petitioner acknowledged that requiring
a GPS on these vehicles does not ensure
that the radiological source will be
found.
The NRC considered the issues
identified by the petitioner and the
petitioner’s suggested approach to
address those issues in the decision-
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making process and final determination
of the rule requirements in the area of
the petitioner’s concern. The NRC
ultimately did not include a
requirement for GPS tracking in the
rule. However, the rule does contain a
requirement to use a telemetric position
monitoring system or an alternative
tracking system when transporting
category 1 quantities of radioactive
material. Use of GPS would be one
method to satisfy this requirement. For
licensees transporting category 2
quantities of radioactive material,
tracking is not required. The licensee is
required to maintain constant control or
surveillance during transit. In addition,
the rule at § 37.53 imposes additional
security measures on mobile devices
that includes using a method to disable
the vehicle or trailer when not under
direct control and constant surveillance
by the licensee. The NRC believes that
these requirements provide adequate
protection for mobile devices and that
GPS is neither justified nor necessary.
The majority of the transportation
security requirements are Compatibility
Category B because there are direct and
significant transboundary implications.
Because the requirements are
Compatibility B, Agreement States must
adopt program elements essentially
identical to those of the NRC and do not
have the flexibility to adopt more
stringent requirements. See also
response to comment D29.
II. Discussion
The NRC has determined that a new
part for Title 10 of the Code of Federal
Regulations (10 CFR) should be
established for the security
requirements for use and transportation
of category 1 and category 2 quantities
of radioactive material. Separate safety
and physical protection requirements
have already been established for
special nuclear material in 10 CFR part
73. The establishment of a new part for
security-related requirements for
byproduct material would be more
effective and efficient compared to
interspersing the requirements with
safety requirements or placing them
with the part 73 security requirements
for special nuclear material. A new part
specifically directed to byproduct
material licensees should make
applicable requirements easier for both
licensees and other stakeholders to
locate and understand.
This discussion section has been
divided into four subsections to better
present information on the final rule.
Each section presents information on a
different aspect of the final rule. Section
A provides information that is generally
applicable to all aspects of this
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rulemaking. Section B provides
information on background
investigations and the access
authorization program. Section C
provides information on the physical
protection of the materials during use.
Lastly, Section D provides information
on transportation security aspects.
A. General Applicability
1. What action is the NRC taking?
The NRC is amending its regulations
to impose security requirements for the
use and transportation of category 1 and
category 2 quantities of radioactive
material. The requirements establish the
objectives and minimum requirements
that licensees must meet to protect
against theft or diversion of this
material. These requirements are
intended to increase the protection of
the public against the unauthorized use
of category 1 or category 2 quantities of
radioactive material by reducing the risk
of the theft or diversion of the material.
The NRC is also amending the
regulations to impose security
requirements for the transportation of
small quantities (100 grams or less) of
irradiated fuel.
2. Why do the requirements need to be
revised?
Prior to September 11, 2001, the NRC
requirements focused on safety and
preventing inadvertent or accidental
exposure of both workers and the public
to these materials. These requirements
also provided security for the material.
The events of September 11, 2001, made
the NRC take a broader look at its
requirements and reevaluate what a
terrorist might do to obtain these
materials. From this effort, the NRC
identified several areas where
additional requirements were necessary
to improve security. The security
requirements need to be placed in the
regulations so that they are generally
applicable to all licensees. Publication
of the proposed rule also provided an
opportunity for all stakeholders to
comment on the proposed requirements.
3. Why doesn’t the NRC just keep the
orders in effect?
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The orders issued by the NRC could
stay in place indefinitely. However, the
regulations would not reflect current
Commission policy or requirements.
reactor licensees may also be impacted.
Most licensees whose activities are
covered under the physical protection
requirements of 10 CFR part 73 are
exempt from the requirements of 10 CFR
part 37. For example, a reactor licensed
under part 50 that also possesses a
radiography source under an NRC
license does not need to implement the
part 37 provisions if the source is
protected under the reactor security
program required by part 73. Licensees
that possess an aggregated quantity of
radioactive waste that equals or exceeds
the category 2 threshold will need to
meet some requirements, but would not
need to meet most of the program
elements in part 37.
Aggregated quantity refers to the total
quantity of radioactive material,
calculated by use of the sum of fractions
method discussed in question 7, that
can be accessed by defeating a single
physical barrier.
Imposing long-term requirements
through orders has not traditionally
been the agency’s preferred method of
regulation. Orders, unlike rules, do not
apply prospectively to applicants for
new licenses. The NRC would have to
periodically issue new orders to cover
new and amended licenses, and perhaps
reissue orders periodically to existing
licensees if requirements or
administrative practices change. In
order to make the requirements
generally applicable to all present and
future licensees, the security-related
requirements need to be placed in the
regulations.
The NRC is now formally revising its
security requirements. The orders will
remain in place for NRC licensees until
the final rule is implemented (1 year
after publication of the final rule). Once
the final rule is implemented, the NRC
will rescind the orders that were issued
to its licensees. For Agreement State
licensees that received an NRC order,
the order will remain in place until the
effective date of compatible
requirements issued by the Agreement
States. Each Agreement State will follow
its own process for issuing these
requirements. Once the State has issued
its requirements and they become
effective, the NRC will rescind the
order.
5. What are Category 1 and Category 2
quantities of radioactive material?
Category 1 quantities of radioactive
material have been called radioactive
material in quantities of concern
(RAMQC). Category 1 and category 2
quantities of radioactive material have
been called risk-significant radioactive
material and refer specifically to 16
radioactive materials (14 single
radionuclides and 2 combinations).
These materials are: Americium-241;
americium-241/beryllium; californium252; curium-244; cobalt-60; cesium-137;
gadolinium-153; iridium-192;
plutonium-238; plutonium-239/
beryllium; promethium-147; radium226; selenium-75; strontium-90
(yttrium-90); thulium-170; and
ytterbium-169. Irradiated fuel and
mixed oxide fuel are not included even
though they may contain category 1 or
category 2 quantities of radioactive
material; these materials are covered by
other regulations. The thresholds for
category 1 and category 2 quantities of
radioactive material are provided in the
following table. Terabecquerels is the
official unit to be used for determining
whether a radioactive material is a
category 1 or category 2 quantity.
Because many licensees use curies in
their activities instead of Becquerels, the
table provides the curie value at three
significant figures for convenience.
4. Whom would this action affect?
These requirements will apply to NRC
and Agreement State licensees that
possess an aggregated category 1 or
category 2 quantity of radioactive
material or that transport irradiated
reactor fuel less than 100 grams net
weight. This includes a wide range of
licensees, including pool-type irradiator
licensees; manufacturer and distributor
licensees; medical facilities with gamma
knife devices; self-shielded irradiator
licensees (including blood irradiators);
teletherapy unit licensees;
radiographers; well loggers; broad scope
users; radioisotope thermoelectric
generator licensees; and licensees that
ship or prepare for shipment category 1
or category 2 quantities of radioactive
material. Nearly 1,400 licensees are
implementing the various orders and are
the entities that will be primarily
impacted by this final rule. In addition,
some fuel cycle and reactor licensees
that possess sources at these levels may
be impacted. Some decommissioning
Category 1 threshold
Radioactive material
Terabecquerels
(TBq)
Americium-241 .............................................................................
Americium-241/Beryllium .............................................................
Californium-252 ............................................................................
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60
20
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Category 2 Threshold
Curies
(Ci)
Terabecquerels
(TBq)
1,620
1,620
540
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Category 1 threshold
Radioactive material
Terabecquerels
(TBq)
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Curium-244 ..................................................................................
Cobalt-60 .....................................................................................
Cesium-137 ..................................................................................
Gadolinium-153 ............................................................................
Iridium-192 ...................................................................................
Plutonium-238 ..............................................................................
Plutonium-239/Beryllium ..............................................................
Promethium-147 ..........................................................................
Radium-226 .................................................................................
Selenium-75 .................................................................................
Strontium-90 (Yttrium-90) ............................................................
Thulium-170 .................................................................................
Ytterbium-169 ..............................................................................
.
These materials and thresholds are
based on the IAEA Code of Conduct.
The IAEA published these results in a
document titled ‘‘Code of Conduct on
the Safety and Security of Radioactive
Sources.’’ A link to this document can
be found on the NRC’s Web site at
https://www.nrc.gov/security/byproduct/
enhanced-security.html. The NRC and
the international community, led by the
IAEA, revised the IAEA Code of
Conduct in 2003, to establish common
international guidance for safety and
security measures for radioactive
sources. In a separate effort, the U.S.
Department of Energy (DOE) and the
NRC reviewed the chemical, physical,
and radiological characteristics of each
radioactive material that is licensed in
the United States, for its attractiveness
to a terrorist. This effort identified 16
radioactive materials that could pose a
serious threat to people and the
environment if used malevolently. This
effort further identified the different
quantities or ‘‘thresholds’’ of materials
that could be useful to a terrorist. The
results of the DOE/NRC effort closely
matched the Code of Conduct Category
2 quantities. The NRC adopted the IAEA
Code of Conduct Category 1 and
Category 2 threshold quantities to
provide consistency between domestic
and international efforts for security of
radioactive materials that are deemed to
be attractive targets for malevolent use.
IAEA Safety Series RS–G–1.9,
Categorization of Radioactive Sources,
provides the underlying methodology
for the development of the Code of
Conduct thresholds. Safety Series RS–
G–1.9 provides a risk-based ranking of
radioactive sources in five categories in
terms of their potential to cause severe
deterministic effects for a range of
scenarios that include both external
exposure from an unshielded source
and internal exposure following
dispersal. The categorization system
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50
30
100
1000
80
60
60
40,000
40
200
1,000
20,000
300
Curies
(Ci)
6. Why are the requirements limited to
these 16 radionuclides?
The Radiation Source Protection and
Security Task Force, an interagency task
force established by the EPAct,
concluded in its 2006 report to Congress
and the President (ADAMS Accession
No. ML062190349) that the appropriate
radioactive sources were being
protected. The Task Force also
concluded that the IAEA Code of
Conduct serves as an appropriate
framework for considering which
sources warrant additional protection.
For its 2010, report to Congress and the
President (ADAMS Accession No.
ML102230141), the Task Force
conducted a reevaluation of the
radionuclides that warrant additional
security and protection. The Task Force
found ‘‘that the Category 1 and 2
quantities remain valid for sealed and
unsealed sources as the list and
threshold levels of radionuclides that
could result in a significant RED or RDD
event and therefore warrant enhanced
security and protection.’’ The Task
Force identified seven additional
radionuclides that may be of concern
when aggregated, but the Task Force did
not recommend at this time that these
additional radionuclides should receive
enhanced protection. If in the future the
Task Force revises its view and
determines that additional security is
Frm 00006
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Terabecquerels
(TBq)
1,350
810
2,700
27,000
2,160
1,620
1,620
1,080,000
1,080
5,400
27,000
540,000
8,100
uses the ‘D’ values as normalizing
factors. The ‘D’ value is the radionuclide
specific activity of a source that, if not
under control, could cause severe
deterministic effects for a range of
scenarios that include both external
exposure from an unshielded source
and internal exposure following
dispersal of the source material. Safety
Series RS–G–1.9 is available on the
IAEA’s Web site at: https://wwwpub.iaea.org/MTCD/publications/PDF/
Pub1227_web.pdf.
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Category 2 Threshold
Curies
(Ci)
0.5
0.3
1
10.0
0.8
0.6
0.6
400
0.4
2.0
10.0
200
3
13.5
8.10
27.0
270
21.6
16.2
16.2
10,800
10.8
54.0
270
5,400
81.0
necessary for these materials, the NRC
would consider requiring additional
security for these materials. The Task
Force periodically reevaluates the list of
radionuclides that warrant additional
security and protection. If the
radionuclides and/or thresholds change
in the future, any changes would be
addressed in a future rulemaking.
7. What is the sum of fractions
methodology or unity rule?
The sum of fractions methodology,
also known as the unity rule, is used to
determine if a licensee is required to
implement 10 CFR part 37
requirements. A licensee may need to
implement the requirements in 10 CFR
part 37 even if it does not possess any
single source or single radionuclide in
excess of the category 2 thresholds. For
combinations of materials (to include
sealed sources, unsealed sources, and
bulk or loose material) and
radionuclides, a licensee must include
multiple items (including bulk material)
of the same radionuclide and multiple
items (including bulk material) of
different radionuclides to determine if
the requirements apply. For the
purposes of this calculation, licensees
are required to consider all of the
aggregated radioactive material from the
list of applicable radionuclides at any
location where the material can be
accessed by breaching a single barrier.
The following formula for the unity rule
is used to determine if a licensee is
required to implement the part 37
requirements: [(Total amount of
radionuclide A) ÷ (category 2 threshold
of radionuclide A)] + [(total amount of
radionuclide B) ÷ (category 2 threshold
of radionuclide B)] + etc.....≥ 1. If the
sum is greater than or equal to 1, the
licensee has at least a category 2
quantity of radioactive material, and the
10 CFR part 37 requirements apply.
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8. Does the NRC plan to issue guidance
on these requirements?
Yes, the NRC plans to issue guidance
on the security requirements for
category 1 and category 2 quantities of
radioactive materials. The draft
guidance was issued for public
comment (75 FR 40756; July 14, 2010)
during the comment period on the
proposed rule. The NRC is issuing new
guidance for the implementation of the
requirements of 10 CFR part 37. The
guidance document is NUREG–2155,
Implementation Guidance for 10 CFR
part 37, ‘‘Physical Protection of Category
1 and Category 2 Quantities of
Radioactive Material’’ (ADAMS
Accession No. ML13053A061). This
guidance and public comments are
available as stated in the ADDRESSES
section of this document.
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9. Will all of the information considered
to be safeguards information under the
orders now be made public?
No. The orders issued to some
licensees contained detailed security
information that could be useful to an
adversary. To increase public awareness
and participation, the NRC identified
the primary security concepts behind
each security measure and included
these concepts in the rule to allow
discussion of the security measures in a
public forum. But the specific measures
that a licensee puts in place may be
considered SGI–M. The final rule on
safeguards information became effective
on February 23, 2009 (73 FR 63546;
October 24, 2008), and established as
SGI–M certain physical protection
information related to panoramic and
underwater irradiators that possess
greater than 370 TBq (10,000 Ci) of
byproduct material in the form of sealed
sources; manufacturers and distributors
of items containing source material,
byproduct material, or special nuclear
material in greater than category 2
quantities; and transportation of source,
byproduct, or special nuclear material
in greater than or equal to category 1
quantities. Physical protection
information for other facilities that fall
under the requirements of 10 CFR part
37 is considered physical protection
information under 10 CFR 2.390(d)(1).
Licensees are also required to protect
the security plan and implementing
information and the list of individuals
that have unescorted access from
unauthorized disclosure. The rule
provisions that address SGI–M or
include references to the SGI–M
requirements in part 73 are reserved for
the NRC and are considered
compatibility category NRC.
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10. What is the authority for this final
rule?
As noted in the background
discussion, the NRC issued some orders
under its authority to protect the
common defense and security and some
orders under its authority to protect the
public health and safety. With respect to
whether the following regulations are
being issued under ‘‘public health and
safety’’ or ‘‘common defense and
security,’’ it should be recognized that
almost all regulations relating to the
security of materials serve both
purposes to some degree. For example,
securing radioactive materials with
multiple barriers protects the public
health and safety by preventing the
unknowing theft of radioactive
materials—such as someone stealing a
vehicle with material stored in the
vehicle, but whose target is the
vehicle—which could result in the
unintentional exposure of members of
the public to the material. The barriers
also protect the common defense and
security by preventing the theft of the
radioactive material by potential
terrorists or others targeting the specific
material intending to use it to affect the
common defense and security by
exposing members of the public to the
material. However, the designation of
the authority being used for these
regulations does have significance in
determining whether Agreement States
or the NRC will be responsible for
overseeing the implementation of these
requirements for Agreement State
licensees.
Although section 274(b) of the AEA
allows the NRC to relinquish its
regulatory authority to Agreement States
for certain radioactive materials and
activities, section 274(m) of the AEA
prevents such agreements from affecting
the authority of the Commission to take
regulatory action to protect the common
defense and security. Thus, as
evidenced by orders issued to
Agreement State licensees after the
events of September 11, 2001, the NRC
has the ability to take necessary steps to
address particular common defense and
security needs. If these regulations were
to be issued under the NRC’s common
defense and security authority, only the
NRC would have the authority to
impose these requirements on
Agreement State licensees and the NRC
would be responsible for inspection and
enforcement of these requirements for
Agreement State licensees.
When regulations such as these
complement both the NRC’s public
health and safety and common defense
and security missions, the operative
question is whether NRC oversight is
PO 00000
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16927
necessary to fulfill the common defense
and security aspects of the regulations.
The NRC believes that the Agreement
States can consistently and adequately
implement the physical protection
requirements on a nationwide basis, and
as such, there will be no need for
independent NRC action to protect the
common defense and security. As
always, the NRC retains the authority
under section 274(m) of the AEA to take
any necessary actions for protection of
the common defense and security
should individual licensees or
Agreement State programs develop
issues requiring immediate action. As
long as all Agreement States continue to
implement compatible and adequate
security requirements, there appears to
be no benefit to the public health and
safety, or common defense and security,
that would justify removing oversight of
these requirements from an established
regulatory program overseeing
Agreement State licensees.
Implementing these regulations under
the NRC’s public health and safety
authority avoids potential complications
with licensees being subject to dual
regulatory authority for a single license.
Thus, the NRC is issuing these
regulations under its public health and
safety authority, and these requirements
are applicable to Agreement State
licensees through the Agreement State
Program.
11. When would the rule be effective?
The final rule is effective 60 days after
publication in the Federal Register;
however, licensees do not need to
comply with the rule until 1 year after
publication. This provides time for
licensees to put in place the necessary
programs, develop procedures, and
conduct training on the new
requirements. While most of the
provisions are similar to those
contained in the orders, there are
differences. The Agreement States will
be required to issue compatible
requirements within 3 years of the
publication date of the final rule instead
of 3 years from the effective date of the
rule. Licensees in an Agreement State
will continue to operate under the
orders or other legally binding
requirements until the Agreement State
issues compatible requirements and
these requirements take effect. The
provisions put in place for the
inspection of licensees in Agreement
States that received the orders issued
under common defense and security
will remain in place until the
Agreement State implements the
requirements. For those Agreement
States that enter into 274i Agreements,
the State can continue inspections
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under the Agreement. For those
Agreement States that did not enter into
274i Agreements, the NRC will continue
to conduct the inspections until the new
Agreement State requirements become
effective. The NRC will rescind the
orders as the regulatory requirements
become effective.
12. How does the NRC ensure licensees
are following these rules?
The NRC and Agreement States
conduct inspections to ensure that
licensees are following the
requirements. The NRC and Agreement
State inspectors will receive training
and follow inspection procedures on
how to ascertain whether licensees are
meeting security requirements. Potential
violations that are identified will be
processed in accordance with the NRC
Enforcement Policy, and depending on
the severity of a violation, licensees
could be subject to civil or criminal
penalties. Additionally, the NRC has
developed enforcement guidance to
ensure consistency in the enforcement
process. Agreement State licensees are
subject to the State’s enforcement
process. Those Agreement State
licensees that were issued NRC orders
under common defense and security
would remain subject to the NRC’s
enforcement process, until the
Agreement State adopts the regulations
with its own legally binding
requirements.
B. Background Investigations and
Access Authorization Program
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1. Who is required to have an access
authorization program?
Any licensee that possesses category 1
or category 2 quantities of radioactive
materials at a facility needs to determine
whether it needs to have an access
authorization program. Only those
licensees that permit unescorted access
to an aggregated category 1 or category
2 quantity of radioactive material are
required to establish and implement an
access authorization program. If the
material can be accessed by the breach
of a single physical barrier, the licensee
needs to implement an access
authorization program. In addition, any
applicant for a license or license
amendment to possess category 1 or
category 2 quantities of radioactive
material at a facility is required to
establish an access authorization
program before obtaining the radioactive
material, if it will be aggregating the
material at or above the category 2
threshold.
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2. What is the objective of the access
authorization program?
The main objective of the access
authorization program is to ensure that
individuals who have unescorted access
to category 1 or category 2 quantities of
radioactive material are trustworthy and
reliable and do not constitute an
unreasonable risk to the public health
and safety or common defense and
security.
3. Who is subject to the licensee’s access
authorization program?
Section 652 of the EPAct authorizes
the Commission to require
fingerprinting of any individual who is
permitted unescorted access to ‘‘any
radioactive material that the
Commission determines to be of such
significance to the public health and
safety or the common defense and
security as to warrant fingerprinting and
background checks.’’ The Commission
has determined that the threshold that
warrants fingerprinting and background
checks is category 2. The Commission
directed that any licensee implementing
the Increased Control Orders should
also have a fingerprinting and an FBI
criminal records check for any
individual with unescorted access to
category 1 or category 2 quantities of
radioactive material. Because only
licensees that had aggregated quantities
at or above the category 2 threshold
implemented the orders, these are the
licensees that need to have an access
authorization program, i.e., any licensee
that has an aggregated quantity of
radioactive material at or above the
category 2 threshold. Therefore,
individuals subject to a licensee’s access
authorization program include anyone
permitted to have unescorted access to
category 1 or category 2 quantities of
radioactive material. Unescorted access
is defined as solitary access to category
1 or category 2 quantities of radioactive
material or the devices that contain the
material. The reviewing official is also
included in the program to ensure that
this individual is subjected to the same
background check and degree of
trustworthiness and reliability.
The access authorization program
may also include individuals that have
access to SGI–M, such as vehicle drivers
and accompanying individuals for road
shipments of category 1 quantities of
radioactive material, movement control
center personnel for shipments of
category 1 quantities of radioactive
material, and any individual whose
assigned duties provide access to
shipment information on category 1
quantities of radioactive material.
Licensees may have a separate program
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Sfmt 4700
for access to SGI or may include the
program with the part 37 program for
unescorted access to the material.
Those individuals who have
unescorted access to certain quantities
of byproduct material could pose a
threat to the public health and safety or
the common defense and security
because they could divert or steal risksignificant radioactive material, or could
aid others in the commission of such
acts. The Radiation Source Protection
and Security Task Force encouraged the
NRC to require fingerprinting and
Federal criminal history checks of any
individual with access to category 1 or
category 2 quantities of radioactive
material.
Certain categories of individuals are
relieved from the background
investigation aspect of the access
authorization program (see Section II,
question B20 and B21). Licensees do
have the option to escort an individual
and not make a trustworthiness and
reliability determination. The escorts
need to be approved for unescorted
access.
4. What are the key access authorization
program requirements?
The key components of an access
authorization program are the reviewing
official, a background investigation, use
of procedures, and the individual’s right
to correct and complete the information
on which the decision to grant
unescorted access is based. Each of
these areas is discussed in more detail
in the following questions and answers.
5. What is the role of the reviewing
official?
The reviewing official is the
individual that makes the
trustworthiness and reliability
determinations for the licensee; the
reviewing official determines who can
be allowed unescorted access
authorization. Note that the Increased
Control Fingerprinting Orders referred
to a trustworthiness and reliability
official (or T&R official) as the
individual who made determinations on
a subject individual’s trustworthiness
and reliability. Unlike the reviewing
official, the T&R official did not have to
be fingerprinted. Under this rule,
fingerprints of the reviewing official(s)
need to be taken by either a law
enforcement agency, a Federal or State
agency that provides fingerprinting
services to the public, or a commercial
fingerprinting service authorized by a
State to take fingerprints and then be
submitted to the NRC. This ensures the
identification of the individual
submitting the fingerprints. Without this
requirement the reviewing official could
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submit the fingerprints of another
individual that is known not to have a
criminal history or known terrorist ties.
Reviewing officials must be permitted
either access to safeguards information
or unescorted access to category 1 or
category 2 quantities of radioactive
material because section 149 of the AEA
only authorizes the collection of
fingerprints for the purposes of
unescorted access to radioactive
material or access to safeguards
information. After the licensee has
completed the background investigation
for the reviewing official and
determined that the individual is
trustworthy and reliable, the licensee
must provide under oath and
affirmation, a certification that the
reviewing official is deemed trustworthy
and reliable. For certain licensees, the
NRC may have approved reviewing
officials, either under the October 17,
2006, orders (EA–06–248, EA–06–250,
and EA–06–249), under the August 21,
2006, SGI–M Orders, or under other
regulatory requirements. In those cases,
the reviewing official may continue to
act in that capacity. If the reviewing (or
T&R) official has not had an FBI
criminal records history check, he or
she needs to be fingerprinted and
undergo a background investigation and
be named by the licensee before making
additional trustworthiness and
reliability determinations. If the
individual falls under one of the
categories of individuals granted relief
from the background investigation, the
individual can be determined to be
trustworthy and reliable without going
through a full background investigation.
The NRC believes that it is important
that the individual who is making the
final determination on whether an
individual is trustworthy and reliable be
trustworthy and reliable themselves and
have undergone the same background
investigation as individuals who would
be granted unescorted access, including
fingerprinting and the FBI criminal
records check. If the reviewing official
is not fingerprinted, a gap could be
created in the security program that
could potentially be exploited. The
reviewing official could have a criminal
history or terrorist ties and allow other
individuals with a criminal history or
terrorist ties to have unescorted access
to radioactive material in quantities of
concern. This addresses the good faith
presumption.
6. What is informed consent?
Informed consent is the authorization
provided by an individual that allows a
background investigation to be
conducted to determine whether the
individual is trustworthy and reliable.
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The signed consent includes
authorization to share personal
information with other individuals or
organizations as necessary to complete
the background investigation. An
individual can withdraw his or her
consent at any time. After the
withdrawal, the licensee may not
initiate any elements of the background
investigation that were not in process at
the time of the withdrawal of consent.
The licensee is required to inform the
individual that withdrawal of consent
for the background investigation is
sufficient cause for denial or
termination of unescorted access
authorization.
Licensees do not need to obtain
signed consent from individuals that
have already undergone a background
investigation that included
fingerprinting and an FBI criminal
history records check, been determined
to be trustworthy and reliable, and
permitted unescorted access to category
1 or category 2 quantities of radioactive
material under the NRC orders or the
legally binding requirements issued by
the Agreement States. A signed consent
is needed for any reinvestigation.
7. What is a personal history disclosure?
The personal history disclosure is the
personal history required to be provided
by the individual seeking unescorted
access to category 1 or category 2
quantities of radioactive material. The
information includes items such as
employment history, education, and any
arrest record. This information provides
the reviewing official with a starting
point for the background investigation.
Failure to provide the information or
falsification of any information could be
grounds for denial of the individual’s
request for unescorted access
authorization or termination of access if
the individual already has access. If the
individual provides false information, it
could be an indication that he or she is
not trustworthy or reliable.
8. What are the components of a
background investigation?
A background investigation includes
several components: Fingerprinting and
an FBI identification and criminal
history records check; verification of
true identity; employment history
verification; verification of education;
and character and reputation
determination.
It is the licensee’s responsibility to
make a trustworthiness and reliability
determination of an employee,
contractor, or other individual who will
be granted unescorted access to category
1 or category 2 quantities of radioactive
material or a device containing such
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16929
radioactive material. It is expected that
licensees will use their best efforts to
obtain the information required to
conduct a background investigation to
determine an individual’s
trustworthiness and reliability.
Information previously obtained during
the hiring process may be used to
support a licensee’s determination of an
individual’s trustworthiness and
reliability without having to reverify
that information. There is no particular
piece of information that would
automatically disqualify an individual
from access. The intent is that the
information is considered as a whole in
determining if an individual is both
trustworthy and reliable.
Fingerprinting an individual for an
FBI criminal history records check is an
important element of the background
investigation. It can provide
comprehensive information regarding
an individual’s recorded criminal
activities within the United States and
its territories and the individual’s
known affiliations with violent gangs or
terrorist organizations.
Verification of true identity is
necessary to make sure that the
individual is who he or she claims to be
and that the documentation matches.
This check is important to make sure
that someone is not posing as someone
else.
Employment history, education
verification, character and reputation
determination; and obtaining
independent information are necessary
to ensure that the individual is who
they claim to be, that the individual has
not made false claims, has a good
reputation, and conducts his or herself
in a trustworthy and reliable manner.
The background investigation is a tool
to determine whether individuals are
trustworthy and reliable and could be
permitted unescorted access to category
1 or category 2 quantities of radioactive
material. It is essential to ensure that
individuals seeking unescorted access to
radioactive material are dependable in
judgment, character, and performance,
such that unescorted access to category
1 or category 2 quantities of radioactive
material by that individual does not
constitute an unreasonable risk to the
public health and safety or common
defense and security.
Nothing in the regulations prevents a
licensee from including other elements
in its background investigation.
Although the NRC did not include the
credit history check as a required
element of the background
investigation, a credit history check can
provide supplemental information that
could be useful to licensees, particularly
in the situation where it is difficult to
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make a trustworthiness and reliability
determination. Information from a credit
history check could provide additional
information that would be useful in
making that final decision. To the extent
that a licensee decides to use a credit
history check as a measure beyond the
regulatory minimum required for the
access authorization program, the NRC
acknowledges the merit of such use.
9. Where does a licensee submit the
fingerprints for processing?
Under the EPAct, licensees are
required to submit the fingerprints to
the NRC, which forwards the
fingerprints to the FBI for processing. If
an individual comes under one of the
categories for relief specified in 10 CFR
37.29, the licensee does not need to
submit the individual’s fingerprints to
the NRC.
10. What should a licensee do if an
individual or entity contacted as part of
a background investigation refuses to
respond?
If a previous employer, educational
institution, or any other entity fails to
provide information or indicates an
inability or unwillingness to provide
information in a timely manner, the
licensee is required to document the
refusal, unwillingness, or inability to
respond in the record of investigation.
The licensee then needs to attempt to
obtain confirmation from at least one
alternate source that has not been
previously used.
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11. Does an individual have the right to
correct his or her criminal history
records?
Yes, an individual has the right to
correct his or her criminal history
records before any final adverse
determination is made. If the individual
believes that his or her criminal history
records are incorrect or incomplete in
any respect, he or she can initiate
challenge procedures. These procedures
include direct application by the
individual challenging the criminal
history records to the law enforcement
agency that contributed the questioned
information. Before an adverse
determination on a request for
unescorted access, individuals have the
right to provide additional information.
12. Is a licensee required to have
procedures for implementing the access
authorization program?
Yes, licensees are required to develop,
implement, and maintain written
procedures for implementing the access
authorization program. At a minimum,
procedures need to address notification
of individuals denied unescorted access
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authorization, including provisions for
review of the denial.
13. What information should the
reviewing official use to determine that
an individual is trustworthy and
reliable?
The reviewing official uses all of the
information gathered during the
background investigation, including the
information received from the FBI, in
making a determination that an
individual is trustworthy and reliable.
The reviewing official may not
determine that an individual is
trustworthy and reliable and grant
unescorted access until the information
obtained for the background
investigation has been evaluated. The
reviewing official may deny unescorted
access to any individual based on any
information obtained at any time during
the background investigation. However,
as required by section 149.c(2)(c) of the
AEA, the licensee may not base a final
determination to deny an individual
unescorted access to category 1 or
category 2 quantities of radioactive
material solely on the basis of
information received from the FBI
involving: (1) An arrest more than 1 year
old for which there is no information of
the disposition of the case; or (2) an
arrest that resulted in dismissal of the
charge or an acquittal. If there is no
record on the disposition of the case, it
may be that information on a dismissal
or acquittal was not recorded.
14. How frequently is a reinvestigation
required?
A reinvestigation is required every 10
years to help maintain the integrity of
the access authorization program. This
is necessary because an individual’s
situation may change over time in a
manner that can adversely affect his or
her trustworthiness and reliability. The
reinvestigation includes only the
fingerprinting and the FBI criminal
history check.
15. Are licensees required to protect
information obtained during a
background investigation?
Yes, licensees are required to protect
the information obtained during a
background investigation. The licensee
is required to establish and maintain a
system of files and procedures for
protection of the information from
unauthorized disclosure. Licensees are
only permitted to disclose the
information to the subject individual,
the individual’s representative, those
who have a need-to-know the
information to perform their assigned
duties to grant or deny unescorted
access to category 1 or category 2
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quantities of material or safeguards
information, or an authorized
representative of the NRC.
16. Can a licensee transfer personal
information obtained during an
investigation to another licensee?
Yes, a licensee can transfer
background information on an
individual to another licensee if the
individual makes a written request to
the licensee to transfer the information
contained in his or her file.
17. If I receive background investigation
information from another licensee, can
I rely on that information?
Yes, a licensee can rely on the
background investigation information
that is transferred from another licensee.
However, a licensee is required to verify
information such as name, date of birth,
social security number, gender, and
other physical characteristics to ensure
that the individual is the person whose
file has been transferred. The licensee
can also choose to verify other
information that is transferred or to
escort the individual and not grant him
or her unescorted access.
18. What records are required to be
maintained?
Licensees are required to retain all
fingerprint and criminal history records
received from the FBI, or a copy if the
individual’s file has been transferred,
for 3 years after the individual no longer
requires unescorted access to category 1
or category 2 quantities of radioactive
material. Licensees are also required to
retain the written confirmation received
from entities concerning a security
clearance or favorably adjudicated
criminal history records check and any
written verifications received from
service providers. A licensee is not
required to retain the actual
fingerprints. The licensee must keep the
determination basis and the list of
individuals permitted unescorted
access.
19. How does a licensee determine the
effectiveness of the access authorization
control program?
Licensees are required to review their
program annually to confirm
compliance with the requirements. The
review evaluates all program
performance objectives and
requirements, documents any findings
and corrective actions, and is conducted
annually. Any records need to be
maintained for 3 years.
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20. Are individuals transporting
radioactive material subject to the
background investigation requirements?
As part of this rulemaking, the NRC
considered what level of responsibility
to place on its licensees regarding
fingerprinting and criminal history
records checks for persons involved in
the transportation of category 1 and
category 2 quantities of radioactive
material. Licensees covered by the
fingerprinting and criminal history
records check requirements of this final
rule may decide to transfer radioactive
material away from the site or may
receive radioactive material from
another entity.
Such transfers or receipts may occur
either as part of a shipment to or from
a domestic company or an international
company. Individuals involved in the
shipment, in particular those employed
by carriers or other organizations
handling shipments, may have
unescorted access to the material during
the shipment process. These persons
may not be employees of the licensee
and thus may not be under the
licensee’s direct control. Section
37.29(a) grants relief from the
background investigation for those
individuals who are commercial vehicle
drivers for road shipments of category 2
quantities of radioactive material and
package handlers at transportation
facilities such as freight terminals and
railroad yards. Individuals that have
access to SGI–M, such as drivers for
category 1 shipments and movement
control personnel for category 1
shipments, must undergo fingerprinting
and an FBI criminal history records
check as required by 10 CFR 73.21.
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21. Who would be relieved from the
background investigation requirements?
Under section 149.b. of the AEA, the
NRC may, by rule, relieve individuals
from the fingerprinting, identification,
and criminal history records check
requirements if it finds that such action
is ‘‘consistent with its obligations to
promote the common defense and
security and to protect the health and
safety of the public.’’ The NRC issued a
final rule, 10 CFR 73.61, relieving
certain individuals who are permitted
unescorted access to radioactive
materials from the fingerprinting,
identification, and criminal history
records checks required by section
149.a. of the AEA (72 FR 4945; February
2, 2007). The individuals relieved from
fingerprinting, identification, and
criminal history records checks under
that rule include Federal, State, and
local officials involved in security
planning; Agreement State employees
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who conduct security inspections on
behalf of the NRC pursuant to 274.i. of
the AEA; and other government officials
who may need unescorted access to
radioactive materials or other property
subject to regulation by the Commission
as part of their oversight function. The
categories of individuals relieved by the
rule included the same individuals as
those relieved in an earlier rulemaking
from fingerprinting and criminal history
records check requirements applicable
to safeguards information (71 FR 33989;
June 13, 2006).
Under this final rule, the Commission
is using the same listing of categories of
individuals with the following
modifications. Emergency response
personnel who are responding to an
emergency are relieved from the
requirements because it is impossible to
predict when emergency access might
be necessary. The need to provide an
escort for those responding to an
emergency could impede the response
function. Employees of carriers that
transport category 2 quantities of
radioactive material and package
handlers at transportation facilities are
also relieved. These individuals would
typically be outside the control of the
licensee and the licensee would have no
way of knowing or influencing who
those individuals might be. The NRC
will rely on the U.S. Department of
Transportation (DOT) and the
Transportation Security Administration
(TSA) programs for background
investigations of these personnel. While
the background investigation may not be
identical to those required under 10
CFR part 37, the NRC believes that the
potential risk that a commercial driver
or package handler might pose due to
any difference in the background
investigation is acceptably small.
Many of the individuals that are
relieved from the background
investigation requirements are
considered trustworthy and reliable by
virtue of their occupational status and
have either already undergone a
background investigation as a condition
of their employment, or are subject to
direct oversight by government
authorities in their day-to-day job
functions.
Certain persons, as part of the duties
of their specific occupation, may be
separately or previously subject to
background investigations, either as a
result of NRC requirements (such as
under other requirements for access to
SGI or SGI–M) or as a result of
requirements of other agencies. These
persons are not subject to separate
background investigation requirements
under this final rule; individuals who
have undergone a background
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16931
investigation, including fingerprinting,
and been found acceptable for
unescorted access under provisions of
other such requirements, do not need to
undergo another background
investigation nor would a separate
determination of their trustworthiness
and reliability need to be made.
Individuals that have undergone
fingerprinting and an FBI criminal
history records check under other
agency programs do not need to be
fingerprinted again, but would be
subject to the other elements of the
background investigation. These
programs include the National Agency
Check, Transportation Worker
Identification Credentials (TWIC) under
49 CFR 1572, Bureau of Alcohol,
Tobacco, Firearms, and Explosives
background check and clearances under
27 CFR 555, Health and Human Services
security risk assessments for possession
and use of select agents and toxins
under 42 CFR 73, Hazardous Material
security threat assessment for hazardous
material endorsement to commercial
drivers license under 49 CFR 1572, and
Customs and Border Patrol’s Free and
Secure Trade (FAST) Program. The
individual must make available the
appropriate documentation. Written
confirmation from the agency/employer
that granted the Federal security
clearance or reviewed the criminal
history records check must be provided
to the licensee.
This rule does not authorize
unescorted access to any radioactive
materials or other property subject to
regulation by the Commission. Rather,
the rule makes clear that a licensee may
permit unescorted access to certain
categories of individuals otherwise
qualified for access without performing
a background investigation. Licensees
still need to decide whether to grant or
deny an individual unescorted access
independently of this provision. Any
required training needs to be conducted
before allowing unescorted access.
C. Physical Protection During Use
1. Who is affected by the requirements?
Any licensee that possesses an
aggregated category 1 or category 2
quantity of radioactive material is
required to establish, implement, and
maintain a security program meeting the
requirements of 10 CFR part 37 of
subpart C. (The NRC considers material
to be ‘‘aggregated’’ if an adversary could
gain access to a category 2 or greater
quantity by breaching a single physical
barrier.) In addition, any applicant for a
license or license amendment to possess
category 1 or category 2 quantities of
radioactive material at a facility is
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required to establish a security program
before obtaining the radioactive
material, if it will be aggregating the
material at or above the category 2
threshold.
2. What is the objective of the security
program and what are the key security
program requirements?
The final rule requires affected
licensees to establish, implement, and
maintain a security program. The
objective of the security program is to
monitor, and without delay detect,
assess, and respond to any actual or
attempted unauthorized access to
category 1 or category 2 quantities of
radioactive materials. A licensee’s
security program needs to include a
written security plan, implementing
procedures, training, use of security
zones, protection of information,
coordination with the LLEA, testing and
maintenance of security-related
equipment, security measures, and a
program review. Each of these areas is
discussed in more detail in the
following questions and answers.
tkelley on DSK3SPTVN1PROD with RULES2
3. What should a licensee’s security
plan address?
The purpose of a security plan is to
establish, in writing, the licensee’s
overall security strategy to ensure that
all of the required security measures
work effectively and in an integrated
way for all facilities and operations
where aggregated quantities of category
1 or category 2 quantities of radioactive
material will be used or stored. The plan
should, among other things, include a
description of the measures and
strategies to implement the security
requirements and identify the security
resources being used to meet the
requirements.
A licensee can revise its security plan
to address changing circumstances. Any
changes to the security plan, as well as
the original plan, must be approved by
the individual with overall
responsibility for the security program.
The security plan must be retained for
3 years after it is no longer needed. The
licensee must retain any superseded
portions of the security plan for 3 years.
Security plans are important for the
implementation of a performance-based
regulation. An adequate plan requires a
licensee to analyze the particular
security needs of its individual facilities
and to explain how it will implement its
chosen security measures to ensure that
they work together to meet the
applicable performance objectives.
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4. Is a licensee required to have security
procedures?
Yes, licensees are required to develop
and maintain written implementing
procedures that document how the
security requirements and the security
plan will be met. These procedures
must be designed to meet the
individualized security needs of each
location where an aggregated category 1
or category 2 quantity of radioactive
material is used or stored. Procedures
need to be approved, in writing, by the
individual with overall responsibility
for the security program. Licensees are
required to keep a copy of the current
procedures as a record for 3 years.
Superseded portions of the procedures
are retained for 3 years. Licensees
should not submit procedures to the
NRC as part of the license application.
5. What training is required?
As part of its physical protection
program, each licensee is required to
conduct training on the security plan to
ensure that those individuals
responsible for implementation of the
plan possess and maintain the
knowledge, skills, and abilities to carry
out their assigned duties and
responsibilities effectively. The extent
of the training needs to be
commensurate with the individual’s
potential involvement in the security of
category 1 or category 2 quantities of
radioactive material. Individuals need to
be instructed in the licensee’s security
program and implementing procedures,
their responsibilities, and the
appropriate response to alarms.
Licensees with dedicated security staff
are encouraged to train their security
personnel in the timely notification of
affected LLEAs during emergencies.
An individual subject to the training
requirements of 10 CFR 37.43(c) needs
to complete the training before being
allowed unescorted access to category 1
or category 2 quantities of radioactive
material. The licensee needs to provide
refresher training annually or when
significant changes have been made to
the security program. The refresher
training addresses any significant
changes; reports on relevant security
issues, problems, or lessons learned;
relevant results from NRC inspections;
and relevant results from the licensee’s
program review and the testing and
maintenance program. Training records
must be maintained for 3 years and need
to include training topics, training
dates, and the list of personnel that
attended the training.
Training is essential if the licensee is
to be adequately prepared for an
effective and coordinated response to
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any effort to steal or divert category 1 or
category 2 quantities of radioactive
material. Adequate training is
indispensable for an appropriate
licensee response to an unauthorized
intrusion.
6. Are licensees required to protect
information concerning their security
program?
Yes. To prevent unauthorized
disclosure, licensees are required to
limit access to their security plans,
implementing procedures, and the list
of individuals that have unescorted
access to the material. These efforts
include measures to allow access to
these documents only to those
individuals who have a need to know
the information to perform their duties
and have been determined to be
trustworthy and reliable based on the
background investigation requirements
set forth in 10 CFR 37.25(a)(2) through
(a)(7). Licensees are required to store
security information in a manner to
prevent unauthorized removal, such as
storage in a locked office or desk
drawer.
To ensure that only trustworthy and
reliable individuals with a need to know
are allowed access to security plans and
procedures, licensees need to develop,
implement, and maintain written
policies and procedures to control
access to their security plan and
security procedures. The licensee’s
information protection policies and
procedures need to ensure the proper
handling and protection of security
plans and implementing procedures
against unauthorized disclosure.
Licensees are required to retain copies
of the policies and procedures.
Licensees that have SGI or SGI–M
would remain subject to the more
stringent information protection
requirements of 10 CFR 73.21, including
fingerprinting and an FBI criminal
records check.
7. What is the purpose of a security
zone?
A security zone is any area
established by a licensee to provide
physical protection for category 1 or
category 2 quantities of radioactive
material. All category 1 and category 2
quantities of radioactive material need
to be used and stored within a security
zone.
The purpose of security zones is to
isolate and control access to the material
to protect it more effectively and deter
theft or diversion by providing, among
other things, more time for licensees
and LLEAs to respond. Isolation
measures protect category 1 or category
2 quantities of radioactive material by
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allowing access to security zones only
through established access control
points. Access control measures allow
only approved individuals to have
unescorted access to the security zone,
and ensure that other individuals with
a need for access are escorted by
approved individuals. A security zone
effectively defines where the licensee
will apply these isolation and access
control measures.
To limit unescorted access to only
approved individuals, licensees could
isolate the radioactive materials using
continuous physical barriers that allow
access to the security zone only through
established access control points; or
licensees could exercise direct control
of the security zone by approved
individuals at all times.
Security zones may be permanent or
temporary. Temporary security zones
need to be established to meet transitory
or intermittent operating requirements
such as periods of maintenance, source
delivery, and source replacement. A
licensee could meet the requirements
for a security zone at some temporary
job sites (such as those involving onsite
operations lasting less than a day)
simply by keeping the area under
‘‘direct supervision’’ by authorized
personnel. Similarly, when work is
being done inside a temporary zone, a
licensee could meet the requirements
for controlling unescorted access by
having the material, persons, and area
within the zone under direct control of
approved individuals at all times.
Because the purpose of security zones
is different from the radiation safety
purposes of the restricted areas and
controlled areas defined in 10 CFR part
20, the security zone does not have to
be the same as either of these areas.
Because measures to control access are
required for both radiation protection
and security, however, a licensee does
have the flexibility to use an area
required for radiation protection
purposes to fulfill the required
functions of a security zone. Thus, for
a temporary well-logging operation
within which the licensee is required by
10 CFR 39.71 to have a ‘‘restricted area’’
to ‘‘maintain direct surveillance * * *
to prevent unauthorized entry into a
restricted area,’’ a licensee could define
a security zone with the same
boundaries as this ‘‘restricted area.’’
Similarly, a radiographer could choose
to define a security zone with the same
boundaries as the ‘‘high radiation area’’
over which radiography licensees are
required by 10 CFR 34.51 to ‘‘maintain
direct visual surveillance * * * to
protect against unauthorized entry.’’
Because materials licensee sites are
differently configured and do not lend
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themselves to generically defined
physical areas, the security zone
concept permits significant flexibility
for licensees to account for a range of
site-specific concerns. It also provides
regulators with a well-defined and
enforceable requirement keyed to
performance objectives of isolation and
access control.
8. When are special additional measures
for category 1 quantities of radioactive
material required?
One provision of the final rule applies
to category 1 quantities of radioactive
material during periods of maintenance,
source receipt, preparation for
shipment, installation, or source
removal or exchange. Licensees are
required to provide, at a minimum, an
approved individual to maintain
continuous surveillance of sources in
temporary security zones and in any
security zone in which physical barriers
or intrusion detection systems have
been disabled to allow the specified
activities.
Due to the natural decay of their
radioactivity, sources lose their
effectiveness as they get older and have
to be replaced or replenished
periodically with new sources to
maintain a device’s expected
performance. Tamper-indicating devices
and other intrusion detection equipment
typically must be disabled to permit the
device to be opened without tripping
alarms. The new sources are typically
shipped by an offsite supplier, who also
often performs removal and exchange or
reinstallation. After replacement, the
removed older sources must be prepared
onsite for shipment back to the
manufacturer or for storage and eventual
disposal. These non-routine operations
by non-licensee employees at the
licensee’s site, during a time when
devices for detecting theft or diversion
are disabled, call for additional
measures to compensate for the
temporary increase in vulnerability.
9. What is required to monitor and
detect an unauthorized entry into a
security zone?
A licensee is required to establish and
maintain the capability to continuously
monitor and detect all unauthorized
entries into its security zone(s).
Monitoring and detection are performed
by either a monitored intrusion
detection system that is linked to an
onsite or offsite central monitoring
facility; electronic devices for intrusion
detection alarms that would alert nearby
facility personnel; monitoring by a
video surveillance system; or direct
visual surveillance by individuals.
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16933
A licensee also needs the capability to
detect unauthorized removal of the
radioactive material. For category 1
quantities of radioactive material, a
licensee needs to immediately detect
any attempted unauthorized removal
through the use of electronic sensors
linked to an alarm or continuous visual
surveillance. For category 2 quantities of
radioactive material, a licensee needs to
verify the presence of the radioactive
material through weekly physical
checks, tamper indicating devices,
actual usage of the material, or other
means.
10. What are the requirements for
personnel communications and data
transmission?
Licensees are required to maintain
continuous capability for personnel
communication and electronic data
transmission and processing among site
security systems for any personnel and
automated or electronic systems used to
support the site security systems.
Licensees are required to have
alternative capability for any system in
the event of loss of the primary means
of communication or data transmission
and processing. The alternative means
cannot be subject to the same failure
mode as the primary systems.
11. What does a licensee need to do
when it detects an intrusion into its
security zone?
A licensee’s response to an intrusion
depends on the licensee’s assessment of
the purpose of the intrusion, but a
response is required without delay. If
the unauthorized access appeared to the
licensee to be an actual or attempted
theft, sabotage, or diversion of category
1 or category 2 quantities of radioactive
material, the licensee needs to
immediately notify and request an
armed response from the appropriate
LLEA. An immediate response by the
licensee permits a more timely response
from law enforcement, thereby,
reducing the risk that the material could
be used for malevolent purposes.
Immediate notification also allows for
early warning to other possible targets of
a simultaneous attempt to divert
material from multiple locations.
A licensee’s decision to call the LLEA
and the NRC depends not only on the
licensee’s assessment of the intent of the
unauthorized access but also on
whether the area where the breach
occurred is an area the licensee had
previously determined needed to be
monitored in order to meet the NRC’s
physical protection requirements. Thus,
a licensee’s assessment and response to
an intrusion alarm in the business office
section of its facility could be entirely
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different from its assessment and
response to an intrusion alarm in a
radioactive materials storage area.
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12. Can a licensee use automated
devices to assess an intrusion and alert
an LLEA?
Depending on the security system, the
layout of controlled areas, and the
design capabilities of the sensors,
automated devices or systems may be
programmed to automatically summon
LLEA assistance in response to an
intrusion alarm.
13. What coordination is required with
LLEA?
Licensees are required to coordinate,
to the extent practicable, with the LLEA
to discuss the LLEA response to threats
to the licensee’s use of Category 1 or 2
quantities of radioactive material. An
LLEA is defined as a public or private
organization that has been approved by
a Federal, State, or local government to
carry firearms and make arrests, and is
authorized and has the capability to
provide an armed response in the
jurisdiction where the licensed category
1 or category 2 quantity of radioactive
material is used, stored, or transported.
In the event of an actual or attempted
theft, sabotage, or diversion of
radioactive material, an armed response
is likely to be necessary. Adversaries
could be well armed, and the small
unarmed or lightly-armed private
security guard service typically used at
byproduct material licensee sites would
not be an adequate substitute for an
LLEA. However, the LLEA need not be
a municipal or county police force. If a
hospital or university campus police
force is the nearest law enforcement
agency to the licensee’s operation
capable of providing an armed response
and making arrests, that police force
would meet the definition of an LLEA.
Coordination activities include
providing a description of the facility,
radioactive materials, and security
measures and notification that the
licensee will request a timely and armed
response to any actual or attempted
theft, sabotage, or diversion of the
licensee’s radioactive materials. The
licensee is required to document its
coordination efforts. The documentation
could include such items as the dates,
times, and locations of meetings or
phone calls and a list of licensee and
LLEA staff present at the meetings.
Licensees are required to coordinate
with the LLEA at least every 12 months.
Coordination with an LLEA is
essential in developing an effective and
efficient physical protection program.
Because certain situations may
necessitate an armed response, a
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strategy that is consistent in scope and
timing with realistic potential
vulnerabilities of the subject radioactive
material should be coordinated well in
advance with the LLEA. Another
purpose of coordination is to provide
the responsible LLEA with an
understanding of the potential
consequences associated with
unauthorized use of the radioactive
material of concern, so that the LLEA
can determine the appropriate priority
of its response. The LLEA response is
needed not only to interdict and disrupt
an attempted theft or sabotage onsite,
but also possibly for offsite coordination
to protect public health and safety and
to mitigate the potential consequences
of unauthorized use of the radioactive
material.
14. What if the LLEA declines to
coordinate with a licensee?
The NRC recognizes that it cannot
exercise authority over LLEAs, or any
party over which a licensee has no
control and the NRC has no legal
jurisdiction. The NRC also recognizes
that an LLEA may have good reasons for
not engaging in coordination activities.
An LLEA’s refusal to coordinate with
a licensee does not by itself render a
licensee’s security plan inadequate. The
NRC recognizes that in an actual
emergency, State and local government
officials will respond to protect the
health and safety of the public. A
licensee is required under 10 CFR
37.45(a)(2) to notify the appropriate
NRC regional office within 3 business
days if the LLEA has not responded to
a request for coordination within 60
days of the coordination request, or if
the LLEA notifies the licensee that the
LLEA does not plan to participate in
coordination activities. The notification
allows the NRC to contact the LLEA
directly to ensure that the LLEA
understands the importance of adequate
coordination. In some cases, the NRC
might contact the Department of
Homeland Security (DHS) and request
DHS assistance with the LLEA. If the
LLEA refuses to coordinate beforehand,
the licensee could still comply by
making and documenting periodic goodfaith efforts to elicit the LLEA’s
participation in planning for a timely
and effective response.
15. What are the LLEA notification
requirements for work at a temporary
job site?
The final rule does not require any
notification of or coordination with the
LLEA for work at temporary jobsites.
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16. What are the special requirements
for mobile sources?
The rule requires licensees using
mobile devices containing a category 1
or category 2 quantity of radioactive
material to have two independent
physical controls that form tangible
barriers to prevent unauthorized
removal of the device. For devices in or
on a vehicle or trailer, a licensee is
required to use a method to disable the
vehicle or trailer when it is not under
direct control and constant surveillance
by the licensee. Licensees are not
allowed to rely on the removal of an
ignition key to meet this requirement.
The rule does allow for the situation
where a site’s health and safety
procedures prohibit the disabling of the
ignition. In those instances, the licensee
would not be required to disable the
ignition. These provisions are in
addition to the other requirements in
subpart C.
Mobile devices, particularly portable
ones, are likely to be more vulnerable to
attempted theft or diversion because an
adversary could more easily remove
these devices before the licensee or
LLEA has an opportunity to respond.
The objective of this requirement is to
delay intruders long enough for a timely
licensee and LLEA response.
A mobile device is defined in the rule
as a piece of equipment containing
licensed radioactive material that is
either: (1) Mounted on wheels or casters
or otherwise equipped for moving
without a need for disassembly or
dismounting, or (2) designed to be hand
carried. Mobile devices do not include
stationary equipment installed in a fixed
location, such as an irradiator, but the
definition includes radiography
cameras, source changers, well logging
equipment, and gauges or controllers.
The definition could also include
storage containers, lead pigs for holding
sources during a source exchange, and
onsite or offsite transportation packages,
if they contained category 1 or category
2 quantities of radioactive material.
17. What maintenance and testing
requirements apply to the security
systems?
Consistent with 10 CFR 37.51,
licensees are required to test intrusion
alarms, physical barriers, and other
systems used for securing and
monitoring access to radioactive
material, and these items need to be
maintained in operable condition. Each
intrusion alarm and associated
communication system subject to the
rule’s requirements for monitoring,
detection, and assessment needs to be
inspected and tested for performance.
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The licensee only needs to test the
equipment that it relies on to meet the
requirements of 10 CFR part 37. This
would include any backup equipment
or systems relied upon in the event of
a primary system failure. If the licensee
has additional equipment or systems
that are not relied on to meet the rule
requirements, the extra equipment and
systems would not need to be tested and
maintained.
The frequency for testing is based on
the manufacturer’s suggested timing. If
the manufacturer does not suggest a
frequency, the licensee must conduct
the maintenance and testing at least
annually. Licensees are required to
maintain records of the maintenance
and testing activities for 3 years.
18. What events does a licensee need to
report to the NRC?
A licensee is required to report any
actual or attempted theft, sabotage, or
diversion of a category 1 or category 2
quantity of radioactive material as soon
as possible after initiating a response,
which includes notification of the
LLEA. The licensee is required to
submit a written report to the NRC
within 30 days after the initial
notification. A licensee is also required
to assess any suspicious activity related
to possible theft, sabotage, or diversion
of category 1 or category 2 quantities of
radioactive material and notify the
LLEA as appropriate. If the licensee
notifies the LLEA, it must also notify the
NRC. The written 30-day report is not
required for suspicious activity reports.
19. How does a licensee determine the
effectiveness of the security program?
Licensees are required to review the
security program annually to confirm
compliance with the requirements. The
review is to evaluate the security
program content and implementation.
The licensee is required to document
any review findings and corrective
actions, and the records need to be
maintained for 3 years.
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D. Transportation Security
1. What is the NRC authority to issue
these transportation security
requirements?
Sections 53, 81, and 161 of the AEA,
as amended, provide the NRC with the
statutory authority to issue these
transportation security requirements.
The NRC shares jurisdiction over the
transport of radioactive material
traveling over public roadways and by
rail with DOT and DHS.
2. Why is this material being shipped?
In general, category 1 and category 2
quantities of radioactive material are
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shipped to medical institutions,
companies that support medical and
academic institutions, and companies
that manufacture and distribute
radioactive material for various
industrial applications. As radioactive
sources get older, radioactive decay
decreases the sources’ strength and the
sources lose their effectiveness and have
to be replaced or replenished with new
sources. The older sources must be
transported for disposal or back to the
manufacturer.
3. What are the new transportation
security requirements?
In general, the final rule includes
requirements for pretransfer checks,
preplanning and coordination of
shipments, advance notification of
shipments, control, monitoring, and
communications during shipments,
procedures, investigations of missing
shipments, and reporting of missing
material. Each of these areas is
discussed in more detail in the
following questions and answers.
These requirements apply to ground
transport of category 1 or category 2
quantities of radioactive material
shipped in a single package or in
multiple packages in a single
conveyance. The category 1
requirements also apply to shipments of
irradiated reactor fuel weighing 100 g
(0.22 lb) or less in net weight of
irradiated fuel, exclusive of cladding or
other structural or packaging material,
which has a total external radiation does
rate in excess of 1 Gray (100 rad) per
hour at a distance of 1 m (3.3 ft) from
any accessible surface without
intervening shielding. Note that a
licensee is not responsible for
complying with these requirements
when a carrier aggregates radioactive
material, during transport or storage
incidental to transport, for two or more
conveyances from separate licensees
that individually do not exceed the
limits. The shipping licensee is
responsible for meeting the
requirements unless the receiving
licensee agrees in writing to arrange for
the in-transit physical protection,
including preplanning and coordination
activities.
4. Is verification of the transferee’s
license necessary?
Yes, 10 CFR 37.71 requires any
licensee transferring category 1 or
category 2 quantities of radioactive
material to a licensee of the NRC or an
Agreement State to verify that the
transferee’s license authorizes the
receipt of the type, form, and quantity
of radioactive material to be transferred.
Licensees that transfer material within
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16935
the same organization do not need to
verify the validity of the license (i.e., for
companies that have licenses in several
States). The licensee should know if its
licenses are valid. For transfers of
category 1 quantities of radioactive
material, the transferring licensee is also
required to verify that the licensee is
authorized to receive radioactive
material at the address requested for
delivery. These verifications are
conducted with the license issuing
authority, i.e., the NRC or the
appropriate Agreement State, or by
using the license verification system.
The license verification system is a new
web-based system that NRC is
developing that may be used to verify
the validity of a license issued by either
NRC or an Agreement State. The license
verification system is currently
scheduled to be operational by the
effective date of the final rule. If it
appears that the system will not be
available in time to support the rule, the
NRC will change the compliance date of
this provision. Licensees should contact
the appropriate NRC regional office to
verify the validity of NRC licensees.
Information on Agreement State
contacts is provided on the NRC’s Web
page at https://nrc-stp.ornl.gov/
asdirectory.html. If the license
verification system is non-functional
and the licensee cannot reach the
license issuing authority, the rule does
have a provision that allows the licensee
to obtain certification from the
requesting licensee. Licensees are
required to document any method of
verification, except for use of the license
verification system. Licensees exporting
material need to meet the requirements
in 10 CFR part 110 for checking the
documentation that the recipient has the
necessary authorization under the laws
and regulations of the importing
country. These actions are intended to
mitigate the risk that the material could
be shipped to an unauthorized
recipient.
5. Is preplanning and coordination of
the shipments necessary?
Yes, 10 CFR 37.75(a) requires
preplanning and coordination of
shipment information for shipments of
category 1 quantities of radioactive
material. The shipping licensee
(licensee sending the licensed material)
is required to coordinate the departure
and arrival times with the receiving
licensee (licensee receiving the licensed
material). This coordination reduces the
risk that theft or diversion of the
material would go unnoticed or
unreported. The licensee also needs to
preplan and coordinate the shipment
information with the State(s) through
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which the shipment will pass. As part
of the coordination activities, the
licensee is required to discuss the
State’s intention to provide law
enforcement escorts for the shipments
and identify safe havens. Under the
rule, safe havens are sites at which
security is present or from which the
transport crew can notify and wait for
the local law enforcement authorities in
the event of an emergency. The licensee
is responsible for identification of the
safe havens. The purpose of the
information sharing is to ensure
minimal delay of the shipment.
For shipments of category 2 quantities
of radioactive material, 10 CFR 37.75(b)
requires that the shipping licensee
verify the shipment no-later-than arrival
time and the expected arrival time with
the receiving licensee.
The definitions section of the final
rule defines the term ‘‘no-later-than
arrival time’’ as the date and time that
the shipping licensee and receiving
licensee have established as the time at
which an investigation will be initiated
if the shipment has not arrived at the
receiving facility. The no-later-thanarrival time may not be more than 6
hours after the estimated arrival time for
category 2 shipments. Verifying that the
shipment arrives on time provides the
licensee with the means to identify and
immediately report an unusual
occurrence that could lead to the theft
or diversion of the material.
tkelley on DSK3SPTVN1PROD with RULES2
6. What does the NRC consider to be a
safe haven?
A safe haven is a readily recognizable
and readily accessible site at which
security is present or from which, in the
event of an emergency, the transport
crew can notify and wait for the LLEA.
The NRC expects safe havens to be
identified and designated by the
licensee.
Licensees should use the following
criteria in identifying safe havens for
shipments: Close proximity to the route,
i.e., readily available to the transport
vehicle; security from local, State, or
Federal assets is present or is accessible
for timely response; the site is well lit,
has adequate parking, and can be used
for emergency repair or to wait for LLEA
response on a 24-hour a day basis; and
additional telephone facilities are
available should the communications
system of the transport vehicle not
function properly. Possible safe haven
sites include: Federal sites having
significant security assets; secure
company terminals; State weigh
stations; truck stops with secure areas;
and LLEA sites, including State police
barracks.
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7. Is the shipping licensee required to
notify the receiving licensee if the nolater-than arrival time changes?
Yes. If the no-later-than arrival time
will not be met, the shipping licensee
must inform the receiving licensee of
the new no-later-than arrival time for
shipments of category 2 quantities of
radioactive material. This provision
allows licensees the ability to modify
departure and arrival times due to
unforeseen events.
8. Whom does the licensee notify when
the shipment arrives?
The receiving licensee is required to
notify the shipping licensee when the
shipment of a category 2 quantity of
radioactive material arrives at its
destination. This requirement ensures
positive communication between the
shipper and recipient. Additionally, this
requirement ensures that the shipper
does not unnecessarily start an
investigation because they are not sure
that the shipment has arrived. The
receiving licensee must notify the
shipping licensee if the shipment has
not arrived by the no-later-than arrival
time. This notification is the trigger to
initiate an investigation into where the
package is located.
9. What does the term state mean in the
requirements?
As used in the definitions section of
the final rule, the term ‘‘State’’ means
the 50 States, the District of Columbia,
the Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern
Mariana Islands. A list of the contact
information for the governor’s designees
is published annually in the Federal
Register, most recently on October 31,
2011 (76 FR 67229). An updated list is
posted on the NRC’s Web site at https://
nrc-stp.ornl.gov/special/designee.pdf.
Copies may also be obtained by
contacting the Director, Division of
Intergovernmental Liaison and
Rulemaking, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001. The NRC will work
with the States to include a separate
column.
10. What advance notifications are
required?
The final rule requires advance
written notifications for shipments
containing category 1 quantities of
radioactive material. The advance
notifications are made to the NRC (or
Agreement State which then would
notify the NRC) and to any State
through which a shipment is being
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transported. The State notification is
made to the governor or the governor’s
designee. The NRC shares the
information with some of its Federal
partners.
Advance notification provides States
and the NRC with knowledge of
shipments so that in the event there is
an increase in the risk of theft or
diversion of the material, the regulator
could delay or reroute the shipment to
minimize the risk. This advance
notification also allows States with
escort requirements to engage in
planning to support the shipment.
Advance notifications are not
required for shipments of category 2
quantities of radioactive material, unless
the shipment falls within the scope of
10 CFR 71.97(b).
11. What information should be
included in an advance notification?
The final rule requires that the
following information be included in an
advance notification for a category 1
shipment of radioactive material, if
available at the time of notification: (1)
The name, address, and telephone
number of the shipper, carrier, and
receiver of the shipment; (2) the license
number of the shipper and receiver; (3)
a description of the radioactive material
contained in the shipment, including
the radionuclides and quantity; (4) the
point of origin of the shipment and the
estimated time and date that shipment
will commence; (5) the estimated time
and date that the shipment is expected
to enter each State along the route; (6)
the estimated time and date of arrival of
the shipment at the destination; and (7)
the contact and telephone number for
the point of contact. For the purpose of
coordination only, the actual
information in the advance notification
would not be considered to be SGI–M.
Any information that is not available at
the time of the initial notification would
be provided in a revised notification
once the information becomes available.
12. What should a licensee do if the
shipment schedule is revised or the
shipment cancelled?
If the category 1 shipment schedule is
revised or cancelled, the final rule
requires the shipping licensee to notify
the appropriate States and the NRC.
13. What should a licensee do if the
shipment does not arrive by the nolater-than arrival time?
The final rule requires a licensee that
has shipped category 2 quantities of
radioactive material to initiate an
investigation for any shipment that has
not arrived at the receiving licensee’s
facility by the designated no-later-than
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arrival time. The no-later-than arrival
time is defined as the date and time that
the shipping licensee and receiving
licensee have established as the time at
which an investigation will be initiated
if the shipment has not arrived at the
receiving facility. The no-later-thanarrival time may not be longer than 6
hours after the estimated arrival time for
a shipment of category 2 quantities of
radioactive material. A no-later-than
arrival time was not included for
category 1 shipments as the licensee is
required to maintain continuous
position monitoring and detect any
unauthorized access to or removal of the
material immediately. This would
enable the shipping licensee of a
category 1 shipment to know right away
if the shipment was late or experiencing
problems.
14. When must a licensee make
notification that a shipment is lost or
missing?
When a licensee determines that a
shipment of a category 1 quantity of
radioactive material is lost or missing,
the rule requires the licensee to notify
the LLEA in the area of the shipment’s
last confirmed location within 1 hour
and then to notify the NRC’s Operations
Center. Notification to the NRC should
be as prompt as possible, but not at the
expense of causing delay or interference
with the LLEA response to the event.
When a licensee determines that a
shipment of category 2 quantities of
radioactive material is lost or missing,
the rule requires the licensee to notify
the NRC’s Operations Center within 4
hours of such determination. The
licensee is also required to immediately
notify the NRC’s Operations Center if,
after 24 hours from its determination
that the shipment was lost or missing,
the location of the material still cannot
be determined.
Early notification provides for a more
timely response from law enforcement,
thereby reducing the risk of the misuse
of the material.
tkelley on DSK3SPTVN1PROD with RULES2
15. Should licensees make notification
that a lost or missing shipment has been
found?
Yes, 10 CFR 37.81(e) and (f), for
category 1 shipments and category 2
shipments, respectively, require the
licensee to notify the NRC’s Operations
Center when a lost or missing shipment
has been located. This notification is
considered an update on the initial
notification.
Without this notification, regulatory
authorities and LLEA may waste
resources continuing any search for the
material.
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16. What is a licensee required to do if
there is an attempt to steal or divert a
shipment?
For shipments of category 1 quantities
of radioactive material, a licensee who
discovers an actual or attempted theft or
diversion of a shipment, or any
suspicious activity related to a
shipment, is required to notify the
designated LLEA along the shipment
route as soon as possible. After notifying
the LLEA, the licensee is required to
notify the NRC’s Operations Center. The
NRC’s Operations Center will notify
other affected States and the agency’s
Federal partners. For shipments of
category 2 quantities of radioactive
material, a licensee who discovers an
actual or attempted theft or diversion of
a shipment, or any suspicious activity
related to a shipment, is required to
notify the NRC’s Operations Center as
soon as possible. These security
measures enhance the likelihood that
the material will be successfully
protected or recovered and allows for
early warning of other possible victims
of a simultaneous attempt to divert
material from multiple locations.
17. What types of procedures are
necessary for shipping category 1
quantities of radioactive material?
Licensees shipping category 1
quantities of radioactive material by
road are required to ensure that normal
and contingency procedures are
developed to cover notifications;
communication protocols; loss of
communication; and response to an
actual or attempted theft or diversion of
a shipment, or any suspicious activity
related to a shipment. The licensees are
required to ensure that drivers,
accompanying personnel, railroad
personnel, and movement control center
personnel have access to the normal and
contingency procedures. Procedures
provide reasonable assurance that these
individuals are prepared for most
situations and are able to act without
delay to prevent the theft or diversion
of shipments.
18. What should be included in the
communication protocols?
The final rule requires that the
communication protocols include a
strategy for the use of authentication
and duress codes and provisions for
refueling or other stops, detours, and
locations where communication is
expected to be temporarily lost.
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19. What are the physical protection
requirements for road shipments of
category 1 quantities of radioactive
material?
The final rule requires that any
licensee that ships category 1 quantities
of radioactive material by road either
establish or use a carrier that has
established, movement control centers
that maintain position information from
a location remote from the activity of
the transport vehicle or trailer. The
control centers are required to monitor
shipments on a continuous and active
monitoring basis (24 hours a day, 7 days
a week), and have the ability to
communicate immediately, in an
emergency, with the appropriate law
enforcement agencies.
The final rule requires that the
licensee ensure that redundant
communications are in place that would
allow the transport to contact an escort
vehicle (if used) and the movement
control center at all times. The
redundant communication must not be
subject to the same interference factors
as the primary communication method.
The same interference factors mean any
two systems that rely on the same
hardware or software to transmit their
signal (e.g., cell tower or proprietary
network).
Redundant communications provide
drivers with the means to immediately
report an unusual occurrence that could
lead to the theft or diversion of the
material. Early notification would
permit a more timely response from law
enforcement, thereby, reducing the risk
of the misuse of the material.
The final rule also requires that the
licensee ensure that category 1
shipments are continuously and actively
monitored by a telemetric position
monitoring system or an alternative
tracking system reporting to a
movement control center. The
movement control center is required to
provide positive confirmation of the
location, status, and control over the
shipment and be prepared to implement
preplanned procedures in response to
deviations from the authorized route or
to a notification of actual or attempted
theft or diversion or suspicious
activities related to the theft, loss, or
diversion of a shipment. These
procedures include the identification of,
and contact information for, the
appropriate LLEA along the shipment
route.
A telemetric position monitoring
system is a data transfer system that
captures information by instrumentation
and/or measuring devices about the
location and status of a transport vehicle
or package between the departure and
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destination locations. The gathering of
this information permits remote
monitoring and reporting of the location
of a transport vehicle or package. GPS
and radiofrequency identification
(RFID) are examples of telemetric
position monitoring systems.
If the driving time period is greater
than the maximum number of allowable
hours of service in a 24-hour duty day
as established by the DOT Federal
Motor Carrier Safety Administration, the
final rule requires that the licensee
ensure that an accompanying individual
is provided for the entire shipment. The
accompanying individual may be
another driver. This security measure
provides reasonable assurance that the
material will be protected from theft or
diversion when it is stationary, as well
as in emergency situations where it
becomes necessary for the driver to stop
or leave the vehicle.
20. Is GPS required?
No, GPS is not required. For category
1 material, the NRC requires continuous
and active monitoring for shipments.
Continuous and active monitoring
means that at any time while the
shipment is enroute, the licensee must
be knowledgeable of the shipment’s
whereabouts. Not specifying a particular
technology provides licensees with
flexibility to design a continuous and
active monitoring system that meets
their unique circumstances. However,
GPS is considered an acceptable method
of continuous and active monitoring.
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Licensees are required to retain
records for 3 years.
The final rule requires each licensee
that ships category 1 quantities of
radioactive material by rail to ensure
that rail shipments are monitored by a
telemetric position monitoring system
or an alternative tracking system
reporting to a licensee, third party, or
railroad communications center which
meets certain criteria. The
communications center needs to
provide positive confirmation of the
location of the shipment and its status.
Rail shipment tracking provides the
means for a communications center to
immediately report an unusual
occurrence that could lead to the theft
or diversion of the material. Early
notification provides for a more timely
response from LLEAs, thereby reducing
the risk of the misuse of the material.
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The final rule requires that a licensee
shipping category 2 quantities of
radioactive material by road maintain
constant control and/or surveillance
during transit and have the capability
for immediate communication to
summon appropriate response or
assistance. In the case of the licensee
using a common carrier, the final rule
requires that licensees use a carrier that
has an established package tracking
system. An established package tracking
system means a documented, proven,
and reliable system routinely used to
transport objects of value. The package
tracking system must allow the shipper
or transporter to identify when and
where the package was last and when it
should arrive at the next point of
control. The licensee is required to use
a carrier that maintains constant control
and surveillance during transit and has
the capability for immediate
communication to summon appropriate
response or assistance. The carrier must
also require an authorized signature
prior to releasing the package for
delivery or return.
In general, the licensee must be able
to contact the shipping carrier and
determine the approximate location of
the shipment. Package tracking systems,
such as common overnight delivery
service with standard tracking, are
acceptable. These requirements mitigate
with reasonable assurance the risk of
loss, theft, or diversion of the material.
23. How long do records related to a
shipment need to be maintained?
21. What are the physical protection
requirements for rail shipments of
category 1 quantities of radioactive
material?
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22. What are the physical protection
requirements for shipments of category
2 quantities of radioactive material?
24. How is the public protected from
loss, theft, or diversion of these
shipments?
Regulating transport of radioactive
material is a joint responsibility of the
NRC and DOT. The quantities of
radioactive materials being considered
as part of this rulemaking are
transported in packages (casks) that
meet rigorous NRC and DOT safety
standards. The NRC fact sheet on
transportation of radioactive materials
can be found at: https://www.nrc.gov/
reading-rm/doc-collections/fact-sheets/
transport-spenfuel-radiomats-bg.html.
The carrier transporting radioactive
material must also meet DOT’s
requirements for shipment of the
radioactive material. A link to DOT’s
Web site is provided on the NRC’s Web
site at: https://www.nrc.gov/materials/
transportation.html.
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25. What are the requirements for small
quantities or irradiated reactor fuel?
The final rule adds a new § 73.35 to
10 CFR part 73, which provides that the
requirements for shipments of irradiated
reactor fuel weighing 100 g (0.22 lb) or
less in net weight of irradiated fuel,
exclusive of cladding or other structural
or packaging material, which has a total
external radiation dose rate in excess of
1 Gray (100 rad) per hour at a distance
of 1 m (3.3 ft) from any accessible
surface without intervening shielding.
The requirements are the same as the
requirements for shipments of category
1 quantities of radioactive material.
26. What means of transportation are
not addressed in this rule?
The rule does not address air or water
transport. Transport of radioactive
material within airports and by air is
regulated by the Federal Aviation
Administration. Transport of radioactive
material within ports and by waterway
is regulated by the U.S. Coast Guard.
The rule also does not address
transshipments of category 1 or category
2 quantities of radioactive material
through the United States.
Transshipments are shipments that are
originated by a foreign company in one
country, pass through the United States,
and then continue on to a company in
another country. Transshipments are
regulated by DOT and DHS.
Finally, this rulemaking does not
address transport of spent fuel, except
irradiated reactor fuel weighing 100 g
(0.22 lb) or less in net weight of
irradiated fuel, exclusive of cladding or
other structural or packaging material,
which has a total external radiation dose
rate in excess of 1 Gray (100 rad) per
hour at a distance of 1 m (3.3 ft) from
any accessible surface without
intervening shielding.
III. Summary and Analysis of Public
Comments on the Proposed Rule
The proposed rule was published on
June 15, 2010 (75 FR 33902), for a 120day public comment period that ended
on October 13, 2010. After receiving
several requests to extend the comment
period, the NRC published an extension
notice on October 8, 2010 (75 FR
62330), that extended the public
comment period until January 18, 2011.
The NRC received comments from 110
organizations and individuals. The
commenters on the proposed rule
included States, licensees, industry
organizations, individuals, and a
Federal agency.
In general, there was a range of
stakeholder views concerning the
rulemaking, supporting some aspects of
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the rulemaking, others opposing some
aspects of the rulemaking. Some
commenters described the new
requirements as going beyond the order
requirements. It is important to note that
the Commission never intended to just
place the orders into the regulations to
make them generically applicable. The
Commission always intended to
consider insights gained from
implementation of the orders and any
lessons learned during implementation.
In addition, the Commission considered
recommendations from the Independent
Review Panel and the Materials
Working Group, as well as a petition
filed by the State of Washington.
The comments and responses have
been grouped into five areas: General,
access authorization program, security
during use, transportation security, and
miscellaneous. To the extent possible,
all of the comments on a particular
subject are grouped together. The
Commission specifically requested
input on eight subjects: (1)
Fingerprinting of the reviewing official;
(2) background investigation elements;
(3) protection of information; (4) LLEA
notification at temporary jobsites; (5)
reporting requirements; (6) disabling
vehicle exemption; (7) license
verification; and (8) monitoring plans
for railroad classification yard. These
eight subjects are addressed within the
appropriate area grouping. A discussion
of the comments and the NRC’s
responses follow.
A. General
Comment A1: One commenter stated
that the definition for access control
should be expanded to include persons
with access to SGI, as such individuals
are subject to the requirements in
§ 37.21(c).
Response: The NRC disagrees with the
comment. A licensee may include the
SGI component in its access
authorization program, but it is not
required to include SGI. The
requirements for SGI are contained in 10
CFR part 73, and the licensee can
choose to use the same reviewing
official and process or may use a
different reviewing official and process.
If a licensee chooses to include SGI in
its access authorization program under
10 CFR part 37, it will meet the
requirements of 10 CFR part 73.
Comment A2: One commenter noted
that the definition for aggregated was
unclear. Another commenter suggested
including unsealed sources and bulk
material in this definition. Commenters
recommended either clarifying
‘‘multiple sources of bulk material’’ or
giving it its own definition. A
commenter noted it was unclear if the
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term bulk material aligns with DOT
terminology for bulk packaging.
Response: The NRC agrees that the
definition could be confusing and has
revised the definition to make it clear
that radioactive material in any form
should be included. The definition is
not related to DOT. The intent was to
include all material, whether it was in
the form of a source (sealed or unsealed)
or was contained in a container of some
sort, such as feed material, that might be
used to create a source.
Comment A3: One commenter noted
that the term ‘‘Aggregated’’ uses the
term ‘‘sealed source’’ in its definition
and that ‘‘sealed source’’ should be
defined in 10 CFR part 37 as the use
lacks clarity and safety significance. The
commenter stated that the definition for
sealed source should also be revised in
10 CFR parts 30 and 70. The commenter
provided a suggested definition for
‘‘sealed source’’ as follows: ‘‘Sealed
source means any radioactive material
contained to minimize the spread of
contamination in accordance with the
presentation made in a Sealed Source
and Device Registry certificate issued by
the U.S. Nuclear Regulatory
Commission, an Agreement State or the
International Atomic Energy Agency.’’
Response: The NRC disagrees with the
comment. The term ‘‘sealed source’’ has
been in the regulations for a long time
and the NRC is not aware of any issues
that have arisen due to a lack of clarity
or safety significance. The term does not
need to also be defined in 10 CFR part
37 as it is defined in the parts under
which a sealed source would be
licensed. Changing the definition of
sealed source in 10 CFR parts 30 and 70
is beyond the scope of this rulemaking.
Comment A4: One commenter
requested that the definition of
‘‘Escorted Access’’ be revised to delete
the term ‘‘line-of-sight’’ as it is too
prescriptive and creates compliance
issues should someone ‘‘look away’’ or
stand in an area of the security zone
where the escorted individual’s view
may be blocked by some object or
equipment in the zone. The commenter
noted that surveillance can also be
accomplished by remote video
monitoring. Two commenters suggested
that the term escorted access should be
revised to allow for video surveillance.
The commenters noted that, although
the definition was a straightforward,
easy way to define escorting, certain
video surveillance systems provide
improved security and should be
allowed. The commenters suggested
revising the definition as follows:
‘‘Escorted access means that the actions
of the individual are observed 100% of
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16939
the time while they are in the security
zone.’’
Response: The NRC agrees with the
comment in part. The NRC has removed
the term ‘‘line-of-sight surveillance’’
from the definition and changed it to
‘‘direct continuous visual surveillance.’’
The revised definition will provide
greater flexibility for the licensee. The
definition of escorted access was not
intended to eliminate a licensee’s use of
video surveillance. Video surveillance is
appropriate in some, but not all cases.
For example, video surveillance of
patients during a treatment would be
appropriate.
Comment A5: One commenter
requested that the definition of license
be revised as follows: ‘‘License, except
where otherwise specified, means a
license for byproduct material issued
pursuant to the regulations in 10 CFR
parts 30 through 36 and 39 of this
chapter or a permit issued by a master
materials licensee.’’
Response: The NRC disagrees that the
definition for license should be revised.
The definition used in 10 CFR part 37
is identical to the definition used in 10
CFR part 30. No license will be issued
under 10 CFR part 37.
Comment A6: One commenter
requested that the definition of license
issuing authority be revised to include
a master materials licensee (MML) as
the MML issues individual permits.
Response: The NRC disagrees with the
comment. An MML is not equivalent to
an Agreement State and does not issue
licenses. The MML does authorize
individual permits for specific
locations, but cannot authorize beyond
what is specified on the MML license.
Comment A7: Several commenters
requested that the definition of LLEAs
be revised by removing the requirement
that the agency be a government entity
and to broaden the definition to include
private security forces that possess the
authority to carry firearms and make
arrests. Commenters felt that the
definition was confusing and was not
clear whether university police could be
considered an LLEA under the
definition. One of the commenters noted
that some university police departments
serve as the LLEA and are a fully badged
and sworn police force with the
authority to make arrests and provide
armed response. Some of the
commenters suggested revised rule
language to clarify the definition.
Response: The NRC agrees with the
commenters and has revised the
definition of LLEA as follows: ‘‘Local
law enforcement agency (LLEA) means a
public or private organization that has
been approved by a federal, state, or
local government to carry firearms and
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make arrests, and is authorized and has
the capability to provide an armed
response in the jurisdiction where the
licensed category 1 or category 2
quantity of radioactive material is used,
stored, or transported.’’
Comment A8: Five commenters
suggested revising the definition of
‘‘Lost or missing licensed material.’’
Commenters indicated that the
definition contains subjective terms that
make compliance with the reporting
criteria difficult. Two commenters
recommended removing ‘‘readily’’ from
the definition as it is too subjective and
could lead to inadvertent
noncompliance. One commenter
recommended linking the definition for
lost or missing licensed material with
the no-later-than arrival time definition
and providing a specific criterion in
regards to time to locate material in
transit. The commenter suggested the
following definition: ‘‘Lost or missing
licensed material’’ means licensed
material whose location is unknown. It
includes material that has been shipped
but has not reached its destination and
whose whereabouts have not been
traced in the transportation system
within 8 hours past the scheduled nolater-than arrival time.’’ The commenter
noted that compliance and enforcement
of the reporting criteria established in
§ 37.81 is difficult and that an 8-hour
investigation period seems reasonable.
Another commenter noted that it
typically gives the carrier 24 hours to
trace within their transportation cycle,
before the package is declared as lost or
missing, and that anything less than the
24 hours does not allow sufficient time
for the carrier to do a complete
document and tracking search and/or a
physical search at potential locations.
The commenter noted that to declare the
package as lost or missing before that
will result in many false positives, as
99.99% of the time the package is
located within the 24-hour window.
Response: The NRC disagrees with the
comment. The term ‘‘lost and missing
licensed material’’ has been in part 20
for some time, and the definition in 10
CFR part 37 is identical. It would be
confusing to have different definitions
for the same term and concept in the
regulations and licensees would still
need to meet the 10 CFR part 20
reporting requirements. A change to 10
CFR part 20 is beyond the scope of this
rulemaking. The NRC will provide
additional information on the securityspecific meaning of ‘‘lost or missing’’ in
the 10 CFR part 37 guidance document.
Comment A9: One commenter stated
that the definition for reviewing official
should include a trustworthiness and
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reliability determination of an
individual who has access to SGI–M.
Response: The NRC disagrees with the
comment. A licensee may use the same
reviewing official for trustworthiness
and reliability determinations for both
unescorted access and access to SGI.
However, the licensee is not required to
use the same reviewing official.
Determining access for SGI can be a
separate program.
Comment A10: One commenter stated
that the definition for ‘‘sabotage’’ should
include a definition of ‘‘security
system’’ that is referenced in the
definition.
Response: The NRC disagrees with the
comment. Security system does not
need to be defined in the definition of
Sabotage. The security system will be
different for each licensee as it is the
system that a licensee uses to protect its
category 1 and category 2 quantities of
radioactive material.
Comment A11: Two commenters
suggested modifications to the
definition for safe haven. Another
commenter noted that the provision
cannot be implemented. The commenter
noted that based on discussions with
military and other Federal institutions,
material shipments could not be
diverted to them under any
circumstances. The commenter
suggested that safe havens be contacted,
confirmed, and identified. The
commenter noted that the licensee and
carrier are capable of determining safe
havens along the route and that past
experience has shown that requesting a
State to identify safe havens has been
fruitless. Two commenters suggested
that the NRC work with the States to
identify potential safe havens and
publish a list with the final rule. One
commenter noted that a licensee does
not need to work with the State to
identify safe havens. Two commenters
noted that the term ‘‘safe haven’’ is
loosely defined by various agencies and
States, and that States do not recognize,
identify, or acknowledge that they have
such sites. Two commenters noted that
DOT removed the term from its
regulations because it could not be
implemented.
Response: The definition for safe
haven has been retained in the final
rule. Licensees, not States, are
responsible for identifying safe havens.
Identification of safe havens has been in
the regulations for spent fuel
transportation for a number of years and
was included in the RAMQC Orders for
transport of category 1 shipments, so it
is not a new concept. If a licensee is
having trouble identifying safe havens
along a route, it may discuss possible
locations with the NRC, State police, or
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the State’s designated contact (usually
State police).
Comment A12: One commenter (a
State) noted that the definition for
temporary job site has a compatibility of
Level B, which requires identical
wording. The commenter noted that this
definition does not meet its definition
which is much more restrictive in that
it limits the amount of time radioactive
material can be used at a temporary job
site. The commenter stated that there
should not be two different definitions
for the same word listed in different
parts of the regulations. Another
commenter stated that the temporary job
site definition would be more
appropriate with a designation of C
instead of B as it would allow States to
be more restrictive.
Response: The NRC agrees with the
comment in part and disagrees in part.
The NRC tries to use the same definition
for terms that are used in more than one
part of the regulations. However, there
are terms that have different meanings
depending on the use. Temporary job
site is defined in both 10 CFR part 34
and part 39 with definitions that are
specific to the part. Since activities that
are covered by both 10 CFR part 34
(radiography) and part 39 (well logging)
may also be subject to 10 CFR part 37
security provisions, the NRC extracted
the common elements of the definitions
for use in 10 CFR part 37. However, the
requirements related to temporary job
sites have been removed from 10 CFR
part 37, and the term is no longer
defined in the rule.
Comment A13: Three commenters
suggested revising the definition of
‘‘Trustworthiness and reliability.’’ One
commenter stated that the definition is
vague and subjective and that use of
subjective terms in the definition such
as ‘‘dependable’’ and ‘‘unreasonable’’
makes it impossible to apply. The
commenter noted that a licensee cannot
ensure that individuals are trustworthy
and reliable and as such do not
constitute an unreasonable risk to
public health and safety. The
commenter requested that concrete and
nonsubjective criteria be provided.
Another commenter requested that the
definition be revised by adding ‘‘or as
provided for in § 37.29’’ to the end of
the definition. One commenter stated
that the definition should be modified
to include characteristics required by
individuals having access to SGI–M.
Response: The NRC disagrees with the
comment. The NRC does not believe
that these terms make it impossible for
licensees to determine trustworthiness
and reliability. The concepts of
dependable and unreasonable were also
contained in the orders. The
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determination is performance based and
provides licensees the flexibility to
develop programs and criteria that they
are comfortable with. The definition in
10 CFR part 37 is consistent with the
definition of the term in 10 CFR part 73.
The NRC does not believe that it is
necessary to add provisions that include
access to SGI. Access to SGI is covered
by 10 CFR part 73. While a licensee may
use the same access authorization
program for determinations for access to
SGI, the licensee may have a separate
program.
Comment A14: One commenter
suggested maintaining the current
interpretation for unescorted access that
an individual having unescorted access
to several less than category 2 quantity
sources which are secured behind their
own physical barrier would not require
inclusion in the trustworthiness and
reliability determination program. The
commenter noted that the rule defines
unescorted access to include
individuals who have access to
sufficient quantities of radioactive
materials such that the individual could
successfully accumulate lesser
quantities of material into a category 1
or category 2 quantity. The commenter
noted that this is a significant change
and would result in a big increase in the
number of individuals who will need
background checks completed or require
very complex source handling
procedures to prevent the ability to
aggregate sources. One commenter
noted that the examples provided in the
Statements of Consideration did not
appear to apply to an individual with
access to multiple licensee facilities
listed on the same license or multiple
separate licenses by the same
organization. The commenter noted that
these persons could aggregate materials
just as easily as if they were at a single
location under one license, but the
security rules would not apply to them.
One commenter stated that the NRC
should reevaluate the need to include
accumulation considerations for access
authorization control.
Response: The NRC has reevaluated
the requirement and has revised the
definition for Unescorted access. All
provisions of the rule now only apply to
licensees that possess an aggregated
quantity of radioactive material that
equals or exceeds the category 2
threshold. The term aggregated contains
the concept of co-location and breach of
a barrier.
Comment A15: One commenter
requested that the NRC add a definition
for master material license to 10 CFR
part 37.
Response: The NRC disagrees with the
comment. Master material license is not
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specifically mentioned anywhere in the
regulations, and the NRC does not
believe that there is a need to mention
it in 10 CFR part 37 as licenses are not
issued under 10 CFR part 37.
Comment A16: One commenter
suggested including a definition for
security plan at least to the extent that
‘security plan’ is meant to encompass a
description of a licensee’s background
investigation process, access control
program, and physical protection
measures with those specific features as
identified elsewhere in the part.
Response: The NRC disagrees with the
comment and does not believe that a
definition of security plan is necessary.
Section 37.43(a) contains the purpose of
the security plan and specifies in
general terms what must be included in
the security plan. A definition would
not add further to the understanding.
Comment A17: One commenter
suggested that a limited exemption be
provided to licensees who consistently
meet the requirements imposed by the
orders. The commenter noted that the
NRC could establish criteria for the
assessment of licensee’s security
programs and if the program was
deemed inadequate, corrective action
could be initiated.
Response: The NRC disagrees with the
comment. The NRC believes that the
requirements in 10 CFR part 37 are
necessary to ensure adequate protection
of category 1 and category 2 quantities
of radioactive material. A licensee can
always ask for relief from a particular
measure and if the NRC agrees that
adequate basis exists and that it is
protective of public health and safety, it
can grant the request.
Comment A18: One commenter, while
supporting the decision to limit the rule
to category 1 and category 2 sources,
noted that not all category 2 sources are
realistically in danger of being tampered
with, particularly in large medical
facilities with exhaustive security
controls in place. The commenter noted
that if a large medical facility’s security
measures are breached, sealed sources
in medical devices are generally not
readily accessible even by technicians
with highly specialized skills and tools.
Two commenters suggested exempting
medical and research facilities from all
of the 10 CFR part 37 requirements
except for the security program or
security plan. The commenters noted
that the public pays for and benefits
from medical and research use of these
sources, and as such, should have a
higher acceptable risk. The commenters
noted that this is similar to the basic
premise behind the patient release
criteria in 10 CFR part 35 (§ 35.75),
generally licensed sources, tritium exit
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16941
signs, and smoke detectors, where the
public can have a higher acceptable risk
for the benefits which the materials
bring them.
Response: The NRC disagrees with the
comment. The category 1 and category
2 quantities of radioactive material
possessed by a medical facility present
the same risk as category 1 and category
2 quantities of radioactive material
possessed by other licensees. Almost
any user could argue that its use
benefits society in some manner. The
comparison to generally-licensed
sources is not applicable, as generally
licensed sources contain less than
category 2 quantities of radioactive
material and are considered safe for use
without additional measures.
Comment A19: One commenter
expressed concern that the source
aggregation changes could cause
additional medical facilities to come
under the rule. The commenter was
opposed to the rule applying to any
facilities beyond those under the orders.
Response: The application of the
source aggregation criteria has not
changed from the orders. The concept of
co-location and breaching of a common
physical barrier are still factors. While
the rule may apply to licensees that
were not subject to a particular order,
the licensee would only be subject to
the requirements if it aggregates the
material. Some licensees that have an
aggregated category 1 quantity may have
only been subject to the Increased
Control Orders and would now be
subject to some additional requirements
under the rule that apply to all licensees
that possess a category 1 quantity of
radioactive material.
Comment A20: Several commenters
expressed concern about the extension
of applicability for the proposed rule
beyond byproduct material licensees to
power reactor, research and test reactor,
and fuel cycle licensees. Commenters
noted that extending the requirements
to large component or radioactive
material storage facilities located on
power reactor plant sites appears
unwarranted. Commenters
recommended limiting the applicability
to exclude material that meet a criterion
for a specific activity, surface
contaminated objects, bulk packages
with mass exceeding 100 pounds or
limit aggregating material to a small
number (fewer than 10) of discrete
sources, and areas where a large number
of packages containing low
concentrations of radionuclides of
interest are stored over a very large area,
because they believe the risk is low and
should not present a security concern.
Commenters recommended that an
appropriate threshold be developed that
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exempts large volume or weight of a
single item or of the aggregated quantity
such that exemption requests are not
necessary and the security provisions of
10 CFR part 37 would not apply.
Commenters noted that such materials
are typically either of such large mass or
volume, or of such a diffuse
constitution, that they should be
considered low risk for any malevolent
purpose. Commenters noted that the
industry is concerned that casting a
wide net will present a situation
whereby certain categories of facilities
are regulated through exemptions.
One commenter suggested that NRC
should consider using dose rates at 1
meter relative to the Appendix I
definitions in IAEA TECDOC–1344 for
other than sealed sources as an
alternative. The commenter noted that
the IAEA document acknowledges that
the categorization system may not be
appropriate for waste management. The
commenter noted that tables in the
document are based primarily on
discrete sealed sources of very high
specific activity and do not apply to
packages in transport. The commenter
further noted that IAEA also
recommends 100 rads (1 Gy) to bone
marrow in 100 hours at 1 meter from
sources that cannot be carried as the
threshold for a ‘‘dangerous’’ source.
With a category 2 source threshold at 10
x D, this also provides a practical
justification for exempting low specific
activity (LSA) materials, as they are
restricted to dose rates of 1 rem/h at 3
meters. Using very restrictive point
source consideration (i.e., an inverse
square relationship), LSA materials
cannot result in dose rates exceeding 10
rads/h at 1 meter. The other
deterministic considerations presented
in the TECDOC are similarly bounded
by the low specific activity of such
wastes.
Commenters noted that there is a
distinct difference between a given
amount of activity confined in a
relatively small sealed source and the
same quantity dispersed around a large
site in numerous containers, none of
which individually contains activity
approaching a category 2 amount.
Commenters noted that low specific
activity material, objects with low levels
of surface contamination, or numerous
small sources would not be attractive for
theft or sabotage because of the disperse
nature of the radioactivity. One
commenter noted that this is recognized
in the transportation arena that allows
use of industrial packages for low
specific activity and surface
contaminated materials versus more
robust Type A or Type B packages for
shipping higher activity materials.
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Commenters noted that the packaging
of the source is relevant to potential
theft and diversion. Commenters
indicated that a quantity of material
where the total activity exceeds a
category 2 level but is dispersed in
contaminated metal and other material
within one or more large concrete and/
or steel containers presents a different
hazard than the same amount in a
relatively small unshielded source.
Commenters noted that large and heavy
containers are difficult to move and
steal without detection and that the
containers themselves are selfprotecting from a sabotage point of
view. The commenter noted that this is
important for licensees engaged in
decommissioning, processing, and
shipping of bulk waste material.
Commenters noted that the volume and
mass required for a category 2 quantity
of material renders theft an incredible
scenario and that damaging and
dispersing a category 2 quantity of
material such that deterministic effects
result from internal or external
exposures are not credible.
Commenters provided examples of:
(1) A commercial waste processor that
could have several thousand packages
in a common storage area, each
containing waste forms of relatively low
specific activity and each with a mass
of several hundred to several thousand
pounds and (2) a radioactive waste
disposal facility that has a 60-car train
of radioactive waste within its
controlled area.
Response: The NRC agrees with the
comment in part. The NRC has
determined that it is appropriate to
include a partial exemption in the
regulation instead of treating
exemptions requests on a case-by-case
basis. Paragraph (c) has been added to
§ 37.11 to address radioactive waste
materials. The provision does require
that some security measures be applied
to the waste, but the majority of the 10
CFR part 37 requirements would not
apply. Measures include the use of
continuous physical barriers, alarmed
locked gates or doors, and assessment
and response of unauthorized entry. The
provision does not include the use of
dose rates, but would cover much of the
low specific activity waste addressed by
the comment.
Comment A21: One commenter felt
that the proposed requirements should
not apply to holders of category 2
sources, particularly since the new
requirements would not apply to the
transshipment of category 1 and
category 2 sources. The commenter
noted that if the Juarez, Goiana and
Mayapuri radioactive material dispersal
incidents all occurred in the United
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States, in a single year, the annualized
risk of premature death would be a
small fraction of the 1E–6 probability
frequently used in establishing
regulatory requirements.
Response: The NRC disagrees with the
comment that the security provisions
should not apply to category 2 sources.
The Commission has determined that
category 2 sources are risk significant
and, therefore, warrant additional
security measures. The NRC does not
regulate transshipments.
Comment A22: One commenter noted
that the scope suggests that 10 CFR part
37 applies to any person who is
authorized to possess or use category 1
or category 2 quantities of radioactive
material at any site or contiguous sites
subject to the control by the licensee.
The commenter pointed out that when
radioactive material is used at
temporary job sites, the licensee will be
in control of the quantities of
radioactive material, but may not
necessarily be in control of the sites.
The commenter also noted that the
scope does not indicate that this applies
to persons who have access to SGI–M
and implies it only applies to those
authorized.
Response: The NRC agrees that the
language may be confusing as it applies
to temporary job sites and has revised
the scope to clarify the intent. The
requirements of 10 CFR part 37 do not
apply to SGI–M. However, some of the
security information developed under
10 CFR part 37 would be considered
SGI–M and needs to be protected in
accordance with 10 CFR part 73. The
requirements for SGI–M are contained
in §§ 73.21 and 73.23.
Comment A23: One commenter stated
that the exemption provided in
§ 37.11(b) for facilities with 10 CFR part
73 security plans should be retained but
offered a suggested revision to clarify
who has inspection/security oversight.
The commenter noted that it would be
a significant paperwork task to keep
records showing compliance with both
sets of controls without a real increase
in the security of either material. The
commenter also noted that it would be
an added inspection burden if the
program required separate inspections
by an Agreement State and the NRC.
The commenter suggested adding a
sentence at the end of the paragraph:
‘‘Although the NRC maintains primary
oversight of these facilities, inspection
by Agreement State representatives is
permitted.’’
Response: The NRC is retaining the
exemption for licensees that possess the
category 1 or category 2 quantities of
radioactive material under an NRC
license. For those licensees located in
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non-Agreement States, the licensee can
choose if it wants to protect the material
under the security plan required by 10
CFR part 73 and approved by the NRC
or protect the material under a 10 CFR
part 37 security plan. If the material is
protected under a 10 CFR part 73
security plan, the licensee’s records
should note that the material is
protected under a 10 CFR part 73
security plan. Any inspection would be
against the security plan under which
the material is protected. For licensees
that are located in an Agreement State
and possess category 1 or category 2
quantities of radioactive material under
an NRC license, the licensee can choose
whether to protect the material under
the 10 CFR part 37 or the required and
approved 10 CFR part 73 security plan.
For licensees that possess the category
1 or category 2 quantities of radioactive
material under an Agreement State
license, it will be up to the Agreement
State to decide if it will allow the
licensee to protect the material under an
NRC-required and approved 10 CFR part
73 security plan. The licensee would
want to discuss this with its State
regulator. Agreement States are not
required to adopt the provision on
exemptions in § 37.11(b) as a matter of
compatibility. As for adding a provision
to allow State personnel to inspect, the
NRC disagrees with the comment. A
new provision is not necessary to allow
an Agreement State to inspect against a
license that it has issued.
Comment A24: One commenter stated
that the NRC should not promulgate the
rule for licensees currently under NRC
274i Security and Fingerprinting Orders
specified in EA–08–225 issued August
29, 2008. The commenter noted that
these licensees are few in number, and
the NRC should continue to regulate
them under the existing orders. The
commenter noted that this should
include possession of certain isotopes
greater than category 1. The commenter
suggested new paragraphs for § 30.34 as
follows: ‘‘30.34(m) Security
requirements for licenses who possess
an individual source less than category
1 but greater than or equal to category
2 of the isotopes listed in Appendix E
to 10 CFR part 20—Nationally Tracked
Sources Thresholds. Licensees or
applicants must submit to NRC for
review and approval of information to
comply with the requirements and time
frames specified in NRC Order EA–07–
305 dated December 5, 2007, and its
attachments titled ‘‘Table 1
Radionuclide of Concern and
Attachment 3 Specific Requirements
Pertaining to Fingerprinting and
Criminal Records Checks’’ which are
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incorporated by reference (or listed in a
new Appendix F of 10 CFR part 30).
This rule is in addition to any other
requirements specified in applicable 10
CFR parts.’’ and ‘‘30.34(n) Licensees
must notify NRC of their intention to
possess an individual source greater
than category 1 of the isotopes listed in
Appendix E to 10 CFR part 20—
Nationally Tracked Sources
Thresholds.’’
Two commenters stated that the
authority to regulate the physical
protection of category 1 and 2 quantities
of material in transit (subpart D) should
not be relinquished to the Agreement
States. The commenter noted that while
the adequacy and compatibility
requirements of Agreement State
programs would require the Agreement
State regulations to be ‘‘essentially
identical’’ to those contained in subpart
D, there are several instances where
Agreement State regulations include
requirements in addition to those found
in the analogous NRC regulations. The
commenter noted that Agreement State
regulations that go beyond those
contained in subpart D could hinder
interstate commerce and result in
additional burden and expense to the
licensees. Another commenter stated
that there is value to Federal
preemption in regulating the
transportation security of category 1 and
category 2 quantities of radioactive
material as this would ensure
uniformity of the administration of the
requirements. One commenter suggested
that the authority be transferred to DOT
and not the States.
Two commenters stated that the NRC
should retain authority for the security
of category 1 licensees under common
defense and security unless the States
are given authority to regulate all
aspects of category 1 sources. The
commenters noted that the rule does not
give the States authority to regulate the
safeguards information and, therefore,
the regulatory authority would be split.
Commenters suggested removing the
SGI designation. One commenter noted
that under Supplementary Information
Item II.(A)(10), it states, ‘‘Although the
NRC relinquishes authority to States for
certain materials, under section 274(m)
of the AEA no such agreement will
affect the authority of the Commission
to take regulatory action to protect the
common defense and security.’’ The
commenter noted that Item 11 states,
‘‘The provisions put in place for the
inspection of licensees that received the
orders issued under common defense
and security would remain in place
until the State implements the
requirements.’’ The commenter stated
that this contradicts Item 19 which
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16943
states the NRC will not enter such
agreement for common defense and
security. The commenter indicated that
category 1 materials must be considered
under the terms of common defense and
security and should remain under NRC
jurisdiction for security. The commenter
noted that the proposed rule states
‘‘licensees who activities are covered
under part 73 would be exempt from
part 37.’’ The commenter stated that
most of the irradiator requirements
(SGI–M) are based in 10 CFR part 73
and therefore indicates that there are no
category 1 licensees that are subject to
State purview. The commenter noted
that there are references to SGI–M in the
proposed rule which further leads to the
need for clarification.
One commenter noted the drafted
document appears to be inconsistent in
this regard and that the issue of
jurisdiction and responsibility for these
licensees must be clearly made and the
necessary inclusions and exclusions to
the rules made accordingly.
Response: The NRC disagrees with the
comment. The NRC believes that it is
appropriate for the Agreement States to
regulate the physical protection of
category 1 and category 2 quantities of
radioactive material. Although some of
the security information is considered to
be SGI–M under 10 CFR part 73, the
NRC does not believe that this prevents
the Agreement States from regulating
the security aspects for those facilities.
While the State could not inspect the
SGI provisions for protection of the
material unless it entered into a 274i
Agreement with the NRC, the State
could inspect and enforce the
provisions of 10 CFR part 37. The
exemption provided in § 37.11 was
intended to only cover facilities that had
a security plan under 10 CFR part 73
and not the information protection
aspects. The NRC has clarified the
exemption. See also the responses to
comments A23, A46, and A47 and the
response to question 10 in Section II.A
of the Statement of Considerations.
Comment A25: One commenter noted
that the rule should adopt the entire
categorization of radioactive sources
from the IAEA Safety Guide No. RS–G–
1.9—Categorization of Radioactive
Sources. The commenter pointed out
that the IAEA Safety Guide provides a
more robust, risk-based categorization of
quantities than the categorization
provided in the proposed rule as it
describes five different categories that
differentiate sources possessed by
various licensees based on quantity as
well as use. The commenter also stated
that the rule should be limited to source
quantities characterized as category 1
and category 2 in the IAEA Safety
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Guide. The commenter noted that the
types of sources used in refineries and
petrochemical plants are considered
category 3 and according to the IAEA
Safety Guide, the types of sources used
in refineries and petrochemical plants
present less risk than the source
quantities in category 1 and 2.
Response: While the NRC agrees that
category 3 sources present less risk
individually than category 2 sources,
the NRC disagrees with the remainder of
the comment. Unlike RS–G–1.9, the
NRC and the IAEA Code of Conduct do
not consider use (e.g., fixed gauges, well
logging, and radiography) in the
determination of source categorization.
Regardless of its intended use, any
category 2 quantity may pose a
significant risk to individuals, society,
and the environment. Additionally, 10
CFR part 37 applies not only to sources,
but also to bulk material. The rule also
addresses aggregation of radioactive
material at or above the category 2
threshold. If several sources are stored
together that individually are
considered to be category 3 sources, but
together form an aggregated category 2
quantity, the attractiveness of the
material as a group would be the same
as if there were only one category 2
source. If the sources used in the
refineries and petrochemical plants are
not aggregated, 10 CFR part 37 would
not apply.
Comment A26: One commenter
indicated that for facilities covered
under the Maritime Transportation
Security Act, the rule would mean
additional burdens, redundancies and
confusion. The commenter
recommended that for facilities
regulated under DHS/DOT Personnel
Surety programs, the rule should allow
a program of reciprocity to reduce
redundancy. The commenter noted that
at National Petrochemical & Refiners
Association (NPRA) member facilities,
the Radiation Safety Officer (RSO) and
technicians have intimate contact with
source holders and the rule would be
best implemented by the RSO and
technicians and not the entire facility
population.
Response: The NRC disagrees that the
rule imposes additional burdens,
redundancies, and confusion. The
Maritime Transportation Security Act,
which amends the Merchant Marine Act
of 1936, establishes a program to ensure
greater security for United States
seaports and provides requirements
pertaining to personnel whose duties
are related to import and export
activities at the ports. Part 37
transportation requirements only apply
to the domestic portion of an import or
export. For an import, the provisions
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would apply once the shipment clears
customs and for exports, up to the point
the shipment crosses the border.
Holders of the TWIC do not need to
undergo fingerprinting and the FBI
criminal history records check again as
§ 37.29 relieves them from the
requirement. However, the individuals
would need to undergo the remaining
elements of the background
investigation.
As for the NPRA member facilities,
the provisions for access authorization
under 10 CFR part 37 would only apply
if the facility allows unescorted access
to category 1 or category 2 quantities of
radioactive material. The licensee
decides who is in charge of the security
program as the regulations do not
specify any specific position.
Comment A27: One commenter asked
for clarification whether the provisions
apply to those licensees authorized to
possess the material or those that
actually possess the material. The
commenter noted that the language
discrepancy occurs throughout the rule
and must be corrected. Another
commenter asked that the requirements
be spelled out separately to avoid
confusion.
Response: The proposed rule
contained some provisions that
pertained to licensees that were
authorized to possess category 1 or
category 2 quantities of radioactive
material. The final rule contains
provisions that apply only to those that
actually possess and aggregate the
material to a category 1 or category 2
quantity.
Comment A28: Some commenters
objected to the need to submit
compliance information. The
commenters felt that this is an
unnecessary burden to both the
licensees who have already
implemented a program and the
regulatory agency. The commenters
noted that the licensees subject to this
part have already been inspected
multiple times and have established a
compliance history, and therefore these
licensees should be exempted from
having to resubmit existing information.
One commenter thought that the
provision was vague as written and
requested clarification that compliance
with the provision would be achieved
by submitting a letter to the NRC
indicating that the licensee has
successfully implemented the program.
One commenter noted that the NRC
must identify in the regulation what
essential elements are to be included
because placing the information in
guidance is unacceptable. One
commenter thought the provisions
should be removed from the rule but if
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retained offered suggested language.
One commenter stated 30 days did not
provide adequate time. Commenters
noted that requiring a licensee to report
compliance was an unnecessary burden
as licensees are expected to comply and
that the normal terms of implementation
for rulemaking are adequate. One
commenter suggested deleting § 37.41(d)
as unnecessary since current
implementation of the Increased Control
Orders is an adequate basis to conclude
the current licensees will transition to
compliance with the new regulations.
Response: The NRC agrees that the
submittal of compliance information is
not needed and has removed the
requirement from the rule. The NRC and
the Agreement States already know
which licensees will need to implement
10 CFR part 37. A provision has been
added in § 37.41 to require a licensee
that has never implemented the orders
or 10 CFR part 37 to notify the NRC 90
days before aggregating material to a
category 1 or category 2 quantity of
radioactive material.
Comment A29: One commenter stated
that in § 30.32 the wording implies the
application must include an affirmation
that the proposed security program
meets the requirements in 10 CFR part
37. The commenter stated that instead
the application should include a
proposal as to how the requirements
will be satisfied and be subject to
evaluation for sufficiency. The
commenter suggested the following
language: ‘‘(1) An application for a
specific license to use, store, or
transport category 1 or category 2
quantities of radioactive material must
include information outlining the
applicant’s security program designed to
satisfy the requirements in part 37 of
this chapter.’’
Response: The NRC has reevaluated
the need for the requirement and has
decided that it is unnecessary. A new
applicant will be evaluated on the need
to implement 10 CFR part 37 as part of
a prelicensing review and inspection. If
the licensee will be aggregating the
material to a category 1 or category 2
quantity of radioactive material, the
licensee will be expected to implement
the provisions of part 37 before
receiving a license.
Comment A30: One commenter noted
that institutions that have aggregated
material may require significant time to
implement the provisions as it will
require a financial investment. The
commenter did not suggest an
appropriate timeframe. Several
commenters noted that 30 days for
implementation was not sufficient for
the changes that need to be made. Two
commenters suggested a 1-year effective
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date. Commenters supported
terminating the orders on the effective
date of the rule to avoid confusion and
noncompliance. One commenter stated
that the rule should be clarified as to the
compliance date and asked what
happens if a licensee is not in
compliance by that date. One
commenter noted that it would be
difficult to comply with the 30-day
timeframe for preparing and
implementing the security plan and
implement the security program at least
90 days before it ‘‘ * * * aggregates
radioactive material to a quantity that
equals or exceeds the category 2
thresholds.’’ The commenter further
noted that work varies significantly
from project to project and that security
plans that are sufficiently robust to be
effective also would vary significantly.
The commenter noted that it is not
possible to prepare or implement a
project-specific security plan without
knowing the details of the project and
that frequently licensees need to
mobilize and initiate work within a
matter of a few days, which would not
be possible if a 90-day advance notice
was required.
Response: The NRC notes that the
proposed rule indicated that the final
rule would be implemented 270 days
after publication in the Federal
Register. The 30-day timeframe was for
the licensee to submit compliance
information. The NRC has removed the
requirement to submit the compliance
information. In addition, the NRC is
providing a 1-year implementation
period for the final rule. This should
allow ample time for licensees to
implement the requirements, including
the development of any new procedures
and the conduct of necessary training.
Agreement States will be given 3 years
from publication of the final rule to
adopt the rule provisions instead of
from the effective date. This will still
provide the States with a 3-year window
to adopt the regulations.
Comment A31: One commenter noted
that its business depends on the ability
to not co-locate or aggregate its
radioactive material and that it manages
its radioactive material through quantity
control and physical separation of
material not in use at any one time. The
commenter noted that, if it was required
to aggregate all of its material, which
includes the standard, returned sources,
sources packed and ready to ship, cell
waste (cell sweep, dust, chips), plus
isotope material, it would be
continuously above the category 2
threshold, and the additional
requirements would be a significant
economic hardship on the company.
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Response: The rule does not require
co-location or aggregation of radioactive
material. If a licensee does not aggregate
the material above a category 2
threshold, the licensee will not need to
implement the provisions of 10 CFR
part 37. The final rule only applies to
those licensees that possess aggregated
quantities at or above the category 2
threshold.
Comment A32: Several commenters
objected to the change from a 3-year
retention period for records to a 5-year
retention period. One of the commenters
believed that the change from the
standard practice where most
documents in the industry have a
mandated 3-year retention period is
redundant and unnecessary and will
add a potential for confusion where
none need exist. One commenter
questioned why there was a need to
keep superseded portions of procedures
and the security plan for 5 years. The
commenter stated that this was an
added burden and does not add to the
security of the material or to the
protection of the health and welfare of
the general public. The commenter also
questioned the need to keep training
records for 5 years stating that it should
be adequate for a licensee to show that
it is conducting annual training and
suggesting a 1-year retention period.
Response: The NRC agrees with the
comment on the retention period and
has changed the record retention period
for most records to 3 years. Safety
records are maintained for 3 years, and
the NRC agrees that there is no benefit
to keeping only the security records for
5 years. There are a few licenses that
have an inspection frequency of 5 years;
however, the majority of the licensees
impacted by 10 CFR part 37 have a 3year inspection frequency. Superseded
procedures and training records are
necessary from an inspection and
enforcement aspect.
Comment A33: One commenter
questioned how long to hold on to the
old security plan once it is updated and
how long the documentation of the
coordination activities is to be
maintained. Another commenter
recommended changing the record
retention period for the security plan so
that the record could be destroyed 5
years after it is no longer needed. The
commenter noted that there was no
value in keeping the security plan once
a licensee was no longer allowed to
possess materials that would require a
security plan.
Response: Section 37.43(a)(4)
specifies that the superseded portions of
the security plan be retained for 3 years
(note the proposed rule specified 5
years). For any record where a retention
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16945
period is not specified, § 37.103
specifies that the record be retained
until the Commission terminates the
license. The NRC has added a retention
period of 3 years for the documentation
records. The NRC agrees with the
comment and has changed § 37.43(a)(4)
to indicate that the security plan must
be retained for 3 years after it is no
longer required.
Comment A34: One commenter
requested clarification in § 37.101 on
the concept of ‘‘safeguards against
tampering with’’ to preclude
unwarranted interpretations during a
regulatory inspection about the
requirements for records. The
commenter offered suggested language
as follows: ‘‘the licensee shall maintain
adequate safeguards against tampering
with and loss of records. The
requirements in § 37.43 for protection of
information are not applicable to this
section.’’ Another commenter
recommended replacing the term
‘‘safeguard’’ with ‘‘protect’’ in § 37.101.
The commenter felt that safeguard
should be only used when referring to
safeguards.
Response: The NRC disagrees with the
comment. The records provision in
§ 37.101 is identical to provisions in
other parts of the regulations. The NRC
is not aware of any issues that have
arisen over interpretation. The
provisions of § 37.43 would apply if the
records were the security plan,
implementing procedures, or the list of
individuals allowed unescorted access.
Comment A35: One commenter stated
that the enforceability in regulations of
records retention for reporting
suspicious activities is unduly
burdensome on the licensee. The
commenter stated that due to the
clandestine nature of reporting
suspicious activities to LLEAs, the
licensee may not have the LLEA’s or
NRC’s fluid responses to these reports
for security reasons and that ongoing
investigations can encompass years, so
the recordkeeping requirement is
inconsistent and can be inconsistent
with other recordkeeping requirements
depending on the incident nature of the
reporting.
Response: The NRC does not
understand the commenter’s concern.
There are no record retention
requirements associated with reporting
suspicious activities. The 30-day written
report is not required for suspicious
activity reporting. The licensee is
required to assess the suspicious
activities and notify the LLEA, only if
the licensee believes it is appropriate to
do so. The licensee is only required to
notify the NRC if the LLEA is notified.
The NRC acknowledges that there is
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some subjectivity involved in
determining what is considered to be
suspicious.
Comment A36: One commenter
questioned who was authorized to
authenticate reproduced records in
§ 37.101.
Response: ‘‘Authorized personnel’’ in
§ 37.101 are those authorized by the
licensee to authenticate duplicated
documents.
Comment A37: In the proposed rule,
the NRC specifically requested comment
on the reporting requirements.
Commenters were requested to provide
information on: (1) Whether the
proposed rule contained the appropriate
items and thresholds to be reported to
the LLEA; (2) whether the proposed rule
contained the appropriate items and
thresholds to be reported to the NRC; (3)
whether suspicious activities should be
reported and if they are reported, what
type of activities should be considered
suspicious; and 4) whether the
timeframe for reporting was appropriate.
Fifteen commenters provided responses
to the specific questions on this subject.
Of those that provided responses to
the questions on the reporting
requirements, the majority agreed that
the reportable items and thresholds
were appropriate, and five commenters
felt the items and/or thresholds should
be changed. One of the commenters
indicated that the NRC and/or FBI
should be notified of any denial for
cause of a request for unescorted access
as this might be domestic intelligence
information of interest to the FBI or
DHS. The commenter also felt that the
NRC/FBI should be notified of activities
determined to be suspect by the LLEA.
Three commenters stated that actual and
attempted theft were appropriate
reportable actions but that suspicious
activities should be removed from the
rule. Of the commenters that supported
reporting of suspicious activities, no
commenter offered suggestions as to
what type of activities should be
considered suspicious. A couple of the
commenters stated that the licensee is
the best judge of what type of activities
would be considered suspicious at its
facility. Other commenters just
suggested that the NRC should provide
guidance to assist the licensee. Most of
the commenters indicated that the
reporting timeframes were appropriate.
One commenter stated that the
timeframes did not allow for a realistic
period of assessment. The commenter
noted that classifying some of these
events will be very subjective and some
may be impossible to distinguish from
events that are not malicious or not
related to a category 1 or category 2
quantity of radioactive material.
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Another commenter stated that a
specific timeframe should be specified
instead of immediate and upon
discovery. The commenter stated that
failure to set specific time limits will
result in delay in implementing the
Federal response framework.
In addition to those that provided
responses to the specific questions,
seven commenters addressed this
subject in their comments. Two
commenters noted that classifying some
of these events will be very subjective
and some are likely to be impossible to
distinguish from events that are not
malicious or are not related to category
1 or category 2 quantities of radioactive
material. The commenters noted that
reasonable persons could interpret the
expectations of the NRC and the details
of a specific event very differently. The
commenters further noted that these
events will require a period of
assessment, and sometimes a lengthy
period of assessment, to determine the
nature of the event and that the
timeframes for reporting do not
anticipate a period of assessment. As an
example the commenters provided the
situation where a discrepancy in the
inventory is discovered without any
evidence of an ‘‘actual theft’’ (e.g., locks
that have been cut), requiring a period
of assessment to determine the nature of
the event. Two commenters stated that
the requirement for sabotage reporting
should be removed. The commenters
noted that it would not be possible for
a licensee to determine the ‘‘intent’’ of
the person causing any damage and
whether his or her ‘‘intent’’ is
malevolent. One commenter noted that
§ 37.57(b) requires NRC notification
when there is ‘‘suspicious’’ activity
related to ‘‘possible’’ theft, sabotage, or
diversion. The commenter stated that it
would only be appropriate to notify the
NRC if the licensee, in conjunction with
the LLEA, determines that there is some
validity to the suspicion. The
commenter noted that the NRC should
encourage open communication
between the licensee and LLEA, and
licensees should feel free to express
even minor concerns, uncertainties, etc.
to LLEAs for their assistance without
having to notify the NRC in each
instance. One commenter agreed with
the reporting requirement for suspicious
activities but noted that it would be
dependent on the licensee’s judgment
based on its circumstances. The
commenter noted that it would be
difficult to quantify what suspicious
activity is ahead of time, and the
licensee should not be second guessed
on whether or not it made this type of
notification. One commenter noted that
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suspicious activities should continue to
be reported on a voluntary basis as it is
very subjective and would be difficult to
enforce. One commenter recommended
defining suspicious activity. One
commenter expressed concern over the
requirement to report suspicious
activities asking how it could be
enforced as individual judgment may
differ as to what constitutes a suspicious
action. The commenter also questioned
why, if the LLEA provides an immediate
assessment and determines that the
event is completely harmless, the NRC
needs to be notified. The commenter
suggested language for § 37.57(b) to
increase the clarity and to allow for
some local interpretation. The suggested
language is as follows: ‘‘The licensee
shall notify the LLEA upon the
discovery, of any security-related events
involving suspicious activity that may
indicate preoperational surveillance,
reconnaissance, or intelligencegathering activities directed against
licensees, or their facilities related to
possible theft, sabotage, or diversion of
category 1 or category 2 quantities of
radioactive material. If the event is not
found to be harmless, the licensee
should notify the NRC’s Operations
Center (301–816–5100) as soon as
possible, but not later than 4 hours, after
notifying the LLEA.’’
Response: The NRC has revised the
reporting requirement to make it clear
the licensee does not need to contact the
LLEA when it has determined that an
alarm was not the result of an attempted
or actual theft, sabotage or diversion.
The NRC does not believe that it is
necessary for the licensee to report to
the NRC the denials for unescorted
access. The NRC has access to the
information during inspections. The
NRC has retained the reporting
requirement for sabotage. If an
individual has caused damage and
placed the radioactive material at risk,
the NRC wants to know regardless of the
individual’s intent. The NRC disagrees
that it is necessary to establish a set
timeframe for reporting attempted theft,
diversion, or sabotage as the
terminology is consistent with other
similar reporting requirements. The
NRC agrees that it is good practice to
have open communication between the
LLEA and the licensee.
On the question of reporting
suspicious activities, the NRC has
decided to retain a requirement on
suspicious activities. The reporting of
suspicious activities is an important
component of evaluating the threat
against licensed facilities and material.
The NRC reviews individual
notifications of suspicious activities to
evaluate whether potential
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preoperational activities (i.e., multiple
events at a single site or multiple events
at multiple sites) may be part of a larger
plan and to integrate this information
with other agencies in the homeland
security and intelligence communities.
The NRC is not requesting that the
licensees actively gather intelligence but
rather that they report information they
believe is relevant to the security of
their facility or activity. The reporting
requirements provide a consistent
means of communicating this
information to the NRC. The
requirement has been revised to require
the licensee to assess suspicious
activities and to only contact the LLEA
if the licensee believes it is appropriate
to do so. The licensee is required to
notify the NRC only if notifying the
LLEA. Some suspicious actions may be
successfully handled by the licensee
without the need to involve law
enforcement or the NRC. The NRC
believes that the revision will provide
the licensee more flexibility in
determining how to address any
situation that involves what might be
considered suspicious activities. The
NRC does recognize that what is
considered to be suspicious is subjective
and not all licensees will handle the
same situation in the same way. On
balance, the NRC believes that it will
receive information on the more serious
instances, but not the trivial instances.
Comment A38: One commenter noted
that in the absence of any suspicious or
known mitigating factors, it has
typically given the carrier 24 hours to
trace within their transportation cycle,
before the package is declared as lost or
missing. The commenter noted that this
has proven to be the most effective time
period and that anything less than the
24 hours does not allow sufficient time
for the carrier to do a complete
document and tracking search and/or a
physical search at potential locations.
The commenter noted that to declare the
package as lost or missing before that
will result in many false positives, as
99.99% of the time the package is
located within the 24-hour window
which will result in significant
resources of both the regulatory agencies
and licensees involved, trying to get
useful information that just isn’t
available.
Response: Part 37 requirements would
not change this practice. The reporting
requirement in § 37.81(b) is similar to
the requirement from the orders. The
licensee is not required to notify the
NRC when the material has not arrived
by the no-later-than arrival time, rather
it is to notify the NRC once it has been
determined that the material is lost or
missing. This allows some time for
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investigation before the first phone call
to the NRC. Similar to the order
requirement, the licensee is required to
notify the NRC a second time if the
material is still missing after 24 hours of
investigating. The rule should not result
in a change in practice and in fact gives
the licensee additional time before
starting an investigation.
Comment A39: Several commenters
requested information on how diversion
differs from a theft as in both cases the
material is removed and the movement
is unauthorized. The commenters felt
that the requirements for reporting
diversion and suspicious activities were
subjective and that the NRC’s
expectations concerning diversion and
suspicious activities were not clear.
Response: Diversion means the
unauthorized movement of radioactive
material subject to this part to a location
different from the material’s authorized
destination inside or outside of the site
at which the material is used or stored.
As an example, a source purchased
using a legitimate license may be
shipped to an unauthorized location.
Diversion does not require the adversary
to defeat the licensee’s physical security
system. Theft is the act of taking
material from a facility, vehicle, or
temporary job site and requires the
adversary to defeat the licensee’s
physical security system.
What constitutes a suspicious activity
can be subjective and may vary from
one licensee to another. Examples of
suspicious activities are provided in the
guidance. The reporting of suspicious
activities is an important component of
evaluating the threat against licensed
facilities and material. The NRC reviews
individual notifications of suspicious
activities to evaluate whether potential
preoperational activities (i.e., multiple
events at a single site or multiple events
at multiple sites) may be part of a larger
plan and to integrate this information
with other agencies in the homeland
security and intelligence communities.
The NRC is not requesting that the
licensees actively gather intelligence,
but rather that they report information
they believe is relevant to the security
of their facility or activity. The reporting
requirements provide a consistent
means of communicating this
information to the NRC.
Comment A40: One commenter
recommended placing the reporting
requirements in §§ 37.57 and 37.81 in
subpart M of 10 CFR part 20 to avoid
duplicative regulations. The commenter
stated that the notifications in § 37.81
should be the same as 10 CFR part 20
and should be immediately after
discovery, but only after initially
notifying the LLEA. The commenter
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16947
noted that immediate notifications of
theft should be made to the LLEA, not
as soon as possible as the proposed rule
would allow. Another commenter noted
that the reporting requirements should
be consistent to ensure that multiple
reports for the same event are not an
unintended consequence.
Response: The NRC disagrees with the
need to move the 10 CFR part 37
reporting requirements to 10 CFR part
20. The NRC has revised § 20.2201(c) to
include a reference to 10 CFR part 37 so
that duplicative reports are not required.
The NRC disagrees with the comment to
change as soon as possible to immediate
in § 37.81(c) and (d). The historic
interpretation of immediate reporting
has been up to 4 hours. The NRC does
not believe that 4 hours is the
appropriate timeframe for the
notification; notifications need to be
made promptly. For this reason, the
NRC has used ‘‘as soon as possible’’ in
both the orders and the rule language.
Comment A41: One commenter
questioned the difference between the
requirements to report no later than 4
hours after the discovery of any actual
theft or diversion in § 37.57 and the
requirement in § 37.81 to report within
1 hour of lost or missing material.
Response: Under § 37.57, the licensee
is to immediately notify the LLEA and
then to contact the NRC as soon as
possible. If contacting the NRC would
somehow interfere with or delay the
LLEA response, the licensee can take up
to 4 hours to notify the NRC. The LLEA
would be in charge of any response as
the occurrence was at a fixed location.
It is the NRC’s expectation that the
notification would occur very quickly
after the LLEA is notified. Under
§ 37.81, the licensee is required to
contact the NRC within 1 hour because
the NRC may need to initiate a response
as the occurrence was during transit.
Comment A42: One commenter noted
that the rule should not require the
licensee to provide a copy of the reports
required under § 37.81(g) to the Office of
Nuclear Security and Incident Response
(NSIR). The commenter believes that the
NRC should provide the copy to NSIR.
One commenter recommended that the
written follow-up report for event
reporting be submitted within 60 days
instead of 30 days. The commenter
noted that 30 days is insufficient time
for licensees to complete an
investigation, prepare, and submit a
written report and that the 30 days is
inconsistent with the timeframe for
submittal of written follow-up reports
that are required elsewhere in 10 CFR
Chapter I. One commenter objected to
the wording of the requirement in
§ 37.81(g) to ‘‘include sufficient
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information for NRC analysis and
evaluation’’ as it is too open-ended and
the commenter felt that further
explanation is necessary. The
commenter stated that the NRC is doing
a disservice to licensees if it wishes to
claim that such items are difficult or
impossible to predict for all cases or
would be more fully addressed in
guidance.
Response: The NRC agrees with the
comment in part and disagrees with the
comment in part. The NRC often
specifies that a copy of a report should
be submitted to a specific office and
does not believe that it presents a large
burden on the licensee. While some of
the follow-up reports contained in Title
10 Chapter I are submitted within 60
days, some are submitted within 30
days. The 30-day timeframe for a
written follow-up report is consistent
with the requirement for the follow-up
report for reporting lost and missing
material contained in 10 CFR part 20. If
the investigation is not complete, a final
report can be submitted upon
completion. The NRC agrees with the
comment on sufficient information and
has added language similar to the
provisions in § 20.2201(b).
Comment A43: One commenter
requested that a subsection be added to
§ 37.57 to clarify requirements for
reporting by a licensee or permittee
under a master materials license that
has an onsite LLEA in order to preclude
unwarranted interpretations during a
regulatory inspection about reporting to
NRC. The commenter offered suggested
language as follows: ‘‘(d) For a licensee
or permittee under a master materials
license with an on-site LLEA, reporting
in this subsection is required only after
the on-site LLEA has confirmed the
attempted, actual, or actual activity
related to theft, sabotage, or diversion of
category 1 or category 2 quantities of
radioactive material.’’
Response: The NRC disagrees with the
comment. The reporting requirements
remain the same whether the LLEA is
on site or off site. The NRC does note
that the LLEA does not need to be
contacted until after the licensee has
assessed the situation. The LLEA needs
to be notified only if the licensee has
determined that an attempted or actual
theft, diversion, or sabotage act has
occurred or is taking place, or, as
appropriate, if the licensee has
identified suspicious activities.
Comment A44: One commenter
recommended defining substantive
information in § 37.81(h). The
commenter noted that the term
substantive information indicated a
higher priority notification than 30
days.
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Response: The NRC disagrees with the
comment. The provision is identical to
the provision in § 20.2201(d). A licensee
should use judgment on whether the
information should be provided sooner
than 30 days.
Comment A45: One commenter stated
that certain provisions of the proposed
rule would be matters of mandatory
compatibility between the NRC and the
Agreement States. The commenter
stated that the NRC has no statutory
basis requiring an Agreement State to
maintain regulations compatible with
those of the Commission. The
commenter believes that the
Commission may request compatibility
by the State, but cannot require it.
Response: Section 274, ‘‘Cooperation
with States,’’ of the AEA provides for
cooperation with States, authorizing the
Commission to enter into Agreements
with States for certain materials
provided that certain conditions are
met. Two specific sections of the AEA
provide for compatibility requirements:
(1) Subsection 274d. gives the
Commission the authority to enter into
an Agreement with a State if the
Commission finds that the State
program is compatible with the
Commission’s program for regulation of
such materials (subsection 274d(2); and
(2) under subsection 274g. of the AEA,
the Commission is authorized and
directed to cooperate with the States in
the formulation of standards for
protection against hazards of radiation
to assure that the State and Commission
programs for protection against hazards
of radiation will be coordinated and
compatible.
In the Commission’s policy statement,
‘‘Policy Statement on Adequacy and
Compatibility’’ (62 FR 46517; September
3, 1997), the Commission addressed a
similar comment. At that time, it was
the Commission’s view that, pursuant to
section 274, an Agreement State’s
program should be compatible with
NRC’s program for the duration of the
Agreement for the following reasons, set
forth in the policy statement:
Subsection 274g. authorizes and directs the
Commission to cooperate with the States in
the formulation of radiation protection
standards ‘‘to assure that the State and
Commission programs for the protection
against hazards of radiation will be
coordinated and compatible.’’ This provision
demonstrates Congress’ intention that the
compatibility between the NRC and
Agreement State programs should be
maintained on a continuing basis.
Subsection 274j.(1) calls on the
Commission to suspend or terminate an
Agreement State’s program if ‘‘the State has
not complied with one or more of the
requirements’’ of Section 274. The
Commission believes that this phrase ‘‘one or
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more of the requirements,’’ encompasses all
requirements of Section 274, including the
requirement for compatibility in Subsection
274(g).
Under Subsection 274d.(2), the
Commission is authorized to enter into an
agreement with a State if the Commission
makes both requisite findings that the State
program is compatible with the NRC’s
program and adequate to protect public
health and safety. Absent a continuing
compatibility requirement, an Agreement
State could divert from having a compatible
program the day after any agreement is
signed with NRC. This would render the
Commission’s initial compatibility finding
required by Subsection 274d.(2) meaningless.
In addition, the NRC has an
obligation, pursuant to section 274j. of
the AEA, to periodically review existing
Agreement State programs to ensure
continued adequacy and compatibility.
Section 274j. of the AEA also provides
that the NRC may terminate or suspend
all or part of its agreement with a State
if the Commission finds that such
termination is necessary to protect
public health and safety or that the State
has not complied with the provisions of
section 274j. In fulfilling this statutory
responsibility, NRC provides oversight
of Agreement State radiation control
programs to ensure that they are
adequate and compatible prior to
entrance into a section 274b. agreement
and that they continue to be adequate
and compatible after an agreement is
effective. The NRC, in cooperation with
the Agreement States, established and
implements a performance evaluation
program to provide NRC and Agreement
State management with systematic,
integrated, and reliable evaluations of
the strengths and weaknesses of their
respective radiation control programs
and identification of areas needing
improvement, the Integrated Materials
Performance Evaluation Program
(IMPEP).
There have been no changes to the
AEA or to Commission policy that
would render a different interpretation
of these sections of the AEA. Therefore,
no changes were made to the rule in
response to this comment.
Comment A46: Two commenters
stated that it was unclear if the rule can
be implemented under a public health
and safety basis. The commenters noted
that the performance objective in
§ 37.21(b) is to prevent an unreasonable
risk to public health and safety or the
common defense and security, but that
the basis for the rule is health and safety
and not common defense and security.
Response: This rule can be
implemented under the NRC’s authority
to protect the public health and safety.
The rule amends NRC’s regulations to
impose security requirements for the
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use of category 1 and category 2
quantities of radioactive material. The
proposed security requirements set forth
the objectives and minimum
requirements that licensees must meet
to protect against theft or diversion of
category 1 or category 2 quantities of
radioactive material. Accordingly, these
requirements increase the protection of
the public from harm resulting from the
unauthorized use of these materials.
As discussed in the Statements of
Consideration for the proposed rule (75
FR 33902, 33907 (June 15, 2010)), when
regulations such as these address both
the NRC’s public health and safety and
common defense and security missions,
the operative question is whether NRC
oversight is necessary to fulfill the
common defense and security aspects of
the regulations. The NRC believes that
the Agreement States can consistently
and adequately implement the physical
protection requirements, and as such,
there is no need for independent NRC
action to protect the common defense
and security. However, the NRC retains
the authority under section 274(m) of
the AEA to take any necessary actions
for protection of common defense and
security should individual licensees or
the State program develop issues
requiring immediate action.
Implementing these regulations under
the NRC’s public health and safety
authority avoids potential complications
with licensees being subject to dual
regulatory authorities for a single
license. Agreement States can impose
these security requirements because
they provide a reasonable assurance of
preventing the theft or diversion of
category 1 and category 2 quantities of
radioactive material that has a potential
to result in significant adverse health
impacts and reasonably constitutes a
threat to public health and safety. In
addition, making these requirements
applicable to Agreement State licensees
through the Agreement State Program
allows Agreement States to impose
these requirements on its licensees and
makes Agreement States responsible for
enforcement of these requirements on
its licensees.
Comment A47: One commenter noted
that while the NRC has regular oversight
of individual Agreement State programs
through its Integrated Materials
Performance Evaluation Program
(IMPEP), the NRC should evaluate its
authority under IMPEP against the
authority granted to the Secretary of
Transportation under U.S.C. Title 49
Section 5125—Preemption. Prior to
relinquishing its regulatory authority to
the Agreement State, the NRC should
ensure that it is authorized and capable
of preempting an Agreement State
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regulation pertaining to the physical
protection in transit of category 1 and
category 2 quantities of radioactive
materials if the Agreement State
regulation does not comply with the
general criteria provided in 49 U.S.C.
5125. The commenter stated that if the
NRC concludes that it is indeed
appropriate for the Agreement States to
regulate the physical protection of
category 1 and 2 quantities of
radioactive material while in transit
then a mechanism has to be in place to
ensure these Agreement State
regulations cannot add requirements in
addition to those provided in 10 CFR
part 37.
Response: The NRC in its Policy
Statement on Criteria for Guidance of
State and NRC in Discontinuance of
NRC Regulatory Authority and
Assumption Thereof by States Through
Agreement, developed criteria to
implement the Agreement State
program, authorized by Public Law 86–
373 which was enacted in the form of
a new section to the AEA (section 274)
and approved by the President on
September 23, 1959 (46 FR 7540–7546;
January 23, 1981). Criterion 10 of the
Policy Statement, Regulations
Governing Shipment of Radioactive
Materials, provides that the State shall
to the extent of its jurisdiction
promulgate regulations applicable to the
shipment of radioactive materials, such
regulations to be compatible with those
established by the U.S. Department of
Transportation and other agencies of the
United States whose jurisdiction over
interstate shipment of such materials
necessarily continues. Therefore, State
regulations regarding transportation of
radioactive materials must be
compatible with 10 CFR part 71.
The NRC believes that it is indeed
appropriate for the Agreement States to
regulate the physical protection of
category 1 and category 2 quantities of
radioactive material while in transit
under the provisions of the 274b.
Agreements and the continued oversight
provided by the NRC. Many of the
transportation requirements fall within
the Compatibility Category B, Program
Elements with Significant
Transboundary Implications. Agreement
State program elements under
Compatibility Category B should be
essentially identical to those of the NRC.
The NRC evaluates these program
elements under IMPEP and can take
actions when a State has a program that
is not compatible including termination
or suspension of an agreement. We
believe that this mechanism
appropriately addresses the concern that
a mechanism be in place to address the
scenario of Agreement State regulations,
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16949
adding requirements beyond those
provided in 10 CFR part 37 where the
additional requirements would not meet
the compatibility designation for a given
provision.
Comment A48: Numerous
commenters stated that the
requirements created too much burden
with little, if any, improvement in
security and are not necessary or
justified and are a waste of taxpayer
money. Some commenters felt that the
requirements were not commensurate
with the risk of the material and were
unnecessarily complex, complicated,
and long. Some commenters noted that
there were no quantifiable benefits, only
qualitative benefits and, therefore, there
is no evidence that additional measures
are necessary. One commenter noted
that there must be a balance between the
real benefit of providing the services
that the category 1 and category 2
sources provide, against a hypothetical
malevolent act that may involve one of
these sources. Some commenters felt
that implementation of the new
requirements would financially cripple
small companies and would limit
funding for new, safer technologies.
Some commenters indicated that the
burden could result in some medical
facilities not offering radiation therapy
services, a reduction in research, and
will negatively impact patient care. One
commenter was of the opinion that the
number of licensees would drop by 25
to 30 percent. Commenters felt that the
original order requirements are adequate
and should be maintained with no
additions as they were sufficient to
ensure security. Commenters felt that
additional requirements should be
based on documented deficiencies in
the orders and not on the very low
likelihood of a terrorist event. One
commenter noted that inspections
insure that licensees are performing
operations in such a manner as to meet
regulatory requirements as they stand.
One commenter noted that the NRC has
not conducted a national performancebased assessment of the current orders.
Commenters stated that the rule was
overly prescriptive. Several commenters
stated that the requirements should be
graded for different types of facilities
and material and fixed versus portable
material. Some commenters felt that the
NRC has lost touch with the way the
industry operates or wouldn’t suggest
unnecessary changes.
Commenters noted that monetary
burden of compliance with the orders
has required industry to reduce the
amount of resources allocated for other
aspects of its business and has made it
challenging to compete in the global
market. Some commenters expressed
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concern over the cumulative impact
noting the implementation of the
National Source Tracking System and
the license verification system. One
commenter noted that it wasn’t just the
initial outlay, but also the annual
burden that needed to be considered.
One commenter noted that the rule
would impact licensees who have
previously not been impacted by the
orders. The commenter noted that
educating and inspecting these new
licensees will impact the NRC staff
resources, and could diminish their
focus on ensuring security compliance
for existing category 1 and category 2
sources. One commenter noted that the
rule would be burdensome on the
regulatory agency and LLEAs, as well as
licensees.
One commenter suggested placing
generic requirements in the rule and
then address subsets of licensees in the
NUREG–1556 series. One commenter
suggested that the proposed rule should
be renoticed after making changes with
more detail provided as to the actual
safety and security benefits to be
obtained. One commenter noted that the
rule does not conform to the recent draft
policy statement on the Protection of Cs137 Chloride sources.
Response: The NRC understands the
concerns of the commenters and has
tried to limit the burden while
continuing to ensure the adequate safety
and security of sources of concern. The
security orders were issued based on the
specific knowledge and information
available to the Commission at the time
the orders were issued. The NRC never
intended to simply make generically
applicable security requirements
identical to the orders. The NRC always
intended to consider insights gained
from the implementation of the orders
and implementation of the inspection
program, as well as other factors. A
number of changes have been made
based on specific public comment. The
result of these rule changes significantly
reduces the burden of the final rule as
compared to the proposed rule. The
NRC believes that the provisions in the
final rule are necessary to protect the
public health and safety and ensure
security. There could be some facilities
impacted by the rule that were not
impacted by the orders. Some facilities,
such as reactors and fuel facilities, may
be impacted by 10 CFR part 37. There
should not be any byproduct material
facilities newly impacted by 10 CFR
part 37 that were not impacted by the
orders.
Comment A49: A couple of
commenters stated that the NRC should
only include the order provisions in the
rule and then start work on developing
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a strategic rulemaking, which may need
to include changes in legislative
authority, to develop a 10 CFR part 37
with a more risk-informed and
performance-based model. The
commenters noted that this effort
should include evaluating requirements
for different types and quantities of
radioactive material and different uses,
working with States and law
enforcement groups to determine
effective ways to transport material and
working with law enforcement groups to
determine effective ways that an LLEA
can know and provide emergency
response support to licensees. Another
commenter suggested using subparts
based on the type of business and
security risks commensurate with each
type. One commenter noted that the
two-part approach would be a major
accomplishment for the NRC and would
be consistent with NRC’s ‘‘Principles of
Good Regulation.’’ The commenter
noted that this approach would reflect
the Commission’s Staff Requirements
Memorandum (SRM) on the draft policy
statement on the protection of Cesium137 Chloride sources (SRM for
COMSECY–09–0029) which states: ‘‘any
additional efforts to enhance security for
these sources should consider whether
there are benefits of further risk
reduction given the NRC’s actions to
date and the current threat
environment.’’
Response: It was never the NRC’s
intent to include in the rulemaking only
the order provisions. While there are
differences from the orders, the NRC
believes that the requirements contained
in the final rule are necessary. As a
general principle, the NRC prefers to
construct performance-based regulation
rather than explicit, prescriptive
regulation where possible. The rule does
not dictate what measures each licensee
must use to protect the radioactive
materials under its possession and
control, rather the rule allows the
licensee to choose those measures that
best meet its needs. The NRC believes
that the rule is risk informed and
contains an optimized mix of
performance-based and prescriptive
requirements. A two-step process to
conduct two rulemakings would be a
waste of not only to the NRC and
Agreement State resources but also
those of licensees. The basic
requirements in the orders were the
same for all licensees. The NRC is aware
of the areas that need enhancements and
these areas are addressed in the rule.
The NRC did add a new option to the
regulatory analysis for the final rule that
addresses only including the order
provisions in the rule.
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Comment A50: One commenter stated
that the total cost of the 10 CFR part 37
revision should include the costs that
the licensees incurred to meet the orders
and that the estimate and burden on
licensees is out of proportion to the
actual risk. Another commenter stated
that the option 1 cost analysis was
inappropriate because it assumed no
security measures had been
implemented, and it should have
considered that the orders were in
place. The commenter stated that an
additional cost option determining the
cost of implementing a new 10 CFR part
37 with requirements equivalent to the
orders would be helpful. Several
commenters stated that the cost
estimates were underestimated but did
not offer better cost estimates. One
commenter stated that the annual
recurring licensee cost was
underestimated by at least a factor of 2.
One commenter estimated that it would
cost about $30,000 to implement the
provisions and about $20,000 every year
to maintain the plan and that the
reinvestigation would cost between
$10,000 and $20,000 depending on the
number of users that need to be
rechecked. One commenter noted that
the regulatory analysis did not
specifically describe the average
licensee on which the analysis is based.
One commenter (a research facility)
noted that it would need to process an
additional 60 individuals per year and
that the rule would cost approximately
$23,000 per year and an initial outlay of
$30,000. One commenter noted that it
had added one additional employee to
address the order requirements and that
the rule would add yet more burden.
One commenter stated that the
regulatory analysis does not provide any
technical data to support the statement
that the qualitative benefits outweigh
the costs of the rule. One commenter
noted that a major medical facility could
have hundreds of individuals in its
access authorization program. One
commenter noted that it had spent about
$250,000 on physical site upgrades
alone and has recurring costs of $50,000
annually for the alarm system to support
the existing orders. One commenter
stated that it spends approximately
$100,000 a year for the transportation of
category 1 and category 2 sources under
the orders. The commenter noted that
the amount of employee resources to
implement and support the orders has
been approximately 400 man days
initially and 75 man days annually with
total costs to date of approximately $1.5
million. The commenter estimated that
to implement the additional
requirements in the rule, it would cost
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$250,000 initially which includes 100
man days to set up all the programs and
procedures and an ongoing annual cost
of $100,000 to $200,000 for hiring at
least one to two individuals as a
technical/administrative resource to
implement all the procedural and
documentation requirements. The
commenter stated that the costs
assumed in the regulatory analysis
($25,000 initially and $27,000 annually)
to be substantially underestimated.
Some commenters noted that the
regulatory analysis did not identify any
quantifiable values and that the
qualitative benefits were identical to the
program in place today. One commenter
noted that National Nuclear Security
Agency (NNSA) is spending $26 million
to implement voluntary enhancements
at certain facilities. One commenter
noted that it was not clear that NRC had
considered the potential impacts to
licensee safety programs, research, and
an increase in disused sources due to
’’deteriorating financial circumstances’’
(mentioned in SECY 10–0164) that may
result from the rulemaking.
Response: The NRC appreciates the
information provided on cost and
considered that information when
estimating the costs in the final
regulatory analysis, increasing the
annual cost of implementing the
measures, increasing the number of
individuals requiring a background
investigation, and using different values
for a small, medium, and large facility.
The regulatory analysis prepared to
support the proposed rule did contain
the cost information on the orders. As
the cost has already been expended, it
is considered a sunk cost and is not
included in the main analysis. The cost
is provided for informational purposes.
Many attributes considered in a
regulatory analysis can only be
expressed in a qualitative way and
cannot be quantified. Differences in
quality cannot be easily assessed or
expressed. While it is possible that some
licensees may decide to go out of
business and there could be additional
disused sources, the NRC is not able to
predict how many, if any, companies
might decide to go out of business.
Comment A51: One commenter noted
that the regulatory analysis and
regulatory flexibility analysis did not
reflect the actual number of licensees
impacted (closer to 2,900) versus the
number actually implementing the
orders (about 1,400).
Response: The regulatory analysis did
reflect the 2,950 licensees that would be
impacted by the proposed rule. Section
3.2.3 lays out the assumptions used in
the analysis. The analysis assumed that
1,400 licensees would need to fully
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implement the security provisions and
that another 1,550 licensees would need
to conduct some activities. The
commenter is correct that the regulatory
flexibility analysis only addressed those
that fully implemented the provisions.
Comment A52: Two commenters
noted that the regulatory analysis does
not address how harmonization between
the NRC proposed rule and eventual
Agreement State regulations will be
assured; specifically in regards to the
requirements contained in subpart D.
The commenter noted that
inconsistencies between Agreement
State transport security requirements
could greatly hinder the ability to
transport category 1 and 2 quantities of
radioactive materials in commerce and
could also serve as barriers to
transporting category 1 and 2 quantities
of materials through an Agreement
State. The commenter noted that it is
also unclear if the NRC considered what
fees Agreement States may impose to
fund the cost of regulating the physical
protection of material in transit. The
commenter noted that the State of Iowa
currently has what Industry considers
excessive fees to transport category 1
quantities of materials through the State.
Response: The commenter is correct
that harmonization of the requirements
between the NRC and the Agreement
States is not addressed in the regulatory
analysis; the cost for the States to adopt
the regulations is addressed. The final
rule is a matter of compatibility between
the NRC and the Agreement States. The
NRC analyzed the final rule in
accordance with the procedure
established within Part III,
‘‘Categorization Process for NRC
Program Elements,’’ of Handbook 5.9 to
Management Directive 5.9, ‘‘Adequacy
and Compatibility of Agreement State
Programs.’’ Most of the provisions in
subpart D are Compatibility Category B
because there are significant
transboundary implications. The
Agreement States must adopt Category B
program elements in an essentially
identical manner. The Agreement States
do have 3 years to adopt the regulations.
For transportation of category 1
quantities of radioactive material, an
Agreement State licensee will continue
to follow the NRC order on
transportation until the State adopts the
regulation. The order would then be
withdrawn and the transportation
would occur under the Agreement
States’ regulations. For category 2
shipments, an Agreement State licensee
will follow the Increased Control
provisions on transportation until the
State adopts the regulations. As for the
fees that a State may charge, the NRC
does not have any control as this is not
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a matter of compatibility. A State could
choose to charge a fee whether the
transport occurred under NRC or State
requirements. The fees aspect is beyond
the scope of this rulemaking.
Comment A53: One commenter noted
that because Agreement States have 3
years to adopt regulations compatible
with the final rule, provisions need to
be made so licensees with both NRC and
Agreement State licenses who modify
their programs to comply with the NRC
requirements are not cited as
noncompliant with the Agreement State
license.
Response: A licensee must be in
compliance with the regulations for the
jurisdiction in which it operates. Part 37
is no different than any other regulation
in that regard. A licensee that has
implemented the 10 CFR part 37
requirements should be in compliance
with the majority of the provisions in
the orders. The licensee can have
discussions with its Agreement State
regulator about adopting the provisions
before the State has issued compatible
requirements.
Comment A54: One commenter
addressed the questions related to small
businesses. The commenter indicated
that the rule needs to be more risk
informed and better recognize the actual
risk associated with category 2 sources
by providing more flexibility. The
commenter indicated that the annual
risk from a category 2 radioactive
material dispersal device is between
10,000 and 100,000 times less likely
than many other sources of premature
death that the United States population
commonly accepts from smoking,
obesity, medical accidents, and auto
accidents.
Response: The Commission has
determined that category 1 and category
2 quantities of radioactive material
warrant additional security measures. In
addition, the Radiation Source
Protection and Security Task Force
found that the category 1 and category
2 quantities warrant enhanced security
and protection. See also QA5 and QA6
in Section II of this document.
Comment A55: Two commenters
provided input on the specific questions
related to information collection. On the
question of whether the proposed
information collection is necessary for
the proper performance of the functions
of the NRC and the information has
practical utility, one commenter agreed
with the need for signed consent but
questioned the usefulness of the credit
history review and the FBI criminal
history records check. The commenter
agreed that a licensee needs to have an
individual’s employment and education
history, but questioned the need to
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require the individual to provide the
information multiple times if the
licensee already has the information in
the individual’s employment record.
The commenter did not address the
utility of any other aspects of the
information collection. Two
commenters did not agree with the
burden estimate. One commenter stated
that the estimate of the number of
individuals who would need to have a
background investigation was low; but
provided no other estimates. The
commenter also indicated that the cost
of the background investigation was
underestimated, and estimated that a
background check would cost from $60
to $250 and higher. The commenter
noted that it would take licensee
personnel 10 hours to gather, submit,
and review background information for
a normal background check, to more
than 20 hours if the individual had
resided in multiple State and foreign
jurisdictions. The commenter estimated
that it would take an individual 2 hours
to complete a personal disclosure
history, and that this was not included
in the analysis. The commenter noted
that a licensee would have to develop a
compliance program required by the
Fair Credit Reporting Act to obtain
credit history and arrest records. A
second commenter stated that the
current labor rate for nonroutine
technical support is $149 per hour. The
commenter stated that first-year
implementation would be about 320
hours, or $47,000 and about $30,000 a
year thereafter. On the question of
whether the burden of the information
collection could be minimized, one
commenter noted that a more prudent
and efficient method of checking
background and overall status of an
employee is to use the federal database
‘‘E-verify.’’ The commenter stated that
the NRC could rely on the E-verify
check as one of the background check
tools for a licensee’s access
authorization program. The commenter
also requested that guidance be given on
FBI criminal background reports to
assist a licensee’s understanding of what
the information in the report means.
Response: The NRC notes that the FBI
criminal history records check is
required by the EPAct. The NRC has
removed the requirement for a credit
history evaluation as part of the
background investigation. See response
to Comment B67 for further discussion
on credit history. There is no
requirement for an individual to provide
employment and education history
multiple times. If the licensee already
has that information, it does not need to
go back to an individual to obtain the
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information a second time. Effort for the
personal history disclosure was not
included because it was viewed as
information that would be provided
when seeking employment and
completing an application for
employment. The information on cost
and time was factored into the
regulatory analysis for the final rule. As
for the E-verify system, a licensee may
use it as one tool for completing a
background investigation, but use of Everify alone would not meet the
requirements for the background
investigation. Guidance on the
background investigation is available in
the implementation guidance.
Comment A56: Commenters requested
guidance for various provisions of the
rule, noting that the guidance was
necessary for both the licensees and the
regulatory agency. Commenters were
specifically interested in guidance for
both the determination on the reviewing
official that would be used by the
regulator and for the determination for
those to be allowed unescorted access to
the material that could be used by the
reviewing official. Commenters felt that
the lack of criteria or guidance will
result in inconsistent approval or denial
of the individuals. Commenters noted
that compliance determinations are
performance based and that the
regulatory agency would have no
recourse but to deem a licensee’s
determination appropriate as long as the
licensee documented the basis. Several
commenters agreed that licensees
should be allowed flexibility in
conducting the background reviews.
One commenter suggested that the NRC
should review 49 CFR 73.8 for specific
guidance for denying an individual
access.
Response: Guidance on the rule is
available in the document
‘‘Implementation Guidance for 10 CFR
part 37 Physical Protection of Byproduct
Material Category 1 and Category 2
Quantities of Radioactive Material,’’
which will be published at
approximately the same time as this
final rule. Guidance on what should be
considered in evaluating the results
from the background investigation is in
the document. The document does not
contain a checklist, but provides general
guidelines for making the determination
on whether to grant an individual
unescorted access. The determination
basis is performance based; each
licensee is responsible for making its
own determination. Under the orders,
the trustworthiness and reliability
official made the determinations of who
was granted access and that official is
now called the reviewing official.
Although there will be additional
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factors to consider, the decision-making
responsibility remains unchanged.
Comment A57: One commenter stated
that the sections for the Paperwork
Reduction Act Statement and
Regulatory Flexibility Certification do
not appear to have included pool
irradiator and manufacturer/distributor
licensees with category 1 quantities of
radioactive material in their scope, and
the documents will need to be
augmented.
Response: Pool irradiator and
manufacturer/distributor licensees were
included in the analysis conducted for
the Paperwork Reduction Act Statement
and the Regulatory Flexibility
Certification.
B. Access Authorization Program
Comment B1: One commenter stated
that § 37.21(a) did not address the
requirements for currently approved
access authorization programs or the
actions that must be taken by the
licensee within a specific timeframe.
Another commenter noted that it was
not clear what licensees that
implemented the orders needed to do.
Response: The NRC did not approve
access authorization programs under the
orders. The NRC approved them in the
sense that we inspected and did not cite
them if their programs were adequate.
All licensees that allow unescorted
access to an aggregated category 1 or
category 2 quantity of radioactive
material must have an access
authorization program that meets the
requirements of subpart B on the date
that the rule is effective in the State in
which the licensee conducts its
operations. The NRC is providing a 1year implementation period for the final
rule.
Comment B2: One commenter
requested clarification as to whether
§ 37.21(a)(2) is based on possession or
authorized possession.
Response: The proposed rule
contained several provisions that were
based on authorization to possess. These
provisions are not contained in the final
rule. The NRC has revised the text to
make clear that the provisions apply
only to those that actually possess the
material.
Comment B3: One commenter stated
that in § 37.21(b), the term
‘‘unreasonable risk’’ should be defined.
Response: The NRC disagrees with the
comment. The NRC acknowledges that
implementation is dependent on the
judgment of the reviewing official;
however, this is a performance-based
requirement and provides the licensee
with flexibility in the implementation of
its program. Although, the NRC has
removed the term ‘‘unreasonable risk’’
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from the requirement, the concept
remains because the concept is inherent
in the definition of trustworthy and
reliable.
Comment B4: One commenter stated
that § 37.21(c) should be deleted as
being redundant to previous sections
about who is approved for unescorted
access.
Response: The NRC disagrees that
§ 37.21(c) is redundant. The section
establishes the individuals that are
subject to the access authorization
program.
Comment B5: One commenter stated
that § 37.21(c)(1) introduces new criteria
for approval (individuals with job duties
that require unescorted access) that are
not otherwise used in the regulations.
The commenter indicated that if it was
considered necessary to limit approvals,
the section should be modified by
inserting the word ‘‘only.’’
Response: The NRC disagrees with the
comment. Section 37.21(c)(1)
establishes the individuals who are
subject to the access authorization
program and, therefore, need to undergo
a background investigation and be
determined to be trustworthy and
reliable.
Comment B6: One commenter asked if
the shipper or the carrier was
responsible in § 37.21.
Response: The licensee is responsible
for assuring that all individuals who
have unescorted access to the category
1 or category 2 quantities of radioactive
material have undergone a background
investigation (or fall under one of the
categories for relief) and been
determined to be trustworthy and
reliable. A commercial carrier is subject
to separate State and federal
transportation security requirements,
and is not a licensee under 10 CFR part
37.
Comment B7: One commenter noted
that movement control center personnel
were included in the list of individuals
who were to be subject to an access
control program. The commenter noted
that the licensee may not have direct
oversight of these centers and the center
may be monitored by LLEA or other
security or emergency personnel which
could make enforcement difficult or
impossible as these individuals would
likely not be responding to an
emergency. One commenter noted that
the vehicle driver and accompanying
individual(s) and movement control
center personnel are typically employed
by the carrier, and the access
authorization program should be under
the carrier’s responsibility. One
commenter stated that licensees can’t
implement the requirement of
§ 37.21(c)(1)(ii) and (iii) when carriers
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are used for shipments of category 1
quantities.
Response: The movement control
center personnel were included because
they have access to SGI–M. The vehicle
driver and accompanying personnel
were included, in part, because they
have access to the SGI–M information.
Whether these individuals come under
10 CFR part 37 access authorization
program or not, they would still need to
be fingerprinted and determined to be
trustworthy and reliable under the
requirements of 10 CFR part 73. The
NRC has revised § 37.21(c) to reflect that
those with access to SGI may be placed
under 10 CFR part 37 access
authorization program or they may be
part of a separate program that meets the
requirements of 10 CFR part 73. Law
enforcement personnel are relieved from
the fingerprinting and background
check that are required for access to SGI
and are relieved from the background
investigation required under 10 CFR
part 37.
Comment B8: One commenter stated
that § 37.21(c)(3) conflicts with the
requirements of § 37.21(c)(1)(ii), (iii),
(iv), and (v) as none of those personnel
require unescorted access to radioactive
material.
Response: The NRC disagrees that
there is conflict with the requirements.
Some of the personnel referenced in
§ 37.21(c)(1) were part of the access
authorization program because they
required access to SGI information
which also requires a determination of
trustworthiness and reliability.
However, the requirements for the
background investigation required for
SGI and unescorted access are not
identical, so the NRC has revised
§ 37.21(c) to reflect that those requiring
access to SGI may be included in the
access authorization program, but are
not required to be included. The
licensee can choose to have a separate
program to provide access to SGI
information.
Comment B9: One commenter noted
that the specific requirement for access
to materials included transport of
category 1 and category 2 materials and
that the requirements should be
consistent with 10 CFR part 71 and 49
CFR 171 through 180.
Response: Part 71 does not contain
requirements related to access of
materials. The referenced DOT
regulations do not contain requirements
for access to materials, except for a
driver who needs a hazardous material
certification which includes fingerprints
and an FBI criminal history check. Part
37 provides relief from the
fingerprinting aspects of the background
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investigation for individuals that have
undergone the DOT check.
Comment B10: Two commenters
requested clarification whether an
engineer designing the security systems
for an irradiator room would need
unescorted access. The commenters
noted that it would be beneficial if the
requirements for individuals with
access to sensitive information were
clearly described.
Response: Whether to grant
unescorted access to an engineer
designing the security systems would be
up to the licensee. The licensee could
arrange for the engineer to be escorted
while in the irradiator room or could
conduct a background investigation and
grant the engineer unescorted access if
the licensee believed it was warranted.
The requirements for individuals with
access to sensitive information are
contained in § 37.43(d).
Comment B11: One commenter asked
what shipping information requires an
access authorization program.
Response: The shipping information
related to shipments of category 1
quantities of radioactive material is
considered to be SGI–M. Part 73
contains requirements for individuals to
undergo a background check and be
determined to be trustworthy and
reliable before being allowed access to
SGI. A licensee can include those
individuals needing access to SGI–M in
its access authorization program under
10 CFR part 37 or in a separate program
under 10 CFR part 73. If a licensee has
an access authorization program that
meets the requirements of 10 CFR part
37, the program will also meet the
requirements of 10 CFR part 73 for
access to SGI–M.
Comment B12: One commenter noted
that a licensee’s access authorization
program expands beyond those
permitted to have unescorted access to
category 1 or 2 sources and, therefore,
the rule text must accurately reflect the
need to include such individuals
without requiring them to have
unescorted access to the sources.
Response: The access authorization
program may also apply to those that
require access to SGI, such as personnel
involved in transportation of category 1
quantities of radioactive material. The
rule has been clarified to reflect that
those with access to SGI may be part of
the access authorization program for
materials unless the licensee chooses to
have a separate program. Although the
comment is not clear, the NRC believes
that the commenter was referring to the
reviewing official as someone that
should not be required to have
unescorted access to the sources. The
NRC believes that it is important that
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the reviewing official undergo the same
background investigation as those being
reviewed and approved by the
reviewing official. Therefore, the
reviewing official is included in the
access authorization program. See also
the responses to B14 and B15.
Comment B13: One commenter noted
that if the radioactive material is in a
secured area within a room, then a
trustworthiness and reliability
determination shouldn’t be required for
personnel who need access to that room.
Response: Secured area can mean
different things. If the material is
accessible by breaching a common
barrier, then the individuals would need
to undergo a background investigation
and be determined to be trustworthy
and reliable. See the implementation
guidance for examples.
Comment B14: In the proposed rule,
the NRC specifically invited comment
on the issue of fingerprinting the
reviewing official. Commenters were
specifically requested to provide
information on: (1) Whether the
reviewing official needs to be
fingerprinted and have an FBI criminal
records check conducted; (2) whether
the other aspects of the background
investigation are adequate to determine
the trustworthiness and reliability of the
reviewing official; (3) whether there are
other methods that could be used to
ensure that the reviewing official is
trustworthy and reliable; (4) whether the
requirement to fingerprint the reviewing
official places too large of a burden on
the licensee; and (5) whether the
Agreement States have the necessary
authority to conduct reviews of the
nominated individual’s criminal history
record. Twenty commenters provided
responses to the specific questions on
this subject.
Of those that provided responses to
the questions on fingerprinting of
reviewing officials, the commenters
were evenly split on whether the
reviewing official should be
fingerprinted. Of those that responded
no on the fingerprinting, most did not
support the concept of a reviewing
official at all and stated that the
trustworthiness and reliability official
established under the Increased Control
Orders should remain in place. One of
those opposed to the fingerprinting of
the reviewing official stated that the
official should be approved by the
licensee as did a couple of the
commenters that indicated support for
fingerprinting. One of those supporting
fingerprinting was opposed to requiring
the individual to have access to
radioactive material. The commenter
suggested that the NRC table this
element until NRC is granted authority
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to require fingerprinting of the
reviewing official. The majority of those
responding indicated that the other
aspects of the background investigation
were adequate to determine the
trustworthiness and reliability of the
reviewing official, including several
commenters that supported the
fingerprinting requirement. Several
responded that specific guidance and
acceptance or rejection criteria must be
made available. Several commenters
indicated that the reviewing official
should meet all of the requirements for
unescorted access. Three commenters
stated that other aspects of the
background investigation were not
adequate but also indicated that they
did not support the concept of a
reviewing official. Based on its
experience with the orders, one
commenter stated that the criminal
history derived from the FBI should
serve as the sole basis. Most of the
commenters did not think that the
fingerprinting placed too large a burden
on the licensee. Of the two commenters
that felt that fingerprinting did place too
large of a burden on the licensee, one of
the commenters did not explain its
rationale and the other stated that it was
unnecessary for the reviewing official to
have access to the material. One
commenter indicated that this placed
too large a burden on the States. On the
question of whether the States have the
authority to conduct reviews of the
nominated individual’s criminal history
record, the response was inconclusive,
with many commenters noting the
authority was undetermined or not clear
whether the State had authority. One
State indicated that it did have the
authority, two States that they probably
had the authority, and one State
indicated that it did only if specific
disqualifying criteria are put in the
regulations. Suggestions for other
methods that could be used to ensure
that the reviewing official is trustworthy
and reliable included deferring the
decision to licensee management using
best business practices; using a
background investigation by a
professional such as a police
investigator, private security clearance
contractor, or human resource
professional; and use of employment
history with the licensee.
In addition to those that addressed the
specific questions, 33 commenters
addressed this subject. The Conference
of Radiation Control Program Directors
(CRCPD) conducted a survey of the
Agreement States, and 69 percent of
those that responded disagreed with the
requirement for the regulatory body to
approve the reviewing official.
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However, 62 percent did support the
requirement that the reviewing official
be fingerprinted. Some commenters
noted that there may be some States that
may not have the authority to adjudicate
fingerprints for approval. CRCPD
reported that 69 percent of the
responders to its survey indicated that
they do not have the necessary authority
to conduct the criminal history reviews
without legislative action. Some of the
States noted that they have the authority
but do not want to conduct fingerprint
reviews. One State indicated that it may
not have the statutory authority to write
a rule to approve the reviewing official,
and another noted that it did not have
the authority unless there were clear
criteria. At least one State noted that it
may not be able to completely protect
the findings of the criminal history
records check from public release.
Several commenters expressed concern
that the regulatory body (NRC or the
Agreement State) would be basing the
regulatory approval of the reviewing
official on only the results of the
fingerprints for a criminal history
records check, and the other elements of
the background investigation would not
be part of the approval process.
Commenters noted that neither the
regulatory body nor the licensee would
have the benefit of the complete
information on an individual in order to
make an informed determination.
Commenters felt that the approval of the
reviewing official should remain with
the licensee and not the regulatory body
because the licensee has more direct
personal knowledge and experience
with the individual, and the licensee
has much more to lose by approving an
incompetent reviewing official. Some
commenters supported the approval of
the reviewing official to be an outside
agency such as the NRC as a logical
methodology.
Some commenters noted that the
regulator should not deny someone
based only on the fingerprint results.
Several commenters noted that this
would put additional resource burden
on the regulatory body and that there is
no compelling evidence of threat to
public health and safety or security or
that the current system is not working.
Some States expressed concern over the
possible liability for approving a
reviewing official. Some commenters
objected to the need to submit or
remove the background check results
outside of their offices and send them to
the regulatory body. Commenters
questioned how the Agreement State
will be able to review the fingerprint
results when the fingerprints are sent to
the NRC. One commenter stated that the
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rule should specify who evaluates all of
the information for the reviewing
official, as a licensee is required to have
the information reviewed before
submittal of the fingerprints. The
proposed rule puts the burden of review
of fingerprint results on the regulatory
body which will result in a resource
burden. Commenters noted that it is
unknown what the impact on
Agreement States’ resources will be to
begin approving reviewing officials.
Response: After considering the
comments, the NRC has decided to
change the approval for the reviewing
official. The NRC (or Agreement State)
will no longer approve the reviewing
official. The final rule adopts a similar
process to what was in the Increased
Control Orders. Each licensee will be
required to provide the name of the
reviewing official(s) to the NRC (or
Agreement State) and certify, under oath
or affirmation, that the reviewing
official is trustworthy and reliable. By
the licensee certifying under oath and
affirmation that the individual is
trustworthy and reliable, the NRC
believes that it adequately addresses the
good faith presumption concern. This
certification occurs after the licensee
has completed the background
investigation for the reviewing official.
The determination basis for the
reviewing official is subject to
inspection. If the individual has
undergone fingerprinting and an FBI
criminal history records check, a
licensee can continue to use the
trustworthiness and reliability official or
the reviewing official used under the
orders.
Comment B15: Many commenters
objected to the need to grant the
reviewing official access to the
radioactive material or SGI. Many
licensees have used Human Resources
(HR) personnel to conduct the
background investigations under the
orders as they are the hiring experts for
their companies. It was further noted
that HR personnel would not have a
need for unescorted access to category 1
and category 2 quantities of radioactive
material. Licensees noted that this
means that HR personnel are either
prohibited from doing the access
authorization or must be permitted
access to the material or SGI. Further,
commenters note that permitting HR
personnel access creates possible
radiation safety/security issues or
creates an untenable business model for
Increased Controls licensees with no
evidence that the current system under
the orders is flawed in any way. Some
commenters noted that if it is the intent
simply to have this person undergo the
same level of scrutiny as those who
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would be given unescorted access, then
the regulation should be amended to
state as much. One commenter noted
that the orders were quite emphatic that
no individual should be granted access
unless the individual actually needed
access and that requiring the reviewing
official to have access appears to reduce
security. Several commenters noted that
the workaround needed to require
fingerprinting was an inappropriate
approach and that NRC should complete
the process of obtaining from Congress
the authority to fingerprint the
reviewing official. Commenters noted
that the requirement is unduly
restrictive on management options and
an invasion of the rights to operate a
business as they see fit. Commenters
also noted that there may be other
requirements surrounding unescorted
access that could be implemented in the
future and may not apply to the
reviewing official that could cause
hardships for licensees. While a few
commenters were opposed to the
requirement to have the reviewing
official fingerprinted, most of the
commenters did not object. One
commenter noted that relying on
someone to compile the information and
have the reviewing official make the
final decision also introduces the
possibility of the individual compiling
the information to act in a malevolent
manner. One commenter suggested the
following language: ‘‘Reviewing officials
must meet the necessary requirements
to have unescorted access to category 1
or category 2 quantities of radioactive
material.’’ Two commenters noted that,
if a reviewing official is granted
unescorted access as a routine job
requirement, the individual receive and
satisfactorily complete radiation safety
training required by the licensee.
Response: The NRC believes that it is
essential that the individual that
approves others for unescorted access to
radioactive material undergo the same
background investigation before
approving individuals for unescorted
access. The NRC needs to have
confidence in the integrity of the
reviewing official. The reviewing
official is one of the layers for defensein-depth of the security program. If the
reviewing official exercises the
permission for unescorted access to the
material, the individual would need to
undergo any required training,
including any safety training, before
actually having unescorted access.
There are often individuals at facilities
that have unescorted access permission
but seldom exercise the permission. The
language has been revised slightly to
note that the reviewing official must be
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permitted unescorted access, and the
phrase ‘‘as part of their job duties’’ has
been removed. However, these
individuals are not being required to
physically access the material. The
changes were made to better match the
language in the AEA. The compatibility
of § 37.23(b)(3) was changed to Category
C to allow States to be more restrictive
as it relates to access to the material.
Some States may have authority to
require fingerprinting by use of other
mechanisms than the AEA.
Comment B16: Several commenters
suggested allowing a reviewing official
approve others to be a reviewing official
as this would provide the licensee with
more flexibility in assigning individual
duties. Commenters noted that the
restriction seemed arbitrary. One of the
commenters noted that there was no
reason why a reviewing official couldn’t
approve someone as there is no
difference in the determination for a
reviewing official and someone for
unescorted access. Commenters noted
that if this requirement was an attempt
to maintain a list of reviewing officials
it could be accomplished in a different
manner.
Response: The NRC does not believe
that the reviewing official should be
allowed to approve another individual
to be a reviewing official. While the
background investigation is identical,
the responsibility for the reviewing
official is greater. However, under the
final rule, a licensee is able to name its
own reviewing officials. The existing
reviewing official could be involved in
the background investigation
evaluation. See also response to
comment B14.
Comment B17: One commenter
suggested adding the word ‘‘nominated’’
before reviewing official in § 37.23(b)(5)
because the person is not a reviewing
official until approved by the NRC.
Response: The requirement for
nominating a reviewing official has
changed in the final rule. A licensee
now names the reviewing official and
certifies under oath and affirmation, to
the NRC, that the reviewing official is
trustworthy and reliable. See also
response to Comment B14.
Comment B18: Two commenters
objected to the wording in § 37.23(b)(4)
and (5) that implies that the reviewing
official permits unescorted access. The
commenters agreed that the reviewing
official should be the individual who
makes the trustworthiness and
reliability determinations but asserted
that the reviewing official should not be
the individual who gives permission for
unescorted access. The commenters
noted that after a positive determination
is made, the actual determinations for
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unescorted access should be controlled
by someone else such as the RSO. The
commenters suggested that the two
sections be revised to remove the permit
unescorted access language. The
commenters also suggested that
§ 37.23(e)(2) be modified by changing
the word ‘‘permit’’ to ‘‘authorize.’’
Response: The NRC agrees with the
comment. The NRC has revised the
language in § 37.23(b)(1) (formerly
paragraph (b)(4)) to read: ‘‘Reviewing
officials are the only individuals who
may make trustworthiness and
reliability determinations that allow
individuals to have unescorted access to
category 1 or category 2 quantities of
radioactive materials possessed by the
licensee.’’ The NRC has removed the
provision in § 37.23(b)(5) as it was
duplicative of paragraph (b)(4) (now
paragraph (b)(1)). The NRC has not
revised the language in § 37.23(e)(2)
because permit is the term used in the
AEA.
Comment B19: One commenter noted
that § 37.23(b)(5) is redundant as
§ 37.23(b)(4) conveys the same
requirement.
Response: The NRC agrees with the
comment and has removed § 37.23(b)(5)
from the rule.
Comment B20: Two commenters
recommended that the reviewing official
be allowed to authorize access to SGI.
Response: The reviewing official may
approve individuals for access to SGI.
Part 73 requires that a reviewing official
conduct the background check review,
but does not specify who that individual
is or specify any qualifications for the
position. A licensee can choose to use
the same individual for both the SGI
access under 10 CFR part 73 and
unescorted access under 10 CFR part 37.
Comment B21: One commenter noted
that licensees were allowed fingerprint
exemptions based on submittal to other
governmental programs, such as those to
access Select Agents or government
clearances. The commenter noted that
these programs allow for licensee
personnel to be trained to take the
fingerprints but that the rule does not
allow the reviewing official to be
fingerprinted by the licensee personnel
which will result in additional cost to
travel to an authorized agency and fees
to have the authorized agency take
fingerprints. Two commenters noted
that the requirement for the fingerprints
of the reviewing official must be taken
by a law enforcement agency, Federal or
State agencies that provide
fingerprinting services to the public, or
commercial fingerprinting services
authorized by a State to take fingerprints
and that this seemed arbitrarily
restrictive and was not a similar
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requirement for other individuals. The
commenters also noted that 10 CFR part
73 did not contain a similar provision.
Response: The NRC disagrees with the
comment. Because the reviewing official
has extra responsibility in the access
authorization program and will be
making the determinations to allow
access, the NRC believes that it is
necessary for the reviewing official’s
fingerprints to be taken by an entity that
will verify that the identification
matches the person being fingerprinted.
This ensures the identification of the
individual submitting the fingerprints.
Without this requirement the reviewing
official could submit the fingerprints of
another individual that is known not to
have a criminal history or known
terrorist ties.
Comment B22: Two commenters
asked how a licensee will know if an
appointed reviewing official has been
approved. Commenters also asked how
long the review would take. One
commenter asked the NRC to describe
the controls that will be in place to
protect the personal information
provided to the NRC on behalf of the
prospective reviewing official. One
commenter noted that the regulation
does not indicate what the NRC will do
with the fingerprints and how long the
NRC retains personal information and
the FBI data. The commenter wanted to
know how long the FBI and NRC retain
the fingerprints and personal
information and who they can or will
share that information with.
Commenters were concerned how the
transition period, before a reviewing
official is approved, could impact a
program. Some commenters questioned
the length of time for NRC review.
Response: The final rule does not
contain the provision for the NRC (or
Agreement State) to approve the
reviewing official. The only information
provided to the NRC is the name of the
individual and the fingerprints. The
NRC typically does not retain the
fingerprints and FBI results beyond 30
days. Either the cards are destroyed or
the electronic file is deleted in
accordance with Federal guidelines.
Comment B23: A few commenters
indicated that the T&R officials under
the orders would be grandfathered and
become reviewing officials under the
rule. Another commenter wanted to
know what is meant by the statement
that the already deemed reviewing
official may continue to act in that
capacity for an expanded set of persons,
i.e., what is classified as an expanded
set of persons. One commenter
recommended revising the rule to
relieve reviewing officials who already
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have fingerprints on file from
submitting fingerprints again.
Response: The NRC disagrees with the
comment in part. The commenters have
misunderstood the grandfather clause.
The T&R officials would only be
grandfathered if they had been
fingerprinted under the orders for either
unescorted access to the radioactive
material or to SGI. If the T&R official has
not previously undergone the
fingerprinting and criminal history
records check, he or she would need to
complete the fingerprinting before
making any additional determinations
for access to material. The expanded set
simply referred to those individuals,
including new employees, who might
newly require a background
investigation.
Comment B24: Several commenters
noted that both the NRC-Agreement
State working group and the NRC staff
steering committee developing the
fingerprinting orders discussed at great
length whether to require fingerprinting
and background checks for T&R
officials. Under the orders, T&R officials
were not subject to the requirements.
Commenters noted that they were not
aware of any subsequent developments
that would change the situation and
now warrant requiring fingerprinting
and background checks for reviewing
officials now required under part 37.
The commenters objected to what they
called the appearance of an attempt to
incorporate in rule a concept that did
not have consensus and was not
incorporated after going through the
previous security orders working group
process. They are opposed to requiring
the reviewing official to undergo
fingerprinting and a background check
because in their opinion the
requirements provide no plausible
added benefit to the existing structure
under the orders.
Response: The 10 CFR part 37
working group considered the order
requirements, lessons learned,
implementation issues, inspection
issues, recommendations from other
reviews, as well as the comments on the
preliminary rule language. The 10 CFR
part 37 working group determined that
there was a potential gap with the
individual approving others for access
without undergoing the same
background investigation. Requiring the
reviewing official to undergo a
background investigation addresses the
good faith presumption. See also the
response to question B5 in Section II.
Comment B25: One commenter
objected to the timing of the submittal
of the fingerprints for the reviewing
official, noting that the approval process
would be timelier if the fingerprints
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were processed at the same time the
licensee is conducting the other
elements of the background
investigation.
Response: The requirement for NRC
approval of the reviewing official has
been removed from the rule. The rule
requires the licensee to certify that the
reviewing official is trustworthy and
reliable and to then provide the name of
that individual designated as the
reviewing official to the NRC. See also
response to Comment B14.
Comment B26: One commenter noted
that many of the items in subparts A
through D do not reference SGI, but the
requirements in this rule apply, and the
inconsistencies must be corrected.
Response: The NRC disagrees with the
comment. Requirements for protection
of SGI are contained in 10 CFR part 73,
not 10 CFR part 37. Part 37 contains
appropriate references to the
requirements for SGI that are contained
in §§ 73.21 and 73.23.
Comment B27: One commenter
requested that a section for a master
materials licensee to approve reviewing
officials at the permittee level facilities
be added.
Response: The licensee is now
responsible for approving the reviewing
official. See also the response to
comment B14.
Comment B28: One commenter noted
that it was not clear how the licensee
would comply with the requirement in
§ 37.25(a)(1) to complete fingerprinting
and an FBI identification and criminal
history records check for reviewing
officials before granting them
unescorted access inasmuch as NRC (or
the Agreement State) would have the
responsibility of reviewing the FBI
identification and criminal history
records check information, in lieu of the
licensee doing so.
Response: The NRC (or the Agreement
State) is no longer involved in the
approval of the reviewing official. See
also response to comment B14.
Comment B29: One commenter raised
the issue of how individuals denied
approval for reviewing official duties
will be tracked to avoid going to another
jurisdiction for approval.
Response: The final rule does not
require the NRC to approve the
reviewing official. The NRC does not
plan a tracking system to track
reviewing officials.
Comment B30: Two commenters
requested information on what happens
if the company appointed reviewing
official is denied, particularly in smaller
companies where the owner, manager,
or RSO may be the appointed reviewing
official and how such a denial might
affect the operation of the company.
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Response: The licensee is now
responsible for approval of the
reviewing official. The NRC is not
involved in the decision. See also
response to comment B14.
Comment B31: One commenter
suggested changing the characteristics
derived from the background
investigation. The commenter stated
that for the reviewing official to state
that an individual is ‘‘trustworthy and
reliable’’ implies more of an intimate
knowledge of the characteristics of a
person than would be gained from
simply running the required checks.
The commenter suggested that defining
an individual as ‘‘low-risk’’ may be
more appropriate.
Response: The NRC disagrees with the
comment to change the rule. The NRC
recognizes that determining that an
individual is considered to be
trustworthy and reliable is subjective,
and not a guarantee that the individual
won’t ever commit, or conspire to assist
others in committing, a malevolent act.
The trustworthy and reliable concept is
in the orders and is in other locations
in the regulations.
Comment B32: One commenter
suggested that, for those individuals
who are relieved from the
fingerprinting, identification, and other
elements under § 37.29, the licensee
should be exempt from the requirement
in § 37.23(c) to provide informed
consent and obtain a signed consent
form. The commenter noted that it
conducts a background investigation on
all badge-holders (employees, fellows,
contractors, etc), the vast majority of
whom have no intent of applying for
purposes of unescorted access and that
there is no opportunity, or it is a
misplaced opportunity, to request an
individual’s signed consent under this
regulation at the point of background
investigation initiation. The commenter
stated that there should also be an
exemption for this situation as there is
no need to repeat the background
investigation just because an individual
later determines a need to request
unescorted access. Other commenters
questioned why an individual that has
already been subject to fingerprinting
now needs to provide consent.
Response: Section 37.23(c) states that
the licensee does not need to obtain
signed consent from those individuals
who have undergone a background
investigation under the orders or 10 CFR
part 73. A signed consent is not
necessary until the reinvestigation
occurs. A licensee would not need to
obtain a signed consent from an
individual subject to § 37.29, unless the
licensee conducted one or more of the
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elements of the background
investigation.
Comment B33: One commenter
questioned whether the NRC would
develop a standard consent form and
background questionnaire form so that
everyone asks the same questions and
evaluates on the same basis.
Response: The NRC has included a
consent form in the guidance that could
be used by licensees. A standard
background questionnaire was not
included as this would be similar to the
information included in applications for
employment. Information would
include job history, education history,
and a list of references.
Comment B34: One commenter stated
that § 37.23(e) was improperly named as
no basis for making a determination was
included, only a requirement for
licensees to develop, implement, and
maintain written procedures with the
determination basis that they deem
appropriate.
Response: The NRC disagrees with the
comment. The section contains the
requirement for the reviewing official to
make determinations on authorizing
unescorted access, and the NRC believes
that it is appropriately named. The
licensee is provided flexibility in the
criteria that it uses to make a
determination.
Comment B35: One commenter stated
that NRC should provide the specific
and detailed adjudication criteria that
will be used to approve the reviewing
official.
Response: The guidance document
contains the general criteria that the
NRC used in approving reviewing
officials under the orders. The specific
criteria to be used are up to each
licensee.
Comment B36: One commenter stated
that licensees are not in a position and
do not have the knowledge and skill to
ensure that personnel are trustworthy
and reliable and that all that licensees
can be expected to do is to follow the
NRC rule that was presumably written
to provide licensees with methods to
screen personnel.
Response: Licensees are required to
follow the requirements in 10 CFR part
37 to acquire information about
personnel and to make their own
judgments of the trustworthiness and
reliability of their employees. These
determinations do not require
specialized knowledge or skill and are
similar to the determinations that
licensees make in hiring decisions.
Comment B37: One commenter
requested that § 37.23(e)(1) and (2) be
revised to remove the requirement to
review all of the background
investigation information required in
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making a determination on
trustworthiness and reliability. The
commenter felt that some of the
information would be impossible to
obtain and therefore, if you are required
to review all information, a licensee
could never approve some personnel.
The commenter suggested that the
language be changed to ‘‘collected
background investigation information.’’
Several commenters suggested removing
the term ‘‘disqualifying’’ from the
paragraph as the NRC has not provided
a list of disqualifying factors.
Response: The NRC agrees with the
comment and has revised the rule to
specify that the evaluation is of the
information collected to meet the
requirements. The NRC has also
removed the term ‘‘disqualifying’’ from
§ 37.23(e)(2).
Comment B38: Two commenters
noted that in § 37.23(e)(3) ‘‘reasonable
assurance’’ is not defined. One of the
commenters felt that the lack of clarity
in this requirement and in what
documentation should consist of will
result in disputes with NRC inspection
findings. One commenter objected to the
need to document the determination
basis for granting someone unescorted
access. The commenter felt that only the
reasons for denial should be
documented.
Response: The NRC does not believe
that ‘‘reasonable assurance’’ needs to be
defined in the regulations. The
determination basis is a performancebased requirement, and licensees are
provided flexibility to develop criteria
that best meet their needs. The NRC
believes that documentation of the
determination basis is essential. The
documentation does not need to be
extensive. It can consist only of an
indication that no negative information
was found during the investigation or an
explanation of why negative
information did not disqualify the
individual. Without documentation an
inspector could not be assured that the
individual had actually undergone the
required background investigation.
Documentation of the basis is also
beneficial to the licensee if it needs to
reevaluate whether an individual
should continue to have unescorted
access.
Comment B39: Several commenters
objected to the requirement in
§ 37.23(e)(3) to immediately remove the
person from the approved list once he
or she no longer require access. One
commenter noted that ‘‘immediately’’ is
not defined and that it is not realistic for
routine terminations such as student
graduations and deaths. The commenter
indicated that the only justification for
immediate removal would be
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demonstrated unreliability that would
result in withdrawal of the person’s
trustworthiness and reliability status.
The other commenter stated that
immediate removal was not warranted
but should be done in a timely manner.
The commenter suggested replacing
‘‘immediately’’ with ‘‘as soon as
practical.’’ Another commenter
suggested removal from the list in a
timely manner not to exceed 30 days
after the determination.
Response: The NRC agrees with the
comment in part. An immediate
removal from the list is probably not
necessary. However, prompt actions do
need to be taken to prevent access, such
as deactivating his or her access code.
The NRC has revised the language to
reflect that the action should occur as
soon as possible but no later than 7
working days. The NRC believes that it
is important to maintain a current list of
those individuals that are allowed
unrestricted access to the material.
Comment B40: One commenter
questioned whether § 37.23(e)(3) means
that the licensee must document its
basis for approval of the trustworthiness
and reliability determination as a
written policy. The commenter noted
that an alternate interpretation could be
that the licensee must document a
rationale for each individual’s
trustworthiness and reliability approval,
as opposed to a generic basis for
approval for all applicants.
Response: The licensee must
document the rationale for each
individual’s trustworthiness and
reliability determination. The
documentation does not need to be
extensive. The NRC notes that the
orders also required the licensee to
document the basis for concluding that
there is reasonable assurance that an
individual granted unescorted access is
trustworthy and reliable.
Comment B41: One commenter stated
that the access authorization program
requirements were overly prescriptive,
particularly the number of required
procedures and amount of associated
documentation. The commenter noted
that the licensee should be allowed to
determine the level of detail of its
program as appropriate depending on
the size and complexity of the program.
Response: The NRC agrees with the
comment, in part, and has made some
changes to the access authorization
program. Section 37.23(f) has been
revised to remove some of the
specificity in the types of required
procedures.
Comment B42: Two commenters
noted that the requirement to have
procedures to ensure that individuals
who have been denied unescorted
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access authorization are not allowed
access was redundant. The commenters
stated that a person denied unescorted
access would not be provided with a
key or codes to access the sources, and
a procedure is not needed.
Response: The NRC believes that
procedures are necessary to implement
the access authorization program. Not
all licensees use keys or codes to control
access to the material.
Comment B43: Two commenters
stated that for licensees subject to 10
CFR part 73 with additional radioactive
materials not covered by the 10 CFR
part 73 security plan, the procedures
used for 10 CFR part 73 background
investigations and updating of
background investigations, etc., should
be considered adequate to meet the
intent of 10 CFR part 37. One of the
commenters suggested adding a new
paragraph (5) to § 37.23(f) to read as
follows: ‘‘Procedures and policies
meeting the requirements of the security
plans required by part 73 meet the
requirements of this subpart B of this
chapter.’’
Response: The NRC agrees that a
licensee does not need to maintain two
sets of procedures; however, a provision
is not needed in the regulations. As long
as 10 CFR part 73 procedure addresses
the content of the required procedures
under 10 CFR part 37, additional
procedures are not necessary.
Comment B44: One commenter
suggested that NRC develop a generic
set of procedures for the conduct of
background investigations as guidance
for licensees.
Response: The NRC has not included
generic procedures for conducting a
background investigation.
Implementation of background
investigation requirements will vary
with the circumstances of individual
licensees. Guidance is available on the
various elements.
Comment B45: One commenter stated
that in § 37.23(g) at least 10 days should
be allowed for an individual to correct,
complete, or explain other components
of the background investigation.
Response: The NRC has not specified
a timeframe in order to allow licensees
flexibility to choose a timeframe that
they believe is appropriate for their
program. The NRC has provided a 10day timeframe to challenge the FBI
criminal history records, and 10 days
would be an appropriate timeframe for
allowing a challenge of other aspects of
the background investigation results.
The licensee may choose the timeframe
that works best for it.
Comment B46: One commenter noted
that since § 37.23(g)(2) specifies that the
licensee can’t act on challenged
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information until the FBI goes through
their due process, the FBI needs to be
on board. The commenter suggested
adding a requirement to allow the
licensee to make a final determination if
nothing is heard from the FBI within 30
days.
Response: The rule contains
procedures for an individual to correct
background check information that are
identical to the procedures in
§ 73.57(e)(2). The NRC disagrees that a
30-day cut-off period is needed because
such a provision would circumvent an
individual’s right to complete, correct,
and explain information obtained as a
result of the licensee’s background
investigation. Further, the 30-day cut-off
period may be unreasonably short. The
FBI has indicated that once it receives
a formal challenge to an individual’s
record, a recheck is completed within
approximately 3–4 weeks (52 FR 6310;
March 2, 1987). Given the rule’s 10-day
window for an individual to initiate a
challenge, the timeframe for resolution
of challenges could potentially be
greater than 30 days. Accordingly, the
NRC declines to impose a 30-day time
limit for challenges to an individual’s
background check information.
Comment B47: One commenter stated
that § 37.23(h)(2) requires the licensee to
retain a list of persons approved for
unescorted access for 5 years after the
list is superseded and noted that the
word ‘‘list’’ implies a written document.
The commenter asked if the ‘‘list’’ may
include database records that contain
unescorted access approval and removal
dates and thus would allow discarding
printed copies that are no longer useful.
The commenter noted that other NRC
regulations (e.g., §§ 20.2110 and 37.51)
allow records to ‘‘be stored in electronic
media with the capability for producing
legible, accurate, and complete records
during the required retention period.’’
The commenter recommended changing
the wording to add similar wording as
in other NRC regulations making it clear
that the ‘‘lists’’ do not need to be printed
copies.
Response: Section 37.101 already
allows records to be maintained in
electronic media. The language is
similar to that provided in § 20.2110
and applies to all records that are
required by 10 CFR part 37.
Comment B48: Two commenters
objected to the requirement in
§ 37.23(h)(3) to maintain a list of
individuals not approved for access.
Two commenters objected to the need to
maintain every change to the list for 5
years. One commenter felt that it would
seem reasonable to ask that a list of all
persons currently granted unescorted
access be maintained (+ a month) and
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that a list of all persons denied or
removed from the unescorted access list
be maintained (± a month). Another
commenter noted that maintaining a list
has no value as a licensee may develop
a badge system that indicates a person’s
level of access. Another commenter
noted that there was no value in keeping
a list since the determination basis has
to be documented.
Response: The NRC agrees, in part,
and disagrees, in part, with the
comment. The NRC agrees that it is not
necessary to maintain a list of those
individuals not approved for access and
has removed the provision. The fact that
someone is not included on the access
list means that they should not be
granted unescorted access to the
material, and a second list is not
needed. There is currently no
mechanism in place to share
information among licensees, so there is
no benefit in maintaining a list of those
not approved for access. The NRC
disagrees with the comment to remove
the requirement to maintain every
change to the list; however, the NRC has
changed the retention time to 3 years.
The superseded lists are necessary for
inspections. If an inspector discovers
something during an inspection, the
superseded list could be reviewed to
determine who had unescorted access
during a given time period.
Comment B49: One commenter
requested clarification whether the
notification required by § 37.27(a)(2) is
different from the informed consent
required by § 37.23(c)(1).
Response: The informed consent
under § 37.23(c)(1) is consent to conduct
the background investigation. The
notification required by § 37.27(a)(2) is
specifically for the FBI criminal history
records check. The licensee may
develop one consent form that covers
both aspects.
Comment B50: In the proposed rule,
the NRC specifically invited comment
on the appropriate elements for a
background investigation. Commenters
were requested to provide information
on: (1) Whether a local criminal history
review is necessary in light of the
requirement for an FBI criminal history
records check; (2) whether a credit
history check provides valuable
information for the determination of
trustworthiness and reliability; (3)
whether the Agreement States have the
authority to require a credit history
check as part of the background
investigation; (4) the appropriate
elements of a background investigation
and why any suggested elements are
appropriate; (5) whether the elements of
the background investigation are too
subjective to be effective; and (6) how
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much time a licensee typically spends
conducting a background investigation
for an individual. Twenty-seven
commenters provided responses to the
specific questions on this subject.
Of those who provided responses to
the questions on the background
investigation elements, no one
supported inclusion of the local
criminal history check as part of the
background investigation elements and
only one commenter indicated that the
credit history check added any value.
Most commenters indicated that the FBI
criminal history records check was
sufficient, and that requiring a local
criminal history check was redundant
and overly burdensome. Many
commenters noted that conducting a
local criminal history check would be
very difficult for foreign nationals and
those who have moved frequently. Most
commenters stated that the credit
history evaluation was not useful, and
that poor credit and untrustworthiness
do not go hand-in-hand. Commenters
were also concerned that there were no
clear guidelines on what credit score
would be cause for concern. Many
commenters expressed concern over the
accuracy of information in credit
histories. Some commenters questioned
whether requiring a credit history check
was legal in some States, noting that the
requirement was an invasion of privacy.
One commenter suggested Social
Security number (SSN) validation
instead of the credit history check.
In response to the question of whether
the Agreement States have the legal
authority to require a credit history
check, most commenters indicated that
they did not know. One State responded
that recent legislation prohibits
discrimination based on credit history,
but did note that the law provides for
exceptions. One State indicated that it
did have authority, and another noted it
did if specific criteria were provided.
The majority of commenters indicated
that the current background
investigation elements from the orders
were adequate. One commenter
suggested as appropriate elements:
Verification of legal citizenship,
personal references, former employers,
education, fingerprinting and FBI
criminal background investigation, and
personal knowledge. Another
commenter noted that the elements
should be employment history,
education history, reference check, and
FBI history check. Two commenters
noted that the background investigation
should be limited to the fingerprintbased criminal history check, and that
an adverse criminal history could be
mitigated by satisfactory employment
history with the licensee. One
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commenter suggested a two-person rule
for truly significant sources instead of a
background check. One commenter
indicated that the area that needed
review is the background investigation
for foreign nationals and students
because the required information is
troublesome to obtain.
Most of the commenters felt that the
elements of the background
investigation were too subjective, and
that guidance or criteria were needed so
that the elements could be consistently
applied across the country with
minimum second guessing by auditors
and inspectors. Other commenters
stated that while the elements were
subjective, this did not mean that they
were ineffective. Commenters stated
that there is a good mixture of
subjectivity and objectivity for the
reviewing official to use in making a
determination of a person’s
trustworthiness and reliability. One
commenter noted that some subjectivity
is necessary to evaluate the situation
and the individual, as strict adherence
to guidelines could lead to rejection and
a serious impact on an applicant’s
career.
NRC also requested information on
how much time a licensee spends
conducting a background investigation.
Responses varied from a few hours to
months; the longer times typically
included wait times and not actual
effort.
One commenter suggested
centralization of the background
investigation process, suggesting that
the security clearance process
performed by the Defense Industrial
Clearance Security Offices for various
Federal agencies could be tailored to
meet the 10 CFR part 37 requirements.
The commenter indicated that this
could be more efficient than requiring
each licensee to develop a process.
In addition to those who provided
responses to the specific questions, 70
commenters addressed this topic.
Several commenters felt that the current
background investigation elements were
sufficient and questioned the value of
the proposed additional elements (credit
history evaluation, verification of true
identity, military history verification,
and criminal history review from local
criminal justice resources). Some
commenters felt that specific justifiable
evidence that current trustworthiness
and reliability programs aren’t working
is needed to justify any new
requirements, and that a cost-benefit
analysis should be used to justify
inclusion of any new elements. Several
commenters noted that the cost of
obtaining the necessary information
may be burdensome in time and money,
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and that the requirements are overly
prescriptive. Commenters expressed
concern that the required checks could
result in lost jobs if individuals did not
meet the standards set forth by the
licensee. One commenter noted that a
licensee would probably investigate the
individual before hiring, which would
result in multiple expenditures for one
eventual employee. One commenter
noted that the background investigation
could deter some talented and
knowledgeable professionals from
applying due to the potential invasion
of privacy. One commenter noted that
the NRC needs to find the fine line
between cautious and correct and overly
cautious and burdensome.
Some commenters felt that the FBI
criminal history checks and work
history are sufficient. Two commenters
felt that the background investigation
should only require a fingerprint-based
criminal history check and that adverse
criminal history may be mitigated by the
employment history of an employee
with more than 3 years employment
with the licensee. Commenters noted
that employment history is far more
accurate for determining
trustworthiness and reliability than any
other check proposed. One commenter
suggested allowing licensees to use a
graded approach taking into
consideration multiple variables, such
as: Whether the activity is category 1 or
category 2; the desirability of the source
to an adversary; the physical security
present; how quickly the radioactivity
could be removed from the device and
readily dispersed or used to cause
serious harm; the mobility of the source
or device, and the frequency of physical
inspection/observation by more than
one individual. One commenter
suggested revising the requirement so
that the licensee could use either
employment history evaluation,
verification of employment, or military
history evaluation. At least one
commenter noted that the insider threat
would be best controlled with
monitoring and detection.
Sixty commenters objected to the
inclusion of the credit history element
in the background investigation.
Commenters noted that, in the current
economic environment, a credit history
evaluation could reflect an inaccurate
and erroneous assessment of a person’s
trustworthiness and reliability and
could result in some skilled individuals
being removed from employment
consideration. Commenters felt that the
credit history check was an unnecessary
invasion of privacy, and that most
individuals would choose not to pursue
unescorted access if faced with a credit
history check. One commenter noted
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that when implementing the orders it
had initiated a credit history evaluation
that created a significant uproar and
resulted in several researchers
withdrawing their irradiator access
privileges. The commenter noted that
this created an atmosphere of distrust.
Commenters felt that the information
was not relevant when attempting to
determine trustworthiness and
reliability and was unjustified and not
a valid gauge of trustworthiness and
reliability. Commenters noted that
having a bad credit history did not make
the individual untrustworthy and that a
good credit history did not define an
individual as trustworthy and reliable.
Some commenters requested that the
NRC provide some study or peer
reviewed document that demonstrates
that persons with poor credit may be
more easily coerced into helping
terrorists. Some commenters stated that
the requirement could potentially be
viewed as discriminatory by workers.
One commenter questioned how to deal
with identity theft.
Commenters noted the difficulty of
obtaining a credit history of individuals
who have lived outside the United
States, such as foreign nationals.
Commenters noted that in some cases it
was impossible to obtain the
information. Commenters noted that
many countries do not have a combined
credit history reporting agency. One
commenter expressed concern that
individuals who have established a
credit history in the United States and
whose credit history is poor will be at
a disadvantage over individuals with a
similar but undocumentable credit
history in another country, as an
employer may choose to allow access to
the foreign national based on
incomplete information and deny access
to a United States citizen based on more
extensive but unfavorable information.
One commenter noted that Title 11 of
the United States Code, Section 525,
makes it illegal to discriminate against
employees or job applicants solely
because of filing for bankruptcy.
Another commenter noted that the
Equal Employment Opportunity
Commission has been cracking down on
efforts to disqualify potential hires with
bad credit history as the practice can be
discriminatory. Several commenters
noted that some States have laws that
prohibit employers from discriminating
against employees on the basis of credit
history and prevent employers from
inquiring about credit history. One
commenter stated that if Congress, in
consultation with the NRC, had deemed
credit history checks significantly useful
to provide for the common defense, the
checks would have been included
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within the most recent amendments in
section 149 of the AEA. Another
commenter noted that Congress has
considered passing an act to make it
unlawful to base adverse employment
decisions on consumer credit reports.
In a CRCPD survey of Agreement
States, 70 percent of those responding
indicated that they did not have the
authority to require a credit history
check as part of a background
investigation. Some Agreement States
indicated that they were not sure if they
had the authority to require a credit
history check. One State indicated that
(assuming it has authority) its
administrative procedures would
require specific criteria for pass/fail.
One commenter noted that there are
State laws that prohibit
‘‘discrimination’’ against employees due
to credit history and asked how this
would affect the credit history check
requirement. The commenter noted that
a Google search indicated that States
that have and/or are considering such
laws include: Connecticut, Wisconsin,
Hawaii, Illinois, Missouri, New York,
Oregon, Washington, and Texas.
One commenter felt that much of the
information obtained from a credit
history report would already be
included in the personal history
disclosure. Two commenters stated that
for category 2 sources it should be up
to the reviewing official to decide if they
have enough information to grant
unescorted access to a category 2 source
without the need for a credit history
check. One commenter noted that
individuals relieved from the
background investigation elements were
just as likely to have negative credit
history but will not be subject to the
same scrutiny. One commenter
recommended defining ‘‘full credit
history,’’ as a licensee can’t comply with
open-ended requirements. Two
commenters noted that this concept had
been considered in the working group
for the orders but was rejected, and,
therefore, should not have been
included in the proposed rule.
Several commenters opposed the
inclusion of the criminal history check
in the background investigation. They
questioned why a criminal history
check from local sources was necessary
if a national check through the FBI was
conducted. One commenter stated that
the local check would be an added
benefit if the FBI check was somehow
inadequate. Commenters stated that the
information would be difficult to obtain
in many locales and would be an
increased burden to both the licensee
and local law enforcement without a
corresponding benefit. Commenters also
noted that the information would be
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impossible to obtain for foreign
nationals, and that a provision must be
provided that allows less-than-absolute
compliance. One commenter noted that
licensees in rural areas may have
limited access to local resources, and
that some local resources may have
limited capabilities to respond to such
requests. Commenters asked how to
determine the appropriate local law
enforcement agency and what
constituted local.
Several commenters objected to the
inclusion of a character and reputation
element in the background
investigation. Commenters felt that the
determination would be very subjective,
added little value, and unnecessarily
added to the licensee’s burden.
Commenters noted that an adverse
judgment about an employee’s character
and reputation could be perceived as
discriminatory. One commenter
suggested removing the term
‘‘trustworthy and reliable’’ from the
character and reputation element and
thereby removing the connotation that a
personal reference can attest to the
present state of an individual’s
trustworthiness or reliability. The
commenter noted that including a
character and reputation check would
require references to be knowledgeable
about that definition, and very few
references can attest to the present
status of an individual, as required by
the words ‘‘continues to be.’’ Some
commenters expressed concern over
possible invasion of privacy. One
commenter recommended requiring a
minimum of three references. One
commenter noted that, for a reference to
provide a worthwhile evaluation of the
applicant, a minimum time frame for
contact with the individual should be
established in the rule. The commenter
also cautioned that the reference should
not be from someone, such as a
supervisor, who may benefit from the
applicant’s unescorted access.
Several commenters objected to the
requirement to obtain independent
information to corroborate the
information provided by the individual.
Commenters stated that the provision
was vague and unreasonable, and they
did not understand how it could be
accomplished. Commenters stated that
it was unreasonable to expect licensees
to track down independent information,
as they are not investigative agencies.
Commenters noted that many entities
cannot or will not provide background
information, and licensees do not have
the resources to obtain information
elsewhere. Commenters noted that the
cost would be prohibitive in many
cases. One commenter recommended
removing the phrase ‘‘to the extent
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16961
possible’’ because it made the section
meaningless. One commenter asked
what he or she should do if it is not
practicable to confirm information.
Another commenter stated that the
documentation would be excessive and
time consuming. One commenter
suggested requiring independent
information only in situations where the
accuracy or completeness of information
provided by the applicant is in doubt,
or where the licensee can’t confidently
make an evaluation based on an analysis
of all of the gathered information. One
commenter suggested changing the
phrase ‘‘to the extent possible’’ to ‘‘to
the extent practicable.’’ Three
commenters objected to the need to
obtain information from an alternate
source when a previous employer or
other entity does not respond. One
commenter noted that where a company
has gone out of business, it would be
impossible to obtain confirmation that
the individual worked at the company.
The commenters felt that it was unclear
how a licensee could obtain this
information in some cases. One
commenter noted that it doesn’t have
the resources to confirm an applicant’s
information independently, particularly
if the person’s family is excluded.
Commenters noted that obtaining the
information for some groups of people,
(e.g., foreign nationals, research
students, and citizens who have resided
outside the United States for long
periods), is difficult or impossible.
Some commenters noted that licensees
with a high turnover, such as
universities and research facilities,
would incur substantial cost and would
have difficulty implementing the
provisions. One commenter provided
some cost information, noting that the
current cost is $131 per applicant,
excluding the $100 average cost for
processing new employees. The costs
included $25 for fingerprinting, $26 for
fingerprint processing through the NRC
and FBI, and $80 for a WorldScan. The
commenter noted that adding the credit
history and military history would
increase the cost per approved person to
$155 for United States records, and even
if the credit history and military records
were obtainable and reliable, getting this
information on foreign applicants would
be prohibitively expensive. Two
commenters noted that a foreign credit
history check costs $170, and one
commenter noted that that a credit
check would cost $1,000 per individual
for a foreign national, and another said
that the cost of military verification was
$80 per person. Another commenter
noted that the current cost of
conducting background investigations
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was $125, and adding a credit check and
military records check would increase
this to $400 per person (assuming that
half the individuals require foreign
credit checks). One commenter noted
that it would take 2 to 3 person-days to
perform the different checks.
Several commenters recommended
that NRC consider using the same
background check process used by the
Centers for Disease Control (CDC) for
select agents because centralized NRC
coordination would probably result in
more consistent evaluations at reduced
cost. Other commenters suggested that
the NRC authorize unescorted access
using a method similar to the
Transportation Safety Administration’s
TWIC program. They noted that the CDC
and the U.S. Department of Agriculture
programs for select agents and the DOT
system for issuing hazardous material
certifications for Commercial Driver’s
Licenses, all have the applicable Federal
government agency perform the reviews
and grant the approvals. The
commenters stated that this approach
would provide consistency in the
conduct of the reviews and would best
assure that all needed information is
collected and reviewed by well-trained
individuals. One commenter suggested
that the NRC review the visa process to
see if any of the requirements could be
replaced with a verification of visa,
since foreign nationals must go through
a Homeland Security review to get a
visa. One commenter noted that it has
reviewed 3,182 persons since the
Fingerprint Order was implemented and
has determined that 38 could not be
judged trustworthy and reliable based
only on the FBI criminal history report
and not because of any other
background investigation elements. The
commenter noted that more than 90% of
the persons it judged to be trustworthy
and reliable were also judged
trustworthy and reliable by the U.S.
Bureau of Alcohol, Tobacco, Firearms,
and Explosives (BATFE), and that this
experience appears to validate why all
other federal agencies that perform
similar checks do so solely on the basis
of the FBI criminal history.
One commenter noted that his or her
industry is subject to three different
Federal background check programs
(BATFE, DOT, and NRC), and
recommended that the agencies come
up with one background check that
would satisfy all three.
Response: The NRC has determined
that the appropriate elements of the
background investigation include:
Fingerprinting and an FBI criminal
history records check, verification of
identity, employment history
verification, education verification, and
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a character and reputation
determination. Many of these items are
part of routine employment checks that
an individual may go through before
being hired by a company. The NRC has
removed military history verification
from the elements as it is considered
part of the employment history and does
not need to be a separate element. The
NRC has also removed the provision to
conduct a local criminal history check
as part of the background investigation.
The NRC determined that while the
local criminal history check would
provide some beneficial information,
the burden of obtaining the information
is not justified by the limited benefit.
The NRC recognizes that conducting the
background investigation for some
individuals, such as foreign nationals,
may be difficult. If there was no
education or military service in the 7year period preceding the need for
unescorted access to the material, the
investigation would not need to include
these items.
After careful deliberation and
consideration of all the comments
received on including credit history as
a background investigation element, the
NRC has decided not to include credit
history as a required element for the
background investigation or
reinvestigation. The credit history can
provide information that is useful in
making a determination that an
individual is trustworthy and reliable.
Credit history can add an extra layer of
defense in mitigating the insider threat
and can provide some information that
is not easily available from other
sources. Credit history was never
intended to be the determining factor for
trustworthiness and reliability but
simply one more piece of information in
making that determination. However, as
many of the commenters pointed out,
there are issues with the accuracy of
credit reports, and a poor credit history
is not necessarily an indicator that an
individual is not trustworthy or reliable,
particularly in these tough economic
times. Although NRC disagrees, some of
the commenters indicated that there is
the potential that some Agreement
States might not be able to implement
the provision due to State laws. These
things could result in uneven
implementation of the provision across
the country. As pointed out by the
commenters, it is harder and more
expensive to obtain a credit history for
those that have resided in other
countries for long periods of time. This
could lead to an imbalance in the
information collected and used in
making the trustworthiness and
reliability determination. In addition,
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some licensees may decide not to grant
unescorted access to fully qualified
individuals because of the lack of
information or the difficulty in
obtaining the information. Many smaller
licensees may not have staff and/or
knowledge to be able to fully utilize the
information obtained from the credit
history. The NRC has determined that
the potential benefit of the credit history
is not justified by the cost and,
therefore, the NRC has not included
credit history as a required element of
the background investigation. While not
requiring a credit history, the NRC does
note that information obtained from the
credit history could be useful to
licensees, and nothing in the NRC
regulations prohibits a licensee from
conducting a credit history. In situations
where a trustworthiness and reliability
determination is difficult, the
information from a credit history could
provide the determining information. A
licensee can always use measures
beyond the regulatory minimum that is
required by the access authorization
program.
The NRC is not providing specific
criteria that would disqualify an
individual from obtaining unescorted
access to the material. There is no
checklist. Because the individual
circumstances of each applicant may
vary significantly, each licensee needs
the flexibility to establish its own
program. The implementation guidance
document does provide general
information and items for consideration,
but no specific disqualifying
information. A licensee should consider
any negative information together with
all of the other information in making a
final determination.
At this time, the NRC has no plans to
establish a new program to conduct
background investigations similar to the
TSA or CDC programs. The NRC does
relieve individuals who have been
approved under these programs from
the fingerprinting element of the
background investigation.
Information provided by the
commenters on the burden of
conducting a background investigation
has been factored into the final
regulatory analysis, as appropriate.
Comment B51: One commenter
expressed concern that the new
requirements could force employment
decisions based on incomplete
information and that this could lead to
significant legal implications for the
facility. The commenter noted that the
intersection of these requirements with
the Equal Employment Opportunity Act
should be investigated.
Response: The NRC does not agree
that the background investigation
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requirements force licensees to make
employment decisions based on
incomplete information. Individuals
who are granted unescorted access to
category 1 or category 2 quantities of
radioactive material must be deemed
trustworthy and reliable. The
background investigation is one
component designed to provide the
licensee with sufficient relevant
information before making this
determination. It is the licensee’s
responsibility to evaluate the
information received as a result of the
background investigation and all other
relevant information to make its
trustworthiness and reliability
determination. These requirements do
not relieve a licensee from its obligation
to comply with all applicable Federal
and State labor laws. Further, the NRC
does not believe that fulfillment of these
trustworthiness and reliability
determination requirements would
cause the licensee to violate any labor
laws. Accordingly, the NRC does not
believe that it is necessary to develop
guidance on this issue.
Comment B52: Two commenters
questioned the 10-year period for the
background investigation versus the 3year period contained in the orders. The
commenters felt that 10 years is an
arbitrary timeframe and that 3 years is
sufficient. One of the commenters noted
that going back 10 years is more
expensive and that it is more important
what happened in the last few years of
the person’s life and not distant history.
Another commenter suggested changing
the timeframe to 7 years as the standard
criminal history and credit checks only
go back 7 years. The commenter noted
that many States charge an extra fee to
extend the check beyond 7 years. One
commenter noted that there could be a
problem when attempting to use the 10
year criteria for students. Another
commenter asked for clarification for
how far back the investigation should go
and what sources could be used. One
commenter noted that the employment
history evaluation period of 10 years
was not consistent with 10 CFR parts 26
and 73 which only cover the most
recent 3 years and that justification
should be provided for going with 10
years. One commenter suggested going
back the last two employers or 10 years
whichever is less restrictive. One
commenter stated that the timeframe
should be left to the discretion of the
licensee based on the situation of the
applicant. One commenter felt that 10
years was too long an evaluation period
and that there was no stopping point to
the 18th birthday. The commenter
recommended changing the 10 years to
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3 years or until the person’s 18th
birthday, whichever is shorter. One
commenter requested that NRC clarify
the date used to determine the 10-year
reinvestigation. One commenter noted
that the rule needs to be clear that the
expectation for the review is to go back
10 years or to such time as the
individual was a minor.
Response: The NRC has reconsidered
the time frame for the initial background
investigation and has changed the
timeframe to 7 years as suggested by the
commenters. This may reduce the cost
of the investigation. The rule does
provide that the investigation only goes
back to the individual’s 18th birthday.
Comment B53: One commenter noted
that the rule did not provide a tiered
approach for individuals who had been
with the licensee for greater than 3
years. The commenter noted that under
the orders the licensee could review the
individual’s employment history (i.e.
personnel files) and obtain the
supervisor’s standardized
recommendation. The commenter
recommended retaining this system for
the initial and reinvestigation for
individuals who have been with the
licensee for a long period of time (i.e. 10
years).
Response: The NRC disagrees with the
comment. The NRC believes that the
longer timeframe is appropriate. If the
individual has been with the company
for 7 years, the licensee would not need
to check with previous employers. The
reinvestigation does not include all of
the elements of the initial background
investigation.
Comment B54: One commenter
requested clarification on whether the
licensee verified the true identity of
individuals or the licensee’s reviewing
official. The commenter also objected to
the language in the rule to verify ‘‘true
identity’’ and ‘‘ensure’’ the individual is
who he or she claims to be. The
commenter felt that making it the
licensee’s responsibility to establish
anyone’s ‘‘true identity’’ is not always
possible as identification documents
(IDs) can be forged, and very few
licensees are experts at identifying
forged documents. The commenter felt
that the language is too strong, cannot
be guaranteed, and needs to be rewritten
to just state that the licensee is
responsible to review the identification
documents. The commenter also stated
that the requirement to compare the
personal information data to identify
any discrepancy in the information is
too vague. The commenter asked what
personal information and what should
be done when discrepancies are
discovered. The commenter suggested
that the language be revised to require
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that the licensee review available
information from an ID that is provided
to the licensee by the applicant, and
resolve any discrepancies. One
commenter asked how verification of
true identity was supposed to be done
and questioned the expense and value.
One commenter noted that it already
performed an I–9 or E-verify for
employees but not in the case of
students at universities.
Response: The licensee is not
expected to determine that an ID has
been forged. Section 37.25(a)(2) states
that the licensee is to review the
identification documents provided,
such as a driver’s license or passport, to
make sure that the information matches
what was provided by the individual. If
the information such as the name of the
individual or social security number
doesn’t match, the licensee should
investigate further. E-verify is one tool
that can be used. The guidance
document on the rule contains
information on how this provision
should be addressed.
Comment B55: One commenter
suggested that the requirements to verify
employment history, education history,
and military history were too rigid and
that the language should be revised to
‘‘the licensee shall attempt to verify
* * *’’ The commenter noted that this
would recognize that businesses fail and
overseas employers and schools may be
impossible to contact. The commenter
indicated that the unsuccessful attempts
should then be documented. Another
commenter noted that it could be very
expensive to verify foreign employment.
Response: The NRC agrees in part
with the comment. Section 37.25(a)(7)
(previously (a)(10)) already contains a
provision for when an employer or other
entity doesn’t provide any information.
The provision had been modified to
provide additional clarification and to
add a requirement that the licensee
document the actions taken when it is
unsuccessful in verifying the history.
Comment B56: One commenter
questioned the relevance of obtaining
military history and how the results
would be used. The commenter stated
that NRC should perform this service for
foreign nationals. Another commenter
noted that military history verification
can be a lengthy and difficult process.
The commenter noted that obtaining
records from the Department of Veterans
Affairs was difficult, particularly for
Korean and Vietnam era veterans, and
compliance is dependent on another
Federal agency. One commenter noted
that in some countries military service
is a requirement of its citizens so
verification has little bearing on an
individual’s trustworthiness and
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reliability. Another commenter noted
that the return rate for requests on
military history has been about 20
percent and takes between 3–6 months.
Commenters do not believe that this
adds any value. Another commenter
questioned how to obtain military
history verification.
Response: Military history is
considered part of the employment
history. The rule text has been revised
to include military history as part of the
employment history instead of a
separate element. For some individuals,
military service could be their only
employment. The licensee only needs to
verify the service if the military service
occurred in the last 7 years. Information
on foreign nationals can be more
difficult to obtain. The NRC notes that
licensees always have the option of
escorting the individuals. Additional
guidance on foreign nationals is
provided in the implementation
guidance.
Comment B57: One commenter
questioned the value of verifying
education history and questioned how
the verification should be
accomplished. Another commenter
questioned how far back a company
needed to go for someone employed at
the company for 10 years. One
commenter noted that the verification
should be for the degree and not the
time period of attendance. The
commenter noted that it would be a
huge burden to verify every time period
at every institution for those who
completed their education over
numerous years at various institutions.
Response: Education history is similar
to employment history and helps to
validate what the individual was
engaged in during the noted timeframe.
Education history would typically be
verified by checking with the
educational institution. Education
history only needs to be verified if it
occurred in the last 7 years.
Comment B58: Two commenters felt
that the employment history was
completely ignored as the rule did not
provide for limiting the background
investigation to the FBI criminal history
check for employees with more than 3
years with the licensee. The commenter
noted that employment history is a
factor that can be used when
determining whether an employee with
a criminal history is trustworthy and
reliable. One of the commenters felt that
employment history is a far more
accurate set of data for determining
trustworthiness and reliability than any
other check proposed and that the
employment history should not be
ignored.
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Response: Employment history was
not ignored by the NRC and it is one of
the elements of the background
investigation. The NRC agrees that
employment history can and should be
used when considering the information
obtained during the background
investigation. The licensee has the
flexibility to determine how much
weight to give each element of the
background investigation.
Comment B59: One commenter noted
that it was impossible to verify
employment if the individual has never
worked before.
Response: Part 37 specifically requires
that the licensee verify the individual’s
employment with each previous
employer for the most recent 7 years
before the date of application. If an
individual has never worked before,
there is no previous employer and no
employment to verify. For this
individual, no employment verification
would be required.
Comment B60: One commenter
questioned what was meant by the
claimed period and indicated it should
be defined in the rule.
Response: The NRC disagrees that
claimed period needs to be defined in
the rule. The claimed period is simply
the period of time for which the
individual indicates that they were
engaged in a particular activity such as
attending college, being a member of the
military, or working for a company.
Comment B61: One commenter asked
for the definition of ‘‘timely manner’’ for
when an entity refuses to respond
during a background investigation.
Response: The rule itself does not use
the term ‘‘timely manner.’’ The rule
indicates that within a timeframe
deemed appropriate by the licensee but
at least after 10 business days of the
request.
Comment B62: One commenter
objected to the language in response B8
in the Statements of Consideration
indicating that licensees should use
their best efforts to obtain background
information. The commenter noted that
best efforts can’t be enforced and must
be clearly defined. The commenter also
objected to the concept of dependable in
judgment, character, and performance
and noted that this must be reduced to
something quantifiable and enforceable
and not subject to disparate
interpretations.
Response: The NRC disagrees with the
comment. The NRC believes that the
concept of best efforts in this context is
necessary because sometimes it is
impossible to obtain information.
Companies going out of business and
entities refusing to provide information
or not getting back to the licensee are
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examples of situations where the
licensee’s best efforts will suffice, as
long as the licensee documents the
efforts taken to obtain the information.
The NRC understands that judgment
and character are subjective items.
Licensees make determinations on
judgment and character every time they
hire someone or trust an individual with
company assets.
Comment B63: One commenter stated
that the NRC should ensure that the FBI
check includes checks against known
terrorists or denied entity lists.
Response: In addition to a criminal
history records check, the names and
fingerprints sent to the FBI are checked
against various terrorist watch lists.
Comment B64: One commenter
requested clarification on whether the
fingerprints and associated criminal
history records check was part of the
background investigation conducted by
the licensee since the FBI does the
check and not the licensee.
Response: The background
investigation includes the collection
and review of all the information
submitted by the applicant and any
information provided by outside sources
upon the licensee’s request. While the
actual criminal records check is
conducted by the FBI upon receipt of an
applicant’s fingerprints, the results of
the FBI’s check are returned to the
licensee, and that information should be
reviewed as part of the licensee’s
determination of an individual’s
trustworthiness and reliability.
Comment B65: One commenter
requested clarification on whether the
background investigation elements
could be outsourced by licensees to a
third-party verification service. Another
commenter requested clarification on
whether some elements of the
background investigation could be
performed by HR personnel and have
them certify what steps had been taken.
Response: The background
investigation elements could be
outsourced. However, the final
determination must be made by the
licensee’s reviewing official. If the
investigation elements were outsourced,
the licensee would need to assure that
the information was properly protected
and controlled.
Comment B66: One commenter
expressed support for grandfathering
individuals already allowed unescorted
access under the orders. One commenter
recommended that the grandfathering
provision also include those individuals
determined trustworthy and reliable
under 10 CFR part 73.
Response: The NRC agrees that those
individuals deemed trustworthy and
reliable under 10 CFR part 73 should be
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grandfathered or relieved from the
fingerprinting and background
investigation elements. Those
individuals who have been deemed to
be trustworthy and reliable under other
security fingerprinting orders (such as
those for fuel cycle facilities and
independent fuel storage installations)
should also be grandfathered. The NRC
has revised the rule to provide
grandfathering for those individuals.
Comment B67: Two commenters
questioned the value of the 10-year
reinvestigation. They felt that
conducting a complete check again
makes no sense if the employee has
worked for the licensee that long. One
commenter recommended removing the
reinvestigation, or if it is retained,
making it simpler, such as a local
criminal history check and supervisor
evaluation. One commenter stated that
the reevaluation needed to include
character and reputation
determinations. The commenter noted
that changes in a person’s attitude or
demeanor can indicate a change in
circumstances that warrants restricting
access, whereas there may have been no
change in a credit or criminal history.
Two commenters recommended using
the FBI background check for the 10year reinvestigation. One commenter
asserted that, if there are no indicators
that something has changed, the FBI
check should be adequate for a
reinvestigation. The commenter noted
that employees are typically evaluated
by their employer at least annually, and
this provides ample opportunity to
ensure that there have been no changes
negatively affecting security concerns.
One commenter noted that § 37.25(c)
suggests that only a criminal history
records check and credit history check
are needed, and this implies that
trustworthiness and reliability is not
sufficiently demonstrated by 10 years’
worth of access without an incident to
revoke the individual’s unescorted
access. The commenter stated that the
reinvestigation requirement seemed
overly draconian, given that the federal
Office of Personnel Management (OPM)
standard for background investigations
only requires a reinvestigation for a
security level higher than even an
NACIC—and the OPM reinvestigation is
required only every 15 years. The
commenter also asked for clarification
on whether the relief provided by
§ 37.29 applies to the reinvestigation.
The commenter also requested
clarification on when the 10-year
reinvestigation is triggered. One
commenter stated that reinvestigation
requirement does not make sense as
there would be insufficient information
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on whether the criminal history will
really be the criminal history or just an
arrest record.
Response: The NRC believes that
periodic reevaluation of an individual’s
trustworthiness and reliability is
important. The reinvestigation is not a
complete check. The reinvestigation is
limited to the FBI criminal history
records check. The relief provided by
§ 37.29 does apply to the
reinvestigation. The licensee would
need to check that the individual still
meets the relief category.
Comment B68: One commenter
questioned whether the reviewing
official was subject to the
reinvestigation requirement.
Response: The reviewing official is
subject to the reinvestigation. The rule
text has been revised.
Comment B69: One commenter stated
that §§ 37.25 and 35.27 have some
duplication of information and that
sections should be reviewed to avoid
duplication.
Response: There is some overlap in
the requirements. However, the
provisions of § 35.27 apply solely to the
fingerprints and FBI criminal history
records checks. The provisions of
§ 37.25 apply to the complete
background investigation.
Comment B70: One commenter noted
that there is potential for discrepancy
between different licensees’ basis
determination for unescorted access and
questioned the wisdom of allowing
transfer of an individual’s
trustworthiness and reliability
determination under § 37.27(a)(4).
Response: The commenter is correct
that there may be differences between
licensees’ determination bases for
unescorted access. The NRC still
believes that there is merit in allowing
licensees to transfer information and
accept another licensee’s determination
on an individual. The individual has
undergone a background investigation
(or met one of the categories for relief)
and been determined to be trustworthy
and reliable. If the second licensee has
reason to doubt the determination or
does not feel comfortable relying on the
first licensee’s determination, the
licensee is not obligated to allow the
individual unescorted access. The
licensee could also decide to conduct its
own background investigation before
allowing the individual unescorted
access.
Comment B71: One commenter
questioned the language in § 37.27(a)(6)
that limits use of information obtained
as part of the criminal history records
check (from the FBI) to determining an
individual’s suitability for unescorted
access to the material or SGI. The
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commenter felt that if the information
indicated that an employee lied on an
employment application, the licensee
should be able to fire the individual
based on this information.
Response: The NRC disagrees with the
commenter’s suggestion that
§ 37.27(a)(6) be deleted. The language in
§ 37.27(a)(6) of the proposed rule
implements the statutory requirement
set forth in section 149c.(2)(B) of the
AEA, 42 U.S.C. 2169(c)(2)(B).
Information obtained from an FBI
criminal history check shall be used by
licensees solely to make suitability
determinations for unescorted access to
category 1 or category 2 quantities of
radioactive material, or access to SGI.
Information which pertains to the
trustworthiness of an employee
obviously is pertinent to a suitability
determination. With that said, the NRC
does not make employment decisions
for the regulated community.
Comment B72: One commenter stated
that the requirement in § 37.27(b)(1)
prohibiting a licensee from basing a
final determination to deny an
individual unescorted access solely on
information received from the FBI is
inconsistent with the intent of the rule
to protect the public from category 1
and category 2 radioactive sources. The
commenter questioned how a
responsible licensee could not use
information provided by the FBI to
restrict a terrorist from access to these
sources.
Response: The prohibition on using
information received from the FBI only
involves information on an arrest more
than a year old for which there is no
information on the disposition of the
case or an arrest that resulted in the
dismissal of a case or an acquittal. The
licensee may still consider the
information, but it cannot base its
decision solely on the information. If
there is no disposition of the case in the
file, the individual may have been
acquitted of the charge, and an acquittal
is information that would be pertinent
to the decision to grant unescorted
access.
Comment B73: One commenter stated
that a licensee would need to have indepth knowledge of constitutional law
to understand the requirement in
§ 37.27(b)(2) that prohibits a licensee
from using the information from a
criminal history records check obtained
under 10 CFR part 37 in a manner that
would infringe upon the rights of any
individual under the first amendment of
the Constitution. The commenter noted
that NRC should not be proposing any
regulation that will be unconstitutional
or be apt to be used to infringe on the
rights of workers.
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Response: The NRC disagrees with the
commenter’s suggestion that
§ 37.27(b)(2) be deleted. The NRC is not
proposing a regulation that is
unconstitutional or that infringes on the
rights of any individual. This provision
implements section 149c.(2)(D) of the
AEA, 42 U.S.C. 2169c.(2)(D), which
provides that the NRC is to protect
individuals subject to fingerprinting
from misuse of criminal history records.
The onus is on the licensee, not the
NRC, to ensure that the information it
obtains as a result of an FBI criminal
history records check will have limited
use, and be used in accordance with all
applicable Federal and State laws.
Comment B74: One commenter stated
that the licensee should be allowed to
submit fingerprint cards to the FBI. The
commenter noted that submittal of
fingerprint cards to the NRC is
cumbersome, time-consuming, and
apparently done only to provide an
additional revenue source to the NRC.
The commenter noted that it had
experienced NRC losing one set of
fingerprint cards. Another commenter
noted that the rule does not allow
licensees with a fully-accredited
program to do their own collection and
transmission of fingerprints to the FBI.
The commenter requested an exemption
to this restriction for licensees who
possess a fully-accredited program.
Response: The NRC cannot exempt a
licensee from the statutory requirement
to submit fingerprint cards to the
Attorney General of the United States
through the Commission, even if that
licensee possesses a fully-accredited
program to collect and transmit
fingerprint cards to the FBI. Section 149
of the AEA states that fingerprints
obtained by an individual or entity must
be submitted to the Attorney General of
the United States through the
Commission for identification and a
criminal history records check.
Consistent with the statutory
requirements, a licensee is required to
submit fingerprint cards to the NRC.
The NRC will then submit the
fingerprint cards to the FBI for
processing and transmit the results
received back from the FBI to the
licensee.
Comment B75: One commenter stated
that the fees for fingerprint processing
should be placed in the regulations
instead of a reference to the Web site.
Response: The NRC disagrees with the
comment. The fees change based on
what the FBI charges. If the fee was
placed in the regulations, it would
require the NRC to conduct a
rulemaking every time the fee changed.
By placing the current fee information
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on the Web site, it can be changed
quickly when necessary.
Comment B76: Two commenters
stated that § 37.29 should be deleted
and that there should not be any
categories of individuals that are
provided relief from the background
investigation elements. One of the
commenters noted that any person
entering a facility and having
unescorted access to or transporting
category 1 or category 2 quantities of
radioactive material should be
fingerprinted, without exemption or
relief. The commenter stated that given
the significance of theft of such material
and the cost of dispersal of such
radioactive material outside a controlled
area, the cost and very minor use of time
for fingerprinting is totally insignificant.
The commenter noted that there are
many examples of Congress or other
persons who have been fingerprinted
and who have broken criminal or other
law and, therefore, should not be
exempted. The commenter noted that
fingerprinting is required in many
situations not involving threats to
national security or dispersal of
radioactive material in public places
and that the process is inexpensive,
unobtrusive, and, if the person being
fingerprinted has no reason to fear the
process, insignificant and irrelevant.
The commenter noted that most of the
individuals covered by the relieved
categories would be escorted and that
providing relief causes confusion and
makes the process more complicated.
The commenter further noted that there
is no more guarantee that these persons
are more reliable than other workers;
therefore, why proceed with exemptions
that weaken the regulation.
Response: The NRC disagrees with the
comment. NRC continues to believe that
these categories of individuals should
be provided relief. Many of these
individuals have undergone equivalent
background investigations or by the
nature of their positions are considered
to be trustworthy and reliable as a
matter of policy. Just because an
individual is relieved from the
background investigation elements, a
licensee is not required to provide
unescorted access to the material. For
example, if a member of Congress were
to visit a facility, the licensee would
likely escort the individual and not
allow him or her to wander the facility
unescorted. An individual would still
need to receive security and radiation
protection training before being granted
unescorted access.
Comment B77: One commenter
disagreed with providing relief from the
background investigation elements other
than the fingerprints and criminal
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history check. The commenter noted
that the relief is inappropriate for
certain categories of individuals, in
particular those covered under
§ 37.29(k). As an example, the
commenter noted that a favorably
adjudicated Security Risk Assessment
under the Select Agent program does
not assess the depth and breadth of
information required under the full
background checks specified either by
existing orders or the proposed
regulations. The commenter noted that
the risk assessment only includes those
checks specified under the Patriot Act
and that character determination, credit
history, verification of education,
verification of employment, and the
gathering of corroborating information
are not explicitly included. The
commenter noted that the acceptance of
a Security Risk Assessment in place of
the more extensive checks creates a
double standard and introduces
potential vulnerability into the
personnel reliability process. The
commenter noted that the information
that would be analyzed for personnel
under § 37.29(k) does not provide
sufficient basis to assess whether an
individual is trustworthy and reliable
under the requirements set forth under
either the NRC orders or under the
proposed background check
requirements.
Response: The NRC agrees with the
comment and has revised the rule. The
relief provided for individuals that
come under § 37.29(b) (formerly
§ 37.39(k)) only applies to the
fingerprints and FBI criminal history
records checks; the other elements of
the background investigation must still
be completed. For the other categories of
individuals in § 37.29(a), relief is
provided from all the background
investigation elements.
Comment B78: One commenter
objected to exempting commercial
vehicle drivers for road shipments of
category 2 quantities of radioactive
material. The commenter felt that
devices and sources are more vulnerable
during shipment by a nonlicensee
carrier than under licensee or
manufacturer control and, therefore,
carriers must require a background
investigation for their staff with
unescorted access to category 2.
Response: While understanding the
commenter’s concern, the NRC believes
that the relief is appropriate. The
licensee does not control the carrier or
whom the carrier employs. However,
the carriers are subject to DOT. Title 49
CFR 172.800 requires that each person
who offers for transportation in
commerce or transports in commerce
category 1 or category 2 quantities of
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radioactive material to develop and
adhere to a transportation security plan.
The components of the transportation
security can be found in 49 CFR
172.802.
Comment B79: One commenter
requested that information be provided
on what elements of the background
investigation each category of
individual relieved from the background
investigation under § 37.29 go through.
Response: The NRC acknowledges
that the background investigation
conducted for individuals in the
relieved categories contained in § 37.29
may not contain all of the aspects of the
background investigation required
under part 37. In some cases, the
background investigation is more
exhaustive, such as the Federal
background investigation for access to
classified information, and some may
contain fewer elements. The licensee is
not required to allow these individuals
unescorted access to radioactive
material and can choose to escort them.
The licensee can also choose to conduct
an investigation that included some or
all of the background investigation
elements before allowing such an
individual unescorted access to the
material.
Comment B80: Two commenters
recommended that the relief from the
background investigation elements for
individuals with a Federal security
clearance be extended to include other
aspects of the authorized individual
process such as NRC approval of the
reviewing official. One commenter
requested clarification as to whether the
relief granted by this regulation may be
extended to individuals who will serve
as the licensee’s reviewing official.
Response: The NRC agrees with the
comment that if the potential reviewing
official meets one of the relief categories
of § 37.29, the individual would not
need to be fingerprinted and undergo a
new background investigation. The rule
has been clarified.
Comment B81: One commenter
requested that § 37.29(g) be revised to
include master materials licensee
employees conducting inspections
under their license authority. The
commenter also requested that
subparagraph (k) be revised to contain
an explicit statement about whether
persons approved under a government
program have to be reapproved after a
specified time interval.
Response: The NRC disagrees with the
comment. A licensee employee
conducting an inspection on the
licensee’s own program is not the same
thing as an NRC or Agreement State
inspector. The NRC disagrees that the
individual should be relieved from the
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background investigation elements as
the individual is still a licensee
employee. The individuals who were
granted relief would be subject to the
10-year reinvestigation. If the individual
still fell under one of the categories,
such as § 37.29(l), he or she would
continue to be relieved. However, the
licensee would need to document that
the relief category still applied.
Comment B82: One commenter
requested that the relief provided by
§ 37.29(i), from background
investigations for emergency personnel
responding to an emergency, be
extended to emergency response
personnel who are not responding to an
emergency. The commenter pointed out
that these individuals need frequent
access for smoke detector checks, safety
inspections of fire walls, assessment of
and response to false alarms, etc.
Response: The NRC disagrees with the
comment. Fire department personnel
who need to check smoke detectors and
conduct safety inspections can be
escorted. The NRC does not see why
these individuals would need
unescorted access to radioactive
material. Someone responding to an
alarm would be considered responding
to an emergency, even if the alarm
turned out to be false.
Comment B83: One commenter
suggested expanding § 37.29(j) to
include handlers at the transportation
facilities, i.e., the people who physically
handle the package at the freight
terminals and move the packages from
one location to another. The commenter
noted that licensees cannot perform
checks for these nonemployees.
Response: The NRC agrees with the
comment and has added a new category
to include handlers at transportation
facilities such as freight terminals and
rail yards.
Comment B84: One commenter noted
that there is a gap whereby § 37.29(m)
does not cover self-employed service
provider licensees who are small
business owners, for example,
independent service technicians who
are licensed to perform maintenance
and repairs on sealed source irradiators.
The commenter noted that these
individuals are qualified in a similar
way for the applicability of § 37.29, yet
the wording of this regulation does not
appear to extend to them.
Response: The NRC believes that
§ 37.29(a)(13) (formerly § 37.29(m)) does
cover a self-employed service provider.
The access authorization program
would not be required of a service
provider that does not possess material;
however, there is nothing in the
regulation that would prevent the
service provider from conducting
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background investigations that meet the
requirements of § 37.25. The service
provider would need to provide written
verification that the individual has been
determined to be trustworthy and
reliable under a subpart B program.
Additional information has been added
to the implementation guidance to
address this situation.
Comment B85: One commenter
indicated that § 37.29 should include
exemption provisions for reputable
security system vendors. The
commenter noted that these vendors
perform extensive background checks as
part of their hiring process and it seems
reasonable to consider the service
providers, software engineers, etc. who
work at or with a licensee’s institution
to be authorized to access the controlled
areas. The commenter noted that it is
unreasonable to expect the licensee to
conduct its own background checks on
all employees of the company who may
be involved in the security system at the
particular institution. The commenter
noted that by not allowing this
exemption, the licensee may be less
inclined to use the state-of-the-art
security systems available and this may
be detrimental to the overall security of
the material. The commenter noted that
although security service providers are
addressed in the ‘‘protection of
information’’ section (§ 37.43(d)), they
should be included here as well, since
they not only have knowledge of the
security program but may also have the
ability to grant access.
Response: The NRC disagrees with the
comment. It is not clear why security
system vendors, particularly software
engineers, would need to have
unescorted access to the radioactive
material. These individuals would need
to have access to some of the licensee’s
security information, which is why they
were included in § 37.43(d). Security
system vendors may or may not conduct
fingerprinting and an FBI criminal
history records check as part of their
investigation during the hiring process.
Licensees may accept documentation
from vendors that vendor employees
have undergone a background check
meeting the requirements of this part,
but in the absence of evidence that all
vendors’ employment checks meet part
37 requirements; vendor employees
should not be exempted by rule.
Licensees also retain the prerogative to
escort such employees when they are
onsite.
Comment B86: One commenter, while
noting that several State employees
listed by job duties are listed as being
relieved from the background
investigation requirements, suggested
that State licensing staff, information
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technology staff, and legal staff be
included. The commenter noted that
these individuals may also have access
to such information.
Response: The NRC believes that the
provisions in § 37.29 are broad enough
to include other State employees that
may require access.
Comment B87: The Nebraska
Emergency Management Agency stated
that it believes that it is exempt from the
fingerprinting, identification, and
criminal history records check
requirements and only needs to provide
physical security for its one category 2
quantity source until such time as the
source is collected under the DOE
source recovery program.
Response: No licensee is exempt from
the provision of 10 CFR part 37. Section
37.29 does provide relief from the
fingerprinting and background
investigations for individuals that fall
under one of the categories. State
employees would likely come under the
provision of § 37.29(a)(4) or (6) and
would be relieved from the background
investigation elements.
Comment B88: One commenter asked
what ‘‘other property’’ refers to in
§ 37.29.
Response: The term ‘‘other property’’
comes from the AEA. The NRC has
removed the term as it has no meaning
in the context of 10 CFR part 37.
Comment B89: One commenter
suggested that the regulation itself
makes it clear that a licensee has the
option of escorting the category of
individuals provided relief from the
background investigation (§ 37.29), and
that granting unescorted access to these
individuals is not required. The
commenter also noted that it should be
made clear that the security training
must be provided before granting
unescorted access.
Response: The NRC does not believe
that the regulation needs to specify that
the licensee has the option of escorting
the individuals. It is always up to the
licensee to decide whom it allows to
have unescorted access. The provision
in § 37.29 only provides relief from the
background investigation elements and
does not require granting unescorted
access to designated categories of
individuals. Any individual allowed
unescorted access to the material must
meet all of the licensee’s applicable
training requirements before having
unescorted access to the material.
Comment B90: One commenter
requested that each subsection in
§ 37.25, ‘‘Background investigations,’’ be
revised to explicitly state if the
subsection is applicable and must be
followed for those who are relieved
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from elements of the background
investigation under § 37.29.
Response: The NRC does not believe
that it is necessary to make the
requested revisions. Section 37.29(a)
relieves the licensee from conducting
the fingerprinting and all other elements
of the background investigation.
However, the licensee can still choose to
conduct all or some of the elements
before providing unescorted access to an
individual who is covered by one of the
categories listed in § 37.29. The licensee
will still need to verify identification.
Comment B91: One commenter, while
supporting the transfer of background
information to outside entities allowed
by § 37.31(c) felt that it would create
additional legal issues and burdens on
the HR department that they would not
be able to meet. The commenter was
concerned about the ability to
authenticate the documentation
presented and avoid fraudulent
documentation. The commenter is
concerned that there is no legally proper
way to transfer such private information
in a secure manner that would not
create legal failure points and possible
violations, as such, they would neither
request nor offer such information.
Response: The language in the
rulemaking under § 37.31(c) states that
the personal information obtained on an
individual from a background
investigation may be provided to
another licensee. While an individual
may request that this information be
transferred or shared, the licensee is not
required by these regulations to do so,
thereby minimizing or eliminating
additional legal issues or burdens on the
HR department that could arise from
such requests. Any decision to request
or provide such information should be
made at the licensee’s discretion. The
rule merely states that NRC considers it
an acceptable practice, provided that the
stipulations in § 37.31(c) are met.
Per the language provided in
§ 37.31(c)(2), the recipient licensee must
verify information such as name, date of
birth, social security number, gender,
and other applicable physical
characteristics, which should aid in
authentication and the avoidance of
utilizing fraudulent documentation.
Comment B92: Two commenters
noted that the proposed rule has no
mention of safeguards of the privacy of
this background information, or of the
method of review. One commenter
requested clarification on whether the
licensee needed to retain the
fingerprints or just the records returned
from the FBI.
Response: Information protection
provisions for the background
investigation are located in § 37.31. The
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licensee is only required to retain the
records returned from the FBI and not
the actual fingerprints. The NRC is not
sure what the commenter meant by
method of review.
Comment B93: Two commenters
suggested revising the language for the
timing of the program review to
‘‘periodically (at least annually) review’’
similar to what is contained in
§ 20.1101. The commenters stated that
the proposed wording is onerous and
unnecessary. Another commenter
suggested adding the access
authorization program review to the
security program review. Several
commenters suggested a 36-month
timeframe or after changes to the
program. The commenter noted that the
program should see little revision once
it is put in place and that an annual
review seems excessive. One commenter
indicated that NRC should specify those
essential program elements for inclusion
in the program review noting that
placing such information in the
guidance would not be enforceable and
would be a disservice to licensees.
Another commenter stated that there
were too many criteria and it could lead
someone to think that the annual
security review was more important
than the safety review. Another
commenter suggested every 3 to 5 years
for the program review. One commenter
noted that the program review could
take from 1 to 3 man days.
Response: The NRC agrees with the
comment in part and has revised the
language for the program review to be
consistent with § 20.1101. The use of
consistent terminology between the
safety and security programs should
enhance the licensee’s understanding of
the requirement. The content of the
program review has not been revised.
Comment B94: Two commenters
recommend that facilities utilizing
Federal security clearances should be
exempted from the program review.
Response: The NRC disagrees with the
comment. While the actual background
investigations and protection of
information would be covered by the
Federal program, other aspects of the
access authorization program would not
necessarily be included in the Federal
program. For example, the licensee
would still need to have a program in
place to document the information on
who has access.
Comment B95: One commenter stated
that the reviewing official and the
individual with overall responsibility
for the security program should be
required to review the access
authorization program review findings.
The commenter felt that it was logical
for the individual with overall security
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responsibility to be involved in the
review; otherwise, the program could
result in split responsibility for the
security program.
Response: The NRC disagrees that a
rule change is warranted. The rule
provides the licensee with flexibility as
to who should be designated to review
the program review findings. The NRC
does agree that it would be appropriate
for both the reviewing official and the
individual with overall responsibility to
conduct the review.
Comment B96: One commenter
questioned whether licensees should be
obligated to provide unescorted access
to any inspectors. The commenter asked
whether Agreement State inspectors are
required to present credentials
indicating that they are in compliance
with the background investigation.
Response: Licensees are not obligated
to provide unescorted access to an
inspector. A licensee always has the
option of accompanying the inspector.
The regulations only require that the
licensee ‘‘shall afford to the Commission
at all reasonable times opportunity to
inspect category 1 or category 2
quantities of radioactive material and
the premises and facilities wherein the
nuclear material is used, produced, or
stored.’’ This means that the licensee
must allow the inspector to go anywhere
in the facility but can choose to
accompany the inspector. A licensee has
the right to request that an inspector
present his or her credentials (e.g., an
agency issued badge) and to confirm
with the inspector’s home office that the
individual is indeed an employee of the
agency. However, the inspector is
relieved from the background
investigation elements and does not
need to present any documentation of
compliance with the background
investigation.
Comment B97: One commenter
recommended adding language that
states that the licensee is not prohibited
from revoking previously granted
authorizations at any time.
Response: The rule contains language
in § 37.23(e)(4) that allows the
reviewing official to terminate or
administratively withdraw an
individual’s unescorted access
authorization based on information
obtained after the individual has
obtained unescorted access.
Comment B98: One commenter noted
that language needs to be included to
allow access to SGI–M and other
security related information identified
in the part in addition to unescorted
access privileges for category 1 and
category 2 materials.
Response: The NRC disagrees with the
comment. Provisions for the protection
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of SGI, including access restrictions, are
located in §§ 73.21 and 73.23. The
requirements do not need to be repeated
in 10 CFR part 37. Part 37 contains
appropriate references to the 10 CFR
part 73 SGI requirements.
Comment B99: One commenter noted
that language is necessary to include the
phrase ‘unless otherwise suspended or
revoked’ to address those situations
where such restrictive actions became
necessary in regard to access to
information or the material.
Response: The NRC disagrees with the
comment. Section 37.23(e)(4) contains
language that permits the reviewing
official to terminate or revoke an
individual’s unescorted access
authorization. The NRC does not believe
that additional language is necessary.
Comment B100: One commenter
indicated that the rule should include a
limitation on escorted access to only
those needing such access to perform a
job function or assist in educational
activities.
Response: The NRC disagrees with the
comment. The licensee should be
allowed to determine who should be
provided escorted access to the facility
and materials. While there should be a
need for the escorted access, there could
be reasons other than to perform a job
function or for educational activities.
C. Security During Use
Comment C1: One commenter stated
that § 37.41(a) did not allow for the
concept of co-location of sources, only
addressing aggregated sources. The
commenter noted that it was not cost
effective to require increased controls
on fixed gauges that are scattered
throughout a facility.
Response: The concept of co-location
is built into the definition for
aggregated. Fixed gauges that did not
fall under the orders do not fall under
10 CFR part 37.
Comment C2: Several commenters
stated that the provisions in
§ 37.41(a)(2), providing for a 90-day
notice before aggregation of material,
were confusing and unnecessary and
that aggregation would be detected
during routine inspections. The
commenters felt that the provisions
would lead to unintentional
noncompliance. Another commenter
questioned how the agency would know
when a licensee aggregated the material,
indicating that it would be time
consuming and costly to coordinate and
track. Another commenter suggested
adding language to address the
permittee system under master materials
licenses. One commenter noted that
§ 37.41(a)(4) required implementation
before possession. One commenter
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noted that it should be assumed that
licensees are implementing the
measures if they aggregate. One
commenter disagreed with the
notification for activation of the security
plans.
Response: The NRC agrees in part and
disagrees in part. The provision was
added to help licensees that do not
routinely possess an aggregated category
2 quantity, but may on occasion. The
provision was intended to provide some
relief from the need to always meet the
requirements. However, since the
wording has caused confusion, the NRC
has revised the provision to simplify
and clarify the requirement. A licensee
only needs to provide a 90-day notice
before aggregating the material if the
licensee has never implemented either
the orders or the 10 CFR part 37
provisions.
Comment C3: One commenter
suggested adding a provision in
§ 37.41(2) to note that the NRC or
Agreement State may prohibit the
transfer of radioactive material in
quantities of concern should an
evaluation of the security plan be found
lacking until corrective measures are
taken and verified.
Response: The NRC disagrees with the
comment. The NRC or State may take
action to prohibit the transfer of
material in such a situation; however, a
provision in the regulations is not
necessary. NRC would typically issue an
order to the licensee or issue a
confirmatory action letter documenting
the licensee’s agreement not to ship
material until the issues have been
resolved.
Comment C4: One commenter
recommended that the general
performance objective in § 37.41(b) be
revised to remove the phrases ‘‘without
delay’’ and ‘‘an actual or attempted.’’
Two commenters noted that this
objective is unrealistic during normal
business hours as unauthorized access,
whether actual or attempted, would
only be detected ‘‘without delay’’ if
individuals were in the vicinity and
could witness the access or attempt to
access. One of the commenters stated
that ‘‘without delay’’ is unrealistic
during normal business hours as a
business’ security system will not be set
to alarm. One of the commenters noted
that areas that may contain category 1 or
category 2 quantities may be locked and
unoccupied but not monitored. The
commenters further noted that, after
business hours, an armed security
system could detect (without delay)
unauthorized access to an area that
contained a category 1 or category 2
quantity of material but may not be able
to detect an ‘‘attempt’’ to access the area
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as the attempt may have failed without
compromising a security measure or
triggering an alarm. One commenter
suggested revising the performance
objective in § 37.41(b) as follows: ‘‘Each
licensee shall establish, implement, and
maintain a security program that is
designed to monitor, detect, assess, and
respond to unauthorized access to
category 1 or category 2 quantities of
radioactive material.’’ One commenter
recommended defining ‘‘without delay’’
in § 37.41(b), particularly with regard to
the assessment of an access incident.
One commenter suggested the following
language for § 37.41(b): ‘‘Each licensee
shall establish, implement, and
maintain a security program that is
designed to monitor, and without undue
delay detect, assess, and respond to an
actual or attempted unauthorized access
to category 1 or category 2 quantities of
radioactive material as outlined in their
security plan.’’
Response: The NRC disagrees with the
comment. The purpose of the security
program is to prevent unauthorized
access and to detect unauthorized
removal of the material. The sooner
material is discovered to be missing, the
more quickly a response can be started
that includes trying to apprehend those
who stole the material and to recover
the material before it can be used for
malevolent purposes. The NRC agrees
that the licensee is not expected to
respond to events that do not trigger the
security system. The threshold for the
security systems should not be set so
high that actual attempts, such as
someone trying to pry open the door, are
not detected or so low such as someone
casually brushing a doorknob sets off
the alarm. The NRC does not see any
benefit to adding ‘‘as outlined in their
security plan’’ to the rule text. The
security plan must meet the
requirements, and the licensee must
follow the security plan.
Comment C5: One commenter
recommended that a provision be added
to require the licensee to appoint an
individual with overall responsibility
for the security program. The
commenter noted examples where no
one individual had responsibility to
implement the security measures and
noted that a default person such as the
RSO may not have the necessary
authority or ability to ensure that the
program is working. The commenter
noted that having the licensee
specifically designate an individual will
clarify responsibility and provide some
authority. Another commenter noted
that the individual should be placed on
the license as is done for the RSO.
Response: The NRC, while agreeing
that it is good practice to have an
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individual with overall responsibility
for the security program, does not
believe that the requirement needs to be
in the regulations. If there were a
requirement most licensees would likely
name the individual on the license and
then it would take a license amendment
to change the named individual.
Comment C6: Several commenters
objected to the requirement to develop
a security plan if they are authorized but
never possess a category 2 quantity or
never aggregate the material above a
category 2 threshold. Commenters felt
that the exercise to develop a plan was
a waste of time and manpower and
questioned the value of preparing for an
eventuality that will never occur. Some
commenters noted that the material was
in different buildings or scattered
throughout a facility. One commenter
stated that physical protection
requirements during use have already
been met and there isn’t any evidence
that requiring licensees to try and track
locations of small amounts of source
material so as not to aggregate to a
threshold quantity is unnecessary to
protect the security of the general
public. One commenter asked what the
security plan should contain if a
licensee doesn’t possess category 2
quantities of material. Two commenters
stated that a licensee must implement a
full security program based on
authorization and not possession and
that this is inconsistent and places an
undue burden on licensees. One
commenter requested clarification on
whether the security plan would need to
be implemented if the licensee was
authorized for sources above the
category 2 threshold but the sources
were located at different sites.
Response: The NRC agrees with the
comment and has revised the rule.
Licensees will only be required to
develop and implement a security plan
if it aggregates the material to a category
1 or category 2 quantity of radioactive
material at a specific location.
Comment C7: Several commenters felt
that the specified contents for the
security plan were too prescriptive.
Commenters felt that each facility needs
to have the flexibility necessary to
develop a security plan that works best
for them and that every security plan
may not need all the prescriptive
requirements specified in the proposed
rule. Commenters noted that licensees
have already developed their programs
to implement the orders and that the
programs have already been inspected
and compliance verified. Commenters
felt that the specificity of the rule was
in conflict with the concept of a
performance-based regulation. One
commenter noted that the blind ‘‘broad
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brush’’ application of arbitrary
requirements is not how to increase
security; it should be based on each
licensee’s unique requirements. One
commenter noted that there should be
an exemption for licensees that already
have a security plan in place.
Response: The NRC does not agree
with the comment that the security
program is too prescriptive. The
licensee is free to choose the methods
that work best for its facility; the exact
security measures to be used are not
prescribed. The content of the security
plan is based on the measures that the
licensee chooses to use. The NRC has
made changes to § 37.43(a) to clarify
that the security plan is specific to a
facility and its operation and to remove
the requirement to address site-specific
conditions that affect implementation.
The NRC has determined that the sitespecific aspects would be addressed by
the measures used by the licensee and
could not be addressed for temporary
jobsites without creating a security plan
for each site. It was not the NRC’s intent
to require a unique security plan for
each temporary jobsite. The NRC has
also removed the requirement to include
a description of the training program.
There is a separate requirement that
addresses training, and it is not
necessary to describe the program in the
security plan.
Comment C8: One commenter noted
that the original security plan must be
reviewed and approved by the
individual with overall security
responsibility but that any revisions to
the plan must also be reviewed by
licensee management. The commenter
questioned the different review and
approval requirements. The commenter
further noted that licensee management
may not have a need-to-know and may
not wish to go through the background
investigation process just to review a
plan, particularly if the authority and
responsibility have been delegated.
Another commenter noted that this also
contradicts the requirement to limit
access to the security plan.
Response: The NRC agrees with the
comment and has removed the
requirement for licensee management to
review the revised plan.
Comment C9: One commenter stated
that the phrase ‘‘measures and
strategies’’ in § 37.43(a)(1)(i) is
meaningless and unenforceable even as
a performance-based goal. The
commenter stated that the phrase
should either be removed or the intent
made clear by measurable, quantifiable,
or otherwise objective expectations.
Response: The NRC disagrees with the
comment. The licensee is required to
describe the overall approach, methods,
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and equipment that it uses to meet the
security requirements. Additional
information has been added to the
guidance.
Comment C10: One commenter
indicated that the present security plan
(from the orders) is sufficient and that
a more stringent security plan is
unnecessary.
Response: The NRC disagrees with the
comment. The orders did not require
licensees to even develop a security
plan. The NRC does not believe that the
requirements for the security plan are
overly stringent. In fact, the licensee has
the flexibility to include in the plan the
site-specific measures that the licensee
employs.
Comment C11: One commenter
requested clarification in the situation
where there is a high-level corporate
security plan in place. The commenter’s
interpretation is that the security plan is
not required to apply exclusively to the
security of category 1 and 2 radioactive
materials but can be an adaptation of a
preexisting site or corporate-wide plan
as long as the required elements are met.
Response: The NRC agrees with the
comment. As long as a preexisting site
or corporate-wide plan meets the
requirements of subpart C as to the
content of the security plan, the plan
would be acceptable and a new plan
would not need to be developed.
Comment C12: One commenter asked
whether the written security plan must
be a separate document in addition to
the Standard Operating Procedures
(SOPs) that pertain to security. The
commenter felt that it is acceptable for
a set of written SOPs to constitute a
‘‘written security plan’’ and would like
the regulation to confirm that. Another
commenter requested that a subsection
be added to § 37.43 to allow the security
plan and procedures to be the same
document or a group of documents.
Response: Each licensee must
determine what information is
applicable to its facility and must be
included and documented in its security
plan. If a licensee already has a security
plan developed to meet the
requirements of an order or for other
purposes, and this plan meets all the
requirements in 10 CFR part 37, there is
no need to develop a new plan.
However, it is unlikely that many
licensees will already have all the
required information in place in existing
procedures.
If a licensee has existing written
procedures and policies in place that
will be incorporated as part of its
security plan under 10 CFR part 37,
these may be referenced in the security
plan as such; however, if these existing
procedures contain information which
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would require marking and handling as
SGI–M, then the licensee must ensure
that all copies of the existing documents
are appropriately marked and handled.
Comment C13: One commenter
proposed that for mobile licensees the
rule be modified to allow the
preparation and submittal of a generic
security plan that would be
supplemented by a project-specific
security plan prior to initiating work on
any given project. The commenter
proposed that the submittal of the
generic security plan be required within
30 days of publication of the final rule
as proposed by NRC; however, the 90day requirement would not apply.
Response: It was not the intent of the
NRC to require the development of a
site-specific security plan for each
temporary jobsite. Development of a
general security plan that addresses how
security will be applied at temporary
jobsites will meet the requirement for
having a security plan. The security
plan is not submitted to the NRC for
approval but would be available at a
facility or temporary jobsite during
inspection. The NRC has removed the
requirement that the security plan
address site-specific conditions.
Comment C14: One commenter noted
that, since the security plan is to
include a description of the
environment, buildings, or facility
where the material is used or stored,
this would require companies that work
at temporary jobsites to develop a
separate plan for each jobsite. The
commenter noted that this would be
extremely costly and would require at
least one additional employee per crew
to follow the workers around, assess the
surrounding environment, write a
security plan, and train the crew in the
new security plan prior to any work
being performed each day. The
commenter stated that this would cause
undue burden on the licensee with no
evidence that it would in any way stop
an attack or protect the general public.
Response: The NRC agrees with the
comment and has removed the
requirement for the security plan to
address site-specific conditions. It was
not the intent of the NRC to require the
development of a site-specific plan for
each temporary jobsite. Development of
a general security plan that addresses
how security will be applied at
temporary jobsites will meet the
requirement for having a security plan.
For those temporary jobsites that may be
considered permanent (i.e., pipe yards),
the licensee should develop a more
specific security plan.
Comment C15: One commenter noted
that references to the security plan
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should be more specific to avoid
security plans required by other parts.
Response: The NRC disagrees with the
comment. The term, as used in 10 CFR
part 37, refers to the security plan
required by 10 CFR part 37, and there
should be no confusion. Anywhere in
this Federal Register notice or in the
guidance for the rule where a different
security plan is being referred to,
language has been added to make clear
that it is a 10 CFR part 73 security plan.
Comment C16: One commenter stated
that the security program is too
prescriptive and suggested using
language similar to § 20.1101 to
implement a program commensurate
with the scope and extent of licensing
activities and sufficient to ensure
compliance with the provision of this
Part. The commenter stated that this
would allow the licensee the necessary
flexibility in documenting its specific
program but would not be prescriptive.
Response: The NRC disagrees with the
comment. The NRC believes that the 10
CFR part 37 requirements provide the
licensee flexibility. The rule does not
specify what specific measures that a
licensee must use; a licensee can choose
those methods that fit its facility. The
security plan, procedures, and training
would address the measures that the
licensee has chosen to use to protect the
material.
Comment C17: One commenter
suggested deleting § 37.43(b) on
implementing procedures because
separate procedures for the
implementation of the security program
are unnecessary since they should be
incorporated into the security
procedures. Another commenter stated
that many implementing procedures
will be developed that do not include
specific security measures designed to
protect the sources and that do not need
to be protected under this section. As
examples the commenter offered
procedures and forms on how to apply
for unescorted access, how to add
people to Radiation Use Authorizations
involving irradiators, or procedures on
record destruction.
Response: The NRC disagrees with the
comment in part and agrees in part.
Implementing procedures are a
necessary component of both safety and
security programs. If a licensee already
has security procedures, it is acceptable
to continue using those procedures and
update the procedures to reflect any
changes to the program. The licensee is
not required to protect all of its
procedures under this provision. The
only procedures that require protection
are procedures that document how the
security program is implemented. This
would include procedures on alarm
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response, security guard checks, and
procedures that describe actual security
measures. It would not include the
types of procedures mentioned by the
commenter. Examples have been added
to the guidance document.
Comment C18: One commenter noted
that § 37.43 does not mention that the
requirements apply to individuals who
have access to SGI.
Response: Section 37.43(d)(8) does
contain a reference to the protection of
SGI. The requirements for access to and
protection and handling of SGI are
contained in 10 CFR part 73.
Comment C19: Several commenters
stated that there was no need for the
refresher training unless something
specific about the program changes.
Commenters felt that only those
individuals with a need-to-know should
receive training on specific changes and
that not everyone should be trained on
the security plan. One commenter noted
that those who just use the device do
not need to be trained on the security
of the device. Two commenters felt that
refresher training every 12 months
would be burdensome, particularly if
you have many employees needing the
training. One commenter suggested that
the periodicity of the refresher training
be based on licensee’s expectations and
assessments for a need for refresher
training. One commenter noted that the
inclusion of training on the security
program just added to the overhead.
Another commenter expressed concern
with the probable cost of the training
program and noted that it could require
a staff member to be assigned to the task
full time to keep up with the training,
refresher training, and testing for large
numbers of diverse individuals with
frequent turnover such as at a
university. One commenter requested
cost estimates specific to the training
requirement.
Response: The NRC disagrees with the
comment. The NRC believes that
training is an essential element of any
program. If employees are not trained,
how will they know what to do if an
alarm sounds or material is determined
to be missing? The training needs to be
commensurate with the individuals’
responsibilities. The estimated cost for
the training is included in the regulatory
analysis prepared to support the rule.
Comment C20: One commenter stated
that the training program requirements
were too prescriptive and go well above
what is in the existing orders. One
commenter wanted to know what the
training entails and requested a
definition of the term ‘‘adequate
training.’’
Response: The NRC disagrees with the
comment that the training program
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requirements are too prescriptive. The
NRC believes that training is an
essential element of any program and
should be required. The orders did not
require any training to be conducted.
The training must address the licensee’s
security program and procedures and
the security measures employed by the
facility. Individuals do not need to be
trained on the complete security plan;
the training should be commensurate
with their responsibilities. The
provisions in § 37.43(c)(1)(ii), (iii), and
(iv) are also general and are similar to
the training provisions of § 19.12.
The term ‘‘adequate training’’ is not
used in the rule language. However, the
training must cover the information for
an individual to carry out his or her
assigned duties and responsibilities.
Comment C21: One commenter stated
that § 37.23(a)(2) requires users to be
trained in all aspects of the security
plan and that this conflicts with
§ 37.43(c)(2) which notes that the
training should be commensurate with
the individual’s responsibilities.
Response: The NRC disagrees that
there is a conflict between the sections.
Section 37.23(a)(2) requires the training
required by § 37.43(c) to be completed
before allowing the individual to have
unescorted access. It does not state that
the individual must be trained on all
aspects of the security plan.
Comment C22: One commenter
recommended defining ‘‘relevant
results’’ in § 37.43(c)(3).
Response: The NRC disagrees with the
comment. The term relevant is a
common term and in this case simply
refers to items that are related to
security. Examples of some items that
would be included are areas where staff
has had trouble following the security
requirements, violations of the security
requirements that have been discussed
in an inspection report, and measures
taken to fix any identified security
issues. Additional information has been
added to the associated implementation
guidance.
Comment C23: Two commenters
requested clarification on the timing of
the refresher training. The commenters
noted that their understanding was that
refresher training could be taken more
than 365 days after the previous
training, as long as it is taken within the
same month of the succeeding year.
Response: The commenter is correct
in its understanding that the training is
to be provided at a 12-month frequency
and be conducted within the same
month of each succeeding year. This
allows licensees greater scheduling
flexibility to accommodate the needs of
their operations, instead of holding
them to a strict 365-day time constraint.
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Comment C24: One commenter did
not think that the licensee should be
training the LLEA on rules of
engagement, such as the proper
response to an alarm. The commenter
also asked whether it would be
considered self defense to shoot a
perpetrator that holds a category 2
source up as to expose the responder.
Another commenter noted that the
LLEA does not have the time or the
inclination to undergo licensee training.
One commenter requested clarification
on whether the training program
included LLEAs.
Response: The training is not for the
LLEA but for the licensee’s staff that
would be responding to the alarm. The
licensee is not required to conduct any
training of the LLEA, although
providing the LLEA an overview of the
facility is a good practice. The rule does
not authorize lethal force or arming of
licensee personnel.
Comment C25: In the proposed rule,
the NRC specifically invited comment
on the requirement to protect securityrelated information. Commenters were
requested to provide information on: (1)
Whether the Agreement States have
adequate authority to impose the
information protection requirements in
this proposed rule; (2) whether the
Agreement States can protect the
information from disclosure in the event
of a request under a State’s Freedom of
Information Act or comparable State
law; (3) whether the proposed rule is
adequate to protect the licensee’s
security plan and implementing
procedures from unauthorized
disclosure, whether additional or
different provisions are necessary, or
whether the proposed requirements are
unnecessarily strict; (4) whether other
information beyond the security plan
and implementing procedures should be
protected under this proposed
requirement; and (5) whether the
background investigation elements for
determining if an individual is
trustworthy and reliable for access to
the security information should be the
same as for determining access to
category 1 and category 2 quantities of
radioactive material. Nineteen
commenters provided responses to the
specific questions on this subject.
Of those that provided responses to
the questions on the protection of
information, the commenters were
divided in their views. Some felt that
the proposed provisions were sufficient,
some felt that they were unnecessarily
strict, and some felt that the current
provisions from the Increased Control
Orders were sufficient. One commenter
stated that with the proposed
provisions, there was no continued need
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for any of the security information to be
considered SGI or SGI–M. One
commenter stated that the requirements
should be clarified to indicate that only
written copies of the plan and
procedures will be protected. One
commenter stated that the rule was
unnecessarily strict by requiring that
persons with access to the security plan
and procedures also be permitted
unescorted access to the sources. Two
commenters suggested that the list of
individuals granted unescorted access to
the security zone should also be
protected. Most of the commenters
agreed that the background investigation
elements for determining whether an
individual has access to the information
and radioactive material should be the
same. Two individuals stated that a
criminal history records check should
be part of the background investigation
for access to the information. Two
commenters stated that the elements
should be different but did not indicate
what should be different. On the
question of whether the States have
adequate authority to impose the
information requirements, many
commenters indicated that the States do
have the authority or that they thought
the States did. On the question of
whether the States can protect the
information from disclosure in the event
of a request under a State’s Freedom of
Information Act, most of the responses
were not definitive. Several commenters
indicated that an opinion from the State
Attorney General’s Office would be
necessary; four States indicated that
they did have the necessary authority.
In addition to those that provided
responses to the specific questions, 8
commenters addressed the information
protection provisions. One State noted
that it did have authority to impose the
information protection requirements
and could protect the information from
disclosure. One commenter noted that
there are already processes in place
under SGI and/or official use only
(OUO) to protect security information.
One commenter recommended adding
the list of individuals approved for
unescorted access authorization to the
information that must be protected from
unauthorized disclosure, noting that if
the names become public, the
individuals could potentially be
targeted to gain unabated access to
sources. One commenter requested that
§ 37.43(d)(1) be revised to clarify that
the protection of information refers to
the written security plan or procedures
only, so as to preclude unwarranted
interpretations during a regulatory
inspection about what information or
discussions to restrict. The commenter
offered suggested language as follows:
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‘‘(1) Except as provided in paragraph
(d)(8) of this section, licensees
authorized to possess category 1 or
category 2 quantities of radioactive
material shall limit access to copies of
their written security plan and
implementing procedures and
unauthorized disclosure of substantive
details of the plan or procedures that
facilitate unauthorized access.’’
Commenters noted that the
fingerprinting element was not included
in the background investigation
elements for access to security
information, and several commenters
stated that it should be included. Other
commenters requested clarification
whether fingerprints were prohibited for
this purpose. Commenters requested
that the NRC make the requirements for
background checks consistent
throughout the rule. One of the
commenters noted that a licensee is left
either to perform incomplete checks on
individuals with whom information is
shared, or to grant unrestricted access to
individuals who truly do not need the
access, just to allow the licensee to
conduct the main element of the
background check (i.e., the FBI
identification and criminal history
records check). One commenter stated
that the response discussion for C6 in
the Statements of Consideration should
be modified to include the requirement
that anyone seeking information on
category 1 quantities of radioactive
material must also have undergone the
access authorization process, including
the FBI criminal history review and
fingerprint identification verification.
The commenter stated that this would
be a practical threshold for States to
have equivalent rules in place that
mimic the NRC’s SGI–M requirements
in 10 CFR part 73.
One commenter stated that the phrase
‘‘security service provider employees’’
as used in paragraph § 37.43(d)(4)(ii) is
too general. The commenter indicated
that it didn’t appear that the intent of
the NRC was to require background
checks on individuals who do not
access the facility and simply monitor
the facility’s security system from an
offsite location, such as alarm service
providers. The commenter further asked
if the requirement is intended to address
security guard service employees who
work on the licensee’s premises that
contain category 1 and category 2
quantities of materials. Another
commenter requested clarification and
suggested revised language. One
commenter noted that the exemption to
performing background investigations
for employees of security service
providers requires written verification
from the provider for each employee.
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The commenter stated that it may be
more appropriate to approve the
security service provider as a whole
since it may be difficult for the licensee
to maintain a current list of all
employees of the vendor who may have
intimate knowledge of the security
system at the licensee’s location(s). The
commenter noted that it would be
burdensome for the licensee to track
individual employees of these
companies. The commenter stated that a
letter documenting the background
investigation procedures of the security
vendor could be provided to the
licensee to allow it to forego the access
authorization procedures for the
security vendor employees. One
commenter stated that each subsection
on the protection of information
(background investigation information)
should be revised to state explicitly
which subsections are applicable and
must be followed for individuals
provided relief in § 37.29.
One commenter stated that there
should be no need to have another
documented basis for an individual to
have access to the security plan if it has
already been documented that the
individual has unescorted access to
material as it is redundant and create
additional burden. One commenter also
requested that a table or flow diagram be
added to the guidance document to
show when the background
investigation elements apply.
Response: All aspects of the
information protection requirements
apply to all of the background
investigation information possessed by
the licensee whether the information is
the full background investigation or
information on how the individual met
a category in § 37.29 for relief from
background investigation requirements.
The NRC agrees that the list of
individuals that have been approved for
unescorted access should be protected
and has added it to the list of items for
protection. Individuals do not need to
have unescorted access to the
radioactive material in order to have
access to the protected information. An
individual who has been granted
unescorted access to the radioactive
material would not need to undergo
another background investigation to
have access to the security information.
The licensee would need to document
that the individual has a need-to-know
the information. The rule has been
clarified that a second background
investigation is not necessary.
On the issue of protecting only
written copies of sensitive information,
the NRC disagrees with the comment.
The licensee must protect against any
form of unauthorized disclosure of the
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protected information, including verbal
or electronic disclosure.
On the issue of the security service
provider, the NRC disagrees with the
suggested change as a security service
provider may not be a guard and could
include other occupations. Language in
§ 37.43(d)(4)(ii) allows the licensee to
accept a security service provider’s
determination of trustworthiness and
reliability based on a full background
investigation. Additional information
has been added to the implementation
guidance.
On the issue of requiring fingerprints
and FBI criminal history records for
access to the information, the NRC does
not have the authority to require
fingerprints for access to this type of
security information. The NRC can only
require fingerprints for access to SGI
and unescorted access to radioactive
material. The NRC has added a table to
the guidance document on the
background investigation elements.
Comment C26: One commenter
requested clarification of § 37.43(d)(3) as
to whether individuals, who by nature
of their job position have knowledge of
critical components of the security plan,
would be required to undergo a
background investigation unless they
have access to the security plan
document or any of its implementing
SOPs. Examples include a security
guard with access to an alarm-response
schematic or an IT specialist who
supports an IT system responsible for
alerting security personnel of adverse
indicators in the area of category 1 or
category 2 radioactive sources. In each
case the individual has knowledge of
security plan components but would not
have access to the plan itself or
implementing SOPs.
Response: Employees or service
providers with limited knowledge of the
security plan but without access to the
plan or the implementing procedures
would not necessarily need to undergo
a background investigation. The
licensee would have to decide in some
cases how much knowledge of the plan
the employee has; if the employee is
familiar with the plan and procedures,
even if he does not have access to the
document, it may be necessary to
conduct a background investigation and
make a determination of trustworthiness
and reliability. Note that new language
in § 37.43(d)(4)(ii) allows the licensee to
accept a security service provider’s
determination of trustworthiness and
reliability based on a full background
investigation.
Comment C27: One commenter
requested that the language in
§ 37.43(d)(5) requiring that ‘‘* * * the
licensee shall immediately remove the
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person * * *’’ be revised to remove the
word ‘‘immediately’’ and to substitute
‘‘as soon as practical.’’ The commenter
noted that the person won’t
immediately forget the information in
the plan and that there is no need for
immediate removal.
Response: The NRC agrees with the
comment. An immediate removal from
the list is probably not necessary. The
NRC has revised the language to reflect
that the removal should occur as soon
as possible but no later than 7 working
days.
Comment C28: One commenter
objected to the phrase ‘‘in a manner to
prevent removal’’ in § 37.43(d)(6). The
commenter felt that the phrase was
exceedingly vague. The commenter
suggested a change to ‘‘secure the plan
to prevent unauthorized access.’’
Response: The NRC agrees with the
comment and has revised the rule text
to read: ‘‘When not in use, the licensee
shall store its security plan and
implementing procedures in a manner
to prevent unauthorized access.’’
Comment C29: One commenter
requested clarification on whether a
reinvestigation is required for
individuals who have access to sensitive
information only, and if so, the
procedure that should be followed.
Response: Yes, the reinvestigation
applies to individuals who have access
to sensitive information. The rule has
been clarified to make the requirement
clear.
Comment C30: One commenter
requested that language from the orders
addressing marking and transmission of
security related documents be added to
the rule.
Response: The NRC disagrees with the
comment and does not believe that the
marking and transmission measures
need to be added to the rule. Licensees
are not required to submit either the
security plan or implementing
procedures to the NRC. The NRC
reviews these documents during
inspections at the site. The transmission
portion is therefore not necessary. The
necessary elements from the orders on
access to and protection of the
information are in the rule. The other
elements are good practice, but the NRC
does not believe that they are essential
for the adequate protection of the
information. However, if a licensee
believes that information submitted to
the NRC should be withheld from
public disclosure, the licensee should
follow the requirements in § 2.390.
Comment C31: One commenter
suggested that the terms ‘‘Safeguards
information’’ and ‘‘Safeguards
information modified handling’’ be
defined in 10 CFR part 37.
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Response: The NRC disagrees with the
comment. Safeguards information and
safeguards information modified
handling are defined in 10 CFR part 73
where the requirements for handling
such material are located. The reference
in 10 CFR part 37 is merely a pointer to
the requirements and does not establish
any new requirements; therefore, the
NRC does not believe that a definition
for these terms is necessary in 10 CFR
part 37.
Comment C32: One commenter asked
that the NRC define ‘‘to the extent
practicable’’ for coordination with
LLEAs.
Response: This provision was added
to the rule to provide the licensee with
some flexibility. Some LLEAs may be
reluctant to engage in coordination
activities with a licensee. The provision
‘‘to the extent practicable’’ allows the
licensee to remain in compliance with
the rule when an LLEA will not
participate in any coordination
activities. The NRC does not believe that
phrase needs to be defined. Guidance is
available on this topic and other aspects
of the rule in the associated
implementation guidance.
Comment C33: Two commenters
recommended deleting paragraph
§ 37.45(a)(1)(ii) as this information
would be classified as SGI or SGI–M for
some licensees and would require
handling and control in accordance
with § 73.21. The commenter indicated
that there appears to be little if any
benefit in providing this information to
the LLEA that would warrant the
dissemination of SGI or SGI–M. Another
commenter felt it was unnecessary to
describe specific security measures such
as alarm types and locations unless the
LLEA is actually monitoring these
alarms. The commenter asserted that a
generic description would be adequate
for the purpose of LLEA situational
awareness.
Response: The NRC disagrees with the
comments. The NRC believes that the
information on the facility can be useful
to the LLEA. In an event where someone
is trying to steal the material, the LLEA
can mount a more informed response if
information about the facility is
available to the responders. When NRC
staff has met with LLEA representatives,
the representatives have indicated
interest in the coordination activities.
LLEAs are deemed trustworthy and
reliable for access to sensitive security
information as well as SGI.
Comment C34: One commenter noted
that an LLEA is not going to tell every
licensee whether the initial response to
an emergency involving radioactive
materials must be provided by other
than armed LLEA personnel and
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questioned how a licensee would know
this information. The commenter
suggested removing the provision as it
was a nonsense requirement. One
commenter stated that the NRC should
coordinate with the States to be notified
instead of requiring the licensee to
notify the NRC after the licensee
becomes aware of any State or local
requirements that an initial response to
an emergency involving radioactive
material must be provided by other than
armed LLEA personnel. Another
commenter recommended removing the
requirement. One commenter asked
what the NRC would do after such
notification.
Response: The NRC agrees that there
may be some reluctance on the part of
the LLEA to provide the information.
The provision is not included in the
final rule.
Comment C35: One commenter
questioned the need for a specific
written agreement for response. The
commenter also requested clarification
on what must be included in the
agreement. Some commenters
questioned the benefit of requiring
coordination with the LLEAs and
questioned whether this was the best
use of LLEA resources given the low
probability of an actual threat to
sabotage or steal a category 2 source.
Commenters indicated that, based on
their experience to date with the orders,
the LLEA coordination was not
beneficial, noting that at best the LLEAs
would acknowledge the coordination
attempts with no commitments, other
than to respond in the manner they
believed was proper, and that most
LLEAs were completely disinterested
and did not acknowledge any
information provided by the licensee.
They noted that in their discussions
with those LLEAs where feedback was
provided, the LLEAs were unwilling to
discuss the manner in which they
planned to respond and unwilling to
commit to any specific action as each
decision to respond must be based on
their judgment of the circumstance. One
commenter indicated that LLEAs would
not want to disclose their capabilities.
One commenter noted that the LLEA is
not required to comply with the request.
At least one commenter questioned
whether it would be more efficient to
inform/train only the LLEA involved
when the billions we spend on
intelligence indicate a credible threat.
Commenters felt that adding a
requirement does not address the root
cause. One commenter expressed
concern that security could be reduced
if the LLEA failed to protect the
information or had to release the
information under a FOIA request. The
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commenter suggested a reevaluation of
the information provided to the LLEA
such that release of information would
not cause a breach in security. Two
commenters noted that they had
successfully coordinated with their
LLEA under the orders and do not
believe that any additional requirements
are needed. One commenter indicated
that the coordination process should be
a clearly defined process. One
commenter stated that LLEA
coordination requirements were overly
prescriptive and difficult to implement.
The commenter stated that, if NRC feels
this is necessary, NRC should take the
lead and identify contacts and provide
training. A commenter noted that the
use of 911 is effective for all kinds of
emergencies and should be used by
licensees. One commenter agreed that
there is value in a coordinated response
from an LLEA and that such a response
should include the capability of
bringing armed force; however, the
commenter stated that it was
inappropriate to place the requirement
on the licensee. The commenter stated
that the extent of the response should be
left to the discretion of the LLEA. The
commenter noted that the requirement
for a written agreement with the LLEA
was unenforceable and outside the
State’s jurisdiction. Two commenters
noted that the LLEA coordination was
one of the most difficult areas to
implement from the orders and places
responsibility on licensees for activities
they cannot control.
Response: While the orders contained
a requirement for a prearranged plan
with the LLEA, the proposed rule only
contained a provision to request that the
LLEA enter into a written agreement.
After evaluation of all of the comments
on the LLEA coordination, the NRC has
simplified the requirement. The NRC
continues to believe that coordination
with the LLEA is important, and the
rule contains a requirement for
coordination. However, the decision
was made that several of the items,
while good ideas, were better addressed
in the guidance document and not in
the rule itself. A written agreement and
several of the coordination activities are
not included in the final rule. Even if a
written agreement had been reached, an
LLEA will respond as it feels is
appropriate to the particular situation.
Comment C36: One commenter
objected to requesting the LLEA to
provide updated contact information as
it places a burden on the LLEA. Two
commenters suggested that this only be
a requirement if a facility is not served
by a 911 system.
Response: The NRC agrees that it is
not necessary to request contact
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information or updated contact
information. Most licensees in the case
of an actual threat would call 911 and
not the contact. Additionally, no contact
would be available 24/7. The provision
is not included in the final rule.
Comment C37: Many commenters
objected to the requirement that a
licensee request the LLEA to notify it of
degraded capabilities as unrealistic,
unnecessary, unenforceable, and would
probably violate LLEA ‘‘need-to-know’’
procedures. Some commenters felt that
the requirement that the LLEA notify
licensees of a degradation of their
response capabilities was clearly
outside the purview of the regulating
agencies. Others noted that licensees
have no authority over nonlicensed
entities such as LLEAs. Commenters felt
that the LLEA is better equipped to
arrange for alternative response
capabilities than would the licensee and
that this would be an inherent part of
LLEA organizational framework; some
commenters asked what the direction
was if a licensee was notified of a
degraded LLEA response capability.
Another commenter asked what the
State was to do if notified that the LLEA
was not cooperating in providing the
degraded capability information.
Commenters noted that it is
inconceivable to believe that the LLEA
would notify a licensee that their
response capabilities have become
degraded, not only because that would
appear to be an open invitation to the
criminal sector, but also, if capabilities
are degraded, logically the LLEA would
not have the capability to notify
licensees. Commenters asked what they
would do with the information if
provided. One commenter suggested as
an alternative that the licensee request
the LLEA to confirm that it has a
contingency plan in case of
compromised response capabilities.
Another commenter noted that it was
more important for the licensee to
discuss this issue with the LLEA during
the coordination meetings. Another
commenter noted that there is not
prescribed action for the licensee to take
if notified and questioned the purpose
of the notification.
Response: The NRC agrees that many
LLEAs may not want to provide
information on degraded capabilities.
The provision is not included in the
final rule.
Comment C38: One commenter stated
that the participation of licensees and
LLEAs in drills and exercises was an
unfunded mandate and should not be
required. The commenter also
questioned whether drills and exercises
contribute to the security of the sources
or the public health and safety. Two
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commenters suggested removing this
requirement as there is no requirement
to conduct such drills.
Response: The NRC agrees in part and
disagrees in part. The proposed rule did
not require that drills and exercises be
conducted. The rule did contain a
provision that required the licensee to
ask whether the LLEA would be willing
to participate in drills and exercises. As
there is no requirement to conduct drills
and exercises, the NRC has removed this
provision as suggested by the
commenters. The NRC does note that
drills and exercises can contribute to the
public health and safety and the
security of the material.
Comment C39: Several commenters
felt that the requirement for a licensee
to notify the regulatory agency if an
LLEA declines to participate in
coordination activities creates an
unnecessary burden for the regulatory
agencies that will now be required to
notify the Department of Homeland
Security or contact the LLEA directly to
explain the importance of cooperating.
Some commenters suggested that if NRC
believes this is truly a critical issue,
NRC should coordinate with the Federal
Department of Homeland Security’s
Nuclear Sector Government
Coordination Council to engage law
enforcement from a broader perspective.
One commenter asked what actions the
NRC would take when notified and
what the NRC would do if the NRC did
not gain confidence that the LLEA
would respond in an actual emergency.
Response: The NRC disagrees with the
comment. The NRC believes it is vitally
important for the licensee to coordinate
with the LLEA, and the agency wants to
know if the LLEA won’t participate.
There were instances during
implementation of the orders where the
NRC met with the LLEA to explain the
importance of LLEA cooperation with
the licensee. The State is not required to
contact DHS or the LLEA if the LLEA
does not want to participate in
coordination activities. DHS does have
training programs to educate LLEAs.
Comment C40: Two commenters
objected to the requirement to
coordinate with the LLEA every 12
months, noting that it took several
months to set up a meeting for the
coordination required by the orders. The
commenter felt that, as there had been
no events requiring contact with the
LLEA and no changes to the security
program, there was no need to meet
annually. The commenter noted that
both parties have plenty of work and are
not just sitting around and focusing on
this one agenda item. The commenters
asked whether the licensee would be
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cited if the LLEA refused to meet on an
annual basis.
Response: The NRC disagrees with the
comment. The NRC believes that it is
important to maintain contact with the
LLEA. Turnover at both the LLEA and
the licensee occurs over time and if
contacts are not maintained, the
knowledge obtained during the initial
coordination is lost. The annual follow
up does not need to be extensive. If the
LLEA refuses to participate, the licensee
should document the attempt. The
licensee would not be cited as long as
it had documented the attempt(s).
Comment C41: One commenter noted
that the requirement to document
coordination activities with the LLEA
would now require regulatory agency
inspectors to visit LLEAs to determine
licensee compliance, resulting in longer
inspection times and possibly creating a
situation that may be interpreted by the
LLEA as intrusive.
Response: It is not clear why the
commenter feels that an inspector
would be required to visit the LLEA to
determine a licensee’s compliance with
the rule’s coordination requirements
under § 37.45. The licensee is required
to document the coordination activities,
and an inspector would be expected to
review the documentation. An inspector
may choose to contact the LLEA to gain
a greater understanding of the nature of
the coordination efforts. However, this
rule does not require that an inspector
contact the LLEA to determine licensee
compliance with § 37.45.
Comment C42: Two commenters
noted that the goals and objectives for
coordination activities with LLEAs are
admirable, but the commenters stated
that this is an area where the NRC
should consider taking concerted efforts
to engage law enforcement communities
to improve situational awareness now,
rather than waiting for feedback from
licensees regarding potential LLEAs
refusing to cooperate. The commenters
suggested that the NRC consider an
outreach campaign aimed at direct
communications with LLEAs to better
understand their perspectives regarding
these issues. Another commenter
suggested a Federal outreach training
program to LLEAs for radioactive
materials incident response. The
commenter noted that DOT has an
outreach program for transportation
incident response.
Response: During the security
inspection process, the NRC inspectors
have been contacting the LLEAs to both
ensure that licensees have been
coordinating and to improve the LLEAs
understanding of the importance of
providing a timely response. At this
time, the NRC is not planning any
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additional outreach to LLEAs. However,
the DOE has a program to provide
LLEAs with additional training for
responding to the attempted or actual
theft of category 1 or category 2
quantities of radioactive material. The
Global Threat Reduction Initiative
(GTRI) program provides security
personnel and local law enforcement
with tools (e.g. radios, repeaters, and
personal detection devices) and
additional training to respond to a
security incident. To ensure that both
onsite and offsite responders
understand how to respond to enhanced
security system alarms, GTRI developed
an alarm response training course,
which is held at the Y–12 National
Security Complex in Oak Ridge,
Tennessee. This alarm response training
also prepares responders to protect
themselves and the public when
responding to events involving
radiological materials. The participants
conduct hands-on training in a realistic
setting using actual protection
equipment and real radioactive sources.
The courses include operational
exercise scenarios that build on
classroom instruction and allow
response forces to exercise their own
procedures during realistic alarm
scenarios.
Comment C43: One commenter noted
that not all events that occur are of a
nature that an LLEA would have to be
involved and questioned why it should
be mandatory that an LLEA respond to
events that could be handled by internal
security.
Response: It is not mandatory that the
LLEA respond to all events. The
licensee is suppose to assess the event
and contact the LLEA only if there has
been an actual or attempted theft,
diversion, or sabotage attempt. The
language has been clarified.
Comment C44: One commenter
questioned how the failure of the LLEA
to coordinate fully with the licensee
would impact the status of a license.
The commenter noted that licensees
should not be held accountable for
noncooperation or lack of resources on
the part of the LLEA. The commenter
stated that it should be under the
purview of the NRC or Agreement State
to ensure that the LLEA works with the
licensee in the requested manner.
Response: Failure of the LLEA to
coordinate does not affect the status of
the license, and licensees will not be
held responsible if the LLEAs do not
coordinate. Under § 37.45(b) and (c),
licensees are only required to document
their coordination efforts and notify
their appropriate NRC regional office if
the LLEA does not wish to coordinate.
The NRC will contact the LLEA to
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explain the potential consequences of
the theft of category 1 or category 2
quantities of radioactive material and
encourage the LLEA to participate in
coordination activities with the
licensee.
Comment C45: One commenter
requested that the NRC add a subsection
to clarify requirements for coordination
by a licensee or permittee under a
master materials license that has an
onsite LLEA that would preclude
unwarranted interpretations during a
regulatory inspection about the extent
that coordination must be documented.
The commenter offered suggested
language as follows: ‘‘For a licensee or
permittee under a master materials
license with an on-site LLEA,
coordination requirements in this
subsection are considered to have been
completed if the security plan and
implementing procedures establish
methods for LLEA response at the
facility.’’ Another commenter raised the
issue of unnecessary documentation of
coordination activities when the LLEA
is part of the same organization that
owns the radioactive material. The
commenter noted that the lack of
documentation activities should be seen
as good news unless the LLEA refuses
to respond to appropriate requests for
assistance. The commenter also notes
that burdening the police with detailed
paperwork is an ‘‘insult to their
understanding of the risks inherent to
their mission.’’ This commenter also
suggested adding a new subparagraph as
follows: ‘‘When the LLEA is part of the
organization that owns and controls the
Category sources, the documentation in
§ 37.45(a)(2)’’ {was (a)(1)} ‘‘is not
required provided all the elements of
good willful coordination are clear.’’
Response: Even when the LLEA is on
site, the licensee should conduct
coordination activities. The
coordination would likely be simplified
but still needs to occur. The
coordination activities to meet the
requirements of § 37.45 need to be
documented even if the LLEA is part of
the same organization. The licensee
would not need to document all
interactions with the LLEA, only those
necessary to meet the requirements.
Note that it is not the LLEA that is
required to document the coordination
activities.
Comment C46: One licensee asked
whether a written agreement with a
third party service that provides offduty local law enforcement agents on
site at all times would be acceptable to
demonstrate compliance with the LLEA
coordination requirement. The
commenter stated that the agents have
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full response and arrest capabilities
while working at the facility.
Response: If the third-party service
provides individuals that meet the
definition of LLEA and the third-party
service can provide a timely armed
response 24 hours per day, then the
third party service providers meet the
requirement for LLEA coordination.
Comment C47: One commenter
questioned what would be expected of
the State if the LLEA did not respond to
an event?
Response: The expected response
would depend on the circumstances and
would be up to the State. The NRC
believes that it would be highly unlikely
that the LLEA would not respond to an
actual or attempted theft of radioactive
material.
Comment C48: In the proposed rule,
the NRC specifically invited comment
on the requirement to contact the LLEA
for work at a temporary jobsite.
Commenters were requested to provide
information on: (1) Whether there is any
benefit in requiring that the LLEA be
notified of work at a temporary jobsite;
(2) whether notifications should be
made by licensees for work at every
temporary jobsite or only those where
the licensee will be working for longer
periods, such as the 7 day timeframe
proposed in the rule; (3) whether 7 days
is the appropriate threshold for
notification of the LLEA or should there
be a different threshold; (4) whether
licensees can easily identify the LLEA
with jurisdiction for temporary jobsites
or whether this imposes an undue
burden; and (5) whether LLEAs are
interested in receiving these
notifications. Eighteen commenters
provided responses to the specific
questions on this subject.
Of those that provided responses to
the questions on LLEA notification at
temporary jobsites, the majority
indicated that there was no benefit to
notifying the LLEA of temporary
jobsites. Only one commenter indicated
that there is some benefit for
notification of work using category 1
materials and one noting some benefit
for a temporary jobsite lasting longer
than 30 days. Commenters indicated
that temporary jobsites are
unpredictable in nature and therefore
unlikely to be a primary target.
Commenters noted that in most cases
the licensee does not know 3 days in
advance where work might occur and
that due to the nature of the job it is
often not possible to determine the
length of the job in advance.
Commenters noted that the notifications
may cause confusion for the LLEA and
would likely be intrusive. Commenters
indicated that the emergency 911
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system is adequate in the case of a
security event. One commenter noted
that the LLEA would also need to be
notified when the job ended. One
commenter suggested that notifications
go to a central location, such as the NRC
or Agreement State, and then the central
organization could coordinate with
State and local police. The commenter
indicated that this would reduce the
confusion and workload on both the
licensees and the LLEA and help to
maintain a healthy working relationship
and be more effective. Some
commenters noted that clarification
would be needed to address cumulative
time where 7 days are not consecutive
and to better define the boundary of a
temporary jobsite for jobs along
pipelines. Commenters indicated that it
would be difficult to identify LLEA with
jurisdiction over temporary jobsites,
noting issues with overlapping
jurisdictions, moving jobsites, offshore
locations, etc. Commenters stated that
this would impose a huge burden
without meaningful benefit. Most
commenters indicated that the LLEA
would not be interested in receiving
temporary jobsite notifications.
Commenters indicated that LLEAs
would respond in the case of an
emergency whether there was an
advance notification or not. No LLEAs
provided comments.
In addition to those commenters that
provided responses to the questions, 32
commenters provided comment on the
issue of LLEA notification for temporary
jobsites. Most of the commenters
objected to the requirement to notify
LLEA for work at temporary jobsites.
Commenters thought that the
requirement was unrealistic and created
an unnecessary burden, both in
personnel and operations. One licensee
noted that its company had over 5,000
jobs a year that would meet the
requirement and that in addition many
jobs, that were to be less than 7 days,
experience delays that are beyond the
control of the company. Commenters
noted that the paperwork for the
notifications will be time consuming to
produce and, if it is to be valuable, time
consuming for LLEAs to read and
comprehend. Many noted that there is
no practical means to identify the
appropriate LLEA, particularly in areas
that the licensee is not familiar with,
and in some cases a temporary jobsite
might cover a very large area with
several overlapping jurisdictions, and it
can be difficult to determine which
agency is the first responder.
Commenters noted that many times
licensees are notified of the necessity of
work on the same day the work is
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required and don’t know 3 days in
advance, with one commenter noting
that only about 3 percent of its jobs are
known 3 days in advance. Commenters
noted that these jobs often involve
repair of critical oil and gas
infrastructure which could be delayed
while attempting to determine which
LLEA has jurisdiction and coordinating
with them, creating significant cost to
the industries with no benefit. One
commenter suggested that, if the
provision was retained, it be modified to
require the notification be made within
three business days subsequent to
beginning work as this would alleviate
some of the problems created by
advance notifications.
Some commenters noted that the
LLEAs do not want to receive these
notifications and would be unprepared
to receive the notifications. Some
commenters thought that the contacts
with the LLEA without possible
response from the LLEA may
accomplish nothing but aggravation and
frustration for the LLEA. One
commenter (a State) indicated that,
based on a survey of LLEAs, the LLEAs
want to know about a temporary jobsite,
no matter how long the site will be
used, so they can plan for emergencies.
The commenter indicated that the LLEA
would like a standardized form to be
used by States that clearly indicates the
high priority of the information. Many
commenters noted that the 911 system
is the best tool if there was an attempted
theft and that responders would quickly
respond once they realized that
radioactive material was involved.
Commenters noted that it is expected
that the LLEA will respond to a security
event in fulfillment of their
responsibility to protect life and
property and that in many jurisdictions
LLEA resources are somewhat limited.
Commenters felt that the NRC lacked a
true understanding of the nature of the
temporary jobsite work that is done or
the concept of using the 911 system
when law enforcement is needed. At
least one commenter felt that the NRC
was placing the licensee in a position
that would likely result in unintentional
violations to the rule. Commenters felt
that due to the itinerant nature of
temporary jobsites and being constantly
on the move, it would be very difficult
to plan a theft in the field setting. One
commenter noted that licensees are
already required to negotiate and pay for
reciprocity, as well as inform the
applicable State agency as to when and
where operations are planned and the
duration of the project and that
expansion of this requirement to
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include local authorities was asking a
lot.
One commenter suggested an
alternative of requiring daily contact
with the home office and noted that
failure to contact would prompt an
investigation by the home office which
would lead to LLEA notification as
appropriate. Commenters asked who
will offer training to every jurisdiction
and who will subsidize those
jurisdictions, current local budgets
being what they are.
Response: After reviewing the
comments received on this issue, the
NRC has decided not to include the
LLEA notification for work at temporary
jobsites in the final rule. While there is
some limited benefit in receiving the
notifications, the benefit does not
outweigh the burden that the
requirement would impose.
Identification of the appropriate LLEA
would not be easy. The notifications
could also cause confusion among the
LLEAs as to what they should do with
the information. In the event of a theft,
the licensees will likely call 911, and
the LLEA will respond as appropriate to
the call. Also, as pointed out by the
commenters, companies often don’t
know where they will be working in
advance. Locations, particularly along
pipelines, shift consistently making it
difficult to know who to contact.
Comment C49: One commenter
suggested that instead of mandating the
licensees to take on this burden, the
Commission’s approach should be to
encourage licensees to offer LLEAs their
expertise and offer some form of
training to the local departments. The
commenter noted that the Increased
Control Orders require the licensees to
establish their presence with LLEAs as
the facilities clearly are a much more
attractive target to an attack than the
mobile fleets. The commenter suggested
that an adjustment in the rule
encouraging a closer relationship in this
area would be more accepted by all
parties involved and would not overly
impact said parties financially or on a
personnel basis. Creating a program that
encourages and supports licensees and
LLEAs working together would or could
create close relationships that will have
far more impacting and lasting results
than calls to the departments advising
them of work that is proposed to last
more than 7 days.
Response: The NRC has not included
the notification provision for work at
temporary jobsites in the final rule, and
there are no requirements for training
affected LLEAs. See the response to
comment C48. The NRC recognizes the
benefits to licensees of having a close
working relationship with the LLEA for
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the security of any jobsite, permanent or
temporary. Licensees are free to take
whatever actions they feel are
appropriate to develop this type of
working relationship.
Comment C50: One commenter noted
that the temporary jobsite notification
could be via email and that email is
generally unsecured unless it is
encrypted or sent as password protected
attachments. The commenter noted that
the rule does not contain any
restrictions as outlined in Regulatory
Issue Summary 2005–31.
Response: The provision for LLEA
notification for temporary jobsites is not
included in the final rule. See the
response to comment C48.
Comment C51: Some commenters
objected to the concept of a security
zone because they believe it is abstract,
nebulous, and unworkable in actual
work environments of the types of
licensees who must comply with the
regulation, and unnecessary and
burdensome with no benefit.
Commenters felt that the concept would
cause confusion. Commenters stated
that it would add an unneeded term and
concept that would likely lead to
confusion and would add burden with
little intrinsic benefit. The commenters
noted that the licensees’ procedures that
have been put into place to meet the
current orders create security and have
been verified through inspections and
that no change is necessary. Two of the
commenters stated that the security
zone concept was discussed during the
orders working group process and that
the concept was not incorporated in the
orders. The two commenters indicated
that this had the appearance of an
attempt to incorporate in rule a concept
that did not have consensus and was not
incorporated after going through the
orders working group process. One
commenter noted that the industrial use
of radioactive materials when used at its
facility is essentially a security zone
because facility access is restricted due
to ITAR requirements. This commenter
said it should be sufficiently secure to
set up restricted areas based on the
radiation level and monitor the material
until it is secured in storage. One
commenter noted that the increased
controls are in place, and it was not
aware of any situations that have
occurred that now warrant the inclusion
of a security zone designation.
Response: While working groups for
the orders may not have been able to
reach a consensus on an issue, this does
not mean that the working group for the
rule was unable to reach consensus. The
10 CFR part 37 rule working group had
information available that was not
available to the orders working group.
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The 10 CFR part 37 working group
considered the orders, lessons learned,
implementation issues, inspection
issues, recommendations from other
reviews, as well as the comments on the
preliminary rule language and proposed
rule. The purpose of security zones is to
isolate and control access to category 1
and category 2 quantities of radioactive
material to protect them more
effectively and deter theft or diversion.
A security zone effectively defines
where the licensee will apply these
isolation and access control measures. It
is thus a logical extension of the
requirement in the Increased Control
Orders that licensees ‘‘control access at
all times to [category 1 and category 2]
radioactive material quantities * * *
and limit access to such radioactive
material and devices to only approved
individuals who require access to
perform their duties.’’
Because the purpose of security zones
is different from the radiation safety
purposes of the restricted areas and
controlled areas defined in 10 CFR part
20, the security zone does not have to
be the same as either of these areas.
Because measures to control access are
required for both radiation protection
and security, however, a licensee does
have the flexibility to use an area
required for radiation protection
purposes to fulfill the required
functions of a security zone.
Comment C52: One commenter noted
that the security zone concept
potentially has serious operational and
financial repercussions and is expensive
overkill. The commenter noted that
adding continuous barriers could be
extremely expensive and may introduce
scattered radiation into labs that have
very specific operational requirements.
The commenter noted that isolating and
controlling access does not appear to
comply with the requirements for the
physical barriers and that locks, cables,
etc. would not isolate the same
radioactive material in a security zone
as required. The commenter noted that
individuals could frequent the security
zones but still be separated from the
radioactive material due to the lock but
that the rule requires that only
authorized individuals have access to
the security zones. The commenter
stated that these two concepts seem to
conflict with each other and if the
common physical barrier concept is not
acceptable, then many more licensees
will fall under these requirements due
to the aggregation of radioactive
material. The commenter noted that it
would cost over $200,000 to develop
continuous barriers and redo
calibrations, procedures, etc., if it can be
done at all. The commenter suggested
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allowing the licensee to propose
measures to compensate for the lack of
a continuous barrier when that barrier
would obstruct the use of the
radioactive material for its intended
purpose and when there is no available
alternative.
Response: A continuous barrier is not
the only method that a licensee can use
to meet the requirement. Direct
observation is also allowed, as is a
combination of barrier and direct
observation. A continuous barrier does
not have to be expensive; it can be a
metal cage or walls. The commenter
seems to believe that unauthorized
individuals cannot be in a security zone.
This was not the intent of the rule.
Unauthorized individuals can have
access to the security zone as long as
they are escorted by an approved
individual. The rule language has been
clarified, and additional information has
been added to the implementation
guidance. The licensee can establish the
boundaries of the security zone as
appropriate for a particular facility; the
rule does not dictate where the security
zone is located. In most cases, whatever
a licensee used to meet the orders will
also meet the 10 CFR part 37
requirements. The Increased Control
Orders did not use the term ‘‘security
zones’’ but the concept was a factor.
Comment C53: One commenter
expressed concern with the security
zone concept at temporary jobsites. The
commenter noted that implementation
would require additional personnel and
expense, and the security zone will
require areas that will be larger than the
radiation areas. Another commenter
noted that the concept could cause
confusion in certain types of jobsites
where aggregation of multiple low level
sources would constitute a security
zone. The commenter provided the
example of petrochemical plants that
use low level sources to monitor
product levels, noting that aggregation
of these sources will constitute a
security zone which would require
direct control by approved individuals
at all times and\or intrusion detection
systems and physical barriers. The
commenter felt that this could mean
that the entire plant would be a security
zone, and only trustworthy and reliable
employees could enter.
Response: The NRC disagrees with the
comment. It is not clear why the
security zone concept would result in
additional personnel and expense, or
why it will require security zones larger
than the radiation areas at either
temporary or permanent jobsites. A
security zone effectively defines where
the licensee will apply the isolation and
access control measures required under
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the Increased Control Orders. The NRC
is unaware of any operating conditions
that would require more space for
compliance with any of the additional
measures required by this rule. The
licensee establishes the security zone,
and because measures to control access
are required for both radiation
protection and security, a licensee has
the flexibility to use an area required for
radiation protection purposes to fulfill
the required functions of a security
zone. The NRC is unaware of any
petrochemical or other industrial plants
that have designated the entire plant as
a radiation safety area for their
radiography or other sources, and the
NRC sees no reason why such licensees
or licensed service providers would
need to designate the entire plant a
security zone for the purposes of this
rule. A licensee could of course choose
to do so.
Because the concept of aggregation is
no different from the concept of
aggregation and co-location under the
orders, it is not clear why the
application of security zone
requirements would result in confusion
at jobsites where multiple low-level
radiation sources are aggregated.
Comment C54: Several commenters
requested clarification on what
constitutes a physical barrier and
recommended that physical barrier be
either defined or guidance provided.
Another commenter suggested changing
the term to physical security barrier to
avoid confusion with the definition of
physical barrier in 10 CFR part 73. One
commenter suggested the physical
barrier is where the security zone has
been established.
Response: The NRC has revised
§ 37.47(c)(1) to provide additional
clarity. This provision now notes that a
physical barrier is ‘‘a natural or manmade structure or formation sufficient
for the isolation of the category 1 or
category 2 quantities of radioactive
material within a security zone.’’
Additional information has also been
added to the implementation guidance.
Comment C55: One commenter asked
how many security zones needed to be
designated and noted that the rule is
unclear for those licensees within fixed
facilities.
Response: The licensee is responsible
for establishing security zones. The
number of security zones established by
a licensee is dependent on the needs of
the licensee. A licensee may have only
one security zone or may have several.
Comment C56: One commenter
recommended including a provision in
§ 37.47 that exempts the security zone
requirements for category 1 or category
2 quantities of material stored in casks
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or packages that require specialized
equipment to move, open, or access, if
the equipment needed to access the
material is unavailable. One commenter
noted that the continuous monitoring of
security zones and detection capability
is a significant additional cost without
any benefit for category 1 and category
2 materials that may be stored at a
nuclear facility in a concrete
mausoleum or within individual
concrete vaults that require heavy
equipment, such as a crane, to access.
One commenter stated that clear criteria
for applicability would be needed to
implement security zones. The
commenter offered the example of
multiple high integrity containers with
lids weighing 10 tons, each inside a
shield, stored inside a fenced common
area which contains, in the aggregate, a
category 1 or category 2 quantity of
radioactive material and no crane in the
area to lift the shield container lid. The
commenter stated that establishing a
security zone for the common storage
area is required and that this is
excessive.
Response: A licensee can always
request an exemption for material or
items that it believes should be exempt
from all or some of the 10 CFR part 37
requirements. Exemptions are handled
on a case-by-case basis. Some of the
material addressed by this comment is
covered by the partial exemption in
§ 37.11(c). See also response to
comment A20.
Comment C57: One commenter noted
that large manufacturing and
distribution facilities will have several
security zones with significant
quantities of category 2 sources in
storage and that it would be impossible
to perform an effective physical check
on a weekly basis. The commenter also
noted that a weekly check is not
consistent with the ALARA principle.
The commenter noted that putting
tamper indicators on each source/device
would be cost prohibitive and require a
significant amount of time and
personnel dose to install, monitor, and
subsequently remove. The commenter
noted that sources are constantly
transferred from one container to
another in the course of manufacturing,
storage, and preparing for shipment and
receiving. The commenter requested
clarification as what ‘‘other means’’
would cover and/or be acceptable in
§ 37.49(a)(3)(ii). The commenter noted
that under the orders it has a method
approved by the Regulatory Authority to
ensure that the category 2 radioactive
material is present and that the process
is considered SGI–M information. The
commenter wanted to know how such
pre-existing compliance agreements
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would be handled under the rule. The
commenter also requested clarification
on the situation where there are
individual sources that are each less
than category 2 but when they are
collocated/aggregated the total quantity
exceeds category 2, whether the
individual sources need to have this
physical check performed. The
commenter noted that depending on the
answer, the quantity of sources affected
at a large facility could be more than a
thousand and that this would affect
many smaller facilities including
medical institutions, universities, and
gauging. The commenter noted that the
requirement has significant implication
and needs to be carefully considered to
avoid unintended adverse
consequences.
Response: The licensee is not required
to conduct a weekly physical inventory
of the category 2 quantities of
radioactive material; other methods can
be used. The other means allowed by
the rule are intended to provide the
licensee with the flexibility to use the
method that works best for its facility.
A licensee could use methods to detect
removal of the material from the
security zone. If a licensee is currently
using an agreed on method, the method
should continue to meet the intent of
the requirement. Any of the methods
deployed for category 1 materials could
also be used for category 2 materials.
Additional information is available in
the implementation guidance.
Comment C58: One commenter
requested clarification on where an NRC
security zone at a licensee site and a
DOT security zone for transport take
effect for shipments leaving a facility.
One commenter noted that the NRC
should clarify at what point the
shipment is under DOT rules and not
under 10 CFR part 37. The commenter
asked if this occurs once a shipment of
category 1 or category 2 radioactive
material is prepared (DOT paperwork in
possession of the driver) but still on a
licensee’s site. The commenter noted
that a temporary security zone cannot
accompany the shipment until it
physically exits the licensee’s property
or jobsite.
Response: It is the licensee’s
responsibility to implement the
requirements of 10 CFR part 37
throughout the shipment regardless of
the location.
Comment C59: One commenter noted
that § 37.47(d) is not clear whether the
regulation requires a physical presence
for maintaining continuous
surveillance, or whether the continuous
surveillance may be by remote
monitoring. The commenter also noted
that the wording implies that the
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licensee must provide an approved
individual and questioned whether the
service provider approved under
§ 37.29(m) is permitted to provide the
continuous surveillance while working.
Response: The continuous
surveillance may be by remote
monitoring. If a service provider has
been approved for unescorted access,
then the individual can provide the
surveillance. It is noted that if that
individual is conducting work of some
sort, it may be difficult for that
individual to also maintain continuous
surveillance.
Comment C60: One commenter noted
that § 37.47(d) requires additional
measures for security zones for category
1 radioactive material during
maintenance, source receipt, etc. when
security zones are compromised and
that permanent security zones are
required in § 37.47(c) for both category
1 and 2 radioactive material. The
commenter questioned why the
additional measures are required only
for category 1 radioactive material if the
security zones are compromised during
certain times. The commenter noted that
it appears that the isolation
requirements for radiation protection
under restricted, radiation, high
radiation and very high radiation areas
provide the same or better levels of
security than those described (i.e.,
continuous physical barriers that allow
access to the security zone only through
established access control points; or
licensees could exercise direct control
of the security zone by approved
individuals at all times). The
commenter noted that you do not need
to have duplicate regulations that apply
to category 1 and category 2 quantities
of radioactive material.
Response: The additional measures
are only required for the category 1
material because these materials are
considered higher risk than the category
2 materials. A security zone can be the
same as the area used for radiation
protection if it meets the requirements
of part 37. The measures in part 37 are
intended to prevent/detect theft of the
material and not to protect an
individual from radiation exposure.
Comment C61: One commenter noted
that § 37.47(d) indicates that during
those identified periods an approved
individual must be provided to
maintain continuous surveillance of the
sources. The commenter noted that
‘‘approved individual’’ is not defined.
The commenter also noted that
depending on the design of the facility,
multiple approved individuals may be
necessary to adequately monitor
activities throughout a site, which does
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not appear to be clearly required by the
rule.
Response: The NRC agrees with the
comment and has revised the rule to
clarify that an approved individual is
someone approved for unescorted
access and to reflect that more than one
individual may be necessary.
Comment C62: One commenter
recommend deleting the phrase
‘‘without delay’’ from § 37.49(a)(1) as
the phrase is unrealistic during normal
business hours. The commenter noted
that unauthorized access whether actual
or attempted would only be detected
‘‘without delay’’ if individuals were in
the vicinity and could witness the
access or attempt to access. One
commenter stated that the monitoring,
detection and assessment requirements
in § 37.49 are unduly onerous. The
commenter indicated that the
requirement to maintain the capability
to detect without delay attempted
unauthorized entry into the security
zone should be eliminated or defined in
a more concrete manner for the sake of
clarity in enforcement. One commenter
asked how much time is allowed for
response when an unauthorized entry
into the security zone is discovered. The
commenter also asked for clarification
on the meaning of without delay. One
commenter requested clarification on
what is meant by detect without delay
all unauthorized entries into a security
zone. The commenter asked if the
licensee was to respond immediately
and also asked how this could be
accomplished when using an alarm
monitoring service. The commenter
recommended removing ‘‘without
delay’’ from § 37.49(a)(1). The
commenter stated that ‘‘without delay’’
is unrealistic during normal business
hours as a business’ security system will
not be set to alarm. The commenter
noted that areas that may contain
category 1 or category 2 quantities may
be locked and unoccupied but not
monitored. The commenter noted that
unauthorized access whether actual or
attempted would only be detected
‘‘without delay’’ if individuals were in
the vicinity and could witness the
access or attempt to access.
Response: The NRC disagrees with the
comment. The NRC notes that the orders
contain a similar provision to
immediately detect, assess, and respond
to unauthorized access. ‘‘Without
delay’’ means promptly or immediately.
The purpose of security provisions is to
quickly detect and respond to any
potential theft of the material. The NRC
further notes that, if a licensee is merely
locking the material in a room and not
implementing any other security
provisions, they would not be in
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compliance with the orders or the rule.
No change has been made to the rule.
Comment C63: One commenter noted
that the intent of § 37.49(a)(1), in the
event of a power failure or tampering
that affects the monitoring and detection
system, should be to provide (1) a
reliable power back up or (2) prompt
notification of the power failure/
tampering such that the licensee will
take immediate corrective action to
restore the power and provide for
alternate monitoring and detection that
meets the requirements of the part until
the system is repaired. One commenter
asked what the NRC’s expectations were
for implementation of the security
requirements in an emergency,
including the expectation as to how
long backup systems were required to
operate. The commenter asked how a
licensee is supposed to implement these
requirements when there are no
provisions for individuals to even
reenter a disaster area.
Response: The backup power for the
monitoring and detection system needs
to be available until power is restored or
other measures need to be used such as
direct surveillance. Disaster situations
such as flooding or earthquakes that
prevent entry to the facility would be
addressed on a case-by-case basis.
Comment C64: One commenter stated
that § 37.49(a)(2)(ii) should contain a
more accurate description such as
‘‘* * * alert personnel within audible
range of the alarm.’’ Another commenter
noted that ‘‘nearby’’ needed to be
clarified as NNSA representatives
recommended only silent alarms in the
area immediately surrounding category
2 sources.
Response: The NRC believes that the
language is appropriate and has not
revised the rule. Additional information
is provided in the implementation
guidance document.
Comment C65: Two commenters
recommended adding a 4th method to
§ 37.49(a)(3)(i) to allow security zone
intrusion detection alarms. The
commenter explained that when the
intrusion detection system is monitoring
the security zone, an attempt to gain
unauthorized access into the security
zone results in an alarm that is equated
to an attempt to remove or sabotage the
material. The commenter noted that
during normal business hours when an
intrusion detection alarm to a security
zone is disabled the licensee prevents
unauthorized access into security zones
with locks, physical barriers, and
surveillance or some combination of
each. The commenter stated that it is
during these periods that a tamperindicating alarm or radiation detection
alarm or video surveillance could alert
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the licensee of an unauthorized attempt
to remove radioactive material from the
security zone. The commenter stated
that, if the method is not added,
revision is needed in the
implementation guide that allows the
licensee to rely on its main site wide
intrusion detection system when the
intrusion detection system is activated,
the facility is not occupied by the
licensee, AND the intrusion detection
system can detect access to the security
zone.
Response: The NRC disagrees with the
comment that a 4th method needs to be
added to the rule. Although this is not
the preferred method, the situation
described in the comment is not
prohibited under the rule. Additional
information has been added to the
implementation guidance.
Comment C66: One commenter asked
whether a tamper device was sufficient
to verify the presence of material or
would a weekly check still be necessary.
One commenter noted that a weekly
verification should only be performed
for sources/devices that do not have
tamper-indicating devices. Another
commenter stated that the weekly check
was too prescriptive and asked about
the basis for the timeframe. Another
commenter stated that a weekly check
was not adequate. The commenter noted
that the orders require the licensee to
respond immediately to any actual or
attempted theft, sabotage, or diversion
and that a weekly check would allow
the material to be missing for up to a
week before it is discovered. The
commenter suggested that
§ 37.49(a)(3)(ii) be revised to read: ‘‘For
category 2 quantities of radioactive
material, the licensee must maintain
control of licensed material, secure it
from unauthorized removal or access,
and without delay, detect and recover
all stolen, missing or lost licensed
material.’’ One commenter stated that
verification of the radioactive material
may not be appropriate for sources
housed in devices. The commenter
suggested requiring verification ‘‘to
ensure that the source/device is
present’’ and suggested that this
verification could be made by means of
a camera in the room housing the
device/source.
Response: Category 2 quantities of
radioactive material are considered risksignificant and if not in use, the material
needs to be checked to make sure it is
still present. Contrary to the comment,
the rule is not prescriptive. The rule
does not require that a licensee conduct
a physical check. The rule allows the
licensee to pick a method that best fits
its needs; a physical check is one of the
methods that could be used. There are
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many other methods that could be used
to conduct the verification. Tamper
indicating devices are considered
adequate to meet the requirement. The
licensee can also use methods to detect
removal of the material.
Comment C67: One commenter
suggested deleting the weekly
verification for category 2 quantities in
§ 37.49(a)(3)(ii) and include the category
2 material in the category 1 material
requirement for continuous
surveillance. The commenter noted that
the provision implies that it may be
acceptable for a missing category 2
quantity of material to go undetected for
up to a week when this is clearly not the
case.
Response: Category 1 quantities of
radioactive material are considered
higher risk than category 2 quantities of
radioactive material. Therefore, there
are more requirements on the category
1 material. The commenter is correct,
however, that the NRC does not mean to
imply that it is acceptable for missing
category 2 materials to go undetected for
a week. A weekly verification is just one
of several acceptable methods to make
sure that unauthorized removal of the
material has not occurred. Each licensee
must determine its own compliance
strategy to meet the security
requirements of this rule, but the rule
provides significant latitude for each
licensee to comply in a way that
optimizes its individual operating
requirements.
Comment C68: Two commenters
stated that the monitoring and detection
requirements of the security program
need to be more prescriptive, with a
minimum requirement for electronic
sensors and a detection system linked to
an onsite or offsite monitoring facility.
The commenters did not believe that
allowing monitoring and detection to be
performed only by visual inspection or
direct visual surveillance was adequate.
The commenters noted that the concepts
of detection, delay, and deterrence are
best implemented through multiple tiers
of security. The commenters stated that
in the scenario of armed terrorists with
explosives attacking a facility, reliance
on individuals to be the sentinels would
allow the security program to be
defeated rather easily.
Response: While the NRC agrees that
defense in depth is always a good
practice, the NRC believes that allowing
direct visual surveillance is appropriate.
The NRC attempts to balance the burden
of imposing additional requirements
against the risk of the material and the
added protection a measure provides.
Comment C69: One commenter stated
that the requirement to have a means to
detect unauthorized removal of the
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radioactive material from the security
zone was unnecessary and would create
a huge burden to establish. The
commenter also noted that the
requirement does not even account for
the fact that the alarm has to be
monitored or by whom.
Response: The purpose of the security
program is to detect and prevent
unauthorized removal of the category 1
and category 2 quantities of radioactive
material. The provision in question does
not require an alarm. If alarms are used,
the licensee has flexibility in
determining who conducts the
monitoring and who responds.
Comment C70: One commenter asked
what the NRC’s expectation was for
implementation of the requirement to
immediately detect any attempted
unauthorized removal through the use
of electronic sensors linked to an alarm.
The commenter wanted to know if the
electronic sensors are to be mounted to
the actual source, hot cell, or storage
area. The commenter noted that there
are numerous ways to shield radioactive
material, therefore, the method has to be
able to detect an unauthorized removal
of a shielded container, and using a
building or area alarm is specifically not
allowed.
Response: The NRC assumes the
commenter is referring to the
requirements in § 37.49(a)(3). This
requirement is in addition to the
requirements in §§ 37.49(a)(1) and
37.49(a)(2). Licensees must be able to
detect the unauthorized removal of a
category 1 source. Licensees can choose
any method to detect unauthorized
removal. Some methods that the
licensee may use to meet this
requirement include, but are not limited
to, the following:
• Alarming electronic tamperindicating device;
• Alarming radiation detector; or
• Visual surveillance by an approved
individual.
If a licensee uses electronic tamperindicating alarms, the alarm should be
capable of alarming either when an
attempt is made to remove a category 1
quantity of radioactive material from a
device, or when an attempt is made to
remove the device itself. The tamperindicating alarms should be armed at all
times, except during periods of
maintenance.
Comment C71: One commenter stated
that it is an unreal expectation that
licensees can assess an attempted
unauthorized entry and that the
requirement should be removed as there
is no resulting gain in security. The
commenter noted that this increases the
surveillance burden on licensees to
monitor not just access but attempted
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access. As an example the commenter
noted the situation where someone
walking by tries to open the door and
the licensee would be required to be
able to detect that and assess. For the
same reasons, the commenter stated that
the requirement to respond to attempted
unauthorized access should also be
removed. Another commenter felt that
the requirement was too broad. This
commenter also noted the situation
where someone (including an inspector)
tries a locked doorknob of a secured
area. The commenter noted that there is
no point in responding to this sort of
challenge to the system as long as the
door remains locked as there is no
security benefit gained by responding to
this type of situation. The commenter
stated that to prevent and reduce
unnecessary responses to this sort of
trivial challenge, a continuous
watchman would be needed or a locked
door outside the security zone to
prevent access to the boundary of the
security zone to keep individuals away
from the security zone. The commenter
suggested the following change to the
rule text: ‘‘The licensee shall
immediately respond to any action that
breaches the perimeter of the Security
Zone.’’ One commenter noted that
§ 37.49(d) requires the licensee to
immediately respond to any actual or
attempted unauthorized access in
addition to requesting an armed LLEA
response. The commenter noted that
presumably this means the alarm
service will notify the LLEA on behalf
of the licensee as requiring the licensee
to physically respond could put them in
harm’s way should the intruder be
armed. The commenter also asked what
other actions the licensee should take
(i.e., do surveys, inventory material,
etc.).
Response: The NRC disagrees with the
comment. The NRC believes that it is
important to assess the attempts to gain
unauthorized entry. An individual
could test the system before an actual
break-in to steal the material.
Comment C72: One commenter
pointed out that the NRC supported and
recommended that licensee’s volunteer
to participate in the NNSA GTRI
program. The commenter noted that the
rule does not acknowledge or
differentiate its requirements for fixed
facilities which have completed or are
in the process of completing
participation in the GTRI and that the
NRC should acknowledge the
differences between facilities that
merely meet the NRC requirements and
those that have the robust security
provided by the GTRI. The commenter
stated that licensees will be unable to
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meet specific requirements prescribed
in proposed part 37.
Response: The NRC does support the
GTRI program that provides security
upgrades to licensee facilities. However,
all licensees are required to meet all of
the requirements of 10 CFR part 37
regardless of participation in the GTRI
program. Licensees that participate in
the GTRI program may take credit for
those upgrades that meet the 10 CFR
part 37 requirements.
Comment C73: One commenter asked
how long the continuous (primary or
alternative) communication capability
must continue to be operable. The
commenter asked what arrangements
need to be made to maintain the
capability in any emergency. The
commenter noted that there is no
practicable means to implement this
requirement as no communications
systems work reliably for many hours or
days, particularly if there is no power
available, nor personnel allowed in the
area to start a generator.
Response: During most emergencies,
the licensee would be expected to
maintain operability of either the
primary or alternative system
throughout the emergency. Disaster
situations such as flooding or
earthquakes that prevent entry to the
facility would be addressed on a caseby-case basis.
Comment C74: One commenter noted
that guidance on allowable dose limits
should be added to § 37.49(d) for LLEA
first responders. The commenter noted
that most licensees are probably
following the EPA’s Protective Action
Guidance of 25 rem whole body dose for
life-saving actions and protection of
large populations and that it would be
helpful to have guidance on what to
plan for, as part of LLEA training.
Response: The NRC disagrees with the
comment and notes that guidance does
not belong in the regulations. First
responders are subject to the dose
restrictions in State or Federal
occupational safety regulations.
Comment C75: Several commenters
suggested revising the frequency of the
testing, maintenance, and calibration
requirement. One commenter
questioned the technical basis to require
operability and performance testing of
intrusion alarms and communication
systems every 3 months and asked if the
frequency was supported by industry
data or a probabilistic risk analysis from
the nuclear power industry. Another
commenter stated that the test frequency
for a device should have a relationship
to the device’s known failure rate.
Another commenter stated that the
requirement was extremely vague,
questioned what standard things are to
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be tested and calibrated, what
performance standard should be used,
and noted that the timeframe was
arbitrary. The commenter suggested that
annual testing would be more consistent
with other requirements. One
commenter suggested every quarter at
intervals not to exceed 5 months. The
same commenter also suggested adding
‘‘Equipment without a known failure
mechanism shall be tested after initial
installation and at a frequency not to
exceed 10 years.’’ One commenter
suggested a monthly frequency, another
suggested an annual frequency. One
commenter stated that testing should be
more frequent than quarterly but did not
specify a timeframe. One commenter
suggested testing every 6 months and
noted that testing required 40 manhours to complete. One commenter
stated that any testing should include
verification of the notification process to
the responding individuals, including
the LLEA, on at least an annual basis.
One commenter recommended an
annual requirement to exercise the
assessment and response portions of the
physical protection systems including
an invitation to the LLEA to participate
if reasonable to do so. One commenter
stated that an annual requirement
should be included that exercises the
assessment and response portions of the
physical protection systems.
Response: The NRC reevaluated the
testing frequency. The requirement has
been changed to allow the licensee to
conduct the maintenance and testing at
the manufacturer’s suggested frequency.
The manufacturer’s suggested frequency
would presumably account for known
failure rates. If the manufacturer does
not suggest a frequency, the testing must
not exceed 1 year.
The NRC agrees that exercising the
response portion of the security plan is
a good practice, and we encourage
licensees to exercise their plans with the
LLEA. However, requiring licensees to
exercise their response plans may be too
burdensome for small licensees with
less complex security plans.
Comment C76: One commenter stated
that the rule and guidance should allow
licensees to limit testing of alarms,
associated communication systems, and
other physical components of the
security system to those alarms,
systems, and components necessary to
meet the requirements. The commenter
pointed out that testing all alarms,
systems, and components quarterly is a
long-term financial burden and could
result in licensees removing all
unnecessary alarms, systems, and
components. The commenter noted that
requiring only testing of necessary
equipment leaves the requirement open
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for interpretation but that performancebased regulations should allow for a
risk-based analysis. The commenter
stated that testing of all alarms places an
unnecessary burden on licensees and
will encourage licensees to minimize
the number of alarm points in a system
which is counter to the intent of this
regulation. Testing of necessary alarms
will show that the system is functioning
appropriately. Another commenter
noted that some devices may require
partial disassembly of the equipment for
testing and that repeated disassembly
and reassembly for testing purposes
could lead to premature failure or wear
on components. The commenter
suggested that internally installed
detection devices be allowed to be
tested on an annual basis, which could
coincide with an annual preventive
maintenance of the equipment. One
commenter noted that the rule needs to
be modified to indicate what testing is
required. One commenter requested that
the following be addressed in the
discussion when the final rule is
published. If an alarm system/device is
removed/de-energized from service
because the ‘‘individual with overall
responsibility for the security program’’
deemed the device unnecessary,
obviously there are no testing/
maintenance requirements; however, if
the device is deemed unnecessary, but
remains energized, must testing/
maintenance be performed and
documented?
Response: The NRC agrees with the
comment. The licensee is only required
to maintain and test those components
that it relies on to meet the security
requirements of 10 CFR part 37. See also
the response to C75.
Comment C77: Three commenters
recommended removing the
requirement for calibration from § 37.51.
One commenter noted that there are
procedures to test and maintain these
systems, but the term calibration seems
out of place. Another commenter
questioned how you calibrate an
intrusion detection system. Several
commenters requested clarification on
what is expected beyond maintenance
and testing. One commenter suggested
changing calibration to appropriate
operational checks. The commenter
noted that true calibration of radiation
monitors would expose staff to
unnecessary radiation dose.
Response: The NRC agrees with the
comment and has removed the
calibration requirement. Testing the
operability of a system is sufficient to
ensure that the equipment is operational
and able to serve its function. Some of
the equipment, such as meters, relied on
for safety may be calibrated, but some
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equipment would not be calibrated as
the term is typically considered.
Comment C78: One commenter stated
that it was not clear what is expected for
compliance for the maintenance, testing,
and calibration requirement. Another
commenter asked what was considered
acceptable maintenance, testing, and
calibration.
Response: The licensee must ensure
that the intrusion detection system (IDS)
is operational and capable of performing
its required function. To maintain
functionality, licensees must
periodically test the IDS and perform
maintenance on malfunctioning
components. The testing program is
considered acceptable if the IDS
operates in a manner consistent with the
licensees’ physical security plan.
Licensees will be required to test the
entire IDS or components of the IDS at
the frequency specified by the
manufacturer or at least annually. The
licensee may choose to test the entire
IDS or components of the IDS
throughout the 12 months.
Comment C79: In the proposed rule,
the NRC specifically requested comment
on whether an exemption for disabling
vehicles should be provided in certain
hazardous situations. Commenters were
requested to provide information on: (1)
Whether relief from the vehicle
disabling provisions should be
provided; (2) any problems experienced
in implementing this aspect of the
Increased Controls; (3) whether there
should be an exemption written into the
regulations or should licensees with
overriding safety concerns be required
to request an exemption from the
regulations to obtain relief from the
provision; (4) whether any exemption
should be a blanket exemption or a
specific exemption for the oil and gas
industry; and (5) whether the disabling
provision conflicts with any
Occupational Safety and Health
Administration (OSHA) requirements or
any State requirements. Fourteen
commenters provided responses to the
specific questions on this subject.
Of those that provided responses to
the questions on the exemption for
disabling vehicles when a mobile source
is in or on the vehicle, the majority
supported providing some sort of relief
from the vehicle disabling provisions
where there is a potential threat due to
the work environment, such as a
refinery or oil field. Only one
commenter opposed providing relief. A
couple of commenters did indicate that
they had had problems in implementing
the vehicle disabling requirement under
the Increased Controls, some
commenters noted that the provision
was in opposition to the facility safety
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rules. A couple of commenters noted
that the requirement was in conflict
with OSHA and/or State requirements.
On the question of whether an
exemption should be written into the
regulations or handled on a case-by-case
basis, the commenters were split, but a
slight majority favored writing the
exemption into the regulations. Those
supporting the exemption being written
into the regulations noted that providing
an exemption on a case-by-case basis
creates a burden on the licensee to
prepare the request and on the
regulatory agency to review the request.
One of the commenters supporting the
regulatory exemption still felt that the
licensee should provide adequate
justification for claiming the exemption.
Those not supporting the regulatory
exemption felt that the case-by-case
review would allow the regulator to
review whether the exemption was
actually warranted. Two of the
commenters stated that the requirement
should be removed as the requirement
to remove the ignition key is not
warranted and unnecessary. On the
question of whether an exemption
should be specific for the oil and gas
industry or be broader, most
commenters supported a blanket or
broader exemption. One commenter
suggested a blanket exemption for all
category 2 sources. On the question of
whether the disabling provision was in
conflict with OSHA or any State
requirements, three commenters
indicated a possible conflict but did not
provide any specifics.
In addition to those that responded to
the specific questions, five commenters
provided comments on this topic. One
commenter noted that the requirement
for disabling mobile sources presents
safety concerns within a refinery or
petrochemical plant. The commenter
noted that individuals must be able to
quickly evacuate the site in the event of
an emergency and that unoccupied
vehicles must be able to be moved by
other evacuees or emergency
responders. The commenter noted that
requiring a secondary securing device
other than the key from a vehicle
prevents the easy movement of the
vehicle and compromises safety in the
event of an emergency. One commenter
indicated that relief should be provided
on an as-needed basis. Another
commenter noted that there is a
possibility that an individual using a
mobile device needs to evacuate an area
quickly and that using a disabling
device could jeopardize the health and
safety of the individual. The commenter
suggested the following language: ‘‘For
devices in or on a vehicle or trailer, the
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licensee shall secure the vehicle or
trailer containing the device from theft
when not under the direct control of the
licensee. This may be accomplished by
removing the ignition key and arming a
vehicle alarm system, or through the use
of disabling device or by the removal of
component that would result in the
inability to operate the vehicle or
trailer.’’ One commenter stated that
further guidance was necessary on what
was meant by disable and that the
commenter assumed that the disabling
was temporary. One commenter
indicated that any exemption should be
broader than just for the oil and gas
industry. One commenter recommend
revising § 37.53(b) to allow credit for
removing the key from the ignition and
maintaining the key with the individual.
The commenter noted that a disabling
device could add additional risks to the
worker; for instance, if the device fails,
the individual may become stranded, or
it may slow emergency egress.
Response: After consideration of the
comments on this issue, the NRC has
decided that an exemption should be
added to the regulations instead of
doing reviews on a case-by-case basis.
Requiring licensees to submit an
application for an exemption that would
in most cases be approved imposes
unnecessary burden on both the
licensee and the agency staff. The NRC
has also decided that the exemption
should be broader than for just the oil
and gas industry as there are other
situations where a similar health and
safety issue may arise. The NRC has
revised § 37.53(b) to provide flexibility
for situations where the health and
safety requirements for a site prohibit
the disabling of the vehicle.
Comment C80: One commenter
indicated that the terms ‘‘mobile’’ and
‘‘portable devices’’ are used differently
in 10 CFR part 37 than elsewhere in the
regulations. The commenter stated that
the NRC should change the terminology
or the requirements be changed to be
applicable to already defined mobile
and portable devices.
Response: The NRC disagrees with the
interpretation that the terms ‘‘mobile’’
and ‘‘portable devices’’ are used
differently in 10 CFR part 37 than
elsewhere in the regulations. The usage
of the terms in 10 CFR part 37 is in
agreement with previously issued NRC
guidance. Specifically, the Increased
Controls Question and Answer #159,
provides guidance for definitions for
‘‘portable’’ and ‘‘mobile’’ as provided by
the American National Standard for
Gamma Radiography.
Comment C81: A few commenters
suggested a change to the timing of the
program reviews. Commenters
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suggested an annual frequency not to
exceed 14 months between the dates of
the reviews, a timeframe of 15 months,
a timeframe of 8 to 15 months, and
language similar to § 20.1101 of
periodically (at least annually). The
commenters noted that this would
provide some flexibility to allow for
circumstances beyond the control of the
workforce. One commenter noted that
the program review could be eliminated
and included under § 20.1101(c). One
commenter stated that the review
should include a requirement for the
licensee to summarize those occasions
where an unauthorized access resulted
in activation of the monitoring and
detection systems, but the licensee’s
assessment showed no actual or
attempted theft or diversion of
radioactive material as such alarms
could be indicative of a ‘probe’ to test
or evaluate a licensee’s response by a
potential intruder.
Response: The NRC agrees with the
comment and has revised the language
for the program review to be consistent
with § 20.1101. The use of consistent
terminology between the safety and
security programs should enhance the
licensee’s understanding of the
requirement. The NRC does not believe
that it is necessary to add additional
detail on what must be included in the
program review.
Comment C82: One commenter noted
that § 37.55 introduces the term
‘‘radioactive material security program’’
which should be clarified and
consistently used in the regulations.
Response: The concept of the security
program is introduced in § 37.41. The
NRC believes that the term has been
used consistently in the regulations and
that the concept is clear. The
implementation guidance contains
information on the security program.
Comment C83: One commenter
requested clarification on what
radioactive materials should be
included in the security program
review.
Response: Part 37 only applies to
category 1 and category 2 quantities of
radioactive material. The security
program review would only address the
security of the category 1 and category
2 quantities of radioactive material.
Comment C84: One commenter
indicated that the LLEA required it to
file Non-Residential Burglary Alarm
Registrations for each room in which an
irradiator is housed (and to which they
are expected to respond in the event of
an alarm). The commenter noted that
the LLEA has indicated that an LLEA
response is deemed false if no evidence
of criminal activity is found, in which
case a ‘‘False Alarm Notice’’ will be
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served, including penalties escalating
up to $4000 for requested LLEA
responses that are judged to be false.
The commenter noted that this places
the licensee in a very bad position to
attempt compliance with this regulation
and risk fines from the LLEA. The
commenter noted that there does not
need to be evidence of criminal activity
for the licensee to perceive a threat to
its facility, and appropriately request
LLEA response. The commenter
requested that NRC conduct outreach to
the LLEA community with the intent of
clarifying NRC’s expectations on this
topic.
Response: Section 37.57 states that
the licensee shall immediately notify
the LLEA after determining that an
unauthorized entry was an actual or
attempted theft, sabotage, or diversion
of a category 1 or category 2 quantity of
radioactive material. The NRC believes
that such an unauthorized entry would
likely constitute criminal activity.
Furthermore, suspicious activity related
to possible theft, sabotage, or diversion
of category 1 or category 2 quantities of
radioactive material would also
constitute suspicion of criminal activity.
When coordinating with the LLEA, the
licensee must explain that it will
request a timely armed response to any
actual or attempted theft, sabotage, or
diversion of category 1 or category 2
quantities of material.
Comment C85: One commenter
requested that §§ 37.41 and 37.49 be
revised to reflect that a licensee is
restricted in detection and assessment
by available technology and resources.
Response: The NRC does not believe
the change is necessary. The
requirements do not specify a
technology, and the licensee can change
the method used to meet the
requirements whenever it wants, as long
as the plan is updated and training
conducted on the revised plan.
Comment C86: One commenter
expressed concern that the vocabulary
was not consistent with part 73 and that
it was unclear exactly what the rule
required from a security standpoint in
§§ 37.41(b) and 37.49.
Response: The commenter is correct
that the terminology between 10 CFR
parts 73 and 37 may not be consistent.
Part 37 does not have any requirement
for a design basis accident and pertains
to less risky materials. Part 37 applies to
a different type of material and licensee
in most cases. The terminology used in
10 CFR part 37 is geared for a materials
licensee and not a reactor or fuel cycle
facility. Guidance for implementing 10
CFR part 37 is contained in the
implementation guidance.
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Comment C87: One commenter stated
that the proposed regulations, as
applied to Gamma Knife radiosurgery
units, do not give sufficient weight to
engineered controls. The commenter felt
that the greatest risk was during source
exchange, which only occurs every 5 to
7 years, and not from someone obtaining
access to the equipment overnight or on
a weekend. The commenter further
stated the opinion that there is almost
no danger during the ordinary operation
of the equipment to treat patients.
Response: The NRC acknowledges
that accessibility of a category 2
source(s) depends on the design of the
device containing the source(s) and the
means used to gain access to and
possibly remove the source(s). However
it is anticipated that an adversary will
use whatever means is available to gain
access to and possibly remove a source.
The category 2 designation has no basis
in regard to the time it would take to
remove a source from the device in
which it is contained. The security
program is designed to deny an
adversary the opportunity to gain access
to a category 2 source. It is reasonable
to expect that overnight and weekend
periods would provide an opportunity
to an adversary.
Comment C88: One commenter stated
that the requirement limiting unescorted
access to approved individuals would
appear to preclude the treatment of
patients with a Gamma Knife
radiosurgery unit since the patient is
required to be unescorted in the
treatment room due to the high
radiation levels, and the treatment room
would normally be considered to be the
security zone. The commenter noted
that closed circuit television is used to
monitor the patient rather than line-ofsight observation, and that this could be
used in place of human escort for those
individuals needing entry to the
treatment room.
Response: A patient undergoing
treatment is considered to be an
escorted individual. Closed circuit
television used to monitor the patient
meets the requirements of §§ 37.45 and
37.47.
Comment C89: One commenter stated
that for a Gamma Knife radiosurgery
unit, individuals subject to background
investigations should be defined as
those who have the key or pass code for
the treatment room door and the ability
to turn off the security system and not
the personnel who may need access to
a patient on treatment day. The
commenter stated that individuals with
the keys or pass code are the ones that
can enter a room and have access to the
unit for a long enough time, such as
outside of normal treatment days, to
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remove any or all of the radioactive
sources.
Response: Gamma Knife radiosurgery
is typically performed by a team of
individuals. The licensee has the option
of escorting those team members not
authorized for unescorted access. For
example, the licensee may decide to
grant unescorted access to authorized
medical physicists and have them
provide escorted access for physicians,
nurses, technologists, etc.
Comment C90: One commenter noted
that it is important that Gamma Knife
units secured behind electronically
locked doors have a backup door alarm
which operates during a fire alarm. The
commenter noted that hospitals are
increasingly adopting electronic locks
for securing rooms and that the fire code
requires electronic locks to be disabled
during a fire alarm. The commenter
noted that frequently the door alarm and
motion detector are tied into the same
system.
Response: The licensee must meet the
requirements of the rule. Any additional
alarms or other systems beyond those
used to meet the requirements are at the
discretion of the licensee.
Comment C91: One commenter noted
that since a Gamma Knife treatment
room has a single entrance that could be
controlled by an assailant, one or more
panic alarm buttons, unobtrusively
placed, should be installed so that the
staff could summon security without
being noticed. The commenter also
suggested requiring use of a portal
radiation monitor tied into security at
the exit.
Response: The use of duress/panic
alarms could be used to enhance the
licensee’s response plans and a
radiation monitor can be used to detect
a situation where a source has been
removed from a device. The licensee
can determine which methods it will
use to comply with the rule. Any
additional alarms or other systems
beyond those used to meet the
requirements are at the discretion of the
licensee.
Comment C92: One commenter stated
that additional security measures
addressing radioactive materials are not
necessary in the refining or
petrochemicals industry due to the
location, lack of accessibility, source
holder design, and currently applicable
security requirements. The commenter
noted that the sources are continually
monitored by process control systems
and there would be an immediate
response, due to process safety
concerns, if they were to go off-line. The
commenter noted that most sources are
contained within source holders bolted
individually to a process column or
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equipment and the source holders are
typically very large, heavy, cumbersome
metal containers. The commenter noted
that to remove the source holders
requires tools, cranes, hoist or scaffold
support because of their weight and
position on the process equipment. The
commenter also noted that the sources
are not aggregated but are located within
the various operating unit locations
scattered over several acres.
Response: Part 37 only applies if the
material is aggregated such that the total
equals or exceeds the category 2
threshold. As with the orders, the
licensee can take measures such that the
provisions do not apply. For example, if
a source holder is welded to the column
and has a cage around it, the NRC has
determined that this is sufficient and
the sources would not need to be
considered in aggregating the material.
Additional information has been added
to the implementation guidance to
clarify what types of barriers would be
sufficient.
Comment C93: One commenter noted
that the type and configuration of
irradiators would render the probability
of their use in an act of terrorism as
extremely unlikely. The commenter
noted that they are stationary, weigh in
excess of 1000 pounds, and are secured
within segregated and separately locked
facilities on a secure campus requiring
separate authorized keycard access to
both the buildings themselves and the
irradiator rooms 365 days per year. The
commenter recommended that the NRC
exempt irradiators from 10 CFR part 37.
Response: The NRC disagrees that
irradiators should be exempt from the
requirements of 10 CFR part 37. The
requirements are designed to control
access both to the radioactive material
and to the irradiator by controlling
access to the security zone. The NRC
has engaged the expertise of national
laboratories that have shown that these
devices may be vulnerable to theft,
sabotage, or diversion under certain
scenarios. For this reason, and the
possibility that the necessary trained
individual could be a malevolent
insider, the NRC has determined that
certain additional security measures are
necessary in the current threat
environment. Part 37 uses a layered,
defense-in-depth approach to enhance
the security of radioactive material in
category 1 and category 2 quantities. No
single measure can provide the required
security for this material. Therefore, a
licensee must implement all applicable
10 CFR part 37 requirements.
D. Transportation Security
Comment D1: In the proposed rule,
the NRC specifically invited public
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comment on several aspects of license
and address verification. Commenters
were requested to provide information
on: (1) Whether there should be a
requirement for verification of the
license for transfers of category 2
quantities of radioactive material or
whether it would be acceptable to wait
for the system being developed before
requiring license verification for
transfers of category 2 quantities of
radioactive material; (2) how the
address verification might work for
shipments to temporary job sites and the
ability of both licensees and the
Agreement States to comply with such
a requirement; (3) the frequency of the
license verification, and (4) how the
transferring licensee would know if a
license has been modified since the last
check and that the licensee is still
authorized to receive the material.
Seventeen commenters provided
responses to the specific questions on
this subject.
Of those that provided responses to
the questions on license verification,
most commenters indicated that the
current system for license verification
for category 2 quantities of radioactive
material is acceptable until the license
verification is developed and ready for
implementation. A few commenters
indicated that phone verification for
category 2 would be acceptable before
the new system is available; others
indicated that the NRC should wait for
the new system. One commenter
suggested that verification not be
required for shipments that result in a
change of jurisdiction but not a change
of licensee. Most commenters did not
support a requirement for address
verification for temporary jobsites,
noting that in most cases the regulatory
authority will not know the address for
a temporary site and that in some cases
there is no address. One State indicated
that it did not allow shipments to
temporary jobsites. On the issue of
frequency of license verification (every
transfer, annual, etc.), the response was
mixed; some noted that annual
verification was adequate, some noted
that every transfer should be verified,
some noted that every transfer would be
ok once the new system is available,
some suggested semiannual, and some
felt that use of the National Source
Tracking System was sufficient. One
commenter noted that amendments and
enforcement actions typically take a
long time so the likelihood of a license
being modified after a copy is obtained
by the transferor is very small. The
commenter indicated that there was no
compelling reason to take extra
measures to verify that the license has
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not been modified since that last check.
Most commenters noted the current
practice was acceptable until the new
license verification system is up and
running. One commenter suggested
obtaining a written statement from the
receiving licensee RSO attesting to the
current amendment number.
In addition to those that responded to
the specific questions, 18 commenters
provided comments on this topic. One
commenter noted that it was unclear
why additional work over and beyond
the current requirements in § 30.41 is
needed. Some commenters objected to
the need to verify a licensee’s validity
prior to shipment as it creates a large
burden on the licensee and the
regulatory agency. At least one
commenter felt that the current method
of obtaining a copy of the receiving
licensee’s license via either fax or email
was adequate to verify the validity of a
licensee. Commenters felt that, for
companies with which they do frequent
business, verification was not necessary
and that having a copy of the license on
file or verification within the last year
was adequate. Some commenters noted
that verifying for every shipment would
take time and personnel and increase
the cost of doing business. One
commenter indicated that they felt that
it would take half a day to process 30
orders using the system which is 4 times
the current time. Other commenters felt
that that an annual check would not be
acceptable and the verification should
occur close to the shipping date. One
commenter stated that a company
should not be required to verify a same
company license in another State prior
to transfer between the same company
but at different locations. Two
commenters requested clarification on
the need to report shipments within the
same company but within different
jurisdictions, such as temporary jobsites
in another State.
One commenter suggested that the
verification requirement be revised to
allow for verification of the delivery
address through the receiving licensee’s
RSO or another individual specifically
identified on the license. The
commenter pointed out that some
licenses may list the primary address
but not individual buildings and that
the delivery (or dock) address may be
different than the official building
address that is listed on the license.
Commenters were opposed to including
a requirement to validate the address for
transfers of category 2 quantities of
radioactive material.
Commenters noted that it can be
difficult to reach the regulator and once
reached that it may take the individual
some time to look up the license and
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verify the information. Commenters
indicated that this could result in delays
and/or stopped shipments. As an
alternative, one commenter suggested
that the regulatory agency could send a
copy of an amended license to ensure
up to date and valid copies are on file.
One commenter recommended
removing reference to the License
Verification System as it does not exist
yet and another commenter noted that
the system would unlikely be
operational when the final rule is
published. Several commenters
expressed some concern over how well
the license verification system will
work; some asked for clarification on
possible access to the system. One
commenter recommended that the
verification provision should not be
implemented until the system is fully
operational and demonstrated to be
effective.
One commenter asked if the
verification of license provisions
applied to exports. One commenter
asked if these requirements would
replace the National Source Tracking
System requirements.
One commenter noted that there is no
need to document that a check has been
done as it can be covered under a
procedure that the licensee has in place
for license checks and that adding
additional documentation just adds time
and effort without value. One
commenter questioned what
documentation was required for the
transfer verification.
Response: One of the
recommendations from the Independent
Review Panel was that licenses be
confirmed for all transfers of radioactive
material in risk-significant quantities.
The NRC agrees with the
recommendation and believes that
verification of the license before transfer
is an important component that
enhances the security of the material by
validating the licensee’s legitimacy. Use
of the License Verification System is a
key component to allow 100 percent
validation of licenses before transfer of
category 1 or category 2 quantities of
radioactive material. While some
commenters felt that a fax or email was
adequate to verify the validity of a
license, the NRC disagrees. An
individual can alter or tamper with a
license to change the possession limits
or location of use, or even the person
that received the license. Currently,
many licensees obtain copies of the
license and keep the copy on file. The
problem with this method is that the
license could be amended or terminated
and the licensee would not know that
the license was no longer valid. The
License Verification System is being
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developed to prevent these scenarios
from occurring. Licensees are required
to use either the License Verification
System or contact the regulatory agency
(NRC or Agreement State) to verify that
a license is valid before shipping
category 1 or category 2 quantities of
radioactive material to a domestic
company. For category 1 shipments, the
licensee must also verify that the
shipping address is valid. Transfers
within the same company in a different
State do not need to be verified as the
company knows what it is authorized to
possess. The rule language has been
clarified to make this clear. Verification
is not required for imports and exports;
the requirements of part 110 apply. The
NRC agrees that the License Verification
System (LVS) needs to be fully
functional before this provision of the
regulations is implemented. Although
the NRC expects a timely startup of the
LVS, this provision of 10 CFR part 37
permits a separate compliance date that
can be changed if this startup is
delayed.
The NRC does understand that it can
be difficult to reach regulator personnel
and that there may be times when the
system is down. Therefore, the NRC has
added a new provision that provides an
alternative so that licensees can still
ship. If the licensee cannot reach the
regulator and the system is
nonfunctional, the licensee will be able
to use certification from the receiving
licensee that the licensee is authorized
to receive the requested radioactive
material. The licensee must follow-up
by the end of the next business day to
confirm the license was valid.
The NRC has also changed the
documentation requirement. The final
rule only requires documentation if the
licensee conducts the verification by
contacting the license issuing authority
(NRC or Agreement State). The
documentation can simply be a note to
file or a copy of an email response from
the NRC or Agreement State. The
license verification system will keep the
record of any verification conducted
using the system, therefore, the licensee
is not required to keep separate
documentation. Documentation is
important from an inspection and
enforcement aspect.
Comment D2: One commenter noted
that the verification requirement
appears to duplicate the transfer
requirements under § 30.41. The
commenter noted that licensees should
be exempted from § 30.41 if they have
category 1 or category 2 quantities and
follow 10 CFR part 37. The commenter
noted that this is an example of an area
where industry and the NRC could
constructively work together through
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public meetings to find the most
efficient and effective solution to
address NRC’s concern. One commenter
noted that the proposed regulations
should be consistent with existing NRC
regulations related to radioactive
materials, should not duplicate any
existing requirements, and should not
rely on the general statements of ‘‘not
withstanding the requirements of any
other regulations in this chapter.’’
Response: The verification
requirements in § 37.71 are in place of
the requirements in § 30.41(d). The
language has been revised to make this
clear. In addition, the NRC has added a
provision to address emergency
situations where the License
Verification System is down and the
licensee cannot reach the licensing
authority.
Comment D3: One commenter
objected to the preplanning and
coordination requirements in § 37.75
stating that it would be impossible to
implement for category 2 sources for
facilities that make numerous shipments
a day. The commenter noted that it
would require a dedicated individual to
constantly communicate with customers
and carriers throughout the day for the
40–60 shipments and receipts that occur
during the day. The commenter noted
that currently the customer is told of the
shipment date and method of shipment
and that the preplanning system takes
advantage of the already understood
arrival times if using FedEx or similar.
The commenter noted that the shipper
can review the FedEx confirmed
deliveries each day (one central
location) which verifies receipt by the
customer. The commenter noted that
this has been working very effectively,
so there is no reason to change to a
much more burdensome method.
Response: It is not clear why the
commenter believes that it will need to
constantly communicate with customers
and carriers throughout the day. The
basic requirements are similar to the
orders, with the exception of
establishing a no-later-than arrival time.
The licensee could easily establish the
no-later-than arrival time as the close of
the business day on the expected arrival
date. If the licensee is already telling the
customer the shipping information, the
addition of one additional piece of
information does not present a large
burden and does not require the
shipping licensee to conduct its
business in a different manner than it
currently does. The NRC has revised the
language to clarify the coordination
activities and has removed the
requirement that specified methods of
sharing information to provide licensees
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more flexibility. Information has been
added to the implementation guidance.
Comment D4: One commenter stated
that in § 37.75(a)(2) alternate
requirements should be added for those
States who will not be providing law
enforcement escorts for the licensee to
identify the intended LLEA contacts it
will use to summon an armed response
should there be an actual or attempted
theft or diversion of the shipment.
Response: The NRC disagrees with the
comment. Part 37 does not require the
use of escorts for shipments of category
1 or category 2 quantities of radioactive
material; therefore, an alternate
requirement is not necessary.
Comment D5: Two commenters noted
that in § 37.75(a)(2)(i) the term
‘‘minimal delay’’ is ambiguous and
subject to interpretation. The
commenter recommended that the term
be clarified or deleted.
Response: The NRC agrees with the
comment and has removed the
requirement. While the purpose of the
preplanning and coordination with the
State is to ensure minimal delays, the
language is not necessary in the rule
itself.
Comment D6: Several commenters
recommended removing the provisions
for preplanning and coordination
activities with the Governors of each
State that the category 1 shipment will
pass through. The commenters noted
that the advanced notification provided
to the State by the licensee provides
sufficient time for the State to contact
the licensee if a revision to the route or
additional State imposed controls, such
as escorts, are to be implemented. The
commenters noted that Appendix A of
the regulatory analysis indicates that
there had been zero event notifications
in the past 10 years regarding missing or
lost material, suspicious activities, theft,
or diversion of category 1 materials and
questioned how additional coordination
efforts that are not currently required by
the orders can be justified. The
commenters noted that the licensee
would be unable to comply with the
requirement to arrange for positional
information sharing when required by
the State because, as written, States
would be authorized to dictate which
position tracking provider a carrier must
utilize, or the State could request that
the carrier authorize the State to log into
the carrier’s tracking system. This
would result in additional costs as there
are licensing and data communication
fees associated with tracking systems.
One commenter asked if the NRC has
determined whether carriers are willing
to share their positional information real
time. One commenter noted that this
requirement could provide a mechanism
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for a State to block the transport of
category 1 material through the State if
the requesting state official cannot log
onto the tracking system. Another
commenter expressed concern over
possible denial of a shipment through a
State due to tracking system
incompatibility. The commenter noted
that denial of shipment could result in
noncompliance with Federal interstate
transportation laws. The commenter
noted that the licensee and carrier are
capable of determining safe havens
along the route and that past experience
has shown that requesting a State to
identify safe havens has been fruitless.
One commenter strongly agreed with
the preplanning and coordination
requirements as both necessary and
desirable. The commenter urged the
NRC to encourage States to coordinate
with the LLEAs and affected Tribes,
including route and schedule
information in the shipment verification
system, as it can help States monitor
shipments and the no-later-than arrival
times. One commenter noted that the
coordination with the States is typically
conducted by email and that there is no
discussion unless the State initiates one
in response to the licensee’s
notification. One commenter stated that
there shouldn’t be any additional
requirements for category 1 quantities
that might serve to dilute attention paid
to highway route control quantities
(HRCQ). One commenter suggested
including the Agreement State program
on the list for notification and
preplanning coordination for category 1
shipments. The commenter noted that
the Governor’s designee is not always
the Agreement State program director.
One commenter noted that the need to
coordinate with all States for transport
will be very burdensome unless there is
a tool to assist with implementation.
Response: The NRC has determined
that the requirement for preplanning
and coordination with each State for
category 1 shipments is necessary, but
has removed several of the proposed
elements.
The NRC believes that it is necessary
to coordinate with the State to
determine whether the State plans to
provide escorts. If the licensee doesn’t
find out about the need for an escort
until after the advance notification is
provided to the State, the licensee
would likely need to adjust the schedule
and reissue the advance notifications.
Knowing upfront about the need for
escorts is likely to reduce the overall
burden on the licensee and allow the
licensee to better plan the route for any
shipment. The licensee is responsible
for identifying safe havens along the
route. The licensee would provide that
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information to the State. If the licensee
has difficulty identifying safe havens, it
may want to discuss this with the NRC,
State police, or other State contact. (See
also response to Comment A11.)
The NRC agrees that the other
elements of preplanning and
coordination are not necessary. It was
not the intent that the State be given
direct access to the position monitoring
system, only that the state be provided
information about the shipment’s
location upon request. This provision is
not included in the final rule. The NRC
has only retained what it believes are
the minimum requirements for the
preplanning and coordination. The rule
does not specify the method for
conducting the preplanning and
coordination. The licensee can conduct
the preplanning and coordination by
email.
The NRC will maintain the list of
State contacts as it does for 10 CFR part
73 shipments. The list will be available
on the NRC’s Web site at https://nrcstp.ornl.gov/special/designee.pdf. The
list will also be published in the Federal
Register on an annual basis, typically in
early July.
Comment D7: Some commenters
objected to the requirement to establish
a no-later-than arrival time. One
commenter pointed out that the
shipping licensee has no control over
when a common carrier delivers the
material, noting that typically they
know the day but not an exact hour. The
commenter felt that the requirement
would result in many unnecessary
reports or an exaggeration of the time in
order to avoid making reports and noted
that licensees are responsible enough
not to need a regulation that will burden
them and ultimately be subverted.
Another commenter felt that the rule
would be extremely costly and time
consuming to implement and
impractical. The commenter stated that
the NRC should place the requirement
on the carrier and not the licensee, as
the licensee has no control. Another
commenter suggested waiting until the
end of the day, which was previously
agreed to, and send a report (NRC 748)
into NSTS and hope that it gets put into
the system, maybe receiving
confirmation that the reports were
received. Two commenters
recommended allowing licensees to use
the NSTS as method to fulfill the
notification requirement in § 37.75(b)
and (c). One commenter supported the
concept and suggested timeframes. One
commenter noted that a loss of material
is an immediate notification and that
the rule as proposed places the licensee
in a burdensome position of devoting
additional time, effort, and concern over
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movement of material that is not
completely in their control. The
commenter did agree that notification
between the shipper and consignee is
important but felt no need for further
restrictions or regulations in this area.
Another commenter noted that the
shipper currently sends an email
notification that has a receiving
document attached to the message
noting when the shipment was received.
The commenters believe that licensees
already effectively track the movement
of sources without the need to impose
additional regulation. One commenter
noted that category 1 shipments are
often held up in States for inspection.
Commenters noted that common carrier
delivery guarantees are not accurate to
within 4 hours. Commenters noted that
the 2- and 4-hour timeframes would
result in numerous modifications to the
time or ultra conservative estimates.
Several commenters suggested 24 hours
as the timeframe. One commenter noted
that licensees routinely monitor the
status of shipments and notify the
carrier and regulatory agency when the
shipment does not arrive within a
reasonable timeframe. The commenter
stated that the regulations should
specify what is required and not how to
achieve it. One commenter noted that
the time of a shipment will not be
known for material that is transported
by common carrier as shippers like
FedEx simply verify that a shipment
will arrive by a certain date, and often
the only notice that a shipment will be
late is that it doesn’t arrive by the end
of the business day. One commenter
requested clarification that the no-laterthan arrival time applies only to
domestic transfers, either within the
definition or in the guidance. One
commenter noted that § 37.75(b)
requires licensees to email or fax arrival
times for shipments of category 2
material and that licensees must be
made aware that the email must be
encrypted and faxes be made to an
awaiting, known entity as was noted in
Regulatory Issue Summary 2005–31.
Response: The NRC continues to
believe that the establishment of a nolater-than arrival time is beneficial. The
NRC notes that the orders currently
require the licensee to coordinate the
expected arrival time of the shipment
and to initiate an investigation if the
shipment has not arrived by the
expected arrival time. The provision for
the no-later-than arrival time actually
provides the licensee with more
flexibility. The no-later-than arrival time
allows for traffic delays due to weather
and other circumstances before an
investigation is initiated. The no-later-
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than arrival time for category 1
shipments has been removed as the
licensee is required to maintain
continuous communication capability.
The no-later-than arrival time provision
only applies to domestic shipments.
There is no requirement that email be
encrypted and faxes be made to an
awaiting, known entity.
Comment D8: One commenter stated
that § 37.75(c) is a redundant
requirement as licensees are already
required to input data into the NSTS
when shipping or receiving radioactive
material. The commenter noted that
licensees are already required to initiate
an investigation if a shipment does not
arrive and that there is no reason to
require a licensee to notify the shipper
when the shipment occurs as it is
scheduled. The commenter noted that
this would require a tremendous
amount of resources and is unnecessary
as a licensee is already required to
notify the shipper if the shipment does
not arrive. One commenter requested
clarification on whether § 37.75(c)
applied to notify international shippers
of receipt within 4 hours. One
commenter noted that the transferee
licensee should notify the NRC (and the
License Verification System) and the
host State when a shipment arrives. The
commenter indicated that the
notification should reasonably occur
within 2 hours after arrival instead of
the 4 hours proposed in the rule.
Another commenter objected to the
need to confirm a shipment with the
shipper and noted that it was redundant
to current requirements for the NSTS. A
commenter noted that if a notification
must be made when a shipment does
not arrive that it doesn’t make sense to
also require that a notification be made
when and if it does arrive and therefore
it just adds burden without benefit. One
commenter recommended that the
licensee should notify the NRC (and the
License Verification System) as well as
the States affected when a shipment is
revised or cancelled. The commenter
noted that the change should be
reported by the carrier company after
communication/coordination with the
driver. One commenter objected to the
requirement for the receiving licensee to
notify the shipping licensee within 4
hours of a package arrival and
recommended that the requirement be
removed from the rule. The commenter
indicated that this would result in an
undue cost and would require licensees
to have personnel on evenings,
weekends, and holidays to receive/send
the information. One commenter asked
why using NSTS wasn’t sufficient.
Response: The requirement in
§ 37.75(c) to notify that a shipment has
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been received and the requirement to
report to NSTS are not redundant. The
reporting to NSTS is a report to a system
and does not notify the shipping
licensee that a source has been received.
The shipping licensee would need to
access the system to see if the status of
the source has changed in order to
determine if a shipment has been
received. The reporting to NSTS is by
the close of the next business day which
means information on the receipt of the
shipment might not be available for
several days and this would be too long
for a shipment to go missing without
starting an investigation. Additionally,
not all shipments are reported to NSTS.
When shipments don’t arrive on time,
the shipping licensee needs to start an
investigation to determine if the
material is missing or just delayed in
shipment. The requirement to confirm
shipment is not new as it is a current
requirement from the orders. The
notification provisions do not apply to
international shipments.
Comment D9: One commenter noted
an inconsistency in the timeframes for
the receiving licensee to notify the
shipping licensee no later than 4 hours
after the package arrives but that the
shipping licensee is to begin an
investigation within 2 hours of a
category 1 shipment not arriving by the
no-later-than arrival time.
Response: The NRC has removed the
no-later-than arrival requirements for
shipments of category 1 quantities of
radioactive material because they are
not needed with the communication
and monitoring requirements associated
with these shipments. The provision for
no-later-than arrival time remains for
category 2 shipments. The arrival time
and the no-later-than arrival time are
not the same times. The arrival time is
the time the shipment actually arrives at
the facility. The no-later-than arrival
time is the time established that when
a shipment has not arrived and an
investigation will be started to
determine the whereabouts of the
shipment.
Comment D10: Two commenters
pointed out an editorial error in
§ 37.75(d), noting that the reference to
§ 37.75(a)(1) should be § 37.75(b).
Response: The NRC agrees with the
comment and has made the correction.
Comment D11: One commenter noted
that it may not be possible to provide
the information for an advance
notification before the shipment. The
commenter stated that the information
is not available to most licensees
because carriers are not willing and may
not be able to provide the detailed
information to licensees. The
commenter noted that for an import, a
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licensee may not have this information
until the shipment is in progress, or
even when it is received. The
commenter noted that if it is assumed
that this requirement is only applicable
from the point of customs clearance,
then it may be practicable. The
commenter indicated that the regulation
should specifically state that it is
applicable to the portion of the
movement of shipments after customs
clearance. One commenter asked if NRC
has coordinated with DOT to determine
if the advance notification is
practicable. One commenter noted that
the activity levels are not available with
much degree of accuracy as the activity
is often not measured until the
shipment arrives. One commenter noted
that the shipper may not know when a
shipment will commence, cross State
lines, and arrive. The commenter also
noted that the shipper may not know of
schedule changes ahead of time.
Response: The NRC understands that
all of the information may not be
available at the time of the initial
advance notification. Section 37.77(b)
specifically states that the licensee must
provide the required information if
available at the time of the notification.
In addition, § 37.77(c) provides for
revised notifications for information
that was not available at the time of the
initial notification and for instances
where information changes. The
commenter is correct that the provisions
only apply to the domestic portion of
the transport for both imports and
exports. The requirements would begin
at the point of customs clearance for
imports and end at the border for
exports. Section 37.73(d) and (e) notes
that the provisions only apply to the
domestic portion of the shipment. Both
sections have been revised to address
exports.
Although the NRC coordinates with
DOT on a number of safety and security
matters of mutual interest, licensees
have implemented advance notification
requirements for many years, and the
practicability of these notifications is no
longer in serious question.
Comment D12: Two commenters
recommended that the advanced
notifications to the Governor be made
through the NRC’s Operations Center.
The commenters noted that the licensee
could simply provide the advanced
notification to the NRC’s Operations
Center with a list of States affected and
the NRC’s Operations Center would
then transmit the advanced notification
to the affected States. The commenters
noted that this would reduce the record
retention and notification burden on the
licensee and would ensure consistency
in how the States receive notifications.
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Response: The NRC disagrees with the
comment. It is the licensee’s
responsibility to notify the affected
States. The need for the NRC’s
Operations Center to notify affected
States could interfere with its primary
responsibility to be available for
response to events. Additionally, for
those shipments that are made by an
Agreement State licensee, the NRC
would not be notified as the notification
would go to the Agreement State. The
Agreement State will need to provide
the information to the NRC so that the
NRC can share the information with its
Federal partners.
Comment D13: Two commenters
recommended including an email
address and fax number for the NRC
point of contact receiving the
notification in § 37.77(a)(1). The
commenters noted that the email
address and fax numbers should be
readily available as most notifications
are made by email or fax.
Response: The NRC agrees with the
comment and has included the secure
fax number and email address to submit
the notifications to the NRC.
Comment D14: Two commenters
recommended removing the option in
§ 37.77(a)(2) to mail in notifications or
require that notifications not submitted
by fax or email be sent via certified mail
or delivery service. The commenters
noted that 7 days prior to the shipment
date may not be sufficient time to allow
a notification transmitted through the
regular mail to reach the intended
recipient.
Response: The NRC disagrees with the
comment. The 7 days prior notice
requirement is consistent with the
similar provision for advance
notifications for spent fuel shipments.
Transmittal of the SGI–M information
must meet the requirements of § 73.23.
The licensee always has the option of
sending the notification earlier than
required. The NRC has revised
§ 37.77(a) to clarify the procedures for
submitting the notifications.
Comment D15: Two commenters
recommended increasing the
notification requirement in § 37.77(a)(3)
from 4 days to 7 days. The commenters
noted that the additional time would
provide States enough time to review
and evaluate the details regarding the
shipment and would preclude the need
to conduct the required preplanning and
coordination. The commenters noted
that this advance notification process
has been in place and proven effective
for the past 6 years. One commenter
recommended that ‘‘other means’’ in
§ 37.77(a)(3) be defined or clarified. The
commenter assumed it meant by email
or fax.
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Response: The NRC disagrees with the
comment. The NRC believes that 4 days
provide sufficient time for the States to
review and evaluate, particularly since
the licensee is required to conduct
preplanning and coordination with the
States in addition to the advance
notifications. The timeframe is also
consistent with the similar provision for
advance notifications for spent fuel
shipments. No State that commented on
the rule indicated that additional time
was necessary. Other means could
include fax or email, or delivery by
messenger. Additional information has
been added to the implementation
guidance.
Comment D16: Two commenters
indicated that it was unclear what
information the point of contact,
requested in § 37.77(b)(7) for the
advance notifications, should be able to
provide. The commenter noted that
‘‘current shipping information’’ could
imply that the point of contact should
be a person accompanying the
shipment, or did it mean someone who
has information regarding the details of
the notification.
Response: The point of contact would
be someone that has information
regarding the details of the notification.
It is not intended to be a person
accompanying the shipment. Additional
information has been added to the
implementation guidance.
Comment D17: One commenter noted
that the NRC should provide for
advance notification to Tribes for
shipments that cross their reservation.
The commenter noted that this rule
should be consistent with the rule that
the NRC promulgates for Tribal
notifications.
Response: The NRC may consider
providing advance notification of these
materials to Tribes in the future but
does not currently plan to include the
provision.
Comment D18: Three commenters
suggested changing the phrase
‘‘movement control center’’ to
‘‘communication control center’’ in
§ 37.79 to maintain consistency with the
orders.
Response: The NRC disagrees with the
comment. Although the orders called
the centers communication control
centers, these centers are typically
called movement control centers. The
terms refer to the same function. The
NRC is retaining the term movement
control center to be consistent with the
term in 10 CFR part 73 as the centers
serve the same function.
Comment D19: One commenter noted
that in the definition of ‘‘movement
control center’’ various functions are
combined and that there is no value in
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requiring that they all be accomplished
by one entity as the functions may be
accomplished by separate departments
or personnel.
Response: The movement control
center definition does not require that
all of the functions be carried out by the
same department or personnel. It does
require an operations center or base
from which all of the functions are
handled. The primary purpose of the
movement control center is to have staff
available that can immediately respond
to an emergency and coordinate the
required response.
Comment D20: One commenter
requested clarification in
§ 37.79(c)(1)(ii) on the use of
authentication and duress codes. The
commenter noted that it wasn’t clear if
there were two codes or if there needed
to be a strategy for the ‘‘use’’ and
‘‘authentication’’ of duress codes.
Response: The NRC has revised the
rule language to clarify that there are
two types of codes.
Comment D21: One commenter noted
that redundant communications systems
are required but it was not clear if
redundant position location or tracking
systems are necessary.
Response: The rule does not contain
a requirement for a redundant position
location or tracking system.
Comment D22: One commenter noted
that although a licensee can make
arrangements to ensure that personnel
are trained and can audit the carrier for
compliance, it cannot ensure that
personnel are trained as required. One
commenter objected to the requirement
for licensees providing training to
entities beyond its control such as
railroad personnel. The commenter
noted that the carriers already have
training and certification requirements
under DOT. Two commenters
recommended allowing the licensee to
provide current copies of normal and
contingency procedures in lieu of
training as required by § 37.79(c)(2). The
commenter noted that it is not feasible
to provide ‘‘appropriate training’’ to a
group of individuals that the licensee
has no control over.
Response: The NRC agrees with the
comment. The NRC agrees that it is
acceptable to provide copies of the
normal and contingency procedures in
lieu of a formal training program. If this
mechanism is used, the licensee should
have a signoff sheet associated with the
procedure that the individual would
sign indicating that he or she has read
and understands the procedure. The
NRC also agrees that the licensee would
be unable to dictate that railroad
personnel undergo training and follow
the licensee’s procedures. Railroads
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have their own processes and
procedures in place and would be
required to follow them. The NRC has
removed the requirement for railroad
shipments.
Comment D23: One commenter stated
that the regulation must make it clear
that the requirements in § 37.79 are only
applicable from the point of customs
clearance.
Response: Section 37.73(d) and (e)
makes it clear that the provisions only
apply during the domestic portion of the
shipment. For imports, the provisions
begin at the point of customs clearance.
Comment D24: One commenter noted
that § 37.79 requires licensees to use
companies who use package tracking
systems (for category 2) and that it
should be clarified that the package
itself should be accounted for and not
simply the paperwork.
Response: The NRC believes that the
regulations are clear that it is the
package that is being tracked and not
the paperwork. No change to the
regulations is needed.
Comment D25: One commenter
objected to the requirement to start an
investigation if a package does not
arrive within 2 to 4 hours of its
designated arrival time. The commenter
noted that weather, traffic, etc. could
affect delivery times and that starting an
investigation because a package did not
arrive on time due to poor weather, etc
is a waste of time and resources with no
foreseeable gains for security. The
commenter noted that the timeframe
should allow some time for
investigation and suggested an 8- and
24-hour timeframes.
Response: The NRC agrees in part
with the comment. The NRC has
clarified the text in § 37.79(d) to remove
reference to lost or unaccounted for
material. The requirement to establish a
no-later-than-arrival time for shipment
of category 1 quantities has been
removed as the licensee is required to
maintain constant communication
capability. The NRC has increased the
timeframe for the no-later-than arrival
time for category 2 shipments to 6
hours.
Comment D26: One commenter stated
that when shipping radioactive material
meeting the requirements of HRCQ and
RAMQC the requirements should
include having two forms of
communications available at all times
for reporting incidents and requesting
assistance.
Response: The NRC agrees and
included a requirement for redundant
communication capability for category 1
shipments (RAMQC) in the proposed
rule. The final rule in § 37.79(a)(1)(ii)
requires licensees to ‘‘Ensure that
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redundant communications are
established that allow the transport to
contact the escort vehicle (when used)
and movement control center at all
times. Redundant communications may
not be subject to the same interference
factors as the primary communication.’’
Redundant communications are
required to mitigate an interruption,
caused by either natural events, such as
storms, or deliberate actions, such as
signal jamming, that may cause
communications to be lost on the
primary communication device. One or
more additional communication devices
must be available to operate
independently of the primary device,
thereby minimizing the possibility that
whatever disabled the primary device
will impact the redundant devices. For
category 2 shipments, the NRC is not
requiring a redundant means of
communication.
The requirements for HRCQ
shipments, other than the category 1
material, are beyond the scope of this
rulemaking.
Comment D27: One commenter felt
that the rule should be revised to
require the licensee to provide some
level of armed security during transport
of HRCQ.
Response: The NRC disagrees and
feels that the physical protection
measures in place are adequate without
requiring the use of armed security
personnel. The licensees that ship
category 1 quantities of radioactive
material by road would be required to
have sufficient protective measures
which include: A movement control
center that maintains periodic position
information from a location remote from
the activity of the transport vehicle or
trailer and monitors shipments 24 hours
a day, 7 days a week; redundant
communications that would allow the
transport to contact an escort vehicle;
and the ability to communicate an
emergency immediately to appropriate
law enforcement agencies that would
provide an armed response. Since the
appropriate States are to be notified in
advance of the shipment, the State may
decide to have armed escorts
accompany the shipment within the
State’s borders.
The requirements for HRCQ
shipments, other than the category 1
material, are beyond the scope of this
rulemaking.
Comment D28: One commenter
suggested adding an exemption to
§ 37.79 for shipments transported as
Exclusive Use, in accordance with 49
CFR 173.441. The commenter noted that
package tracking systems are necessary
when a carrier handles multiple
consignments on single vehicles and
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when packages traverse through
delivery hubs. The commenter noted
that an exclusive use shipment removes
the risk of lost or misdirected packages
and would provide the same level of
control as a package tracking system.
The commenter noted that adding the
exemption would give the licensee the
ability to transport their own category 1
materials.
Response: The NRC disagrees with the
comment and does not believe that an
exemption is appropriate for shipments
transported as Exclusive Use. The
shipment should still have the same
security measures applied even if the
shipment is in a dedicated truck. While
it might remove the risk of a misdirected
package, it does not remove the
possibility that the material could be
stolen during transport. The licensee is
allowed to transport its own category 1
or category 2 material under the rule.
Comment D29: One commenter was
disappointed that the proposed rule did
not contain the requirement for GPS
tracking for trucks carrying category 2
quantities of radioactive material that
was requested in PRM–71–13 or,
alternatively, for the rule to give
Agreement States the flexibility to be
more stringent than NRC. The
commenter was disappointed that the
NRC did not request comments on the
issues raised in the petition nor
provided any further discussion or
explanation for not including the two
recommendations in the proposed rule.
The commenter noted that NMED data
shows that since the letter was sent,
another truck carrying radiography
sources was stolen, and the commenter
further noted that it only takes one to
become the terrorist event. The
commenter noted that GPS tracking is
very inexpensive and an easy way to
help with rapid recovery should
preventative measures fail and that GPS
tracking for category 2 sources should
be required.
Response: The NRC reevaluated the
need for requiring GPS tracking for
trucks carrying category 2 quantities of
material. The NRC continues to disagree
with the comment. Tracking a truck can
be misleading as either the source or the
device containing the source can be
removed and the GPS would provide no
benefit. There is no easy method of
placing the GPS tracking mechanism on
either the source or device. While GPS
could help with locating the truck, the
source/device may not still be on the
truck. For devices in or on a vehicle, the
licensee is supposed to maintain control
and have constant surveillance of the
material or use a method to disable the
vehicle. The NRC believes that these
measures are adequate. As for the
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compatibility of the provisions, the
provisions need to remain compatibility
B because there are significant
transboundary implications.
Comment D30: One commenter noted
that the shipping requirements are
somewhat demanding with the
authorized shippers having added
responsibilities. The commenter
assumed that the Commission will
communicate with the shipping
agencies accordingly. The commenter
noted that the addition of GPS
capabilities combined with vehicle/
trailer alarms with remote features will
be an added expense. Another
commenter asked how to find the
approved carriers.
Response: The NRC is not sure what
the commenter meant by authorized
shipper, but assumes that it refers to the
licensee that is shipping the material.
The NRC is also uncertain what the
commenter meant by shipping agencies,
but assumes that the term refers to
common carriers. Common carriers do
not have any responsibilities under part
37 as the NRC does not regulate the
carrier. It is each licensee’s
responsibility to make sure that its
shipments are compliant with the
regulations. The NRC believes that the
requirements in subpart D are necessary
for the safe transport of category 1 and
category 2 quantities of radioactive
material. The regulations do not require
the licensee to use GPS or vehicle/trailer
alarms during shipment of the material.
Alarms may be necessary, however, if
the material is stored in the vehicle or
trailer while the vehicle is unoccupied.
The NRC does not approve the carriers.
Comment D31: One commenter stated
that § 73.35 is not clear on what to
include/exclude from the calculation for
‘‘net weight.’’ The commenter indicated
that if the ‘‘net weight’’ is intended to
include only the weight of the nuclear
or radioactive material contained in the
irradiated fuel, then this should be
clearly stated. The commenter noted
that calculation by ‘‘exclusion’’ may
lead to wide variation in interpretation.
Response: The rule addresses the
irradiated reactor fuel weighing 100 g
(0.22 lb) or less in net weight of
irradiated fuel, exclusive of cladding or
other structural or packaging material,
and that has a total external radiation
dose rate in excess of 1 Gray (100 rad)
per hour at a distance of 1 m (3.3 ft)
from any accessible surface without
intervening shielding.
Comment D32: One commenter
proposed an exemption for the
aggregation of packages that
individually each contain less than a
category 2 quantity of material and were
in a package with an external volume
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exceeding 1 cubic foot and with a mass
exceeding 100 pounds. The commenter
noted that these parameters would
present a practical, individual barrier to
theft. The commenter also suggested, as
an alternative, the addition of a specific
activity threshold to the category 2
table, and materials not exceeding the
specified concentration values (sum of
fractions could be applied to packages
containing multiple radionuclides of
interest) would be exempted from the
requirements.
Response: The NRC disagrees that the
parameters described would present a
practical barrier to theft. The
requirements do not allow an individual
licensee to aggregate less-than-category2-quantity packages of material to
exceed category 2 limits for an
individual shipment unless the
shipment complies with 10 CFR part 37
requirements. If two or more packages,
each containing less than a category 2
quantity, in aggregate reach or exceed a
category 2 quantity in a shipment from
one NRC licensee, the licensee would be
required to meet applicable subpart D
requirements before shipping.
The NRC did consider specific
activity and grants an exemption as
stated in § 37.11(c), which states that
licensees that possess radioactive waste
that contains category 1 or category 2
quantities of radioactive material are
exempt from the requirements of
subpart B, C, and D of 10 CFR part 37,
unless the radioactive waste contains
discrete sources, ion-exchange resins, or
activated material that weighs less than
2,000 kg (4,409 lbs).
Comment D33: One commenter noted
that category 1 rail shipments should be
by dedicated trains.
Response: The NRC disagrees with the
comment. There is no security or health
and safety basis for requiring dedicated
trains for rail shipments of category 1
quantities of radioactive material.
Comment D34: The proposed rule
contained a provision that would
require the licensee to have an NRCapproved monitoring plan to ensure that
no unauthorized access to the shipment
takes place while the shipment is in a
railroad classification yard. The NRC
specifically sought comment on the
feasibility of this requirement.
Commenters were requested to provide
information on: (1) Whether
surveillance of the shipment could be
accomplished while in the classification
yard; (2) whether the classification yard
would allow an individual to
accompany a shipment while the
shipment is held in the classification
yard; and (3) what precautions might be
necessary from a personal safety
standpoint. Five commenters provided
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responses to the specific questions on
this subject.
Of the commenters that addressed the
questions on the monitoring plans for
use in railroad classification yards, only
one commenter gave an answer other
than unknown. The commenter noted
that, due to insurance and liability
concerns, it was highly unlikely that the
classification yard would allow an
individual to accompany a shipment.
The commenter noted that DOT
regulations were sufficient for personal
safety from a radiological perspective.
In addition to those that addressed the
specific questions, two commenters
provided comment in this area. One
commenter indicated that additional
monitoring while the shipment is in a
railroad classification yard is an
impractical and unenforceable
requirement. The commenter noted that
the systems that are currently in place
are sufficient. One commenter stated
that remote monitoring of the package
and not the railcar is necessary in a
classification yard.
Response: The NRC has decided not
to include the provision for an NRCapproved monitoring plan for the time
that a shipment is located in a railroad
classification yard. The NRC agrees that
DOT regulations are sufficient.
Comment D35: One commenter asked
if the requirement for continuous and
active monitoring by licensees applies
only to shipments carried by the
licensee. The commenter noted that
real-time information is not available to
the licensee when a carrier is used.
Response: The continuous and active
monitoring of category 1 shipments,
whether by the licensee or by a carrier,
is the responsibility of the licensee. It is
also the licensee’s responsibility to
ensure that its carrier has the
capabilities for continuous and active
monitoring. Any time a shipment is
enroute, the licensee must be
knowledgeable of its whereabouts,
which can be verified by a phone call
to the movement control center or other
means of communication. This provides
licensees with flexibility to design
continuous and active monitoring
systems that meet their unique
circumstances. A licensee may use a
carrier or third-party communications
center in lieu of establishing one itself.
Comment D36: One commenter asked
if FedEx’s tracking system is considered
to be proven and reliable as they are the
primary carrier of radioactive material.
Response: The NRC does not
prescribe a particular system for
tracking shipments. The NRC
regulations describe the performance
characteristics for a method used for
category 2 shipments and does not
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endorse any particular company. The
regulations require licensees to use
carriers that have an established
package tracking system which is a
documented, proven, and reliable
system routinely used to transport
objects of value. This gives licensees the
flexibility to use tracking systems that
work within their organization. The
package tracking system must allow the
shipper or transporter to identify when
and where the package was last located
and when it should arrive at the next
point of control. The NRC does not
object to the use of Federal Express, as
long as they continue to meet these
requirements.
Comment D37: One commenter asked
how the security provision must be
implemented when using a freight
forwarder.
Response: Transportation security
requirements will still apply to
shipments using a freight forwarder.
The NRC expects licensees to ensure
that their shipments are received by the
recipient in a timely manner and that
any suspicious, attempted, or actual acts
against a shipment would be quickly
detected, assessed, and immediately
reported to law enforcement authorities.
Comment D38: One commenter
questioned who would be responsible
for complying with the security
requirements when a carrier aggregates
the material during transport or storage
incidental to transport. The commenter
noted that it would be logical for the
responsibility to be with the carrier.
Response: Licensees are not
responsible for packages that are
aggregated by the carrier as long as the
individual licensee does not exceed
category 2 thresholds. The licensees are
not responsible if the carrier picks up
radioactive material from multiple
locations that, in the aggregate, meet or
exceed the category 2 threshold, since
the licensees have no knowledge of
what the total quantity of material might
be in the shipment. The NRC does not
regulate the carrier.
Comment D39: One commenter
suggested using a table to denote
applicability for the different types of
shipments in § 37.73 as the paragraph
format was confusing.
Response: The NRC has added a table
to denote applicability for different
types of shipments to the
implementation guidance.
Comment D40: One commenter
indicated that synchronization of the
NRC and DOT requirements should be
addressed. The commenter noted that
the rulemaking does not discuss the
connection between the NRC and DOT
requirements on security and physical
protection. The commenter noted that
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the rulemaking appears to regulate
carriers even if only for security
purposes. The commenter felt that this
situation could violate the separation of
responsibilities that the two
organizations have and will, at a
minimum, create confusion among
carriers. One commenter felt that the
rule should more closely align with the
DOT requirements for HRCQ shipments
for routes used. One commenter asked
if there has been coordination between
DOT and NRC regarding security during
transport, particularly in light of
HM232F.
Response: The NRC shares
responsibility for the safe and secure
transport of radioactive material with
DOT and DHS. The NRC has a
Memorandum of Understanding (MOU)
with DOT for safety and is currently in
the process of developing an MOU with
DOE, DHS, and DOT on transportation
security to ensure that the agencies
work together. The Commission believes
that it is necessary and appropriate to
require licensees to implement the
proposed requirements, believes that the
issuance of security requirements for the
transport of the material is not a
significant regulatory impediment, and
believes that licensees and carriers can
successfully implement the
requirements of both Title 49 and Title
10.
Comment D41: One commenter noted
that the NRC’s intent for shipments of
category 2 quantities of radioactive
material is not clear for licensees that
are consignee, shipper, and consignor,
as is the case for the movement of most
industrial radiography sources used in
the field. The commenter noted that this
common situation should be addressed
for clarity either by inclusion or
exclusion in the rule.
Response: The situation where a
licensee is transporting its own material
is covered by § 37.79(a)(2).
Comment D42: One commenter stated
that the requirements placed on
licensees to coordinate with and to
notify the LLEA for transport of category
I and category 2 quantities cannot be
achieved by the licensee alone, and thus
seem unreasonable.
Response: The NRC disagrees with the
comment. The rule does not contain any
provisions to coordinate with the LLEA
for transport of material. Licensees are
required to notify the LLEA if a
shipment of category 1 materials is lost
or missing. The NRC continues to
believe that this is an appropriate
notification and sees nothing
unreasonable in the requirement.
Comment D43: One commenter (a
State) noted that a number of shippers
are routing around States that charge
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fees for transportation of HRCQ
shipments of radioactive material and
that this results in longer transportation
times and greater risk for shipment
incidents because of the additional
transit time and miles traveled. The
commenter noted that because
shipments of radioactive material are
being routed around the fee States, they
are now traveling through areas where
there is little training and coordination
of response to radioactive material
incidents increasing the risk and
vulnerability. The commenter suggested
that language be added to require the
shortest, most direct, approved route for
all HRCQ shipments and to prohibit
avoidance of States with transportation
fees. The commenter further suggested
that licensees and shippers of HRCQ
materials be required to meet and
preplan shipment routes with States on
an annual basis to ensure the States are
ready to respond to incidents as needed.
Response: Routing of HRCQ material
lies within the jurisdiction of DOT’s
regulations and is beyond the scope of
this rulemaking. For category 1
shipments, the licensee is required to
preplan and coordinate with the States
along the shipment route.
Comment D44: One commenter
questioned why spent fuel was not
addressed in the rule.
Response: The rule does address
transportation security of small
quantities (less than 100 grams) of
irradiated fuel. Transportation security
of spent fuel is being addressed in a
separate rulemaking. The proposed rule
was published for public comment on
October 13, 2010; 75 FR 62695. Most of
the licensees impacted by 10 CFR part
37 do not possess spent fuel and large
quantities of special nuclear material.
Security of special nuclear material and
spent fuel security is addressed in 10
CFR part 73 and in orders that were
issued to specific licensees possessing
the material. Security for independent
spent fuel storage installations will be
addressed in a future rulemaking.
Comment D45: One commenter noted
that the link for Agreement State
contacts did not appear to work.
Response: The NRC has tested the
link for Agreement State contacts
provided in the response to Q4 and it
does take you to the Web page on the
Agreement States. From that location,
you can access the State transportation
contacts. Part 37 contacts will not be
added until just before the rule is
implemented.
Comment D46: One commenter stated
that it is imperative that the
requirements for the transshipment of
radioactive material be identical to
those for domestic shipments, and urged
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the NRC to work with other Federal
agencies to harmonize the regulations so
that licensees and their regulators at the
Federal and State level follow consistent
rules for all shipments. The commenter
suggested general licensing of carriers as
one way to resolve this issue. One
commenter asked why transuranic
shipments were not addressed in 10
CFR part 37 and whether these
shipments fell under other security
program requirements. Another
commenter asked what security
requirements covered transshipments
and noted that it does not make sense
to impose additional security on
licensees, if transshipments are not
covered. Another commenter
recommended consistent regulations for
transshipments, air shipments, and
water shipments regardless of the
Federal authority and that the standards
for transshipments must be consistent
with domestic shipments. The
commenter urged the NRC to provide
leadership in promoting consistency,
perhaps via interagency agreement. The
commenter also recommended that the
license verification system (licensees
and shipments by and among licensees)
incorporate all RAMQC shipments,
regardless of the Federal authority
under which they are made and that the
relevant information in the License
Verification System be appropriately
shared with the State and local
authorities involved in enforcement.
Response: The NRC does not have any
authority over transshipments and does
not regulate common carriers. However,
the NRC has provided copies of
transportation security orders to
companies that transship category 1
quantities of radioactive materials.
These companies have agreed to
voluntarily implement the security
requirements for transshipments. DHS
has the overall lead for harmonizing
transshipment security, and the NRC
has and will continue to work with
other Federal agencies on the security
requirements for transshipments. The
License Verification System will be
available to Agreement State personnel.
Comment D47: One commenter
recommended that NRC work with the
States and law enforcement groups to
determine effective ways to support
transport of category 1 and category 2
quantities of radioactive material.
Response: The NRC did coordinate
with the States. The Agreement States
were involved in both the development
of the orders and development of 10
CFR part 37. Law enforcement is not
involved in the routine transport of
category 1 and category 2 quantities of
radioactive material. If a shipment is
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lost or stolen, law enforcement would
be contacted to assist.
E. Miscellaneous
Comment E1: One commenter wanted
a clear, concise statement that the
requirements in 10 CFR part 37
supersede the Increased Control Orders.
The commenter suggested adding a
second paragraph to § 37.1.
Response: The NRC disagrees with the
comment. A provision in the rule is not
necessary to note that the rule
supersedes the orders. The orders will
be formally rescinded (withdrawn) on
the effective date of the final rule in
each jurisdiction (Agreement State or
NRC).
Comment E2: One commenter noted
that the rule does not contain any
punitive provisions regarding situations
where employees or outside persons
compromise safety and/or security. The
commenter noted that there are no
provisions that can be cited in the event
that a licensee or an unlicensed person
attempts to or gains unauthorized
access, breaches security systems, or
otherwise compromises the security of
radioactive material.
Response: The NRC does not agree
with the commenter’s statement. The
proposed rule does contain punitive
provisions for situations where
employees or outside persons
compromise safety and/or security.
Specifically, § 37.109 provides for
criminal penalties. Section 37.109 of
subpart G states that section 223 of the
AEA provides criminal sanctions for
violations of any regulation issued
under 161b., 161i., or 161o., of the AEA.
As stated in § 37.109, all relevant
portions of this final rule have been
issued pursuant to one or more of
sections 161b., 161i., or 161o. of the
AEA. Further, there are other applicable
statutory provisions that provide
punitive sanctions for trespass and
sabotage of nuclear facilities or fuel that
could be imposed on employees or
outside persons who compromise safety
and/or security.
Comment E3: One commenter noted
that the proposed rule fails to provide
descriptions in most sections to outline
how the regulations are applicable to a
master materials licensee or a Federal
agency. The commenter felt that this
lack of descriptions follows the pattern
of the previously issued increased
controls and will likely result in
confusion during NRC compliance
inspections at master materials licensee
facilities.
Response: A master material licensee
and a Federal agency are still a licensee
and are treated the same as any other
licensee. While a master material
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licensee can issue permits within its
organization for the use of material, the
permittees must still meet the
requirements of the license and the
regulations. The NRC is not aware of
any implementation or inspection issues
that have resulted from a licensee being
a master material licensee or a Federal
agency.
Comment E4: Some States expressed
concern that the proposed rule would
result in a potential increase in
workload for the Agreement State
programs and that many States,
particularly smaller States, may have
trouble accommodating the additional
workload. Some of the Agreement States
also noted that the radiation control
programs within the States do not have
the necessary expertise to handle what
are essentially ‘‘law enforcement’’
activities, nor will they likely be able to
hire additional staff to undertake these
responsibilities. They also noted that
many of the proposed changes would
impose duties that are beyond
traditional radiation control agency
functions, and it is likely that they
would need to seek amendments to
enabling legislation to undertake the
activities. One commenter stated that
since the regulatory activities formerly
carried out under the NRC’s Common
Defense and Security authority are being
shifted to the Agreement States because
the rule is being issued under the NRC’s
Health and Safety authority, the NRC
should provide the funds necessary to
pay the direct costs incurred by the
Agreement State governments in
implementing the regulation. One
commenter (a State) indicated that NRC
must determine if funding will be
provided to the States to increase
staffing levels to implement the rule or
if other health and safety programs
should be cut.
Response: The NRC acknowledges
that the rule will result in a potential
increase in workload for the Agreement
State programs. However, this is not
unique to 10 CFR part 37. Any time the
NRC issues a rule that is a matter of
compatibility for the Agreement States,
there will be an increased workload for
the States. The State must expend some
effort to adopt the regulations and to
include the provisions in its inspection
programs. These costs are addressed in
the regulatory analysis. The Agreement
States will now need to conduct the
security inspections for those facilities
in their State that were issued orders
under common defense and security
and budget for those inspections instead
of being reimbursed by the NRC for
conducting the inspections. The NRC
disagrees that the rule contains
provisions that are essentially ‘‘law
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16995
enforcement’’ activities. The NRC
assumes that the commenters are
referring to the regulatory agency
approval of the reviewing official. The
NRC does not believe that this is a law
enforcement function, but in any case,
regulatory agency approval of the
reviewing official has been removed and
is not in the final rule. As for the NRC
paying the direct costs of increased
staffing levels, the NRC is not
authorized to pay the salary costs for
Agreement State staff. The NRC can and
will continue to pay for the necessary
training for Agreement State staff.
Comment E5: One commenter agreed
with the proposed provisions to remove
the concept of sensitive information as
used in the orders and address
information security in relevant sections
of the proposed rule. One commenter
noted that placing all of the security
requirements in one chapter
significantly enhanced their clarity. One
commenter supported the NRC decision
to forgo conventional significant figure
conventions and list the actual curie
activity equivalents to three figures as
many licensees use curies in their
activities instead of Becquerels. One
commenter supported the general
objective of the rulemaking. Two
commenters supported the approach to
terminate the orders coincident with the
effective date of the rule in each
jurisdiction to avoid potential confusion
and noncompliance. One commenter
expressed general support for the
overall rulemaking and suggested
enhancements in the transportation
security area. Several commenters
supported placing the security
requirements in a rule instead of in
orders as it allows for public input and
shows the American population steps
that are being taken to ensure their
security.
Response: No response necessary.
Suggested enhancements were
considered as separate comments.
Comment E6: One commenter
suggested that the NRC develop
programs and information packets to all
involved (regulatory personnel,
shipping agencies, law enforcement
agencies, Governors) so that everyone
can be on the same page.
Response: The NRC does have
information on its Web site. Information
on radioactive material security can be
found at https://www.nrc.gov/security/
byproduct.html and information on
radioactive material transportation at
https://www.nrc.gov/materials/
transportation.html. These sites provide
links to a variety of source documents
and specific NRC security enhancement
activities, including those on a Web
page on current NRC radioactive
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material security orders and
requirements (https://www.nrc.gov/
security/byproduct/orders.html) and a
Web page on material transportation
regulations, guidance, and
communications (https://www.nrc.gov/
materials/transportation/regs-guidescomm.html). The NRC also routinely
participates in interagency efforts, such
as the Task Force on Radiation Source
Protection and Security, where subjects
of common interest are discussed.
Comment E7: One commenter (a State
agency that possesses radioactive
material subject to the rule) stated that
the State would not provide the
additional funding necessary to
implement the requirements in 10 CFR
part 37.
Response: Licensees are responsible
for implementing and complying with
relevant regulations. A licensee may
always request an exemption from
specific aspects of the requirements for
its regulator to consider.
Comment E8: One commenter stated
that the phrase ‘Background Check’ was
used inconsistently and seemed to mean
different things in different places. The
commenter recommended reviewing the
rule text for consistent use of all
terminology.
Response: The term ‘‘background
check’’ is only used in the rule in the
context of the Bureau of Alcohol,
Tobacco, Firearms, and Explosives
background checks. The term is used
consistently in the rule. The NRC tries
to be consistent within the document,
and any inconsistencies identified have
been corrected.
Comment E9: Three commenters
addressed plain language in the rule.
One commenter suggested using ‘‘you’’
instead of ‘‘licensee,’’ pointed out some
long sentences, and noted some use of
passive instead of active voice. One
commenter suggested rewriting the rule
to address these concerns. Another
commenter noted that a single standard,
clearly spelled out in living room
language, would better meet the need of
all licensees. One commenter noted that
the rule did not meet the goal or the
intent of the President’s directive.
Response: The NRC has considered
the editorial changes and made changes
as appropriate.
Comment E10: One commenter noted
that 10 CFR part 37 does nothing to
improve the security of radioactive
materials that could be introduced into
the United States from foreign origins.
Response: The NRC’s regulations only
apply once the radioactive material is in
the U.S. The NRC does not have
authority over material in foreign
countries.
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Comment E11: One commenter noted
that while the rule will help protect the
United States from terrorists, we should
be thinking of the environmental
consequences.
Response: The NRC prepared an
environmental assessment to support
the rulemaking.
Comment E12: One commenter
suggested that the concept of what
category 1 and category 2 quantities are
should be introduced earlier in the
summary and background sections to
ensure that the distinction between
radioactive materials and category 1 and
2 quantities of radioactive material is
clear and that each term is used
appropriately.
Response: The NRC disagrees with the
comment. The summary notes that the
rule establishes security requirements
for category 1 and category 2 quantities
of radioactive material and that the
category 1 and category 2 thresholds are
based on the IAEA Code of Conduct.
The NRC believes that the Statements of
Consideration adequately describe the
material and are clear on what
radioactive material is covered by the
rule.
Comment E13: One commenter noted
that since few changes were made by
NRC as a result of Agreement States
comments on the predecisional draft of
the proposed regulations, the NRC
should make available to the Director of
the Office of Management and Budget
(OMB) any written communications
submitted to the agency by State
officials, including State comments on
the pre-decisional draft of 10 CFR part
37.
Response: The NRC made a number of
changes in response to Agreement State
comments on the predecisional draft of
the proposed rule. The NRC did not
make changes to the major issues on the
reviewing official, background
investigation, and temporary jobsites,
but specifically invited comment on
these issues in the proposed rule. Major
differences with the States were
identified to the Commission as is
common practice. The NRC does not
provide any comments to OMB, other
than comments on the information
collection associated with the rule.
Comment E14: One commenter stated
that the title of the rule should also
include a reference to the protection of
information (SGI–M and SUNSI). The
commenter also stated that references to
the protection of information need to be
made more consistent throughout the
rule as most sections and subsections
only require implementation if
individuals have access to category 1
and category 2 quantities of radioactive
material. The commenter stated that
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those having access to safeguarded or
sensitive information also need to be
included in the majority of the sections
in the rule, and the NRC should
consider the inclusion of 10 CFR part 73
among the list of provisions of parts
affecting licensees in § 37.1.
Response: The NRC disagrees with the
comment. Part 73 contains the physical
protection requirements for special
nuclear material as well as requirements
for protection of SGI. Reference to the
SGI provisions in 10 CFR part 73 were
added to parts 30, 35, etc., as part of the
SGI rule that was published in the
Federal Register on October 24, 2008;
73 FR 63546. References to 10 CFR part
73 are included at appropriate locations
in 10 CFR part 37. Section 37.1 contains
the purpose of 10 CFR part 37 and does
not include a reference to any affected
provisions of other NRC rules.
Comment E15: One commenter stated
that the rule (and orders) moves the
emphasis for security away from
engineered controls toward
administrative controls and that this
goes against decades of NRC safety
policy and generally-accepted safety
philosophy.
Response: The NRC disagrees with the
comment. Part 37 contains a mix of
engineered controls and administrative
controls.
Comment E16: One Agreement State
expressed disappointment in what was
viewed to be the overly prescriptive
content of the proposed rule and the
resurgence of issues that were
previously discussed and agreed upon
as resolved in the orders. One
Agreement State indicated that the
operational and practical understanding
of the orders, together with the
knowledge of the effectiveness of the
orders that the collective Agreement
States have gained during this time,
should be taken into consideration by
the NRC. Other Agreement States noted
disappointment and concern that many
concepts that were discussed at length
during the development of the orders
and rejected by the orders working
groups/steering committees now appear
in this proposed rule. They further
noted that they disagree with the new
provisions and do not believe that the
added benefit warrants the significant
resource burden that would be incurred.
One Agreement State felt that the rule
contained too many prescriptive items
and was not adequately performance
based. One commenter noted that the
knowledge and understanding that the
Agreement States have obtained during
implementation of the orders should be
helpful to the NRC in improving the
rulemaking.
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Response: The rulemaking process is
a more deliberative process than what is
used to develop an order. The 10 CFR
part 37 working group also had
additional information to consider that
included information from lessons
learned, implementation issues,
inspection issues, recommendations
from other reviews, as well as the
comments on the preliminary rule
language. In some cases the 10 CFR part
37 working group and steering
committee came to a different resolution
than that for the orders. Agreement State
experience was utilized. There were
Agreement State representatives on the
10 CFR part 37 working group and on
the steering committee that brought
their experience to the discussions. In
some areas where agreement could not
be reached, the NRC sought public
comment on the issue to better inform
the final decision.
Comment E17: One commenter
suggested that the NRC reconsider its
decision to use the same software
developers for the verification system as
were used for the National Source
Tracking System based on the multiple
continuing problems with the system.
Response: The comment is beyond the
scope of the rulemaking.
Comment E18: Two commenters
suggested that NRC conduct one or more
additional public workshops prior to
submitting the draft final rule and
implementation guidance to the
Commission for approval. The
commenters noted that the NRC could
explain at the meeting how it addressed
and resolved the more significant or
controversial topics addressed by the
public comments. The commenters
noted that the September 2008
workshop that NRC conducted on the
Security and Continued Use of Cesium137 Chloride sources could serve as an
excellent model for such workshops.
One commenter suggested holding
public meetings to discuss the
regulatory analysis document and
receive insights and perspectives on its
content.
Response: The NRC does not plan to
hold any public meetings or workshops
on the 10 CFR part 37 final rule. The
public was provided opportunity to
provide input on the rule and regulatory
analysis during the public comment
period. The NRC considered the
comments received and made changes
to the rule and supporting documents as
appropriate.
Comment E19: Two commenters
stated that continued stakeholder input
and involvement in the security area are
essential and requested that the NRC
allow substantive opportunities to
engage industry over the next 4 years on
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the myriad of issues that the
Congressionally mandated Radiation
Source Protection and Security Task
Force is addressing as all stakeholders
continue to work collectively toward
mutual safety and security objectives.
Response: Continued stakeholder
involvement in the security area is
beyond the scope of this rulemaking.
Comment E20: Two commenters
noted that the NRC does not routinely
share the technical basis for
rulemakings with stakeholders and
recommended that this become routine
practice. The commenters noted that
providing the technical basis may have
proven helpful for this rule.
Response: Stakeholder involvement in
regulatory basis development is beyond
the scope of this rulemaking. The
decision to solicit stakeholder input
during the development of the
regulatory (technical) basis for a
potential rule is decided on a case-bycase basis. The NRC does obtain
stakeholder input more routinely than it
did a few years ago. The NRC did obtain
stakeholder input during the
development of the technical basis for
the transportation security portion of
this rulemaking.
Comment E21: One commenter stated
that the NRC should conduct
inspections to ensure that licensees are
following the requirements and that the
focus on compliance verified by
inspection should receive greater
emphasis instead of imposing additional
administrative burdens based on
authorized use. Another commenter
noted that the NRC must ensure
compliance through periodic
inspections as is currently done. Several
commenters recommended that the NRC
perform compliance audit based reviews
similar to what was done after the
orders were implemented. The
commenter noted that the reviews were
done with a level of discretion and
without citation as long as the licensee
made significant efforts to address the
orders. One commenter requested that
the inspection frequency be modified to
more closely coincide with the risk.
Response: The NRC will conduct
inspections to ensure that licensees are
complying with 10 CFR part 37
requirements. The inspections will be
conducted as part of the normal
inspection program. The comment on
inspection frequency is beyond the
scope of the rulemaking as the
inspection frequency is not set by the
rule.
Comment E22: One commenter noted
that a new licensee must have the
physical protection measures in place
prior to a license being issued and that
this would be part of any prelicensing
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inspection. The commenter noted that
the agency should ensure
implementation before issuing a license.
Response: The NRC agrees that
licensees should have the majority of
the provisions in place before the
license is issued; some measures could
not be implemented until material is
actually at the facility. The NRC
conducts prelicensing inspections
before granting a license to anyone that
would be authorized to possess category
1 or category 2 quantities of radioactive
material.
Comment E23: One commenter noted
that certain materials licensees would
remain subject to the SGI requirements.
The commenter recommended that
conforming changes to 10 CFR part 73
be included as part of the regulation
development under 10 CFR part 37, to
ensure efficiency, clarity, and help
ensure compliance. The commenter
noted that SECY–09–0181 was silent on
the timing of the future rulemaking to
revise 10 CFR part 73 to remove the SGI
handling requirements for licensees
subject to 10 CFR part 37.
Response: The changes to 10 CFR part
73 to revise the SGI requirements are
beyond the scope of this rulemaking.
The timing of any potential changes to
10 CFR part 73 is unknown at this time.
Comment E24: One commenter noted
that the rule could result in institutions
choosing to store materials, including
waste, in separate locations. The
commenter noted that this could cause
logistical problems to keep track of the
material and could inadvertently
increase the risk to the security of these
materials.
Response: A licensee may choose to
store radioactive materials, in any form,
in separate locations to avoid being
subject to the proposed security
requirements. Such action would not
conflict with the intent of the proposed
rule, which is to limit access to an
aggregated category 2 quantity of
radioactive material listed in Table 1.
Aggregated, for purposes of this rule,
means accessible by breach of a single
physical barrier.
Comment E25: One commenter made
several comments related to a change in
the annual occupational radiation dose
to a lower range and how it would
impact the licensee.
Response: These comments are
beyond the scope of the rulemaking as
the proposed rule did not include any
changes to the annual occupational
radiation dose. These comments
appeared to be filed under the wrong
docket and were provided to the NRC
working group that is looking at
possible changes to 10 CFR part 20.
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IV. Discussion of Final Amendments by
Section
Section 20.2201(c) Reports of Theft or
Loss of Licensed Material
This section is revised to include a
reference to the reporting requirements
in 10 CFR part 37 so that a licensee is
not required to file duplicate reports for
the same event.
Section 30.6 Communications
This section is revised to include a
reference to the new 10 CFR part 37.
Section 30.13 Carriers
This section is revised to include 10
CFR part 37 in the list of regulations
that exempt common carriers.
Section 30.33 General Requirements
for Issuance of Specific Licenses
Paragraph (a)(4) is revised to include
a reference to the new 10 CFR part 37.
Section 32.1 Purpose and Scope
10 CFR part 37 is added to the list of
10 CFR parts that apply to applications
and licenses subject to this part.
Section 33.1 Purpose and Scope
10 CFR part 37 is added to the list of
10 CFR parts that apply to applications
and licenses subject to this part.
Section 34.1 Purpose and Scope
10 CFR part 37 is added to the list of
10 CFR parts that apply to applications
and licensees subject to this part.
Section 35.1 Purpose and Scope
10 CFR part 37 is added to the list of
10 CFR parts that apply to applications
and licenses subject to this part.
Section 36.1 Purpose and Scope
10 CFR part 37 is added to the list of
10 CFR parts that apply to applications
and licenses subject to this part.
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Section 37.1 Purpose
This section establishes the purpose
for the new 10 CFR part 37.
Section 37.3 Scope
This section establishes the scope of
the proposed new 10 CFR part 37. These
regulations apply to any person licensed
by the NRC, who possesses, uses, or
transports an aggregated category 1 or
category 2 quantity of radioactive
material. Paragraph (a) establishes the
applicability for subpart B and C.
Paragraph (b) establishes the
applicability for subpart D.
Section 37.5 Definitions
Definitions of the following terms that
are included in this part are identical to
the definition of the term in other parts
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of this chapter: Act, Agreement State,
Becquerel, Byproduct material, Carrier,
Commission, Curie, Government
agency, License, Lost or missing
material, Person, State, and United
States. In addition, definitions for the
following terms are included in this
Part: Approved individuals, Access
control, Aggregated, Background
investigation, Category 1 quantity of
radioactive material, Category 2 quantity
of radioactive material, Diversion,
Escorted access, Fingerprint Orders,
License issuing authority, Local law
enforcement agency, Mobile device,
Movement control center, No-later-than
arrival time, Reviewing official,
Sabotage, Security zone, Telemetric
position monitoring system,
Trustworthiness and reliability, and
Unescorted access.
Section 37.7
Communications
This section specifies where all
communications and reports concerning
10 CFR part 37 are to be sent.
Section 37.9
Interpretations
This section establishes that no
interpretations of the meaning of the
regulations in 10 CFR part 37 by any
officer or employee of the Commission
other than a written interpretation by
the General Counsel will be recognized
as binding upon the Commission, unless
specifically authorized by the
Commission in writing.
Section 37.11
Specific Exemptions
This section establishes that the
Commission may grant exemptions from
the requirements of the regulations in 10
CFR part 37 that it determines are
authorized by law and that will not
endanger life or property or the common
defense and security, and are otherwise
in the public interest. Paragraph (b)
exempts an NRC licensee’s activities
from 10 CFR part 37 to the extent that
the activities are covered under the
physical protection requirements of 10
CFR part 73. Paragraph (c) provides
security measures for certain radioactive
waste that contains category 1 or
category 2 quantities of radioactive
waste.
Section 37.13 Information Collection
Requirements: OMB Approval
Paragraph (a) specifies that the NRC
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number. Paragraph (b) lists those
sections in 10 CFR part 37 that have
approved information collection
requirements.
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Section 37.21 Personnel Access
Authorization Requirements for
Category 1 or Category 2 Quantities of
Radioactive Material
Paragraph (a) of this section
establishes which licensees need to
comply with the requirements of
subpart B of 10 CFR part 37.
Paragraph (b) establishes the general
performance objective to ensure that the
individuals subject to the access
authorization program are trustworthy
and reliable.
Paragraph (c)(1) establishes the
individuals that are subject to the access
authorization program. Paragraph (c)(2)
allows licensees to not subject those
individuals listed in § 37.29(a) to the
investigation elements of the access
authorization program. Paragraph (c)(3)
requires that licensees only approve
those individuals whose job duties
permit unescorted access to category 1
or category 2 quantities of radioactive
material.
Section 37.23 Access Authorization
Program Requirements
This section establishes the general
requirements for the access
authorization program, such as the use
of reviewing officials, informed consent,
personal history disclosure,
determination basis, procedures, the
right to correct and complete
information, and record retention.
Section 37.25 Background
Investigations
This section establishes the elements
of the background investigation that are
necessary before granting an individual
unescorted access to category 1 or
category 2 quantities of radioactive
material. The scope of the initial
investigation is the past 7 years. This
section also addresses reinvestigation
and grandfathering of individuals.
Section 37.27 Requirements for
Criminal History Records Checks of
Individuals Granted Unescorted Access
to Category 1 or Category 2 Quantities
of Radioactive Material
Paragraph (a) establishes the general
requirements for criminal history
records checks of individuals to be
granted unescorted access to category 1
or category 2 quantities of radioactive
material.
Paragraph (b) prohibits a licensee
from basing a final determination to
deny an individual unescorted access
authorization solely on the basis of
certain information received from the
FBI.
Paragraph (c) establishes the
procedure for submitting fingerprint
records to the NRC.
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Section 37.29 Relief From
Fingerprinting, Identification, and
Criminal History Records Checks and
Other Elements of Background
Investigations for Designated Categories
of Individuals Permitted Unescorted
Access to Certain Radioactive Materials
This section provides relief from the
fingerprinting and criminal history
records check requirements and the
background investigation requirements
of this subpart for certain categories of
individuals.
Section 37.31 Protection of
Information
This section outlines the requirements
for the protection and release to
authorized personnel of personal
information collected by a licensee
during a background investigation.
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Section 37.33 Access Authorization
Program Review
This section outlines the requirements
for an annual access authorization
program review to confirm compliance
with the requirements of subpart B of 10
CFR part 37 and for comprehensive
corrective actions to be taken in
response to any nonconformance
identified by the review.
Section 37.41 Security Program
Paragraph (a) establishes the
applicability of the security program.
Paragraph (a)(1) requires licensees that
possess an aggregated quantity of
category 1 or category 2 quantities of
radioactive material to establish,
implement, and maintain a security
program. Paragraph (a)(2) requires those
licensees that are newly subject to
subpart C, upon application for
modification of its license or an
applicant submitting a new application,
to implement the requirements before
taking possession of an aggregated
category 1 or category 2 quantity of
radioactive material. Paragraph (a)(3)
requires any licensee that has not
previously implemented either the
orders or subpart C to notify the NRC at
least 90 days before aggregating
radioactive material to a quantity that
equals or exceeds the category 2
threshold.
Paragraph (b) establishes the general
performance objective of the security
program.
Paragraph (c) establishes the program
features that must be addressed in the
security program.
Section 37.43 General Security
Program Requirements
Paragraph (a)(1) requires licensees to
develop a written security plan that
addresses how the licensee will
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implement the security program
requirements. Paragraph (a)(2) requires
the security plan to be reviewed and
approved by the individual with overall
responsibility for the security program.
Paragraph (a)(3) allows a licensee to
revise its security plan to ensure
effective implementation of the plan.
Paragraph (a)(4) requires the licensee to
retain a copy of the current security
plan until the license is terminated and
any security plan revisions for 3 years.
Paragraph (b)(1) requires licensees to
develop and maintain written
procedures for implementation of the
security plan. Paragraph (b)(2) requires
the procedures to be approved by the
individual with overall responsibility
for the security program. Paragraph
(b)(3) requires the licensee to retain a
copy of the procedures for 3 years after
the procedure is no longer needed or
upon termination of the license and any
revisions for 3 years.
Paragraph (c) requires licensees to
conduct training and annual refresher
training on the security plan. Licensees
are required to maintain training records
for 3 years from the date of the training.
Paragraph (d) requires licensees to
protect the security plan, implementing
procedures, and the list of individuals
that have been approved for unescorted
access from unauthorized disclosure.
Licensees are required to develop,
maintain and implement written
policies and procedures for controlling
access to, and for proper handling and
protection against unauthorized
disclosure of, the security plan and
implementing procedures. Only
individuals with a need-to-know and
that have been determined to be
trustworthy and reliable should have
access to the protected information. The
information protection procedures are
retained for 3 years after the document
is no longer needed.
Paragraph (b) requires the
establishment of temporary security
zones, as necessary, to meet transitory
or intermittent business activities.
Paragraph (c) requires that security
zones use physical barriers or direct
control of the security zone to allow
unescorted access only to approved
individuals.
Paragraph (d) requires licensees to
provide an approved individual to
maintain constant surveillance of
sources in temporary security zones or
in a security zone in which a physical
barrier or intrusion detection system has
been disabled to allow maintenance,
source receipt, preparation for
shipment, source installation, or
removal or exchange of category 1
quantities of radioactive material.
Paragraph (e) requires individuals not
approved for unescorted access to be
escorted by an approved individual
when in a security zone.
Section 37.45
Section 37.51 Maintenance and
Testing
This section requires licensees to
implement a maintenance and testing
program to ensure that intrusion alarms,
associated communication systems, and
other physical components of the
systems used to secure or detect
unauthorized access to radioactive
material are maintained in operable
condition, are capable of performing
their intended function when needed,
and are inspected and tested for
operability and performance. The
testing and maintenance are to be
conducted at the frequency
recommended by the manufacturer or
annually if there is no manufacturer’s
recommended frequency. Licensees are
LLEA Coordination
Paragraph (a) requires that a licensee
attempt to coordinate with an LLEA and
specifies the types of information to be
shared with the LLEA.
Paragraph (b) requires the licensee to
notify the NRC if the LLEA isn’t willing
to participate in coordination activities
or does not respond to the coordination
request.
Paragraph (c) requires the licensee to
maintain records of its coordination
activities with any LLEA.
Section 37.47
Security Zones
Paragraph (a) requires licensees to
establish security zones for the use of
category 1 or category 2 quantities of
radioactive material.
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Section 37.49 Monitoring, Detection,
and Assessment
Paragraph (a) requires the licensee to
establish and maintain the capability to
continuously monitor and detect
without delay all unauthorized entries
into the security zones.
Paragraph (b) requires the licensee to
assess without delay each actual or
attempted unauthorized entry into the
security zone.
Paragraph (c)(1) requires the licensee
to maintain continuous capability for
personnel communication and
electronic data transmission and
processing among site security systems.
Paragraph (c)(2) requires the licensee
to provide alternative capabilities for
personnel communication and data
transmission and processing.
Paragraph (d) requires the licensee to
respond without delay to any actual or
attempted unauthorized access to the
security zone.
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required to maintain the maintenance
and testing records for 3 years.
Section 37.53
Devices
Requirements for Mobile
This section requires licensees that
possess mobile devices containing
category 1 or category 2 quantities of
radioactive materials to have two
independent physical controls to secure
the radioactive material from
unauthorized removal and to use a
method to disable the vehicle or trailer
when the device is on a vehicle or
trailer, unless the site prohibits the use
of a disabling mechanism due to health
and safety concerns.
Section 37.55
Review
Security Program
This section requires licensees to
conduct an annual review of the
security program. The licensee is
required to document the results of the
review and any findings and keep the
records for 3 years.
Section 37.57
Reporting of Events
Paragraph (a) requires licensees to
immediately notify the LLEA of any
actual or attempted theft, sabotage, or
diversion of category 1 or category 2
quantities of radioactive material and to
then notify the NRC.
Paragraph (b) requires licensees to
assess any suspicious activity related to
the theft, sabotage, or diversion of
category 1 or category 2 quantities of
radioactive material and to notify the
LLEA as appropriate and then notify the
NRC.
Paragraph (c) requires licensees to
submit a written report to the NRC
within 30 days of any report of actual
or attempted theft, sabotage, or
diversion of radioactive material.
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Section 37.71 Additional
Requirements for Transfer of Category 1
and Category 2 Quantities of
Radioactive Material
Paragraphs (a) and (b) establish new
requirements for licensees transferring
category 1 and category 2 quantities of
radioactive material. The licensee is
required to verify the validity of the
license by using the license verification
system or contacting the license issuing
authority.
Paragraph (c) provides an emergency
method for when the licensee can’t
reach the license issuing authority and
the license verification system is
nonfunctional.
Paragraph (d) requires documentation
to be maintained for 3 years.
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Section 37.73 Applicability of Physical
Protection of Category 1 and Category 2
Quantities of Radioactive Material
During Transit
This section establishes which
requirements apply to licensees
shipping category 1 or category 2
quantities of radioactive material and
what requirements apply during the
domestic portion of a shipment that is
imported from another country or
exported to another country. This
section also allows the receiving
licensee to arrange for the in-transit
physical protection of a shipment
instead of the shipping licensee as long
as the agreement is in writing.
Section 37.75 Preplanning and
Coordination of Shipment of Category 1
or Category 2 Quantities of Radioactive
Material
This section establishes the
preplanning and coordination necessary
for a shipment of category 1 or category
2 quantities of radioactive material.
Section 37.77 Advance Notification of
Shipment of Category 1 Quantities of
Radioactive Material
This section establishes the
requirements for advance notification to
the NRC and the governor of a State, or
the governor’s designee, of the shipment
of category 1 quantities of radioactive
material that will pass through or across
the State.
Section 37.79 Requirements for
Physical Protection of Category 1 and
Category 2 Quantities of Radioactive
Material During Shipment
This section establishes the physical
protection requirements for shipments
of category 1 and category 2 quantities
of radioactive material. Paragraph (a)(1)
establishes the requirements for
shipping a category 1 quantity of
radioactive material by road. Paragraph
(a)(2) establishes the requirements for a
licensee that transports category 2
quantities of radioactive material by
road. Paragraph (a)(3) establishes the
requirements for a licensee that uses a
carrier for shipping category 2 quantities
of radioactive material.
Paragraph (b)(1) establishes the
requirements for shipping category 1
quantities of radioactive material by rail.
Paragraph (b)(2) establishes the security
requirements for shipping category 2
quantities of radioactive material by rail.
Paragraph (c) requires the shipping
licensee to immediately conduct an
investigation of any shipment of
category 2 quantities of radioactive
material that is lost or unaccounted for
after the designated no-later-than arrival
time. It also requires the licensee to
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conduct an investigation once it is
determined that a category 1 shipment
is lost or missing.
Section 37.81
Reporting of Events
This section establishes requirements
for the shipping licensee to make
notifications upon the discovery that a
shipment is lost or missing and upon
discovery of any actual or attempted
theft or diversion of a shipment, or
suspicious activities related to the theft
or diversion of a shipment of either a
category 1 or category 2 quantity of
radioactive material. This section also
establishes requirements for notification
upon recovery of a lost or missing
shipment. Written follow-up reports are
required for notifications of actual theft
or attempted theft or diversion of a
shipment.
Section 37.101
Form of Records
This section establishes the
requirements for the storage and
protection of records required by this
part.
Section 37.103
Record Retention
This section establishes the
Commission’s termination of the license
as the end point of the retention period
for any record where a specific retention
period is not specified.
Section 37.105
Inspections
Paragraph (a) requires licensees to
allow the Commission the opportunity
to inspect the materials and facilities
subject to 10 CFR part 37.
Paragraph (b) requires the licensee to
make available for inspection any
records subject to 10 CFR part 37.
Section 37.107
Violations
Paragraph (a) of this section
establishes that the Commission may
obtain an injunction or other court order
to prevent a violation of the AEA, Title
II of the Energy Reorganization Act of
1974, as amended; or a regulation or
order issued under those Acts.
Paragraph (b) of this section
establishes the violations for which the
Commission may obtain a court order
for the payment of a civil penalty
imposed under Section 234 of the AEA.
Section 37.109
Criminal Penalties
This section establishes the sections
in 10 CFR part 37 that are issued under
one or more of Sections 161b, 161i, or
161o and are therefore subject to
criminal sanctions for willful violation
of, attempted violation of, or conspiracy
to violate the regulation.
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Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Rules and Regulations
Appendix A to 10 CFR Part 37—
Category 1 and Category 2 Radioactive
Materials
Table 1 of this appendix establishes
the radionuclides and associated
thresholds for category 1 and category 2
quantities of radioactive material. The
appendix also provides the
methodology for calculating the sum of
fractions for evaluating combinations of
multiple radionuclides.
category 1 quantities of radioactive
material.
Section 39.1 Purpose and Scope
10 CFR part 37 is added to the list of
10 CFR parts that apply to applications
and licenses subject to this part.
VI. Agreement State Compatibility
Under the ‘‘Policy Statement on
Adequacy and Compatibility of
Agreement State Programs’’ approved by
the Commission on June 30, 1997, and
published in the Federal Register (62
FR 46517; September 3, 1997), this final
rule is a matter of compatibility between
the NRC and the Agreement States,
thereby providing consistency among
the Agreement States and the NRC
requirements. The NRC analyzed the
final rule in accordance with the
procedure established within part III,
‘‘Categorization Process for NRC
Program Elements,’’ of Handbook 5.9 to
Management Directive 5.9, ‘‘Adequacy
and Compatibility of Agreement State
Programs’’ (a copy of which may be
viewed at https://www.nrc.gov/readingrm/doc-collections/managementdirectives/).
The NRC program elements
(including regulations) are placed into
four compatibility categories (see the
Compatibility Table in this section). In
addition, the NRC program elements can
also be identified as having particular
health and safety significance or as
being reserved solely to the NRC.
Compatibility Category A elements are
those program elements that are basic
radiation protection standards and
scientific terms and definitions that are
necessary to understand radiation
protection concepts. An Agreement
State should adopt Category A program
elements in an essentially identical
manner to provide uniformity in the
regulation of agreement material on a
nationwide basis. Compatibility
Category B elements are those program
elements that apply to activities that
Section 51.22 Criterion for Categorical
Exclusion; Identification of Licensing
and Regulatory Actions Eligible for
Categorical Exclusion or Otherwise Not
Requiring Environmental Review
Paragraph (c)(3) is revised to include
10 CFR part 37.
Section 71.97 Advance Notification of
Shipment of Irradiated Reactor Fuel and
Nuclear Waste
Paragraph (b) is revised to delete the
reference to shipments of irradiated
reactor fuel in quantities less than those
subject to the advance notification
requirements of 10 CFR 73.37(f). Section
73.35 provides that such irradiated
reactor fuel shipments be subject to the
same requirements that apply to
shipments of category 1 radioactive
material, including the advance
notification requirements.
Section 73.35 Requirements for
Physical Protection of Irradiated Reactor
Fuel (100 Grams or Less) in Transit
A new section is added to 10 CFR part
73 to address the physical protection
requirements for shipments of irradiated
reactor fuel weighing 100 g (0.22 lb) or
less in net weight of irradiated fuel,
exclusive of cladding or other structural
or packaging material, which has a total
external radiation dose rate in excess of
1 Gray (100 rad) per hour at a distance
of 1 m (3.3 ft) from any accessible
surface without intervening shielding.
The material is subject to the same
transportation security requirements as
V. Criminal Penalties
For the purpose of Section 223 of the
AEA, the Commission is amending 10
CFR parts 20, 30, 32, 33, 34, 35, 36, 39,
51, 71, and 73 and adding new 10 CFR
part 37 under one or more of Sections
161b, 161i, or 161o of the AEA. Willful
violations of the rule would be subject
to criminal enforcement.
have direct and significant effects in
multiple jurisdictions. An Agreement
State should adopt Category B program
elements in an essentially identical
manner. Compatibility Category C
elements are those program elements
that do not meet the criteria of Category
A or B, but the essential objectives of
which an Agreement State should adopt
to avoid conflict, duplication, gaps, or
other conditions that would jeopardize
an orderly pattern in the regulation of
agreement material on a nationwide
basis. An Agreement State should adopt
the essential objectives of the Category
C program elements. Compatibility
Category D elements are those program
elements that do not meet any of the
criteria of Category A, B, or C, above,
and, thus, do not need to be adopted by
Agreement States for purposes of
compatibility.
Health and Safety (H&S) elements are
program elements that are not required
for compatibility, but are identified as
having a particular health and safety
role (i.e., adequacy) in the regulation of
agreement material within the State.
Although not required for compatibility,
the State should adopt program
elements in this H&S Category based on
those of the NRC that embody the
essential objectives of the NRC program
elements because of particular health
and safety considerations. Compatibility
Category NRC elements are those
program elements that address areas of
regulation that cannot be relinquished
to Agreement States under the AEA or
provisions of 10 CFR. These program
elements are not adopted by Agreement
States. The following table lists the parts
and sections that have been created or
revised and their corresponding
categorization under the ‘‘Policy
Statement on Adequacy and
Compatibility of Agreement State
Programs.’’ A bracket around a category
means that the section may have been
adopted elsewhere, and it is not
necessary to adopt it again.
The Agreement States have 3 years
from the publication of the final rule in
the Federal Register to adopt
compatible regulations.
COMPATIBILITY TABLE FOR FINAL RULE
Compatibility
Section
Change
Subject
tkelley on DSK3SPTVN1PROD with RULES2
Existing
New
Part 20
20.2201(c) ...............................
Amend ..........
Reports of theft or loss of licensed material ...............................................
D ..........
D
D ..........
D
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30.6 .........................................
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COMPATIBILITY TABLE FOR FINAL RULE—Continued
Compatibility
Section
Change
Subject
Existing
30.13 .......................................
30.33(a)(4) ..............................
Amend ..........
Amend ..........
Carriers ........................................................................................................
General requirements for issuance of specific licenses .............................
New
B ...........
D ..........
B
D
D ..........
D
D ..........
D
Part 32
32.1(b) .....................................
Amend ..........
Purpose and scope .....................................................................................
Part 33
33.1 .........................................
Amend ..........
Purpose and scope .....................................................................................
Part 34
34.1 .........................................
Amend ..........
Purpose and scope .....................................................................................
D ..........
D
35.1 .........................................
Amend ..........
Part 35
Purpose and scope .....................................................................................
D ..........
D
36.1 .........................................
Amend ..........
Part 36
Purpose and scope .....................................................................................
D ..........
D
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C
D
C
[B]
B
C
[A]
[H&S]
[B]
B
B
D
[A]
C
B
C
D
D
D
C
[B]
B
B
B
[C]
C
C
B
C
D
B
B
B
D
D
D
D
D
B
D
C
B
B
B
B
C
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Part 37
37.1 .........................................
37.3 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.5 .........................................
37.7 .........................................
37.9 .........................................
37.11(a) ...................................
37.11(b) ...................................
37.11(c) ...................................
37.13 .......................................
37.21(a) ...................................
37.21(b) ...................................
37.21(c) ...................................
37.23(a) ...................................
37.23(b)(1), (2), (4), (5) ..........
37.23(b)(3) ..............................
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Purpose .......................................................................................................
Scope ..........................................................................................................
Definition Access control .............................................................................
Definition Act ...............................................................................................
Definition Aggregated ..................................................................................
Definition Agreement State .........................................................................
Definition Approved individual .....................................................................
Definition Background Investigation ............................................................
Definition Becquerel ....................................................................................
Definition Byproduct Material ......................................................................
Definition Carrier .........................................................................................
Definition Category 1 quantities of radioactive material .............................
Definition Category 2 quantities of radioactive material .............................
Definition Commission ................................................................................
Definition Curie ............................................................................................
Definition Diversion .....................................................................................
Definition Escorted access ..........................................................................
Definition Fingerprint Orders .......................................................................
Definition Government agency ....................................................................
Definition License ........................................................................................
Definition License issuing agency ...............................................................
Definition Local law enforcement agency ...................................................
Definition Lost or missing material ..............................................................
Definition Mobile device ..............................................................................
Definition Movement control center ............................................................
Definition No-later-than arrival time ............................................................
Definition Person .........................................................................................
Definition Reviewing official ........................................................................
Definition Sabotage .....................................................................................
Safe haven ..................................................................................................
Definition Security zone ..............................................................................
Definition State ............................................................................................
Definition Telemetric position monitoring system .......................................
Definition Trustworthiness and reliability ....................................................
Definition Unescorted access .....................................................................
Definition United States ..............................................................................
Communications ..........................................................................................
Interpretations .............................................................................................
Specific exemptions ....................................................................................
Specific exemptions ....................................................................................
Specific exemptions ....................................................................................
Information collection requirements: OMB approval ...................................
General ........................................................................................................
General performance objective ...................................................................
Applicability .................................................................................................
Granting unescorted access authorization .................................................
Reviewing officials .......................................................................................
Reviewing officials .......................................................................................
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COMPATIBILITY TABLE FOR FINAL RULE—Continued
Compatibility
Section
Change
Subject
Existing
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37.31(a)–(d) ............................
37.31(e) ...................................
37.33(a), (b), (c) ......................
37.41(a) ...................................
37.41(b) ...................................
37.41(c) ...................................
37.43(a) ...................................
37.43(b) ...................................
37.43(c)(1)–(c)(3) ....................
37.43(c)(4) ..............................
37.43(d)(1)–(d)(8) ...................
37.43(d)(9) ..............................
37.45(a), (b), (d) .....................
37.45(c) ...................................
37.47(a)–(e) ............................
37.49(a) ...................................
37.49(b) ...................................
37.49(c) ...................................
37.49(d) ...................................
37.51 .......................................
37.53 .......................................
37.55(a), (b), (c) ......................
37.57(a) ...................................
37.57(b) ...................................
37.71 .......................................
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New ..............
37.73(a), (b), (d), (e) ...............
New ..............
37.73(c) ...................................
New ..............
37.75(a)–(d) ............................
New ..............
37.75(e) ...................................
New ..............
37.77 .......................................
tkelley on DSK3SPTVN1PROD with RULES2
37.23(c) ...................................
37.23(d) ...................................
37.23(e) ...................................
37.23(f) ....................................
37.23(g) ...................................
37.23(h) ...................................
37.25(a) ...................................
37.25(b) ...................................
37.25(c) ...................................
37.27(a) ...................................
37.27(b) ...................................
37.27(c) ...................................
37.29(a), (b) ............................
New ..............
37.77(a) ...................................
37.77(b) ...................................
37.77(c) ...................................
37.77(d) ...................................
37.77(e) ...................................
37.77(f) ....................................
37.79(a) ...................................
37.79(b) ...................................
37.79(c) ...................................
37.81(a) ...................................
37.81(b) ...................................
37.81(c) ...................................
37.81(d) ...................................
37.81(e) ...................................
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Jkt 229001
Informed consent ........................................................................................
Personal history disclosure .........................................................................
Determination basis ....................................................................................
Procedures ..................................................................................................
Right to correct and complete information ..................................................
Records .......................................................................................................
Initial investigation .......................................................................................
Grandfathering ............................................................................................
Reinvestigations ..........................................................................................
General performance objective and requirements .....................................
Prohibitions ..................................................................................................
Procedures for processing fingerprint checks ............................................
Relief from fingerprinting, identification, and criminal history records
checks and other elements of a background investigations for designated categories of individuals permitted unescorted access to certain radioactive materials.
Protection of information .............................................................................
Protection of information .............................................................................
Access authorization program review .........................................................
Applicability .................................................................................................
General performance objective ...................................................................
Program features ........................................................................................
Security plan ...............................................................................................
Implementing procedures ............................................................................
Training .......................................................................................................
Training .......................................................................................................
Protection of Information .............................................................................
Protection of Information .............................................................................
LLEA coordination .......................................................................................
LLEA coordination (records) .......................................................................
Security zones .............................................................................................
Monitoring and detection .............................................................................
Assessment .................................................................................................
Personnel communications and data transmission ....................................
Response ....................................................................................................
Maintenance and testing .............................................................................
Requirements for mobile devices ...............................................................
Security program review .............................................................................
Reporting of events .....................................................................................
Reporting of events .....................................................................................
Additional requirements for transfer of category 1 and category 2 quantities of radioactive material.
Additional requirements for transfer of category 1 and category 2 quantities of radioactive material.
Additional requirements for transfer of category 1 and category 2 quantities of radioactive material.
Applicability of physical protection of category 1 and category 2 quantities of radioactive material during transit.
Applicability of physical protection of category 1 and category 2 quantities of radioactive material during transit.
Preplanning and coordination of shipment of category 1 or category 2
quantities of radioactive material.
Preplanning and coordination of shipment of category 1 or category 2
quantities of radioactive material.
Advance notification for shipments of category 1 quantities of radioactive
material.
Procedures for submitting advance notification ..........................................
Information to be furnished in advance notification of shipment ................
Revision notice ............................................................................................
Cancellation notice ......................................................................................
Records .......................................................................................................
Protection of information .............................................................................
Shipments by road ......................................................................................
Shipments by rail ........................................................................................
Investigations ..............................................................................................
Reporting of events .....................................................................................
Reporting of events .....................................................................................
Reporting of events .....................................................................................
Reporting of events .....................................................................................
Reporting of events .....................................................................................
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B
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B
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B
B
C
NRC
B
B
B
B
B
B
B
B
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COMPATIBILITY TABLE FOR FINAL RULE—Continued
Compatibility
Section
Change
Subject
Existing
37.81(f) ....................................
37.81(g) ...................................
37.81(h) ...................................
37.101 .....................................
37.103 .....................................
37.105 .....................................
37.107 .....................................
37.109 .....................................
Appendix A .............................
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Reporting of events .....................................................................................
Reporting of events .....................................................................................
Reporting of events .....................................................................................
Form of records ...........................................................................................
Record retention ..........................................................................................
Inspections ..................................................................................................
Violations .....................................................................................................
Criminal penalties ........................................................................................
Category 1 and 2 thresholds ......................................................................
New
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D
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D
NRC .....
NRC
B ...........
B
..............
NRC
Part 39
39.1 .........................................
Amend ..........
Purpose and scope .....................................................................................
Part 51
51.22(c)(3) ..............................
Amend ..........
Criterion for categorical exclusion; identification of licensing and regulatory actions eligible for categorical exclusion or otherwise not requiring environmental review.
Part 71
71.97(b) ...................................
Amend ..........
Advance notification of shipment of irradiated reactor fuel and nuclear
waste.
Part 73
73.35 .......................................
New ..............
VII. Plain Writing
The Plain Writing Act of 2010 (Pub.
L. 111–274) requires Federal agencies to
write documents in a clear, concise, and
well-organized manner. The NRC has
written this document to be consistent
with the Plain Writing Act as well as the
Presidential Memorandum, ‘‘Plain
Language in Government Writing,’’
published June 10, 1998 (63 FR 31883).
tkelley on DSK3SPTVN1PROD with RULES2
VIII. Voluntary Consensus Standards
The National Technology Transfer
and Advancement Act of 1995 (Pub. L.
104–113), requires that Federal agencies
use technical standards that are
developed or adopted by voluntary
consensus standards bodies unless the
use of such a standard is inconsistent
with applicable law or otherwise
impractical. In this final rule, the NRC
is establishing security requirements for
the use of category 1 and category 2
quantities of radioactive materials. The
NRC is not aware of any voluntary
consensus standards that address the
subject matter of this final rule. This
action does not constitute the
establishment of a standard that
establishes generally applicable
requirements.
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Requirements for physical protection of irradiated reactor fuel (100
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IX. Finding of No Significant
Environmental Impact: Availability
Under the National Environmental
Policy Act of 1969, as amended, and the
NRC regulations in subpart A of 10 CFR
part 51, the NRC has determined that
this final rule, if adopted, would not be
a major Federal action significantly
affecting the quality of the human
environment, and therefore an
environmental impact statement is not
required for this rulemaking. The NRC
has prepared an environmental
assessment and, on the basis of this
environmental assessment, has made a
finding of no significant impact.
The implementation of the final rule’s
security requirements would not result
in significant changes to the licensee’s
facilities, nor would such
implementation result in any significant
increase in effluents released to the
environment. Similarly, the
implementation of the final rule’s
security requirements would not affect
occupational exposure requirements. No
major construction or other earthdisturbing activities on the part of
affected licensees are anticipated in
connection with licensees’
implementation of the final rule’s
requirements. The Commission has
determined that the implementation of
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this final rule is procedural and
administrative in nature.
The determination of this
environmental assessment is that there
will be no significant impact to the
public from this action.
This conclusion was published in the
environmental assessment that was
posted to the NRC’s rulemaking Web
site: https://www.regulations.gov after
publication of the proposed rule. No
comments were received on the content
of the environmental assessment.
X. Paperwork Reduction Act Statement
This final rule contains new
information collection requirements in
10 CFR part 37 that are subject to the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.). These requirements
were approved by the Office of
Management and Budget (OMB),
approval number 3150–0214. The
changes to 10 CFR parts 20, 30, 32, 33,
34, 35, 36, 39, 51, 71, and 73 do not
contain new or amended information
collection requirements. Existing
requirements were approved by the
OMB, approval numbers 3150–0014,
3150–0017, 3150–0001, 3150–0015,
3150–0007, 3150–0010, 3150–0158,
3150–0130, 3150–0021, 3150–0008, and
3150–0002.
The burden to the public for the
information collections in 10 CFR part
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17005
implement the final rule. The NRC
believes that the selected alternative
reflected in the final rule is the least
burdensome, most flexible alternative
that accomplishes the NRC’s regulatory
objective. The Regulatory Flexibility
Analysis is included as an Appendix to
this final rule.
10 CFR Part 35
XIII. Backfit Analysis
10 CFR Part 36
The NRC has determined that the
backfit rule, which is found in the
regulations at 10 CFR 50.109, 70.76,
72.62, 76.76, and in 10 CFR part 52,
does not apply to this final rule because
this amendment would not involve any
provisions that would impose backfits
as defined in 10 CFR chapter I.
Therefore, a backfit analysis is not
required.
Byproduct material, Criminal
penalties, Nuclear materials, Reporting
and recordkeeping requirements,
Scientific equipment, Security
measures.
Public Protection Notification
The NRC may not conduct or sponsor,
and a person is not required to respond
to, a request for information or an
information collection requirement
unless the requesting document
displays a currently valid OMB control
number.
XIV. Congressional Review Act
XI. Regulatory Analysis
The Commission has prepared a
regulatory analysis on this final
regulation. The analysis examines the
costs and benefits of the alternatives
considered by the Commission.
The analysis is available for
inspection in the NRC’s Public
Document Room, 11555 Rockville Pike,
Rockville, Maryland 20852. The
analysis may also be viewed and
downloaded electronically via the
Federal erulemaking portal at https://
www.regulations.gov by searching for
Docket ID NRC–2008–0120.
tkelley on DSK3SPTVN1PROD with RULES2
37 is estimated to average1.7 hours per
response. This includes the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the
information collection. Send comments
on any aspect of these information
collections, including suggestions for
reducing the burden, to the Information
Services Branch (T–5 F53), U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, or by Internet
electronic mail to INFOCOLLECTS.
RESOURCE@NRC.GOV; and to the Desk
Officer, Chad Whiteman, Office of
Information and Regulatory Affairs,
NEOB–10202, (3150–0214), Office of
Management and Budget, Washington,
DC 20503.
List of Subjects
XII. Regulatory Flexibility Certification
The NRC has prepared a regulatory
analysis of the impact of this final rule
on small entities. The final rule will
affect about 300 NRC licensees and an
additional 1,100 Agreement State
licensees. Affected licensees include
laboratories, reactors, universities,
colleges, medical clinics, hospitals,
irradiators, manufacturers and
distributors, well loggers, and
radiographers, some of which may
qualify as small business entities as
defined by 10 CFR 2.810. Based on the
regulatory analysis conducted for this
action, the costs of the rule for affected
licensees are estimated to be between
$358 million and $488 million (7percent and 3-percent discount rate over
20 years, respectively) total. The average
licensee will have a one-time cost of
approximately $23,375 and an annual
cost of approximately $21,736 to fully
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In accordance with the Congressional
Review Act of 1996, the NRC has
determined that this action is a major
rule and has verified this determination
with the Office of Information and
Regulatory Affairs of OMB.
10 CFR Part 20
Byproduct material, Criminal
penalties, Licensed material, Nuclear
materials, Nuclear power plants and
reactors, Occupational safety and
health, Packaging and containers,
Radiation protection, Reporting and
recordkeeping requirements, Source
material, Special nuclear material,
Waste treatment and disposal.
10 CFR Part 30
Byproduct material, Criminal
penalties, Government contracts,
Intergovernmental relations, Isotopes,
Nuclear materials, Radiation protection,
Reporting and recordkeeping
requirements.
10 CFR Part 32
Byproduct material, Criminal
penalties, Labeling, Nuclear materials,
Radiation protection, Reporting and
recordkeeping requirements.
10 CFR Part 33
Byproduct material, Criminal
penalties, Nuclear materials, Radiation
protection, Reporting and recordkeeping
requirements.
10 CFR Part 34
Criminal penalties, Packaging and
containers, Radiation protection,
Radiography, Reporting and
recordkeeping requirements, Scientific
equipment, Security measures.
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Byproduct material, Criminal
penalties, Drugs, Health facilities,
Health professions, Medical devices,
Nuclear materials, Occupational safety
and health, Radiation protection,
Reporting and recordkeeping
requirements.
10 CFR Part 37
Byproduct material, Criminal
penalties, Export, Hazardous materials
transportation, Import, Licensed
material, Nuclear materials, Reporting
and recordkeeping requirements,
Security measures.
10 CFR Part 39
Byproduct material, Criminal
penalties, Nuclear material, Oil and gas
exploration—well logging, Reporting
and recordkeeping requirements,
Scientific equipment, Security
measures, Source material, Special
nuclear material.
10 CFR Part 51
Administrative practice and
procedure, Environmental impact
statement, Nuclear materials, Nuclear
power plants and reactors, Reporting
and recordkeeping requirements.
10 CFR Part 71
Criminal penalties, Hazardous
materials transportation, Nuclear
materials, Packaging and containers,
Reporting and recordkeeping
requirements.
10 CFR Part 73
Criminal penalties, Export, Hazardous
materials transportation, Import,
Nuclear materials, Nuclear power plants
and reactors, Reporting and
recordkeeping requirements, Security
measures.
For the reasons set out in the
preamble and under the authority of the
Atomic Energy Act of 1954, as amended;
the Energy Reorganization Act of 1974,
as amended; and 5 U.S.C. 552 and 553;
the NRC is adopting the following
amendments to 10 CFR parts 20, 30, 32,
33, 34, 35, 36, 37, 39, 51, 71, and 73.
PART 20—STANDARDS FOR
PROTECTION AGAINST RADIATION
1. The authority citation for part 20
continues to read as follows:
■
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Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Rules and Regulations
Authority: Atomic Energy Act secs. 53, 63,
65, 81, 103, 104, 161, 182, 186, 223. 234 1701
(42 U.S.C. 2073, 2093, 2095, 2111, 2133,
2134, 2201, 2232, 2236, 2273, 2282, 2297f),
Energy Reorganization Act secs. 201, 202,
206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005 sec. 651(e), Pub. L. No. 109–58, 119
Stat. 549 (2005) (42 U.S.C. 2014, 2021, 2021b,
2111).
regulations in this part and parts 31
through 37 and 39 of this chapter and
the requirements for a license set forth
in section 81 of the Act to the extent that
they transport or store byproduct
material in the regular course of carriage
for another or storage incident thereto.
6. In § 30.33, paragraph (a)(4) is
revised to read as follows:
■
2. In § 20.2201, paragraph (c) is
revised to read as follows:
§ 30.33 General requirements for issuance
of specific licenses.
§ 20.2201 Reports of theft or loss of
licensed material.
(a) * * *
(4) The applicant satisfies any special
requirements contained in parts 32
through 37 and 39 of this chapter; and
*
*
*
*
*
■
*
*
*
*
*
(c) A duplicate report is not required
under paragraph (b) of this section if the
licensee is also required to submit a
report pursuant to §§ 30.55(c), 37.57,
37.81, 40.64(c), 50.72, 50.73, 70.52,
73.27(b), 73.67(e)(3)(vii), 73.67(g)(3)(iii),
73.71, or 150.19(c) of this chapter.
*
*
*
*
*
PART 30—RULES OF GENERAL
APPLICABILITY TO DOMESTIC
LICENSING OF BYPRODUCT
MATERIAL
3. The authority citation for part 30
continues to read as follows:
■
Authority: Atomic Energy Act secs. 81, 82,
161, 181, 182, 183, 186, 223, 234 (42 U.S.C.
2111, 2112, 2201, 2231, 2232, 2233, 2236,
2273, 2282); Energy Reorganization Act secs.
201, 202, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, Pub. L. No. 109–58, 119 Stat. 549
(2005).
Section 30.7 also issued under Energy
Reorganization Act sec. 211, Pub. L. 95–601,
sec. 10, as amended by Pub. L. 102–486, sec.
2902 (42 U.S.C. 5851). Section 30.34(b) also
issued under Atomic Energy Act sec. 184 (42
U.S.C. 2234). Section 30.61 also issued under
Atomic Energy Act sec. 187 (42 U.S.C. 2237).
4. In § 30.6, the introductory text of
paragraph (a) is revised to read as
follows:
■
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§ 30.6
Communications.
(a) Unless otherwise specified or
covered under the regional licensing
program as provided in paragraph (b) of
this section, any communication or
report concerning the regulations in
parts 30 through 37 and 39 of this
chapter and any application filed under
these regulations may be submitted to
the Commission as follows:
*
*
*
*
*
■ 5. Section 30.13 is revised to read as
follows:
§ 30.13
Carriers.
Common and contract carriers, freight
forwarders, warehousemen, and the U.S.
Postal Service are exempt from the
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PART 32—SPECIFIC DOMESTIC
LICENSES TO MANUFACTURE OR
TRANSFER CERTAIN ITEMS
CONTAINING BYPRODUCT MATERIAL
7. The authority citation for part 32
continues to read as follows:
■
Authority: Atomic Energy Act secs. 81,
161, 181, 182, 183, 223, 234 (42 U.S.C. 2111,
2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841);
Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, sec. 651(e), Pub. L. No. 109–58, 119
Stat. 806–810 (42 U.S.C. 2014, 2021, 2021b,
2111).
8. In § 32.1, paragraph (b) is revised to
read as follows:
■
§ 32.1
Purpose and scope.
*
*
*
*
*
(b) The provisions and requirements
of this part are in addition to, and not
in substitution for, other requirements
of this chapter. In particular, the
provisions of part 30 of this chapter
apply to applications, licenses and
certificates of registration subject to this
part, and the provisions of part 37 of
this chapter apply to applications and
licenses subject to this part.
*
*
*
*
*
PART 33—SPECIFIC DOMESTIC
LICENSES OF BROAD SCOPE FOR
BYPRODUCT MATERIAL
§ 33.1
Purpose and scope.
This part prescribes requirements for
the issuance of specific licenses of broad
scope for byproduct material (‘‘broad
licenses’’) and certain regulations
governing holders of such licenses. The
provisions and requirements of this part
are in addition to, and not in
substitution for, other requirements of
this chapter. In particular, the
provisions of parts 30 and 37 of this
chapter apply to applications and
licenses subject to this part.
PART 34—LICENSES FOR
INDUSTRIAL RADIOGRAPHY AND
RADIATION SAFETY REQUIREMENTS
FOR INDUSTRIAL RADIOGRAPHIC
OPERATIONS
11. The authority citation for part 34
continues to read as follows:
■
Authority: Atomic Energy Act secs. 81,
161, 181, 182, 183, 223, 234 (42 U.S.C. 2111,
2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841);
Government Paperwork Elimination Act sec.
1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
Atomic Energy Act of 2005 sec. 651(e), Pub.
L. No. 109–58, 119 Stat. 806–810 (42 U.S.C.
2014, 2021, 2021b, 2111). Section 34.45 also
issued under Energy Reorganization Act sec.
206 (42 U.S.C. 5846).
12. Section 34.1 is revised to read as
follows:
■
§ 34.1
Purpose and scope.
This part prescribes requirements for
the issuance of licenses for the use of
sealed sources containing byproduct
material and radiation safety
requirements for persons using these
sealed sources in industrial
radiography. The provisions and
requirements of this part are in addition
to, and not in substitution for, other
requirements of this chapter. In
particular, the requirements and
provisions of parts 19, 20, 21, 30, 37, 71,
150, 170, and 171 of this chapter apply
to applications and licenses subject to
this part. This rule does not apply to
medical uses of byproduct material.
PART 35—MEDICAL USE OF
BYPRODUCT MATERIAL
9. The authority citation for part 33
continues to read as follows:
■
Authority: Atomic Energy Act secs. 81,
161, 181, 182, 183, 223, 234 (42 U.S.C. 2111,
2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841);
Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005 sec. 651(e), Public Law 109–58, 119
Stat. 806–810 (42 U.S.C. 2014, 2021, 2021b,
2111).
Authority: Atomic Energy Act secs. 81,
161, 181, 182, 183, 223, 234 (42 U.S.C. 2111,
2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201, 206 (42 U.S.C.
5841, 5842, 5846); sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005, sec. 651(e),
Public Law 109–58, 119 Stat. 806–810 (42
U.S.C. 2014, 2021, 2021b, 2111).
■
10. Section 33.1 is revised to read as
follows:
■
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13. The authority citation for part 35
continues to read as follows:
14. Section 35.1 is revised to read as
follows:
■
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Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Rules and Regulations
§ 35.1
Purpose and scope.
This part contains the requirements
and provisions for the medical use of
byproduct material and for issuance of
specific licenses authorizing the
medical use of this material. These
requirements and provisions provide for
the radiation safety of workers, the
general public, patients, and human
research subjects. The requirements and
provisions of this part are in addition to,
and not in substitution for, others in this
chapter. The requirements and
provisions of parts 19, 20, 21, 30, 37, 71,
170, and 171 of this chapter apply to
applicants and licensees subject to this
part unless specifically exempted.
PART 36—LICENSES AND RADIATION
SAFETY REQUIREMENTS FOR
IRRADIATORS
15. The authority citation for part 36
continues to read as follows:
■
Authority: Atomic Energy Act secs. 81, 82,
161, 181, 182, 183, 186, 223, 234 (42 U.S.C.
2111, 2112, 2201, 2232, 2233, 2236, 2273,
2282); Energy Reorganization Act secs. 201,
202, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Atomic Energy
Act of 2005 sec. 651(e), Pub. L. No. 109–58,
119 Stat. 806–810 (42 U.S.C. 2014, 2021,
2021b, 2111).
16. In § 36.1, paragraph (a) is revised
to read as follows:
■
§ 36.1
Purpose and scope.
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(a) This part contains requirements for
the issuance of a license authorizing the
use of sealed sources containing
radioactive materials in irradiators used
to irradiate objects or materials using
gamma radiation. This part also
contains radiation safety requirements
for operating irradiators. The
requirements of this part are in addition
to other requirements of this chapter. In
particular, the provisions of parts 19, 20,
21, 30, 37, 71, 170, and 171 of this
chapter apply to applications and
licenses subject to this part. Nothing in
this part relieves the licensee from
complying with other applicable
Federal, State and local regulations
governing the siting, zoning, land use,
and building code requirements for
industrial facilities.
*
*
*
*
*
■ 17. Part 37 is added to read as follows:
PART 37—PHYSICAL PROTECTION OF
CATEGORY 1 AND CATEGORY 2
QUANTITIES OF RADIOACTIVE
MATERIAL
Subpart A—General Provisions
37.1 Purpose.
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37.3 Scope.
37.5 Definitions.
37.7 Communications.
37.9 Interpretations.
37.11 Specific exemptions.
37.13 Information collection requirements:
OMB approval.
Appendix A to Part 37—Category 1 and
Category 2 Radioactive Materials
Subpart B—Background Investigations and
Access Control Program
Subpart A—General Provisions
37.21 Personnel access authorization
requirements for category 1 or category 2
quantities of radioactive material.
37.23 Access authorization program
requirements.
37.25 Background investigations.
37.27 Requirements for criminal history
records checks of individuals granted
unescorted access to category 1 or
category 2 quantities of radioactive
material.
37.29 Relief from fingerprinting,
identification, and criminal history
records checks and other elements of
background investigations for designated
categories of individuals permitted
unescorted access to certain radioactive
materials.
37.31 Protection of information.
37.33 Access authorization program review.
§ 37.1
Subpart C—Physical Protection
Requirements During Use
(a) Subparts B and C of this part apply
to any person who, under the
regulations in this chapter, possesses or
uses at any site, an aggregated category
1 or category 2 quantity of radioactive
material.
(b) Subpart D of this part applies to
any person who, under the regulations
of this chapter:
(1) Transports or delivers to a carrier
for transport in a single shipment, a
category 1 or category 2 quantity of
radioactive material; or
(2) Imports or exports a category 1 or
category 2 quantity of radioactive
material; the provisions only apply to
the domestic portion of the transport.
37.41 Security program.
37.43 General security program
requirements.
37.45 LLEA coordination.
37.47 Security zones.
37.49 Monitoring, detection, and
assessment.
37.51 Maintenance and testing.
37.53 Requirements for mobile devices.
37.55 Security program review.
37.57 Reporting of events.
Subpart D—Physical Protection in Transit
37.71 Additional requirements for transfer
of category 1 and category 2 quantities of
radioactive material.
37.73 Applicability of physical protection
of category 1 and category 2 quantities of
radioactive material during transit.
37.75 Preplanning and coordination of
shipment of category 1 or category 2
quantities of radioactive material.
37.77 Advance notification of shipment of
category 1 quantities of radioactive
material.
37.79 Requirements for physical protection
of category 1 and category 2 quantities of
radioactive material during shipment.
37.81 Reporting of events.
Subpart E—[Reserved]
Subpart F—Records
37.101
37.103
Form of records.
Record retention.
Subpart G—Enforcement
Sec.
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37.105
37.107
37.109
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Inspections.
Violations.
Criminal penalties.
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Authority: Atomic Energy Act secs. 53, 81,
103, 104, 147, 148, 149, 161, 182, 183, 223,
234 (42 U.S.C. 2073, 2111, 2133, 2134, 2167,
2168, 2169, 2201a., 2232, 2233, 2273, 2282).
Purpose.
This part has been established to
provide the requirements for the
physical protection program for any
licensee that possesses an aggregated
category 1 or category 2 quantity of
radioactive material listed in Appendix
A to this part. These requirements
provide reasonable assurance of the
security of category 1 or category 2
quantities of radioactive material by
protecting these materials from theft or
diversion. Specific requirements for
access to material, use of material,
transfer of material, and transport of
material are included. No provision of
this part authorizes possession of
licensed material.
§ 37.3
§ 37.5
Scope.
Definitions.
As used in this part:
Access control means a system for
allowing only approved individuals to
have unescorted access to the security
zone and for ensuring that all other
individuals are subject to escorted
access.
Act means the Atomic Energy Act of
1954 (68 Stat. 919), including any
amendments thereto.
Aggregated means accessible by the
breach of a single physical barrier that
would allow access to radioactive
material in any form, including any
devices that contain the radioactive
material, when the total activity equals
or exceeds a category 2 quantity of
radioactive material.
Agreement State means any state with
which the Atomic Energy Commission
or the U.S. Nuclear Regulatory
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Commission has entered into an
effective agreement under subsection
274b. of the Act. Non-agreement State
means any other State.
Approved individual means an
individual whom the licensee has
determined to be trustworthy and
reliable for unescorted access in
accordance with subpart B of this part
and who has completed the training
required by § 37.43(c).
Background investigation means the
investigation conducted by a licensee or
applicant to support the determination
of trustworthiness and reliability.
Becquerel (Bq) means one
disintegration per second.
Byproduct material means—
(1) Any radioactive material (except
special nuclear material) yielded in, or
made radioactive by, exposure to the
radiation incident to the process of
producing or using special nuclear
material;
(2) The tailings or wastes produced by
the extraction or concentration of
uranium or thorium from ore processed
primarily for its source material content,
including discrete surface wastes
resulting from uranium solution
extraction processes. Underground ore
bodies depleted by these solution
extraction operations do not constitute
‘‘byproduct material’’ within this
definition;
(3)(i) Any discrete source of radium226 that is produced, extracted, or
converted after extraction, before, on, or
after August 8, 2005, for use for a
commercial, medical, or research
activity; or
(ii) Any material that—
(A) Has been made radioactive by use
of a particle accelerator; and
(B) Is produced, extracted, or
converted after extraction, before, on, or
after August 8, 2005, for use for a
commercial, medical, or research
activity; and
(4) Any discrete source of naturally
occurring radioactive material, other
than source material, that—
(i) The Commission, in consultation
with the Administrator of the
Environmental Protection Agency, the
Secretary of Energy, the Secretary of
Homeland Security, and the head of any
other appropriate Federal agency,
determines would pose a threat similar
to the threat posed by a discrete source
of radium-226 to the public health and
safety or the common defense and
security; and
(ii) Before, on, or after August 8, 2005,
is extracted or converted after extraction
for use in a commercial, medical, or
research activity.
Carrier means a person engaged in the
transportation of passengers or property
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by land or water as a common, contract,
or private carrier, or by civil aircraft.
Category 1 quantity of radioactive
material means a quantity of radioactive
material meeting or exceeding the
category 1 threshold in Table 1 of
Appendix A to this part. This is
determined by calculating the ratio of
the total activity of each radionuclide to
the category 1 threshold for that
radionuclide and adding the ratios
together. If the sum is equal to or
exceeds 1, the quantity would be
considered a category 1 quantity.
Category 1 quantities of radioactive
material do not include the radioactive
material contained in any fuel assembly,
subassembly, fuel rod, or fuel pellet.
Category 2 quantity of radioactive
material means a quantity of radioactive
material meeting or exceeding the
category 2 threshold but less than the
category 1 threshold in Table 1 of
Appendix A to this part. This is
determined by calculating the ratio of
the total activity of each radionuclide to
the category 2 threshold for that
radionuclide and adding the ratios
together. If the sum is equal to or
exceeds 1, the quantity would be
considered a category 2 quantity.
Category 2 quantities of radioactive
material do not include the radioactive
material contained in any fuel assembly,
subassembly, fuel rod, or fuel pellet.
Commission means the U.S. Nuclear
Regulatory Commission or its duly
authorized representatives.
Curie means that amount of
radioactive material which disintegrates
at the rate of 37 billion atoms per
second.
Diversion means the unauthorized
movement of radioactive material
subject to this part to a location different
from the material’s authorized
destination inside or outside of the site
at which the material is used or stored.
Escorted access means
accompaniment while in a security zone
by an approved individual who
maintains continuous direct visual
surveillance at all times over an
individual who is not approved for
unescorted access.
Fingerprint orders means the orders
issued by the U.S. Nuclear Regulatory
Commission or the legally binding
requirements issued by Agreement
States that require fingerprints and
criminal history records checks for
individuals with unescorted access to
category 1 and category 2 quantities of
radioactive material or safeguards
information-modified handling.
Government agency means any
executive department, commission,
independent establishment, corporation,
wholly or partly owned by the United
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States of America which is an
instrumentality of the United States, or
any board, bureau, division, service,
office, officer, authority, administration,
or other establishment in the executive
branch of the Government.
License, except where otherwise
specified, means a license for byproduct
material issued pursuant to the
regulations in parts 30 through 36 and
39 of this chapter;
License issuing authority means the
licensing agency that issued the license,
i.e. the U.S. Nuclear Regulatory
Commission or the appropriate agency
of an Agreement State;
Local law enforcement agency (LLEA)
means a public or private organization
that has been approved by a federal,
state, or local government to carry
firearms and make arrests, and is
authorized and has the capability to
provide an armed response in the
jurisdiction where the licensed category
1 or category 2 quantity of radioactive
material is used, stored, or transported.
Lost or missing licensed material
means licensed material whose location
is unknown. It includes material that
has been shipped but has not reached its
destination and whose location cannot
be readily traced in the transportation
system.
Mobile device means a piece of
equipment containing licensed
radioactive material that is either
mounted on wheels or casters, or
otherwise equipped for moving without
a need for disassembly or dismounting;
or designed to be hand carried. Mobile
devices do not include stationary
equipment installed in a fixed location.
Movement control center means an
operations center that is remote from
transport activity and that maintains
position information on the movement
of radioactive material, receives reports
of attempted attacks or thefts, provides
a means for reporting these and other
problems to appropriate agencies and
can request and coordinate appropriate
aid.
No-later-than arrival time means the
date and time that the shipping licensee
and receiving licensee have established
as the time at which an investigation
will be initiated if the shipment has not
arrived at the receiving facility. The nolater-than-arrival time may not be more
than 6 hours after the estimated arrival
time for shipments of category 2
quantities of radioactive material.
Person means—
(1) Any individual, corporation,
partnership, firm, association, trust,
estate, public or private institution,
group, Government agency other than
the Commission or the DOE (except that
the Department shall be considered a
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person within the meaning of the
regulations in 10 CFR chapter I to the
extent that its facilities and activities are
subject to the licensing and related
regulatory authority of the Commission
under section 202 of the Energy
Reorganization Act of 1974 (88 Stat.
1244), the Uranium Mill Tailings
Radiation Control Act of 1978 (92 Stat.
3021), the Nuclear Waste Policy Act of
1982 (96 Stat. 2201), and section 3(b)(2)
of the Low-Level Radioactive Waste
Policy Amendments Act of 1985 (99
Stat. 1842), any State or any political
subdivision of or any political entity
within a State, any foreign government
or nation or any political subdivision of
any such government or nation, or other
entity; and
(2) Any legal successor,
representative, agent, or agency of the
foregoing.
Reviewing official means the
individual who shall make the
trustworthiness and reliability
determination of an individual to
determine whether the individual may
have, or continue to have, unescorted
access to the category 1 or category 2
quantities of radioactive materials that
are possessed by the licensee.
Sabotage means deliberate damage,
with malevolent intent, to a category 1
or category 2 quantity of radioactive
material, a device that contains a
category 1 or category 2 quantity of
radioactive material, or the components
of the security system.
Safe haven means a readily
recognizable and readily accessible site
at which security is present or from
which, in the event of an emergency, the
transport crew can notify and wait for
the local law enforcement authorities.
Security zone means any temporary or
permanent area determined and
established by the licensee for the
physical protection of category 1 or
category 2 quantities of radioactive
material.
State means a State of the United
States, the District of Columbia, the
Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern
Mariana Islands.
Telemetric position monitoring
system means a data transfer system that
captures information by instrumentation
and/or measuring devices about the
location and status of a transport vehicle
or package between the departure and
destination locations.
Trustworthiness and reliability are
characteristics of an individual
considered dependable in judgment,
character, and performance, such that
unescorted access to category 1 or
category 2 quantities of radioactive
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material by that individual does not
constitute an unreasonable risk to the
public health and safety or security. A
determination of trustworthiness and
reliability for this purpose is based upon
the results from a background
investigation.
Unescorted access means solitary
access to an aggregated category 1 or
category 2 quantity of radioactive
material or the devices that contain the
material.
United States, when used in a
geographical sense, includes Puerto
Rico and all territories and possessions
of the United States.
§ 37.7
Communications.
Except where otherwise specified or
covered under the regional licensing
program as provided in § 30.6(b) of this
chapter, all communications and reports
concerning the regulations in this part
may be sent as follows:
(a) By mail addressed to: ATTN:
Document Control Desk; Director, Office
of Nuclear Reactor Regulation; Director,
Office of New Reactors; Director, Office
of Nuclear Material Safety and
Safeguards; Director, Office of Federal
and State Materials and Environmental
Management Programs; or Director,
Division of Security Policy, Office of
Nuclear Security and Incident
Response, as appropriate, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001;
(b) By hand delivery to the NRC’s
offices at 11555 Rockville Pike,
Rockville, Maryland 20852;
(c) Where practicable, by electronic
submission, for example, Electronic
Information Exchange, or CD–ROM.
Electronic submissions must be made in
a manner that enables the NRC to
receive, read, authenticate, distribute,
and archive the submission, and process
and retrieve it a single page at a time.
Detailed guidance on making electronic
submissions can be obtained by visiting
the NRC’s Web site at https://
www.nrc.gov/site-help/esubmittals.html; by email to
MSHD.Resource@nrc.gov; or by writing
the Office of Information Services, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001. The
guidance discusses, among other topics,
the formats the NRC can accept, the use
of electronic signatures, and the
treatment of nonpublic information.
§ 37.9
Interpretations.
Except as specifically authorized by
the Commission in writing, no
interpretations of the meaning of the
regulations in this part by any officer or
employee of the Commission other than
a written interpretation by the General
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17009
Counsel will be recognized as binding
upon the Commission.
§ 37.11
Specific exemptions.
(a) The Commission may, upon
application of any interested person or
upon its own initiative, grant such
exemptions from the requirements of
the regulations in this part as it
determines are authorized by law and
will not endanger life or property or the
common defense and security, and are
otherwise in the public interest.
(b) Any licensee’s NRC-licensed
activities are exempt from the
requirements of subparts B and C of this
part to the extent that its activities are
included in a security plan required by
part 73 of this chapter.
(c) A licensee that possesses
radioactive waste that contains category
1 or category 2 quantities of radioactive
material is exempt from the
requirements of subparts B, C, and D of
this part. Except that any radioactive
waste that contains discrete sources,
ion-exchange resins, or activated
material that weighs less than 2,000 kg
(4,409 lbs) is not exempt from the
requirements of this part. The licensee
shall implement the following
requirements to secure the radioactive
waste:
(1) Use continuous physical barriers
that allow access to the radioactive
waste only through established access
control points;
(2) Use a locked door or gate with
monitored alarm at the access control
point;
(3) Assess and respond to each actual
or attempted unauthorized access to
determine whether an actual or
attempted theft, sabotage, or diversion
occurred; and
(4) Immediately notify the LLEA and
request an armed response from the
LLEA upon determination that there
was an actual or attempted theft,
sabotage, or diversion of the radioactive
waste that contains category 1 or
category 2 quantities of radioactive
material.
§ 37.13 Information collection
requirements: OMB approval.
(a) The U.S. Nuclear Regulatory
Commission has submitted the
information collection requirements
contained in this part to the Office of
Management and Budget (OMB) for
approval as required by the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.).
The NRC may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. The OMB has approved the
information collection requirements
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contained in this part under control
number 3150–0214.
(b) The approved information
collection requirements contained in
this part appear in §§ 37.11, 37.21,
37.23, 37.25, 37.27, 37.29, 37.31, 37.33,
37.41, 37.43, 37.45, 37.49, 37.51, 37.55,
37.57, 37.71, 37.75, 37.77, 37.79, and
37.81.
Subpart B—Background Investigations
and Access Authorization Program
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§ 37.21 Personnel access authorization
requirements for category 1 or category 2
quantities of radioactive material.
(a) General. (1) Each licensee that
possesses an aggregated quantity of
radioactive material at or above the
category 2 threshold shall establish,
implement, and maintain its access
authorization program in accordance
with the requirements of this subpart.
(2) An applicant for a new license and
each licensee that would become newly
subject to the requirements of this
subpart upon application for
modification of its license shall
implement the requirements of this
subpart, as appropriate, before taking
possession of an aggregated category 1
or category 2 quantity of radioactive
material.
(3) Any licensee that has not
previously implemented the Security
Orders or been subject to the provisions
of this subpart B shall implement the
provisions of this subpart B before
aggregating radioactive material to a
quantity that equals or exceeds the
category 2 threshold.
(b) General performance objective.
The licensee’s access authorization
program must ensure that the
individuals specified in paragraph (c)(1)
of this section are trustworthy and
reliable.
(c) Applicability. (1) Licensees shall
subject the following individuals to an
access authorization program:
(i) Any individual whose assigned
duties require unescorted access to
category 1 or category 2 quantities of
radioactive material or to any device
that contains the radioactive material;
and
(ii) Reviewing officials.
(2) Licensees need not subject the
categories of individuals listed in
§ 37.29(a)(1) through (13) to the
investigation elements of the access
authorization program.
(3) Licensees shall approve for
unescorted access to category 1 or
category 2 quantities of radioactive
material only those individuals with job
duties that require unescorted access to
category 1 or category 2 quantities of
radioactive material.
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(4) Licensees may include individuals
needing access to safeguards
information-modified handling under
part 73 of this chapter in the access
authorization program under this
subpart B.
§ 37.23 Access authorization program
requirements.
(a) Granting unescorted access
authorization. (1) Licensees shall
implement the requirements of this
subpart for granting initial or reinstated
unescorted access authorization.
(2) Individuals who have been
determined to be trustworthy and
reliable shall also complete the security
training required by § 37.43(c) before
being allowed unescorted access to
category 1 or category 2 quantities of
radioactive material.
(b) Reviewing officials. (1) Reviewing
officials are the only individuals who
may make trustworthiness and
reliability determinations that allow
individuals to have unescorted access to
category 1 or category 2 quantities of
radioactive materials possessed by the
licensee.
(2) Each licensee shall name one or
more individuals to be reviewing
officials. After completing the
background investigation on the
reviewing official, the licensee shall
provide under oath or affirmation, a
certification that the reviewing official
is deemed trustworthy and reliable by
the licensee. The fingerprints of the
named reviewing official must be taken
by a law enforcement agency, Federal or
State agencies that provide
fingerprinting services to the public, or
commercial fingerprinting services
authorized by a State to take
fingerprints. The licensee shall recertify
that the reviewing official is deemed
trustworthy and reliable every 10 years
in accordance with § 37.25(b).
(3) Reviewing officials must be
permitted to have unescorted access to
category 1 or category 2 quantities of
radioactive materials or access to
safeguards information or safeguards
information-modified handling, if the
licensee possesses safeguards
information or safeguards informationmodified handling.
(4) Reviewing officials cannot approve
other individuals to act as reviewing
officials.
(5) A reviewing official does not need
to undergo a new background
investigation before being named by the
licensee as the reviewing official if:
(i) The individual has undergone a
background investigation that included
fingerprinting and an FBI criminal
history records check and has been
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determined to be trustworthy and
reliable by the licensee; or
(ii) The individual is subject to a
category listed in § 37.29(a).
(c) Informed consent. (1) Licensees
may not initiate a background
investigation without the informed and
signed consent of the subject individual.
This consent must include authorization
to share personal information with other
individuals or organizations as
necessary to complete the background
investigation. Before a final adverse
determination, the licensee shall
provide the individual with an
opportunity to correct any inaccurate or
incomplete information that is
developed during the background
investigation. Licensees do not need to
obtain signed consent from those
individuals that meet the requirements
of § 37.25(b). A signed consent must be
obtained prior to any reinvestigation.
(2) The subject individual may
withdraw his or her consent at any time.
Licensees shall inform the individual
that:
(i) If an individual withdraws his or
her consent, the licensee may not
initiate any elements of the background
investigation that were not in progress
at the time the individual withdrew his
or her consent; and
(ii) The withdrawal of consent for the
background investigation is sufficient
cause for denial or termination of
unescorted access authorization.
(d) Personal history disclosure. Any
individual who is applying for
unescorted access authorization shall
disclose the personal history
information that is required by the
licensee’s access authorization program
for the reviewing official to make a
determination of the individual’s
trustworthiness and reliability. Refusal
to provide, or the falsification of, any
personal history information required
by this subpart is sufficient cause for
denial or termination of unescorted
access.
(e) Determination basis. (1) The
reviewing official shall determine
whether to permit, deny, unfavorably
terminate, maintain, or administratively
withdraw an individual’s unescorted
access authorization based on an
evaluation of all of the information
collected to meet the requirements of
this subpart.
(2) The reviewing official may not
permit any individual to have
unescorted access until the reviewing
official has evaluated all of the
information collected to meet the
requirements of this subpart and
determined that the individual is
trustworthy and reliable. The reviewing
official may deny unescorted access to
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any individual based on information
obtained at any time during the
background investigation.
(3) The licensee shall document the
basis for concluding whether or not
there is reasonable assurance that an
individual is trustworthy and reliable.
(4) The reviewing official may
terminate or administratively withdraw
an individual’s unescorted access
authorization based on information
obtained after the background
investigation has been completed and
the individual granted unescorted
access authorization.
(5) Licensees shall maintain a list of
persons currently approved for
unescorted access authorization. When
a licensee determines that a person no
longer requires unescorted access or
meets the access authorization
requirement, the licensee shall remove
the person from the approved list as
soon as possible, but no later than 7
working days, and take prompt
measures to ensure that the individual
is unable to have unescorted access to
the material.
(f) Procedures. Licensees shall
develop, implement, and maintain
written procedures for implementing
the access authorization program. The
procedures must include provisions for
the notification of individuals who are
denied unescorted access. The
procedures must include provisions for
the review, at the request of the affected
individual, of a denial or termination of
unescorted access authorization. The
procedures must contain a provision to
ensure that the individual is informed of
the grounds for the denial or
termination of unescorted access
authorization and allow the individual
an opportunity to provide additional
relevant information.
(g) Right to correct and complete
information. (1) Prior to any final
adverse determination, licensees shall
provide each individual subject to this
subpart with the right to complete,
correct, and explain information
obtained as a result of the licensee’s
background investigation. Confirmation
of receipt by the individual of this
notification must be maintained by the
licensee for a period of 1 year from the
date of the notification.
(2) If, after reviewing his or her
criminal history record, an individual
believes that it is incorrect or
incomplete in any respect and wishes to
change, correct, update, or explain
anything in the record, the individual
may initiate challenge procedures.
These procedures include direct
application by the individual
challenging the record to the law
enforcement agency that contributed the
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questioned information or a direct
challenge as to the accuracy or
completeness of any entry on the
criminal history record to the Federal
Bureau of Investigation, Criminal Justice
Information Services (CJIS) Division,
ATTN: SCU, Mod. D–2, 1000 Custer
Hollow Road, Clarksburg, WV 26306 as
set forth in 28 CFR 16.30 through 16.34.
In the latter case, the Federal Bureau of
Investigation (FBI) will forward the
challenge to the agency that submitted
the data, and will request that the
agency verify or correct the challenged
entry. Upon receipt of an official
communication directly from the agency
that contributed the original
information, the FBI Identification
Division makes any changes necessary
in accordance with the information
supplied by that agency. Licensees must
provide at least 10 days for an
individual to initiate action to challenge
the results of an FBI criminal history
records check after the record being
made available for his or her review.
The licensee may make a final adverse
determination based upon the criminal
history records only after receipt of the
FBI’s confirmation or correction of the
record.
(h) Records. (1) The licensee shall
retain documentation regarding the
trustworthiness and reliability of
individual employees for 3 years from
the date the individual no longer
requires unescorted access to category 1
or category 2 quantities of radioactive
material.
(2) The licensee shall retain a copy of
the current access authorization
program procedures as a record for 3
years after the procedure is no longer
needed. If any portion of the procedure
is superseded, the licensee shall retain
the superseded material for 3 years after
the record is superseded.
(3) The licensee shall retain the list of
persons approved for unescorted access
authorization for 3 years after the list is
superseded or replaced.
§ 37.25
Background investigations.
(a) Initial investigation. Before
allowing an individual unescorted
access to category 1 or category 2
quantities of radioactive material or to
the devices that contain the material,
licensees shall complete a background
investigation of the individual seeking
unescorted access authorization. The
scope of the investigation must
encompass at least the 7 years preceding
the date of the background investigation
or since the individual’s eighteenth
birthday, whichever is shorter. The
background investigation must include
at a minimum:
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(1) Fingerprinting and an FBI
identification and criminal history
records check in accordance with
§ 37.27;
(2) Verification of true identity.
Licensees shall verify the true identity
of the individual who is applying for
unescorted access authorization to
ensure that the applicant is who he or
she claims to be. A licensee shall review
official identification documents (e.g.,
driver’s license; passport; government
identification; certificate of birth issued
by the state, province, or country of
birth) and compare the documents to
personal information data provided by
the individual to identify any
discrepancy in the information.
Licensees shall document the type,
expiration, and identification number of
the identification document, or
maintain a photocopy of identifying
documents on file in accordance with
§ 37.31. Licensees shall certify in
writing that the identification was
properly reviewed, and shall maintain
the certification and all related
documents for review upon inspection;
(3) Employment history verification.
Licensees shall complete an
employment history verification,
including military history. Licensees
shall verify the individual’s
employment with each previous
employer for the most recent 7 years
before the date of application;
(4) Verification of education.
Licensees shall verify that the
individual participated in the education
process during the claimed period;
(5) Character and reputation
determination. Licensees shall complete
reference checks to determine the
character and reputation of the
individual who has applied for
unescorted access authorization. Unless
other references are not available,
reference checks may not be conducted
with any person who is known to be a
close member of the individual’s family,
including but not limited to the
individual’s spouse, parents, siblings, or
children, or any individual who resides
in the individual’s permanent
household. Reference checks under this
subpart must be limited to whether the
individual has been and continues to be
trustworthy and reliable;
(6) The licensee shall also, to the
extent possible, obtain independent
information to corroborate that provided
by the individual (e.g., seek references
not supplied by the individual); and
(7) If a previous employer,
educational institution, or any other
entity with which the individual claims
to have been engaged fails to provide
information or indicates an inability or
unwillingness to provide information
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within a time frame deemed appropriate
by the licensee but at least after 10
business days of the request or if the
licensee is unable to reach the entity,
the licensee shall document the refusal,
unwillingness, or inability in the record
of investigation; and attempt to obtain
the information from an alternate
source.
(b) Grandfathering. (1) Individuals
who have been determined to be
trustworthy and reliable for unescorted
access to category 1 or category 2
quantities of radioactive material under
the Fingerprint Orders may continue to
have unescorted access to category 1
and category 2 quantities of radioactive
material without further investigation.
These individuals shall be subject to the
reinvestigation requirement.
(2) Individuals who have been
determined to be trustworthy and
reliable under the provisions of part 73
of this chapter or the security orders for
access to safeguards information,
safeguards information-modified
handling, or risk-significant material
may have unescorted access to category
1 and category 2 quantities of
radioactive material without further
investigation. The licensee shall
document that the individual was
determined to be trustworthy and
reliable under the provisions of part 73
of this chapter or a security order.
Security order, in this context, refers to
any order that was issued by the NRC
that required fingerprints and an FBI
criminal history records check for
access to safeguards information,
safeguards information-modified
handling, or risk significant material
such as special nuclear material or large
quantities of uranium hexafluoride.
These individuals shall be subject to the
reinvestigation requirement.
(c) Reinvestigations. Licensees shall
conduct a reinvestigation every 10 years
for any individual with unescorted
access to category 1 or category 2
quantities of radioactive material. The
reinvestigation shall consist of
fingerprinting and an FBI identification
and criminal history records check in
accordance with § 37.27. The
reinvestigations must be completed
within 10 years of the date on which
these elements were last completed.
§ 37.27 Requirements for criminal history
records checks of individuals granted
unescorted access to category 1 or
category 2 quantities of radioactive
material.
(a) General performance objective and
requirements. (1) Except for those
individuals listed in § 37.29 and those
individuals grandfathered under
§ 37.25(b), each licensee subject to the
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provisions of this subpart shall
fingerprint each individual who is to be
permitted unescorted access to category
1 or category 2 quantities of radioactive
material. Licensees shall transmit all
collected fingerprints to the
Commission for transmission to the FBI.
The licensee shall use the information
received from the FBI as part of the
required background investigation to
determine whether to grant or deny
further unescorted access to category 1
or category 2 quantities of radioactive
materials for that individual.
(2) The licensee shall notify each
affected individual that his or her
fingerprints will be used to secure a
review of his or her criminal history
record, and shall inform him or her of
the procedures for revising the record or
adding explanations to the record.
(3) Fingerprinting is not required if a
licensee is reinstating an individual’s
unescorted access authorization to
category 1 or category 2 quantities of
radioactive materials if:
(i) The individual returns to the same
facility that granted unescorted access
authorization within 365 days of the
termination of his or her unescorted
access authorization; and
(ii) The previous access was
terminated under favorable conditions.
(4) Fingerprints do not need to be
taken if an individual who is an
employee of a licensee, contractor,
manufacturer, or supplier has been
granted unescorted access to category 1
or category 2 quantities of radioactive
material, access to safeguards
information, or safeguards informationmodified handling by another licensee,
based upon a background investigation
conducted under this subpart, the
Fingerprint Orders, or part 73 of this
chapter. An existing criminal history
records check file may be transferred to
the licensee asked to grant unescorted
access in accordance with the
provisions of § 37.31(c).
(5) Licensees shall use the
information obtained as part of a
criminal history records check solely for
the purpose of determining an
individual’s suitability for unescorted
access authorization to category 1 or
category 2 quantities of radioactive
materials, access to safeguards
information, or safeguards informationmodified handling.
(b) Prohibitions. (1) Licensees may not
base a final determination to deny an
individual unescorted access
authorization to category 1 or category
2 quantities of radioactive material
solely on the basis of information
received from the FBI involving:
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(i) An arrest more than 1 year old for
which there is no information of the
disposition of the case; or
(ii) An arrest that resulted in
dismissal of the charge or an acquittal.
(2) Licensees may not use information
received from a criminal history records
check obtained under this subpart in a
manner that would infringe upon the
rights of any individual under the First
Amendment to the Constitution of the
United States, nor shall licensees use
the information in any way that would
discriminate among individuals on the
basis of race, religion, national origin,
gender, or age.
(c) Procedures for processing of
fingerprint checks. (1) For the purpose
of complying with this subpart,
licensees shall use an appropriate
method listed in § 37.7 to submit to the
U.S. Nuclear Regulatory Commission,
Director, Division of Facilities and
Security, 11545 Rockville Pike, ATTN:
Criminal History Program/Mail Stop
TWB–05 B32M, Rockville, Maryland
20852, one completed, legible standard
fingerprint card (Form FD–258,
ORIMDNRCOOOZ), electronic
fingerprint scan or, where practicable,
other fingerprint record for each
individual requiring unescorted access
to category 1 or category 2 quantities of
radioactive material. Copies of these
forms may be obtained by writing the
Office of Information Services, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, by calling
1–630–829–9565, or by email to
FORMS.Resource@nrc.gov. Guidance on
submitting electronic fingerprints can be
found at https://www.nrc.gov/site-help/esubmittals.html.
(2) Fees for the processing of
fingerprint checks are due upon
application. Licensees shall submit
payment with the application for the
processing of fingerprints through
corporate check, certified check,
cashier’s check, money order, or
electronic payment, made payable to
‘‘U.S. NRC.’’ (For guidance on making
electronic payments, contact the
Security Branch, Division of Facilities
and Security at 301–492–3531.)
Combined payment for multiple
applications is acceptable. The
Commission publishes the amount of
the fingerprint check application fee on
the NRC’s public Web site. (To find the
current fee amount, go to the Electronic
Submittals page at https://www.nrc.gov/
site-help/e-submittals.html and see the
link for the Criminal History Program
under Electronic Submission Systems.)
(3) The Commission will forward to
the submitting licensee all data received
from the FBI as a result of the licensee’s
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application(s) for criminal history
records checks.
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§ 37.29 Relief from fingerprinting,
identification, and criminal history records
checks and other elements of background
investigations for designated categories of
individuals permitted unescorted access to
certain radioactive materials.
(a) Fingerprinting, and the
identification and criminal history
records checks required by section 149
of the Atomic Energy Act of 1954, as
amended, and other elements of the
background investigation are not
required for the following individuals
prior to granting unescorted access to
category 1 or category 2 quantities of
radioactive materials:
(1) An employee of the Commission
or of the Executive Branch of the U.S.
Government who has undergone
fingerprinting for a prior U.S.
Government criminal history records
check;
(2) A Member of Congress;
(3) An employee of a member of
Congress or Congressional committee
who has undergone fingerprinting for a
prior U.S. Government criminal history
records check;
(4) The Governor of a State or his or
her designated State employee
representative;
(5) Federal, State, or local law
enforcement personnel;
(6) State Radiation Control Program
Directors and State Homeland Security
Advisors or their designated State
employee representatives;
(7) Agreement State employees
conducting security inspections on
behalf of the NRC under an agreement
executed under section 274.i. of the
Atomic Energy Act;
(8) Representatives of the
International Atomic Energy Agency
(IAEA) engaged in activities associated
with the U.S./IAEA Safeguards
Agreement who have been certified by
the NRC;
(9) Emergency response personnel
who are responding to an emergency;
(10) Commercial vehicle drivers for
road shipments of category 2 quantities
of radioactive material;
(11) Package handlers at
transportation facilities such as freight
terminals and railroad yards;
(12) Any individual who has an active
Federal security clearance, provided
that he or she makes available the
appropriate documentation. Written
confirmation from the agency/employer
that granted the Federal security
clearance or reviewed the criminal
history records check must be provided
to the licensee. The licensee shall retain
this documentation for a period of 3
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years from the date the individual no
longer requires unescorted access to
category 1 or category 2 quantities of
radioactive material; and
(13) Any individual employed by a
service provider licensee for which the
service provider licensee has conducted
the background investigation for the
individual and approved the individual
for unescorted access to category 1 or
category 2 quantities of radioactive
material. Written verification from the
service provider must be provided to the
licensee. The licensee shall retain the
documentation for a period of 3 years
from the date the individual no longer
requires unescorted access to category 1
or category 2 quantities of radioactive
material.
(b) Fingerprinting, and the
identification and criminal history
records checks required by section 149
of the Atomic Energy Act of 1954, as
amended, are not required for an
individual who has had a favorably
adjudicated U.S. Government criminal
history records check within the last 5
years, under a comparable U.S.
Government program involving
fingerprinting and an FBI identification
and criminal history records check
provided that he or she makes available
the appropriate documentation. Written
confirmation from the agency/employer
that reviewed the criminal history
records check must be provided to the
licensee. The licensee shall retain this
documentation for a period of 3 years
from the date the individual no longer
requires unescorted access to category 1
or category 2 quantities of radioactive
material. These programs include, but
are not limited to:
(1) National Agency Check;
(2) Transportation Worker
Identification Credentials (TWIC) under
49 CFR part 1572;
(3) Bureau of Alcohol, Tobacco,
Firearms, and Explosives background
check and clearances under 27 CFR part
555;
(4) Health and Human Services
security risk assessments for possession
and use of select agents and toxins
under 42 CFR part 73;
(5) Hazardous Material security threat
assessment for hazardous material
endorsement to commercial drivers
license under 49 CFR part 1572; and
(6) Customs and Border Protection’s
Free and Secure Trade (FAST) Program.
§ 37.31
Protection of information.
(a) Each licensee who obtains
background information on an
individual under this subpart shall
establish and maintain a system of files
and written procedures for protection of
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the record and the personal information
from unauthorized disclosure.
(b) The licensee may not disclose the
record or personal information collected
and maintained to persons other than
the subject individual, his or her
representative, or to those who have a
need to have access to the information
in performing assigned duties in the
process of granting or denying
unescorted access to category 1 or
category 2 quantities of radioactive
material, safeguards information, or
safeguards information-modified
handling. No individual authorized to
have access to the information may
disseminate the information to any
other individual who does not have a
need to know.
(c) The personal information obtained
on an individual from a background
investigation may be provided to
another licensee:
(1) Upon the individual’s written
request to the licensee holding the data
to disseminate the information
contained in his or her file; and
(2) The recipient licensee verifies
information such as name, date of birth,
social security number, gender, and
other applicable physical
characteristics.
(d) The licensee shall make
background investigation records
obtained under this subpart available for
examination by an authorized
representative of the NRC to determine
compliance with the regulations and
laws.
(e) The licensee shall retain all
fingerprint and criminal history records
(including data indicating no record)
received from the FBI, or a copy of these
records if the individual’s file has been
transferred, on an individual for 3 years
from the date the individual no longer
requires unescorted access to category 1
or category 2 quantities of radioactive
material.
§ 37.33 Access authorization program
review.
(a) Each licensee shall be responsible
for the continuing effectiveness of the
access authorization program. Each
licensee shall ensure that access
authorization programs are reviewed to
confirm compliance with the
requirements of this subpart and that
comprehensive actions are taken to
correct any noncompliance that is
identified. The review program shall
evaluate all program performance
objectives and requirements. Each
licensee shall periodically (at least
annually) review the access program
content and implementation.
(b) The results of the reviews, along
with any recommendations, must be
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documented. Each review report must
identify conditions that are adverse to
the proper performance of the access
authorization program, the cause of the
condition(s), and, when appropriate,
recommend corrective actions, and
corrective actions taken. The licensee
shall review the findings and take any
additional corrective actions necessary
to preclude repetition of the condition,
including reassessment of the deficient
areas where indicated.
(c) Review records must be
maintained for 3 years.
Subpart C—Physical Protection
Requirements During Use
§ 37.41
Security program.
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(a) Applicability. (1) Each licensee
that possesses an aggregated category 1
or category 2 quantity of radioactive
material shall establish, implement, and
maintain a security program in
accordance with the requirements of
this subpart.
(2) An applicant for a new license and
each licensee that would become newly
subject to the requirements of this
subpart upon application for
modification of its license shall
implement the requirements of this
subpart, as appropriate, before taking
possession of an aggregated category 1
or category 2 quantity of radioactive
material.
(3) Any licensee that has not
previously implemented the Security
Orders or been subject to the provisions
of subpart C shall provide written
notification to the NRC regional office
specified in § 30.6 of this chapter at
least 90 days before aggregating
radioactive material to a quantity that
equals or exceeds the category 2
threshold.
(b) General performance objective.
Each licensee shall establish,
implement, and maintain a security
program that is designed to monitor
and, without delay, detect, assess, and
respond to an actual or attempted
unauthorized access to category 1 or
category 2 quantities of radioactive
material.
(c) Program features. Each licensee’s
security program must include the
program features, as appropriate,
described in §§ 37.43, 37.45, 37.47,
37.49, 37.51, 37.53, and 37.55.
§ 37.43 General security program
requirements.
(a) Security plan. (1) Each licensee
identified in § 37.41(a) shall develop a
written security plan specific to its
facilities and operations. The purpose of
the security plan is to establish the
licensee’s overall security strategy to
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ensure the integrated and effective
functioning of the security program
required by this subpart. The security
plan must, at a minimum:
(i) Describe the measures and
strategies used to implement the
requirements of this subpart; and
(ii) Identify the security resources,
equipment, and technology used to
satisfy the requirements of this subpart.
(2) The security plan must be
reviewed and approved by the
individual with overall responsibility
for the security program.
(3) A licensee shall revise its security
plan as necessary to ensure the effective
implementation of Commission
requirements. The licensee shall ensure
that:
(i) The revision has been reviewed
and approved by the individual with
overall responsibility for the security
program; and
(ii) The affected individuals are
instructed on the revised plan before the
changes are implemented.
(4) The licensee shall retain a copy of
the current security plan as a record for
3 years after the security plan is no
longer required. If any portion of the
plan is superseded, the licensee shall
retain the superseded material for 3
years after the record is superseded.
(b) Implementing procedures. (1) The
licensee shall develop and maintain
written procedures that document how
the requirements of this subpart and the
security plan will be met.
(2) The implementing procedures and
revisions to these procedures must be
approved in writing by the individual
with overall responsibility for the
security program.
(3) The licensee shall retain a copy of
the current procedure as a record for 3
years after the procedure is no longer
needed. Superseded portions of the
procedure must be retained for 3 years
after the record is superseded.
(c) Training. (1) Each licensee shall
conduct training to ensure that those
individuals implementing the security
program possess and maintain the
knowledge, skills, and abilities to carry
out their assigned duties and
responsibilities effectively. The training
must include instruction in:
(i) The licensee’s security program
and procedures to secure category 1 or
category 2 quantities of radioactive
material, and in the purposes and
functions of the security measures
employed;
(ii) The responsibility to report
promptly to the licensee any condition
that causes or may cause a violation of
Commission requirements;
(iii) The responsibility of the licensee
to report promptly to the local law
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enforcement agency and licensee any
actual or attempted theft, sabotage, or
diversion of category 1 or category 2
quantities of radioactive material; and
(iv) The appropriate response to
security alarms.
(2) In determining those individuals
who shall be trained on the security
program, the licensee shall consider
each individual’s assigned activities
during authorized use and response to
potential situations involving actual or
attempted theft, diversion, or sabotage
of category 1 or category 2 quantities of
radioactive material. The extent of the
training must be commensurate with the
individual’s potential involvement in
the security of category 1 or category 2
quantities of radioactive material.
(3) Refresher training must be
provided at a frequency not to exceed 12
months and when significant changes
have been made to the security program.
This training must include:
(i) Review of the training
requirements of paragraph (c) of this
section and any changes made to the
security program since the last training;
(ii) Reports on any relevant security
issues, problems, and lessons learned;
(iii) Relevant results of NRC
inspections; and
(iv) Relevant results of the licensee’s
program review and testing and
maintenance.
(4) The licensee shall maintain
records of the initial and refresher
training for 3 years from the date of the
training. The training records must
include dates of the training, topics
covered, a list of licensee personnel in
attendance, and related information.
(d) Protection of information. (1)
Except as provided in paragraph (d)(9)
of this section, licensees authorized to
possess category 1 or category 2
quantities of radioactive material shall
limit access to and unauthorized
disclosure of their security plan,
implementing procedures, and the list
of individuals that have been approved
for unescorted access.
(2) Efforts to limit access shall include
the development, implementation, and
maintenance of written policies and
procedures for controlling access to, and
for proper handling and protection
against unauthorized disclosure of, the
security plan and implementing
procedures.
(3) Before granting an individual
access to the security plan or
implementing procedures, licensees
shall:
(i) Evaluate an individual’s need to
know the security plan or implementing
procedures; and
(ii) If the individual has not been
authorized for unescorted access to
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category 1 or category 2 quantities of
radioactive material, safeguards
information, or safeguards informationmodified handling, the licensee must
complete a background investigation to
determine the individual’s
trustworthiness and reliability. A
trustworthiness and reliability
determination shall be conducted by the
reviewing official and shall include the
background investigation elements
contained in § 37.25(a)(2) through (a)(7).
(4) Licensees need not subject the
following individuals to the background
investigation elements for protection of
information:
(i) The categories of individuals listed
in § 37.29(a)(1) through (13); or
(ii) Security service provider
employees, provided written
verification that the employee has been
determined to be trustworthy and
reliable, by the required background
investigation in § 37.25(a)(2) through
(a)(7), has been provided by the security
service provider.
(5) The licensee shall document the
basis for concluding that an individual
is trustworthy and reliable and should
be granted access to the security plan or
implementing procedures.
(6) Licensees shall maintain a list of
persons currently approved for access to
the security plan or implementing
procedures. When a licensee determines
that a person no longer needs access to
the security plan or implementing
procedures or no longer meets the
access authorization requirements for
access to the information, the licensee
shall remove the person from the
approved list as soon as possible, but no
later than 7 working days, and take
prompt measures to ensure that the
individual is unable to obtain the
security plan or implementing
procedures.
(7) When not in use, the licensee shall
store its security plan and implementing
procedures in a manner to prevent
unauthorized access. Information stored
in nonremovable electronic form must
be password protected.
(8) The licensee shall retain as a
record for 3 years after the document is
no longer needed:
(i) A copy of the information
protection procedures; and
(ii) The list of individuals approved
for access to the security plan or
implementing procedures.
(9) Licensees that possess safeguards
information or safeguards informationmodified handling are subject to the
requirements of § 73.21 of this chapter,
and shall protect any safeguards
information or safeguards informationmodified handling in accordance with
the requirements of that section.
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§ 37.45
LLEA coordination.
(a) A licensee subject to this subpart
shall coordinate, to the extent
practicable, with an LLEA for
responding to threats to the licensee’s
facility, including any necessary armed
response. The information provided to
the LLEA must include:
(1) A description of the facilities and
the category 1 and category 2 quantities
of radioactive materials along with a
description of the licensee’s security
measures that have been implemented
to comply with this subpart; and
(2) A notification that the licensee
will request a timely armed response by
the LLEA to any actual or attempted
theft, sabotage, or diversion of category
1 or category 2 quantities of material.
(b) The licensee shall notify the
appropriate NRC regional office listed in
§ 30.6(a)(2) of this chapter within 3
business days if:
(1) The LLEA has not responded to
the request for coordination within 60
days of the coordination request; or
(2) The LLEA notifies the licensee that
the LLEA does not plan to participate in
coordination activities.
(c) The licensee shall document its
efforts to coordinate with the LLEA. The
documentation must be kept for 3 years.
(d) The licensee shall coordinate with
the LLEA at least every 12 months, or
when changes to the facility design or
operation adversely affect the potential
vulnerability of the licensee’s material
to theft, sabotage, or diversion.
§ 37.47
Security zones.
(a) Licensees shall ensure that all
aggregated category 1 and category 2
quantities of radioactive material are
used or stored within licenseeestablished security zones. Security
zones may be permanent or temporary.
(b) Temporary security zones must be
established as necessary to meet the
licensee’s transitory or intermittent
business activities, such as periods of
maintenance, source delivery, and
source replacement.
(c) Security zones must, at a
minimum, allow unescorted access only
to approved individuals through:
(1) Isolation of category 1 and
category 2 quantities of radioactive
materials by the use of continuous
physical barriers that allow access to the
security zone only through established
access control points. A physical barrier
is a natural or man-made structure or
formation sufficient for the isolation of
the category 1 or category 2 quantities
of radioactive material within a security
zone; or
(2) Direct control of the security zone
by approved individuals at all times; or
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(3) A combination of continuous
physical barriers and direct control.
(d) For category 1 quantities of
radioactive material during periods of
maintenance, source receipt,
preparation for shipment, installation,
or source removal or exchange, the
licensee shall, at a minimum, provide
sufficient individuals approved for
unescorted access to maintain
continuous surveillance of sources in
temporary security zones and in any
security zone in which physical barriers
or intrusion detection systems have
been disabled to allow such activities.
(e) Individuals not approved for
unescorted access to category 1 or
category 2 quantities of radioactive
material must be escorted by an
approved individual when in a security
zone.
§ 37.49 Monitoring, detection, and
assessment.
(a) Monitoring and detection. (1)
Licensees shall establish and maintain
the capability to continuously monitor
and detect without delay all
unauthorized entries into its security
zones. Licensees shall provide the
means to maintain continuous
monitoring and detection capability in
the event of a loss of the primary power
source, or provide for an alarm and
response in the event of a loss of this
capability to continuously monitor and
detect unauthorized entries.
(2) Monitoring and detection must be
performed by:
(i) A monitored intrusion detection
system that is linked to an onsite or
offsite central monitoring facility; or
(ii) Electronic devices for intrusion
detection alarms that will alert nearby
facility personnel; or
(iii) A monitored video surveillance
system; or
(iv) Direct visual surveillance by
approved individuals located within the
security zone; or
(v) Direct visual surveillance by a
licensee designated individual located
outside the security zone.
(3) A licensee subject to this subpart
shall also have a means to detect
unauthorized removal of the radioactive
material from the security zone. This
detection capability must provide:
(i) For category 1 quantities of
radioactive material, immediate
detection of any attempted
unauthorized removal of the radioactive
material from the security zone. Such
immediate detection capability must be
provided by:
(A) Electronic sensors linked to an
alarm; or
(B) Continuous monitored video
surveillance; or
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(C) Direct visual surveillance.
(ii) For category 2 quantities of
radioactive material, weekly verification
through physical checks, tamper
indicating devices, use, or other means
to ensure that the radioactive material is
present.
(b) Assessment. Licensees shall
immediately assess each actual or
attempted unauthorized entry into the
security zone to determine whether the
unauthorized access was an actual or
attempted theft, sabotage, or diversion.
(c) Personnel communications and
data transmission. For personnel and
automated or electronic systems
supporting the licensee’s monitoring,
detection, and assessment systems,
licensees shall:
(1) Maintain continuous capability for
personnel communication and
electronic data transmission and
processing among site security systems;
and
(2) Provide an alternative
communication capability for
personnel, and an alternative data
transmission and processing capability,
in the event of a loss of the primary
means of communication or data
transmission and processing.
Alternative communications and data
transmission systems may not be subject
to the same failure modes as the primary
systems.
(d) Response. Licensees shall
immediately respond to any actual or
attempted unauthorized access to the
security zones, or actual or attempted
theft, sabotage, or diversion of category
1 or category 2 quantities of radioactive
material at licensee facilities or
temporary job sites. For any
unauthorized access involving an actual
or attempted theft, sabotage, or
diversion of category 1 or category 2
quantities of radioactive material, the
licensee’s response shall include
requesting, without delay, an armed
response from the LLEA.
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§ 37.51
Maintenance and testing.
(a) Each licensee subject to this
subpart shall implement a maintenance
and testing program to ensure that
intrusion alarms, associated
communication systems, and other
physical components of the systems
used to secure or detect unauthorized
access to radioactive material are
maintained in operable condition and
are capable of performing their intended
function when needed. The equipment
relied on to meet the security
requirements of this part must be
inspected and tested for operability and
performance at the manufacturer’s
suggested frequency. If there is no
suggested manufacturer’s suggested
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frequency, the testing must be
performed at least annually, not to
exceed 12 months.
(b) The licensee shall maintain
records on the maintenance and testing
activities for 3 years.
§ 37.53
Requirements for mobile devices.
Each licensee that possesses mobile
devices containing category 1 or
category 2 quantities of radioactive
material must:
(a) Have two independent physical
controls that form tangible barriers to
secure the material from unauthorized
removal when the device is not under
direct control and constant surveillance
by the licensee; and
(b) For devices in or on a vehicle or
trailer, unless the health and safety
requirements for a site prohibit the
disabling of the vehicle, the licensee
shall utilize a method to disable the
vehicle or trailer when not under direct
control and constant surveillance by the
licensee. Licensees shall not rely on the
removal of an ignition key to meet this
requirement.
§ 37.55
Security program review.
(a) Each licensee shall be responsible
for the continuing effectiveness of the
security program. Each licensee shall
ensure that the security program is
reviewed to confirm compliance with
the requirements of this subpart and
that comprehensive actions are taken to
correct any noncompliance that is
identified. The review must include the
radioactive material security program
content and implementation. Each
licensee shall periodically (at least
annually) review the security program
content and implementation.
(b) The results of the review, along
with any recommendations, must be
documented. Each review report must
identify conditions that are adverse to
the proper performance of the security
program, the cause of the condition(s),
and, when appropriate, recommend
corrective actions, and corrective
actions taken. The licensee shall review
the findings and take any additional
corrective actions necessary to preclude
repetition of the condition, including
reassessment of the deficient areas
where indicated.
(c) The licensee shall maintain the
review documentation for 3 years.
§ 37.57
Reporting of events.
(a) The licensee shall immediately
notify the LLEA after determining that
an unauthorized entry resulted in an
actual or attempted theft, sabotage, or
diversion of a category 1 or category 2
quantity of radioactive material. As soon
as possible after initiating a response,
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but not at the expense of causing delay
or interfering with the LLEA response to
the event, the licensee shall notify the
NRC’s Operations Center (301–816–
5100). In no case shall the notification
to the NRC be later than 4 hours after
the discovery of any attempted or actual
theft, sabotage, or diversion.
(b) The licensee shall assess any
suspicious activity related to possible
theft, sabotage, or diversion of category
1 or category 2 quantities of radioactive
material and notify the LLEA as
appropriate. As soon as possible but not
later than 4 hours after notifying the
LLEA, the licensee shall notify the
NRC’s Operations Center (301–816–
5100).
(c) The initial telephonic notification
required by paragraph (a) of this section
must be followed within a period of 30
days by a written report submitted to
the NRC by an appropriate method
listed in § 37.7. The report must include
sufficient information for NRC analysis
and evaluation, including identification
of any necessary corrective actions to
prevent future instances.
Subpart D—Physical Protection in
Transit
§ 37.71 Additional requirements for
transfer of category 1 and category 2
quantities of radioactive material.
A licensee transferring a category 1 or
category 2 quantity of radioactive
material to a licensee of the Commission
or an Agreement State shall meet the
license verification provisions listed
below instead of those listed in
§ 30.41(d) of this chapter:
(a) Any licensee transferring category
1 quantities of radioactive material to a
licensee of the Commission or an
Agreement State, prior to conducting
such transfer, shall verify with the
NRC’s license verification system or the
license issuing authority that the
transferee’s license authorizes the
receipt of the type, form, and quantity
of radioactive material to be transferred
and that the licensee is authorized to
receive radioactive material at the
location requested for delivery. If the
verification is conducted by contacting
the license issuing authority, the
transferor shall document the
verification. For transfers within the
same organization, the licensee does not
need to verify the transfer.
(b) Any licensee transferring category
2 quantities of radioactive material to a
licensee of the Commission or an
Agreement State, prior to conducting
such transfer, shall verify with the
NRC’s license verification system or the
license issuing authority that the
transferee’s license authorizes the
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receipt of the type, form, and quantity
of radioactive material to be transferred.
If the verification is conducted by
contacting the license issuing authority,
the transferor shall document the
verification. For transfers within the
same organization, the licensee does not
need to verify the transfer.
(c) In an emergency where the
licensee cannot reach the license issuing
authority and the license verification
system is nonfunctional, the licensee
may accept a written certification by the
transferee that it is authorized by license
to receive the type, form, and quantity
of radioactive material to be transferred.
The certification must include the
license number, current revision
number, issuing agency, expiration date,
and for a category 1 shipment the
authorized address. The licensee shall
keep a copy of the certification. The
certification must be confirmed by use
of the NRC’s license verification system
or by contacting the license issuing
authority by the end of the next
business day.
(d) The transferor shall keep a copy of
the verification documentation as a
record for 3 years.
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§ 37.73 Applicability of physical protection
of category 1 and category 2 quantities of
radioactive material during transit.
(a) For shipments of category 1
quantities of radioactive material, each
shipping licensee shall comply with the
requirements for physical protection
contained in §§ 37.75(a) and (e); 37.77;
37.79(a)(1), (b)(1), and (c); and 37.81(a),
(c), (e), (g) and (h).
(b) For shipments of category 2
quantities of radioactive material, each
shipping licensee shall comply with the
requirements for physical protection
contained in §§ 37.75(b) through (e);
37.79(a)(2), (a)(3), (b)(2), and (c); and
37.81(b), (d), (f), (g), and (h). For those
shipments of category 2 quantities of
radioactive material that meet the
criteria of § 71.97(b) of this chapter, the
shipping licensee shall also comply
with the advance notification provisions
of § 71.97 of this chapter.
(c) The shipping licensee shall be
responsible for meeting the
requirements of this subpart unless the
receiving licensee has agreed in writing
to arrange for the in-transit physical
protection required under this subpart.
(d) Each licensee that imports or
exports category 1 quantities of
radioactive material shall comply with
the requirements for physical protection
during transit contained in
§§ 37.75(a)(2) and (e); 37.77; 37.79(a)(1),
(b)(1), and (c); and 37.81(a), (c), (e), (g),
and (h) for the domestic portion of the
shipment.
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(e) Each licensee that imports or
exports category 2 quantities of
radioactive material shall comply with
the requirements for physical protection
during transit contained in
§§ 37.79(a)(2), (a)(3), and (b)(2); and
37.81(b), (d), (f), (g), and (h) for the
domestic portion of the shipment.
§ 37.75 Preplanning and coordination of
shipment of category 1 or category 2
quantities of radioactive material.
(a) Each licensee that plans to
transport, or deliver to a carrier for
transport, licensed material that is a
category 1 quantity of radioactive
material outside the confines of the
licensee’s facility or other place of use
or storage shall:
(1) Preplan and coordinate shipment
arrival and departure times with the
receiving licensee;
(2) Preplan and coordinate shipment
information with the governor or the
governor’s designee of any State through
which the shipment will pass to:
(i) Discuss the State’s intention to
provide law enforcement escorts; and
(ii) Identify safe havens; and
(3) Document the preplanning and
coordination activities.
(b) Each licensee that plans to
transport, or deliver to a carrier for
transport, licensed material that is a
category 2 quantity of radioactive
material outside the confines of the
licensee’s facility or other place of use
or storage shall coordinate the shipment
no-later-than arrival time and the
expected shipment arrival with the
receiving licensee. The licensee shall
document the coordination activities.
(c) Each licensee who receives a
shipment of a category 2 quantity of
radioactive material shall confirm
receipt of the shipment with the
originator. If the shipment has not
arrived by the no-later-than arrival time,
the receiving licensee shall notify the
originator.
(d) Each licensee, who transports or
plans to transport a shipment of a
category 2 quantity of radioactive
material, and determines that the
shipment will arrive after the no-laterthan arrival time provided pursuant to
paragraph (b) of this section, shall
promptly notify the receiving licensee of
the new no-later-than arrival time.
(e) The licensee shall retain a copy of
the documentation for preplanning and
coordination and any revision thereof,
as a record for 3 years.
§ 37.77 Advance notification of shipment
of category 1 quantities of radioactive
material.
As specified in paragraphs (a) and (b)
of this section, each licensee shall
PO 00000
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17017
provide advance notification to the NRC
and the governor of a State, or the
governor’s designee, of the shipment of
licensed material in a category 1
quantity, through or across the
boundary of the State, before the
transport, or delivery to a carrier for
transport of the licensed material
outside the confines of the licensee’s
facility or other place of use or storage.
(a) Procedures for submitting advance
notification. (1) The notification must be
made to the NRC and to the office of
each appropriate governor or governor’s
designee. The contact information,
including telephone and mailing
addresses, of governors and governors’
designees, is available on the NRC’s
Web site at https://nrc-stp.ornl.gov/
special/designee.pdf. A list of the
contact information is also available
upon request from the Director, Division
of Intergovernmental Liaison and
Rulemaking, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001. Notifications to the
NRC must be to the NRC’s Director,
Division of Security Policy, Office of
Nuclear Security and Incident
Response, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001. The notification to the NRC may
be made by email to RAMQC_
SHIPMENTS@nrc.gov or by fax
to 301–816–5151.
(2) A notification delivered by mail
must be postmarked at least 7 days
before transport of the shipment
commences at the shipping facility.
(3) A notification delivered by any
means other than mail must reach NRC
at least 4 days before the transport of the
shipment commences and must reach
the office of the governor or the
governor’s designee at least 4 days
before transport of a shipment within or
through the State.
(b) Information to be furnished in
advance notification of shipment. Each
advance notification of shipment of
category 1 quantities of radioactive
material must contain the following
information, if available at the time of
notification:
(1) The name, address, and telephone
number of the shipper, carrier, and
receiver of the category 1 radioactive
material;
(2) The license numbers of the
shipper and receiver;
(3) A description of the radioactive
material contained in the shipment,
including the radionuclides and
quantity;
(4) The point of origin of the shipment
and the estimated time and date that
shipment will commence;
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(5) The estimated time and date that
the shipment is expected to enter each
State along the route;
(6) The estimated time and date of
arrival of the shipment at the
destination; and
(7) A point of contact, with a
telephone number, for current shipment
information.
(c) Revision notice. (1) The licensee
shall provide any information not
previously available at the time of the
initial notification, as soon as the
information becomes available but not
later than commencement of the
shipment, to the governor of the State or
the governor’s designee and to the
NRC’s Director of Nuclear Security,
Office of Nuclear Security and Incident
Response, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001.
(2) A licensee shall promptly notify
the governor of the State or the
governor’s designee of any changes to
the information provided in accordance
with paragraphs (b) and (c)(1) of this
section. The licensee shall also
immediately notify the NRC’s Director,
Division of Security Policy, Office of
Nuclear Security and Incident
Response, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001 of any such changes.
(d) Cancellation notice. Each licensee
who cancels a shipment for which
advance notification has been sent shall
send a cancellation notice to the
governor of each State or to the
governor’s designee previously notified
and to the NRC’s Director, Division of
Security Policy, Office of Nuclear
Security and Incident Response, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001. The
licensee shall send the cancellation
notice before the shipment would have
commenced or as soon thereafter as
possible. The licensee shall state in the
notice that it is a cancellation and
identify the advance notification that is
being cancelled.
(e) Records. The licensee shall retain
a copy of the advance notification and
any revision and cancellation notices as
a record for 3 years.
(f) Protection of information. State
officials, State employees, and other
individuals, whether or not licensees of
the Commission or an Agreement State,
who receive schedule information of the
kind specified in § 37.77(b) shall protect
that information against unauthorized
disclosure as specified in § 73.21 of this
chapter.
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§ 37.79 Requirements for physical
protection of category 1 and category 2
quantities of radioactive material during
shipment.
(a) Shipments by road. (1) Each
licensee who transports, or delivers to a
carrier for transport, in a single
shipment, a category 1 quantity of
radioactive material shall:
(i) Ensure that movement control
centers are established that maintain
position information from a remote
location. These control centers must
monitor shipments 24 hours a day, 7
days a week, and have the ability to
communicate immediately, in an
emergency, with the appropriate law
enforcement agencies.
(ii) Ensure that redundant
communications are established that
allow the transport to contact the escort
vehicle (when used) and movement
control center at all times. Redundant
communications may not be subject to
the same interference factors as the
primary communication.
(iii) Ensure that shipments are
continuously and actively monitored by
a telemetric position monitoring system
or an alternative tracking system
reporting to a movement control center.
A movement control center must
provide positive confirmation of the
location, status, and control over the
shipment. The movement control center
must be prepared to promptly
implement preplanned procedures in
response to deviations from the
authorized route or a notification of
actual, attempted, or suspicious
activities related to the theft, loss, or
diversion of a shipment. These
procedures will include, but not be
limited to, the identification of and
contact information for the appropriate
LLEA along the shipment route.
(iv) Provide an individual to
accompany the driver for those highway
shipments with a driving time period
greater than the maximum number of
allowable hours of service in a 24-hour
duty day as established by the
Department of Transportation Federal
Motor Carrier Safety Administration.
The accompanying individual may be
another driver.
(v) Develop written normal and
contingency procedures to address:
(A) Notifications to the
communication center and law
enforcement agencies;
(B) Communication protocols.
Communication protocols must include
a strategy for the use of authentication
codes and duress codes and provisions
for refueling or other stops, detours, and
locations where communication is
expected to be temporarily lost;
(C) Loss of communications; and
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Fmt 4701
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(D) Responses to an actual or
attempted theft or diversion of a
shipment.
(vi) Each licensee who makes
arrangements for the shipment of
category 1 quantities of radioactive
material shall ensure that drivers,
accompanying personnel, and
movement control center personnel
have access to the normal and
contingency procedures.
(2) Each licensee that transports
category 2 quantities of radioactive
material shall maintain constant control
and/or surveillance during transit and
have the capability for immediate
communication to summon appropriate
response or assistance.
(3) Each licensee who delivers to a
carrier for transport, in a single
shipment, a category 2 quantity of
radioactive material shall:
(i) Use carriers that have established
package tracking systems. An
established package tracking system is a
documented, proven, and reliable
system routinely used to transport
objects of value. In order for a package
tracking system to maintain constant
control and/or surveillance, the package
tracking system must allow the shipper
or transporter to identify when and
where the package was last and when it
should arrive at the next point of
control.
(ii) Use carriers that maintain constant
control and/or surveillance during
transit and have the capability for
immediate communication to summon
appropriate response or assistance; and
(iii) Use carriers that have established
tracking systems that require an
authorized signature prior to releasing
the package for delivery or return.
(b) Shipments by rail. (1) Each
licensee who transports, or delivers to a
carrier for transport, in a single
shipment, a category 1 quantity of
radioactive material shall:
(i) Ensure that rail shipments are
monitored by a telemetric position
monitoring system or an alternative
tracking system reporting to the
licensee, third-party, or railroad
communications center. The
communications center shall provide
positive confirmation of the location of
the shipment and its status. The
communications center shall implement
preplanned procedures in response to
deviations from the authorized route or
to a notification of actual, attempted, or
suspicious activities related to the theft
or diversion of a shipment. These
procedures will include, but not be
limited to, the identification of and
contact information for the appropriate
LLEA along the shipment route.
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(ii) Ensure that periodic reports to the
communications center are made at
preset intervals.
(2) Each licensee who transports, or
delivers to a carrier for transport, in a
single shipment, a category 2 quantity of
radioactive material shall:
(i) Use carriers that have established
package tracking systems. An
established package tracking system is a
documented, proven, and reliable
system routinely used to transport
objects of value. In order for a package
tracking system to maintain constant
control and/or surveillance, the package
tracking system must allow the shipper
or transporter to identify when and
where the package was last and when it
should arrive at the next point of
control.
(ii) Use carriers that maintain constant
control and/or surveillance during
transit and have the capability for
immediate communication to summon
appropriate response or assistance; and
(iii) Use carriers that have established
tracking systems that require an
authorized signature prior to releasing
the package for delivery or return.
(c) Investigations. Each licensee who
makes arrangements for the shipment of
category 1 quantities of radioactive
material shall immediately conduct an
investigation upon the discovery that a
category 1 shipment is lost or missing.
Each licensee who makes arrangements
for the shipment of category 2 quantities
of radioactive material shall
immediately conduct an investigation,
in coordination with the receiving
licensee, of any shipment that has not
arrived by the designated no-later-than
arrival time.
tkelley on DSK3SPTVN1PROD with RULES2
§ 37.81
Reporting of events.
(a) The shipping licensee shall notify
the appropriate LLEA and the NRC’s
Operations Center (301–816–5100)
within 1 hour of its determination that
a shipment of category 1 quantities of
radioactive material is lost or missing.
The appropriate LLEA would be the law
enforcement agency in the area of the
shipment’s last confirmed location.
During the investigation required by
§ 37.79(c), the shipping licensee will
provide agreed upon updates to the
NRC’s Operations Center on the status
of the investigation.
(b) The shipping licensee shall notify
the NRC’s Operations Center (301–816–
5100) within 4 hours of its
determination that a shipment of
category 2 quantities of radioactive
material is lost or missing. If, after 24
hours of its determination that the
shipment is lost or missing, the
radioactive material has not been
located and secured, the licensee shall
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immediately notify the NRC’s
Operations Center.
(c) The shipping licensee shall notify
the designated LLEA along the shipment
route as soon as possible upon
discovery of any actual or attempted
theft or diversion of a shipment or
suspicious activities related to the theft
or diversion of a shipment of a category
1 quantity of radioactive material. As
soon as possible after notifying the
LLEA, the licensee shall notify the
NRC’s Operations Center (301–816–
5100) upon discovery of any actual or
attempted theft or diversion of a
shipment, or any suspicious activity
related to the shipment of category 1
radioactive material.
(d) The shipping licensee shall notify
the NRC’s Operations Center (301–816–
5100) as soon as possible upon
discovery of any actual or attempted
theft or diversion of a shipment, or any
suspicious activity related to the
shipment, of a category 2 quantity of
radioactive material.
(e) The shipping licensee shall notify
the NRC’s Operations Center (301–816–
5100) and the LLEA as soon as possible
upon recovery of any lost or missing
category 1 quantities of radioactive
material.
(f) The shipping licensee shall notify
the NRC’s Operations Center (301–816–
5100) as soon as possible upon recovery
of any lost or missing category 2
quantities of radioactive material.
(g) The initial telephonic notification
required by paragraphs (a) through (d) of
this section must be followed within a
period of 30 days by a written report
submitted to the NRC by an appropriate
method listed in § 37.7. A written report
is not required for notifications on
suspicious activities required by
paragraphs (c) and (d) of this section. In
addition, the licensee shall provide one
copy of the written report addressed to
the Director, Division of Security Policy,
Office of Nuclear Security and Incident
Response, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001. The report must set forth the
following information:
(1) A description of the licensed
material involved, including kind,
quantity, and chemical and physical
form;
(2) A description of the circumstances
under which the loss or theft occurred;
(3) A statement of disposition, or
probable disposition, of the licensed
material involved;
(4) Actions that have been taken, or
will be taken, to recover the material;
and
(5) Procedures or measures that have
been, or will be, adopted to ensure
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17019
against a recurrence of the loss or theft
of licensed material.
(h) Subsequent to filing the written
report, the licensee shall also report any
additional substantive information on
the loss or theft within 30 days after the
licensee learns of such information.
Subpart E—[Reserved]
Subpart F—Records
§ 37.101
Form of records.
Each record required by this part must
be legible throughout the retention
period specified by each Commission
regulation. The record may be the
original or a reproduced copy or a
microform, provided that the copy or
microform is authenticated by
authorized personnel and that the
microform is capable of producing a
clear copy throughout the required
retention period. The record may also be
stored in electronic media with the
capability for producing legible,
accurate, and complete records during
the required retention period. Records
such as letters, drawings, and
specifications, must include all
pertinent information such as stamps,
initials, and signatures. The licensee
shall maintain adequate safeguards
against tampering with and loss of
records.
§ 37.103
Record retention.
Licensees shall maintain the records
that are required by the regulations in
this part for the period specified by the
appropriate regulation. If a retention
period is not otherwise specified, these
records must be retained until the
Commission terminates the facility’s
license. All records related to this part
may be destroyed upon Commission
termination of the facility license.
Subpart G—Enforcement
§ 37.105
Inspections.
(a) Each licensee shall afford to the
Commission at all reasonable times
opportunity to inspect category 1 or
category 2 quantities of radioactive
material and the premises and facilities
wherein the nuclear material is used,
produced, or stored.
(b) Each licensee shall make available
to the Commission for inspection, upon
reasonable notice, records kept by the
licensee pertaining to its receipt,
possession, use, acquisition, import,
export, or transfer of category 1 or
category 2 quantities of radioactive
material.
§ 37.107
Violations.
(a) The Commission may obtain an
injunction or other court order to
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prevent a violation of the provisions
of—
(1) The Atomic Energy Act of 1954, as
amended;
(2) Title II of the Energy
Reorganization Act of 1974, as
amended; or
(3) A regulation or order issued
pursuant to those Acts.
(b) The Commission may obtain a
court order for the payment of a civil
penalty imposed under section 234 of
the Atomic Energy Act:
(1) For violations of—
(i) Sections 53, 57, 62, 63, 81, 82, 101,
103, 104, 107, or 109 of the Atomic
Energy Act of 1954, as amended:
(ii) Section 206 of the Energy
Reorganization Act;
(iii) Any rule, regulation, or order
issued pursuant to the sections specified
in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation
of any license issued under the sections
specified in paragraph (b)(1)(i) of this
section.
(2) For any violation for which a
license may be revoked under Section
186 of the Atomic Energy Act of 1954,
as amended.
§ 37.109
Criminal penalties.
(a) Section 223 of the Atomic Energy
Act of 1954, as amended, provides for
criminal sanctions for willful violation
of, attempted violation of, or conspiracy
to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act.
For purposes of section 223, all the
regulations in this part 37 are issued
Category 1
(TBq)
Radioactive material
tkelley on DSK3SPTVN1PROD with RULES2
Americium-241 .................................................................................................
Americium-241/Be ...........................................................................................
Californium-252 ................................................................................................
Cobalt-60 .........................................................................................................
Curium-244 ......................................................................................................
Cesium-137 ......................................................................................................
Gadolinium-153 ................................................................................................
Iridium-192 .......................................................................................................
Plutonium-238 ..................................................................................................
Plutonium-239/Be ............................................................................................
Promethium-147 ..............................................................................................
Radium-226 .....................................................................................................
Selenium-75 .....................................................................................................
Strontium-90 ....................................................................................................
Thulium-170 .....................................................................................................
Ytterbium-169 ..................................................................................................
Note: Calculations Concerning Multiple
Sources or Multiple Radionuclides
The ’’sum of fractions’’ methodology for
evaluating combinations of multiple sources
or multiple radionuclides is to be used in
determining whether a location meets or
exceeds the threshold and is thus subject to
the requirements of this part.
I. If multiple sources of the same
radionuclide and/or multiple radionuclides
are aggregated at a location, the sum of the
ratios of the total activity of each of the
radionuclides must be determined to verify
whether the activity at the location is less
than the category 1 or category 2 thresholds
of Table 1, as appropriate. If the calculated
sum of the ratios, using the equation below,
is greater than or equal to 1.0, then the
applicable requirements of this part apply.
II. First determine the total activity for each
radionuclide from Table 1. This is done by
adding the activity of each individual source,
material in any device, and any loose or bulk
material that contains the radionuclide. Then
use the equation below to calculate the sum
of the ratios by inserting the total activity of
the applicable radionuclides from Table 1 in
the numerator of the equation and the
corresponding threshold activity from Table
1 in the denominator of the equation.
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R1 = total activity for radionuclide 1
R2 = total activity for radionuclide 2
RN = total activity for radionuclide n
AR1 = activity threshold for
radionuclide 1
AR2 = activity threshold for
radionuclide 2
ARN = activity threshold for
radionuclide n
PART 39—LICENSES AND RADIATION
SAFETY REQUIREMENTS FOR WELL
LOGGING
18. The authority citation for part 39
continues to read as follows:
■
Authority: Atomic Energy Act secs. 53, 57,
62, 63, 65, 69, 81, 82, 161, 181, 182, 183, 186,
223, 234 (42 U.S.C. 2073, 2077, 2092, 2093,
2095, 2099, 2111, 2112, 2201, 2231, 2232,
Frm 00100
Fmt 4701
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Appendix A to Part 37—Category 1 and
Category 2 Radioactive Materials
Table 1—Category 1 and Category 2
Threshold
The terabecquerel (TBq) values are the
regulatory standard. The curie (Ci)
values specified are obtained by
converting from the TBq value. The
curie values are provided for practical
usefulness only.
Category 1
(Ci)
60
60
20
30
50
100
1,000
80
60
60
40,000
40
200
1,000
20,000
300
Calculations must be performed in metric
values (i.e., TBq) and the numerator and
denominator values must be in the same
units.
PO 00000
under one or more of sections 161b,
161i, or 161o, except for the sections
listed in paragraph (b) of this section.
(b) The regulations in this part 37 that
are not issued under sections 161b,
161i, or 161o for the purposes of section
223 are as follows: §§ 37.1, 37.3, 37.5,
37.7, 37.9, 37.11, 37.13, 37.107, and
37.109.
1,620
1,620
540
810
1,350
2,700
27,000
2,160
1,620
1,620
1,080,000
1,080
5,400
27,000
540,000
8,100
Category 2
(TBq)
0.6
0.6
0.2
0.3
0.5
1
10
0.8
0.6
0.6
400
0.4
2
10
200
3
Category 2
(Ci)
16.2
16.2
5.40
8.10
13.5
27.0
270
21.6
16.2
16.2
10,800
10.8
54.0
270
5,400
81.0
2233, 2236, 2273, 2282); Energy
Reorganization Act secs. 201, 202, 206 (42
U.S.C. 5841, 5842, 5846); Government
Paperwork Elimination Act sec. 1704 (44
U.S.C. 3504 note).
19. In § 39.1, paragraph (a) is revised
to read as follows:
■
§ 39.1
Purpose and scope.
(a) This part prescribes requirements
for the issuance of a license authorizing
the use of licensed materials including
sealed sources, radioactive tracers,
radioactive markers, and uranium sinker
bars in well logging in a single well.
This part also prescribes radiation safety
requirements for persons using licensed
materials in these operations. The
provisions and requirements of this part
are in addition to, and not in
substitution for, other requirements of
this chapter. In particular, the
provisions of parts 19, 20, 21, 30, 37, 40,
70, 71, and 150 of this chapter apply to
applicants and licensees subject to this
part.
*
*
*
*
*
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PART 51—ENVIRONMENTAL
PROTECTION REGULATIONS FOR
DOMESTIC LICENSING AND RELATED
REGULATORY FUNCTIONS
PART 73—PHYSICAL PROTECTION OF
PLANTS AND MATERIALS
20. The authority citation for part 51
continues to read as follows:
■
Authority: Atomic Energy Act sec. 161,
1701 (42 U.S.C. 2201, 2297f); Energy
Reorganization Act secs. 201, 202, 211 (42
U.S.C. 5841, 5842, 5851); Government
Paperwork Elimination Act sec. 1704 (44
U.S.C. 3504 note). Subpart A also issued
under National Environmental Policy Act
secs. 102, 104, 105 (42 U.S.C. 4332, 4334,
4335); Pub. L. 95–604, Title II, 92 Stat. 3033
3041; Atomic Energy Act sec. 193 (42 U.S.C.
2243). Sections 51.20, 51.30, 51.60, 51.80.
and 51.97 also issued under Nuclear Waste
Policy Act secs. 135, 141, 148 (42 U.S.C.
10155, 10161, 10168). Section 51.22 also
issued under Atomic Energy Act sec. 274 (42
U.S.C. 2021) and under Nuclear Waste Policy
Act sec. 121 (42 U.S.C. 10141). Sections
51.43, 51.67, and 51.109 also issued under
Nuclear Waste Policy Act sec. 114(f) (42
U.S.C. 10134(f)).
21. In § 51.22, the introductory text of
paragraph (c)(3) is revised to read as
follows:
■
§ 51.22 Criterion for categorical exclusion;
identification of licensing and regulatory
actions eligible for categorical exclusion or
otherwise not requiring environmental
review.
*
*
*
*
*
(c) * * *
(3) Amendments to parts 20, 30, 31,
32, 33, 34, 35, 37, 39, 40, 50, 51, 52, 54,
60, 61, 63, 70, 71, 72, 73, 74, 81, and 100
of this chapter which relate to—
*
*
*
*
*
PART 71—PACKAGING AND
TRANSPORTATION OF RADIOACTIVE
MATERIAL
22. The authority citation for part 71
continues to read as follows:
■
Authority: Atomic Energy Act secs. 53, 57,
62, 63, 81, 161, 182, 183, 223, 234, 1701 (42
U.S.C. 2073, 2077, 2092, 2093, 2111, 2201,
2232, 2233, 2273, 2282, 2297f); Energy
Reorganization Act secs. 201, 202, 206, 211
(42 U.S.C. 5841, 5842, 5846, 5851); Nuclear
Waste Policy Act sec. 180 (42 U.S.C. 10175);
Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, Pub. L. No. 109–58, 119 Stat. 594
(2005). Section 71.97 also issued under sec.
301, Pub. L. 96–295, 94 Stat. 789 790.
23. In § 71.97, the introductory text of
paragraph (b) is revised to read as
follows:
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■
§ 71.97 Advance notification of shipment
of irradiated reactor fuel and nuclear waste.
*
*
*
*
*
(b) Advance notification is also
required under this section for the
shipment of licensed material, other
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than irradiated fuel, meeting the
following three conditions:
*
*
*
*
*
24. The authority citation for part 73
continues to read as follows:
■
Authority: Atomic Energy Act secs. 53,
147, 161, 223, 234, 1701 (42 U.S.C. 2073,
2167, 2169, 2201, 2273, 2282, 2297(f),
2210(e)); Energy Reorganization Act sec. 201,
204 (42 U.S.C. 5841, 5844); Government
Paperwork Elimination Act sec. 1704, 112
Stat. 2750 (44 U.S.C. 3504 note); Energy
Policy Act of 2005, Pub. L. 109–58, 119 Stat.
594 (2005).
Section 73.1 also issued under Nuclear
Waste Policy Act secs. 135, 141 (42 U.S.C,
10155, 10161). Section 73.37(f) also issued
under sec. 301, Pub. L. 96–295, 94 Stat. 789
(42 U.S.C. 5841 note).
25. A new § 73.35 is added to read as
follows:
■
§ 73.35 Requirements for physical
protection of irradiated reactor fuel (100
grams or less) in transit.
Each licensee who transports, or
delivers to a carrier for transport, in a
single shipment, a quantity of irradiated
reactor fuel weighing 100 grams (0.22
pounds) or less in net weight of
irradiated fuel, exclusive of cladding or
other structural or packaging material,
which has a total external radiation dose
rate in excess of 1 Gray (100 rad) per
hour at a distance of 1 meter (3.3 feet)
from any accessible surface without
intervening shielding, shall follow the
physical protection requirements for
category 1 quantities of radioactive
material in subpart D of part 37 of this
chapter.
Dated at Rockville, Maryland, this 8th day
of March, 2013.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
Note: This Appendix Will Not Appear in
the Code of Federal Regulations.
APPENDIX A TO THIS FINAL RULE—
REGULATORY FLEXIBILITY
ANALYSIS FOR THE AMENDMENTS
TO 10 CFR PARTS 20, 30, 32, 33, 34,
35, 36, 37, 39, 51, 71, AND 73
(PHYSICAL PROTECTION OF
BYPRODUCT MATERIAL)
I. Background
The Regulatory Flexibility Act (RFA), as
amended 5 U.S.C. 601 et seq., requires that
agencies consider the impact of their
rulemakings on small entities and, consistent
with applicable statutes, consider
alternatives to minimize these impacts on the
businesses, organizations, and government
jurisdictions to which they apply.
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17021
The U.S. Nuclear Regulatory Commission
(NRC) has established standards for
determining which NRC licensees qualify as
small entities (10 CFR 2.810). These size
standards were based on the Small Business
Administration’s most common receiptsbased size standards and include a size
standard for business concerns that are
manufacturing entities.
Description of the Reasons That Action by
the Agency Is Being Considered
The NRC has long participated in efforts to
address radioactive source protection and
security. The terrorist attacks of September
11, 2001, heightened concerns about the use
of risk-significant radioactive materials in a
malevolent act. Such an attack is of particular
concern because of the widespread use of
radioactive materials in the United States by
industrial, medical, and academic
institutions. The theft or diversion of risksignificant radioactive materials could lead to
their unauthorized use in a radiological
dispersal device or a radiological exposure
device.
Commission regulations provide
requirements for the safe use, transport, and
control of licensed material. A licensee’s loss
of control of risk-significant radioactive
material, whether it is inadvertent or through
a deliberate act, could result in significant
adverse impacts that could reasonably
constitute a threat to the public health and
safety or the common defense and security of
the United States. After the attacks of
September 11, 2001, the Commission
determined that certain licensed material
should be subject to enhanced security
provisions and safeguarded during transport,
and that individuals with unescorted access
to risk-significant radioactive material should
be subject to background investigations. For
additional information see the Discussion
portion of the Statements of Consideration
(SOC).
Succinct Statement of the Objectives of, and
Legal Basis for, the Final Rule
The objective of this rule is to establish
generically applicable security requirements
for the protection of category 1 and category
2 quantities of radioactive materials
possessed by certain NRC and Agreement
State licensees. These security requirements
are similar to the requirements imposed on
these licensees through the NRC’s applicable
previously-issued security orders. The NRC
has determined that it is preferable to
regulate through rulemaking rather than
order because notice and comment
rulemaking is an open and transparent
process that facilitates public participation.
In developing the final rule, the NRC
considered, among other things, the various
orders, lessons-learned during
implementation, the recommendations from
the Independent Review Panel and the
Materials Working Group, and stakeholder
comments. The rule also considered a
petition for rulemaking submitted by the
State of Washington. For additional
information see the Discussion portion of the
SOC. The authority citation sections of the
final rule contain the statutory authority for
the rule.
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Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Rules and Regulations
Description of and, Where Feasible, an
Estimate of the Number of Small Entities to
Which the Final Rule Will Apply
The final rule would affect about 300 NRC
licensees and about 1,100 Agreement State
licensees. This includes a wide range of
licensees, including pool-type irradiator
licensees; manufacturer and distributor
licensees; medical facilities with gamma
knife devices; self-shielded irradiator
licensees (including blood irradiators);
teletherapy unit licensees; radiographers;
well loggers; broad scope users; radioisotope
thermoelectric generator licensees; and
licensees that ship or prepare for shipment
category 1 or category 2 quantities of
radioactive material. Some of these licensees
would be considered small entities. In fiscal
year 2008, about 26 percent of materials
licensees qualified as small entities. Using
the same percentage, approximately 364 of
the licensees that will be affected by the rule
would be considered small entities.
tkelley on DSK3SPTVN1PROD with RULES2
Description of the Projected Reporting,
Recordkeeping, and Other Compliance
Requirements of the Final Rule, Including an
Estimate of the Classes of Small Entities That
Will Be Subject to the Requirements, and the
Type of Professional Skills Necessary for
Preparation of Reports and Records
Licensees will be required to: (1) Develop
procedures for implementation of the
security provisions; (2) develop a security
plan that describes how security is being
implemented; (3) conduct training on the
procedures and security plan; (4) conduct
background investigations for those
individuals permitted access to category 1 or
category 2 quantities of radioactive material;
(5) coordinate with local law enforcement
agencies (LLEAs) so the LLEAs would be
better prepared to respond in an emergency;
(6) conduct preplanning and coordination
activities before shipping radioactive
material; and (7) implement security
measures for the protection of the radioactive
material. Licensees will be required to
promptly report any attempted or actual theft
or diversion of the radioactive material.
Licensees will be required to keep copies of
the security plan, procedures, background
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investigation records, training records, and
documentation that certain activities have
occurred. For additional information on the
requirements, see the SOC or the final rule
text. No special skills are necessary for the
preparation of reports or records.
On average, a licensee would have a onetime cost of approximately $23,375 and an
annual cost of approximately $21,736 to fully
implement the final rule. Much of this cost
would result from the requirements to have
procedures, conduct training, and to develop
a security plan. Although not required by the
various orders, many licensees may have
developed procedures and conducted
training that may require only minor
revisions; if so, the actual cost may be lower.
Additional large costs are the annual program
review and the maintenance and testing of
the security-related equipment. The program
review is important for licensees to review
the effectiveness of the program and to
ensure that requirements are being
implemented. Maintenance and testing is
essential to ensure that the equipment is
operational and available when needed. More
information on the cost of the rule is
contained in the Regulatory Analysis.
Identification, to the Extent Practicable, of
All Relevant Federal Rules That May
Duplicate, Overlap, or Conflict With the Final
Rule
Several U.S. Government programs involve
fingerprinting and an FBI identification and
criminal history records check. These
include the National Agency Check;
Transportation Worker Identification
Credentials in accordance with 49 CFR 1572;
Bureau of Alcohol, Tobacco, Firearms, and
Explosives background check and clearances
in accordance with 27 CFR 555; Health and
Human Services security risk assessments for
possession and use of select agents and
toxins in accordance with 42 CFR 73;
Hazardous Material security threat
assessment for hazardous material
endorsement to commercial drivers license in
accordance with 49 CFR 1572; and Customs
and Border Protection’s Free and Secure
Trade Program. Any individual that has
favorably undergone the background
investigation required by these programs
PO 00000
Frm 00102
Fmt 4701
Sfmt 9990
would be relieved from the fingerprinting
and FBI criminal history records check
element of the final rule as long as the
licensee has appropriate documentation. Any
individual who has an active Federal security
clearance would also be relieved assuming
appropriate documentation is provided.
The Department of Transportation requires
security plans for the transport of highway
route control quantities of radioactive
material in accordance with 49 CFR 172.800.
This provision covers only a small portion of
the category 1 and category 2 quantities of
radioactive material covered by the rule.
The NRC is not aware of any other relevant
Federal rules that may duplicate, overlap, or
conflict with the final rule.
Description of any significant alternatives
to the final rule that accomplish the stated
objectives of applicable statutes and that
minimize any significant economic impact of
the final rule on small entities, including
alternatives considered, such as: (1)
Establishment of differing compliance or
reporting requirements or timetables that
take into account the resources available to
small entities; (2) clarification, consolidation,
or simplification of compliance and reporting
requirements under the rule for small
entities; (3) use of performance rather than
design standards; and (4) any exemption
from coverage of the rule, or any part thereof,
for such small entities.
As noted earlier, some of the licensees that
would be impacted by the final rule are small
businesses. The rule would impose the
minimum requirements that the NRC
believes are necessary to adequately protect
the public health and safety and the common
defense and security. Therefore, the NRC
could not generically grant relief to small
entities to allow them to implement less
effective measures. The final rule provides
some flexibility in the particular measures
that a licensee can choose to employ.
Licensees affected by the rule have already
implemented the bulk of the rule’s
requirements in response to various orders.
[FR Doc. 2013–05895 Filed 3–18–13; 8:45 am]
BILLING CODE 7590–01–P
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Agencies
[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Rules and Regulations]
[Pages 16921-17022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05895]
[[Page 16921]]
Vol. 78
Tuesday,
No. 53
March 19, 2013
Part II
Nuclear Regulatory Commission
-----------------------------------------------------------------------
10 CFR Parts 20, 30, 32, et al.
Physical Protection of Byproduct Material; Rule
Federal Register / Vol. 78 , No. 53 / Tuesday, March 19, 2013 / Rules
and Regulations
[[Page 16922]]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71, and 73
[NRC-2008-0120; NRC-2010-0194]
RIN 3150-AI12
Physical Protection of Byproduct Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
regulations to establish security requirements for the use and
transport of category 1 and category 2 quantities of radioactive
material. The NRC considers these quantities to be risk significant
and, therefore, to warrant additional protection. Category 1 and
category 2 thresholds are based on the quantities established by the
International Atomic Energy Agency (IAEA) in its Code of Conduct on the
Safety and Security of Radioactive Sources, which the NRC endorses. The
objective of this final rule is to provide reasonable assurance of
preventing the theft or diversion of category 1 and category 2
quantities of radioactive material. The regulations also include
security requirements for the transportation of irradiated reactor fuel
that weighs 100 grams or less in net weight of irradiated fuel. The
final rule affects any licensee that possesses an aggregated category 1
or category 2 quantity of radioactive material, any licensee that
transports these materials using ground transportation, and any
licensee that transports small quantities of irradiated reactor fuel.
The rule also considers a petition for rulemaking (PRM-71-13) submitted
by the State of Washington that requested that the NRC adopt the use of
global positioning satellite tracking as a national requirement for
vehicles transporting highly radioactive mobile or portable radioactive
devices.
DATES: Effective Date: This final rule is effective on May 20, 2013.
Compliance Date: Compliance with this final rule is required on
March 19, 2014.
ADDRESSES: You can access publicly available documents related to this
document 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, O1-F21, One White Flint North, 11555 Rockville Pike, Rockville,
Maryland 20852.
NRC's Agencywide Documents Access and Management System
(ADAMS): Publicly available documents created or received at the NRC
are available online in the NRC Library at https://www.nrc.gov/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's PDR reference staff
at 1-800-397-4209, 301-415-4737, or by email to nrc.gov">pdr.resource@nrc.gov.
Federal Rulemaking Web site: Public comments and
supporting materials related to this final rule can be found at https://www.regulations.gov by searching on Docket ID NRC-2008-0120. Public
comments on the guidance document supporting this rule can be found by
searching Docket ID NRC-2010-0194. Address questions about NRC dockets
to Carol Gallagher, telephone: 301-492-3668; email:
nrc.gov">Carol.Gallagher@nrc.gov.
Availability of Guidance
The NRC is issuing new guidance for the implementation of the
requirements of 10 CFR part 37. The guidance document is NUREG-2155,
Implementation Guidance for 10 CFR part 37, ``Physical Protection of
Category 1 and Category 2 Quantities of Radioactive Material'' (ADAMS
Accession No. ML13053A061). This guidance is publicly available as
stated in this ADDRESSES section.
FOR FURTHER INFORMATION CONTACT: Merri Horn, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001; telephone: 01-415-
8126, email: nrc.gov">Merri.Horn@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PRM 71-1
II. Discussion
A. General Applicability
B. Background Investigations and Access Authorization Program
C. Physical Protection During Use
D. Transportation Security
III. Summary and Analysis of Public Comments on the Proposed Rule
IV. Discussion of Final Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Writing
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental Impact: Availability
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis
XIV. Congressional Review Act
I. Background
The NRC has long participated in efforts to ensure radioactive
source protection and security. The terrorist attacks of September 11,
2001, heightened concerns about the use of risk-significant radioactive
materials in a malevolent act. Such an attack is of particular concern
because of the widespread use of radioactive materials in the United
States by industrial, medical, and academic institutions. The theft or
diversion of risk-significant quantities of radioactive materials could
lead to their use in a radiological dispersal device (RDD) or a
radiological exposure device (RED).
The NRC's current regulations provide requirements for the safe
use, transportation, and control of licensed radioactive material. Loss
of control of risk-significant radioactive material, whether
inadvertent or through a deliberate act, could result in significant
adverse impacts that could reasonably constitute a threat to the public
health and safety or the common defense and security of the United
States. In the changed threat environment after the attacks of
September 11, 2001, the Commission determined that certain licensed
material should be subject to enhanced security requirements and
safeguarded during transport, and that individuals with unescorted
access to risk-significant quantities of radioactive material should be
subject to background investigations.
As part of the development of the enhanced security measures, the
NRC performed threat and vulnerability assessments to identify gaps or
vulnerabilities in security and the effectiveness and costs of certain
physical protection enhancements at various licensed facilities. The
results of these assessments were used in the development of security
enhancement orders that were issued to licensees using a graded
approach based on the relative risk and quantity of material possessed
by the licensee.
The NRC issued the first series of orders to certain panoramic and
underwater irradiator licensees that possessed more than 370
Terabequerels (TBq) (10,000 curies (Ci)) of radioactive material (EA-
02-249; June 6, 2003) (68 FR 35458; June 13, 2003). The next series of
orders were issued to certain manufacturing and distribution (M&D)
licensees (EA-03-225; January 12, 2004) (69 FR 5375; February 4, 2004).
These orders require the implementation of additional security measures
and the protection of the licensee's physical
[[Page 16923]]
protection information as Safeguards Information--Modified Handling
(SGI-M). The original orders are not publicly available because they
contain detailed security requirements that are designated as SGI-M.
However, redacted versions of these orders have been made available to
the public (73 FR 33859; June 13, 2008, and 73 FR 49714; August 22,
2008). These orders were issued to both NRC and Agreement State
licensees under the NRC's authority to protect the common defense and
security.
Subsequently, the NRC issued Increased Control Orders (EA-05-090;
November 14, 2005) (70 FR 72128; December 1, 2005) to other licensees
authorized to possess certain risk-significant quantities of
radioactive material (category 1 and category 2 quantities). The
Increased Control Orders do not contain safeguards information (SGI) or
SGI-M, and are available on the NRC's public Web site at https://www.nrc.gov/security/byproduct/orders.html. These orders were issued
under the NRC's authority to protect public health and safety, and
require licensees to implement enhanced security measures known as
Increased Controls. To effect nationwide implementation of the
Increased Control Orders, each Agreement State issued legally binding
requirements to impose enhanced security measures, identical to the
Increased Controls, for licensees under that State's regulatory
jurisdiction.
All of the orders described above specifically address the security
of byproduct material possessed in quantities equal to or greater than
category 1 or category 2 quantities. The orders provide for enhanced
security measures for such things as license verification before the
transfer of these materials, access control, intrusion detection and
response, and coordination with local law enforcement authorities
(LLEAs). The orders also contain requirements for the licensee to
determine the trustworthiness and reliability of individuals permitted
unescorted access to risk-significant radioactive materials. The
determination involves a background investigation of the individual.
The background investigations were originally limited to local criminal
history records checks with law enforcement agencies, verification of
employment history, education, personal references, and confirmation of
employment eligibility (legal immigration status).
In 2005, Congress passed, and the President signed, the Energy
Policy Act of 2005 (EPAct). The EPAct amended Section 149 of the Atomic
Energy Act (AEA) to authorize the Commission to require to be
fingerprinted any individual who is permitted unescorted access to
radioactive material or other property subject to regulation by the
Commission that the Commission determines to be of such significance to
the public health and safety or the common defense and security as to
warrant fingerprinting and a Federal Bureau of Investigation (FBI)
criminal history records check. With this new authority, the Commission
determined that individuals who have access to category 1 and category
2 quantities of radioactive material warrant fingerprinting and FBI
criminal history records checks.
On October 17, 2006, the NRC issued orders to panoramic and
underwater irradiator licensees (EA-06-248) (71 FR 63043; October 27,
2006), M&D licensees (EA-06-250) (71 FR 63046; October 27, 2006), and
licensees making shipments of category 1 quantities of radioactive
material (EA-06-249) (71 FR 62302; October 24, 2006) to require
fingerprinting and FBI criminal history records checks for unescorted
access to risk-significant quantities of radioactive material at their
facilities. In issuing these orders, the NRC noted that a malevolent
act by an individual with unescorted access to these materials could
result in significant adverse impacts to the public health and safety
or the common defense and security and, thus, necessitated expedited
implementation of fingerprinting requirements. The orders were issued
to both NRC and Agreement State licensees under the NRC's authority to
protect the common defense and security. On December 5, 2007, the NRC
issued orders to all other NRC licensees that possessed category 1 or
category 2 quantities of radioactive material (EA-07-305) (72 FR 70901;
December 13, 2007) to require fingerprinting and FBI criminal history
records checks for unescorted access to category 1 or category 2
quantities of radioactive material. These orders were issued under the
NRC's authority to protect the public health and safety and are
available on the NRC's public Web site at https://www.nrc.gov/security/byproduct/orders.html. To effect nationwide implementation, each
Agreement State issued legally binding requirements consistent with the
Increased Control Orders to licensees under their regulatory
jurisdiction.
In 2005, the NRC issued two sets of orders to licensees
transporting radioactive material in quantities of concern. The first
set of transportation security orders was issued to certain licensees
that might be expected to transport radioactive materials in category 1
quantities (EA-05-006; July 19, 2005) (70 FR 44407; August 2, 2005).
These orders require the implementation of additional security measures
and the protection of the licensee's physical protection information as
SGI-M. The original orders are not publicly available because they
contain detailed security requirements that are designated as SGI-M.
However, a redacted version of the order is publicly available (73 FR
51016; August 29, 2008). These orders were issued to both NRC and
Agreement State licensees under the NRC's authority to protect the
common defense and security.
Subsequently, the NRC issued orders (EA-05-090; November 14, 2005)
(70 FR 72128; December 1, 2005) to specifically address the
transportation security of byproduct material transported in quantities
equal to or greater than category 2. The Increased Control Orders
mentioned earlier also contain requirements for transporting category 2
quantities of radioactive material. The additional security measures
contained in these two sets of orders provide for enhanced security
measures during transportation that are beyond the regulations then
applicable, and include: Enhanced security in preplanning and
coordinating shipments; advance notification of shipments to the NRC
and States through which the shipment will pass; control and monitoring
of shipments that are underway; trustworthiness and reliability of
transport personnel; information security considerations; and control
of mobile or portable devices such as radiography cameras and well-
logging devices.
In November 2009, the NRC issued the Increased Control Order and
the Fingerprint Order to power reactor licensees that are undergoing
decommissioning (EA-09-204 and EA-09-205; November 23, 2009) (74 FR
66168 and 74 FR 66164; December 14, 2009). The orders required these
licensees to implement the Increased Controls and to obtain
fingerprints and criminal history records checks for individuals to
have or continue having unescorted access to aggregated category 1 or
category 2 quantities of radioactive material.
In December 2009, the NRC issued orders to service provider
licensees that were not manufacturers or distributors (EA-09-293;
December 16, 2009 (75 FR 160; January 4, 2010). The order required
service provider licensees to implement specific measures to ensure the
trustworthiness and reliability of
[[Page 16924]]
their service representatives that have unescorted access to category 1
or category 2 quantities of radioactive materials.
The requirements put in place by all these above-described orders
supplement the existing regulatory requirements. These additional
requirements are primarily intended to provide reasonable assurance of
preventing the theft or diversion of risk-significant radioactive
material. These requirements provide the Commission with reasonable
assurance that public health and safety and the common defense and
security continue to be adequately protected.
It is the Commission's preference to implement generically
applicable requirements through rulemaking rather than by orders. An
order is legally binding only on the licensee or licensees receiving
the order. Further, the notice-and-comment rulemaking process allows
members of the public to provide comments on the proposed rule.
This rulemaking promulgates generically applicable security
requirements for licensees possessing category 1 and category 2
quantities of radioactive material in the regulations. New requirements
for background investigations and an access authorization program are
included to ensure that individuals who have access to these materials
have gone through background investigations and are determined to be
trustworthy and reliable. New requirements are also included to
establish physical protection systems to detect, assess, and respond to
unauthorized access to category 1 and category 2 quantities of
radioactive material. For transport of the radioactive materials, new
requirements for recipient license verification; preplanning and
coordination of shipments; advance notification of shipments;
notification of shipment delays, schedule changes, and suspected loss
of a shipment; and control and monitoring of shipments are included.
The amendments also include security requirements for shipments of
irradiated reactor fuel that weigh 100 grams (g) (0.22 pounds (lb)) or
less in net weight of irradiated fuel, exclusive of cladding or other
structural or packaging material, which has a total external radiation
dose rate in excess of 1 Gray (100 rad) per hour at a distance of 1
meters (m) (3.3 feet (ft)) from any accessible surface without
intervening shielding.
In developing this final rule, the NRC considered, among other
things, the various orders, lessons-learned during implementation of
the orders, the recommendations of the Independent External Review
Panel and the Materials Program Working Group, and stakeholder comments
received on the proposed rule and the draft implementation guidance.
The Commission chartered the Independent External Review Panel to: (1)
Identify vulnerabilities in the NRC's materials licensing program with
respect to import, export, specific, and general licenses; (2) validate
the ongoing byproduct material security efforts; and (3) evaluate the
apparent ``good faith presumption'' in the NRC licensing process that
had in the past justified minimal investigation of new license
applicants or inspection of their facilities before allowing their
possession of radioactive material. The Panel's March 2008 report is
available in ADAMS under Accession No. ML080700957. The Materials
Program Working Group conducted a comprehensive evaluation of the
materials program to identify short- and long-term strategies to
mitigate security vulnerabilities. The Working Group report contains
sensitive information and is not publicly available. However, the
Group's comments on the Panel's report are publicly available in ADAMS
under Accession No. ML080660424.
PRM-71-13
On July 16, 2008 (73 FR 40767), the NRC published the resolution
and closure of a petition for rulemaking filed by Christine O.
Gregoire, Governor of the State of Washington (PRM-71-13). The NRC
indicated that the issues raised by the petitioner would be considered
in an ongoing rulemaking on security requirements for the
transportation of radioactive material in quantities of concern.
The petitioner requested that the NRC adopt the use of global
positioning system (GPS) tracking as a national requirement for
vehicles transporting highly radioactive mobile or portable radioactive
devices. As an alternative, the petitioner stated that the Commission
could grant States the flexibility to impose more stringent
requirements than those required under the current Increased Controls
Orders. The petitioner believes that GPS technology is an effective and
relatively inexpensive tool that would give law enforcement a
significant advantage in locating a missing source. However, the
petitioner acknowledged that requiring a GPS on these vehicles does not
ensure that the radiological source will be found.
The NRC considered the issues identified by the petitioner and the
petitioner's suggested approach to address those issues in the
decision-making process and final determination of the rule
requirements in the area of the petitioner's concern. The NRC
ultimately did not include a requirement for GPS tracking in the rule.
However, the rule does contain a requirement to use a telemetric
position monitoring system or an alternative tracking system when
transporting category 1 quantities of radioactive material. Use of GPS
would be one method to satisfy this requirement. For licensees
transporting category 2 quantities of radioactive material, tracking is
not required. The licensee is required to maintain constant control or
surveillance during transit. In addition, the rule at Sec. 37.53
imposes additional security measures on mobile devices that includes
using a method to disable the vehicle or trailer when not under direct
control and constant surveillance by the licensee. The NRC believes
that these requirements provide adequate protection for mobile devices
and that GPS is neither justified nor necessary. The majority of the
transportation security requirements are Compatibility Category B
because there are direct and significant transboundary implications.
Because the requirements are Compatibility B, Agreement States must
adopt program elements essentially identical to those of the NRC and do
not have the flexibility to adopt more stringent requirements. See also
response to comment D29.
II. Discussion
The NRC has determined that a new part for Title 10 of the Code of
Federal Regulations (10 CFR) should be established for the security
requirements for use and transportation of category 1 and category 2
quantities of radioactive material. Separate safety and physical
protection requirements have already been established for special
nuclear material in 10 CFR part 73. The establishment of a new part for
security-related requirements for byproduct material would be more
effective and efficient compared to interspersing the requirements with
safety requirements or placing them with the part 73 security
requirements for special nuclear material. A new part specifically
directed to byproduct material licensees should make applicable
requirements easier for both licensees and other stakeholders to locate
and understand.
This discussion section has been divided into four subsections to
better present information on the final rule. Each section presents
information on a different aspect of the final rule. Section A provides
information that is generally applicable to all aspects of this
[[Page 16925]]
rulemaking. Section B provides information on background investigations
and the access authorization program. Section C provides information on
the physical protection of the materials during use. Lastly, Section D
provides information on transportation security aspects.
A. General Applicability
1. What action is the NRC taking?
The NRC is amending its regulations to impose security requirements
for the use and transportation of category 1 and category 2 quantities
of radioactive material. The requirements establish the objectives and
minimum requirements that licensees must meet to protect against theft
or diversion of this material. These requirements are intended to
increase the protection of the public against the unauthorized use of
category 1 or category 2 quantities of radioactive material by reducing
the risk of the theft or diversion of the material. The NRC is also
amending the regulations to impose security requirements for the
transportation of small quantities (100 grams or less) of irradiated
fuel.
2. Why do the requirements need to be revised?
Prior to September 11, 2001, the NRC requirements focused on safety
and preventing inadvertent or accidental exposure of both workers and
the public to these materials. These requirements also provided
security for the material. The events of September 11, 2001, made the
NRC take a broader look at its requirements and reevaluate what a
terrorist might do to obtain these materials. From this effort, the NRC
identified several areas where additional requirements were necessary
to improve security. The security requirements need to be placed in the
regulations so that they are generally applicable to all licensees.
Publication of the proposed rule also provided an opportunity for all
stakeholders to comment on the proposed requirements.
3. Why doesn't the NRC just keep the orders in effect?
The orders issued by the NRC could stay in place indefinitely.
However, the regulations would not reflect current Commission policy or
requirements. Imposing long-term requirements through orders has not
traditionally been the agency's preferred method of regulation. Orders,
unlike rules, do not apply prospectively to applicants for new
licenses. The NRC would have to periodically issue new orders to cover
new and amended licenses, and perhaps reissue orders periodically to
existing licensees if requirements or administrative practices change.
In order to make the requirements generally applicable to all present
and future licensees, the security-related requirements need to be
placed in the regulations.
The NRC is now formally revising its security requirements. The
orders will remain in place for NRC licensees until the final rule is
implemented (1 year after publication of the final rule). Once the
final rule is implemented, the NRC will rescind the orders that were
issued to its licensees. For Agreement State licensees that received an
NRC order, the order will remain in place until the effective date of
compatible requirements issued by the Agreement States. Each Agreement
State will follow its own process for issuing these requirements. Once
the State has issued its requirements and they become effective, the
NRC will rescind the order.
4. Whom would this action affect?
These requirements will apply to NRC and Agreement State licensees
that possess an aggregated category 1 or category 2 quantity of
radioactive material or that transport irradiated reactor fuel less
than 100 grams net weight. This includes a wide range of licensees,
including pool-type irradiator licensees; manufacturer and distributor
licensees; medical facilities with gamma knife devices; self-shielded
irradiator licensees (including blood irradiators); teletherapy unit
licensees; radiographers; well loggers; broad scope users; radioisotope
thermoelectric generator licensees; and licensees that ship or prepare
for shipment category 1 or category 2 quantities of radioactive
material. Nearly 1,400 licensees are implementing the various orders
and are the entities that will be primarily impacted by this final
rule. In addition, some fuel cycle and reactor licensees that possess
sources at these levels may be impacted. Some decommissioning reactor
licensees may also be impacted. Most licensees whose activities are
covered under the physical protection requirements of 10 CFR part 73
are exempt from the requirements of 10 CFR part 37. For example, a
reactor licensed under part 50 that also possesses a radiography source
under an NRC license does not need to implement the part 37 provisions
if the source is protected under the reactor security program required
by part 73. Licensees that possess an aggregated quantity of
radioactive waste that equals or exceeds the category 2 threshold will
need to meet some requirements, but would not need to meet most of the
program elements in part 37.
Aggregated quantity refers to the total quantity of radioactive
material, calculated by use of the sum of fractions method discussed in
question 7, that can be accessed by defeating a single physical
barrier.
5. What are Category 1 and Category 2 quantities of radioactive
material?
Category 1 quantities of radioactive material have been called
radioactive material in quantities of concern (RAMQC). Category 1 and
category 2 quantities of radioactive material have been called risk-
significant radioactive material and refer specifically to 16
radioactive materials (14 single radionuclides and 2 combinations).
These materials are: Americium-241; americium-241/beryllium;
californium-252; curium-244; cobalt-60; cesium-137; gadolinium-153;
iridium-192; plutonium-238; plutonium-239/beryllium; promethium-147;
radium-226; selenium-75; strontium-90 (yttrium-90); thulium-170; and
ytterbium-169. Irradiated fuel and mixed oxide fuel are not included
even though they may contain category 1 or category 2 quantities of
radioactive material; these materials are covered by other regulations.
The thresholds for category 1 and category 2 quantities of radioactive
material are provided in the following table. Terabecquerels is the
official unit to be used for determining whether a radioactive material
is a category 1 or category 2 quantity. Because many licensees use
curies in their activities instead of Becquerels, the table provides
the curie value at three significant figures for convenience.
----------------------------------------------------------------------------------------------------------------
Category 1 threshold Category 2 Threshold
-------------------------------------------------------------------------
Radioactive material Terabecquerels Terabecquerels
(TBq) Curies (Ci) (TBq) Curies (Ci)
----------------------------------------------------------------------------------------------------------------
Americium-241......................... 60 1,620 0.6 16.2
Americium-241/Beryllium............... 60 1,620 0.6 16.2
Californium-252....................... 20 540 0.2 5.40
[[Page 16926]]
Curium-244............................ 50 1,350 0.5 13.5
Cobalt-60............................. 30 810 0.3 8.10
Cesium-137............................ 100 2,700 1 27.0
Gadolinium-153........................ 1000 27,000 10.0 270
Iridium-192........................... 80 2,160 0.8 21.6
Plutonium-238......................... 60 1,620 0.6 16.2
Plutonium-239/Beryllium............... 60 1,620 0.6 16.2
Promethium-147........................ 40,000 1,080,000 400 10,800
Radium-226............................ 40 1,080 0.4 10.8
Selenium-75........................... 200 5,400 2.0 54.0
Strontium-90 (Yttrium-90)............. 1,000 27,000 10.0 270
Thulium-170........................... 20,000 540,000 200 5,400
Ytterbium-169......................... 300 8,100 3 81.0
----------------------------------------------------------------------------------------------------------------
These materials and thresholds are based on the IAEA Code of
Conduct. The IAEA published these results in a document titled ``Code
of Conduct on the Safety and Security of Radioactive Sources.'' A link
to this document can be found on the NRC's Web site at https://www.nrc.gov/security/byproduct/enhanced-security.html. The NRC and the
international community, led by the IAEA, revised the IAEA Code of
Conduct in 2003, to establish common international guidance for safety
and security measures for radioactive sources. In a separate effort,
the U.S. Department of Energy (DOE) and the NRC reviewed the chemical,
physical, and radiological characteristics of each radioactive material
that is licensed in the United States, for its attractiveness to a
terrorist. This effort identified 16 radioactive materials that could
pose a serious threat to people and the environment if used
malevolently. This effort further identified the different quantities
or ``thresholds'' of materials that could be useful to a terrorist. The
results of the DOE/NRC effort closely matched the Code of Conduct
Category 2 quantities. The NRC adopted the IAEA Code of Conduct
Category 1 and Category 2 threshold quantities to provide consistency
between domestic and international efforts for security of radioactive
materials that are deemed to be attractive targets for malevolent use.
IAEA Safety Series RS-G-1.9, Categorization of Radioactive Sources,
provides the underlying methodology for the development of the Code of
Conduct thresholds. Safety Series RS-G-1.9 provides a risk-based
ranking of radioactive sources in five categories in terms of their
potential to cause severe deterministic effects for a range of
scenarios that include both external exposure from an unshielded source
and internal exposure following dispersal. The categorization system
uses the `D' values as normalizing factors. The `D' value is the
radionuclide specific activity of a source that, if not under control,
could cause severe deterministic effects for a range of scenarios that
include both external exposure from an unshielded source and internal
exposure following dispersal of the source material. Safety Series RS-
G-1.9 is available on the IAEA's Web site at: https://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf.
6. Why are the requirements limited to these 16 radionuclides?
The Radiation Source Protection and Security Task Force, an
interagency task force established by the EPAct, concluded in its 2006
report to Congress and the President (ADAMS Accession No. ML062190349)
that the appropriate radioactive sources were being protected. The Task
Force also concluded that the IAEA Code of Conduct serves as an
appropriate framework for considering which sources warrant additional
protection. For its 2010, report to Congress and the President (ADAMS
Accession No. ML102230141), the Task Force conducted a reevaluation of
the radionuclides that warrant additional security and protection. The
Task Force found ``that the Category 1 and 2 quantities remain valid
for sealed and unsealed sources as the list and threshold levels of
radionuclides that could result in a significant RED or RDD event and
therefore warrant enhanced security and protection.'' The Task Force
identified seven additional radionuclides that may be of concern when
aggregated, but the Task Force did not recommend at this time that
these additional radionuclides should receive enhanced protection. If
in the future the Task Force revises its view and determines that
additional security is necessary for these materials, the NRC would
consider requiring additional security for these materials. The Task
Force periodically reevaluates the list of radionuclides that warrant
additional security and protection. If the radionuclides and/or
thresholds change in the future, any changes would be addressed in a
future rulemaking.
7. What is the sum of fractions methodology or unity rule?
The sum of fractions methodology, also known as the unity rule, is
used to determine if a licensee is required to implement 10 CFR part 37
requirements. A licensee may need to implement the requirements in 10
CFR part 37 even if it does not possess any single source or single
radionuclide in excess of the category 2 thresholds. For combinations
of materials (to include sealed sources, unsealed sources, and bulk or
loose material) and radionuclides, a licensee must include multiple
items (including bulk material) of the same radionuclide and multiple
items (including bulk material) of different radionuclides to determine
if the requirements apply. For the purposes of this calculation,
licensees are required to consider all of the aggregated radioactive
material from the list of applicable radionuclides at any location
where the material can be accessed by breaching a single barrier. The
following formula for the unity rule is used to determine if a licensee
is required to implement the part 37 requirements: [(Total amount of
radionuclide A) / (category 2 threshold of radionuclide A)] + [(total
amount of radionuclide B) / (category 2 threshold of radionuclide B)] +
etc.....>= 1. If the sum is greater than or equal to 1, the licensee
has at least a category 2 quantity of radioactive material, and the 10
CFR part 37 requirements apply.
[[Page 16927]]
8. Does the NRC plan to issue guidance on these requirements?
Yes, the NRC plans to issue guidance on the security requirements
for category 1 and category 2 quantities of radioactive materials. The
draft guidance was issued for public comment (75 FR 40756; July 14,
2010) during the comment period on the proposed rule. The NRC is
issuing new guidance for the implementation of the requirements of 10
CFR part 37. The guidance document is NUREG-2155, Implementation
Guidance for 10 CFR part 37, ``Physical Protection of Category 1 and
Category 2 Quantities of Radioactive Material'' (ADAMS Accession No.
ML13053A061). This guidance and public comments are available as stated
in the ADDRESSES section of this document.
9. Will all of the information considered to be safeguards information
under the orders now be made public?
No. The orders issued to some licensees contained detailed security
information that could be useful to an adversary. To increase public
awareness and participation, the NRC identified the primary security
concepts behind each security measure and included these concepts in
the rule to allow discussion of the security measures in a public
forum. But the specific measures that a licensee puts in place may be
considered SGI-M. The final rule on safeguards information became
effective on February 23, 2009 (73 FR 63546; October 24, 2008), and
established as SGI-M certain physical protection information related to
panoramic and underwater irradiators that possess greater than 370 TBq
(10,000 Ci) of byproduct material in the form of sealed sources;
manufacturers and distributors of items containing source material,
byproduct material, or special nuclear material in greater than
category 2 quantities; and transportation of source, byproduct, or
special nuclear material in greater than or equal to category 1
quantities. Physical protection information for other facilities that
fall under the requirements of 10 CFR part 37 is considered physical
protection information under 10 CFR 2.390(d)(1). Licensees are also
required to protect the security plan and implementing information and
the list of individuals that have unescorted access from unauthorized
disclosure. The rule provisions that address SGI-M or include
references to the SGI-M requirements in part 73 are reserved for the
NRC and are considered compatibility category NRC.
10. What is the authority for this final rule?
As noted in the background discussion, the NRC issued some orders
under its authority to protect the common defense and security and some
orders under its authority to protect the public health and safety.
With respect to whether the following regulations are being issued
under ``public health and safety'' or ``common defense and security,''
it should be recognized that almost all regulations relating to the
security of materials serve both purposes to some degree. For example,
securing radioactive materials with multiple barriers protects the
public health and safety by preventing the unknowing theft of
radioactive materials--such as someone stealing a vehicle with material
stored in the vehicle, but whose target is the vehicle--which could
result in the unintentional exposure of members of the public to the
material. The barriers also protect the common defense and security by
preventing the theft of the radioactive material by potential
terrorists or others targeting the specific material intending to use
it to affect the common defense and security by exposing members of the
public to the material. However, the designation of the authority being
used for these regulations does have significance in determining
whether Agreement States or the NRC will be responsible for overseeing
the implementation of these requirements for Agreement State licensees.
Although section 274(b) of the AEA allows the NRC to relinquish its
regulatory authority to Agreement States for certain radioactive
materials and activities, section 274(m) of the AEA prevents such
agreements from affecting the authority of the Commission to take
regulatory action to protect the common defense and security. Thus, as
evidenced by orders issued to Agreement State licensees after the
events of September 11, 2001, the NRC has the ability to take necessary
steps to address particular common defense and security needs. If these
regulations were to be issued under the NRC's common defense and
security authority, only the NRC would have the authority to impose
these requirements on Agreement State licensees and the NRC would be
responsible for inspection and enforcement of these requirements for
Agreement State licensees.
When regulations such as these complement both the NRC's public
health and safety and common defense and security missions, the
operative question is whether NRC oversight is necessary to fulfill the
common defense and security aspects of the regulations. The NRC
believes that the Agreement States can consistently and adequately
implement the physical protection requirements on a nationwide basis,
and as such, there will be no need for independent NRC action to
protect the common defense and security. As always, the NRC retains the
authority under section 274(m) of the AEA to take any necessary actions
for protection of the common defense and security should individual
licensees or Agreement State programs develop issues requiring
immediate action. As long as all Agreement States continue to implement
compatible and adequate security requirements, there appears to be no
benefit to the public health and safety, or common defense and
security, that would justify removing oversight of these requirements
from an established regulatory program overseeing Agreement State
licensees. Implementing these regulations under the NRC's public health
and safety authority avoids potential complications with licensees
being subject to dual regulatory authority for a single license. Thus,
the NRC is issuing these regulations under its public health and safety
authority, and these requirements are applicable to Agreement State
licensees through the Agreement State Program.
11. When would the rule be effective?
The final rule is effective 60 days after publication in the
Federal Register; however, licensees do not need to comply with the
rule until 1 year after publication. This provides time for licensees
to put in place the necessary programs, develop procedures, and conduct
training on the new requirements. While most of the provisions are
similar to those contained in the orders, there are differences. The
Agreement States will be required to issue compatible requirements
within 3 years of the publication date of the final rule instead of 3
years from the effective date of the rule. Licensees in an Agreement
State will continue to operate under the orders or other legally
binding requirements until the Agreement State issues compatible
requirements and these requirements take effect. The provisions put in
place for the inspection of licensees in Agreement States that received
the orders issued under common defense and security will remain in
place until the Agreement State implements the requirements. For those
Agreement States that enter into 274i Agreements, the State can
continue inspections
[[Page 16928]]
under the Agreement. For those Agreement States that did not enter into
274i Agreements, the NRC will continue to conduct the inspections until
the new Agreement State requirements become effective. The NRC will
rescind the orders as the regulatory requirements become effective.
12. How does the NRC ensure licensees are following these rules?
The NRC and Agreement States conduct inspections to ensure that
licensees are following the requirements. The NRC and Agreement State
inspectors will receive training and follow inspection procedures on
how to ascertain whether licensees are meeting security requirements.
Potential violations that are identified will be processed in
accordance with the NRC Enforcement Policy, and depending on the
severity of a violation, licensees could be subject to civil or
criminal penalties. Additionally, the NRC has developed enforcement
guidance to ensure consistency in the enforcement process. Agreement
State licensees are subject to the State's enforcement process. Those
Agreement State licensees that were issued NRC orders under common
defense and security would remain subject to the NRC's enforcement
process, until the Agreement State adopts the regulations with its own
legally binding requirements.
B. Background Investigations and Access Authorization Program
1. Who is required to have an access authorization program?
Any licensee that possesses category 1 or category 2 quantities of
radioactive materials at a facility needs to determine whether it needs
to have an access authorization program. Only those licensees that
permit unescorted access to an aggregated category 1 or category 2
quantity of radioactive material are required to establish and
implement an access authorization program. If the material can be
accessed by the breach of a single physical barrier, the licensee needs
to implement an access authorization program. In addition, any
applicant for a license or license amendment to possess category 1 or
category 2 quantities of radioactive material at a facility is required
to establish an access authorization program before obtaining the
radioactive material, if it will be aggregating the material at or
above the category 2 threshold.
2. What is the objective of the access authorization program?
The main objective of the access authorization program is to ensure
that individuals who have unescorted access to category 1 or category 2
quantities of radioactive material are trustworthy and reliable and do
not constitute an unreasonable risk to the public health and safety or
common defense and security.
3. Who is subject to the licensee's access authorization program?
Section 652 of the EPAct authorizes the Commission to require
fingerprinting of any individual who is permitted unescorted access to
``any radioactive material that the Commission determines to be of such
significance to the public health and safety or the common defense and
security as to warrant fingerprinting and background checks.'' The
Commission has determined that the threshold that warrants
fingerprinting and background checks is category 2. The Commission
directed that any licensee implementing the Increased Control Orders
should also have a fingerprinting and an FBI criminal records check for
any individual with unescorted access to category 1 or category 2
quantities of radioactive material. Because only licensees that had
aggregated quantities at or above the category 2 threshold implemented
the orders, these are the licensees that need to have an access
authorization program, i.e., any licensee that has an aggregated
quantity of radioactive material at or above the category 2 threshold.
Therefore, individuals subject to a licensee's access authorization
program include anyone permitted to have unescorted access to category
1 or category 2 quantities of radioactive material. Unescorted access
is defined as solitary access to category 1 or category 2 quantities of
radioactive material or the devices that contain the material. The
reviewing official is also included in the program to ensure that this
individual is subjected to the same background check and degree of
trustworthiness and reliability.
The access authorization program may also include individuals that
have access to SGI-M, such as vehicle drivers and accompanying
individuals for road shipments of category 1 quantities of radioactive
material, movement control center personnel for shipments of category 1
quantities of radioactive material, and any individual whose assigned
duties provide access to shipment information on category 1 quantities
of radioactive material. Licensees may have a separate program for
access to SGI or may include the program with the part 37 program for
unescorted access to the material.
Those individuals who have unescorted access to certain quantities
of byproduct material could pose a threat to the public health and
safety or the common defense and security because they could divert or
steal risk-significant radioactive material, or could aid others in the
commission of such acts. The Radiation Source Protection and Security
Task Force encouraged the NRC to require fingerprinting and Federal
criminal history checks of any individual with access to category 1 or
category 2 quantities of radioactive material.
Certain categories of individuals are relieved from the background
investigation aspect of the access authorization program (see Section
II, question B20 and B21). Licensees do have the option to escort an
individual and not make a trustworthiness and reliability
determination. The escorts need to be approved for unescorted access.
4. What are the key access authorization program requirements?
The key components of an access authorization program are the
reviewing official, a background investigation, use of procedures, and
the individual's right to correct and complete the information on which
the decision to grant unescorted access is based. Each of these areas
is discussed in more detail in the following questions and answers.
5. What is the role of the reviewing official?
The reviewing official is the individual that makes the
trustworthiness and reliability determinations for the licensee; the
reviewing official determines who can be allowed unescorted access
authorization. Note that the Increased Control Fingerprinting Orders
referred to a trustworthiness and reliability official (or T&R
official) as the individual who made determinations on a subject
individual's trustworthiness and reliability. Unlike the reviewing
official, the T&R official did not have to be fingerprinted. Under this
rule, fingerprints of the reviewing official(s) need to be taken by
either a law enforcement agency, a Federal or State agency that
provides fingerprinting services to the public, or a commercial
fingerprinting service authorized by a State to take fingerprints and
then be submitted to the NRC. This ensures the identification of the
individual submitting the fingerprints. Without this requirement the
reviewing official could
[[Page 16929]]
submit the fingerprints of another individual that is known not to have
a criminal history or known terrorist ties. Reviewing officials must be
permitted either access to safeguards information or unescorted access
to category 1 or category 2 quantities of radioactive material because
section 149 of the AEA only authorizes the collection of fingerprints
for the purposes of unescorted access to radioactive material or access
to safeguards information. After the licensee has completed the
background investigation for the reviewing official and determined that
the individual is trustworthy and reliable, the licensee must provide
under oath and affirmation, a certification that the reviewing official
is deemed trustworthy and reliable. For certain licensees, the NRC may
have approved reviewing officials, either under the October 17, 2006,
orders (EA-06-248, EA-06-250, and EA-06-249), under the August 21,
2006, SGI-M Orders, or under other regulatory requirements. In those
cases, the reviewing official may continue to act in that capacity. If
the reviewing (or T&R) official has not had an FBI criminal records
history check, he or she needs to be fingerprinted and undergo a
background investigation and be named by the licensee before making
additional trustworthiness and reliability determinations. If the
individual falls under one of the categories of individuals granted
relief from the background investigation, the individual can be
determined to be trustworthy and reliable without going through a full
background investigation. The NRC believes that it is important that
the individual who is making the final determination on whether an
individual is trustworthy and reliable be trustworthy and reliable
themselves and have undergone the same background investigation as
individuals who would be granted unescorted access, including
fingerprinting and the FBI criminal records check. If the reviewing
official is not fingerprinted, a gap could be created in the security
program that could potentially be exploited. The reviewing official
could have a criminal history or terrorist ties and allow other
individuals with a criminal history or terrorist ties to have
unescorted access to radioactive material in quantities of concern.
This addresses the good faith presumption.
6. What is informed consent?
Informed consent is the authorization provided by an individual
that allows a background investigation to be conducted to determine
whether the individual is trustworthy and reliable. The signed consent
includes authorization to share personal information with other
individuals or organizations as necessary to complete the background
investigation. An individual can withdraw his or her consent at any
time. After the withdrawal, the licensee may not initiate any elements
of the background investigation that were not in process at the time of
the withdrawal of consent. The licensee is required to inform the
individual that withdrawal of consent for the background investigation
is sufficient cause for denial or termination of unescorted access
authorization.
Licensees do not need to obtain signed consent from individuals
that have already undergone a background investigation that included
fingerprinting and an FBI criminal history records check, been
determined to be trustworthy and reliable, and permitted unescorted
access to category 1 or category 2 quantities of radioactive material
under the NRC orders or the legally binding requirements issued by the
Agreement States. A signed consent is needed for any reinvestigation.
7. What is a personal history disclosure?
The personal history disclosure is the personal history required to
be provided by the individual seeking unescorted access to category 1
or category 2 quantities of radioactive material. The information
includes items such as employment history, education, and any arrest
record. This information provides the reviewing official with a
starting point for the background investigation. Failure to provide the
information or falsification of any information could be grounds for
denial of the individual's request for unescorted access authorization
or termination of access if the individual already has access. If the
individual provides false information, it could be an indication that
he or she is not trustworthy or reliable.
8. What are the components of a background investigation?
A background investigation includes several components:
Fingerprinting and an FBI identification and criminal history records
check; verification of true identity; employment history verification;
verification of education; and character and reputation determination.
It is the licensee's responsibility to make a trustworthiness and
reliability determination of an employee, contractor, or other
individual who will be granted unescorted access to category 1 or
category 2 quantities of radioactive material or a device containing
such radioactive material. It is expected that licensees will use their
best efforts to obtain the information required to conduct a background
investigation to determine an individual's trustworthiness and
reliability. Information previously obtained during the hiring process
may be used to support a licensee's determination of an individual's
trustworthiness and reliability without having to reverify that
information. There is no particular piece of information that would
automatically disqualify an individual from access. The intent is that
the information is considered as a whole in determining if an
individual is both trustworthy and reliable.
Fingerprinting an individual for an FBI criminal history records
check is an important element of the background investigation. It can
provide comprehensive information regarding an individual's recorded
criminal activities within the United States and its territories and
the individual's known affiliations with violent gangs or terrorist
organizations.
Verification of true identity is necessary to make sure that the
individual is who he or she claims to be and that the documentation
matches. This check is important to make sure that someone is not
posing as someone else.
Employment history, education verification, character and
reputation determination; and obtaining independent information are
necessary to ensure that the individual is who they claim to be, that
the individual has not made false claims, has a good reputation, and
conducts his or herself in a trustworthy and reliable manner.
The background investigation is a tool to determine whether
individuals are trustworthy and reliable and could be permitted
unescorted access to category 1 or category 2 quantities of radioactive
material. It is essential to ensure that individuals seeking unescorted
access to radioactive material are dependable in judgment, character,
and performance, such that unescorted access to category 1 or category
2 quantities of radioactive material by that individual does not
constitute an unreasonable risk to the public health and safety or
common defense and security.
Nothing in the regulations prevents a licensee from including other
elements in its background investigation. Although the NRC did not
include the credit history check as a required element of the
background investigation, a credit history check can provide
supplemental information that could be useful to licensees,
particularly in the situation where it is difficult to
[[Page 16930]]
make a trustworthiness and reliability determination. Information from
a credit history check could provide additional information that would
be useful in making that final decision. To the extent that a licensee
decides to use a credit history check as a measure beyond the
regulatory minimum required for the access authorization program, the
NRC acknowledges the merit of such use.
9. Where does a licensee submit the fingerprints for processing?
Under the EPAct, licensees are required to submit the fingerprints
to the NRC, which forwards the fingerprints to the FBI for processing.
If an individual comes under one of the categories for relief specified
in 10 CFR 37.29, the licensee does not need to submit the individual's
fingerprints to the NRC.
10. What should a licensee do if an individual or entity contacted as
part of a background investigation refuses to respond?
If a previous employer, educational institution, or any other
entity fails to provide information or indicates an inability or
unwillingness to provide information in a timely manner, the licensee
is required to document the refusal, unwillingness, or inability to
respond in the record of investigation. The licensee then needs to
attempt to obtain confirmation from at least one alternate source that
has not been previously used.
11. Does an individual have the right to correct his or her criminal
history records?
Yes, an individual has the right to correct his or her criminal
history records before any final adverse determination is made. If the
individual believes that his or her criminal history records are
incorrect or incomplete in any respect, he or she can initiate
challenge procedures. These procedures include direct application by
the individual challenging the criminal history records to the law
enforcement agency that contributed the questioned information. Before
an adverse determination on a request for unescorted access,
individuals have the right to provide additional information.
12. Is a licensee required to have procedures for implementing the
access authorization program?
Yes, licensees are required to develop, implement, and maintain
written procedures for implementing the access authorization program.
At a minimum, procedures need to address notification of individuals
denied unescorted access authorization, including provisions for review
of the denial.
13. What information should the reviewing official use to determine
that an individual is trustworthy and reliable?
The reviewing official uses all of the information gathered during
the background investigation, including the information received from
the FBI, in making a determination that an individual is trustworthy
and reliable. The reviewing official may not determine that an
individual is trustworthy and reliable and grant unescorted access
until the information obtained for the background investigation has
been evaluated. The reviewing official may deny unescorted access to
any individual based on any information obtained at any time during the
background investigation. However, as required by section 149.c(2)(c)
of the AEA, the licensee may not base a final determination to deny an
individual unescorted access to category 1 or category 2 quantities of
radioactive material solely on the basis of information received from
the FBI involving: (1) An arrest more than 1 year old for which there
is no information of the disposition of the case; or (2) an arrest that
resulted in dismissal of the charge or an acquittal. If there is no
record on the disposition of the case, it may be that information on a
dismissal or acquittal was not recorded.
14. How frequently is a reinvestigation required?
A reinvestigation is required every 10 years to help maintain the
integrity of the access authorization program. This is necessary
because an individual's situation may change over time in a manner that
can adversely affect his or her trustworthiness and reliability. The
reinvestigation includes only the fingerprinting and the FBI criminal
history check.
15. Are licensees required to protect information obtained during a
background investigation?
Yes, licensees are required to protect the information obtained
during a background investigation. The licensee is required to
establish and maintain a system of files and procedures for protection
of the information from unauthorized disclosure. Licensees are only
permitted to disclose the information to the subject individual, the
individual's representative, those who have a need-to-know the
information to perform their assigned duties to grant or deny
unescorted access to category 1 or category 2 quantities of material or
safeguards information, or an authorized representative of the NRC.
16. Can a licensee transfer personal information obtained during an
investigation to another licensee?
Yes, a licensee can transfer background information on an
individual to another licensee if the individual makes a written
request to the licensee to transfer the information contained in his or
her file.
17. If I receive background investigation information from another
licensee, can I rely on that information?
Yes, a licensee can rely on the background investigation
information that is transferred from another licensee. However, a
licensee is required to verify information such as name, date of birth,
social security number, gender, and other physical characteristics to
ensure that the individual is the person whose file has been
transferred. The licensee can also choose to verify other information
that is transferred or to escort the individual and not grant him or
her unescorted access.
18. What records are required to be maintained?
Licensees are required to retain all fingerprint and criminal
history records received from the FBI, or a copy if the individual's
file has been transferred, for 3 years after the individual no longer
requires unescorted access to category 1 or category 2 quantities of
radioactive material. Licensees are also required to retain the written
confirmation received from entities concerning a security clearance or
favorably adjudicated criminal history records check and any written
verifications received from service providers. A licensee is not
required to retain the actual fingerprints. The licensee must keep the
determination basis and the list of individuals permitted unescorted
access.
19. How does a licensee determine the effectiveness of the access
authorization control program?
Licensees are required to review their program annually to confirm
compliance with the requirements. The review evaluates all program
performance objectives and requirements, documents any findings and
corrective actions, and is conducted annually. Any records need to be
maintained for 3 years.
[[Page 16931]]
20. Are individuals transporting radioactive material subject to the
background investigation requirements?
As part of this rulemaking, the NRC considered what level of
responsibility to place on its licensees regarding fingerprinting and
criminal history records checks for persons involved in the
transportation of category 1 and category 2 quantities of radioactive
material. Licensees covered by the fingerprinting and criminal history
records check requirements of this final rule may decide to transfer
radioactive material away from the site or may receive radioactive
material from another entity.
Such transfers or receipts may occur either as part of a shipment
to or from a domestic company or an international company. Individuals
involved in the shipment, in particular those employed by carriers or
other organizations handling shipments, may have unescorted access to
the material during the shipment process. These persons may not be
employees of the licensee and thus may not be under the licensee's
direct control. Section 37.29(a) grants relief from the background
investigation for those individuals who are commercial vehicle drivers
for road shipments of category 2 quantities of radioactive material and
package handlers at transportation facilities such as freight terminals
and railroad yards. Individuals that have access to SGI-M, such as
drivers for category 1 shipments and movement control personnel for
category 1 shipments, must undergo fingerprinting and an FBI criminal
history records check as required by 10 CFR 73.21.
21. Who would be relieved from the background investigation
requirements?
Under section 149.b. of the AEA, the NRC may, by rule, relieve
individuals from the fingerprinting, identification, and criminal
history records check requirements if it finds that such action is
``consistent with its obligations to promote the common defense and
security and to protect the health and safety of the public.'' The NRC
issued a final rule, 10 CFR 73.61, relieving certain individuals who
are permitted unescorted access to radioactive materials from the
fingerprinting, identification, and criminal history records checks
required by section 149.a. of the AEA (72 FR 4945; February 2, 2007).
The individuals relieved from fingerprinting, identification, and
criminal history records checks under that rule include Federal, State,
and local officials involved in security planning; Agreement State
employees who conduct security inspections on behalf of the NRC
pursuant to 274.i. of the AEA; and other government officials who may
need unescorted access to radioactive materials or other property
subject to regulation by the Commission as part of their oversight
function. The categories of individuals relieved by the rule included
the same individuals as those relieved in an earlier rulemaking from
fingerprinting and criminal history records check requirements
applicable to safeguards information (71 FR 33989; June 13, 2006).
Under this final rule, the Commission is using the same listing of
categories of individuals with the following modifications. Emergency
response personnel who are responding to an emergency are relieved from
the requirements because it is impossible to predict when emergency
access might be necessary. The need to provide an escort for those
responding to an emergency could impede the response function.
Employees of carriers that transport category 2 quantities of
radioactive material and package handlers at transportation facilities
are also relieved. These individuals would typically be outside the
control of the licensee and the licensee would have no way of knowing
or influencing who those individuals might be. The NRC will rely on the
U.S. Department of Transportation (DOT) and the Transportation Security
Administration (TSA) programs for background investigations of these
personnel. While the background investigation may not be identical to
those required under 10 CFR part 37, the NRC believes that the
potential risk that a commercial driver or package handler might pose
due to any difference in the background investigation is acceptably
small.
Many of the individuals that are relieved from the background
investigation requirements are considered trustworthy and reliable by
virtue of their occupational status and have either already undergone a
background investigation as a condition of their employment, or are
subject to direct oversight by government authorities in their day-to-
day job functions.
Certain persons, as part of the duties of their specific
occupation, may be separately or previously subject to background
investigations, either as a result of NRC requirements (such as under
other requirements for access to SGI or SGI-M) or as a result of
requirements of other agencies. These persons are not subject to
separate background investigation requirements under this final rule;
individuals who have undergone a background investigation, including
fingerprinting, and been found acceptable for unescorted access under
provisions of other such requirements, do not need to undergo another
background investigation nor would a separate determination of their
trustworthiness and reliability need to be made. Individuals that have
undergone fingerprinting and an FBI criminal history records check
under other agency programs do not need to be fingerprinted again, but
would be subject to the other elements of the background investigation.
These programs include the National Agency Check, Transportation Worker
Identification Credentials (TWIC) under 49 CFR 1572, Bureau of Alcohol,
Tobacco, Firearms, and Explosives background check and clearances under
27 CFR 555, Health and Human Services security risk assessments for
possession and use of select agents and toxins under 42 CFR 73,
Hazardous Material security threat assessment for hazardous material
endorsement to commercial drivers license under 49 CFR 1572, and
Customs and Border Patrol's Free and Secure Trade (FAST) Program. The
individual must make available the appropriate documentation. Written
confirmation from the agency/employer that granted the Federal security
clearance or reviewed the criminal history records check must be
provided to the licensee.
This rule does not authorize unescorted access to any radioactive
materials or other property subject to regulation by the Commission.
Rather, the rule makes clear that a licensee may permit unescorted
access to certain categories of individuals otherwise qualified for
access without performing a background investigation. Licensees still
need to decide whether to grant or deny an individual unescorted access
independently of this provision. Any required training needs to be
conducted before allowing unescorted access.
C. Physical Protection During Use
1. Who is affected by the requirements?
Any licensee that possesses an aggregated category 1 or category 2
quantity of radioactive material is required to establish, implement,
and maintain a security program meeting the requirements of 10 CFR part
37 of subpart C. (The NRC considers material to be ``aggregated'' if an
adversary could gain access to a category 2 or greater quantity by
breaching a single physical barrier.) In addition, any applicant for a
license or license amendment to possess category 1 or category 2
quantities of radioactive material at a facility is
[[Page 16932]]
required to establish a security program before obtaining the
radioactive material, if it will be aggregating the material at or
above the category 2 threshold.
2. What is the objective of the security program and what are the key
security program requirements?
The final rule requires affected licensees to establish, implement,
and maintain a security program. The objective of the security program
is to monitor, and without delay detect, assess, and respond to any
actual or attempted unauthorized access to category 1 or category 2
quantities of radioactive materials. A licensee's security program
needs to include a written security plan, implementing procedures,
training, use of security zones, protection of information,
coordination with the LLEA, testing and maintenance of security-related
equipment, security measures, and a program review. Each of these areas
is discussed in more detail in the following questions and answers.
3. What should a licensee's security plan address?
The purpose of a security plan is to establish, in writing, the
licensee's overall security strategy to ensure that all of the required
security measures work effectively and in an integrated way for all
facilities and operations where aggregated quantities of category 1 or
category 2 quantities of radioactive material will be used or stored.
The plan should, among other things, include a description of the
measures and strategies to implement the security requirements and
identify the security resources being used to meet the requirements.
A licensee can revise its security plan to address changing
circumstances. Any changes to the security plan, as well as the
original plan, must be approved by the individual with overall
responsibility for the security program. The security plan must be
retained for 3 years after it is no longer needed. The licensee must
retain any superseded portions of the security plan for 3 years.
Security plans are important for the implementation of a
performance-based regulation. An adequate plan requires a licensee to
analyze the particular security needs of its individual facilities and
to explain how it will implement its chosen security measures to ensure
that they work together to meet the applicable performance objectives.
4. Is a licensee required to have security procedures?
Yes, licensees are required to develop and maintain written
implementing procedures that document how the security requirements and
the security plan will be met. These procedures must be designed to
meet the individualized security needs of each location where an
aggregated category 1 or category 2 quantity of radioactive material is
used or stored. Procedures need to be approved, in writing, by the
individual with overall responsibility for the security program.
Licensees are required to keep a copy of the current procedures as a
record for 3 years. Superseded portions of the procedures are retained
for 3 years. Licensees should not submit procedures to the NRC as part
of the license application.
5. What training is required?
As part of its physical protection program, each licensee is
required to conduct training on the security plan to ensure that those
individuals responsible for implementation of the plan possess and
maintain the knowledge, skills, and abilities to carry out their
assigned duties and responsibilities effectively. The extent of the
training needs to be commensurate with the individual's potential
involvement in the security of category 1 or category 2 quantities of
radioactive material. Individuals need to be instructed in the
licensee's security program and implementing procedures, their
responsibilities, and the appropriate response to alarms. Licensees
with dedicated security staff are encouraged to train their security
personnel in the timely notification of affected LLEAs during
emergencies.
An individual subject to the training requirements of 10 CFR
37.43(c) needs to complete the training before being allowed unescorted
access to category 1 or category 2 quantities of radioactive material.
The licensee needs to provide refresher training annually or when
significant changes have been made to the security program. The
refresher training addresses any significant changes; reports on
relevant security issues, problems, or lessons learned; relevant
results from NRC inspections; and relevant results from the licensee's
program review and the testing and maintenance program. Training
records must be maintained for 3 years and need to include training
topics, training dates, and the list of personnel that attended the
training.
Training is essential if the licensee is to be adequately prepared
for an effective and coordinated response to any effort to steal or
divert category 1 or category 2 quantities of radioactive material.
Adequate training is indispensable for an appropriate licensee response
to an unauthorized intrusion.
6. Are licensees required to protect information concerning their
security program?
Yes. To prevent unauthorized disclosure, licensees are required to
limit access to their security plans, implementing procedures, and the
list of individuals that have unescorted access to the material. These
efforts include measures to allow access to these documents only to
those individuals who have a need to know the information to perform
their duties and have been determined to be trustworthy and reliable
based on the background investigation requirements set forth in 10 CFR
37.25(a)(2) through (a)(7). Licensees are required to store security
information in a manner to prevent unauthorized removal, such as
storage in a locked office or desk drawer.
To ensure that only trustworthy and reliable individuals with a
need to know are allowed access to security plans and procedures,
licensees need to develop, implement, and maintain written policies and
procedures to control access to their security plan and security
procedures. The licensee's information protection policies and
procedures need to ensure the proper handling and protection of
security plans and implementing procedures against unauthorized
disclosure. Licensees are required to retain copies of the policies and
procedures.
Licensees that have SGI or SGI-M would remain subject to the more
stringent information protection requirements of 10 CFR 73.21,
including fingerprinting and an FBI criminal records check.
7. What is the purpose of a security zone?
A security zone is any area established by a licensee to provide
physical protection for category 1 or category 2 quantities of
radioactive material. All category 1 and category 2 quantities of
radioactive material need to be used and stored within a security zone.
The purpose of security zones is to isolate and control access to
the material to protect it more effectively and deter theft or
diversion by providing, among other things, more time for licensees and
LLEAs to respond. Isolation measures protect category 1 or category 2
quantities of radioactive material by
[[Page 16933]]
allowing access to security zones only through established access
control points. Access control measures allow only approved individuals
to have unescorted access to the security zone, and ensure that other
individuals with a need for access are escorted by approved
individuals. A security zone effectively defines where the licensee
will apply these isolation and access control measures.
To limit unescorted access to only approved individuals, licensees
could isolate the radioactive materials using continuous physical
barriers that allow access to the security zone only through
established access control points; or licensees could exercise direct
control of the security zone by approved individuals at all times.
Security zones may be permanent or temporary. Temporary security
zones need to be established to meet transitory or intermittent
operating requirements such as periods of maintenance, source delivery,
and source replacement. A licensee could meet the requirements for a
security zone at some temporary job sites (such as those involving
onsite operations lasting less than a day) simply by keeping the area
under ``direct supervision'' by authorized personnel. Similarly, when
work is being done inside a temporary zone, a licensee could meet the
requirements for controlling unescorted access by having the material,
persons, and area within the zone under direct control of approved
individuals at all times.
Because the purpose of security zones is different from the
radiation safety purposes of the restricted areas and controlled areas
defined in 10 CFR part 20, the security zone does not have to be the
same as either of these areas. Because measures to control access are
required for both radiation protection and security, however, a
licensee does have the flexibility to use an area required for
radiation protection purposes to fulfill the required functions of a
security zone. Thus, for a temporary well-logging operation within
which the licensee is required by 10 CFR 39.71 to have a ``restricted
area'' to ``maintain direct surveillance * * * to prevent unauthorized
entry into a restricted area,'' a licensee could define a security zone
with the same boundaries as this ``restricted area.'' Similarly, a
radiographer could choose to define a security zone with the same
boundaries as the ``high radiation area'' over which radiography
licensees are required by 10 CFR 34.51 to ``maintain direct visual
surveillance * * * to protect against unauthorized entry.''
Because materials licensee sites are differently configured and do
not lend themselves to generically defined physical areas, the security
zone concept permits significant flexibility for licensees to account
for a range of site-specific concerns. It also provides regulators with
a well-defined and enforceable requirement keyed to performance
objectives of isolation and access control.
8. When are special additional measures for category 1 quantities of
radioactive material required?
One provision of the final rule applies to category 1 quantities of
radioactive material during periods of maintenance, source receipt,
preparation for shipment, installation, or source removal or exchange.
Licensees are required to provide, at a minimum, an approved individual
to maintain continuous surveillance of sources in temporary security
zones and in any security zone in which physical barriers or intrusion
detection systems have been disabled to allow the specified activities.
Due to the natural decay of their radioactivity, sources lose their
effectiveness as they get older and have to be replaced or replenished
periodically with new sources to maintain a device's expected
performance. Tamper-indicating devices and other intrusion detection
equipment typically must be disabled to permit the device to be opened
without tripping alarms. The new sources are typically shipped by an
offsite supplier, who also often performs removal and exchange or
reinstallation. After replacement, the removed older sources must be
prepared onsite for shipment back to the manufacturer or for storage
and eventual disposal. These non-routine operations by non-licensee
employees at the licensee's site, during a time when devices for
detecting theft or diversion are disabled, call for additional measures
to compensate for the temporary increase in vulnerability.
9. What is required to monitor and detect an unauthorized entry into a
security zone?
A licensee is required to establish and maintain the capability to
continuously monitor and detect all unauthorized entries into its
security zone(s). Monitoring and detection are performed by either a
monitored intrusion detection system that is linked to an onsite or
offsite central monitoring facility; electronic devices for intrusion
detection alarms that would alert nearby facility personnel; monitoring
by a video surveillance system; or direct visual surveillance by
individuals.
A licensee also needs the capability to detect unauthorized removal
of the radioactive material. For category 1 quantities of radioactive
material, a licensee needs to immediately detect any attempted
unauthorized removal through the use of electronic sensors linked to an
alarm or continuous visual surveillance. For category 2 quantities of
radioactive material, a licensee needs to verify the presence of the
radioactive material through weekly physical checks, tamper indicating
devices, actual usage of the material, or other means.
10. What are the requirements for personnel communications and data
transmission?
Licensees are required to maintain continuous capability for
personnel communication and electronic data transmission and processing
among site security systems for any personnel and automated or
electronic systems used to support the site security systems. Licensees
are required to have alternative capability for any system in the event
of loss of the primary means of communication or data transmission and
processing. The alternative means cannot be subject to the same failure
mode as the primary systems.
11. What does a licensee need to do when it detects an intrusion into
its security zone?
A licensee's response to an intrusion depends on the licensee's
assessment of the purpose of the intrusion, but a response is required
without delay. If the unauthorized access appeared to the licensee to
be an actual or attempted theft, sabotage, or diversion of category 1
or category 2 quantities of radioactive material, the licensee needs to
immediately notify and request an armed response from the appropriate
LLEA. An immediate response by the licensee permits a more timely
response from law enforcement, thereby, reducing the risk that the
material could be used for malevolent purposes. Immediate notification
also allows for early warning to other possible targets of a
simultaneous attempt to divert material from multiple locations.
A licensee's decision to call the LLEA and the NRC depends not only
on the licensee's assessment of the intent of the unauthorized access
but also on whether the area where the breach occurred is an area the
licensee had previously determined needed to be monitored in order to
meet the NRC's physical protection requirements. Thus, a licensee's
assessment and response to an intrusion alarm in the business office
section of its facility could be entirely
[[Page 16934]]
different from its assessment and response to an intrusion alarm in a
radioactive materials storage area.
12. Can a licensee use automated devices to assess an intrusion and
alert an LLEA?
Depending on the security system, the layout of controlled areas,
and the design capabilities of the sensors, automated devices or
systems may be programmed to automatically summon LLEA assistance in
response to an intrusion alarm.
13. What coordination is required with LLEA?
Licensees are required to coordinate, to the extent practicable,
with the LLEA to discuss the LLEA response to threats to the licensee's
use of Category 1 or 2 quantities of radioactive material. An LLEA is
defined as a public or private organization that has been approved by a
Federal, State, or local government to carry firearms and make arrests,
and is authorized and has the capability to provide an armed response
in the jurisdiction where the licensed category 1 or category 2
quantity of radioactive material is used, stored, or transported. In
the event of an actual or attempted theft, sabotage, or diversion of
radioactive material, an armed response is likely to be necessary.
Adversaries could be well armed, and the small unarmed or lightly-armed
private security guard service typically used at byproduct material
licensee sites would not be an adequate substitute for an LLEA.
However, the LLEA need not be a municipal or county police force. If a
hospital or university campus police force is the nearest law
enforcement agency to the licensee's operation capable of providing an
armed response and making arrests, that police force would meet the
definition of an LLEA.
Coordination activities include providing a description of the
facility, radioactive materials, and security measures and notification
that the licensee will request a timely and armed response to any
actual or attempted theft, sabotage, or diversion of the licensee's
radioactive materials. The licensee is required to document its
coordination efforts. The documentation could include such items as the
dates, times, and locations of meetings or phone calls and a list of
licensee and LLEA staff present at the meetings. Licensees are required
to coordinate with the LLEA at least every 12 months.
Coordination with an LLEA is essential in developing an effective
and efficient physical protection program. Because certain situations
may necessitate an armed response, a strategy that is consistent in
scope and timing with realistic potential vulnerabilities of the
subject radioactive material should be coordinated well in advance with
the LLEA. Another purpose of coordination is to provide the responsible
LLEA with an understanding of the potential consequences associated
with unauthorized use of the radioactive material of concern, so that
the LLEA can determine the appropriate priority of its response. The
LLEA response is needed not only to interdict and disrupt an attempted
theft or sabotage onsite, but also possibly for offsite coordination to
protect public health and safety and to mitigate the potential
consequences of unauthorized use of the radioactive material.
14. What if the LLEA declines to coordinate with a licensee?
The NRC recognizes that it cannot exercise authority over LLEAs, or
any party over which a licensee has no control and the NRC has no legal
jurisdiction. The NRC also recognizes that an LLEA may have good
reasons for not engaging in coordination activities.
An LLEA's refusal to coordinate with a licensee does not by itself
render a licensee's security plan inadequate. The NRC recognizes that
in an actual emergency, State and local government officials will
respond to protect the health and safety of the public. A licensee is
required under 10 CFR 37.45(a)(2) to notify the appropriate NRC
regional office within 3 business days if the LLEA has not responded to
a request for coordination within 60 days of the coordination request,
or if the LLEA notifies the licensee that the LLEA does not plan to
participate in coordination activities. The notification allows the NRC
to contact the LLEA directly to ensure that the LLEA understands the
importance of adequate coordination. In some cases, the NRC might
contact the Department of Homeland Security (DHS) and request DHS
assistance with the LLEA. If the LLEA refuses to coordinate beforehand,
the licensee could still comply by making and documenting periodic
good-faith efforts to elicit the LLEA's participation in planning for a
timely and effective response.
15. What are the LLEA notification requirements for work at a temporary
job site?
The final rule does not require any notification of or coordination
with the LLEA for work at temporary jobsites.
16. What are the special requirements for mobile sources?
The rule requires licensees using mobile devices containing a
category 1 or category 2 quantity of radioactive material to have two
independent physical controls that form tangible barriers to prevent
unauthorized removal of the device. For devices in or on a vehicle or
trailer, a licensee is required to use a method to disable the vehicle
or trailer when it is not under direct control and constant
surveillance by the licensee. Licensees are not allowed to rely on the
removal of an ignition key to meet this requirement. The rule does
allow for the situation where a site's health and safety procedures
prohibit the disabling of the ignition. In those instances, the
licensee would not be required to disable the ignition. These
provisions are in addition to the other requirements in subpart C.
Mobile devices, particularly portable ones, are likely to be more
vulnerable to attempted theft or diversion because an adversary could
more easily remove these devices before the licensee or LLEA has an
opportunity to respond. The objective of this requirement is to delay
intruders long enough for a timely licensee and LLEA response.
A mobile device is defined in the rule as a piece of equipment
containing licensed radioactive material that is either: (1) Mounted on
wheels or casters or otherwise equipped for moving without a need for
disassembly or dismounting, or (2) designed to be hand carried. Mobile
devices do not include stationary equipment installed in a fixed
location, such as an irradiator, but the definition includes
radiography cameras, source changers, well logging equipment, and
gauges or controllers. The definition could also include storage
containers, lead pigs for holding sources during a source exchange, and
onsite or offsite transportation packages, if they contained category 1
or category 2 quantities of radioactive material.
17. What maintenance and testing requirements apply to the security
systems?
Consistent with 10 CFR 37.51, licensees are required to test
intrusion alarms, physical barriers, and other systems used for
securing and monitoring access to radioactive material, and these items
need to be maintained in operable condition. Each intrusion alarm and
associated communication system subject to the rule's requirements for
monitoring, detection, and assessment needs to be inspected and tested
for performance.
[[Page 16935]]
The licensee only needs to test the equipment that it relies on to meet
the requirements of 10 CFR part 37. This would include any backup
equipment or systems relied upon in the event of a primary system
failure. If the licensee has additional equipment or systems that are
not relied on to meet the rule requirements, the extra equipment and
systems would not need to be tested and maintained.
The frequency for testing is based on the manufacturer's suggested
timing. If the manufacturer does not suggest a frequency, the licensee
must conduct the maintenance and testing at least annually. Licensees
are required to maintain records of the maintenance and testing
activities for 3 years.
18. What events does a licensee need to report to the NRC?
A licensee is required to report any actual or attempted theft,
sabotage, or diversion of a category 1 or category 2 quantity of
radioactive material as soon as possible after initiating a response,
which includes notification of the LLEA. The licensee is required to
submit a written report to the NRC within 30 days after the initial
notification. A licensee is also required to assess any suspicious
activity related to possible theft, sabotage, or diversion of category
1 or category 2 quantities of radioactive material and notify the LLEA
as appropriate. If the licensee notifies the LLEA, it must also notify
the NRC. The written 30-day report is not required for suspicious
activity reports.
19. How does a licensee determine the effectiveness of the security
program?
Licensees are required to review the security program annually to
confirm compliance with the requirements. The review is to evaluate the
security program content and implementation. The licensee is required
to document any review findings and corrective actions, and the records
need to be maintained for 3 years.
D. Transportation Security
1. What is the NRC authority to issue these transportation security
requirements?
Sections 53, 81, and 161 of the AEA, as amended, provide the NRC
with the statutory authority to issue these transportation security
requirements. The NRC shares jurisdiction over the transport of
radioactive material traveling over public roadways and by rail with
DOT and DHS.
2. Why is this material being shipped?
In general, category 1 and category 2 quantities of radioactive
material are shipped to medical institutions, companies that support
medical and academic institutions, and companies that manufacture and
distribute radioactive material for various industrial applications. As
radioactive sources get older, radioactive decay decreases the sources'
strength and the sources lose their effectiveness and have to be
replaced or replenished with new sources. The older sources must be
transported for disposal or back to the manufacturer.
3. What are the new transportation security requirements?
In general, the final rule includes requirements for pretransfer
checks, preplanning and coordination of shipments, advance notification
of shipments, control, monitoring, and communications during shipments,
procedures, investigations of missing shipments, and reporting of
missing material. Each of these areas is discussed in more detail in
the following questions and answers.
These requirements apply to ground transport of category 1 or
category 2 quantities of radioactive material shipped in a single
package or in multiple packages in a single conveyance. The category 1
requirements also apply to shipments of irradiated reactor fuel
weighing 100 g (0.22 lb) or less in net weight of irradiated fuel,
exclusive of cladding or other structural or packaging material, which
has a total external radiation does rate in excess of 1 Gray (100 rad)
per hour at a distance of 1 m (3.3 ft) from any accessible surface
without intervening shielding. Note that a licensee is not responsible
for complying with these requirements when a carrier aggregates
radioactive material, during transport or storage incidental to
transport, for two or more conveyances from separate licensees that
individually do not exceed the limits. The shipping licensee is
responsible for meeting the requirements unless the receiving licensee
agrees in writing to arrange for the in-transit physical protection,
including preplanning and coordination activities.
4. Is verification of the transferee's license necessary?
Yes, 10 CFR 37.71 requires any licensee transferring category 1 or
category 2 quantities of radioactive material to a licensee of the NRC
or an Agreement State to verify that the transferee's license
authorizes the receipt of the type, form, and quantity of radioactive
material to be transferred. Licensees that transfer material within the
same organization do not need to verify the validity of the license
(i.e., for companies that have licenses in several States). The
licensee should know if its licenses are valid. For transfers of
category 1 quantities of radioactive material, the transferring
licensee is also required to verify that the licensee is authorized to
receive radioactive material at the address requested for delivery.
These verifications are conducted with the license issuing authority,
i.e., the NRC or the appropriate Agreement State, or by using the
license verification system. The license verification system is a new
web-based system that NRC is developing that may be used to verify the
validity of a license issued by either NRC or an Agreement State. The
license verification system is currently scheduled to be operational by
the effective date of the final rule. If it appears that the system
will not be available in time to support the rule, the NRC will change
the compliance date of this provision. Licensees should contact the
appropriate NRC regional office to verify the validity of NRC
licensees. Information on Agreement State contacts is provided on the
NRC's Web page at https://nrc-stp.ornl.gov/asdirectory.html. If the
license verification system is non-functional and the licensee cannot
reach the license issuing authority, the rule does have a provision
that allows the licensee to obtain certification from the requesting
licensee. Licensees are required to document any method of
verification, except for use of the license verification system.
Licensees exporting material need to meet the requirements in 10 CFR
part 110 for checking the documentation that the recipient has the
necessary authorization under the laws and regulations of the importing
country. These actions are intended to mitigate the risk that the
material could be shipped to an unauthorized recipient.
5. Is preplanning and coordination of the shipments necessary?
Yes, 10 CFR 37.75(a) requires preplanning and coordination of
shipment information for shipments of category 1 quantities of
radioactive material. The shipping licensee (licensee sending the
licensed material) is required to coordinate the departure and arrival
times with the receiving licensee (licensee receiving the licensed
material). This coordination reduces the risk that theft or diversion
of the material would go unnoticed or unreported. The licensee also
needs to preplan and coordinate the shipment information with the
State(s) through
[[Page 16936]]
which the shipment will pass. As part of the coordination activities,
the licensee is required to discuss the State's intention to provide
law enforcement escorts for the shipments and identify safe havens.
Under the rule, safe havens are sites at which security is present or
from which the transport crew can notify and wait for the local law
enforcement authorities in the event of an emergency. The licensee is
responsible for identification of the safe havens. The purpose of the
information sharing is to ensure minimal delay of the shipment.
For shipments of category 2 quantities of radioactive material, 10
CFR 37.75(b) requires that the shipping licensee verify the shipment
no-later-than arrival time and the expected arrival time with the
receiving licensee.
The definitions section of the final rule defines the term ``no-
later-than arrival time'' as the date and time that the shipping
licensee and receiving licensee have established as the time at which
an investigation will be initiated if the shipment has not arrived at
the receiving facility. The no-later-than-arrival time may not be more
than 6 hours after the estimated arrival time for category 2 shipments.
Verifying that the shipment arrives on time provides the licensee with
the means to identify and immediately report an unusual occurrence that
could lead to the theft or diversion of the material.
6. What does the NRC consider to be a safe haven?
A safe haven is a readily recognizable and readily accessible site
at which security is present or from which, in the event of an
emergency, the transport crew can notify and wait for the LLEA. The NRC
expects safe havens to be identified and designated by the licensee.
Licensees should use the following criteria in identifying safe
havens for shipments: Close proximity to the route, i.e., readily
available to the transport vehicle; security from local, State, or
Federal assets is present or is accessible for timely response; the
site is well lit, has adequate parking, and can be used for emergency
repair or to wait for LLEA response on a 24-hour a day basis; and
additional telephone facilities are available should the communications
system of the transport vehicle not function properly. Possible safe
haven sites include: Federal sites having significant security assets;
secure company terminals; State weigh stations; truck stops with secure
areas; and LLEA sites, including State police barracks.
7. Is the shipping licensee required to notify the receiving licensee
if the no-later-than arrival time changes?
Yes. If the no-later-than arrival time will not be met, the
shipping licensee must inform the receiving licensee of the new no-
later-than arrival time for shipments of category 2 quantities of
radioactive material. This provision allows licensees the ability to
modify departure and arrival times due to unforeseen events.
8. Whom does the licensee notify when the shipment arrives?
The receiving licensee is required to notify the shipping licensee
when the shipment of a category 2 quantity of radioactive material
arrives at its destination. This requirement ensures positive
communication between the shipper and recipient. Additionally, this
requirement ensures that the shipper does not unnecessarily start an
investigation because they are not sure that the shipment has arrived.
The receiving licensee must notify the shipping licensee if the
shipment has not arrived by the no-later-than arrival time. This
notification is the trigger to initiate an investigation into where the
package is located.
9. What does the term state mean in the requirements?
As used in the definitions section of the final rule, the term
``State'' means the 50 States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern Mariana Islands. A list of the
contact information for the governor's designees is published annually
in the Federal Register, most recently on October 31, 2011 (76 FR
67229). An updated list is posted on the NRC's Web site at https://nrc-stp.ornl.gov/special/designee.pdf. Copies may also be obtained by
contacting the Director, Division of Intergovernmental Liaison and
Rulemaking, Office of Federal and State Materials and Environmental
Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001. The NRC will work with the States to include a separate
column.
10. What advance notifications are required?
The final rule requires advance written notifications for shipments
containing category 1 quantities of radioactive material. The advance
notifications are made to the NRC (or Agreement State which then would
notify the NRC) and to any State through which a shipment is being
transported. The State notification is made to the governor or the
governor's designee. The NRC shares the information with some of its
Federal partners.
Advance notification provides States and the NRC with knowledge of
shipments so that in the event there is an increase in the risk of
theft or diversion of the material, the regulator could delay or
reroute the shipment to minimize the risk. This advance notification
also allows States with escort requirements to engage in planning to
support the shipment.
Advance notifications are not required for shipments of category 2
quantities of radioactive material, unless the shipment falls within
the scope of 10 CFR 71.97(b).
11. What information should be included in an advance notification?
The final rule requires that the following information be included
in an advance notification for a category 1 shipment of radioactive
material, if available at the time of notification: (1) The name,
address, and telephone number of the shipper, carrier, and receiver of
the shipment; (2) the license number of the shipper and receiver; (3) a
description of the radioactive material contained in the shipment,
including the radionuclides and quantity; (4) the point of origin of
the shipment and the estimated time and date that shipment will
commence; (5) the estimated time and date that the shipment is expected
to enter each State along the route; (6) the estimated time and date of
arrival of the shipment at the destination; and (7) the contact and
telephone number for the point of contact. For the purpose of
coordination only, the actual information in the advance notification
would not be considered to be SGI-M. Any information that is not
available at the time of the initial notification would be provided in
a revised notification once the information becomes available.
12. What should a licensee do if the shipment schedule is revised or
the shipment cancelled?
If the category 1 shipment schedule is revised or cancelled, the
final rule requires the shipping licensee to notify the appropriate
States and the NRC.
13. What should a licensee do if the shipment does not arrive by the
no-later-than arrival time?
The final rule requires a licensee that has shipped category 2
quantities of radioactive material to initiate an investigation for any
shipment that has not arrived at the receiving licensee's facility by
the designated no-later-than
[[Page 16937]]
arrival time. The no-later-than arrival time is defined as the date and
time that the shipping licensee and receiving licensee have established
as the time at which an investigation will be initiated if the shipment
has not arrived at the receiving facility. The no-later-than-arrival
time may not be longer than 6 hours after the estimated arrival time
for a shipment of category 2 quantities of radioactive material. A no-
later-than arrival time was not included for category 1 shipments as
the licensee is required to maintain continuous position monitoring and
detect any unauthorized access to or removal of the material
immediately. This would enable the shipping licensee of a category 1
shipment to know right away if the shipment was late or experiencing
problems.
14. When must a licensee make notification that a shipment is lost or
missing?
When a licensee determines that a shipment of a category 1 quantity
of radioactive material is lost or missing, the rule requires the
licensee to notify the LLEA in the area of the shipment's last
confirmed location within 1 hour and then to notify the NRC's
Operations Center. Notification to the NRC should be as prompt as
possible, but not at the expense of causing delay or interference with
the LLEA response to the event.
When a licensee determines that a shipment of category 2 quantities
of radioactive material is lost or missing, the rule requires the
licensee to notify the NRC's Operations Center within 4 hours of such
determination. The licensee is also required to immediately notify the
NRC's Operations Center if, after 24 hours from its determination that
the shipment was lost or missing, the location of the material still
cannot be determined.
Early notification provides for a more timely response from law
enforcement, thereby reducing the risk of the misuse of the material.
15. Should licensees make notification that a lost or missing shipment
has been found?
Yes, 10 CFR 37.81(e) and (f), for category 1 shipments and category
2 shipments, respectively, require the licensee to notify the NRC's
Operations Center when a lost or missing shipment has been located.
This notification is considered an update on the initial notification.
Without this notification, regulatory authorities and LLEA may
waste resources continuing any search for the material.
16. What is a licensee required to do if there is an attempt to steal
or divert a shipment?
For shipments of category 1 quantities of radioactive material, a
licensee who discovers an actual or attempted theft or diversion of a
shipment, or any suspicious activity related to a shipment, is required
to notify the designated LLEA along the shipment route as soon as
possible. After notifying the LLEA, the licensee is required to notify
the NRC's Operations Center. The NRC's Operations Center will notify
other affected States and the agency's Federal partners. For shipments
of category 2 quantities of radioactive material, a licensee who
discovers an actual or attempted theft or diversion of a shipment, or
any suspicious activity related to a shipment, is required to notify
the NRC's Operations Center as soon as possible. These security
measures enhance the likelihood that the material will be successfully
protected or recovered and allows for early warning of other possible
victims of a simultaneous attempt to divert material from multiple
locations.
17. What types of procedures are necessary for shipping category 1
quantities of radioactive material?
Licensees shipping category 1 quantities of radioactive material by
road are required to ensure that normal and contingency procedures are
developed to cover notifications; communication protocols; loss of
communication; and response to an actual or attempted theft or
diversion of a shipment, or any suspicious activity related to a
shipment. The licensees are required to ensure that drivers,
accompanying personnel, railroad personnel, and movement control center
personnel have access to the normal and contingency procedures.
Procedures provide reasonable assurance that these individuals are
prepared for most situations and are able to act without delay to
prevent the theft or diversion of shipments.
18. What should be included in the communication protocols?
The final rule requires that the communication protocols include a
strategy for the use of authentication and duress codes and provisions
for refueling or other stops, detours, and locations where
communication is expected to be temporarily lost.
19. What are the physical protection requirements for road shipments of
category 1 quantities of radioactive material?
The final rule requires that any licensee that ships category 1
quantities of radioactive material by road either establish or use a
carrier that has established, movement control centers that maintain
position information from a location remote from the activity of the
transport vehicle or trailer. The control centers are required to
monitor shipments on a continuous and active monitoring basis (24 hours
a day, 7 days a week), and have the ability to communicate immediately,
in an emergency, with the appropriate law enforcement agencies.
The final rule requires that the licensee ensure that redundant
communications are in place that would allow the transport to contact
an escort vehicle (if used) and the movement control center at all
times. The redundant communication must not be subject to the same
interference factors as the primary communication method. The same
interference factors mean any two systems that rely on the same
hardware or software to transmit their signal (e.g., cell tower or
proprietary network).
Redundant communications provide drivers with the means to
immediately report an unusual occurrence that could lead to the theft
or diversion of the material. Early notification would permit a more
timely response from law enforcement, thereby, reducing the risk of the
misuse of the material.
The final rule also requires that the licensee ensure that category
1 shipments are continuously and actively monitored by a telemetric
position monitoring system or an alternative tracking system reporting
to a movement control center. The movement control center is required
to provide positive confirmation of the location, status, and control
over the shipment and be prepared to implement preplanned procedures in
response to deviations from the authorized route or to a notification
of actual or attempted theft or diversion or suspicious activities
related to the theft, loss, or diversion of a shipment. These
procedures include the identification of, and contact information for,
the appropriate LLEA along the shipment route.
A telemetric position monitoring system is a data transfer system
that captures information by instrumentation and/or measuring devices
about the location and status of a transport vehicle or package between
the departure and
[[Page 16938]]
destination locations. The gathering of this information permits remote
monitoring and reporting of the location of a transport vehicle or
package. GPS and radiofrequency identification (RFID) are examples of
telemetric position monitoring systems.
If the driving time period is greater than the maximum number of
allowable hours of service in a 24-hour duty day as established by the
DOT Federal Motor Carrier Safety Administration, the final rule
requires that the licensee ensure that an accompanying individual is
provided for the entire shipment. The accompanying individual may be
another driver. This security measure provides reasonable assurance
that the material will be protected from theft or diversion when it is
stationary, as well as in emergency situations where it becomes
necessary for the driver to stop or leave the vehicle.
20. Is GPS required?
No, GPS is not required. For category 1 material, the NRC requires
continuous and active monitoring for shipments. Continuous and active
monitoring means that at any time while the shipment is enroute, the
licensee must be knowledgeable of the shipment's whereabouts. Not
specifying a particular technology provides licensees with flexibility
to design a continuous and active monitoring system that meets their
unique circumstances. However, GPS is considered an acceptable method
of continuous and active monitoring.
21. What are the physical protection requirements for rail shipments of
category 1 quantities of radioactive material?
The final rule requires each licensee that ships category 1
quantities of radioactive material by rail to ensure that rail
shipments are monitored by a telemetric position monitoring system or
an alternative tracking system reporting to a licensee, third party, or
railroad communications center which meets certain criteria. The
communications center needs to provide positive confirmation of the
location of the shipment and its status. Rail shipment tracking
provides the means for a communications center to immediately report an
unusual occurrence that could lead to the theft or diversion of the
material. Early notification provides for a more timely response from
LLEAs, thereby reducing the risk of the misuse of the material.
22. What are the physical protection requirements for shipments of
category 2 quantities of radioactive material?
The final rule requires that a licensee shipping category 2
quantities of radioactive material by road maintain constant control
and/or surveillance during transit and have the capability for
immediate communication to summon appropriate response or assistance.
In the case of the licensee using a common carrier, the final rule
requires that licensees use a carrier that has an established package
tracking system. An established package tracking system means a
documented, proven, and reliable system routinely used to transport
objects of value. The package tracking system must allow the shipper or
transporter to identify when and where the package was last and when it
should arrive at the next point of control. The licensee is required to
use a carrier that maintains constant control and surveillance during
transit and has the capability for immediate communication to summon
appropriate response or assistance. The carrier must also require an
authorized signature prior to releasing the package for delivery or
return.
In general, the licensee must be able to contact the shipping
carrier and determine the approximate location of the shipment. Package
tracking systems, such as common overnight delivery service with
standard tracking, are acceptable. These requirements mitigate with
reasonable assurance the risk of loss, theft, or diversion of the
material.
23. How long do records related to a shipment need to be maintained?
Licensees are required to retain records for 3 years.
24. How is the public protected from loss, theft, or diversion of these
shipments?
Regulating transport of radioactive material is a joint
responsibility of the NRC and DOT. The quantities of radioactive
materials being considered as part of this rulemaking are transported
in packages (casks) that meet rigorous NRC and DOT safety standards.
The NRC fact sheet on transportation of radioactive materials can be
found at: https://www.nrc.gov/reading-rm/doc-collections/fact-sheets/transport-spenfuel-radiomats-bg.html.
The carrier transporting radioactive material must also meet DOT's
requirements for shipment of the radioactive material. A link to DOT's
Web site is provided on the NRC's Web site at: https://www.nrc.gov/materials/transportation.html.
25. What are the requirements for small quantities or irradiated
reactor fuel?
The final rule adds a new Sec. 73.35 to 10 CFR part 73, which
provides that the requirements for shipments of irradiated reactor fuel
weighing 100 g (0.22 lb) or less in net weight of irradiated fuel,
exclusive of cladding or other structural or packaging material, which
has a total external radiation dose rate in excess of 1 Gray (100 rad)
per hour at a distance of 1 m (3.3 ft) from any accessible surface
without intervening shielding. The requirements are the same as the
requirements for shipments of category 1 quantities of radioactive
material.
26. What means of transportation are not addressed in this rule?
The rule does not address air or water transport. Transport of
radioactive material within airports and by air is regulated by the
Federal Aviation Administration. Transport of radioactive material
within ports and by waterway is regulated by the U.S. Coast Guard.
The rule also does not address transshipments of category 1 or
category 2 quantities of radioactive material through the United
States. Transshipments are shipments that are originated by a foreign
company in one country, pass through the United States, and then
continue on to a company in another country. Transshipments are
regulated by DOT and DHS.
Finally, this rulemaking does not address transport of spent fuel,
except irradiated reactor fuel weighing 100 g (0.22 lb) or less in net
weight of irradiated fuel, exclusive of cladding or other structural or
packaging material, which has a total external radiation dose rate in
excess of 1 Gray (100 rad) per hour at a distance of 1 m (3.3 ft) from
any accessible surface without intervening shielding.
III. Summary and Analysis of Public Comments on the Proposed Rule
The proposed rule was published on June 15, 2010 (75 FR 33902), for
a 120-day public comment period that ended on October 13, 2010. After
receiving several requests to extend the comment period, the NRC
published an extension notice on October 8, 2010 (75 FR 62330), that
extended the public comment period until January 18, 2011. The NRC
received comments from 110 organizations and individuals. The
commenters on the proposed rule included States, licensees, industry
organizations, individuals, and a Federal agency.
In general, there was a range of stakeholder views concerning the
rulemaking, supporting some aspects of
[[Page 16939]]
the rulemaking, others opposing some aspects of the rulemaking. Some
commenters described the new requirements as going beyond the order
requirements. It is important to note that the Commission never
intended to just place the orders into the regulations to make them
generically applicable. The Commission always intended to consider
insights gained from implementation of the orders and any lessons
learned during implementation. In addition, the Commission considered
recommendations from the Independent Review Panel and the Materials
Working Group, as well as a petition filed by the State of Washington.
The comments and responses have been grouped into five areas:
General, access authorization program, security during use,
transportation security, and miscellaneous. To the extent possible, all
of the comments on a particular subject are grouped together. The
Commission specifically requested input on eight subjects: (1)
Fingerprinting of the reviewing official; (2) background investigation
elements; (3) protection of information; (4) LLEA notification at
temporary jobsites; (5) reporting requirements; (6) disabling vehicle
exemption; (7) license verification; and (8) monitoring plans for
railroad classification yard. These eight subjects are addressed within
the appropriate area grouping. A discussion of the comments and the
NRC's responses follow.
A. General
Comment A1: One commenter stated that the definition for access
control should be expanded to include persons with access to SGI, as
such individuals are subject to the requirements in Sec. 37.21(c).
Response: The NRC disagrees with the comment. A licensee may
include the SGI component in its access authorization program, but it
is not required to include SGI. The requirements for SGI are contained
in 10 CFR part 73, and the licensee can choose to use the same
reviewing official and process or may use a different reviewing
official and process. If a licensee chooses to include SGI in its
access authorization program under 10 CFR part 37, it will meet the
requirements of 10 CFR part 73.
Comment A2: One commenter noted that the definition for aggregated
was unclear. Another commenter suggested including unsealed sources and
bulk material in this definition. Commenters recommended either
clarifying ``multiple sources of bulk material'' or giving it its own
definition. A commenter noted it was unclear if the term bulk material
aligns with DOT terminology for bulk packaging.
Response: The NRC agrees that the definition could be confusing and
has revised the definition to make it clear that radioactive material
in any form should be included. The definition is not related to DOT.
The intent was to include all material, whether it was in the form of a
source (sealed or unsealed) or was contained in a container of some
sort, such as feed material, that might be used to create a source.
Comment A3: One commenter noted that the term ``Aggregated'' uses
the term ``sealed source'' in its definition and that ``sealed source''
should be defined in 10 CFR part 37 as the use lacks clarity and safety
significance. The commenter stated that the definition for sealed
source should also be revised in 10 CFR parts 30 and 70. The commenter
provided a suggested definition for ``sealed source'' as follows:
``Sealed source means any radioactive material contained to minimize
the spread of contamination in accordance with the presentation made in
a Sealed Source and Device Registry certificate issued by the U.S.
Nuclear Regulatory Commission, an Agreement State or the International
Atomic Energy Agency.''
Response: The NRC disagrees with the comment. The term ``sealed
source'' has been in the regulations for a long time and the NRC is not
aware of any issues that have arisen due to a lack of clarity or safety
significance. The term does not need to also be defined in 10 CFR part
37 as it is defined in the parts under which a sealed source would be
licensed. Changing the definition of sealed source in 10 CFR parts 30
and 70 is beyond the scope of this rulemaking.
Comment A4: One commenter requested that the definition of
``Escorted Access'' be revised to delete the term ``line-of-sight'' as
it is too prescriptive and creates compliance issues should someone
``look away'' or stand in an area of the security zone where the
escorted individual's view may be blocked by some object or equipment
in the zone. The commenter noted that surveillance can also be
accomplished by remote video monitoring. Two commenters suggested that
the term escorted access should be revised to allow for video
surveillance. The commenters noted that, although the definition was a
straightforward, easy way to define escorting, certain video
surveillance systems provide improved security and should be allowed.
The commenters suggested revising the definition as follows: ``Escorted
access means that the actions of the individual are observed 100% of
the time while they are in the security zone.''
Response: The NRC agrees with the comment in part. The NRC has
removed the term ``line-of-sight surveillance'' from the definition and
changed it to ``direct continuous visual surveillance.'' The revised
definition will provide greater flexibility for the licensee. The
definition of escorted access was not intended to eliminate a
licensee's use of video surveillance. Video surveillance is appropriate
in some, but not all cases. For example, video surveillance of patients
during a treatment would be appropriate.
Comment A5: One commenter requested that the definition of license
be revised as follows: ``License, except where otherwise specified,
means a license for byproduct material issued pursuant to the
regulations in 10 CFR parts 30 through 36 and 39 of this chapter or a
permit issued by a master materials licensee.''
Response: The NRC disagrees that the definition for license should
be revised. The definition used in 10 CFR part 37 is identical to the
definition used in 10 CFR part 30. No license will be issued under 10
CFR part 37.
Comment A6: One commenter requested that the definition of license
issuing authority be revised to include a master materials licensee
(MML) as the MML issues individual permits.
Response: The NRC disagrees with the comment. An MML is not
equivalent to an Agreement State and does not issue licenses. The MML
does authorize individual permits for specific locations, but cannot
authorize beyond what is specified on the MML license.
Comment A7: Several commenters requested that the definition of
LLEAs be revised by removing the requirement that the agency be a
government entity and to broaden the definition to include private
security forces that possess the authority to carry firearms and make
arrests. Commenters felt that the definition was confusing and was not
clear whether university police could be considered an LLEA under the
definition. One of the commenters noted that some university police
departments serve as the LLEA and are a fully badged and sworn police
force with the authority to make arrests and provide armed response.
Some of the commenters suggested revised rule language to clarify the
definition.
Response: The NRC agrees with the commenters and has revised the
definition of LLEA as follows: ``Local law enforcement agency (LLEA)
means a public or private organization that has been approved by a
federal, state, or local government to carry firearms and
[[Page 16940]]
make arrests, and is authorized and has the capability to provide an
armed response in the jurisdiction where the licensed category 1 or
category 2 quantity of radioactive material is used, stored, or
transported.''
Comment A8: Five commenters suggested revising the definition of
``Lost or missing licensed material.'' Commenters indicated that the
definition contains subjective terms that make compliance with the
reporting criteria difficult. Two commenters recommended removing
``readily'' from the definition as it is too subjective and could lead
to inadvertent noncompliance. One commenter recommended linking the
definition for lost or missing licensed material with the no-later-than
arrival time definition and providing a specific criterion in regards
to time to locate material in transit. The commenter suggested the
following definition: ``Lost or missing licensed material'' means
licensed material whose location is unknown. It includes material that
has been shipped but has not reached its destination and whose
whereabouts have not been traced in the transportation system within 8
hours past the scheduled no-later-than arrival time.'' The commenter
noted that compliance and enforcement of the reporting criteria
established in Sec. 37.81 is difficult and that an 8-hour
investigation period seems reasonable. Another commenter noted that it
typically gives the carrier 24 hours to trace within their
transportation cycle, before the package is declared as lost or
missing, and that anything less than the 24 hours does not allow
sufficient time for the carrier to do a complete document and tracking
search and/or a physical search at potential locations. The commenter
noted that to declare the package as lost or missing before that will
result in many false positives, as 99.99% of the time the package is
located within the 24-hour window.
Response: The NRC disagrees with the comment. The term ``lost and
missing licensed material'' has been in part 20 for some time, and the
definition in 10 CFR part 37 is identical. It would be confusing to
have different definitions for the same term and concept in the
regulations and licensees would still need to meet the 10 CFR part 20
reporting requirements. A change to 10 CFR part 20 is beyond the scope
of this rulemaking. The NRC will provide additional information on the
security-specific meaning of ``lost or missing'' in the 10 CFR part 37
guidance document.
Comment A9: One commenter stated that the definition for reviewing
official should include a trustworthiness and reliability determination
of an individual who has access to SGI-M.
Response: The NRC disagrees with the comment. A licensee may use
the same reviewing official for trustworthiness and reliability
determinations for both unescorted access and access to SGI. However,
the licensee is not required to use the same reviewing official.
Determining access for SGI can be a separate program.
Comment A10: One commenter stated that the definition for
``sabotage'' should include a definition of ``security system'' that is
referenced in the definition.
Response: The NRC disagrees with the comment. Security system does
not need to be defined in the definition of Sabotage. The security
system will be different for each licensee as it is the system that a
licensee uses to protect its category 1 and category 2 quantities of
radioactive material.
Comment A11: Two commenters suggested modifications to the
definition for safe haven. Another commenter noted that the provision
cannot be implemented. The commenter noted that based on discussions
with military and other Federal institutions, material shipments could
not be diverted to them under any circumstances. The commenter
suggested that safe havens be contacted, confirmed, and identified. The
commenter noted that the licensee and carrier are capable of
determining safe havens along the route and that past experience has
shown that requesting a State to identify safe havens has been
fruitless. Two commenters suggested that the NRC work with the States
to identify potential safe havens and publish a list with the final
rule. One commenter noted that a licensee does not need to work with
the State to identify safe havens. Two commenters noted that the term
``safe haven'' is loosely defined by various agencies and States, and
that States do not recognize, identify, or acknowledge that they have
such sites. Two commenters noted that DOT removed the term from its
regulations because it could not be implemented.
Response: The definition for safe haven has been retained in the
final rule. Licensees, not States, are responsible for identifying safe
havens. Identification of safe havens has been in the regulations for
spent fuel transportation for a number of years and was included in the
RAMQC Orders for transport of category 1 shipments, so it is not a new
concept. If a licensee is having trouble identifying safe havens along
a route, it may discuss possible locations with the NRC, State police,
or the State's designated contact (usually State police).
Comment A12: One commenter (a State) noted that the definition for
temporary job site has a compatibility of Level B, which requires
identical wording. The commenter noted that this definition does not
meet its definition which is much more restrictive in that it limits
the amount of time radioactive material can be used at a temporary job
site. The commenter stated that there should not be two different
definitions for the same word listed in different parts of the
regulations. Another commenter stated that the temporary job site
definition would be more appropriate with a designation of C instead of
B as it would allow States to be more restrictive.
Response: The NRC agrees with the comment in part and disagrees in
part. The NRC tries to use the same definition for terms that are used
in more than one part of the regulations. However, there are terms that
have different meanings depending on the use. Temporary job site is
defined in both 10 CFR part 34 and part 39 with definitions that are
specific to the part. Since activities that are covered by both 10 CFR
part 34 (radiography) and part 39 (well logging) may also be subject to
10 CFR part 37 security provisions, the NRC extracted the common
elements of the definitions for use in 10 CFR part 37. However, the
requirements related to temporary job sites have been removed from 10
CFR part 37, and the term is no longer defined in the rule.
Comment A13: Three commenters suggested revising the definition of
``Trustworthiness and reliability.'' One commenter stated that the
definition is vague and subjective and that use of subjective terms in
the definition such as ``dependable'' and ``unreasonable'' makes it
impossible to apply. The commenter noted that a licensee cannot ensure
that individuals are trustworthy and reliable and as such do not
constitute an unreasonable risk to public health and safety. The
commenter requested that concrete and nonsubjective criteria be
provided. Another commenter requested that the definition be revised by
adding ``or as provided for in Sec. 37.29'' to the end of the
definition. One commenter stated that the definition should be modified
to include characteristics required by individuals having access to
SGI-M.
Response: The NRC disagrees with the comment. The NRC does not
believe that these terms make it impossible for licensees to determine
trustworthiness and reliability. The concepts of dependable and
unreasonable were also contained in the orders. The
[[Page 16941]]
determination is performance based and provides licensees the
flexibility to develop programs and criteria that they are comfortable
with. The definition in 10 CFR part 37 is consistent with the
definition of the term in 10 CFR part 73. The NRC does not believe that
it is necessary to add provisions that include access to SGI. Access to
SGI is covered by 10 CFR part 73. While a licensee may use the same
access authorization program for determinations for access to SGI, the
licensee may have a separate program.
Comment A14: One commenter suggested maintaining the current
interpretation for unescorted access that an individual having
unescorted access to several less than category 2 quantity sources
which are secured behind their own physical barrier would not require
inclusion in the trustworthiness and reliability determination program.
The commenter noted that the rule defines unescorted access to include
individuals who have access to sufficient quantities of radioactive
materials such that the individual could successfully accumulate lesser
quantities of material into a category 1 or category 2 quantity. The
commenter noted that this is a significant change and would result in a
big increase in the number of individuals who will need background
checks completed or require very complex source handling procedures to
prevent the ability to aggregate sources. One commenter noted that the
examples provided in the Statements of Consideration did not appear to
apply to an individual with access to multiple licensee facilities
listed on the same license or multiple separate licenses by the same
organization. The commenter noted that these persons could aggregate
materials just as easily as if they were at a single location under one
license, but the security rules would not apply to them. One commenter
stated that the NRC should reevaluate the need to include accumulation
considerations for access authorization control.
Response: The NRC has reevaluated the requirement and has revised
the definition for Unescorted access. All provisions of the rule now
only apply to licensees that possess an aggregated quantity of
radioactive material that equals or exceeds the category 2 threshold.
The term aggregated contains the concept of co-location and breach of a
barrier.
Comment A15: One commenter requested that the NRC add a definition
for master material license to 10 CFR part 37.
Response: The NRC disagrees with the comment. Master material
license is not specifically mentioned anywhere in the regulations, and
the NRC does not believe that there is a need to mention it in 10 CFR
part 37 as licenses are not issued under 10 CFR part 37.
Comment A16: One commenter suggested including a definition for
security plan at least to the extent that `security plan' is meant to
encompass a description of a licensee's background investigation
process, access control program, and physical protection measures with
those specific features as identified elsewhere in the part.
Response: The NRC disagrees with the comment and does not believe
that a definition of security plan is necessary. Section 37.43(a)
contains the purpose of the security plan and specifies in general
terms what must be included in the security plan. A definition would
not add further to the understanding.
Comment A17: One commenter suggested that a limited exemption be
provided to licensees who consistently meet the requirements imposed by
the orders. The commenter noted that the NRC could establish criteria
for the assessment of licensee's security programs and if the program
was deemed inadequate, corrective action could be initiated.
Response: The NRC disagrees with the comment. The NRC believes that
the requirements in 10 CFR part 37 are necessary to ensure adequate
protection of category 1 and category 2 quantities of radioactive
material. A licensee can always ask for relief from a particular
measure and if the NRC agrees that adequate basis exists and that it is
protective of public health and safety, it can grant the request.
Comment A18: One commenter, while supporting the decision to limit
the rule to category 1 and category 2 sources, noted that not all
category 2 sources are realistically in danger of being tampered with,
particularly in large medical facilities with exhaustive security
controls in place. The commenter noted that if a large medical
facility's security measures are breached, sealed sources in medical
devices are generally not readily accessible even by technicians with
highly specialized skills and tools. Two commenters suggested exempting
medical and research facilities from all of the 10 CFR part 37
requirements except for the security program or security plan. The
commenters noted that the public pays for and benefits from medical and
research use of these sources, and as such, should have a higher
acceptable risk. The commenters noted that this is similar to the basic
premise behind the patient release criteria in 10 CFR part 35 (Sec.
35.75), generally licensed sources, tritium exit signs, and smoke
detectors, where the public can have a higher acceptable risk for the
benefits which the materials bring them.
Response: The NRC disagrees with the comment. The category 1 and
category 2 quantities of radioactive material possessed by a medical
facility present the same risk as category 1 and category 2 quantities
of radioactive material possessed by other licensees. Almost any user
could argue that its use benefits society in some manner. The
comparison to generally-licensed sources is not applicable, as
generally licensed sources contain less than category 2 quantities of
radioactive material and are considered safe for use without additional
measures.
Comment A19: One commenter expressed concern that the source
aggregation changes could cause additional medical facilities to come
under the rule. The commenter was opposed to the rule applying to any
facilities beyond those under the orders.
Response: The application of the source aggregation criteria has
not changed from the orders. The concept of co-location and breaching
of a common physical barrier are still factors. While the rule may
apply to licensees that were not subject to a particular order, the
licensee would only be subject to the requirements if it aggregates the
material. Some licensees that have an aggregated category 1 quantity
may have only been subject to the Increased Control Orders and would
now be subject to some additional requirements under the rule that
apply to all licensees that possess a category 1 quantity of
radioactive material.
Comment A20: Several commenters expressed concern about the
extension of applicability for the proposed rule beyond byproduct
material licensees to power reactor, research and test reactor, and
fuel cycle licensees. Commenters noted that extending the requirements
to large component or radioactive material storage facilities located
on power reactor plant sites appears unwarranted. Commenters
recommended limiting the applicability to exclude material that meet a
criterion for a specific activity, surface contaminated objects, bulk
packages with mass exceeding 100 pounds or limit aggregating material
to a small number (fewer than 10) of discrete sources, and areas where
a large number of packages containing low concentrations of
radionuclides of interest are stored over a very large area, because
they believe the risk is low and should not present a security concern.
Commenters recommended that an appropriate threshold be developed that
[[Page 16942]]
exempts large volume or weight of a single item or of the aggregated
quantity such that exemption requests are not necessary and the
security provisions of 10 CFR part 37 would not apply. Commenters noted
that such materials are typically either of such large mass or volume,
or of such a diffuse constitution, that they should be considered low
risk for any malevolent purpose. Commenters noted that the industry is
concerned that casting a wide net will present a situation whereby
certain categories of facilities are regulated through exemptions.
One commenter suggested that NRC should consider using dose rates
at 1 meter relative to the Appendix I definitions in IAEA TECDOC-1344
for other than sealed sources as an alternative. The commenter noted
that the IAEA document acknowledges that the categorization system may
not be appropriate for waste management. The commenter noted that
tables in the document are based primarily on discrete sealed sources
of very high specific activity and do not apply to packages in
transport. The commenter further noted that IAEA also recommends 100
rads (1 Gy) to bone marrow in 100 hours at 1 meter from sources that
cannot be carried as the threshold for a ``dangerous'' source. With a
category 2 source threshold at 10 x D, this also provides a practical
justification for exempting low specific activity (LSA) materials, as
they are restricted to dose rates of 1 rem/h at 3 meters. Using very
restrictive point source consideration (i.e., an inverse square
relationship), LSA materials cannot result in dose rates exceeding 10
rads/h at 1 meter. The other deterministic considerations presented in
the TECDOC are similarly bounded by the low specific activity of such
wastes.
Commenters noted that there is a distinct difference between a
given amount of activity confined in a relatively small sealed source
and the same quantity dispersed around a large site in numerous
containers, none of which individually contains activity approaching a
category 2 amount. Commenters noted that low specific activity
material, objects with low levels of surface contamination, or numerous
small sources would not be attractive for theft or sabotage because of
the disperse nature of the radioactivity. One commenter noted that this
is recognized in the transportation arena that allows use of industrial
packages for low specific activity and surface contaminated materials
versus more robust Type A or Type B packages for shipping higher
activity materials.
Commenters noted that the packaging of the source is relevant to
potential theft and diversion. Commenters indicated that a quantity of
material where the total activity exceeds a category 2 level but is
dispersed in contaminated metal and other material within one or more
large concrete and/or steel containers presents a different hazard than
the same amount in a relatively small unshielded source. Commenters
noted that large and heavy containers are difficult to move and steal
without detection and that the containers themselves are self-
protecting from a sabotage point of view. The commenter noted that this
is important for licensees engaged in decommissioning, processing, and
shipping of bulk waste material. Commenters noted that the volume and
mass required for a category 2 quantity of material renders theft an
incredible scenario and that damaging and dispersing a category 2
quantity of material such that deterministic effects result from
internal or external exposures are not credible.
Commenters provided examples of: (1) A commercial waste processor
that could have several thousand packages in a common storage area,
each containing waste forms of relatively low specific activity and
each with a mass of several hundred to several thousand pounds and (2)
a radioactive waste disposal facility that has a 60-car train of
radioactive waste within its controlled area.
Response: The NRC agrees with the comment in part. The NRC has
determined that it is appropriate to include a partial exemption in the
regulation instead of treating exemptions requests on a case-by-case
basis. Paragraph (c) has been added to Sec. 37.11 to address
radioactive waste materials. The provision does require that some
security measures be applied to the waste, but the majority of the 10
CFR part 37 requirements would not apply. Measures include the use of
continuous physical barriers, alarmed locked gates or doors, and
assessment and response of unauthorized entry. The provision does not
include the use of dose rates, but would cover much of the low specific
activity waste addressed by the comment.
Comment A21: One commenter felt that the proposed requirements
should not apply to holders of category 2 sources, particularly since
the new requirements would not apply to the transshipment of category 1
and category 2 sources. The commenter noted that if the Juarez, Goiana
and Mayapuri radioactive material dispersal incidents all occurred in
the United States, in a single year, the annualized risk of premature
death would be a small fraction of the 1E-6 probability frequently used
in establishing regulatory requirements.
Response: The NRC disagrees with the comment that the security
provisions should not apply to category 2 sources. The Commission has
determined that category 2 sources are risk significant and, therefore,
warrant additional security measures. The NRC does not regulate
transshipments.
Comment A22: One commenter noted that the scope suggests that 10
CFR part 37 applies to any person who is authorized to possess or use
category 1 or category 2 quantities of radioactive material at any site
or contiguous sites subject to the control by the licensee. The
commenter pointed out that when radioactive material is used at
temporary job sites, the licensee will be in control of the quantities
of radioactive material, but may not necessarily be in control of the
sites. The commenter also noted that the scope does not indicate that
this applies to persons who have access to SGI-M and implies it only
applies to those authorized.
Response: The NRC agrees that the language may be confusing as it
applies to temporary job sites and has revised the scope to clarify the
intent. The requirements of 10 CFR part 37 do not apply to SGI-M.
However, some of the security information developed under 10 CFR part
37 would be considered SGI-M and needs to be protected in accordance
with 10 CFR part 73. The requirements for SGI-M are contained in
Sec. Sec. 73.21 and 73.23.
Comment A23: One commenter stated that the exemption provided in
Sec. 37.11(b) for facilities with 10 CFR part 73 security plans should
be retained but offered a suggested revision to clarify who has
inspection/security oversight. The commenter noted that it would be a
significant paperwork task to keep records showing compliance with both
sets of controls without a real increase in the security of either
material. The commenter also noted that it would be an added inspection
burden if the program required separate inspections by an Agreement
State and the NRC. The commenter suggested adding a sentence at the end
of the paragraph: ``Although the NRC maintains primary oversight of
these facilities, inspection by Agreement State representatives is
permitted.''
Response: The NRC is retaining the exemption for licensees that
possess the category 1 or category 2 quantities of radioactive material
under an NRC license. For those licensees located in
[[Page 16943]]
non-Agreement States, the licensee can choose if it wants to protect
the material under the security plan required by 10 CFR part 73 and
approved by the NRC or protect the material under a 10 CFR part 37
security plan. If the material is protected under a 10 CFR part 73
security plan, the licensee's records should note that the material is
protected under a 10 CFR part 73 security plan. Any inspection would be
against the security plan under which the material is protected. For
licensees that are located in an Agreement State and possess category 1
or category 2 quantities of radioactive material under an NRC license,
the licensee can choose whether to protect the material under the 10
CFR part 37 or the required and approved 10 CFR part 73 security plan.
For licensees that possess the category 1 or category 2 quantities of
radioactive material under an Agreement State license, it will be up to
the Agreement State to decide if it will allow the licensee to protect
the material under an NRC-required and approved 10 CFR part 73 security
plan. The licensee would want to discuss this with its State regulator.
Agreement States are not required to adopt the provision on exemptions
in Sec. 37.11(b) as a matter of compatibility. As for adding a
provision to allow State personnel to inspect, the NRC disagrees with
the comment. A new provision is not necessary to allow an Agreement
State to inspect against a license that it has issued.
Comment A24: One commenter stated that the NRC should not
promulgate the rule for licensees currently under NRC 274i Security and
Fingerprinting Orders specified in EA-08-225 issued August 29, 2008.
The commenter noted that these licensees are few in number, and the NRC
should continue to regulate them under the existing orders. The
commenter noted that this should include possession of certain isotopes
greater than category 1. The commenter suggested new paragraphs for
Sec. 30.34 as follows: ``30.34(m) Security requirements for licenses
who possess an individual source less than category 1 but greater than
or equal to category 2 of the isotopes listed in Appendix E to 10 CFR
part 20--Nationally Tracked Sources Thresholds. Licensees or applicants
must submit to NRC for review and approval of information to comply
with the requirements and time frames specified in NRC Order EA-07-305
dated December 5, 2007, and its attachments titled ``Table 1
Radionuclide of Concern and Attachment 3 Specific Requirements
Pertaining to Fingerprinting and Criminal Records Checks'' which are
incorporated by reference (or listed in a new Appendix F of 10 CFR part
30). This rule is in addition to any other requirements specified in
applicable 10 CFR parts.'' and ``30.34(n) Licensees must notify NRC of
their intention to possess an individual source greater than category 1
of the isotopes listed in Appendix E to 10 CFR part 20--Nationally
Tracked Sources Thresholds.''
Two commenters stated that the authority to regulate the physical
protection of category 1 and 2 quantities of material in transit
(subpart D) should not be relinquished to the Agreement States. The
commenter noted that while the adequacy and compatibility requirements
of Agreement State programs would require the Agreement State
regulations to be ``essentially identical'' to those contained in
subpart D, there are several instances where Agreement State
regulations include requirements in addition to those found in the
analogous NRC regulations. The commenter noted that Agreement State
regulations that go beyond those contained in subpart D could hinder
interstate commerce and result in additional burden and expense to the
licensees. Another commenter stated that there is value to Federal
preemption in regulating the transportation security of category 1 and
category 2 quantities of radioactive material as this would ensure
uniformity of the administration of the requirements. One commenter
suggested that the authority be transferred to DOT and not the States.
Two commenters stated that the NRC should retain authority for the
security of category 1 licensees under common defense and security
unless the States are given authority to regulate all aspects of
category 1 sources. The commenters noted that the rule does not give
the States authority to regulate the safeguards information and,
therefore, the regulatory authority would be split. Commenters
suggested removing the SGI designation. One commenter noted that under
Supplementary Information Item II.(A)(10), it states, ``Although the
NRC relinquishes authority to States for certain materials, under
section 274(m) of the AEA no such agreement will affect the authority
of the Commission to take regulatory action to protect the common
defense and security.'' The commenter noted that Item 11 states, ``The
provisions put in place for the inspection of licensees that received
the orders issued under common defense and security would remain in
place until the State implements the requirements.'' The commenter
stated that this contradicts Item 19 which states the NRC will not
enter such agreement for common defense and security. The commenter
indicated that category 1 materials must be considered under the terms
of common defense and security and should remain under NRC jurisdiction
for security. The commenter noted that the proposed rule states
``licensees who activities are covered under part 73 would be exempt
from part 37.'' The commenter stated that most of the irradiator
requirements (SGI-M) are based in 10 CFR part 73 and therefore
indicates that there are no category 1 licensees that are subject to
State purview. The commenter noted that there are references to SGI-M
in the proposed rule which further leads to the need for clarification.
One commenter noted the drafted document appears to be inconsistent
in this regard and that the issue of jurisdiction and responsibility
for these licensees must be clearly made and the necessary inclusions
and exclusions to the rules made accordingly.
Response: The NRC disagrees with the comment. The NRC believes that
it is appropriate for the Agreement States to regulate the physical
protection of category 1 and category 2 quantities of radioactive
material. Although some of the security information is considered to be
SGI-M under 10 CFR part 73, the NRC does not believe that this prevents
the Agreement States from regulating the security aspects for those
facilities. While the State could not inspect the SGI provisions for
protection of the material unless it entered into a 274i Agreement with
the NRC, the State could inspect and enforce the provisions of 10 CFR
part 37. The exemption provided in Sec. 37.11 was intended to only
cover facilities that had a security plan under 10 CFR part 73 and not
the information protection aspects. The NRC has clarified the
exemption. See also the responses to comments A23, A46, and A47 and the
response to question 10 in Section II.A of the Statement of
Considerations.
Comment A25: One commenter noted that the rule should adopt the
entire categorization of radioactive sources from the IAEA Safety Guide
No. RS-G-1.9--Categorization of Radioactive Sources. The commenter
pointed out that the IAEA Safety Guide provides a more robust, risk-
based categorization of quantities than the categorization provided in
the proposed rule as it describes five different categories that
differentiate sources possessed by various licensees based on quantity
as well as use. The commenter also stated that the rule should be
limited to source quantities characterized as category 1 and category 2
in the IAEA Safety
[[Page 16944]]
Guide. The commenter noted that the types of sources used in refineries
and petrochemical plants are considered category 3 and according to the
IAEA Safety Guide, the types of sources used in refineries and
petrochemical plants present less risk than the source quantities in
category 1 and 2.
Response: While the NRC agrees that category 3 sources present less
risk individually than category 2 sources, the NRC disagrees with the
remainder of the comment. Unlike RS-G-1.9, the NRC and the IAEA Code of
Conduct do not consider use (e.g., fixed gauges, well logging, and
radiography) in the determination of source categorization. Regardless
of its intended use, any category 2 quantity may pose a significant
risk to individuals, society, and the environment. Additionally, 10 CFR
part 37 applies not only to sources, but also to bulk material. The
rule also addresses aggregation of radioactive material at or above the
category 2 threshold. If several sources are stored together that
individually are considered to be category 3 sources, but together form
an aggregated category 2 quantity, the attractiveness of the material
as a group would be the same as if there were only one category 2
source. If the sources used in the refineries and petrochemical plants
are not aggregated, 10 CFR part 37 would not apply.
Comment A26: One commenter indicated that for facilities covered
under the Maritime Transportation Security Act, the rule would mean
additional burdens, redundancies and confusion. The commenter
recommended that for facilities regulated under DHS/DOT Personnel
Surety programs, the rule should allow a program of reciprocity to
reduce redundancy. The commenter noted that at National Petrochemical &
Refiners Association (NPRA) member facilities, the Radiation Safety
Officer (RSO) and technicians have intimate contact with source holders
and the rule would be best implemented by the RSO and technicians and
not the entire facility population.
Response: The NRC disagrees that the rule imposes additional
burdens, redundancies, and confusion. The Maritime Transportation
Security Act, which amends the Merchant Marine Act of 1936, establishes
a program to ensure greater security for United States seaports and
provides requirements pertaining to personnel whose duties are related
to import and export activities at the ports. Part 37 transportation
requirements only apply to the domestic portion of an import or export.
For an import, the provisions would apply once the shipment clears
customs and for exports, up to the point the shipment crosses the
border. Holders of the TWIC do not need to undergo fingerprinting and
the FBI criminal history records check again as Sec. 37.29 relieves
them from the requirement. However, the individuals would need to
undergo the remaining elements of the background investigation.
As for the NPRA member facilities, the provisions for access
authorization under 10 CFR part 37 would only apply if the facility
allows unescorted access to category 1 or category 2 quantities of
radioactive material. The licensee decides who is in charge of the
security program as the regulations do not specify any specific
position.
Comment A27: One commenter asked for clarification whether the
provisions apply to those licensees authorized to possess the material
or those that actually possess the material. The commenter noted that
the language discrepancy occurs throughout the rule and must be
corrected. Another commenter asked that the requirements be spelled out
separately to avoid confusion.
Response: The proposed rule contained some provisions that
pertained to licensees that were authorized to possess category 1 or
category 2 quantities of radioactive material. The final rule contains
provisions that apply only to those that actually possess and aggregate
the material to a category 1 or category 2 quantity.
Comment A28: Some commenters objected to the need to submit
compliance information. The commenters felt that this is an unnecessary
burden to both the licensees who have already implemented a program and
the regulatory agency. The commenters noted that the licensees subject
to this part have already been inspected multiple times and have
established a compliance history, and therefore these licensees should
be exempted from having to resubmit existing information. One commenter
thought that the provision was vague as written and requested
clarification that compliance with the provision would be achieved by
submitting a letter to the NRC indicating that the licensee has
successfully implemented the program. One commenter noted that the NRC
must identify in the regulation what essential elements are to be
included because placing the information in guidance is unacceptable.
One commenter thought the provisions should be removed from the rule
but if retained offered suggested language. One commenter stated 30
days did not provide adequate time. Commenters noted that requiring a
licensee to report compliance was an unnecessary burden as licensees
are expected to comply and that the normal terms of implementation for
rulemaking are adequate. One commenter suggested deleting Sec.
37.41(d) as unnecessary since current implementation of the Increased
Control Orders is an adequate basis to conclude the current licensees
will transition to compliance with the new regulations.
Response: The NRC agrees that the submittal of compliance
information is not needed and has removed the requirement from the
rule. The NRC and the Agreement States already know which licensees
will need to implement 10 CFR part 37. A provision has been added in
Sec. 37.41 to require a licensee that has never implemented the orders
or 10 CFR part 37 to notify the NRC 90 days before aggregating material
to a category 1 or category 2 quantity of radioactive material.
Comment A29: One commenter stated that in Sec. 30.32 the wording
implies the application must include an affirmation that the proposed
security program meets the requirements in 10 CFR part 37. The
commenter stated that instead the application should include a proposal
as to how the requirements will be satisfied and be subject to
evaluation for sufficiency. The commenter suggested the following
language: ``(1) An application for a specific license to use, store, or
transport category 1 or category 2 quantities of radioactive material
must include information outlining the applicant's security program
designed to satisfy the requirements in part 37 of this chapter.''
Response: The NRC has reevaluated the need for the requirement and
has decided that it is unnecessary. A new applicant will be evaluated
on the need to implement 10 CFR part 37 as part of a prelicensing
review and inspection. If the licensee will be aggregating the material
to a category 1 or category 2 quantity of radioactive material, the
licensee will be expected to implement the provisions of part 37 before
receiving a license.
Comment A30: One commenter noted that institutions that have
aggregated material may require significant time to implement the
provisions as it will require a financial investment. The commenter did
not suggest an appropriate timeframe. Several commenters noted that 30
days for implementation was not sufficient for the changes that need to
be made. Two commenters suggested a 1-year effective
[[Page 16945]]
date. Commenters supported terminating the orders on the effective date
of the rule to avoid confusion and noncompliance. One commenter stated
that the rule should be clarified as to the compliance date and asked
what happens if a licensee is not in compliance by that date. One
commenter noted that it would be difficult to comply with the 30-day
timeframe for preparing and implementing the security plan and
implement the security program at least 90 days before it `` * * *
aggregates radioactive material to a quantity that equals or exceeds
the category 2 thresholds.'' The commenter further noted that work
varies significantly from project to project and that security plans
that are sufficiently robust to be effective also would vary
significantly. The commenter noted that it is not possible to prepare
or implement a project-specific security plan without knowing the
details of the project and that frequently licensees need to mobilize
and initiate work within a matter of a few days, which would not be
possible if a 90-day advance notice was required.
Response: The NRC notes that the proposed rule indicated that the
final rule would be implemented 270 days after publication in the
Federal Register. The 30-day timeframe was for the licensee to submit
compliance information. The NRC has removed the requirement to submit
the compliance information. In addition, the NRC is providing a 1-year
implementation period for the final rule. This should allow ample time
for licensees to implement the requirements, including the development
of any new procedures and the conduct of necessary training. Agreement
States will be given 3 years from publication of the final rule to
adopt the rule provisions instead of from the effective date. This will
still provide the States with a 3-year window to adopt the regulations.
Comment A31: One commenter noted that its business depends on the
ability to not co-locate or aggregate its radioactive material and that
it manages its radioactive material through quantity control and
physical separation of material not in use at any one time. The
commenter noted that, if it was required to aggregate all of its
material, which includes the standard, returned sources, sources packed
and ready to ship, cell waste (cell sweep, dust, chips), plus isotope
material, it would be continuously above the category 2 threshold, and
the additional requirements would be a significant economic hardship on
the company.
Response: The rule does not require co-location or aggregation of
radioactive material. If a licensee does not aggregate the material
above a category 2 threshold, the licensee will not need to implement
the provisions of 10 CFR part 37. The final rule only applies to those
licensees that possess aggregated quantities at or above the category 2
threshold.
Comment A32: Several commenters objected to the change from a 3-
year retention period for records to a 5-year retention period. One of
the commenters believed that the change from the standard practice
where most documents in the industry have a mandated 3-year retention
period is redundant and unnecessary and will add a potential for
confusion where none need exist. One commenter questioned why there was
a need to keep superseded portions of procedures and the security plan
for 5 years. The commenter stated that this was an added burden and
does not add to the security of the material or to the protection of
the health and welfare of the general public. The commenter also
questioned the need to keep training records for 5 years stating that
it should be adequate for a licensee to show that it is conducting
annual training and suggesting a 1-year retention period.
Response: The NRC agrees with the comment on the retention period
and has changed the record retention period for most records to 3
years. Safety records are maintained for 3 years, and the NRC agrees
that there is no benefit to keeping only the security records for 5
years. There are a few licenses that have an inspection frequency of 5
years; however, the majority of the licensees impacted by 10 CFR part
37 have a 3-year inspection frequency. Superseded procedures and
training records are necessary from an inspection and enforcement
aspect.
Comment A33: One commenter questioned how long to hold on to the
old security plan once it is updated and how long the documentation of
the coordination activities is to be maintained. Another commenter
recommended changing the record retention period for the security plan
so that the record could be destroyed 5 years after it is no longer
needed. The commenter noted that there was no value in keeping the
security plan once a licensee was no longer allowed to possess
materials that would require a security plan.
Response: Section 37.43(a)(4) specifies that the superseded
portions of the security plan be retained for 3 years (note the
proposed rule specified 5 years). For any record where a retention
period is not specified, Sec. 37.103 specifies that the record be
retained until the Commission terminates the license. The NRC has added
a retention period of 3 years for the documentation records. The NRC
agrees with the comment and has changed Sec. 37.43(a)(4) to indicate
that the security plan must be retained for 3 years after it is no
longer required.
Comment A34: One commenter requested clarification in Sec. 37.101
on the concept of ``safeguards against tampering with'' to preclude
unwarranted interpretations during a regulatory inspection about the
requirements for records. The commenter offered suggested language as
follows: ``the licensee shall maintain adequate safeguards against
tampering with and loss of records. The requirements in Sec. 37.43 for
protection of information are not applicable to this section.'' Another
commenter recommended replacing the term ``safeguard'' with ``protect''
in Sec. 37.101. The commenter felt that safeguard should be only used
when referring to safeguards.
Response: The NRC disagrees with the comment. The records provision
in Sec. 37.101 is identical to provisions in other parts of the
regulations. The NRC is not aware of any issues that have arisen over
interpretation. The provisions of Sec. 37.43 would apply if the
records were the security plan, implementing procedures, or the list of
individuals allowed unescorted access.
Comment A35: One commenter stated that the enforceability in
regulations of records retention for reporting suspicious activities is
unduly burdensome on the licensee. The commenter stated that due to the
clandestine nature of reporting suspicious activities to LLEAs, the
licensee may not have the LLEA's or NRC's fluid responses to these
reports for security reasons and that ongoing investigations can
encompass years, so the recordkeeping requirement is inconsistent and
can be inconsistent with other recordkeeping requirements depending on
the incident nature of the reporting.
Response: The NRC does not understand the commenter's concern.
There are no record retention requirements associated with reporting
suspicious activities. The 30-day written report is not required for
suspicious activity reporting. The licensee is required to assess the
suspicious activities and notify the LLEA, only if the licensee
believes it is appropriate to do so. The licensee is only required to
notify the NRC if the LLEA is notified. The NRC acknowledges that there
is
[[Page 16946]]
some subjectivity involved in determining what is considered to be
suspicious.
Comment A36: One commenter questioned who was authorized to
authenticate reproduced records in Sec. 37.101.
Response: ``Authorized personnel'' in Sec. 37.101 are those
authorized by the licensee to authenticate duplicated documents.
Comment A37: In the proposed rule, the NRC specifically requested
comment on the reporting requirements. Commenters were requested to
provide information on: (1) Whether the proposed rule contained the
appropriate items and thresholds to be reported to the LLEA; (2)
whether the proposed rule contained the appropriate items and
thresholds to be reported to the NRC; (3) whether suspicious activities
should be reported and if they are reported, what type of activities
should be considered suspicious; and 4) whether the timeframe for
reporting was appropriate. Fifteen commenters provided responses to the
specific questions on this subject.
Of those that provided responses to the questions on the reporting
requirements, the majority agreed that the reportable items and
thresholds were appropriate, and five commenters felt the items and/or
thresholds should be changed. One of the commenters indicated that the
NRC and/or FBI should be notified of any denial for cause of a request
for unescorted access as this might be domestic intelligence
information of interest to the FBI or DHS. The commenter also felt that
the NRC/FBI should be notified of activities determined to be suspect
by the LLEA. Three commenters stated that actual and attempted theft
were appropriate reportable actions but that suspicious activities
should be removed from the rule. Of the commenters that supported
reporting of suspicious activities, no commenter offered suggestions as
to what type of activities should be considered suspicious. A couple of
the commenters stated that the licensee is the best judge of what type
of activities would be considered suspicious at its facility. Other
commenters just suggested that the NRC should provide guidance to
assist the licensee. Most of the commenters indicated that the
reporting timeframes were appropriate. One commenter stated that the
timeframes did not allow for a realistic period of assessment. The
commenter noted that classifying some of these events will be very
subjective and some may be impossible to distinguish from events that
are not malicious or not related to a category 1 or category 2 quantity
of radioactive material. Another commenter stated that a specific
timeframe should be specified instead of immediate and upon discovery.
The commenter stated that failure to set specific time limits will
result in delay in implementing the Federal response framework.
In addition to those that provided responses to the specific
questions, seven commenters addressed this subject in their comments.
Two commenters noted that classifying some of these events will be very
subjective and some are likely to be impossible to distinguish from
events that are not malicious or are not related to category 1 or
category 2 quantities of radioactive material. The commenters noted
that reasonable persons could interpret the expectations of the NRC and
the details of a specific event very differently. The commenters
further noted that these events will require a period of assessment,
and sometimes a lengthy period of assessment, to determine the nature
of the event and that the timeframes for reporting do not anticipate a
period of assessment. As an example the commenters provided the
situation where a discrepancy in the inventory is discovered without
any evidence of an ``actual theft'' (e.g., locks that have been cut),
requiring a period of assessment to determine the nature of the event.
Two commenters stated that the requirement for sabotage reporting
should be removed. The commenters noted that it would not be possible
for a licensee to determine the ``intent'' of the person causing any
damage and whether his or her ``intent'' is malevolent. One commenter
noted that Sec. 37.57(b) requires NRC notification when there is
``suspicious'' activity related to ``possible'' theft, sabotage, or
diversion. The commenter stated that it would only be appropriate to
notify the NRC if the licensee, in conjunction with the LLEA,
determines that there is some validity to the suspicion. The commenter
noted that the NRC should encourage open communication between the
licensee and LLEA, and licensees should feel free to express even minor
concerns, uncertainties, etc. to LLEAs for their assistance without
having to notify the NRC in each instance. One commenter agreed with
the reporting requirement for suspicious activities but noted that it
would be dependent on the licensee's judgment based on its
circumstances. The commenter noted that it would be difficult to
quantify what suspicious activity is ahead of time, and the licensee
should not be second guessed on whether or not it made this type of
notification. One commenter noted that suspicious activities should
continue to be reported on a voluntary basis as it is very subjective
and would be difficult to enforce. One commenter recommended defining
suspicious activity. One commenter expressed concern over the
requirement to report suspicious activities asking how it could be
enforced as individual judgment may differ as to what constitutes a
suspicious action. The commenter also questioned why, if the LLEA
provides an immediate assessment and determines that the event is
completely harmless, the NRC needs to be notified. The commenter
suggested language for Sec. 37.57(b) to increase the clarity and to
allow for some local interpretation. The suggested language is as
follows: ``The licensee shall notify the LLEA upon the discovery, of
any security-related events involving suspicious activity that may
indicate preoperational surveillance, reconnaissance, or intelligence-
gathering activities directed against licensees, or their facilities
related to possible theft, sabotage, or diversion of category 1 or
category 2 quantities of radioactive material. If the event is not
found to be harmless, the licensee should notify the NRC's Operations
Center (301-816-5100) as soon as possible, but not later than 4 hours,
after notifying the LLEA.''
Response: The NRC has revised the reporting requirement to make it
clear the licensee does not need to contact the LLEA when it has
determined that an alarm was not the result of an attempted or actual
theft, sabotage or diversion. The NRC does not believe that it is
necessary for the licensee to report to the NRC the denials for
unescorted access. The NRC has access to the information during
inspections. The NRC has retained the reporting requirement for
sabotage. If an individual has caused damage and placed the radioactive
material at risk, the NRC wants to know regardless of the individual's
intent. The NRC disagrees that it is necessary to establish a set
timeframe for reporting attempted theft, diversion, or sabotage as the
terminology is consistent with other similar reporting requirements.
The NRC agrees that it is good practice to have open communication
between the LLEA and the licensee.
On the question of reporting suspicious activities, the NRC has
decided to retain a requirement on suspicious activities. The reporting
of suspicious activities is an important component of evaluating the
threat against licensed facilities and material. The NRC reviews
individual notifications of suspicious activities to evaluate whether
potential
[[Page 16947]]
preoperational activities (i.e., multiple events at a single site or
multiple events at multiple sites) may be part of a larger plan and to
integrate this information with other agencies in the homeland security
and intelligence communities. The NRC is not requesting that the
licensees actively gather intelligence but rather that they report
information they believe is relevant to the security of their facility
or activity. The reporting requirements provide a consistent means of
communicating this information to the NRC. The requirement has been
revised to require the licensee to assess suspicious activities and to
only contact the LLEA if the licensee believes it is appropriate to do
so. The licensee is required to notify the NRC only if notifying the
LLEA. Some suspicious actions may be successfully handled by the
licensee without the need to involve law enforcement or the NRC. The
NRC believes that the revision will provide the licensee more
flexibility in determining how to address any situation that involves
what might be considered suspicious activities. The NRC does recognize
that what is considered to be suspicious is subjective and not all
licensees will handle the same situation in the same way. On balance,
the NRC believes that it will receive information on the more serious
instances, but not the trivial instances.
Comment A38: One commenter noted that in the absence of any
suspicious or known mitigating factors, it has typically given the
carrier 24 hours to trace within their transportation cycle, before the
package is declared as lost or missing. The commenter noted that this
has proven to be the most effective time period and that anything less
than the 24 hours does not allow sufficient time for the carrier to do
a complete document and tracking search and/or a physical search at
potential locations. The commenter noted that to declare the package as
lost or missing before that will result in many false positives, as
99.99% of the time the package is located within the 24-hour window
which will result in significant resources of both the regulatory
agencies and licensees involved, trying to get useful information that
just isn't available.
Response: Part 37 requirements would not change this practice. The
reporting requirement in Sec. 37.81(b) is similar to the requirement
from the orders. The licensee is not required to notify the NRC when
the material has not arrived by the no-later-than arrival time, rather
it is to notify the NRC once it has been determined that the material
is lost or missing. This allows some time for investigation before the
first phone call to the NRC. Similar to the order requirement, the
licensee is required to notify the NRC a second time if the material is
still missing after 24 hours of investigating. The rule should not
result in a change in practice and in fact gives the licensee
additional time before starting an investigation.
Comment A39: Several commenters requested information on how
diversion differs from a theft as in both cases the material is removed
and the movement is unauthorized. The commenters felt that the
requirements for reporting diversion and suspicious activities were
subjective and that the NRC's expectations concerning diversion and
suspicious activities were not clear.
Response: Diversion means the unauthorized movement of radioactive
material subject to this part to a location different from the
material's authorized destination inside or outside of the site at
which the material is used or stored. As an example, a source purchased
using a legitimate license may be shipped to an unauthorized location.
Diversion does not require the adversary to defeat the licensee's
physical security system. Theft is the act of taking material from a
facility, vehicle, or temporary job site and requires the adversary to
defeat the licensee's physical security system.
What constitutes a suspicious activity can be subjective and may
vary from one licensee to another. Examples of suspicious activities
are provided in the guidance. The reporting of suspicious activities is
an important component of evaluating the threat against licensed
facilities and material. The NRC reviews individual notifications of
suspicious activities to evaluate whether potential preoperational
activities (i.e., multiple events at a single site or multiple events
at multiple sites) may be part of a larger plan and to integrate this
information with other agencies in the homeland security and
intelligence communities. The NRC is not requesting that the licensees
actively gather intelligence, but rather that they report information
they believe is relevant to the security of their facility or activity.
The reporting requirements provide a consistent means of communicating
this information to the NRC.
Comment A40: One commenter recommended placing the reporting
requirements in Sec. Sec. 37.57 and 37.81 in subpart M of 10 CFR part
20 to avoid duplicative regulations. The commenter stated that the
notifications in Sec. 37.81 should be the same as 10 CFR part 20 and
should be immediately after discovery, but only after initially
notifying the LLEA. The commenter noted that immediate notifications of
theft should be made to the LLEA, not as soon as possible as the
proposed rule would allow. Another commenter noted that the reporting
requirements should be consistent to ensure that multiple reports for
the same event are not an unintended consequence.
Response: The NRC disagrees with the need to move the 10 CFR part
37 reporting requirements to 10 CFR part 20. The NRC has revised Sec.
20.2201(c) to include a reference to 10 CFR part 37 so that duplicative
reports are not required. The NRC disagrees with the comment to change
as soon as possible to immediate in Sec. 37.81(c) and (d). The
historic interpretation of immediate reporting has been up to 4 hours.
The NRC does not believe that 4 hours is the appropriate timeframe for
the notification; notifications need to be made promptly. For this
reason, the NRC has used ``as soon as possible'' in both the orders and
the rule language.
Comment A41: One commenter questioned the difference between the
requirements to report no later than 4 hours after the discovery of any
actual theft or diversion in Sec. 37.57 and the requirement in Sec.
37.81 to report within 1 hour of lost or missing material.
Response: Under Sec. 37.57, the licensee is to immediately notify
the LLEA and then to contact the NRC as soon as possible. If contacting
the NRC would somehow interfere with or delay the LLEA response, the
licensee can take up to 4 hours to notify the NRC. The LLEA would be in
charge of any response as the occurrence was at a fixed location. It is
the NRC's expectation that the notification would occur very quickly
after the LLEA is notified. Under Sec. 37.81, the licensee is required
to contact the NRC within 1 hour because the NRC may need to initiate a
response as the occurrence was during transit.
Comment A42: One commenter noted that the rule should not require
the licensee to provide a copy of the reports required under Sec.
37.81(g) to the Office of Nuclear Security and Incident Response
(NSIR). The commenter believes that the NRC should provide the copy to
NSIR. One commenter recommended that the written follow-up report for
event reporting be submitted within 60 days instead of 30 days. The
commenter noted that 30 days is insufficient time for licensees to
complete an investigation, prepare, and submit a written report and
that the 30 days is inconsistent with the timeframe for submittal of
written follow-up reports that are required elsewhere in 10 CFR Chapter
I. One commenter objected to the wording of the requirement in Sec.
37.81(g) to ``include sufficient
[[Page 16948]]
information for NRC analysis and evaluation'' as it is too open-ended
and the commenter felt that further explanation is necessary. The
commenter stated that the NRC is doing a disservice to licensees if it
wishes to claim that such items are difficult or impossible to predict
for all cases or would be more fully addressed in guidance.
Response: The NRC agrees with the comment in part and disagrees
with the comment in part. The NRC often specifies that a copy of a
report should be submitted to a specific office and does not believe
that it presents a large burden on the licensee. While some of the
follow-up reports contained in Title 10 Chapter I are submitted within
60 days, some are submitted within 30 days. The 30-day timeframe for a
written follow-up report is consistent with the requirement for the
follow-up report for reporting lost and missing material contained in
10 CFR part 20. If the investigation is not complete, a final report
can be submitted upon completion. The NRC agrees with the comment on
sufficient information and has added language similar to the provisions
in Sec. 20.2201(b).
Comment A43: One commenter requested that a subsection be added to
Sec. 37.57 to clarify requirements for reporting by a licensee or
permittee under a master materials license that has an onsite LLEA in
order to preclude unwarranted interpretations during a regulatory
inspection about reporting to NRC. The commenter offered suggested
language as follows: ``(d) For a licensee or permittee under a master
materials license with an on-site LLEA, reporting in this subsection is
required only after the on-site LLEA has confirmed the attempted,
actual, or actual activity related to theft, sabotage, or diversion of
category 1 or category 2 quantities of radioactive material.''
Response: The NRC disagrees with the comment. The reporting
requirements remain the same whether the LLEA is on site or off site.
The NRC does note that the LLEA does not need to be contacted until
after the licensee has assessed the situation. The LLEA needs to be
notified only if the licensee has determined that an attempted or
actual theft, diversion, or sabotage act has occurred or is taking
place, or, as appropriate, if the licensee has identified suspicious
activities.
Comment A44: One commenter recommended defining substantive
information in Sec. 37.81(h). The commenter noted that the term
substantive information indicated a higher priority notification than
30 days.
Response: The NRC disagrees with the comment. The provision is
identical to the provision in Sec. 20.2201(d). A licensee should use
judgment on whether the information should be provided sooner than 30
days.
Comment A45: One commenter stated that certain provisions of the
proposed rule would be matters of mandatory compatibility between the
NRC and the Agreement States. The commenter stated that the NRC has no
statutory basis requiring an Agreement State to maintain regulations
compatible with those of the Commission. The commenter believes that
the Commission may request compatibility by the State, but cannot
require it.
Response: Section 274, ``Cooperation with States,'' of the AEA
provides for cooperation with States, authorizing the Commission to
enter into Agreements with States for certain materials provided that
certain conditions are met. Two specific sections of the AEA provide
for compatibility requirements: (1) Subsection 274d. gives the
Commission the authority to enter into an Agreement with a State if the
Commission finds that the State program is compatible with the
Commission's program for regulation of such materials (subsection
274d(2); and (2) under subsection 274g. of the AEA, the Commission is
authorized and directed to cooperate with the States in the formulation
of standards for protection against hazards of radiation to assure that
the State and Commission programs for protection against hazards of
radiation will be coordinated and compatible.
In the Commission's policy statement, ``Policy Statement on
Adequacy and Compatibility'' (62 FR 46517; September 3, 1997), the
Commission addressed a similar comment. At that time, it was the
Commission's view that, pursuant to section 274, an Agreement State's
program should be compatible with NRC's program for the duration of the
Agreement for the following reasons, set forth in the policy statement:
Subsection 274g. authorizes and directs the Commission to
cooperate with the States in the formulation of radiation protection
standards ``to assure that the State and Commission programs for the
protection against hazards of radiation will be coordinated and
compatible.'' This provision demonstrates Congress' intention that
the compatibility between the NRC and Agreement State programs
should be maintained on a continuing basis.
Subsection 274j.(1) calls on the Commission to suspend or
terminate an Agreement State's program if ``the State has not
complied with one or more of the requirements'' of Section 274. The
Commission believes that this phrase ``one or more of the
requirements,'' encompasses all requirements of Section 274,
including the requirement for compatibility in Subsection 274(g).
Under Subsection 274d.(2), the Commission is authorized to enter
into an agreement with a State if the Commission makes both
requisite findings that the State program is compatible with the
NRC's program and adequate to protect public health and safety.
Absent a continuing compatibility requirement, an Agreement State
could divert from having a compatible program the day after any
agreement is signed with NRC. This would render the Commission's
initial compatibility finding required by Subsection 274d.(2)
meaningless.
In addition, the NRC has an obligation, pursuant to section 274j.
of the AEA, to periodically review existing Agreement State programs to
ensure continued adequacy and compatibility. Section 274j. of the AEA
also provides that the NRC may terminate or suspend all or part of its
agreement with a State if the Commission finds that such termination is
necessary to protect public health and safety or that the State has not
complied with the provisions of section 274j. In fulfilling this
statutory responsibility, NRC provides oversight of Agreement State
radiation control programs to ensure that they are adequate and
compatible prior to entrance into a section 274b. agreement and that
they continue to be adequate and compatible after an agreement is
effective. The NRC, in cooperation with the Agreement States,
established and implements a performance evaluation program to provide
NRC and Agreement State management with systematic, integrated, and
reliable evaluations of the strengths and weaknesses of their
respective radiation control programs and identification of areas
needing improvement, the Integrated Materials Performance Evaluation
Program (IMPEP).
There have been no changes to the AEA or to Commission policy that
would render a different interpretation of these sections of the AEA.
Therefore, no changes were made to the rule in response to this
comment.
Comment A46: Two commenters stated that it was unclear if the rule
can be implemented under a public health and safety basis. The
commenters noted that the performance objective in Sec. 37.21(b) is to
prevent an unreasonable risk to public health and safety or the common
defense and security, but that the basis for the rule is health and
safety and not common defense and security.
Response: This rule can be implemented under the NRC's authority to
protect the public health and safety. The rule amends NRC's regulations
to impose security requirements for the
[[Page 16949]]
use of category 1 and category 2 quantities of radioactive material.
The proposed security requirements set forth the objectives and minimum
requirements that licensees must meet to protect against theft or
diversion of category 1 or category 2 quantities of radioactive
material. Accordingly, these requirements increase the protection of
the public from harm resulting from the unauthorized use of these
materials.
As discussed in the Statements of Consideration for the proposed
rule (75 FR 33902, 33907 (June 15, 2010)), when regulations such as
these address both the NRC's public health and safety and common
defense and security missions, the operative question is whether NRC
oversight is necessary to fulfill the common defense and security
aspects of the regulations. The NRC believes that the Agreement States
can consistently and adequately implement the physical protection
requirements, and as such, there is no need for independent NRC action
to protect the common defense and security. However, the NRC retains
the authority under section 274(m) of the AEA to take any necessary
actions for protection of common defense and security should individual
licensees or the State program develop issues requiring immediate
action.
Implementing these regulations under the NRC's public health and
safety authority avoids potential complications with licensees being
subject to dual regulatory authorities for a single license. Agreement
States can impose these security requirements because they provide a
reasonable assurance of preventing the theft or diversion of category 1
and category 2 quantities of radioactive material that has a potential
to result in significant adverse health impacts and reasonably
constitutes a threat to public health and safety. In addition, making
these requirements applicable to Agreement State licensees through the
Agreement State Program allows Agreement States to impose these
requirements on its licensees and makes Agreement States responsible
for enforcement of these requirements on its licensees.
Comment A47: One commenter noted that while the NRC has regular
oversight of individual Agreement State programs through its Integrated
Materials Performance Evaluation Program (IMPEP), the NRC should
evaluate its authority under IMPEP against the authority granted to the
Secretary of Transportation under U.S.C. Title 49 Section 5125--
Preemption. Prior to relinquishing its regulatory authority to the
Agreement State, the NRC should ensure that it is authorized and
capable of preempting an Agreement State regulation pertaining to the
physical protection in transit of category 1 and category 2 quantities
of radioactive materials if the Agreement State regulation does not
comply with the general criteria provided in 49 U.S.C. 5125. The
commenter stated that if the NRC concludes that it is indeed
appropriate for the Agreement States to regulate the physical
protection of category 1 and 2 quantities of radioactive material while
in transit then a mechanism has to be in place to ensure these
Agreement State regulations cannot add requirements in addition to
those provided in 10 CFR part 37.
Response: The NRC in its Policy Statement on Criteria for Guidance
of State and NRC in Discontinuance of NRC Regulatory Authority and
Assumption Thereof by States Through Agreement, developed criteria to
implement the Agreement State program, authorized by Public Law 86-373
which was enacted in the form of a new section to the AEA (section 274)
and approved by the President on September 23, 1959 (46 FR 7540-7546;
January 23, 1981). Criterion 10 of the Policy Statement, Regulations
Governing Shipment of Radioactive Materials, provides that the State
shall to the extent of its jurisdiction promulgate regulations
applicable to the shipment of radioactive materials, such regulations
to be compatible with those established by the U.S. Department of
Transportation and other agencies of the United States whose
jurisdiction over interstate shipment of such materials necessarily
continues. Therefore, State regulations regarding transportation of
radioactive materials must be compatible with 10 CFR part 71.
The NRC believes that it is indeed appropriate for the Agreement
States to regulate the physical protection of category 1 and category 2
quantities of radioactive material while in transit under the
provisions of the 274b. Agreements and the continued oversight provided
by the NRC. Many of the transportation requirements fall within the
Compatibility Category B, Program Elements with Significant
Transboundary Implications. Agreement State program elements under
Compatibility Category B should be essentially identical to those of
the NRC. The NRC evaluates these program elements under IMPEP and can
take actions when a State has a program that is not compatible
including termination or suspension of an agreement. We believe that
this mechanism appropriately addresses the concern that a mechanism be
in place to address the scenario of Agreement State regulations, adding
requirements beyond those provided in 10 CFR part 37 where the
additional requirements would not meet the compatibility designation
for a given provision.
Comment A48: Numerous commenters stated that the requirements
created too much burden with little, if any, improvement in security
and are not necessary or justified and are a waste of taxpayer money.
Some commenters felt that the requirements were not commensurate with
the risk of the material and were unnecessarily complex, complicated,
and long. Some commenters noted that there were no quantifiable
benefits, only qualitative benefits and, therefore, there is no
evidence that additional measures are necessary. One commenter noted
that there must be a balance between the real benefit of providing the
services that the category 1 and category 2 sources provide, against a
hypothetical malevolent act that may involve one of these sources. Some
commenters felt that implementation of the new requirements would
financially cripple small companies and would limit funding for new,
safer technologies. Some commenters indicated that the burden could
result in some medical facilities not offering radiation therapy
services, a reduction in research, and will negatively impact patient
care. One commenter was of the opinion that the number of licensees
would drop by 25 to 30 percent. Commenters felt that the original order
requirements are adequate and should be maintained with no additions as
they were sufficient to ensure security. Commenters felt that
additional requirements should be based on documented deficiencies in
the orders and not on the very low likelihood of a terrorist event. One
commenter noted that inspections insure that licensees are performing
operations in such a manner as to meet regulatory requirements as they
stand. One commenter noted that the NRC has not conducted a national
performance-based assessment of the current orders. Commenters stated
that the rule was overly prescriptive. Several commenters stated that
the requirements should be graded for different types of facilities and
material and fixed versus portable material. Some commenters felt that
the NRC has lost touch with the way the industry operates or wouldn't
suggest unnecessary changes.
Commenters noted that monetary burden of compliance with the orders
has required industry to reduce the amount of resources allocated for
other aspects of its business and has made it challenging to compete in
the global market. Some commenters expressed
[[Page 16950]]
concern over the cumulative impact noting the implementation of the
National Source Tracking System and the license verification system.
One commenter noted that it wasn't just the initial outlay, but also
the annual burden that needed to be considered. One commenter noted
that the rule would impact licensees who have previously not been
impacted by the orders. The commenter noted that educating and
inspecting these new licensees will impact the NRC staff resources, and
could diminish their focus on ensuring security compliance for existing
category 1 and category 2 sources. One commenter noted that the rule
would be burdensome on the regulatory agency and LLEAs, as well as
licensees.
One commenter suggested placing generic requirements in the rule
and then address subsets of licensees in the NUREG-1556 series. One
commenter suggested that the proposed rule should be renoticed after
making changes with more detail provided as to the actual safety and
security benefits to be obtained. One commenter noted that the rule
does not conform to the recent draft policy statement on the Protection
of Cs-137 Chloride sources.
Response: The NRC understands the concerns of the commenters and
has tried to limit the burden while continuing to ensure the adequate
safety and security of sources of concern. The security orders were
issued based on the specific knowledge and information available to the
Commission at the time the orders were issued. The NRC never intended
to simply make generically applicable security requirements identical
to the orders. The NRC always intended to consider insights gained from
the implementation of the orders and implementation of the inspection
program, as well as other factors. A number of changes have been made
based on specific public comment. The result of these rule changes
significantly reduces the burden of the final rule as compared to the
proposed rule. The NRC believes that the provisions in the final rule
are necessary to protect the public health and safety and ensure
security. There could be some facilities impacted by the rule that were
not impacted by the orders. Some facilities, such as reactors and fuel
facilities, may be impacted by 10 CFR part 37. There should not be any
byproduct material facilities newly impacted by 10 CFR part 37 that
were not impacted by the orders.
Comment A49: A couple of commenters stated that the NRC should only
include the order provisions in the rule and then start work on
developing a strategic rulemaking, which may need to include changes in
legislative authority, to develop a 10 CFR part 37 with a more risk-
informed and performance-based model. The commenters noted that this
effort should include evaluating requirements for different types and
quantities of radioactive material and different uses, working with
States and law enforcement groups to determine effective ways to
transport material and working with law enforcement groups to determine
effective ways that an LLEA can know and provide emergency response
support to licensees. Another commenter suggested using subparts based
on the type of business and security risks commensurate with each type.
One commenter noted that the two-part approach would be a major
accomplishment for the NRC and would be consistent with NRC's
``Principles of Good Regulation.'' The commenter noted that this
approach would reflect the Commission's Staff Requirements Memorandum
(SRM) on the draft policy statement on the protection of Cesium-137
Chloride sources (SRM for COMSECY-09-0029) which states: ``any
additional efforts to enhance security for these sources should
consider whether there are benefits of further risk reduction given the
NRC's actions to date and the current threat environment.''
Response: It was never the NRC's intent to include in the
rulemaking only the order provisions. While there are differences from
the orders, the NRC believes that the requirements contained in the
final rule are necessary. As a general principle, the NRC prefers to
construct performance-based regulation rather than explicit,
prescriptive regulation where possible. The rule does not dictate what
measures each licensee must use to protect the radioactive materials
under its possession and control, rather the rule allows the licensee
to choose those measures that best meet its needs. The NRC believes
that the rule is risk informed and contains an optimized mix of
performance-based and prescriptive requirements. A two-step process to
conduct two rulemakings would be a waste of not only to the NRC and
Agreement State resources but also those of licensees. The basic
requirements in the orders were the same for all licensees. The NRC is
aware of the areas that need enhancements and these areas are addressed
in the rule. The NRC did add a new option to the regulatory analysis
for the final rule that addresses only including the order provisions
in the rule.
Comment A50: One commenter stated that the total cost of the 10 CFR
part 37 revision should include the costs that the licensees incurred
to meet the orders and that the estimate and burden on licensees is out
of proportion to the actual risk. Another commenter stated that the
option 1 cost analysis was inappropriate because it assumed no security
measures had been implemented, and it should have considered that the
orders were in place. The commenter stated that an additional cost
option determining the cost of implementing a new 10 CFR part 37 with
requirements equivalent to the orders would be helpful. Several
commenters stated that the cost estimates were underestimated but did
not offer better cost estimates. One commenter stated that the annual
recurring licensee cost was underestimated by at least a factor of 2.
One commenter estimated that it would cost about $30,000 to implement
the provisions and about $20,000 every year to maintain the plan and
that the reinvestigation would cost between $10,000 and $20,000
depending on the number of users that need to be rechecked. One
commenter noted that the regulatory analysis did not specifically
describe the average licensee on which the analysis is based. One
commenter (a research facility) noted that it would need to process an
additional 60 individuals per year and that the rule would cost
approximately $23,000 per year and an initial outlay of $30,000. One
commenter noted that it had added one additional employee to address
the order requirements and that the rule would add yet more burden. One
commenter stated that the regulatory analysis does not provide any
technical data to support the statement that the qualitative benefits
outweigh the costs of the rule. One commenter noted that a major
medical facility could have hundreds of individuals in its access
authorization program. One commenter noted that it had spent about
$250,000 on physical site upgrades alone and has recurring costs of
$50,000 annually for the alarm system to support the existing orders.
One commenter stated that it spends approximately $100,000 a year for
the transportation of category 1 and category 2 sources under the
orders. The commenter noted that the amount of employee resources to
implement and support the orders has been approximately 400 man days
initially and 75 man days annually with total costs to date of
approximately $1.5 million. The commenter estimated that to implement
the additional requirements in the rule, it would cost
[[Page 16951]]
$250,000 initially which includes 100 man days to set up all the
programs and procedures and an ongoing annual cost of $100,000 to
$200,000 for hiring at least one to two individuals as a technical/
administrative resource to implement all the procedural and
documentation requirements. The commenter stated that the costs assumed
in the regulatory analysis ($25,000 initially and $27,000 annually) to
be substantially underestimated. Some commenters noted that the
regulatory analysis did not identify any quantifiable values and that
the qualitative benefits were identical to the program in place today.
One commenter noted that National Nuclear Security Agency (NNSA) is
spending $26 million to implement voluntary enhancements at certain
facilities. One commenter noted that it was not clear that NRC had
considered the potential impacts to licensee safety programs, research,
and an increase in disused sources due to ''deteriorating financial
circumstances'' (mentioned in SECY 10-0164) that may result from the
rulemaking.
Response: The NRC appreciates the information provided on cost and
considered that information when estimating the costs in the final
regulatory analysis, increasing the annual cost of implementing the
measures, increasing the number of individuals requiring a background
investigation, and using different values for a small, medium, and
large facility. The regulatory analysis prepared to support the
proposed rule did contain the cost information on the orders. As the
cost has already been expended, it is considered a sunk cost and is not
included in the main analysis. The cost is provided for informational
purposes. Many attributes considered in a regulatory analysis can only
be expressed in a qualitative way and cannot be quantified. Differences
in quality cannot be easily assessed or expressed. While it is possible
that some licensees may decide to go out of business and there could be
additional disused sources, the NRC is not able to predict how many, if
any, companies might decide to go out of business.
Comment A51: One commenter noted that the regulatory analysis and
regulatory flexibility analysis did not reflect the actual number of
licensees impacted (closer to 2,900) versus the number actually
implementing the orders (about 1,400).
Response: The regulatory analysis did reflect the 2,950 licensees
that would be impacted by the proposed rule. Section 3.2.3 lays out the
assumptions used in the analysis. The analysis assumed that 1,400
licensees would need to fully implement the security provisions and
that another 1,550 licensees would need to conduct some activities. The
commenter is correct that the regulatory flexibility analysis only
addressed those that fully implemented the provisions.
Comment A52: Two commenters noted that the regulatory analysis does
not address how harmonization between the NRC proposed rule and
eventual Agreement State regulations will be assured; specifically in
regards to the requirements contained in subpart D. The commenter noted
that inconsistencies between Agreement State transport security
requirements could greatly hinder the ability to transport category 1
and 2 quantities of radioactive materials in commerce and could also
serve as barriers to transporting category 1 and 2 quantities of
materials through an Agreement State. The commenter noted that it is
also unclear if the NRC considered what fees Agreement States may
impose to fund the cost of regulating the physical protection of
material in transit. The commenter noted that the State of Iowa
currently has what Industry considers excessive fees to transport
category 1 quantities of materials through the State.
Response: The commenter is correct that harmonization of the
requirements between the NRC and the Agreement States is not addressed
in the regulatory analysis; the cost for the States to adopt the
regulations is addressed. The final rule is a matter of compatibility
between the NRC and the Agreement States. The NRC analyzed the final
rule in accordance with the procedure established within Part III,
``Categorization Process for NRC Program Elements,'' of Handbook 5.9 to
Management Directive 5.9, ``Adequacy and Compatibility of Agreement
State Programs.'' Most of the provisions in subpart D are Compatibility
Category B because there are significant transboundary implications.
The Agreement States must adopt Category B program elements in an
essentially identical manner. The Agreement States do have 3 years to
adopt the regulations. For transportation of category 1 quantities of
radioactive material, an Agreement State licensee will continue to
follow the NRC order on transportation until the State adopts the
regulation. The order would then be withdrawn and the transportation
would occur under the Agreement States' regulations. For category 2
shipments, an Agreement State licensee will follow the Increased
Control provisions on transportation until the State adopts the
regulations. As for the fees that a State may charge, the NRC does not
have any control as this is not a matter of compatibility. A State
could choose to charge a fee whether the transport occurred under NRC
or State requirements. The fees aspect is beyond the scope of this
rulemaking.
Comment A53: One commenter noted that because Agreement States have
3 years to adopt regulations compatible with the final rule, provisions
need to be made so licensees with both NRC and Agreement State licenses
who modify their programs to comply with the NRC requirements are not
cited as noncompliant with the Agreement State license.
Response: A licensee must be in compliance with the regulations for
the jurisdiction in which it operates. Part 37 is no different than any
other regulation in that regard. A licensee that has implemented the 10
CFR part 37 requirements should be in compliance with the majority of
the provisions in the orders. The licensee can have discussions with
its Agreement State regulator about adopting the provisions before the
State has issued compatible requirements.
Comment A54: One commenter addressed the questions related to small
businesses. The commenter indicated that the rule needs to be more risk
informed and better recognize the actual risk associated with category
2 sources by providing more flexibility. The commenter indicated that
the annual risk from a category 2 radioactive material dispersal device
is between 10,000 and 100,000 times less likely than many other sources
of premature death that the United States population commonly accepts
from smoking, obesity, medical accidents, and auto accidents.
Response: The Commission has determined that category 1 and
category 2 quantities of radioactive material warrant additional
security measures. In addition, the Radiation Source Protection and
Security Task Force found that the category 1 and category 2 quantities
warrant enhanced security and protection. See also QA5 and QA6 in
Section II of this document.
Comment A55: Two commenters provided input on the specific
questions related to information collection. On the question of whether
the proposed information collection is necessary for the proper
performance of the functions of the NRC and the information has
practical utility, one commenter agreed with the need for signed
consent but questioned the usefulness of the credit history review and
the FBI criminal history records check. The commenter agreed that a
licensee needs to have an individual's employment and education
history, but questioned the need to
[[Page 16952]]
require the individual to provide the information multiple times if the
licensee already has the information in the individual's employment
record. The commenter did not address the utility of any other aspects
of the information collection. Two commenters did not agree with the
burden estimate. One commenter stated that the estimate of the number
of individuals who would need to have a background investigation was
low; but provided no other estimates. The commenter also indicated that
the cost of the background investigation was underestimated, and
estimated that a background check would cost from $60 to $250 and
higher. The commenter noted that it would take licensee personnel 10
hours to gather, submit, and review background information for a normal
background check, to more than 20 hours if the individual had resided
in multiple State and foreign jurisdictions. The commenter estimated
that it would take an individual 2 hours to complete a personal
disclosure history, and that this was not included in the analysis. The
commenter noted that a licensee would have to develop a compliance
program required by the Fair Credit Reporting Act to obtain credit
history and arrest records. A second commenter stated that the current
labor rate for nonroutine technical support is $149 per hour. The
commenter stated that first-year implementation would be about 320
hours, or $47,000 and about $30,000 a year thereafter. On the question
of whether the burden of the information collection could be minimized,
one commenter noted that a more prudent and efficient method of
checking background and overall status of an employee is to use the
federal database ``E-verify.'' The commenter stated that the NRC could
rely on the E-verify check as one of the background check tools for a
licensee's access authorization program. The commenter also requested
that guidance be given on FBI criminal background reports to assist a
licensee's understanding of what the information in the report means.
Response: The NRC notes that the FBI criminal history records check
is required by the EPAct. The NRC has removed the requirement for a
credit history evaluation as part of the background investigation. See
response to Comment B67 for further discussion on credit history. There
is no requirement for an individual to provide employment and education
history multiple times. If the licensee already has that information,
it does not need to go back to an individual to obtain the information
a second time. Effort for the personal history disclosure was not
included because it was viewed as information that would be provided
when seeking employment and completing an application for employment.
The information on cost and time was factored into the regulatory
analysis for the final rule. As for the E-verify system, a licensee may
use it as one tool for completing a background investigation, but use
of E-verify alone would not meet the requirements for the background
investigation. Guidance on the background investigation is available in
the implementation guidance.
Comment A56: Commenters requested guidance for various provisions
of the rule, noting that the guidance was necessary for both the
licensees and the regulatory agency. Commenters were specifically
interested in guidance for both the determination on the reviewing
official that would be used by the regulator and for the determination
for those to be allowed unescorted access to the material that could be
used by the reviewing official. Commenters felt that the lack of
criteria or guidance will result in inconsistent approval or denial of
the individuals. Commenters noted that compliance determinations are
performance based and that the regulatory agency would have no recourse
but to deem a licensee's determination appropriate as long as the
licensee documented the basis. Several commenters agreed that licensees
should be allowed flexibility in conducting the background reviews. One
commenter suggested that the NRC should review 49 CFR 73.8 for specific
guidance for denying an individual access.
Response: Guidance on the rule is available in the document
``Implementation Guidance for 10 CFR part 37 Physical Protection of
Byproduct Material Category 1 and Category 2 Quantities of Radioactive
Material,'' which will be published at approximately the same time as
this final rule. Guidance on what should be considered in evaluating
the results from the background investigation is in the document. The
document does not contain a checklist, but provides general guidelines
for making the determination on whether to grant an individual
unescorted access. The determination basis is performance based; each
licensee is responsible for making its own determination. Under the
orders, the trustworthiness and reliability official made the
determinations of who was granted access and that official is now
called the reviewing official. Although there will be additional
factors to consider, the decision-making responsibility remains
unchanged.
Comment A57: One commenter stated that the sections for the
Paperwork Reduction Act Statement and Regulatory Flexibility
Certification do not appear to have included pool irradiator and
manufacturer/distributor licensees with category 1 quantities of
radioactive material in their scope, and the documents will need to be
augmented.
Response: Pool irradiator and manufacturer/distributor licensees
were included in the analysis conducted for the Paperwork Reduction Act
Statement and the Regulatory Flexibility Certification.
B. Access Authorization Program
Comment B1: One commenter stated that Sec. 37.21(a) did not
address the requirements for currently approved access authorization
programs or the actions that must be taken by the licensee within a
specific timeframe. Another commenter noted that it was not clear what
licensees that implemented the orders needed to do.
Response: The NRC did not approve access authorization programs
under the orders. The NRC approved them in the sense that we inspected
and did not cite them if their programs were adequate. All licensees
that allow unescorted access to an aggregated category 1 or category 2
quantity of radioactive material must have an access authorization
program that meets the requirements of subpart B on the date that the
rule is effective in the State in which the licensee conducts its
operations. The NRC is providing a 1-year implementation period for the
final rule.
Comment B2: One commenter requested clarification as to whether
Sec. 37.21(a)(2) is based on possession or authorized possession.
Response: The proposed rule contained several provisions that were
based on authorization to possess. These provisions are not contained
in the final rule. The NRC has revised the text to make clear that the
provisions apply only to those that actually possess the material.
Comment B3: One commenter stated that in Sec. 37.21(b), the term
``unreasonable risk'' should be defined.
Response: The NRC disagrees with the comment. The NRC acknowledges
that implementation is dependent on the judgment of the reviewing
official; however, this is a performance-based requirement and provides
the licensee with flexibility in the implementation of its program.
Although, the NRC has removed the term ``unreasonable risk''
[[Page 16953]]
from the requirement, the concept remains because the concept is
inherent in the definition of trustworthy and reliable.
Comment B4: One commenter stated that Sec. 37.21(c) should be
deleted as being redundant to previous sections about who is approved
for unescorted access.
Response: The NRC disagrees that Sec. 37.21(c) is redundant. The
section establishes the individuals that are subject to the access
authorization program.
Comment B5: One commenter stated that Sec. 37.21(c)(1) introduces
new criteria for approval (individuals with job duties that require
unescorted access) that are not otherwise used in the regulations. The
commenter indicated that if it was considered necessary to limit
approvals, the section should be modified by inserting the word
``only.''
Response: The NRC disagrees with the comment. Section 37.21(c)(1)
establishes the individuals who are subject to the access authorization
program and, therefore, need to undergo a background investigation and
be determined to be trustworthy and reliable.
Comment B6: One commenter asked if the shipper or the carrier was
responsible in Sec. 37.21.
Response: The licensee is responsible for assuring that all
individuals who have unescorted access to the category 1 or category 2
quantities of radioactive material have undergone a background
investigation (or fall under one of the categories for relief) and been
determined to be trustworthy and reliable. A commercial carrier is
subject to separate State and federal transportation security
requirements, and is not a licensee under 10 CFR part 37.
Comment B7: One commenter noted that movement control center
personnel were included in the list of individuals who were to be
subject to an access control program. The commenter noted that the
licensee may not have direct oversight of these centers and the center
may be monitored by LLEA or other security or emergency personnel which
could make enforcement difficult or impossible as these individuals
would likely not be responding to an emergency. One commenter noted
that the vehicle driver and accompanying individual(s) and movement
control center personnel are typically employed by the carrier, and the
access authorization program should be under the carrier's
responsibility. One commenter stated that licensees can't implement the
requirement of Sec. 37.21(c)(1)(ii) and (iii) when carriers are used
for shipments of category 1 quantities.
Response: The movement control center personnel were included
because they have access to SGI-M. The vehicle driver and accompanying
personnel were included, in part, because they have access to the SGI-M
information. Whether these individuals come under 10 CFR part 37 access
authorization program or not, they would still need to be fingerprinted
and determined to be trustworthy and reliable under the requirements of
10 CFR part 73. The NRC has revised Sec. 37.21(c) to reflect that
those with access to SGI may be placed under 10 CFR part 37 access
authorization program or they may be part of a separate program that
meets the requirements of 10 CFR part 73. Law enforcement personnel are
relieved from the fingerprinting and background check that are required
for access to SGI and are relieved from the background investigation
required under 10 CFR part 37.
Comment B8: One commenter stated that Sec. 37.21(c)(3) conflicts
with the requirements of Sec. 37.21(c)(1)(ii), (iii), (iv), and (v) as
none of those personnel require unescorted access to radioactive
material.
Response: The NRC disagrees that there is conflict with the
requirements. Some of the personnel referenced in Sec. 37.21(c)(1)
were part of the access authorization program because they required
access to SGI information which also requires a determination of
trustworthiness and reliability. However, the requirements for the
background investigation required for SGI and unescorted access are not
identical, so the NRC has revised Sec. 37.21(c) to reflect that those
requiring access to SGI may be included in the access authorization
program, but are not required to be included. The licensee can choose
to have a separate program to provide access to SGI information.
Comment B9: One commenter noted that the specific requirement for
access to materials included transport of category 1 and category 2
materials and that the requirements should be consistent with 10 CFR
part 71 and 49 CFR 171 through 180.
Response: Part 71 does not contain requirements related to access
of materials. The referenced DOT regulations do not contain
requirements for access to materials, except for a driver who needs a
hazardous material certification which includes fingerprints and an FBI
criminal history check. Part 37 provides relief from the fingerprinting
aspects of the background investigation for individuals that have
undergone the DOT check.
Comment B10: Two commenters requested clarification whether an
engineer designing the security systems for an irradiator room would
need unescorted access. The commenters noted that it would be
beneficial if the requirements for individuals with access to sensitive
information were clearly described.
Response: Whether to grant unescorted access to an engineer
designing the security systems would be up to the licensee. The
licensee could arrange for the engineer to be escorted while in the
irradiator room or could conduct a background investigation and grant
the engineer unescorted access if the licensee believed it was
warranted. The requirements for individuals with access to sensitive
information are contained in Sec. 37.43(d).
Comment B11: One commenter asked what shipping information requires
an access authorization program.
Response: The shipping information related to shipments of category
1 quantities of radioactive material is considered to be SGI-M. Part 73
contains requirements for individuals to undergo a background check and
be determined to be trustworthy and reliable before being allowed
access to SGI. A licensee can include those individuals needing access
to SGI-M in its access authorization program under 10 CFR part 37 or in
a separate program under 10 CFR part 73. If a licensee has an access
authorization program that meets the requirements of 10 CFR part 37,
the program will also meet the requirements of 10 CFR part 73 for
access to SGI-M.
Comment B12: One commenter noted that a licensee's access
authorization program expands beyond those permitted to have unescorted
access to category 1 or 2 sources and, therefore, the rule text must
accurately reflect the need to include such individuals without
requiring them to have unescorted access to the sources.
Response: The access authorization program may also apply to those
that require access to SGI, such as personnel involved in
transportation of category 1 quantities of radioactive material. The
rule has been clarified to reflect that those with access to SGI may be
part of the access authorization program for materials unless the
licensee chooses to have a separate program. Although the comment is
not clear, the NRC believes that the commenter was referring to the
reviewing official as someone that should not be required to have
unescorted access to the sources. The NRC believes that it is important
that
[[Page 16954]]
the reviewing official undergo the same background investigation as
those being reviewed and approved by the reviewing official. Therefore,
the reviewing official is included in the access authorization program.
See also the responses to B14 and B15.
Comment B13: One commenter noted that if the radioactive material
is in a secured area within a room, then a trustworthiness and
reliability determination shouldn't be required for personnel who need
access to that room.
Response: Secured area can mean different things. If the material
is accessible by breaching a common barrier, then the individuals would
need to undergo a background investigation and be determined to be
trustworthy and reliable. See the implementation guidance for examples.
Comment B14: In the proposed rule, the NRC specifically invited
comment on the issue of fingerprinting the reviewing official.
Commenters were specifically requested to provide information on: (1)
Whether the reviewing official needs to be fingerprinted and have an
FBI criminal records check conducted; (2) whether the other aspects of
the background investigation are adequate to determine the
trustworthiness and reliability of the reviewing official; (3) whether
there are other methods that could be used to ensure that the reviewing
official is trustworthy and reliable; (4) whether the requirement to
fingerprint the reviewing official places too large of a burden on the
licensee; and (5) whether the Agreement States have the necessary
authority to conduct reviews of the nominated individual's criminal
history record. Twenty commenters provided responses to the specific
questions on this subject.
Of those that provided responses to the questions on fingerprinting
of reviewing officials, the commenters were evenly split on whether the
reviewing official should be fingerprinted. Of those that responded no
on the fingerprinting, most did not support the concept of a reviewing
official at all and stated that the trustworthiness and reliability
official established under the Increased Control Orders should remain
in place. One of those opposed to the fingerprinting of the reviewing
official stated that the official should be approved by the licensee as
did a couple of the commenters that indicated support for
fingerprinting. One of those supporting fingerprinting was opposed to
requiring the individual to have access to radioactive material. The
commenter suggested that the NRC table this element until NRC is
granted authority to require fingerprinting of the reviewing official.
The majority of those responding indicated that the other aspects of
the background investigation were adequate to determine the
trustworthiness and reliability of the reviewing official, including
several commenters that supported the fingerprinting requirement.
Several responded that specific guidance and acceptance or rejection
criteria must be made available. Several commenters indicated that the
reviewing official should meet all of the requirements for unescorted
access. Three commenters stated that other aspects of the background
investigation were not adequate but also indicated that they did not
support the concept of a reviewing official. Based on its experience
with the orders, one commenter stated that the criminal history derived
from the FBI should serve as the sole basis. Most of the commenters did
not think that the fingerprinting placed too large a burden on the
licensee. Of the two commenters that felt that fingerprinting did place
too large of a burden on the licensee, one of the commenters did not
explain its rationale and the other stated that it was unnecessary for
the reviewing official to have access to the material. One commenter
indicated that this placed too large a burden on the States. On the
question of whether the States have the authority to conduct reviews of
the nominated individual's criminal history record, the response was
inconclusive, with many commenters noting the authority was
undetermined or not clear whether the State had authority. One State
indicated that it did have the authority, two States that they probably
had the authority, and one State indicated that it did only if specific
disqualifying criteria are put in the regulations. Suggestions for
other methods that could be used to ensure that the reviewing official
is trustworthy and reliable included deferring the decision to licensee
management using best business practices; using a background
investigation by a professional such as a police investigator, private
security clearance contractor, or human resource professional; and use
of employment history with the licensee.
In addition to those that addressed the specific questions, 33
commenters addressed this subject. The Conference of Radiation Control
Program Directors (CRCPD) conducted a survey of the Agreement States,
and 69 percent of those that responded disagreed with the requirement
for the regulatory body to approve the reviewing official. However, 62
percent did support the requirement that the reviewing official be
fingerprinted. Some commenters noted that there may be some States that
may not have the authority to adjudicate fingerprints for approval.
CRCPD reported that 69 percent of the responders to its survey
indicated that they do not have the necessary authority to conduct the
criminal history reviews without legislative action. Some of the States
noted that they have the authority but do not want to conduct
fingerprint reviews. One State indicated that it may not have the
statutory authority to write a rule to approve the reviewing official,
and another noted that it did not have the authority unless there were
clear criteria. At least one State noted that it may not be able to
completely protect the findings of the criminal history records check
from public release. Several commenters expressed concern that the
regulatory body (NRC or the Agreement State) would be basing the
regulatory approval of the reviewing official on only the results of
the fingerprints for a criminal history records check, and the other
elements of the background investigation would not be part of the
approval process. Commenters noted that neither the regulatory body nor
the licensee would have the benefit of the complete information on an
individual in order to make an informed determination. Commenters felt
that the approval of the reviewing official should remain with the
licensee and not the regulatory body because the licensee has more
direct personal knowledge and experience with the individual, and the
licensee has much more to lose by approving an incompetent reviewing
official. Some commenters supported the approval of the reviewing
official to be an outside agency such as the NRC as a logical
methodology.
Some commenters noted that the regulator should not deny someone
based only on the fingerprint results. Several commenters noted that
this would put additional resource burden on the regulatory body and
that there is no compelling evidence of threat to public health and
safety or security or that the current system is not working. Some
States expressed concern over the possible liability for approving a
reviewing official. Some commenters objected to the need to submit or
remove the background check results outside of their offices and send
them to the regulatory body. Commenters questioned how the Agreement
State will be able to review the fingerprint results when the
fingerprints are sent to the NRC. One commenter stated that the
[[Page 16955]]
rule should specify who evaluates all of the information for the
reviewing official, as a licensee is required to have the information
reviewed before submittal of the fingerprints. The proposed rule puts
the burden of review of fingerprint results on the regulatory body
which will result in a resource burden. Commenters noted that it is
unknown what the impact on Agreement States' resources will be to begin
approving reviewing officials.
Response: After considering the comments, the NRC has decided to
change the approval for the reviewing official. The NRC (or Agreement
State) will no longer approve the reviewing official. The final rule
adopts a similar process to what was in the Increased Control Orders.
Each licensee will be required to provide the name of the reviewing
official(s) to the NRC (or Agreement State) and certify, under oath or
affirmation, that the reviewing official is trustworthy and reliable.
By the licensee certifying under oath and affirmation that the
individual is trustworthy and reliable, the NRC believes that it
adequately addresses the good faith presumption concern. This
certification occurs after the licensee has completed the background
investigation for the reviewing official. The determination basis for
the reviewing official is subject to inspection. If the individual has
undergone fingerprinting and an FBI criminal history records check, a
licensee can continue to use the trustworthiness and reliability
official or the reviewing official used under the orders.
Comment B15: Many commenters objected to the need to grant the
reviewing official access to the radioactive material or SGI. Many
licensees have used Human Resources (HR) personnel to conduct the
background investigations under the orders as they are the hiring
experts for their companies. It was further noted that HR personnel
would not have a need for unescorted access to category 1 and category
2 quantities of radioactive material. Licensees noted that this means
that HR personnel are either prohibited from doing the access
authorization or must be permitted access to the material or SGI.
Further, commenters note that permitting HR personnel access creates
possible radiation safety/security issues or creates an untenable
business model for Increased Controls licensees with no evidence that
the current system under the orders is flawed in any way. Some
commenters noted that if it is the intent simply to have this person
undergo the same level of scrutiny as those who would be given
unescorted access, then the regulation should be amended to state as
much. One commenter noted that the orders were quite emphatic that no
individual should be granted access unless the individual actually
needed access and that requiring the reviewing official to have access
appears to reduce security. Several commenters noted that the
workaround needed to require fingerprinting was an inappropriate
approach and that NRC should complete the process of obtaining from
Congress the authority to fingerprint the reviewing official.
Commenters noted that the requirement is unduly restrictive on
management options and an invasion of the rights to operate a business
as they see fit. Commenters also noted that there may be other
requirements surrounding unescorted access that could be implemented in
the future and may not apply to the reviewing official that could cause
hardships for licensees. While a few commenters were opposed to the
requirement to have the reviewing official fingerprinted, most of the
commenters did not object. One commenter noted that relying on someone
to compile the information and have the reviewing official make the
final decision also introduces the possibility of the individual
compiling the information to act in a malevolent manner. One commenter
suggested the following language: ``Reviewing officials must meet the
necessary requirements to have unescorted access to category 1 or
category 2 quantities of radioactive material.'' Two commenters noted
that, if a reviewing official is granted unescorted access as a routine
job requirement, the individual receive and satisfactorily complete
radiation safety training required by the licensee.
Response: The NRC believes that it is essential that the individual
that approves others for unescorted access to radioactive material
undergo the same background investigation before approving individuals
for unescorted access. The NRC needs to have confidence in the
integrity of the reviewing official. The reviewing official is one of
the layers for defense-in-depth of the security program. If the
reviewing official exercises the permission for unescorted access to
the material, the individual would need to undergo any required
training, including any safety training, before actually having
unescorted access. There are often individuals at facilities that have
unescorted access permission but seldom exercise the permission. The
language has been revised slightly to note that the reviewing official
must be permitted unescorted access, and the phrase ``as part of their
job duties'' has been removed. However, these individuals are not being
required to physically access the material. The changes were made to
better match the language in the AEA. The compatibility of Sec.
37.23(b)(3) was changed to Category C to allow States to be more
restrictive as it relates to access to the material. Some States may
have authority to require fingerprinting by use of other mechanisms
than the AEA.
Comment B16: Several commenters suggested allowing a reviewing
official approve others to be a reviewing official as this would
provide the licensee with more flexibility in assigning individual
duties. Commenters noted that the restriction seemed arbitrary. One of
the commenters noted that there was no reason why a reviewing official
couldn't approve someone as there is no difference in the determination
for a reviewing official and someone for unescorted access. Commenters
noted that if this requirement was an attempt to maintain a list of
reviewing officials it could be accomplished in a different manner.
Response: The NRC does not believe that the reviewing official
should be allowed to approve another individual to be a reviewing
official. While the background investigation is identical, the
responsibility for the reviewing official is greater. However, under
the final rule, a licensee is able to name its own reviewing officials.
The existing reviewing official could be involved in the background
investigation evaluation. See also response to comment B14.
Comment B17: One commenter suggested adding the word ``nominated''
before reviewing official in Sec. 37.23(b)(5) because the person is
not a reviewing official until approved by the NRC.
Response: The requirement for nominating a reviewing official has
changed in the final rule. A licensee now names the reviewing official
and certifies under oath and affirmation, to the NRC, that the
reviewing official is trustworthy and reliable. See also response to
Comment B14.
Comment B18: Two commenters objected to the wording in Sec.
37.23(b)(4) and (5) that implies that the reviewing official permits
unescorted access. The commenters agreed that the reviewing official
should be the individual who makes the trustworthiness and reliability
determinations but asserted that the reviewing official should not be
the individual who gives permission for unescorted access. The
commenters noted that after a positive determination is made, the
actual determinations for
[[Page 16956]]
unescorted access should be controlled by someone else such as the RSO.
The commenters suggested that the two sections be revised to remove the
permit unescorted access language. The commenters also suggested that
Sec. 37.23(e)(2) be modified by changing the word ``permit'' to
``authorize.''
Response: The NRC agrees with the comment. The NRC has revised the
language in Sec. 37.23(b)(1) (formerly paragraph (b)(4)) to read:
``Reviewing officials are the only individuals who may make
trustworthiness and reliability determinations that allow individuals
to have unescorted access to category 1 or category 2 quantities of
radioactive materials possessed by the licensee.'' The NRC has removed
the provision in Sec. 37.23(b)(5) as it was duplicative of paragraph
(b)(4) (now paragraph (b)(1)). The NRC has not revised the language in
Sec. 37.23(e)(2) because permit is the term used in the AEA.
Comment B19: One commenter noted that Sec. 37.23(b)(5) is
redundant as Sec. 37.23(b)(4) conveys the same requirement.
Response: The NRC agrees with the comment and has removed Sec.
37.23(b)(5) from the rule.
Comment B20: Two commenters recommended that the reviewing official
be allowed to authorize access to SGI.
Response: The reviewing official may approve individuals for access
to SGI. Part 73 requires that a reviewing official conduct the
background check review, but does not specify who that individual is or
specify any qualifications for the position. A licensee can choose to
use the same individual for both the SGI access under 10 CFR part 73
and unescorted access under 10 CFR part 37.
Comment B21: One commenter noted that licensees were allowed
fingerprint exemptions based on submittal to other governmental
programs, such as those to access Select Agents or government
clearances. The commenter noted that these programs allow for licensee
personnel to be trained to take the fingerprints but that the rule does
not allow the reviewing official to be fingerprinted by the licensee
personnel which will result in additional cost to travel to an
authorized agency and fees to have the authorized agency take
fingerprints. Two commenters noted that the requirement for the
fingerprints of the reviewing official must be taken by a law
enforcement agency, Federal or State agencies that provide
fingerprinting services to the public, or commercial fingerprinting
services authorized by a State to take fingerprints and that this
seemed arbitrarily restrictive and was not a similar requirement for
other individuals. The commenters also noted that 10 CFR part 73 did
not contain a similar provision.
Response: The NRC disagrees with the comment. Because the reviewing
official has extra responsibility in the access authorization program
and will be making the determinations to allow access, the NRC believes
that it is necessary for the reviewing official's fingerprints to be
taken by an entity that will verify that the identification matches the
person being fingerprinted. This ensures the identification of the
individual submitting the fingerprints. Without this requirement the
reviewing official could submit the fingerprints of another individual
that is known not to have a criminal history or known terrorist ties.
Comment B22: Two commenters asked how a licensee will know if an
appointed reviewing official has been approved. Commenters also asked
how long the review would take. One commenter asked the NRC to describe
the controls that will be in place to protect the personal information
provided to the NRC on behalf of the prospective reviewing official.
One commenter noted that the regulation does not indicate what the NRC
will do with the fingerprints and how long the NRC retains personal
information and the FBI data. The commenter wanted to know how long the
FBI and NRC retain the fingerprints and personal information and who
they can or will share that information with. Commenters were concerned
how the transition period, before a reviewing official is approved,
could impact a program. Some commenters questioned the length of time
for NRC review.
Response: The final rule does not contain the provision for the NRC
(or Agreement State) to approve the reviewing official. The only
information provided to the NRC is the name of the individual and the
fingerprints. The NRC typically does not retain the fingerprints and
FBI results beyond 30 days. Either the cards are destroyed or the
electronic file is deleted in accordance with Federal guidelines.
Comment B23: A few commenters indicated that the T&R officials
under the orders would be grandfathered and become reviewing officials
under the rule. Another commenter wanted to know what is meant by the
statement that the already deemed reviewing official may continue to
act in that capacity for an expanded set of persons, i.e., what is
classified as an expanded set of persons. One commenter recommended
revising the rule to relieve reviewing officials who already have
fingerprints on file from submitting fingerprints again.
Response: The NRC disagrees with the comment in part. The
commenters have misunderstood the grandfather clause. The T&R officials
would only be grandfathered if they had been fingerprinted under the
orders for either unescorted access to the radioactive material or to
SGI. If the T&R official has not previously undergone the
fingerprinting and criminal history records check, he or she would need
to complete the fingerprinting before making any additional
determinations for access to material. The expanded set simply referred
to those individuals, including new employees, who might newly require
a background investigation.
Comment B24: Several commenters noted that both the NRC-Agreement
State working group and the NRC staff steering committee developing the
fingerprinting orders discussed at great length whether to require
fingerprinting and background checks for T&R officials. Under the
orders, T&R officials were not subject to the requirements. Commenters
noted that they were not aware of any subsequent developments that
would change the situation and now warrant requiring fingerprinting and
background checks for reviewing officials now required under part 37.
The commenters objected to what they called the appearance of an
attempt to incorporate in rule a concept that did not have consensus
and was not incorporated after going through the previous security
orders working group process. They are opposed to requiring the
reviewing official to undergo fingerprinting and a background check
because in their opinion the requirements provide no plausible added
benefit to the existing structure under the orders.
Response: The 10 CFR part 37 working group considered the order
requirements, lessons learned, implementation issues, inspection
issues, recommendations from other reviews, as well as the comments on
the preliminary rule language. The 10 CFR part 37 working group
determined that there was a potential gap with the individual approving
others for access without undergoing the same background investigation.
Requiring the reviewing official to undergo a background investigation
addresses the good faith presumption. See also the response to question
B5 in Section II.
Comment B25: One commenter objected to the timing of the submittal
of the fingerprints for the reviewing official, noting that the
approval process would be timelier if the fingerprints
[[Page 16957]]
were processed at the same time the licensee is conducting the other
elements of the background investigation.
Response: The requirement for NRC approval of the reviewing
official has been removed from the rule. The rule requires the licensee
to certify that the reviewing official is trustworthy and reliable and
to then provide the name of that individual designated as the reviewing
official to the NRC. See also response to Comment B14.
Comment B26: One commenter noted that many of the items in subparts
A through D do not reference SGI, but the requirements in this rule
apply, and the inconsistencies must be corrected.
Response: The NRC disagrees with the comment. Requirements for
protection of SGI are contained in 10 CFR part 73, not 10 CFR part 37.
Part 37 contains appropriate references to the requirements for SGI
that are contained in Sec. Sec. 73.21 and 73.23.
Comment B27: One commenter requested that a section for a master
materials licensee to approve reviewing officials at the permittee
level facilities be added.
Response: The licensee is now responsible for approving the
reviewing official. See also the response to comment B14.
Comment B28: One commenter noted that it was not clear how the
licensee would comply with the requirement in Sec. 37.25(a)(1) to
complete fingerprinting and an FBI identification and criminal history
records check for reviewing officials before granting them unescorted
access inasmuch as NRC (or the Agreement State) would have the
responsibility of reviewing the FBI identification and criminal history
records check information, in lieu of the licensee doing so.
Response: The NRC (or the Agreement State) is no longer involved in
the approval of the reviewing official. See also response to comment
B14.
Comment B29: One commenter raised the issue of how individuals
denied approval for reviewing official duties will be tracked to avoid
going to another jurisdiction for approval.
Response: The final rule does not require the NRC to approve the
reviewing official. The NRC does not plan a tracking system to track
reviewing officials.
Comment B30: Two commenters requested information on what happens
if the company appointed reviewing official is denied, particularly in
smaller companies where the owner, manager, or RSO may be the appointed
reviewing official and how such a denial might affect the operation of
the company.
Response: The licensee is now responsible for approval of the
reviewing official. The NRC is not involved in the decision. See also
response to comment B14.
Comment B31: One commenter suggested changing the characteristics
derived from the background investigation. The commenter stated that
for the reviewing official to state that an individual is ``trustworthy
and reliable'' implies more of an intimate knowledge of the
characteristics of a person than would be gained from simply running
the required checks. The commenter suggested that defining an
individual as ``low-risk'' may be more appropriate.
Response: The NRC disagrees with the comment to change the rule.
The NRC recognizes that determining that an individual is considered to
be trustworthy and reliable is subjective, and not a guarantee that the
individual won't ever commit, or conspire to assist others in
committing, a malevolent act. The trustworthy and reliable concept is
in the orders and is in other locations in the regulations.
Comment B32: One commenter suggested that, for those individuals
who are relieved from the fingerprinting, identification, and other
elements under Sec. 37.29, the licensee should be exempt from the
requirement in Sec. 37.23(c) to provide informed consent and obtain a
signed consent form. The commenter noted that it conducts a background
investigation on all badge-holders (employees, fellows, contractors,
etc), the vast majority of whom have no intent of applying for purposes
of unescorted access and that there is no opportunity, or it is a
misplaced opportunity, to request an individual's signed consent under
this regulation at the point of background investigation initiation.
The commenter stated that there should also be an exemption for this
situation as there is no need to repeat the background investigation
just because an individual later determines a need to request
unescorted access. Other commenters questioned why an individual that
has already been subject to fingerprinting now needs to provide
consent.
Response: Section 37.23(c) states that the licensee does not need
to obtain signed consent from those individuals who have undergone a
background investigation under the orders or 10 CFR part 73. A signed
consent is not necessary until the reinvestigation occurs. A licensee
would not need to obtain a signed consent from an individual subject to
Sec. 37.29, unless the licensee conducted one or more of the elements
of the background investigation.
Comment B33: One commenter questioned whether the NRC would develop
a standard consent form and background questionnaire form so that
everyone asks the same questions and evaluates on the same basis.
Response: The NRC has included a consent form in the guidance that
could be used by licensees. A standard background questionnaire was not
included as this would be similar to the information included in
applications for employment. Information would include job history,
education history, and a list of references.
Comment B34: One commenter stated that Sec. 37.23(e) was
improperly named as no basis for making a determination was included,
only a requirement for licensees to develop, implement, and maintain
written procedures with the determination basis that they deem
appropriate.
Response: The NRC disagrees with the comment. The section contains
the requirement for the reviewing official to make determinations on
authorizing unescorted access, and the NRC believes that it is
appropriately named. The licensee is provided flexibility in the
criteria that it uses to make a determination.
Comment B35: One commenter stated that NRC should provide the
specific and detailed adjudication criteria that will be used to
approve the reviewing official.
Response: The guidance document contains the general criteria that
the NRC used in approving reviewing officials under the orders. The
specific criteria to be used are up to each licensee.
Comment B36: One commenter stated that licensees are not in a
position and do not have the knowledge and skill to ensure that
personnel are trustworthy and reliable and that all that licensees can
be expected to do is to follow the NRC rule that was presumably written
to provide licensees with methods to screen personnel.
Response: Licensees are required to follow the requirements in 10
CFR part 37 to acquire information about personnel and to make their
own judgments of the trustworthiness and reliability of their
employees. These determinations do not require specialized knowledge or
skill and are similar to the determinations that licensees make in
hiring decisions.
Comment B37: One commenter requested that Sec. 37.23(e)(1) and (2)
be revised to remove the requirement to review all of the background
investigation information required in
[[Page 16958]]
making a determination on trustworthiness and reliability. The
commenter felt that some of the information would be impossible to
obtain and therefore, if you are required to review all information, a
licensee could never approve some personnel. The commenter suggested
that the language be changed to ``collected background investigation
information.'' Several commenters suggested removing the term
``disqualifying'' from the paragraph as the NRC has not provided a list
of disqualifying factors.
Response: The NRC agrees with the comment and has revised the rule
to specify that the evaluation is of the information collected to meet
the requirements. The NRC has also removed the term ``disqualifying''
from Sec. 37.23(e)(2).
Comment B38: Two commenters noted that in Sec. 37.23(e)(3)
``reasonable assurance'' is not defined. One of the commenters felt
that the lack of clarity in this requirement and in what documentation
should consist of will result in disputes with NRC inspection findings.
One commenter objected to the need to document the determination basis
for granting someone unescorted access. The commenter felt that only
the reasons for denial should be documented.
Response: The NRC does not believe that ``reasonable assurance''
needs to be defined in the regulations. The determination basis is a
performance-based requirement, and licensees are provided flexibility
to develop criteria that best meet their needs. The NRC believes that
documentation of the determination basis is essential. The
documentation does not need to be extensive. It can consist only of an
indication that no negative information was found during the
investigation or an explanation of why negative information did not
disqualify the individual. Without documentation an inspector could not
be assured that the individual had actually undergone the required
background investigation. Documentation of the basis is also beneficial
to the licensee if it needs to reevaluate whether an individual should
continue to have unescorted access.
Comment B39: Several commenters objected to the requirement in
Sec. 37.23(e)(3) to immediately remove the person from the approved
list once he or she no longer require access. One commenter noted that
``immediately'' is not defined and that it is not realistic for routine
terminations such as student graduations and deaths. The commenter
indicated that the only justification for immediate removal would be
demonstrated unreliability that would result in withdrawal of the
person's trustworthiness and reliability status. The other commenter
stated that immediate removal was not warranted but should be done in a
timely manner. The commenter suggested replacing ``immediately'' with
``as soon as practical.'' Another commenter suggested removal from the
list in a timely manner not to exceed 30 days after the determination.
Response: The NRC agrees with the comment in part. An immediate
removal from the list is probably not necessary. However, prompt
actions do need to be taken to prevent access, such as deactivating his
or her access code. The NRC has revised the language to reflect that
the action should occur as soon as possible but no later than 7 working
days. The NRC believes that it is important to maintain a current list
of those individuals that are allowed unrestricted access to the
material.
Comment B40: One commenter questioned whether Sec. 37.23(e)(3)
means that the licensee must document its basis for approval of the
trustworthiness and reliability determination as a written policy. The
commenter noted that an alternate interpretation could be that the
licensee must document a rationale for each individual's
trustworthiness and reliability approval, as opposed to a generic basis
for approval for all applicants.
Response: The licensee must document the rationale for each
individual's trustworthiness and reliability determination. The
documentation does not need to be extensive. The NRC notes that the
orders also required the licensee to document the basis for concluding
that there is reasonable assurance that an individual granted
unescorted access is trustworthy and reliable.
Comment B41: One commenter stated that the access authorization
program requirements were overly prescriptive, particularly the number
of required procedures and amount of associated documentation. The
commenter noted that the licensee should be allowed to determine the
level of detail of its program as appropriate depending on the size and
complexity of the program.
Response: The NRC agrees with the comment, in part, and has made
some changes to the access authorization program. Section 37.23(f) has
been revised to remove some of the specificity in the types of required
procedures.
Comment B42: Two commenters noted that the requirement to have
procedures to ensure that individuals who have been denied unescorted
access authorization are not allowed access was redundant. The
commenters stated that a person denied unescorted access would not be
provided with a key or codes to access the sources, and a procedure is
not needed.
Response: The NRC believes that procedures are necessary to
implement the access authorization program. Not all licensees use keys
or codes to control access to the material.
Comment B43: Two commenters stated that for licensees subject to 10
CFR part 73 with additional radioactive materials not covered by the 10
CFR part 73 security plan, the procedures used for 10 CFR part 73
background investigations and updating of background investigations,
etc., should be considered adequate to meet the intent of 10 CFR part
37. One of the commenters suggested adding a new paragraph (5) to Sec.
37.23(f) to read as follows: ``Procedures and policies meeting the
requirements of the security plans required by part 73 meet the
requirements of this subpart B of this chapter.''
Response: The NRC agrees that a licensee does not need to maintain
two sets of procedures; however, a provision is not needed in the
regulations. As long as 10 CFR part 73 procedure addresses the content
of the required procedures under 10 CFR part 37, additional procedures
are not necessary.
Comment B44: One commenter suggested that NRC develop a generic set
of procedures for the conduct of background investigations as guidance
for licensees.
Response: The NRC has not included generic procedures for
conducting a background investigation. Implementation of background
investigation requirements will vary with the circumstances of
individual licensees. Guidance is available on the various elements.
Comment B45: One commenter stated that in Sec. 37.23(g) at least
10 days should be allowed for an individual to correct, complete, or
explain other components of the background investigation.
Response: The NRC has not specified a timeframe in order to allow
licensees flexibility to choose a timeframe that they believe is
appropriate for their program. The NRC has provided a 10-day timeframe
to challenge the FBI criminal history records, and 10 days would be an
appropriate timeframe for allowing a challenge of other aspects of the
background investigation results. The licensee may choose the timeframe
that works best for it.
Comment B46: One commenter noted that since Sec. 37.23(g)(2)
specifies that the licensee can't act on challenged
[[Page 16959]]
information until the FBI goes through their due process, the FBI needs
to be on board. The commenter suggested adding a requirement to allow
the licensee to make a final determination if nothing is heard from the
FBI within 30 days.
Response: The rule contains procedures for an individual to correct
background check information that are identical to the procedures in
Sec. 73.57(e)(2). The NRC disagrees that a 30-day cut-off period is
needed because such a provision would circumvent an individual's right
to complete, correct, and explain information obtained as a result of
the licensee's background investigation. Further, the 30-day cut-off
period may be unreasonably short. The FBI has indicated that once it
receives a formal challenge to an individual's record, a recheck is
completed within approximately 3-4 weeks (52 FR 6310; March 2, 1987).
Given the rule's 10-day window for an individual to initiate a
challenge, the timeframe for resolution of challenges could potentially
be greater than 30 days. Accordingly, the NRC declines to impose a 30-
day time limit for challenges to an individual's background check
information.
Comment B47: One commenter stated that Sec. 37.23(h)(2) requires
the licensee to retain a list of persons approved for unescorted access
for 5 years after the list is superseded and noted that the word
``list'' implies a written document. The commenter asked if the
``list'' may include database records that contain unescorted access
approval and removal dates and thus would allow discarding printed
copies that are no longer useful. The commenter noted that other NRC
regulations (e.g., Sec. Sec. 20.2110 and 37.51) allow records to ``be
stored in electronic media with the capability for producing legible,
accurate, and complete records during the required retention period.''
The commenter recommended changing the wording to add similar wording
as in other NRC regulations making it clear that the ``lists'' do not
need to be printed copies.
Response: Section 37.101 already allows records to be maintained in
electronic media. The language is similar to that provided in Sec.
20.2110 and applies to all records that are required by 10 CFR part 37.
Comment B48: Two commenters objected to the requirement in Sec.
37.23(h)(3) to maintain a list of individuals not approved for access.
Two commenters objected to the need to maintain every change to the
list for 5 years. One commenter felt that it would seem reasonable to
ask that a list of all persons currently granted unescorted access be
maintained (+ a month) and that a list of all persons denied or removed
from the unescorted access list be maintained ( a month).
Another commenter noted that maintaining a list has no value as a
licensee may develop a badge system that indicates a person's level of
access. Another commenter noted that there was no value in keeping a
list since the determination basis has to be documented.
Response: The NRC agrees, in part, and disagrees, in part, with the
comment. The NRC agrees that it is not necessary to maintain a list of
those individuals not approved for access and has removed the
provision. The fact that someone is not included on the access list
means that they should not be granted unescorted access to the
material, and a second list is not needed. There is currently no
mechanism in place to share information among licensees, so there is no
benefit in maintaining a list of those not approved for access. The NRC
disagrees with the comment to remove the requirement to maintain every
change to the list; however, the NRC has changed the retention time to
3 years. The superseded lists are necessary for inspections. If an
inspector discovers something during an inspection, the superseded list
could be reviewed to determine who had unescorted access during a given
time period.
Comment B49: One commenter requested clarification whether the
notification required by Sec. 37.27(a)(2) is different from the
informed consent required by Sec. 37.23(c)(1).
Response: The informed consent under Sec. 37.23(c)(1) is consent
to conduct the background investigation. The notification required by
Sec. 37.27(a)(2) is specifically for the FBI criminal history records
check. The licensee may develop one consent form that covers both
aspects.
Comment B50: In the proposed rule, the NRC specifically invited
comment on the appropriate elements for a background investigation.
Commenters were requested to provide information on: (1) Whether a
local criminal history review is necessary in light of the requirement
for an FBI criminal history records check; (2) whether a credit history
check provides valuable information for the determination of
trustworthiness and reliability; (3) whether the Agreement States have
the authority to require a credit history check as part of the
background investigation; (4) the appropriate elements of a background
investigation and why any suggested elements are appropriate; (5)
whether the elements of the background investigation are too subjective
to be effective; and (6) how much time a licensee typically spends
conducting a background investigation for an individual. Twenty-seven
commenters provided responses to the specific questions on this
subject.
Of those who provided responses to the questions on the background
investigation elements, no one supported inclusion of the local
criminal history check as part of the background investigation elements
and only one commenter indicated that the credit history check added
any value. Most commenters indicated that the FBI criminal history
records check was sufficient, and that requiring a local criminal
history check was redundant and overly burdensome. Many commenters
noted that conducting a local criminal history check would be very
difficult for foreign nationals and those who have moved frequently.
Most commenters stated that the credit history evaluation was not
useful, and that poor credit and untrustworthiness do not go hand-in-
hand. Commenters were also concerned that there were no clear
guidelines on what credit score would be cause for concern. Many
commenters expressed concern over the accuracy of information in credit
histories. Some commenters questioned whether requiring a credit
history check was legal in some States, noting that the requirement was
an invasion of privacy. One commenter suggested Social Security number
(SSN) validation instead of the credit history check.
In response to the question of whether the Agreement States have
the legal authority to require a credit history check, most commenters
indicated that they did not know. One State responded that recent
legislation prohibits discrimination based on credit history, but did
note that the law provides for exceptions. One State indicated that it
did have authority, and another noted it did if specific criteria were
provided.
The majority of commenters indicated that the current background
investigation elements from the orders were adequate. One commenter
suggested as appropriate elements: Verification of legal citizenship,
personal references, former employers, education, fingerprinting and
FBI criminal background investigation, and personal knowledge. Another
commenter noted that the elements should be employment history,
education history, reference check, and FBI history check. Two
commenters noted that the background investigation should be limited to
the fingerprint-based criminal history check, and that an adverse
criminal history could be mitigated by satisfactory employment history
with the licensee. One
[[Page 16960]]
commenter suggested a two-person rule for truly significant sources
instead of a background check. One commenter indicated that the area
that needed review is the background investigation for foreign
nationals and students because the required information is troublesome
to obtain.
Most of the commenters felt that the elements of the background
investigation were too subjective, and that guidance or criteria were
needed so that the elements could be consistently applied across the
country with minimum second guessing by auditors and inspectors. Other
commenters stated that while the elements were subjective, this did not
mean that they were ineffective. Commenters stated that there is a good
mixture of subjectivity and objectivity for the reviewing official to
use in making a determination of a person's trustworthiness and
reliability. One commenter noted that some subjectivity is necessary to
evaluate the situation and the individual, as strict adherence to
guidelines could lead to rejection and a serious impact on an
applicant's career.
NRC also requested information on how much time a licensee spends
conducting a background investigation. Responses varied from a few
hours to months; the longer times typically included wait times and not
actual effort.
One commenter suggested centralization of the background
investigation process, suggesting that the security clearance process
performed by the Defense Industrial Clearance Security Offices for
various Federal agencies could be tailored to meet the 10 CFR part 37
requirements. The commenter indicated that this could be more efficient
than requiring each licensee to develop a process.
In addition to those who provided responses to the specific
questions, 70 commenters addressed this topic. Several commenters felt
that the current background investigation elements were sufficient and
questioned the value of the proposed additional elements (credit
history evaluation, verification of true identity, military history
verification, and criminal history review from local criminal justice
resources). Some commenters felt that specific justifiable evidence
that current trustworthiness and reliability programs aren't working is
needed to justify any new requirements, and that a cost-benefit
analysis should be used to justify inclusion of any new elements.
Several commenters noted that the cost of obtaining the necessary
information may be burdensome in time and money, and that the
requirements are overly prescriptive. Commenters expressed concern that
the required checks could result in lost jobs if individuals did not
meet the standards set forth by the licensee. One commenter noted that
a licensee would probably investigate the individual before hiring,
which would result in multiple expenditures for one eventual employee.
One commenter noted that the background investigation could deter some
talented and knowledgeable professionals from applying due to the
potential invasion of privacy. One commenter noted that the NRC needs
to find the fine line between cautious and correct and overly cautious
and burdensome.
Some commenters felt that the FBI criminal history checks and work
history are sufficient. Two commenters felt that the background
investigation should only require a fingerprint-based criminal history
check and that adverse criminal history may be mitigated by the
employment history of an employee with more than 3 years employment
with the licensee. Commenters noted that employment history is far more
accurate for determining trustworthiness and reliability than any other
check proposed. One commenter suggested allowing licensees to use a
graded approach taking into consideration multiple variables, such as:
Whether the activity is category 1 or category 2; the desirability of
the source to an adversary; the physical security present; how quickly
the radioactivity could be removed from the device and readily
dispersed or used to cause serious harm; the mobility of the source or
device, and the frequency of physical inspection/observation by more
than one individual. One commenter suggested revising the requirement
so that the licensee could use either employment history evaluation,
verification of employment, or military history evaluation. At least
one commenter noted that the insider threat would be best controlled
with monitoring and detection.
Sixty commenters objected to the inclusion of the credit history
element in the background investigation. Commenters noted that, in the
current economic environment, a credit history evaluation could reflect
an inaccurate and erroneous assessment of a person's trustworthiness
and reliability and could result in some skilled individuals being
removed from employment consideration. Commenters felt that the credit
history check was an unnecessary invasion of privacy, and that most
individuals would choose not to pursue unescorted access if faced with
a credit history check. One commenter noted that when implementing the
orders it had initiated a credit history evaluation that created a
significant uproar and resulted in several researchers withdrawing
their irradiator access privileges. The commenter noted that this
created an atmosphere of distrust. Commenters felt that the information
was not relevant when attempting to determine trustworthiness and
reliability and was unjustified and not a valid gauge of
trustworthiness and reliability. Commenters noted that having a bad
credit history did not make the individual untrustworthy and that a
good credit history did not define an individual as trustworthy and
reliable. Some commenters requested that the NRC provide some study or
peer reviewed document that demonstrates that persons with poor credit
may be more easily coerced into helping terrorists. Some commenters
stated that the requirement could potentially be viewed as
discriminatory by workers. One commenter questioned how to deal with
identity theft.
Commenters noted the difficulty of obtaining a credit history of
individuals who have lived outside the United States, such as foreign
nationals. Commenters noted that in some cases it was impossible to
obtain the information. Commenters noted that many countries do not
have a combined credit history reporting agency. One commenter
expressed concern that individuals who have established a credit
history in the United States and whose credit history is poor will be
at a disadvantage over individuals with a similar but undocumentable
credit history in another country, as an employer may choose to allow
access to the foreign national based on incomplete information and deny
access to a United States citizen based on more extensive but
unfavorable information.
One commenter noted that Title 11 of the United States Code,
Section 525, makes it illegal to discriminate against employees or job
applicants solely because of filing for bankruptcy. Another commenter
noted that the Equal Employment Opportunity Commission has been
cracking down on efforts to disqualify potential hires with bad credit
history as the practice can be discriminatory. Several commenters noted
that some States have laws that prohibit employers from discriminating
against employees on the basis of credit history and prevent employers
from inquiring about credit history. One commenter stated that if
Congress, in consultation with the NRC, had deemed credit history
checks significantly useful to provide for the common defense, the
checks would have been included
[[Page 16961]]
within the most recent amendments in section 149 of the AEA. Another
commenter noted that Congress has considered passing an act to make it
unlawful to base adverse employment decisions on consumer credit
reports.
In a CRCPD survey of Agreement States, 70 percent of those
responding indicated that they did not have the authority to require a
credit history check as part of a background investigation. Some
Agreement States indicated that they were not sure if they had the
authority to require a credit history check. One State indicated that
(assuming it has authority) its administrative procedures would require
specific criteria for pass/fail. One commenter noted that there are
State laws that prohibit ``discrimination'' against employees due to
credit history and asked how this would affect the credit history check
requirement. The commenter noted that a Google search indicated that
States that have and/or are considering such laws include: Connecticut,
Wisconsin, Hawaii, Illinois, Missouri, New York, Oregon, Washington,
and Texas.
One commenter felt that much of the information obtained from a
credit history report would already be included in the personal history
disclosure. Two commenters stated that for category 2 sources it should
be up to the reviewing official to decide if they have enough
information to grant unescorted access to a category 2 source without
the need for a credit history check. One commenter noted that
individuals relieved from the background investigation elements were
just as likely to have negative credit history but will not be subject
to the same scrutiny. One commenter recommended defining ``full credit
history,'' as a licensee can't comply with open-ended requirements. Two
commenters noted that this concept had been considered in the working
group for the orders but was rejected, and, therefore, should not have
been included in the proposed rule.
Several commenters opposed the inclusion of the criminal history
check in the background investigation. They questioned why a criminal
history check from local sources was necessary if a national check
through the FBI was conducted. One commenter stated that the local
check would be an added benefit if the FBI check was somehow
inadequate. Commenters stated that the information would be difficult
to obtain in many locales and would be an increased burden to both the
licensee and local law enforcement without a corresponding benefit.
Commenters also noted that the information would be impossible to
obtain for foreign nationals, and that a provision must be provided
that allows less-than-absolute compliance. One commenter noted that
licensees in rural areas may have limited access to local resources,
and that some local resources may have limited capabilities to respond
to such requests. Commenters asked how to determine the appropriate
local law enforcement agency and what constituted local.
Several commenters objected to the inclusion of a character and
reputation element in the background investigation. Commenters felt
that the determination would be very subjective, added little value,
and unnecessarily added to the licensee's burden. Commenters noted that
an adverse judgment about an employee's character and reputation could
be perceived as discriminatory. One commenter suggested removing the
term ``trustworthy and reliable'' from the character and reputation
element and thereby removing the connotation that a personal reference
can attest to the present state of an individual's trustworthiness or
reliability. The commenter noted that including a character and
reputation check would require references to be knowledgeable about
that definition, and very few references can attest to the present
status of an individual, as required by the words ``continues to be.''
Some commenters expressed concern over possible invasion of privacy.
One commenter recommended requiring a minimum of three references. One
commenter noted that, for a reference to provide a worthwhile
evaluation of the applicant, a minimum time frame for contact with the
individual should be established in the rule. The commenter also
cautioned that the reference should not be from someone, such as a
supervisor, who may benefit from the applicant's unescorted access.
Several commenters objected to the requirement to obtain
independent information to corroborate the information provided by the
individual. Commenters stated that the provision was vague and
unreasonable, and they did not understand how it could be accomplished.
Commenters stated that it was unreasonable to expect licensees to track
down independent information, as they are not investigative agencies.
Commenters noted that many entities cannot or will not provide
background information, and licensees do not have the resources to
obtain information elsewhere. Commenters noted that the cost would be
prohibitive in many cases. One commenter recommended removing the
phrase ``to the extent possible'' because it made the section
meaningless. One commenter asked what he or she should do if it is not
practicable to confirm information. Another commenter stated that the
documentation would be excessive and time consuming. One commenter
suggested requiring independent information only in situations where
the accuracy or completeness of information provided by the applicant
is in doubt, or where the licensee can't confidently make an evaluation
based on an analysis of all of the gathered information. One commenter
suggested changing the phrase ``to the extent possible'' to ``to the
extent practicable.'' Three commenters objected to the need to obtain
information from an alternate source when a previous employer or other
entity does not respond. One commenter noted that where a company has
gone out of business, it would be impossible to obtain confirmation
that the individual worked at the company. The commenters felt that it
was unclear how a licensee could obtain this information in some cases.
One commenter noted that it doesn't have the resources to confirm an
applicant's information independently, particularly if the person's
family is excluded.
Commenters noted that obtaining the information for some groups of
people, (e.g., foreign nationals, research students, and citizens who
have resided outside the United States for long periods), is difficult
or impossible. Some commenters noted that licensees with a high
turnover, such as universities and research facilities, would incur
substantial cost and would have difficulty implementing the provisions.
One commenter provided some cost information, noting that the current
cost is $131 per applicant, excluding the $100 average cost for
processing new employees. The costs included $25 for fingerprinting,
$26 for fingerprint processing through the NRC and FBI, and $80 for a
WorldScan. The commenter noted that adding the credit history and
military history would increase the cost per approved person to $155
for United States records, and even if the credit history and military
records were obtainable and reliable, getting this information on
foreign applicants would be prohibitively expensive. Two commenters
noted that a foreign credit history check costs $170, and one commenter
noted that that a credit check would cost $1,000 per individual for a
foreign national, and another said that the cost of military
verification was $80 per person. Another commenter noted that the
current cost of conducting background investigations
[[Page 16962]]
was $125, and adding a credit check and military records check would
increase this to $400 per person (assuming that half the individuals
require foreign credit checks). One commenter noted that it would take
2 to 3 person-days to perform the different checks.
Several commenters recommended that NRC consider using the same
background check process used by the Centers for Disease Control (CDC)
for select agents because centralized NRC coordination would probably
result in more consistent evaluations at reduced cost. Other commenters
suggested that the NRC authorize unescorted access using a method
similar to the Transportation Safety Administration's TWIC program.
They noted that the CDC and the U.S. Department of Agriculture programs
for select agents and the DOT system for issuing hazardous material
certifications for Commercial Driver's Licenses, all have the
applicable Federal government agency perform the reviews and grant the
approvals. The commenters stated that this approach would provide
consistency in the conduct of the reviews and would best assure that
all needed information is collected and reviewed by well-trained
individuals. One commenter suggested that the NRC review the visa
process to see if any of the requirements could be replaced with a
verification of visa, since foreign nationals must go through a
Homeland Security review to get a visa. One commenter noted that it has
reviewed 3,182 persons since the Fingerprint Order was implemented and
has determined that 38 could not be judged trustworthy and reliable
based only on the FBI criminal history report and not because of any
other background investigation elements. The commenter noted that more
than 90% of the persons it judged to be trustworthy and reliable were
also judged trustworthy and reliable by the U.S. Bureau of Alcohol,
Tobacco, Firearms, and Explosives (BATFE), and that this experience
appears to validate why all other federal agencies that perform similar
checks do so solely on the basis of the FBI criminal history.
One commenter noted that his or her industry is subject to three
different Federal background check programs (BATFE, DOT, and NRC), and
recommended that the agencies come up with one background check that
would satisfy all three.
Response: The NRC has determined that the appropriate elements of
the background investigation include: Fingerprinting and an FBI
criminal history records check, verification of identity, employment
history verification, education verification, and a character and
reputation determination. Many of these items are part of routine
employment checks that an individual may go through before being hired
by a company. The NRC has removed military history verification from
the elements as it is considered part of the employment history and
does not need to be a separate element. The NRC has also removed the
provision to conduct a local criminal history check as part of the
background investigation. The NRC determined that while the local
criminal history check would provide some beneficial information, the
burden of obtaining the information is not justified by the limited
benefit. The NRC recognizes that conducting the background
investigation for some individuals, such as foreign nationals, may be
difficult. If there was no education or military service in the 7-year
period preceding the need for unescorted access to the material, the
investigation would not need to include these items.
After careful deliberation and consideration of all the comments
received on including credit history as a background investigation
element, the NRC has decided not to include credit history as a
required element for the background investigation or reinvestigation.
The credit history can provide information that is useful in making a
determination that an individual is trustworthy and reliable. Credit
history can add an extra layer of defense in mitigating the insider
threat and can provide some information that is not easily available
from other sources. Credit history was never intended to be the
determining factor for trustworthiness and reliability but simply one
more piece of information in making that determination. However, as
many of the commenters pointed out, there are issues with the accuracy
of credit reports, and a poor credit history is not necessarily an
indicator that an individual is not trustworthy or reliable,
particularly in these tough economic times. Although NRC disagrees,
some of the commenters indicated that there is the potential that some
Agreement States might not be able to implement the provision due to
State laws. These things could result in uneven implementation of the
provision across the country. As pointed out by the commenters, it is
harder and more expensive to obtain a credit history for those that
have resided in other countries for long periods of time. This could
lead to an imbalance in the information collected and used in making
the trustworthiness and reliability determination. In addition, some
licensees may decide not to grant unescorted access to fully qualified
individuals because of the lack of information or the difficulty in
obtaining the information. Many smaller licensees may not have staff
and/or knowledge to be able to fully utilize the information obtained
from the credit history. The NRC has determined that the potential
benefit of the credit history is not justified by the cost and,
therefore, the NRC has not included credit history as a required
element of the background investigation. While not requiring a credit
history, the NRC does note that information obtained from the credit
history could be useful to licensees, and nothing in the NRC
regulations prohibits a licensee from conducting a credit history. In
situations where a trustworthiness and reliability determination is
difficult, the information from a credit history could provide the
determining information. A licensee can always use measures beyond the
regulatory minimum that is required by the access authorization
program.
The NRC is not providing specific criteria that would disqualify an
individual from obtaining unescorted access to the material. There is
no checklist. Because the individual circumstances of each applicant
may vary significantly, each licensee needs the flexibility to
establish its own program. The implementation guidance document does
provide general information and items for consideration, but no
specific disqualifying information. A licensee should consider any
negative information together with all of the other information in
making a final determination.
At this time, the NRC has no plans to establish a new program to
conduct background investigations similar to the TSA or CDC programs.
The NRC does relieve individuals who have been approved under these
programs from the fingerprinting element of the background
investigation.
Information provided by the commenters on the burden of conducting
a background investigation has been factored into the final regulatory
analysis, as appropriate.
Comment B51: One commenter expressed concern that the new
requirements could force employment decisions based on incomplete
information and that this could lead to significant legal implications
for the facility. The commenter noted that the intersection of these
requirements with the Equal Employment Opportunity Act should be
investigated.
Response: The NRC does not agree that the background investigation
[[Page 16963]]
requirements force licensees to make employment decisions based on
incomplete information. Individuals who are granted unescorted access
to category 1 or category 2 quantities of radioactive material must be
deemed trustworthy and reliable. The background investigation is one
component designed to provide the licensee with sufficient relevant
information before making this determination. It is the licensee's
responsibility to evaluate the information received as a result of the
background investigation and all other relevant information to make its
trustworthiness and reliability determination. These requirements do
not relieve a licensee from its obligation to comply with all
applicable Federal and State labor laws. Further, the NRC does not
believe that fulfillment of these trustworthiness and reliability
determination requirements would cause the licensee to violate any
labor laws. Accordingly, the NRC does not believe that it is necessary
to develop guidance on this issue.
Comment B52: Two commenters questioned the 10-year period for the
background investigation versus the 3-year period contained in the
orders. The commenters felt that 10 years is an arbitrary timeframe and
that 3 years is sufficient. One of the commenters noted that going back
10 years is more expensive and that it is more important what happened
in the last few years of the person's life and not distant history.
Another commenter suggested changing the timeframe to 7 years as the
standard criminal history and credit checks only go back 7 years. The
commenter noted that many States charge an extra fee to extend the
check beyond 7 years. One commenter noted that there could be a problem
when attempting to use the 10 year criteria for students. Another
commenter asked for clarification for how far back the investigation
should go and what sources could be used. One commenter noted that the
employment history evaluation period of 10 years was not consistent
with 10 CFR parts 26 and 73 which only cover the most recent 3 years
and that justification should be provided for going with 10 years. One
commenter suggested going back the last two employers or 10 years
whichever is less restrictive. One commenter stated that the timeframe
should be left to the discretion of the licensee based on the situation
of the applicant. One commenter felt that 10 years was too long an
evaluation period and that there was no stopping point to the 18th
birthday. The commenter recommended changing the 10 years to 3 years or
until the person's 18th birthday, whichever is shorter. One commenter
requested that NRC clarify the date used to determine the 10-year
reinvestigation. One commenter noted that the rule needs to be clear
that the expectation for the review is to go back 10 years or to such
time as the individual was a minor.
Response: The NRC has reconsidered the time frame for the initial
background investigation and has changed the timeframe to 7 years as
suggested by the commenters. This may reduce the cost of the
investigation. The rule does provide that the investigation only goes
back to the individual's 18th birthday.
Comment B53: One commenter noted that the rule did not provide a
tiered approach for individuals who had been with the licensee for
greater than 3 years. The commenter noted that under the orders the
licensee could review the individual's employment history (i.e.
personnel files) and obtain the supervisor's standardized
recommendation. The commenter recommended retaining this system for the
initial and reinvestigation for individuals who have been with the
licensee for a long period of time (i.e. 10 years).
Response: The NRC disagrees with the comment. The NRC believes that
the longer timeframe is appropriate. If the individual has been with
the company for 7 years, the licensee would not need to check with
previous employers. The reinvestigation does not include all of the
elements of the initial background investigation.
Comment B54: One commenter requested clarification on whether the
licensee verified the true identity of individuals or the licensee's
reviewing official. The commenter also objected to the language in the
rule to verify ``true identity'' and ``ensure'' the individual is who
he or she claims to be. The commenter felt that making it the
licensee's responsibility to establish anyone's ``true identity'' is
not always possible as identification documents (IDs) can be forged,
and very few licensees are experts at identifying forged documents. The
commenter felt that the language is too strong, cannot be guaranteed,
and needs to be rewritten to just state that the licensee is
responsible to review the identification documents. The commenter also
stated that the requirement to compare the personal information data to
identify any discrepancy in the information is too vague. The commenter
asked what personal information and what should be done when
discrepancies are discovered. The commenter suggested that the language
be revised to require that the licensee review available information
from an ID that is provided to the licensee by the applicant, and
resolve any discrepancies. One commenter asked how verification of true
identity was supposed to be done and questioned the expense and value.
One commenter noted that it already performed an I-9 or E-verify for
employees but not in the case of students at universities.
Response: The licensee is not expected to determine that an ID has
been forged. Section 37.25(a)(2) states that the licensee is to review
the identification documents provided, such as a driver's license or
passport, to make sure that the information matches what was provided
by the individual. If the information such as the name of the
individual or social security number doesn't match, the licensee should
investigate further. E-verify is one tool that can be used. The
guidance document on the rule contains information on how this
provision should be addressed.
Comment B55: One commenter suggested that the requirements to
verify employment history, education history, and military history were
too rigid and that the language should be revised to ``the licensee
shall attempt to verify * * *'' The commenter noted that this would
recognize that businesses fail and overseas employers and schools may
be impossible to contact. The commenter indicated that the unsuccessful
attempts should then be documented. Another commenter noted that it
could be very expensive to verify foreign employment.
Response: The NRC agrees in part with the comment. Section
37.25(a)(7) (previously (a)(10)) already contains a provision for when
an employer or other entity doesn't provide any information. The
provision had been modified to provide additional clarification and to
add a requirement that the licensee document the actions taken when it
is unsuccessful in verifying the history.
Comment B56: One commenter questioned the relevance of obtaining
military history and how the results would be used. The commenter
stated that NRC should perform this service for foreign nationals.
Another commenter noted that military history verification can be a
lengthy and difficult process. The commenter noted that obtaining
records from the Department of Veterans Affairs was difficult,
particularly for Korean and Vietnam era veterans, and compliance is
dependent on another Federal agency. One commenter noted that in some
countries military service is a requirement of its citizens so
verification has little bearing on an individual's trustworthiness and
[[Page 16964]]
reliability. Another commenter noted that the return rate for requests
on military history has been about 20 percent and takes between 3-6
months. Commenters do not believe that this adds any value. Another
commenter questioned how to obtain military history verification.
Response: Military history is considered part of the employment
history. The rule text has been revised to include military history as
part of the employment history instead of a separate element. For some
individuals, military service could be their only employment. The
licensee only needs to verify the service if the military service
occurred in the last 7 years. Information on foreign nationals can be
more difficult to obtain. The NRC notes that licensees always have the
option of escorting the individuals. Additional guidance on foreign
nationals is provided in the implementation guidance.
Comment B57: One commenter questioned the value of verifying
education history and questioned how the verification should be
accomplished. Another commenter questioned how far back a company
needed to go for someone employed at the company for 10 years. One
commenter noted that the verification should be for the degree and not
the time period of attendance. The commenter noted that it would be a
huge burden to verify every time period at every institution for those
who completed their education over numerous years at various
institutions.
Response: Education history is similar to employment history and
helps to validate what the individual was engaged in during the noted
timeframe. Education history would typically be verified by checking
with the educational institution. Education history only needs to be
verified if it occurred in the last 7 years.
Comment B58: Two commenters felt that the employment history was
completely ignored as the rule did not provide for limiting the
background investigation to the FBI criminal history check for
employees with more than 3 years with the licensee. The commenter noted
that employment history is a factor that can be used when determining
whether an employee with a criminal history is trustworthy and
reliable. One of the commenters felt that employment history is a far
more accurate set of data for determining trustworthiness and
reliability than any other check proposed and that the employment
history should not be ignored.
Response: Employment history was not ignored by the NRC and it is
one of the elements of the background investigation. The NRC agrees
that employment history can and should be used when considering the
information obtained during the background investigation. The licensee
has the flexibility to determine how much weight to give each element
of the background investigation.
Comment B59: One commenter noted that it was impossible to verify
employment if the individual has never worked before.
Response: Part 37 specifically requires that the licensee verify
the individual's employment with each previous employer for the most
recent 7 years before the date of application. If an individual has
never worked before, there is no previous employer and no employment to
verify. For this individual, no employment verification would be
required.
Comment B60: One commenter questioned what was meant by the claimed
period and indicated it should be defined in the rule.
Response: The NRC disagrees that claimed period needs to be defined
in the rule. The claimed period is simply the period of time for which
the individual indicates that they were engaged in a particular
activity such as attending college, being a member of the military, or
working for a company.
Comment B61: One commenter asked for the definition of ``timely
manner'' for when an entity refuses to respond during a background
investigation.
Response: The rule itself does not use the term ``timely manner.''
The rule indicates that within a timeframe deemed appropriate by the
licensee but at least after 10 business days of the request.
Comment B62: One commenter objected to the language in response B8
in the Statements of Consideration indicating that licensees should use
their best efforts to obtain background information. The commenter
noted that best efforts can't be enforced and must be clearly defined.
The commenter also objected to the concept of dependable in judgment,
character, and performance and noted that this must be reduced to
something quantifiable and enforceable and not subject to disparate
interpretations.
Response: The NRC disagrees with the comment. The NRC believes that
the concept of best efforts in this context is necessary because
sometimes it is impossible to obtain information. Companies going out
of business and entities refusing to provide information or not getting
back to the licensee are examples of situations where the licensee's
best efforts will suffice, as long as the licensee documents the
efforts taken to obtain the information. The NRC understands that
judgment and character are subjective items. Licensees make
determinations on judgment and character every time they hire someone
or trust an individual with company assets.
Comment B63: One commenter stated that the NRC should ensure that
the FBI check includes checks against known terrorists or denied entity
lists.
Response: In addition to a criminal history records check, the
names and fingerprints sent to the FBI are checked against various
terrorist watch lists.
Comment B64: One commenter requested clarification on whether the
fingerprints and associated criminal history records check was part of
the background investigation conducted by the licensee since the FBI
does the check and not the licensee.
Response: The background investigation includes the collection and
review of all the information submitted by the applicant and any
information provided by outside sources upon the licensee's request.
While the actual criminal records check is conducted by the FBI upon
receipt of an applicant's fingerprints, the results of the FBI's check
are returned to the licensee, and that information should be reviewed
as part of the licensee's determination of an individual's
trustworthiness and reliability.
Comment B65: One commenter requested clarification on whether the
background investigation elements could be outsourced by licensees to a
third-party verification service. Another commenter requested
clarification on whether some elements of the background investigation
could be performed by HR personnel and have them certify what steps had
been taken.
Response: The background investigation elements could be
outsourced. However, the final determination must be made by the
licensee's reviewing official. If the investigation elements were
outsourced, the licensee would need to assure that the information was
properly protected and controlled.
Comment B66: One commenter expressed support for grandfathering
individuals already allowed unescorted access under the orders. One
commenter recommended that the grandfathering provision also include
those individuals determined trustworthy and reliable under 10 CFR part
73.
Response: The NRC agrees that those individuals deemed trustworthy
and reliable under 10 CFR part 73 should be
[[Page 16965]]
grandfathered or relieved from the fingerprinting and background
investigation elements. Those individuals who have been deemed to be
trustworthy and reliable under other security fingerprinting orders
(such as those for fuel cycle facilities and independent fuel storage
installations) should also be grandfathered. The NRC has revised the
rule to provide grandfathering for those individuals.
Comment B67: Two commenters questioned the value of the 10-year
reinvestigation. They felt that conducting a complete check again makes
no sense if the employee has worked for the licensee that long. One
commenter recommended removing the reinvestigation, or if it is
retained, making it simpler, such as a local criminal history check and
supervisor evaluation. One commenter stated that the reevaluation
needed to include character and reputation determinations. The
commenter noted that changes in a person's attitude or demeanor can
indicate a change in circumstances that warrants restricting access,
whereas there may have been no change in a credit or criminal history.
Two commenters recommended using the FBI background check for the 10-
year reinvestigation. One commenter asserted that, if there are no
indicators that something has changed, the FBI check should be adequate
for a reinvestigation. The commenter noted that employees are typically
evaluated by their employer at least annually, and this provides ample
opportunity to ensure that there have been no changes negatively
affecting security concerns. One commenter noted that Sec. 37.25(c)
suggests that only a criminal history records check and credit history
check are needed, and this implies that trustworthiness and reliability
is not sufficiently demonstrated by 10 years' worth of access without
an incident to revoke the individual's unescorted access. The commenter
stated that the reinvestigation requirement seemed overly draconian,
given that the federal Office of Personnel Management (OPM) standard
for background investigations only requires a reinvestigation for a
security level higher than even an NACIC--and the OPM reinvestigation
is required only every 15 years. The commenter also asked for
clarification on whether the relief provided by Sec. 37.29 applies to
the reinvestigation. The commenter also requested clarification on when
the 10-year reinvestigation is triggered. One commenter stated that
reinvestigation requirement does not make sense as there would be
insufficient information on whether the criminal history will really be
the criminal history or just an arrest record.
Response: The NRC believes that periodic reevaluation of an
individual's trustworthiness and reliability is important. The
reinvestigation is not a complete check. The reinvestigation is limited
to the FBI criminal history records check. The relief provided by Sec.
37.29 does apply to the reinvestigation. The licensee would need to
check that the individual still meets the relief category.
Comment B68: One commenter questioned whether the reviewing
official was subject to the reinvestigation requirement.
Response: The reviewing official is subject to the reinvestigation.
The rule text has been revised.
Comment B69: One commenter stated that Sec. Sec. 37.25 and 35.27
have some duplication of information and that sections should be
reviewed to avoid duplication.
Response: There is some overlap in the requirements. However, the
provisions of Sec. 35.27 apply solely to the fingerprints and FBI
criminal history records checks. The provisions of Sec. 37.25 apply to
the complete background investigation.
Comment B70: One commenter noted that there is potential for
discrepancy between different licensees' basis determination for
unescorted access and questioned the wisdom of allowing transfer of an
individual's trustworthiness and reliability determination under Sec.
37.27(a)(4).
Response: The commenter is correct that there may be differences
between licensees' determination bases for unescorted access. The NRC
still believes that there is merit in allowing licensees to transfer
information and accept another licensee's determination on an
individual. The individual has undergone a background investigation (or
met one of the categories for relief) and been determined to be
trustworthy and reliable. If the second licensee has reason to doubt
the determination or does not feel comfortable relying on the first
licensee's determination, the licensee is not obligated to allow the
individual unescorted access. The licensee could also decide to conduct
its own background investigation before allowing the individual
unescorted access.
Comment B71: One commenter questioned the language in Sec.
37.27(a)(6) that limits use of information obtained as part of the
criminal history records check (from the FBI) to determining an
individual's suitability for unescorted access to the material or SGI.
The commenter felt that if the information indicated that an employee
lied on an employment application, the licensee should be able to fire
the individual based on this information.
Response: The NRC disagrees with the commenter's suggestion that
Sec. 37.27(a)(6) be deleted. The language in Sec. 37.27(a)(6) of the
proposed rule implements the statutory requirement set forth in section
149c.(2)(B) of the AEA, 42 U.S.C. 2169(c)(2)(B). Information obtained
from an FBI criminal history check shall be used by licensees solely to
make suitability determinations for unescorted access to category 1 or
category 2 quantities of radioactive material, or access to SGI.
Information which pertains to the trustworthiness of an employee
obviously is pertinent to a suitability determination. With that said,
the NRC does not make employment decisions for the regulated community.
Comment B72: One commenter stated that the requirement in Sec.
37.27(b)(1) prohibiting a licensee from basing a final determination to
deny an individual unescorted access solely on information received
from the FBI is inconsistent with the intent of the rule to protect the
public from category 1 and category 2 radioactive sources. The
commenter questioned how a responsible licensee could not use
information provided by the FBI to restrict a terrorist from access to
these sources.
Response: The prohibition on using information received from the
FBI only involves information on an arrest more than a year old for
which there is no information on the disposition of the case or an
arrest that resulted in the dismissal of a case or an acquittal. The
licensee may still consider the information, but it cannot base its
decision solely on the information. If there is no disposition of the
case in the file, the individual may have been acquitted of the charge,
and an acquittal is information that would be pertinent to the decision
to grant unescorted access.
Comment B73: One commenter stated that a licensee would need to
have in-depth knowledge of constitutional law to understand the
requirement in Sec. 37.27(b)(2) that prohibits a licensee from using
the information from a criminal history records check obtained under 10
CFR part 37 in a manner that would infringe upon the rights of any
individual under the first amendment of the Constitution. The commenter
noted that NRC should not be proposing any regulation that will be
unconstitutional or be apt to be used to infringe on the rights of
workers.
[[Page 16966]]
Response: The NRC disagrees with the commenter's suggestion that
Sec. 37.27(b)(2) be deleted. The NRC is not proposing a regulation
that is unconstitutional or that infringes on the rights of any
individual. This provision implements section 149c.(2)(D) of the AEA,
42 U.S.C. 2169c.(2)(D), which provides that the NRC is to protect
individuals subject to fingerprinting from misuse of criminal history
records. The onus is on the licensee, not the NRC, to ensure that the
information it obtains as a result of an FBI criminal history records
check will have limited use, and be used in accordance with all
applicable Federal and State laws.
Comment B74: One commenter stated that the licensee should be
allowed to submit fingerprint cards to the FBI. The commenter noted
that submittal of fingerprint cards to the NRC is cumbersome, time-
consuming, and apparently done only to provide an additional revenue
source to the NRC. The commenter noted that it had experienced NRC
losing one set of fingerprint cards. Another commenter noted that the
rule does not allow licensees with a fully-accredited program to do
their own collection and transmission of fingerprints to the FBI. The
commenter requested an exemption to this restriction for licensees who
possess a fully-accredited program.
Response: The NRC cannot exempt a licensee from the statutory
requirement to submit fingerprint cards to the Attorney General of the
United States through the Commission, even if that licensee possesses a
fully-accredited program to collect and transmit fingerprint cards to
the FBI. Section 149 of the AEA states that fingerprints obtained by an
individual or entity must be submitted to the Attorney General of the
United States through the Commission for identification and a criminal
history records check. Consistent with the statutory requirements, a
licensee is required to submit fingerprint cards to the NRC. The NRC
will then submit the fingerprint cards to the FBI for processing and
transmit the results received back from the FBI to the licensee.
Comment B75: One commenter stated that the fees for fingerprint
processing should be placed in the regulations instead of a reference
to the Web site.
Response: The NRC disagrees with the comment. The fees change based
on what the FBI charges. If the fee was placed in the regulations, it
would require the NRC to conduct a rulemaking every time the fee
changed. By placing the current fee information on the Web site, it can
be changed quickly when necessary.
Comment B76: Two commenters stated that Sec. 37.29 should be
deleted and that there should not be any categories of individuals that
are provided relief from the background investigation elements. One of
the commenters noted that any person entering a facility and having
unescorted access to or transporting category 1 or category 2
quantities of radioactive material should be fingerprinted, without
exemption or relief. The commenter stated that given the significance
of theft of such material and the cost of dispersal of such radioactive
material outside a controlled area, the cost and very minor use of time
for fingerprinting is totally insignificant. The commenter noted that
there are many examples of Congress or other persons who have been
fingerprinted and who have broken criminal or other law and, therefore,
should not be exempted. The commenter noted that fingerprinting is
required in many situations not involving threats to national security
or dispersal of radioactive material in public places and that the
process is inexpensive, unobtrusive, and, if the person being
fingerprinted has no reason to fear the process, insignificant and
irrelevant. The commenter noted that most of the individuals covered by
the relieved categories would be escorted and that providing relief
causes confusion and makes the process more complicated. The commenter
further noted that there is no more guarantee that these persons are
more reliable than other workers; therefore, why proceed with
exemptions that weaken the regulation.
Response: The NRC disagrees with the comment. NRC continues to
believe that these categories of individuals should be provided relief.
Many of these individuals have undergone equivalent background
investigations or by the nature of their positions are considered to be
trustworthy and reliable as a matter of policy. Just because an
individual is relieved from the background investigation elements, a
licensee is not required to provide unescorted access to the material.
For example, if a member of Congress were to visit a facility, the
licensee would likely escort the individual and not allow him or her to
wander the facility unescorted. An individual would still need to
receive security and radiation protection training before being granted
unescorted access.
Comment B77: One commenter disagreed with providing relief from the
background investigation elements other than the fingerprints and
criminal history check. The commenter noted that the relief is
inappropriate for certain categories of individuals, in particular
those covered under Sec. 37.29(k). As an example, the commenter noted
that a favorably adjudicated Security Risk Assessment under the Select
Agent program does not assess the depth and breadth of information
required under the full background checks specified either by existing
orders or the proposed regulations. The commenter noted that the risk
assessment only includes those checks specified under the Patriot Act
and that character determination, credit history, verification of
education, verification of employment, and the gathering of
corroborating information are not explicitly included. The commenter
noted that the acceptance of a Security Risk Assessment in place of the
more extensive checks creates a double standard and introduces
potential vulnerability into the personnel reliability process. The
commenter noted that the information that would be analyzed for
personnel under Sec. 37.29(k) does not provide sufficient basis to
assess whether an individual is trustworthy and reliable under the
requirements set forth under either the NRC orders or under the
proposed background check requirements.
Response: The NRC agrees with the comment and has revised the rule.
The relief provided for individuals that come under Sec. 37.29(b)
(formerly Sec. 37.39(k)) only applies to the fingerprints and FBI
criminal history records checks; the other elements of the background
investigation must still be completed. For the other categories of
individuals in Sec. 37.29(a), relief is provided from all the
background investigation elements.
Comment B78: One commenter objected to exempting commercial vehicle
drivers for road shipments of category 2 quantities of radioactive
material. The commenter felt that devices and sources are more
vulnerable during shipment by a nonlicensee carrier than under licensee
or manufacturer control and, therefore, carriers must require a
background investigation for their staff with unescorted access to
category 2.
Response: While understanding the commenter's concern, the NRC
believes that the relief is appropriate. The licensee does not control
the carrier or whom the carrier employs. However, the carriers are
subject to DOT. Title 49 CFR 172.800 requires that each person who
offers for transportation in commerce or transports in commerce
category 1 or category 2 quantities of
[[Page 16967]]
radioactive material to develop and adhere to a transportation security
plan. The components of the transportation security can be found in 49
CFR 172.802.
Comment B79: One commenter requested that information be provided
on what elements of the background investigation each category of
individual relieved from the background investigation under Sec. 37.29
go through.
Response: The NRC acknowledges that the background investigation
conducted for individuals in the relieved categories contained in Sec.
37.29 may not contain all of the aspects of the background
investigation required under part 37. In some cases, the background
investigation is more exhaustive, such as the Federal background
investigation for access to classified information, and some may
contain fewer elements. The licensee is not required to allow these
individuals unescorted access to radioactive material and can choose to
escort them. The licensee can also choose to conduct an investigation
that included some or all of the background investigation elements
before allowing such an individual unescorted access to the material.
Comment B80: Two commenters recommended that the relief from the
background investigation elements for individuals with a Federal
security clearance be extended to include other aspects of the
authorized individual process such as NRC approval of the reviewing
official. One commenter requested clarification as to whether the
relief granted by this regulation may be extended to individuals who
will serve as the licensee's reviewing official.
Response: The NRC agrees with the comment that if the potential
reviewing official meets one of the relief categories of Sec. 37.29,
the individual would not need to be fingerprinted and undergo a new
background investigation. The rule has been clarified.
Comment B81: One commenter requested that Sec. 37.29(g) be revised
to include master materials licensee employees conducting inspections
under their license authority. The commenter also requested that
subparagraph (k) be revised to contain an explicit statement about
whether persons approved under a government program have to be
reapproved after a specified time interval.
Response: The NRC disagrees with the comment. A licensee employee
conducting an inspection on the licensee's own program is not the same
thing as an NRC or Agreement State inspector. The NRC disagrees that
the individual should be relieved from the background investigation
elements as the individual is still a licensee employee. The
individuals who were granted relief would be subject to the 10-year
reinvestigation. If the individual still fell under one of the
categories, such as Sec. 37.29(l), he or she would continue to be
relieved. However, the licensee would need to document that the relief
category still applied.
Comment B82: One commenter requested that the relief provided by
Sec. 37.29(i), from background investigations for emergency personnel
responding to an emergency, be extended to emergency response personnel
who are not responding to an emergency. The commenter pointed out that
these individuals need frequent access for smoke detector checks,
safety inspections of fire walls, assessment of and response to false
alarms, etc.
Response: The NRC disagrees with the comment. Fire department
personnel who need to check smoke detectors and conduct safety
inspections can be escorted. The NRC does not see why these individuals
would need unescorted access to radioactive material. Someone
responding to an alarm would be considered responding to an emergency,
even if the alarm turned out to be false.
Comment B83: One commenter suggested expanding Sec. 37.29(j) to
include handlers at the transportation facilities, i.e., the people who
physically handle the package at the freight terminals and move the
packages from one location to another. The commenter noted that
licensees cannot perform checks for these nonemployees.
Response: The NRC agrees with the comment and has added a new
category to include handlers at transportation facilities such as
freight terminals and rail yards.
Comment B84: One commenter noted that there is a gap whereby Sec.
37.29(m) does not cover self-employed service provider licensees who
are small business owners, for example, independent service technicians
who are licensed to perform maintenance and repairs on sealed source
irradiators. The commenter noted that these individuals are qualified
in a similar way for the applicability of Sec. 37.29, yet the wording
of this regulation does not appear to extend to them.
Response: The NRC believes that Sec. 37.29(a)(13) (formerly Sec.
37.29(m)) does cover a self-employed service provider. The access
authorization program would not be required of a service provider that
does not possess material; however, there is nothing in the regulation
that would prevent the service provider from conducting background
investigations that meet the requirements of Sec. 37.25. The service
provider would need to provide written verification that the individual
has been determined to be trustworthy and reliable under a subpart B
program. Additional information has been added to the implementation
guidance to address this situation.
Comment B85: One commenter indicated that Sec. 37.29 should
include exemption provisions for reputable security system vendors. The
commenter noted that these vendors perform extensive background checks
as part of their hiring process and it seems reasonable to consider the
service providers, software engineers, etc. who work at or with a
licensee's institution to be authorized to access the controlled areas.
The commenter noted that it is unreasonable to expect the licensee to
conduct its own background checks on all employees of the company who
may be involved in the security system at the particular institution.
The commenter noted that by not allowing this exemption, the licensee
may be less inclined to use the state-of-the-art security systems
available and this may be detrimental to the overall security of the
material. The commenter noted that although security service providers
are addressed in the ``protection of information'' section (Sec.
37.43(d)), they should be included here as well, since they not only
have knowledge of the security program but may also have the ability to
grant access.
Response: The NRC disagrees with the comment. It is not clear why
security system vendors, particularly software engineers, would need to
have unescorted access to the radioactive material. These individuals
would need to have access to some of the licensee's security
information, which is why they were included in Sec. 37.43(d).
Security system vendors may or may not conduct fingerprinting and an
FBI criminal history records check as part of their investigation
during the hiring process. Licensees may accept documentation from
vendors that vendor employees have undergone a background check meeting
the requirements of this part, but in the absence of evidence that all
vendors' employment checks meet part 37 requirements; vendor employees
should not be exempted by rule. Licensees also retain the prerogative
to escort such employees when they are onsite.
Comment B86: One commenter, while noting that several State
employees listed by job duties are listed as being relieved from the
background investigation requirements, suggested that State licensing
staff, information
[[Page 16968]]
technology staff, and legal staff be included. The commenter noted that
these individuals may also have access to such information.
Response: The NRC believes that the provisions in Sec. 37.29 are
broad enough to include other State employees that may require access.
Comment B87: The Nebraska Emergency Management Agency stated that
it believes that it is exempt from the fingerprinting, identification,
and criminal history records check requirements and only needs to
provide physical security for its one category 2 quantity source until
such time as the source is collected under the DOE source recovery
program.
Response: No licensee is exempt from the provision of 10 CFR part
37. Section 37.29 does provide relief from the fingerprinting and
background investigations for individuals that fall under one of the
categories. State employees would likely come under the provision of
Sec. 37.29(a)(4) or (6) and would be relieved from the background
investigation elements.
Comment B88: One commenter asked what ``other property'' refers to
in Sec. 37.29.
Response: The term ``other property'' comes from the AEA. The NRC
has removed the term as it has no meaning in the context of 10 CFR part
37.
Comment B89: One commenter suggested that the regulation itself
makes it clear that a licensee has the option of escorting the category
of individuals provided relief from the background investigation (Sec.
37.29), and that granting unescorted access to these individuals is not
required. The commenter also noted that it should be made clear that
the security training must be provided before granting unescorted
access.
Response: The NRC does not believe that the regulation needs to
specify that the licensee has the option of escorting the individuals.
It is always up to the licensee to decide whom it allows to have
unescorted access. The provision in Sec. 37.29 only provides relief
from the background investigation elements and does not require
granting unescorted access to designated categories of individuals. Any
individual allowed unescorted access to the material must meet all of
the licensee's applicable training requirements before having
unescorted access to the material.
Comment B90: One commenter requested that each subsection in Sec.
37.25, ``Background investigations,'' be revised to explicitly state if
the subsection is applicable and must be followed for those who are
relieved from elements of the background investigation under Sec.
37.29.
Response: The NRC does not believe that it is necessary to make the
requested revisions. Section 37.29(a) relieves the licensee from
conducting the fingerprinting and all other elements of the background
investigation. However, the licensee can still choose to conduct all or
some of the elements before providing unescorted access to an
individual who is covered by one of the categories listed in Sec.
37.29. The licensee will still need to verify identification.
Comment B91: One commenter, while supporting the transfer of
background information to outside entities allowed by Sec. 37.31(c)
felt that it would create additional legal issues and burdens on the HR
department that they would not be able to meet. The commenter was
concerned about the ability to authenticate the documentation presented
and avoid fraudulent documentation. The commenter is concerned that
there is no legally proper way to transfer such private information in
a secure manner that would not create legal failure points and possible
violations, as such, they would neither request nor offer such
information.
Response: The language in the rulemaking under Sec. 37.31(c)
states that the personal information obtained on an individual from a
background investigation may be provided to another licensee. While an
individual may request that this information be transferred or shared,
the licensee is not required by these regulations to do so, thereby
minimizing or eliminating additional legal issues or burdens on the HR
department that could arise from such requests. Any decision to request
or provide such information should be made at the licensee's
discretion. The rule merely states that NRC considers it an acceptable
practice, provided that the stipulations in Sec. 37.31(c) are met.
Per the language provided in Sec. 37.31(c)(2), the recipient
licensee must verify information such as name, date of birth, social
security number, gender, and other applicable physical characteristics,
which should aid in authentication and the avoidance of utilizing
fraudulent documentation.
Comment B92: Two commenters noted that the proposed rule has no
mention of safeguards of the privacy of this background information, or
of the method of review. One commenter requested clarification on
whether the licensee needed to retain the fingerprints or just the
records returned from the FBI.
Response: Information protection provisions for the background
investigation are located in Sec. 37.31. The licensee is only required
to retain the records returned from the FBI and not the actual
fingerprints. The NRC is not sure what the commenter meant by method of
review.
Comment B93: Two commenters suggested revising the language for the
timing of the program review to ``periodically (at least annually)
review'' similar to what is contained in Sec. 20.1101. The commenters
stated that the proposed wording is onerous and unnecessary. Another
commenter suggested adding the access authorization program review to
the security program review. Several commenters suggested a 36-month
timeframe or after changes to the program. The commenter noted that the
program should see little revision once it is put in place and that an
annual review seems excessive. One commenter indicated that NRC should
specify those essential program elements for inclusion in the program
review noting that placing such information in the guidance would not
be enforceable and would be a disservice to licensees. Another
commenter stated that there were too many criteria and it could lead
someone to think that the annual security review was more important
than the safety review. Another commenter suggested every 3 to 5 years
for the program review. One commenter noted that the program review
could take from 1 to 3 man days.
Response: The NRC agrees with the comment in part and has revised
the language for the program review to be consistent with Sec.
20.1101. The use of consistent terminology between the safety and
security programs should enhance the licensee's understanding of the
requirement. The content of the program review has not been revised.
Comment B94: Two commenters recommend that facilities utilizing
Federal security clearances should be exempted from the program review.
Response: The NRC disagrees with the comment. While the actual
background investigations and protection of information would be
covered by the Federal program, other aspects of the access
authorization program would not necessarily be included in the Federal
program. For example, the licensee would still need to have a program
in place to document the information on who has access.
Comment B95: One commenter stated that the reviewing official and
the individual with overall responsibility for the security program
should be required to review the access authorization program review
findings. The commenter felt that it was logical for the individual
with overall security
[[Page 16969]]
responsibility to be involved in the review; otherwise, the program
could result in split responsibility for the security program.
Response: The NRC disagrees that a rule change is warranted. The
rule provides the licensee with flexibility as to who should be
designated to review the program review findings. The NRC does agree
that it would be appropriate for both the reviewing official and the
individual with overall responsibility to conduct the review.
Comment B96: One commenter questioned whether licensees should be
obligated to provide unescorted access to any inspectors. The commenter
asked whether Agreement State inspectors are required to present
credentials indicating that they are in compliance with the background
investigation.
Response: Licensees are not obligated to provide unescorted access
to an inspector. A licensee always has the option of accompanying the
inspector. The regulations only require that the licensee ``shall
afford to the Commission at all reasonable times opportunity to inspect
category 1 or category 2 quantities of radioactive material and the
premises and facilities wherein the nuclear material is used, produced,
or stored.'' This means that the licensee must allow the inspector to
go anywhere in the facility but can choose to accompany the inspector.
A licensee has the right to request that an inspector present his or
her credentials (e.g., an agency issued badge) and to confirm with the
inspector's home office that the individual is indeed an employee of
the agency. However, the inspector is relieved from the background
investigation elements and does not need to present any documentation
of compliance with the background investigation.
Comment B97: One commenter recommended adding language that states
that the licensee is not prohibited from revoking previously granted
authorizations at any time.
Response: The rule contains language in Sec. 37.23(e)(4) that
allows the reviewing official to terminate or administratively withdraw
an individual's unescorted access authorization based on information
obtained after the individual has obtained unescorted access.
Comment B98: One commenter noted that language needs to be included
to allow access to SGI-M and other security related information
identified in the part in addition to unescorted access privileges for
category 1 and category 2 materials.
Response: The NRC disagrees with the comment. Provisions for the
protection of SGI, including access restrictions, are located in
Sec. Sec. 73.21 and 73.23. The requirements do not need to be repeated
in 10 CFR part 37. Part 37 contains appropriate references to the 10
CFR part 73 SGI requirements.
Comment B99: One commenter noted that language is necessary to
include the phrase `unless otherwise suspended or revoked' to address
those situations where such restrictive actions became necessary in
regard to access to information or the material.
Response: The NRC disagrees with the comment. Section 37.23(e)(4)
contains language that permits the reviewing official to terminate or
revoke an individual's unescorted access authorization. The NRC does
not believe that additional language is necessary.
Comment B100: One commenter indicated that the rule should include
a limitation on escorted access to only those needing such access to
perform a job function or assist in educational activities.
Response: The NRC disagrees with the comment. The licensee should
be allowed to determine who should be provided escorted access to the
facility and materials. While there should be a need for the escorted
access, there could be reasons other than to perform a job function or
for educational activities.
C. Security During Use
Comment C1: One commenter stated that Sec. 37.41(a) did not allow
for the concept of co-location of sources, only addressing aggregated
sources. The commenter noted that it was not cost effective to require
increased controls on fixed gauges that are scattered throughout a
facility.
Response: The concept of co-location is built into the definition
for aggregated. Fixed gauges that did not fall under the orders do not
fall under 10 CFR part 37.
Comment C2: Several commenters stated that the provisions in Sec.
37.41(a)(2), providing for a 90-day notice before aggregation of
material, were confusing and unnecessary and that aggregation would be
detected during routine inspections. The commenters felt that the
provisions would lead to unintentional noncompliance. Another commenter
questioned how the agency would know when a licensee aggregated the
material, indicating that it would be time consuming and costly to
coordinate and track. Another commenter suggested adding language to
address the permittee system under master materials licenses. One
commenter noted that Sec. 37.41(a)(4) required implementation before
possession. One commenter noted that it should be assumed that
licensees are implementing the measures if they aggregate. One
commenter disagreed with the notification for activation of the
security plans.
Response: The NRC agrees in part and disagrees in part. The
provision was added to help licensees that do not routinely possess an
aggregated category 2 quantity, but may on occasion. The provision was
intended to provide some relief from the need to always meet the
requirements. However, since the wording has caused confusion, the NRC
has revised the provision to simplify and clarify the requirement. A
licensee only needs to provide a 90-day notice before aggregating the
material if the licensee has never implemented either the orders or the
10 CFR part 37 provisions.
Comment C3: One commenter suggested adding a provision in Sec.
37.41(2) to note that the NRC or Agreement State may prohibit the
transfer of radioactive material in quantities of concern should an
evaluation of the security plan be found lacking until corrective
measures are taken and verified.
Response: The NRC disagrees with the comment. The NRC or State may
take action to prohibit the transfer of material in such a situation;
however, a provision in the regulations is not necessary. NRC would
typically issue an order to the licensee or issue a confirmatory action
letter documenting the licensee's agreement not to ship material until
the issues have been resolved.
Comment C4: One commenter recommended that the general performance
objective in Sec. 37.41(b) be revised to remove the phrases ``without
delay'' and ``an actual or attempted.'' Two commenters noted that this
objective is unrealistic during normal business hours as unauthorized
access, whether actual or attempted, would only be detected ``without
delay'' if individuals were in the vicinity and could witness the
access or attempt to access. One of the commenters stated that
``without delay'' is unrealistic during normal business hours as a
business' security system will not be set to alarm. One of the
commenters noted that areas that may contain category 1 or category 2
quantities may be locked and unoccupied but not monitored. The
commenters further noted that, after business hours, an armed security
system could detect (without delay) unauthorized access to an area that
contained a category 1 or category 2 quantity of material but may not
be able to detect an ``attempt'' to access the area
[[Page 16970]]
as the attempt may have failed without compromising a security measure
or triggering an alarm. One commenter suggested revising the
performance objective in Sec. 37.41(b) as follows: ``Each licensee
shall establish, implement, and maintain a security program that is
designed to monitor, detect, assess, and respond to unauthorized access
to category 1 or category 2 quantities of radioactive material.'' One
commenter recommended defining ``without delay'' in Sec. 37.41(b),
particularly with regard to the assessment of an access incident. One
commenter suggested the following language for Sec. 37.41(b): ``Each
licensee shall establish, implement, and maintain a security program
that is designed to monitor, and without undue delay detect, assess,
and respond to an actual or attempted unauthorized access to category 1
or category 2 quantities of radioactive material as outlined in their
security plan.''
Response: The NRC disagrees with the comment. The purpose of the
security program is to prevent unauthorized access and to detect
unauthorized removal of the material. The sooner material is discovered
to be missing, the more quickly a response can be started that includes
trying to apprehend those who stole the material and to recover the
material before it can be used for malevolent purposes. The NRC agrees
that the licensee is not expected to respond to events that do not
trigger the security system. The threshold for the security systems
should not be set so high that actual attempts, such as someone trying
to pry open the door, are not detected or so low such as someone
casually brushing a doorknob sets off the alarm. The NRC does not see
any benefit to adding ``as outlined in their security plan'' to the
rule text. The security plan must meet the requirements, and the
licensee must follow the security plan.
Comment C5: One commenter recommended that a provision be added to
require the licensee to appoint an individual with overall
responsibility for the security program. The commenter noted examples
where no one individual had responsibility to implement the security
measures and noted that a default person such as the RSO may not have
the necessary authority or ability to ensure that the program is
working. The commenter noted that having the licensee specifically
designate an individual will clarify responsibility and provide some
authority. Another commenter noted that the individual should be placed
on the license as is done for the RSO.
Response: The NRC, while agreeing that it is good practice to have
an individual with overall responsibility for the security program,
does not believe that the requirement needs to be in the regulations.
If there were a requirement most licensees would likely name the
individual on the license and then it would take a license amendment to
change the named individual.
Comment C6: Several commenters objected to the requirement to
develop a security plan if they are authorized but never possess a
category 2 quantity or never aggregate the material above a category 2
threshold. Commenters felt that the exercise to develop a plan was a
waste of time and manpower and questioned the value of preparing for an
eventuality that will never occur. Some commenters noted that the
material was in different buildings or scattered throughout a facility.
One commenter stated that physical protection requirements during use
have already been met and there isn't any evidence that requiring
licensees to try and track locations of small amounts of source
material so as not to aggregate to a threshold quantity is unnecessary
to protect the security of the general public. One commenter asked what
the security plan should contain if a licensee doesn't possess category
2 quantities of material. Two commenters stated that a licensee must
implement a full security program based on authorization and not
possession and that this is inconsistent and places an undue burden on
licensees. One commenter requested clarification on whether the
security plan would need to be implemented if the licensee was
authorized for sources above the category 2 threshold but the sources
were located at different sites.
Response: The NRC agrees with the comment and has revised the rule.
Licensees will only be required to develop and implement a security
plan if it aggregates the material to a category 1 or category 2
quantity of radioactive material at a specific location.
Comment C7: Several commenters felt that the specified contents for
the security plan were too prescriptive. Commenters felt that each
facility needs to have the flexibility necessary to develop a security
plan that works best for them and that every security plan may not need
all the prescriptive requirements specified in the proposed rule.
Commenters noted that licensees have already developed their programs
to implement the orders and that the programs have already been
inspected and compliance verified. Commenters felt that the specificity
of the rule was in conflict with the concept of a performance-based
regulation. One commenter noted that the blind ``broad brush''
application of arbitrary requirements is not how to increase security;
it should be based on each licensee's unique requirements. One
commenter noted that there should be an exemption for licensees that
already have a security plan in place.
Response: The NRC does not agree with the comment that the security
program is too prescriptive. The licensee is free to choose the methods
that work best for its facility; the exact security measures to be used
are not prescribed. The content of the security plan is based on the
measures that the licensee chooses to use. The NRC has made changes to
Sec. 37.43(a) to clarify that the security plan is specific to a
facility and its operation and to remove the requirement to address
site-specific conditions that affect implementation. The NRC has
determined that the site-specific aspects would be addressed by the
measures used by the licensee and could not be addressed for temporary
jobsites without creating a security plan for each site. It was not the
NRC's intent to require a unique security plan for each temporary
jobsite. The NRC has also removed the requirement to include a
description of the training program. There is a separate requirement
that addresses training, and it is not necessary to describe the
program in the security plan.
Comment C8: One commenter noted that the original security plan
must be reviewed and approved by the individual with overall security
responsibility but that any revisions to the plan must also be reviewed
by licensee management. The commenter questioned the different review
and approval requirements. The commenter further noted that licensee
management may not have a need-to-know and may not wish to go through
the background investigation process just to review a plan,
particularly if the authority and responsibility have been delegated.
Another commenter noted that this also contradicts the requirement to
limit access to the security plan.
Response: The NRC agrees with the comment and has removed the
requirement for licensee management to review the revised plan.
Comment C9: One commenter stated that the phrase ``measures and
strategies'' in Sec. 37.43(a)(1)(i) is meaningless and unenforceable
even as a performance-based goal. The commenter stated that the phrase
should either be removed or the intent made clear by measurable,
quantifiable, or otherwise objective expectations.
Response: The NRC disagrees with the comment. The licensee is
required to describe the overall approach, methods,
[[Page 16971]]
and equipment that it uses to meet the security requirements.
Additional information has been added to the guidance.
Comment C10: One commenter indicated that the present security plan
(from the orders) is sufficient and that a more stringent security plan
is unnecessary.
Response: The NRC disagrees with the comment. The orders did not
require licensees to even develop a security plan. The NRC does not
believe that the requirements for the security plan are overly
stringent. In fact, the licensee has the flexibility to include in the
plan the site-specific measures that the licensee employs.
Comment C11: One commenter requested clarification in the situation
where there is a high-level corporate security plan in place. The
commenter's interpretation is that the security plan is not required to
apply exclusively to the security of category 1 and 2 radioactive
materials but can be an adaptation of a preexisting site or corporate-
wide plan as long as the required elements are met.
Response: The NRC agrees with the comment. As long as a preexisting
site or corporate-wide plan meets the requirements of subpart C as to
the content of the security plan, the plan would be acceptable and a
new plan would not need to be developed.
Comment C12: One commenter asked whether the written security plan
must be a separate document in addition to the Standard Operating
Procedures (SOPs) that pertain to security. The commenter felt that it
is acceptable for a set of written SOPs to constitute a ``written
security plan'' and would like the regulation to confirm that. Another
commenter requested that a subsection be added to Sec. 37.43 to allow
the security plan and procedures to be the same document or a group of
documents.
Response: Each licensee must determine what information is
applicable to its facility and must be included and documented in its
security plan. If a licensee already has a security plan developed to
meet the requirements of an order or for other purposes, and this plan
meets all the requirements in 10 CFR part 37, there is no need to
develop a new plan. However, it is unlikely that many licensees will
already have all the required information in place in existing
procedures.
If a licensee has existing written procedures and policies in place
that will be incorporated as part of its security plan under 10 CFR
part 37, these may be referenced in the security plan as such; however,
if these existing procedures contain information which would require
marking and handling as SGI-M, then the licensee must ensure that all
copies of the existing documents are appropriately marked and handled.
Comment C13: One commenter proposed that for mobile licensees the
rule be modified to allow the preparation and submittal of a generic
security plan that would be supplemented by a project-specific security
plan prior to initiating work on any given project. The commenter
proposed that the submittal of the generic security plan be required
within 30 days of publication of the final rule as proposed by NRC;
however, the 90-day requirement would not apply.
Response: It was not the intent of the NRC to require the
development of a site-specific security plan for each temporary
jobsite. Development of a general security plan that addresses how
security will be applied at temporary jobsites will meet the
requirement for having a security plan. The security plan is not
submitted to the NRC for approval but would be available at a facility
or temporary jobsite during inspection. The NRC has removed the
requirement that the security plan address site-specific conditions.
Comment C14: One commenter noted that, since the security plan is
to include a description of the environment, buildings, or facility
where the material is used or stored, this would require companies that
work at temporary jobsites to develop a separate plan for each jobsite.
The commenter noted that this would be extremely costly and would
require at least one additional employee per crew to follow the workers
around, assess the surrounding environment, write a security plan, and
train the crew in the new security plan prior to any work being
performed each day. The commenter stated that this would cause undue
burden on the licensee with no evidence that it would in any way stop
an attack or protect the general public.
Response: The NRC agrees with the comment and has removed the
requirement for the security plan to address site-specific conditions.
It was not the intent of the NRC to require the development of a site-
specific plan for each temporary jobsite. Development of a general
security plan that addresses how security will be applied at temporary
jobsites will meet the requirement for having a security plan. For
those temporary jobsites that may be considered permanent (i.e., pipe
yards), the licensee should develop a more specific security plan.
Comment C15: One commenter noted that references to the security
plan should be more specific to avoid security plans required by other
parts.
Response: The NRC disagrees with the comment. The term, as used in
10 CFR part 37, refers to the security plan required by 10 CFR part 37,
and there should be no confusion. Anywhere in this Federal Register
notice or in the guidance for the rule where a different security plan
is being referred to, language has been added to make clear that it is
a 10 CFR part 73 security plan.
Comment C16: One commenter stated that the security program is too
prescriptive and suggested using language similar to Sec. 20.1101 to
implement a program commensurate with the scope and extent of licensing
activities and sufficient to ensure compliance with the provision of
this Part. The commenter stated that this would allow the licensee the
necessary flexibility in documenting its specific program but would not
be prescriptive.
Response: The NRC disagrees with the comment. The NRC believes that
the 10 CFR part 37 requirements provide the licensee flexibility. The
rule does not specify what specific measures that a licensee must use;
a licensee can choose those methods that fit its facility. The security
plan, procedures, and training would address the measures that the
licensee has chosen to use to protect the material.
Comment C17: One commenter suggested deleting Sec. 37.43(b) on
implementing procedures because separate procedures for the
implementation of the security program are unnecessary since they
should be incorporated into the security procedures. Another commenter
stated that many implementing procedures will be developed that do not
include specific security measures designed to protect the sources and
that do not need to be protected under this section. As examples the
commenter offered procedures and forms on how to apply for unescorted
access, how to add people to Radiation Use Authorizations involving
irradiators, or procedures on record destruction.
Response: The NRC disagrees with the comment in part and agrees in
part. Implementing procedures are a necessary component of both safety
and security programs. If a licensee already has security procedures,
it is acceptable to continue using those procedures and update the
procedures to reflect any changes to the program. The licensee is not
required to protect all of its procedures under this provision. The
only procedures that require protection are procedures that document
how the security program is implemented. This would include procedures
on alarm
[[Page 16972]]
response, security guard checks, and procedures that describe actual
security measures. It would not include the types of procedures
mentioned by the commenter. Examples have been added to the guidance
document.
Comment C18: One commenter noted that Sec. 37.43 does not mention
that the requirements apply to individuals who have access to SGI.
Response: Section 37.43(d)(8) does contain a reference to the
protection of SGI. The requirements for access to and protection and
handling of SGI are contained in 10 CFR part 73.
Comment C19: Several commenters stated that there was no need for
the refresher training unless something specific about the program
changes. Commenters felt that only those individuals with a need-to-
know should receive training on specific changes and that not everyone
should be trained on the security plan. One commenter noted that those
who just use the device do not need to be trained on the security of
the device. Two commenters felt that refresher training every 12 months
would be burdensome, particularly if you have many employees needing
the training. One commenter suggested that the periodicity of the
refresher training be based on licensee's expectations and assessments
for a need for refresher training. One commenter noted that the
inclusion of training on the security program just added to the
overhead. Another commenter expressed concern with the probable cost of
the training program and noted that it could require a staff member to
be assigned to the task full time to keep up with the training,
refresher training, and testing for large numbers of diverse
individuals with frequent turnover such as at a university. One
commenter requested cost estimates specific to the training
requirement.
Response: The NRC disagrees with the comment. The NRC believes that
training is an essential element of any program. If employees are not
trained, how will they know what to do if an alarm sounds or material
is determined to be missing? The training needs to be commensurate with
the individuals' responsibilities. The estimated cost for the training
is included in the regulatory analysis prepared to support the rule.
Comment C20: One commenter stated that the training program
requirements were too prescriptive and go well above what is in the
existing orders. One commenter wanted to know what the training entails
and requested a definition of the term ``adequate training.''
Response: The NRC disagrees with the comment that the training
program requirements are too prescriptive. The NRC believes that
training is an essential element of any program and should be required.
The orders did not require any training to be conducted. The training
must address the licensee's security program and procedures and the
security measures employed by the facility. Individuals do not need to
be trained on the complete security plan; the training should be
commensurate with their responsibilities. The provisions in Sec.
37.43(c)(1)(ii), (iii), and (iv) are also general and are similar to
the training provisions of Sec. 19.12.
The term ``adequate training'' is not used in the rule language.
However, the training must cover the information for an individual to
carry out his or her assigned duties and responsibilities.
Comment C21: One commenter stated that Sec. 37.23(a)(2) requires
users to be trained in all aspects of the security plan and that this
conflicts with Sec. 37.43(c)(2) which notes that the training should
be commensurate with the individual's responsibilities.
Response: The NRC disagrees that there is a conflict between the
sections. Section 37.23(a)(2) requires the training required by Sec.
37.43(c) to be completed before allowing the individual to have
unescorted access. It does not state that the individual must be
trained on all aspects of the security plan.
Comment C22: One commenter recommended defining ``relevant
results'' in Sec. 37.43(c)(3).
Response: The NRC disagrees with the comment. The term relevant is
a common term and in this case simply refers to items that are related
to security. Examples of some items that would be included are areas
where staff has had trouble following the security requirements,
violations of the security requirements that have been discussed in an
inspection report, and measures taken to fix any identified security
issues. Additional information has been added to the associated
implementation guidance.
Comment C23: Two commenters requested clarification on the timing
of the refresher training. The commenters noted that their
understanding was that refresher training could be taken more than 365
days after the previous training, as long as it is taken within the
same month of the succeeding year.
Response: The commenter is correct in its understanding that the
training is to be provided at a 12-month frequency and be conducted
within the same month of each succeeding year. This allows licensees
greater scheduling flexibility to accommodate the needs of their
operations, instead of holding them to a strict 365-day time
constraint.
Comment C24: One commenter did not think that the licensee should
be training the LLEA on rules of engagement, such as the proper
response to an alarm. The commenter also asked whether it would be
considered self defense to shoot a perpetrator that holds a category 2
source up as to expose the responder. Another commenter noted that the
LLEA does not have the time or the inclination to undergo licensee
training. One commenter requested clarification on whether the training
program included LLEAs.
Response: The training is not for the LLEA but for the licensee's
staff that would be responding to the alarm. The licensee is not
required to conduct any training of the LLEA, although providing the
LLEA an overview of the facility is a good practice. The rule does not
authorize lethal force or arming of licensee personnel.
Comment C25: In the proposed rule, the NRC specifically invited
comment on the requirement to protect security-related information.
Commenters were requested to provide information on: (1) Whether the
Agreement States have adequate authority to impose the information
protection requirements in this proposed rule; (2) whether the
Agreement States can protect the information from disclosure in the
event of a request under a State's Freedom of Information Act or
comparable State law; (3) whether the proposed rule is adequate to
protect the licensee's security plan and implementing procedures from
unauthorized disclosure, whether additional or different provisions are
necessary, or whether the proposed requirements are unnecessarily
strict; (4) whether other information beyond the security plan and
implementing procedures should be protected under this proposed
requirement; and (5) whether the background investigation elements for
determining if an individual is trustworthy and reliable for access to
the security information should be the same as for determining access
to category 1 and category 2 quantities of radioactive material.
Nineteen commenters provided responses to the specific questions on
this subject.
Of those that provided responses to the questions on the protection
of information, the commenters were divided in their views. Some felt
that the proposed provisions were sufficient, some felt that they were
unnecessarily strict, and some felt that the current provisions from
the Increased Control Orders were sufficient. One commenter stated that
with the proposed provisions, there was no continued need
[[Page 16973]]
for any of the security information to be considered SGI or SGI-M. One
commenter stated that the requirements should be clarified to indicate
that only written copies of the plan and procedures will be protected.
One commenter stated that the rule was unnecessarily strict by
requiring that persons with access to the security plan and procedures
also be permitted unescorted access to the sources. Two commenters
suggested that the list of individuals granted unescorted access to the
security zone should also be protected. Most of the commenters agreed
that the background investigation elements for determining whether an
individual has access to the information and radioactive material
should be the same. Two individuals stated that a criminal history
records check should be part of the background investigation for access
to the information. Two commenters stated that the elements should be
different but did not indicate what should be different. On the
question of whether the States have adequate authority to impose the
information requirements, many commenters indicated that the States do
have the authority or that they thought the States did. On the question
of whether the States can protect the information from disclosure in
the event of a request under a State's Freedom of Information Act, most
of the responses were not definitive. Several commenters indicated that
an opinion from the State Attorney General's Office would be necessary;
four States indicated that they did have the necessary authority.
In addition to those that provided responses to the specific
questions, 8 commenters addressed the information protection
provisions. One State noted that it did have authority to impose the
information protection requirements and could protect the information
from disclosure. One commenter noted that there are already processes
in place under SGI and/or official use only (OUO) to protect security
information.
One commenter recommended adding the list of individuals approved
for unescorted access authorization to the information that must be
protected from unauthorized disclosure, noting that if the names become
public, the individuals could potentially be targeted to gain unabated
access to sources. One commenter requested that Sec. 37.43(d)(1) be
revised to clarify that the protection of information refers to the
written security plan or procedures only, so as to preclude unwarranted
interpretations during a regulatory inspection about what information
or discussions to restrict. The commenter offered suggested language as
follows: ``(1) Except as provided in paragraph (d)(8) of this section,
licensees authorized to possess category 1 or category 2 quantities of
radioactive material shall limit access to copies of their written
security plan and implementing procedures and unauthorized disclosure
of substantive details of the plan or procedures that facilitate
unauthorized access.''
Commenters noted that the fingerprinting element was not included
in the background investigation elements for access to security
information, and several commenters stated that it should be included.
Other commenters requested clarification whether fingerprints were
prohibited for this purpose. Commenters requested that the NRC make the
requirements for background checks consistent throughout the rule. One
of the commenters noted that a licensee is left either to perform
incomplete checks on individuals with whom information is shared, or to
grant unrestricted access to individuals who truly do not need the
access, just to allow the licensee to conduct the main element of the
background check (i.e., the FBI identification and criminal history
records check). One commenter stated that the response discussion for
C6 in the Statements of Consideration should be modified to include the
requirement that anyone seeking information on category 1 quantities of
radioactive material must also have undergone the access authorization
process, including the FBI criminal history review and fingerprint
identification verification. The commenter stated that this would be a
practical threshold for States to have equivalent rules in place that
mimic the NRC's SGI-M requirements in 10 CFR part 73.
One commenter stated that the phrase ``security service provider
employees'' as used in paragraph Sec. 37.43(d)(4)(ii) is too general.
The commenter indicated that it didn't appear that the intent of the
NRC was to require background checks on individuals who do not access
the facility and simply monitor the facility's security system from an
offsite location, such as alarm service providers. The commenter
further asked if the requirement is intended to address security guard
service employees who work on the licensee's premises that contain
category 1 and category 2 quantities of materials. Another commenter
requested clarification and suggested revised language. One commenter
noted that the exemption to performing background investigations for
employees of security service providers requires written verification
from the provider for each employee. The commenter stated that it may
be more appropriate to approve the security service provider as a whole
since it may be difficult for the licensee to maintain a current list
of all employees of the vendor who may have intimate knowledge of the
security system at the licensee's location(s). The commenter noted that
it would be burdensome for the licensee to track individual employees
of these companies. The commenter stated that a letter documenting the
background investigation procedures of the security vendor could be
provided to the licensee to allow it to forego the access authorization
procedures for the security vendor employees. One commenter stated that
each subsection on the protection of information (background
investigation information) should be revised to state explicitly which
subsections are applicable and must be followed for individuals
provided relief in Sec. 37.29.
One commenter stated that there should be no need to have another
documented basis for an individual to have access to the security plan
if it has already been documented that the individual has unescorted
access to material as it is redundant and create additional burden. One
commenter also requested that a table or flow diagram be added to the
guidance document to show when the background investigation elements
apply.
Response: All aspects of the information protection requirements
apply to all of the background investigation information possessed by
the licensee whether the information is the full background
investigation or information on how the individual met a category in
Sec. 37.29 for relief from background investigation requirements. The
NRC agrees that the list of individuals that have been approved for
unescorted access should be protected and has added it to the list of
items for protection. Individuals do not need to have unescorted access
to the radioactive material in order to have access to the protected
information. An individual who has been granted unescorted access to
the radioactive material would not need to undergo another background
investigation to have access to the security information. The licensee
would need to document that the individual has a need-to-know the
information. The rule has been clarified that a second background
investigation is not necessary.
On the issue of protecting only written copies of sensitive
information, the NRC disagrees with the comment. The licensee must
protect against any form of unauthorized disclosure of the
[[Page 16974]]
protected information, including verbal or electronic disclosure.
On the issue of the security service provider, the NRC disagrees
with the suggested change as a security service provider may not be a
guard and could include other occupations. Language in Sec.
37.43(d)(4)(ii) allows the licensee to accept a security service
provider's determination of trustworthiness and reliability based on a
full background investigation. Additional information has been added to
the implementation guidance.
On the issue of requiring fingerprints and FBI criminal history
records for access to the information, the NRC does not have the
authority to require fingerprints for access to this type of security
information. The NRC can only require fingerprints for access to SGI
and unescorted access to radioactive material. The NRC has added a
table to the guidance document on the background investigation
elements.
Comment C26: One commenter requested clarification of Sec.
37.43(d)(3) as to whether individuals, who by nature of their job
position have knowledge of critical components of the security plan,
would be required to undergo a background investigation unless they
have access to the security plan document or any of its implementing
SOPs. Examples include a security guard with access to an alarm-
response schematic or an IT specialist who supports an IT system
responsible for alerting security personnel of adverse indicators in
the area of category 1 or category 2 radioactive sources. In each case
the individual has knowledge of security plan components but would not
have access to the plan itself or implementing SOPs.
Response: Employees or service providers with limited knowledge of
the security plan but without access to the plan or the implementing
procedures would not necessarily need to undergo a background
investigation. The licensee would have to decide in some cases how much
knowledge of the plan the employee has; if the employee is familiar
with the plan and procedures, even if he does not have access to the
document, it may be necessary to conduct a background investigation and
make a determination of trustworthiness and reliability. Note that new
language in Sec. 37.43(d)(4)(ii) allows the licensee to accept a
security service provider's determination of trustworthiness and
reliability based on a full background investigation.
Comment C27: One commenter requested that the language in Sec.
37.43(d)(5) requiring that ``* * * the licensee shall immediately
remove the person * * *'' be revised to remove the word ``immediately''
and to substitute ``as soon as practical.'' The commenter noted that
the person won't immediately forget the information in the plan and
that there is no need for immediate removal.
Response: The NRC agrees with the comment. An immediate removal
from the list is probably not necessary. The NRC has revised the
language to reflect that the removal should occur as soon as possible
but no later than 7 working days.
Comment C28: One commenter objected to the phrase ``in a manner to
prevent removal'' in Sec. 37.43(d)(6). The commenter felt that the
phrase was exceedingly vague. The commenter suggested a change to
``secure the plan to prevent unauthorized access.''
Response: The NRC agrees with the comment and has revised the rule
text to read: ``When not in use, the licensee shall store its security
plan and implementing procedures in a manner to prevent unauthorized
access.''
Comment C29: One commenter requested clarification on whether a
reinvestigation is required for individuals who have access to
sensitive information only, and if so, the procedure that should be
followed.
Response: Yes, the reinvestigation applies to individuals who have
access to sensitive information. The rule has been clarified to make
the requirement clear.
Comment C30: One commenter requested that language from the orders
addressing marking and transmission of security related documents be
added to the rule.
Response: The NRC disagrees with the comment and does not believe
that the marking and transmission measures need to be added to the
rule. Licensees are not required to submit either the security plan or
implementing procedures to the NRC. The NRC reviews these documents
during inspections at the site. The transmission portion is therefore
not necessary. The necessary elements from the orders on access to and
protection of the information are in the rule. The other elements are
good practice, but the NRC does not believe that they are essential for
the adequate protection of the information. However, if a licensee
believes that information submitted to the NRC should be withheld from
public disclosure, the licensee should follow the requirements in Sec.
2.390.
Comment C31: One commenter suggested that the terms ``Safeguards
information'' and ``Safeguards information modified handling'' be
defined in 10 CFR part 37.
Response: The NRC disagrees with the comment. Safeguards
information and safeguards information modified handling are defined in
10 CFR part 73 where the requirements for handling such material are
located. The reference in 10 CFR part 37 is merely a pointer to the
requirements and does not establish any new requirements; therefore,
the NRC does not believe that a definition for these terms is necessary
in 10 CFR part 37.
Comment C32: One commenter asked that the NRC define ``to the
extent practicable'' for coordination with LLEAs.
Response: This provision was added to the rule to provide the
licensee with some flexibility. Some LLEAs may be reluctant to engage
in coordination activities with a licensee. The provision ``to the
extent practicable'' allows the licensee to remain in compliance with
the rule when an LLEA will not participate in any coordination
activities. The NRC does not believe that phrase needs to be defined.
Guidance is available on this topic and other aspects of the rule in
the associated implementation guidance.
Comment C33: Two commenters recommended deleting paragraph Sec.
37.45(a)(1)(ii) as this information would be classified as SGI or SGI-M
for some licensees and would require handling and control in accordance
with Sec. 73.21. The commenter indicated that there appears to be
little if any benefit in providing this information to the LLEA that
would warrant the dissemination of SGI or SGI-M. Another commenter felt
it was unnecessary to describe specific security measures such as alarm
types and locations unless the LLEA is actually monitoring these
alarms. The commenter asserted that a generic description would be
adequate for the purpose of LLEA situational awareness.
Response: The NRC disagrees with the comments. The NRC believes
that the information on the facility can be useful to the LLEA. In an
event where someone is trying to steal the material, the LLEA can mount
a more informed response if information about the facility is available
to the responders. When NRC staff has met with LLEA representatives,
the representatives have indicated interest in the coordination
activities. LLEAs are deemed trustworthy and reliable for access to
sensitive security information as well as SGI.
Comment C34: One commenter noted that an LLEA is not going to tell
every licensee whether the initial response to an emergency involving
radioactive materials must be provided by other than armed LLEA
personnel and
[[Page 16975]]
questioned how a licensee would know this information. The commenter
suggested removing the provision as it was a nonsense requirement. One
commenter stated that the NRC should coordinate with the States to be
notified instead of requiring the licensee to notify the NRC after the
licensee becomes aware of any State or local requirements that an
initial response to an emergency involving radioactive material must be
provided by other than armed LLEA personnel. Another commenter
recommended removing the requirement. One commenter asked what the NRC
would do after such notification.
Response: The NRC agrees that there may be some reluctance on the
part of the LLEA to provide the information. The provision is not
included in the final rule.
Comment C35: One commenter questioned the need for a specific
written agreement for response. The commenter also requested
clarification on what must be included in the agreement. Some
commenters questioned the benefit of requiring coordination with the
LLEAs and questioned whether this was the best use of LLEA resources
given the low probability of an actual threat to sabotage or steal a
category 2 source. Commenters indicated that, based on their experience
to date with the orders, the LLEA coordination was not beneficial,
noting that at best the LLEAs would acknowledge the coordination
attempts with no commitments, other than to respond in the manner they
believed was proper, and that most LLEAs were completely disinterested
and did not acknowledge any information provided by the licensee. They
noted that in their discussions with those LLEAs where feedback was
provided, the LLEAs were unwilling to discuss the manner in which they
planned to respond and unwilling to commit to any specific action as
each decision to respond must be based on their judgment of the
circumstance. One commenter indicated that LLEAs would not want to
disclose their capabilities. One commenter noted that the LLEA is not
required to comply with the request. At least one commenter questioned
whether it would be more efficient to inform/train only the LLEA
involved when the billions we spend on intelligence indicate a credible
threat. Commenters felt that adding a requirement does not address the
root cause. One commenter expressed concern that security could be
reduced if the LLEA failed to protect the information or had to release
the information under a FOIA request. The commenter suggested a
reevaluation of the information provided to the LLEA such that release
of information would not cause a breach in security. Two commenters
noted that they had successfully coordinated with their LLEA under the
orders and do not believe that any additional requirements are needed.
One commenter indicated that the coordination process should be a
clearly defined process. One commenter stated that LLEA coordination
requirements were overly prescriptive and difficult to implement. The
commenter stated that, if NRC feels this is necessary, NRC should take
the lead and identify contacts and provide training. A commenter noted
that the use of 911 is effective for all kinds of emergencies and
should be used by licensees. One commenter agreed that there is value
in a coordinated response from an LLEA and that such a response should
include the capability of bringing armed force; however, the commenter
stated that it was inappropriate to place the requirement on the
licensee. The commenter stated that the extent of the response should
be left to the discretion of the LLEA. The commenter noted that the
requirement for a written agreement with the LLEA was unenforceable and
outside the State's jurisdiction. Two commenters noted that the LLEA
coordination was one of the most difficult areas to implement from the
orders and places responsibility on licensees for activities they
cannot control.
Response: While the orders contained a requirement for a
prearranged plan with the LLEA, the proposed rule only contained a
provision to request that the LLEA enter into a written agreement.
After evaluation of all of the comments on the LLEA coordination, the
NRC has simplified the requirement. The NRC continues to believe that
coordination with the LLEA is important, and the rule contains a
requirement for coordination. However, the decision was made that
several of the items, while good ideas, were better addressed in the
guidance document and not in the rule itself. A written agreement and
several of the coordination activities are not included in the final
rule. Even if a written agreement had been reached, an LLEA will
respond as it feels is appropriate to the particular situation.
Comment C36: One commenter objected to requesting the LLEA to
provide updated contact information as it places a burden on the LLEA.
Two commenters suggested that this only be a requirement if a facility
is not served by a 911 system.
Response: The NRC agrees that it is not necessary to request
contact information or updated contact information. Most licensees in
the case of an actual threat would call 911 and not the contact.
Additionally, no contact would be available 24/7. The provision is not
included in the final rule.
Comment C37: Many commenters objected to the requirement that a
licensee request the LLEA to notify it of degraded capabilities as
unrealistic, unnecessary, unenforceable, and would probably violate
LLEA ``need-to-know'' procedures. Some commenters felt that the
requirement that the LLEA notify licensees of a degradation of their
response capabilities was clearly outside the purview of the regulating
agencies. Others noted that licensees have no authority over
nonlicensed entities such as LLEAs. Commenters felt that the LLEA is
better equipped to arrange for alternative response capabilities than
would the licensee and that this would be an inherent part of LLEA
organizational framework; some commenters asked what the direction was
if a licensee was notified of a degraded LLEA response capability.
Another commenter asked what the State was to do if notified that the
LLEA was not cooperating in providing the degraded capability
information. Commenters noted that it is inconceivable to believe that
the LLEA would notify a licensee that their response capabilities have
become degraded, not only because that would appear to be an open
invitation to the criminal sector, but also, if capabilities are
degraded, logically the LLEA would not have the capability to notify
licensees. Commenters asked what they would do with the information if
provided. One commenter suggested as an alternative that the licensee
request the LLEA to confirm that it has a contingency plan in case of
compromised response capabilities. Another commenter noted that it was
more important for the licensee to discuss this issue with the LLEA
during the coordination meetings. Another commenter noted that there is
not prescribed action for the licensee to take if notified and
questioned the purpose of the notification.
Response: The NRC agrees that many LLEAs may not want to provide
information on degraded capabilities. The provision is not included in
the final rule.
Comment C38: One commenter stated that the participation of
licensees and LLEAs in drills and exercises was an unfunded mandate and
should not be required. The commenter also questioned whether drills
and exercises contribute to the security of the sources or the public
health and safety. Two
[[Page 16976]]
commenters suggested removing this requirement as there is no
requirement to conduct such drills.
Response: The NRC agrees in part and disagrees in part. The
proposed rule did not require that drills and exercises be conducted.
The rule did contain a provision that required the licensee to ask
whether the LLEA would be willing to participate in drills and
exercises. As there is no requirement to conduct drills and exercises,
the NRC has removed this provision as suggested by the commenters. The
NRC does note that drills and exercises can contribute to the public
health and safety and the security of the material.
Comment C39: Several commenters felt that the requirement for a
licensee to notify the regulatory agency if an LLEA declines to
participate in coordination activities creates an unnecessary burden
for the regulatory agencies that will now be required to notify the
Department of Homeland Security or contact the LLEA directly to explain
the importance of cooperating. Some commenters suggested that if NRC
believes this is truly a critical issue, NRC should coordinate with the
Federal Department of Homeland Security's Nuclear Sector Government
Coordination Council to engage law enforcement from a broader
perspective. One commenter asked what actions the NRC would take when
notified and what the NRC would do if the NRC did not gain confidence
that the LLEA would respond in an actual emergency.
Response: The NRC disagrees with the comment. The NRC believes it
is vitally important for the licensee to coordinate with the LLEA, and
the agency wants to know if the LLEA won't participate. There were
instances during implementation of the orders where the NRC met with
the LLEA to explain the importance of LLEA cooperation with the
licensee. The State is not required to contact DHS or the LLEA if the
LLEA does not want to participate in coordination activities. DHS does
have training programs to educate LLEAs.
Comment C40: Two commenters objected to the requirement to
coordinate with the LLEA every 12 months, noting that it took several
months to set up a meeting for the coordination required by the orders.
The commenter felt that, as there had been no events requiring contact
with the LLEA and no changes to the security program, there was no need
to meet annually. The commenter noted that both parties have plenty of
work and are not just sitting around and focusing on this one agenda
item. The commenters asked whether the licensee would be cited if the
LLEA refused to meet on an annual basis.
Response: The NRC disagrees with the comment. The NRC believes that
it is important to maintain contact with the LLEA. Turnover at both the
LLEA and the licensee occurs over time and if contacts are not
maintained, the knowledge obtained during the initial coordination is
lost. The annual follow up does not need to be extensive. If the LLEA
refuses to participate, the licensee should document the attempt. The
licensee would not be cited as long as it had documented the
attempt(s).
Comment C41: One commenter noted that the requirement to document
coordination activities with the LLEA would now require regulatory
agency inspectors to visit LLEAs to determine licensee compliance,
resulting in longer inspection times and possibly creating a situation
that may be interpreted by the LLEA as intrusive.
Response: It is not clear why the commenter feels that an inspector
would be required to visit the LLEA to determine a licensee's
compliance with the rule's coordination requirements under Sec. 37.45.
The licensee is required to document the coordination activities, and
an inspector would be expected to review the documentation. An
inspector may choose to contact the LLEA to gain a greater
understanding of the nature of the coordination efforts. However, this
rule does not require that an inspector contact the LLEA to determine
licensee compliance with Sec. 37.45.
Comment C42: Two commenters noted that the goals and objectives for
coordination activities with LLEAs are admirable, but the commenters
stated that this is an area where the NRC should consider taking
concerted efforts to engage law enforcement communities to improve
situational awareness now, rather than waiting for feedback from
licensees regarding potential LLEAs refusing to cooperate. The
commenters suggested that the NRC consider an outreach campaign aimed
at direct communications with LLEAs to better understand their
perspectives regarding these issues. Another commenter suggested a
Federal outreach training program to LLEAs for radioactive materials
incident response. The commenter noted that DOT has an outreach program
for transportation incident response.
Response: During the security inspection process, the NRC
inspectors have been contacting the LLEAs to both ensure that licensees
have been coordinating and to improve the LLEAs understanding of the
importance of providing a timely response. At this time, the NRC is not
planning any additional outreach to LLEAs. However, the DOE has a
program to provide LLEAs with additional training for responding to the
attempted or actual theft of category 1 or category 2 quantities of
radioactive material. The Global Threat Reduction Initiative (GTRI)
program provides security personnel and local law enforcement with
tools (e.g. radios, repeaters, and personal detection devices) and
additional training to respond to a security incident. To ensure that
both onsite and offsite responders understand how to respond to
enhanced security system alarms, GTRI developed an alarm response
training course, which is held at the Y-12 National Security Complex in
Oak Ridge, Tennessee. This alarm response training also prepares
responders to protect themselves and the public when responding to
events involving radiological materials. The participants conduct
hands-on training in a realistic setting using actual protection
equipment and real radioactive sources. The courses include operational
exercise scenarios that build on classroom instruction and allow
response forces to exercise their own procedures during realistic alarm
scenarios.
Comment C43: One commenter noted that not all events that occur are
of a nature that an LLEA would have to be involved and questioned why
it should be mandatory that an LLEA respond to events that could be
handled by internal security.
Response: It is not mandatory that the LLEA respond to all events.
The licensee is suppose to assess the event and contact the LLEA only
if there has been an actual or attempted theft, diversion, or sabotage
attempt. The language has been clarified.
Comment C44: One commenter questioned how the failure of the LLEA
to coordinate fully with the licensee would impact the status of a
license. The commenter noted that licensees should not be held
accountable for noncooperation or lack of resources on the part of the
LLEA. The commenter stated that it should be under the purview of the
NRC or Agreement State to ensure that the LLEA works with the licensee
in the requested manner.
Response: Failure of the LLEA to coordinate does not affect the
status of the license, and licensees will not be held responsible if
the LLEAs do not coordinate. Under Sec. 37.45(b) and (c), licensees
are only required to document their coordination efforts and notify
their appropriate NRC regional office if the LLEA does not wish to
coordinate. The NRC will contact the LLEA to
[[Page 16977]]
explain the potential consequences of the theft of category 1 or
category 2 quantities of radioactive material and encourage the LLEA to
participate in coordination activities with the licensee.
Comment C45: One commenter requested that the NRC add a subsection
to clarify requirements for coordination by a licensee or permittee
under a master materials license that has an onsite LLEA that would
preclude unwarranted interpretations during a regulatory inspection
about the extent that coordination must be documented. The commenter
offered suggested language as follows: ``For a licensee or permittee
under a master materials license with an on-site LLEA, coordination
requirements in this subsection are considered to have been completed
if the security plan and implementing procedures establish methods for
LLEA response at the facility.'' Another commenter raised the issue of
unnecessary documentation of coordination activities when the LLEA is
part of the same organization that owns the radioactive material. The
commenter noted that the lack of documentation activities should be
seen as good news unless the LLEA refuses to respond to appropriate
requests for assistance. The commenter also notes that burdening the
police with detailed paperwork is an ``insult to their understanding of
the risks inherent to their mission.'' This commenter also suggested
adding a new subparagraph as follows: ``When the LLEA is part of the
organization that owns and controls the Category sources, the
documentation in Sec. 37.45(a)(2)'' {was (a)(1){time} ``is not
required provided all the elements of good willful coordination are
clear.''
Response: Even when the LLEA is on site, the licensee should
conduct coordination activities. The coordination would likely be
simplified but still needs to occur. The coordination activities to
meet the requirements of Sec. 37.45 need to be documented even if the
LLEA is part of the same organization. The licensee would not need to
document all interactions with the LLEA, only those necessary to meet
the requirements. Note that it is not the LLEA that is required to
document the coordination activities.
Comment C46: One licensee asked whether a written agreement with a
third party service that provides off-duty local law enforcement agents
on site at all times would be acceptable to demonstrate compliance with
the LLEA coordination requirement. The commenter stated that the agents
have full response and arrest capabilities while working at the
facility.
Response: If the third-party service provides individuals that meet
the definition of LLEA and the third-party service can provide a timely
armed response 24 hours per day, then the third party service providers
meet the requirement for LLEA coordination.
Comment C47: One commenter questioned what would be expected of the
State if the LLEA did not respond to an event?
Response: The expected response would depend on the circumstances
and would be up to the State. The NRC believes that it would be highly
unlikely that the LLEA would not respond to an actual or attempted
theft of radioactive material.
Comment C48: In the proposed rule, the NRC specifically invited
comment on the requirement to contact the LLEA for work at a temporary
jobsite. Commenters were requested to provide information on: (1)
Whether there is any benefit in requiring that the LLEA be notified of
work at a temporary jobsite; (2) whether notifications should be made
by licensees for work at every temporary jobsite or only those where
the licensee will be working for longer periods, such as the 7 day
timeframe proposed in the rule; (3) whether 7 days is the appropriate
threshold for notification of the LLEA or should there be a different
threshold; (4) whether licensees can easily identify the LLEA with
jurisdiction for temporary jobsites or whether this imposes an undue
burden; and (5) whether LLEAs are interested in receiving these
notifications. Eighteen commenters provided responses to the specific
questions on this subject.
Of those that provided responses to the questions on LLEA
notification at temporary jobsites, the majority indicated that there
was no benefit to notifying the LLEA of temporary jobsites. Only one
commenter indicated that there is some benefit for notification of work
using category 1 materials and one noting some benefit for a temporary
jobsite lasting longer than 30 days. Commenters indicated that
temporary jobsites are unpredictable in nature and therefore unlikely
to be a primary target. Commenters noted that in most cases the
licensee does not know 3 days in advance where work might occur and
that due to the nature of the job it is often not possible to determine
the length of the job in advance. Commenters noted that the
notifications may cause confusion for the LLEA and would likely be
intrusive. Commenters indicated that the emergency 911 system is
adequate in the case of a security event. One commenter noted that the
LLEA would also need to be notified when the job ended. One commenter
suggested that notifications go to a central location, such as the NRC
or Agreement State, and then the central organization could coordinate
with State and local police. The commenter indicated that this would
reduce the confusion and workload on both the licensees and the LLEA
and help to maintain a healthy working relationship and be more
effective. Some commenters noted that clarification would be needed to
address cumulative time where 7 days are not consecutive and to better
define the boundary of a temporary jobsite for jobs along pipelines.
Commenters indicated that it would be difficult to identify LLEA with
jurisdiction over temporary jobsites, noting issues with overlapping
jurisdictions, moving jobsites, offshore locations, etc. Commenters
stated that this would impose a huge burden without meaningful benefit.
Most commenters indicated that the LLEA would not be interested in
receiving temporary jobsite notifications. Commenters indicated that
LLEAs would respond in the case of an emergency whether there was an
advance notification or not. No LLEAs provided comments.
In addition to those commenters that provided responses to the
questions, 32 commenters provided comment on the issue of LLEA
notification for temporary jobsites. Most of the commenters objected to
the requirement to notify LLEA for work at temporary jobsites.
Commenters thought that the requirement was unrealistic and created an
unnecessary burden, both in personnel and operations. One licensee
noted that its company had over 5,000 jobs a year that would meet the
requirement and that in addition many jobs, that were to be less than 7
days, experience delays that are beyond the control of the company.
Commenters noted that the paperwork for the notifications will be time
consuming to produce and, if it is to be valuable, time consuming for
LLEAs to read and comprehend. Many noted that there is no practical
means to identify the appropriate LLEA, particularly in areas that the
licensee is not familiar with, and in some cases a temporary jobsite
might cover a very large area with several overlapping jurisdictions,
and it can be difficult to determine which agency is the first
responder. Commenters noted that many times licensees are notified of
the necessity of work on the same day the work is
[[Page 16978]]
required and don't know 3 days in advance, with one commenter noting
that only about 3 percent of its jobs are known 3 days in advance.
Commenters noted that these jobs often involve repair of critical oil
and gas infrastructure which could be delayed while attempting to
determine which LLEA has jurisdiction and coordinating with them,
creating significant cost to the industries with no benefit. One
commenter suggested that, if the provision was retained, it be modified
to require the notification be made within three business days
subsequent to beginning work as this would alleviate some of the
problems created by advance notifications.
Some commenters noted that the LLEAs do not want to receive these
notifications and would be unprepared to receive the notifications.
Some commenters thought that the contacts with the LLEA without
possible response from the LLEA may accomplish nothing but aggravation
and frustration for the LLEA. One commenter (a State) indicated that,
based on a survey of LLEAs, the LLEAs want to know about a temporary
jobsite, no matter how long the site will be used, so they can plan for
emergencies. The commenter indicated that the LLEA would like a
standardized form to be used by States that clearly indicates the high
priority of the information. Many commenters noted that the 911 system
is the best tool if there was an attempted theft and that responders
would quickly respond once they realized that radioactive material was
involved. Commenters noted that it is expected that the LLEA will
respond to a security event in fulfillment of their responsibility to
protect life and property and that in many jurisdictions LLEA resources
are somewhat limited. Commenters felt that the NRC lacked a true
understanding of the nature of the temporary jobsite work that is done
or the concept of using the 911 system when law enforcement is needed.
At least one commenter felt that the NRC was placing the licensee in a
position that would likely result in unintentional violations to the
rule. Commenters felt that due to the itinerant nature of temporary
jobsites and being constantly on the move, it would be very difficult
to plan a theft in the field setting. One commenter noted that
licensees are already required to negotiate and pay for reciprocity, as
well as inform the applicable State agency as to when and where
operations are planned and the duration of the project and that
expansion of this requirement to include local authorities was asking a
lot.
One commenter suggested an alternative of requiring daily contact
with the home office and noted that failure to contact would prompt an
investigation by the home office which would lead to LLEA notification
as appropriate. Commenters asked who will offer training to every
jurisdiction and who will subsidize those jurisdictions, current local
budgets being what they are.
Response: After reviewing the comments received on this issue, the
NRC has decided not to include the LLEA notification for work at
temporary jobsites in the final rule. While there is some limited
benefit in receiving the notifications, the benefit does not outweigh
the burden that the requirement would impose. Identification of the
appropriate LLEA would not be easy. The notifications could also cause
confusion among the LLEAs as to what they should do with the
information. In the event of a theft, the licensees will likely call
911, and the LLEA will respond as appropriate to the call. Also, as
pointed out by the commenters, companies often don't know where they
will be working in advance. Locations, particularly along pipelines,
shift consistently making it difficult to know who to contact.
Comment C49: One commenter suggested that instead of mandating the
licensees to take on this burden, the Commission's approach should be
to encourage licensees to offer LLEAs their expertise and offer some
form of training to the local departments. The commenter noted that the
Increased Control Orders require the licensees to establish their
presence with LLEAs as the facilities clearly are a much more
attractive target to an attack than the mobile fleets. The commenter
suggested that an adjustment in the rule encouraging a closer
relationship in this area would be more accepted by all parties
involved and would not overly impact said parties financially or on a
personnel basis. Creating a program that encourages and supports
licensees and LLEAs working together would or could create close
relationships that will have far more impacting and lasting results
than calls to the departments advising them of work that is proposed to
last more than 7 days.
Response: The NRC has not included the notification provision for
work at temporary jobsites in the final rule, and there are no
requirements for training affected LLEAs. See the response to comment
C48. The NRC recognizes the benefits to licensees of having a close
working relationship with the LLEA for the security of any jobsite,
permanent or temporary. Licensees are free to take whatever actions
they feel are appropriate to develop this type of working relationship.
Comment C50: One commenter noted that the temporary jobsite
notification could be via email and that email is generally unsecured
unless it is encrypted or sent as password protected attachments. The
commenter noted that the rule does not contain any restrictions as
outlined in Regulatory Issue Summary 2005-31.
Response: The provision for LLEA notification for temporary
jobsites is not included in the final rule. See the response to comment
C48.
Comment C51: Some commenters objected to the concept of a security
zone because they believe it is abstract, nebulous, and unworkable in
actual work environments of the types of licensees who must comply with
the regulation, and unnecessary and burdensome with no benefit.
Commenters felt that the concept would cause confusion. Commenters
stated that it would add an unneeded term and concept that would likely
lead to confusion and would add burden with little intrinsic benefit.
The commenters noted that the licensees' procedures that have been put
into place to meet the current orders create security and have been
verified through inspections and that no change is necessary. Two of
the commenters stated that the security zone concept was discussed
during the orders working group process and that the concept was not
incorporated in the orders. The two commenters indicated that this had
the appearance of an attempt to incorporate in rule a concept that did
not have consensus and was not incorporated after going through the
orders working group process. One commenter noted that the industrial
use of radioactive materials when used at its facility is essentially a
security zone because facility access is restricted due to ITAR
requirements. This commenter said it should be sufficiently secure to
set up restricted areas based on the radiation level and monitor the
material until it is secured in storage. One commenter noted that the
increased controls are in place, and it was not aware of any situations
that have occurred that now warrant the inclusion of a security zone
designation.
Response: While working groups for the orders may not have been
able to reach a consensus on an issue, this does not mean that the
working group for the rule was unable to reach consensus. The 10 CFR
part 37 rule working group had information available that was not
available to the orders working group.
[[Page 16979]]
The 10 CFR part 37 working group considered the orders, lessons
learned, implementation issues, inspection issues, recommendations from
other reviews, as well as the comments on the preliminary rule language
and proposed rule. The purpose of security zones is to isolate and
control access to category 1 and category 2 quantities of radioactive
material to protect them more effectively and deter theft or diversion.
A security zone effectively defines where the licensee will apply these
isolation and access control measures. It is thus a logical extension
of the requirement in the Increased Control Orders that licensees
``control access at all times to [category 1 and category 2]
radioactive material quantities * * * and limit access to such
radioactive material and devices to only approved individuals who
require access to perform their duties.''
Because the purpose of security zones is different from the
radiation safety purposes of the restricted areas and controlled areas
defined in 10 CFR part 20, the security zone does not have to be the
same as either of these areas. Because measures to control access are
required for both radiation protection and security, however, a
licensee does have the flexibility to use an area required for
radiation protection purposes to fulfill the required functions of a
security zone.
Comment C52: One commenter noted that the security zone concept
potentially has serious operational and financial repercussions and is
expensive overkill. The commenter noted that adding continuous barriers
could be extremely expensive and may introduce scattered radiation into
labs that have very specific operational requirements. The commenter
noted that isolating and controlling access does not appear to comply
with the requirements for the physical barriers and that locks, cables,
etc. would not isolate the same radioactive material in a security zone
as required. The commenter noted that individuals could frequent the
security zones but still be separated from the radioactive material due
to the lock but that the rule requires that only authorized individuals
have access to the security zones. The commenter stated that these two
concepts seem to conflict with each other and if the common physical
barrier concept is not acceptable, then many more licensees will fall
under these requirements due to the aggregation of radioactive
material. The commenter noted that it would cost over $200,000 to
develop continuous barriers and redo calibrations, procedures, etc., if
it can be done at all. The commenter suggested allowing the licensee to
propose measures to compensate for the lack of a continuous barrier
when that barrier would obstruct the use of the radioactive material
for its intended purpose and when there is no available alternative.
Response: A continuous barrier is not the only method that a
licensee can use to meet the requirement. Direct observation is also
allowed, as is a combination of barrier and direct observation. A
continuous barrier does not have to be expensive; it can be a metal
cage or walls. The commenter seems to believe that unauthorized
individuals cannot be in a security zone. This was not the intent of
the rule. Unauthorized individuals can have access to the security zone
as long as they are escorted by an approved individual. The rule
language has been clarified, and additional information has been added
to the implementation guidance. The licensee can establish the
boundaries of the security zone as appropriate for a particular
facility; the rule does not dictate where the security zone is located.
In most cases, whatever a licensee used to meet the orders will also
meet the 10 CFR part 37 requirements. The Increased Control Orders did
not use the term ``security zones'' but the concept was a factor.
Comment C53: One commenter expressed concern with the security zone
concept at temporary jobsites. The commenter noted that implementation
would require additional personnel and expense, and the security zone
will require areas that will be larger than the radiation areas.
Another commenter noted that the concept could cause confusion in
certain types of jobsites where aggregation of multiple low level
sources would constitute a security zone. The commenter provided the
example of petrochemical plants that use low level sources to monitor
product levels, noting that aggregation of these sources will
constitute a security zone which would require direct control by
approved individuals at all times and\or intrusion detection systems
and physical barriers. The commenter felt that this could mean that the
entire plant would be a security zone, and only trustworthy and
reliable employees could enter.
Response: The NRC disagrees with the comment. It is not clear why
the security zone concept would result in additional personnel and
expense, or why it will require security zones larger than the
radiation areas at either temporary or permanent jobsites. A security
zone effectively defines where the licensee will apply the isolation
and access control measures required under the Increased Control
Orders. The NRC is unaware of any operating conditions that would
require more space for compliance with any of the additional measures
required by this rule. The licensee establishes the security zone, and
because measures to control access are required for both radiation
protection and security, a licensee has the flexibility to use an area
required for radiation protection purposes to fulfill the required
functions of a security zone. The NRC is unaware of any petrochemical
or other industrial plants that have designated the entire plant as a
radiation safety area for their radiography or other sources, and the
NRC sees no reason why such licensees or licensed service providers
would need to designate the entire plant a security zone for the
purposes of this rule. A licensee could of course choose to do so.
Because the concept of aggregation is no different from the concept
of aggregation and co-location under the orders, it is not clear why
the application of security zone requirements would result in confusion
at jobsites where multiple low-level radiation sources are aggregated.
Comment C54: Several commenters requested clarification on what
constitutes a physical barrier and recommended that physical barrier be
either defined or guidance provided. Another commenter suggested
changing the term to physical security barrier to avoid confusion with
the definition of physical barrier in 10 CFR part 73. One commenter
suggested the physical barrier is where the security zone has been
established.
Response: The NRC has revised Sec. 37.47(c)(1) to provide
additional clarity. This provision now notes that a physical barrier is
``a natural or man-made structure or formation sufficient for the
isolation of the category 1 or category 2 quantities of radioactive
material within a security zone.'' Additional information has also been
added to the implementation guidance.
Comment C55: One commenter asked how many security zones needed to
be designated and noted that the rule is unclear for those licensees
within fixed facilities.
Response: The licensee is responsible for establishing security
zones. The number of security zones established by a licensee is
dependent on the needs of the licensee. A licensee may have only one
security zone or may have several.
Comment C56: One commenter recommended including a provision in
Sec. 37.47 that exempts the security zone requirements for category 1
or category 2 quantities of material stored in casks
[[Page 16980]]
or packages that require specialized equipment to move, open, or
access, if the equipment needed to access the material is unavailable.
One commenter noted that the continuous monitoring of security zones
and detection capability is a significant additional cost without any
benefit for category 1 and category 2 materials that may be stored at a
nuclear facility in a concrete mausoleum or within individual concrete
vaults that require heavy equipment, such as a crane, to access. One
commenter stated that clear criteria for applicability would be needed
to implement security zones. The commenter offered the example of
multiple high integrity containers with lids weighing 10 tons, each
inside a shield, stored inside a fenced common area which contains, in
the aggregate, a category 1 or category 2 quantity of radioactive
material and no crane in the area to lift the shield container lid. The
commenter stated that establishing a security zone for the common
storage area is required and that this is excessive.
Response: A licensee can always request an exemption for material
or items that it believes should be exempt from all or some of the 10
CFR part 37 requirements. Exemptions are handled on a case-by-case
basis. Some of the material addressed by this comment is covered by the
partial exemption in Sec. 37.11(c). See also response to comment A20.
Comment C57: One commenter noted that large manufacturing and
distribution facilities will have several security zones with
significant quantities of category 2 sources in storage and that it
would be impossible to perform an effective physical check on a weekly
basis. The commenter also noted that a weekly check is not consistent
with the ALARA principle. The commenter noted that putting tamper
indicators on each source/device would be cost prohibitive and require
a significant amount of time and personnel dose to install, monitor,
and subsequently remove. The commenter noted that sources are
constantly transferred from one container to another in the course of
manufacturing, storage, and preparing for shipment and receiving. The
commenter requested clarification as what ``other means'' would cover
and/or be acceptable in Sec. 37.49(a)(3)(ii). The commenter noted that
under the orders it has a method approved by the Regulatory Authority
to ensure that the category 2 radioactive material is present and that
the process is considered SGI-M information. The commenter wanted to
know how such pre-existing compliance agreements would be handled under
the rule. The commenter also requested clarification on the situation
where there are individual sources that are each less than category 2
but when they are collocated/aggregated the total quantity exceeds
category 2, whether the individual sources need to have this physical
check performed. The commenter noted that depending on the answer, the
quantity of sources affected at a large facility could be more than a
thousand and that this would affect many smaller facilities including
medical institutions, universities, and gauging. The commenter noted
that the requirement has significant implication and needs to be
carefully considered to avoid unintended adverse consequences.
Response: The licensee is not required to conduct a weekly physical
inventory of the category 2 quantities of radioactive material; other
methods can be used. The other means allowed by the rule are intended
to provide the licensee with the flexibility to use the method that
works best for its facility. A licensee could use methods to detect
removal of the material from the security zone. If a licensee is
currently using an agreed on method, the method should continue to meet
the intent of the requirement. Any of the methods deployed for category
1 materials could also be used for category 2 materials. Additional
information is available in the implementation guidance.
Comment C58: One commenter requested clarification on where an NRC
security zone at a licensee site and a DOT security zone for transport
take effect for shipments leaving a facility. One commenter noted that
the NRC should clarify at what point the shipment is under DOT rules
and not under 10 CFR part 37. The commenter asked if this occurs once a
shipment of category 1 or category 2 radioactive material is prepared
(DOT paperwork in possession of the driver) but still on a licensee's
site. The commenter noted that a temporary security zone cannot
accompany the shipment until it physically exits the licensee's
property or jobsite.
Response: It is the licensee's responsibility to implement the
requirements of 10 CFR part 37 throughout the shipment regardless of
the location.
Comment C59: One commenter noted that Sec. 37.47(d) is not clear
whether the regulation requires a physical presence for maintaining
continuous surveillance, or whether the continuous surveillance may be
by remote monitoring. The commenter also noted that the wording implies
that the licensee must provide an approved individual and questioned
whether the service provider approved under Sec. 37.29(m) is permitted
to provide the continuous surveillance while working.
Response: The continuous surveillance may be by remote monitoring.
If a service provider has been approved for unescorted access, then the
individual can provide the surveillance. It is noted that if that
individual is conducting work of some sort, it may be difficult for
that individual to also maintain continuous surveillance.
Comment C60: One commenter noted that Sec. 37.47(d) requires
additional measures for security zones for category 1 radioactive
material during maintenance, source receipt, etc. when security zones
are compromised and that permanent security zones are required in Sec.
37.47(c) for both category 1 and 2 radioactive material. The commenter
questioned why the additional measures are required only for category 1
radioactive material if the security zones are compromised during
certain times. The commenter noted that it appears that the isolation
requirements for radiation protection under restricted, radiation, high
radiation and very high radiation areas provide the same or better
levels of security than those described (i.e., continuous physical
barriers that allow access to the security zone only through
established access control points; or licensees could exercise direct
control of the security zone by approved individuals at all times). The
commenter noted that you do not need to have duplicate regulations that
apply to category 1 and category 2 quantities of radioactive material.
Response: The additional measures are only required for the
category 1 material because these materials are considered higher risk
than the category 2 materials. A security zone can be the same as the
area used for radiation protection if it meets the requirements of part
37. The measures in part 37 are intended to prevent/detect theft of the
material and not to protect an individual from radiation exposure.
Comment C61: One commenter noted that Sec. 37.47(d) indicates that
during those identified periods an approved individual must be provided
to maintain continuous surveillance of the sources. The commenter noted
that ``approved individual'' is not defined. The commenter also noted
that depending on the design of the facility, multiple approved
individuals may be necessary to adequately monitor activities
throughout a site, which does
[[Page 16981]]
not appear to be clearly required by the rule.
Response: The NRC agrees with the comment and has revised the rule
to clarify that an approved individual is someone approved for
unescorted access and to reflect that more than one individual may be
necessary.
Comment C62: One commenter recommend deleting the phrase ``without
delay'' from Sec. 37.49(a)(1) as the phrase is unrealistic during
normal business hours. The commenter noted that unauthorized access
whether actual or attempted would only be detected ``without delay'' if
individuals were in the vicinity and could witness the access or
attempt to access. One commenter stated that the monitoring, detection
and assessment requirements in Sec. 37.49 are unduly onerous. The
commenter indicated that the requirement to maintain the capability to
detect without delay attempted unauthorized entry into the security
zone should be eliminated or defined in a more concrete manner for the
sake of clarity in enforcement. One commenter asked how much time is
allowed for response when an unauthorized entry into the security zone
is discovered. The commenter also asked for clarification on the
meaning of without delay. One commenter requested clarification on what
is meant by detect without delay all unauthorized entries into a
security zone. The commenter asked if the licensee was to respond
immediately and also asked how this could be accomplished when using an
alarm monitoring service. The commenter recommended removing ``without
delay'' from Sec. 37.49(a)(1). The commenter stated that ``without
delay'' is unrealistic during normal business hours as a business'
security system will not be set to alarm. The commenter noted that
areas that may contain category 1 or category 2 quantities may be
locked and unoccupied but not monitored. The commenter noted that
unauthorized access whether actual or attempted would only be detected
``without delay'' if individuals were in the vicinity and could witness
the access or attempt to access.
Response: The NRC disagrees with the comment. The NRC notes that
the orders contain a similar provision to immediately detect, assess,
and respond to unauthorized access. ``Without delay'' means promptly or
immediately. The purpose of security provisions is to quickly detect
and respond to any potential theft of the material. The NRC further
notes that, if a licensee is merely locking the material in a room and
not implementing any other security provisions, they would not be in
compliance with the orders or the rule. No change has been made to the
rule.
Comment C63: One commenter noted that the intent of Sec.
37.49(a)(1), in the event of a power failure or tampering that affects
the monitoring and detection system, should be to provide (1) a
reliable power back up or (2) prompt notification of the power failure/
tampering such that the licensee will take immediate corrective action
to restore the power and provide for alternate monitoring and detection
that meets the requirements of the part until the system is repaired.
One commenter asked what the NRC's expectations were for implementation
of the security requirements in an emergency, including the expectation
as to how long backup systems were required to operate. The commenter
asked how a licensee is supposed to implement these requirements when
there are no provisions for individuals to even reenter a disaster
area.
Response: The backup power for the monitoring and detection system
needs to be available until power is restored or other measures need to
be used such as direct surveillance. Disaster situations such as
flooding or earthquakes that prevent entry to the facility would be
addressed on a case-by-case basis.
Comment C64: One commenter stated that Sec. 37.49(a)(2)(ii) should
contain a more accurate description such as ``* * * alert personnel
within audible range of the alarm.'' Another commenter noted that
``nearby'' needed to be clarified as NNSA representatives recommended
only silent alarms in the area immediately surrounding category 2
sources.
Response: The NRC believes that the language is appropriate and has
not revised the rule. Additional information is provided in the
implementation guidance document.
Comment C65: Two commenters recommended adding a 4th method to
Sec. 37.49(a)(3)(i) to allow security zone intrusion detection alarms.
The commenter explained that when the intrusion detection system is
monitoring the security zone, an attempt to gain unauthorized access
into the security zone results in an alarm that is equated to an
attempt to remove or sabotage the material. The commenter noted that
during normal business hours when an intrusion detection alarm to a
security zone is disabled the licensee prevents unauthorized access
into security zones with locks, physical barriers, and surveillance or
some combination of each. The commenter stated that it is during these
periods that a tamper-indicating alarm or radiation detection alarm or
video surveillance could alert the licensee of an unauthorized attempt
to remove radioactive material from the security zone. The commenter
stated that, if the method is not added, revision is needed in the
implementation guide that allows the licensee to rely on its main site
wide intrusion detection system when the intrusion detection system is
activated, the facility is not occupied by the licensee, AND the
intrusion detection system can detect access to the security zone.
Response: The NRC disagrees with the comment that a 4th method
needs to be added to the rule. Although this is not the preferred
method, the situation described in the comment is not prohibited under
the rule. Additional information has been added to the implementation
guidance.
Comment C66: One commenter asked whether a tamper device was
sufficient to verify the presence of material or would a weekly check
still be necessary. One commenter noted that a weekly verification
should only be performed for sources/devices that do not have tamper-
indicating devices. Another commenter stated that the weekly check was
too prescriptive and asked about the basis for the timeframe. Another
commenter stated that a weekly check was not adequate. The commenter
noted that the orders require the licensee to respond immediately to
any actual or attempted theft, sabotage, or diversion and that a weekly
check would allow the material to be missing for up to a week before it
is discovered. The commenter suggested that Sec. 37.49(a)(3)(ii) be
revised to read: ``For category 2 quantities of radioactive material,
the licensee must maintain control of licensed material, secure it from
unauthorized removal or access, and without delay, detect and recover
all stolen, missing or lost licensed material.'' One commenter stated
that verification of the radioactive material may not be appropriate
for sources housed in devices. The commenter suggested requiring
verification ``to ensure that the source/device is present'' and
suggested that this verification could be made by means of a camera in
the room housing the device/source.
Response: Category 2 quantities of radioactive material are
considered risk-significant and if not in use, the material needs to be
checked to make sure it is still present. Contrary to the comment, the
rule is not prescriptive. The rule does not require that a licensee
conduct a physical check. The rule allows the licensee to pick a method
that best fits its needs; a physical check is one of the methods that
could be used. There are
[[Page 16982]]
many other methods that could be used to conduct the verification.
Tamper indicating devices are considered adequate to meet the
requirement. The licensee can also use methods to detect removal of the
material.
Comment C67: One commenter suggested deleting the weekly
verification for category 2 quantities in Sec. 37.49(a)(3)(ii) and
include the category 2 material in the category 1 material requirement
for continuous surveillance. The commenter noted that the provision
implies that it may be acceptable for a missing category 2 quantity of
material to go undetected for up to a week when this is clearly not the
case.
Response: Category 1 quantities of radioactive material are
considered higher risk than category 2 quantities of radioactive
material. Therefore, there are more requirements on the category 1
material. The commenter is correct, however, that the NRC does not mean
to imply that it is acceptable for missing category 2 materials to go
undetected for a week. A weekly verification is just one of several
acceptable methods to make sure that unauthorized removal of the
material has not occurred. Each licensee must determine its own
compliance strategy to meet the security requirements of this rule, but
the rule provides significant latitude for each licensee to comply in a
way that optimizes its individual operating requirements.
Comment C68: Two commenters stated that the monitoring and
detection requirements of the security program need to be more
prescriptive, with a minimum requirement for electronic sensors and a
detection system linked to an onsite or offsite monitoring facility.
The commenters did not believe that allowing monitoring and detection
to be performed only by visual inspection or direct visual surveillance
was adequate. The commenters noted that the concepts of detection,
delay, and deterrence are best implemented through multiple tiers of
security. The commenters stated that in the scenario of armed
terrorists with explosives attacking a facility, reliance on
individuals to be the sentinels would allow the security program to be
defeated rather easily.
Response: While the NRC agrees that defense in depth is always a
good practice, the NRC believes that allowing direct visual
surveillance is appropriate. The NRC attempts to balance the burden of
imposing additional requirements against the risk of the material and
the added protection a measure provides.
Comment C69: One commenter stated that the requirement to have a
means to detect unauthorized removal of the radioactive material from
the security zone was unnecessary and would create a huge burden to
establish. The commenter also noted that the requirement does not even
account for the fact that the alarm has to be monitored or by whom.
Response: The purpose of the security program is to detect and
prevent unauthorized removal of the category 1 and category 2
quantities of radioactive material. The provision in question does not
require an alarm. If alarms are used, the licensee has flexibility in
determining who conducts the monitoring and who responds.
Comment C70: One commenter asked what the NRC's expectation was for
implementation of the requirement to immediately detect any attempted
unauthorized removal through the use of electronic sensors linked to an
alarm. The commenter wanted to know if the electronic sensors are to be
mounted to the actual source, hot cell, or storage area. The commenter
noted that there are numerous ways to shield radioactive material,
therefore, the method has to be able to detect an unauthorized removal
of a shielded container, and using a building or area alarm is
specifically not allowed.
Response: The NRC assumes the commenter is referring to the
requirements in Sec. 37.49(a)(3). This requirement is in addition to
the requirements in Sec. Sec. 37.49(a)(1) and 37.49(a)(2). Licensees
must be able to detect the unauthorized removal of a category 1 source.
Licensees can choose any method to detect unauthorized removal. Some
methods that the licensee may use to meet this requirement include, but
are not limited to, the following:
Alarming electronic tamper-indicating device;
Alarming radiation detector; or
Visual surveillance by an approved individual.
If a licensee uses electronic tamper-indicating alarms, the alarm
should be capable of alarming either when an attempt is made to remove
a category 1 quantity of radioactive material from a device, or when an
attempt is made to remove the device itself. The tamper-indicating
alarms should be armed at all times, except during periods of
maintenance.
Comment C71: One commenter stated that it is an unreal expectation
that licensees can assess an attempted unauthorized entry and that the
requirement should be removed as there is no resulting gain in
security. The commenter noted that this increases the surveillance
burden on licensees to monitor not just access but attempted access. As
an example the commenter noted the situation where someone walking by
tries to open the door and the licensee would be required to be able to
detect that and assess. For the same reasons, the commenter stated that
the requirement to respond to attempted unauthorized access should also
be removed. Another commenter felt that the requirement was too broad.
This commenter also noted the situation where someone (including an
inspector) tries a locked doorknob of a secured area. The commenter
noted that there is no point in responding to this sort of challenge to
the system as long as the door remains locked as there is no security
benefit gained by responding to this type of situation. The commenter
stated that to prevent and reduce unnecessary responses to this sort of
trivial challenge, a continuous watchman would be needed or a locked
door outside the security zone to prevent access to the boundary of the
security zone to keep individuals away from the security zone. The
commenter suggested the following change to the rule text: ``The
licensee shall immediately respond to any action that breaches the
perimeter of the Security Zone.'' One commenter noted that Sec.
37.49(d) requires the licensee to immediately respond to any actual or
attempted unauthorized access in addition to requesting an armed LLEA
response. The commenter noted that presumably this means the alarm
service will notify the LLEA on behalf of the licensee as requiring the
licensee to physically respond could put them in harm's way should the
intruder be armed. The commenter also asked what other actions the
licensee should take (i.e., do surveys, inventory material, etc.).
Response: The NRC disagrees with the comment. The NRC believes that
it is important to assess the attempts to gain unauthorized entry. An
individual could test the system before an actual break-in to steal the
material.
Comment C72: One commenter pointed out that the NRC supported and
recommended that licensee's volunteer to participate in the NNSA GTRI
program. The commenter noted that the rule does not acknowledge or
differentiate its requirements for fixed facilities which have
completed or are in the process of completing participation in the GTRI
and that the NRC should acknowledge the differences between facilities
that merely meet the NRC requirements and those that have the robust
security provided by the GTRI. The commenter stated that licensees will
be unable to
[[Page 16983]]
meet specific requirements prescribed in proposed part 37.
Response: The NRC does support the GTRI program that provides
security upgrades to licensee facilities. However, all licensees are
required to meet all of the requirements of 10 CFR part 37 regardless
of participation in the GTRI program. Licensees that participate in the
GTRI program may take credit for those upgrades that meet the 10 CFR
part 37 requirements.
Comment C73: One commenter asked how long the continuous (primary
or alternative) communication capability must continue to be operable.
The commenter asked what arrangements need to be made to maintain the
capability in any emergency. The commenter noted that there is no
practicable means to implement this requirement as no communications
systems work reliably for many hours or days, particularly if there is
no power available, nor personnel allowed in the area to start a
generator.
Response: During most emergencies, the licensee would be expected
to maintain operability of either the primary or alternative system
throughout the emergency. Disaster situations such as flooding or
earthquakes that prevent entry to the facility would be addressed on a
case-by-case basis.
Comment C74: One commenter noted that guidance on allowable dose
limits should be added to Sec. 37.49(d) for LLEA first responders. The
commenter noted that most licensees are probably following the EPA's
Protective Action Guidance of 25 rem whole body dose for life-saving
actions and protection of large populations and that it would be
helpful to have guidance on what to plan for, as part of LLEA training.
Response: The NRC disagrees with the comment and notes that
guidance does not belong in the regulations. First responders are
subject to the dose restrictions in State or Federal occupational
safety regulations.
Comment C75: Several commenters suggested revising the frequency of
the testing, maintenance, and calibration requirement. One commenter
questioned the technical basis to require operability and performance
testing of intrusion alarms and communication systems every 3 months
and asked if the frequency was supported by industry data or a
probabilistic risk analysis from the nuclear power industry. Another
commenter stated that the test frequency for a device should have a
relationship to the device's known failure rate. Another commenter
stated that the requirement was extremely vague, questioned what
standard things are to be tested and calibrated, what performance
standard should be used, and noted that the timeframe was arbitrary.
The commenter suggested that annual testing would be more consistent
with other requirements. One commenter suggested every quarter at
intervals not to exceed 5 months. The same commenter also suggested
adding ``Equipment without a known failure mechanism shall be tested
after initial installation and at a frequency not to exceed 10 years.''
One commenter suggested a monthly frequency, another suggested an
annual frequency. One commenter stated that testing should be more
frequent than quarterly but did not specify a timeframe. One commenter
suggested testing every 6 months and noted that testing required 40
man-hours to complete. One commenter stated that any testing should
include verification of the notification process to the responding
individuals, including the LLEA, on at least an annual basis. One
commenter recommended an annual requirement to exercise the assessment
and response portions of the physical protection systems including an
invitation to the LLEA to participate if reasonable to do so. One
commenter stated that an annual requirement should be included that
exercises the assessment and response portions of the physical
protection systems.
Response: The NRC reevaluated the testing frequency. The
requirement has been changed to allow the licensee to conduct the
maintenance and testing at the manufacturer's suggested frequency. The
manufacturer's suggested frequency would presumably account for known
failure rates. If the manufacturer does not suggest a frequency, the
testing must not exceed 1 year.
The NRC agrees that exercising the response portion of the security
plan is a good practice, and we encourage licensees to exercise their
plans with the LLEA. However, requiring licensees to exercise their
response plans may be too burdensome for small licensees with less
complex security plans.
Comment C76: One commenter stated that the rule and guidance should
allow licensees to limit testing of alarms, associated communication
systems, and other physical components of the security system to those
alarms, systems, and components necessary to meet the requirements. The
commenter pointed out that testing all alarms, systems, and components
quarterly is a long-term financial burden and could result in licensees
removing all unnecessary alarms, systems, and components. The commenter
noted that requiring only testing of necessary equipment leaves the
requirement open for interpretation but that performance-based
regulations should allow for a risk-based analysis. The commenter
stated that testing of all alarms places an unnecessary burden on
licensees and will encourage licensees to minimize the number of alarm
points in a system which is counter to the intent of this regulation.
Testing of necessary alarms will show that the system is functioning
appropriately. Another commenter noted that some devices may require
partial disassembly of the equipment for testing and that repeated
disassembly and reassembly for testing purposes could lead to premature
failure or wear on components. The commenter suggested that internally
installed detection devices be allowed to be tested on an annual basis,
which could coincide with an annual preventive maintenance of the
equipment. One commenter noted that the rule needs to be modified to
indicate what testing is required. One commenter requested that the
following be addressed in the discussion when the final rule is
published. If an alarm system/device is removed/de-energized from
service because the ``individual with overall responsibility for the
security program'' deemed the device unnecessary, obviously there are
no testing/maintenance requirements; however, if the device is deemed
unnecessary, but remains energized, must testing/maintenance be
performed and documented?
Response: The NRC agrees with the comment. The licensee is only
required to maintain and test those components that it relies on to
meet the security requirements of 10 CFR part 37. See also the response
to C75.
Comment C77: Three commenters recommended removing the requirement
for calibration from Sec. 37.51. One commenter noted that there are
procedures to test and maintain these systems, but the term calibration
seems out of place. Another commenter questioned how you calibrate an
intrusion detection system. Several commenters requested clarification
on what is expected beyond maintenance and testing. One commenter
suggested changing calibration to appropriate operational checks. The
commenter noted that true calibration of radiation monitors would
expose staff to unnecessary radiation dose.
Response: The NRC agrees with the comment and has removed the
calibration requirement. Testing the operability of a system is
sufficient to ensure that the equipment is operational and able to
serve its function. Some of the equipment, such as meters, relied on
for safety may be calibrated, but some
[[Page 16984]]
equipment would not be calibrated as the term is typically considered.
Comment C78: One commenter stated that it was not clear what is
expected for compliance for the maintenance, testing, and calibration
requirement. Another commenter asked what was considered acceptable
maintenance, testing, and calibration.
Response: The licensee must ensure that the intrusion detection
system (IDS) is operational and capable of performing its required
function. To maintain functionality, licensees must periodically test
the IDS and perform maintenance on malfunctioning components. The
testing program is considered acceptable if the IDS operates in a
manner consistent with the licensees' physical security plan. Licensees
will be required to test the entire IDS or components of the IDS at the
frequency specified by the manufacturer or at least annually. The
licensee may choose to test the entire IDS or components of the IDS
throughout the 12 months.
Comment C79: In the proposed rule, the NRC specifically requested
comment on whether an exemption for disabling vehicles should be
provided in certain hazardous situations. Commenters were requested to
provide information on: (1) Whether relief from the vehicle disabling
provisions should be provided; (2) any problems experienced in
implementing this aspect of the Increased Controls; (3) whether there
should be an exemption written into the regulations or should licensees
with overriding safety concerns be required to request an exemption
from the regulations to obtain relief from the provision; (4) whether
any exemption should be a blanket exemption or a specific exemption for
the oil and gas industry; and (5) whether the disabling provision
conflicts with any Occupational Safety and Health Administration (OSHA)
requirements or any State requirements. Fourteen commenters provided
responses to the specific questions on this subject.
Of those that provided responses to the questions on the exemption
for disabling vehicles when a mobile source is in or on the vehicle,
the majority supported providing some sort of relief from the vehicle
disabling provisions where there is a potential threat due to the work
environment, such as a refinery or oil field. Only one commenter
opposed providing relief. A couple of commenters did indicate that they
had had problems in implementing the vehicle disabling requirement
under the Increased Controls, some commenters noted that the provision
was in opposition to the facility safety rules. A couple of commenters
noted that the requirement was in conflict with OSHA and/or State
requirements. On the question of whether an exemption should be written
into the regulations or handled on a case-by-case basis, the commenters
were split, but a slight majority favored writing the exemption into
the regulations. Those supporting the exemption being written into the
regulations noted that providing an exemption on a case-by-case basis
creates a burden on the licensee to prepare the request and on the
regulatory agency to review the request. One of the commenters
supporting the regulatory exemption still felt that the licensee should
provide adequate justification for claiming the exemption. Those not
supporting the regulatory exemption felt that the case-by-case review
would allow the regulator to review whether the exemption was actually
warranted. Two of the commenters stated that the requirement should be
removed as the requirement to remove the ignition key is not warranted
and unnecessary. On the question of whether an exemption should be
specific for the oil and gas industry or be broader, most commenters
supported a blanket or broader exemption. One commenter suggested a
blanket exemption for all category 2 sources. On the question of
whether the disabling provision was in conflict with OSHA or any State
requirements, three commenters indicated a possible conflict but did
not provide any specifics.
In addition to those that responded to the specific questions, five
commenters provided comments on this topic. One commenter noted that
the requirement for disabling mobile sources presents safety concerns
within a refinery or petrochemical plant. The commenter noted that
individuals must be able to quickly evacuate the site in the event of
an emergency and that unoccupied vehicles must be able to be moved by
other evacuees or emergency responders. The commenter noted that
requiring a secondary securing device other than the key from a vehicle
prevents the easy movement of the vehicle and compromises safety in the
event of an emergency. One commenter indicated that relief should be
provided on an as-needed basis. Another commenter noted that there is a
possibility that an individual using a mobile device needs to evacuate
an area quickly and that using a disabling device could jeopardize the
health and safety of the individual. The commenter suggested the
following language: ``For devices in or on a vehicle or trailer, the
licensee shall secure the vehicle or trailer containing the device from
theft when not under the direct control of the licensee. This may be
accomplished by removing the ignition key and arming a vehicle alarm
system, or through the use of disabling device or by the removal of
component that would result in the inability to operate the vehicle or
trailer.'' One commenter stated that further guidance was necessary on
what was meant by disable and that the commenter assumed that the
disabling was temporary. One commenter indicated that any exemption
should be broader than just for the oil and gas industry. One commenter
recommend revising Sec. 37.53(b) to allow credit for removing the key
from the ignition and maintaining the key with the individual. The
commenter noted that a disabling device could add additional risks to
the worker; for instance, if the device fails, the individual may
become stranded, or it may slow emergency egress.
Response: After consideration of the comments on this issue, the
NRC has decided that an exemption should be added to the regulations
instead of doing reviews on a case-by-case basis. Requiring licensees
to submit an application for an exemption that would in most cases be
approved imposes unnecessary burden on both the licensee and the agency
staff. The NRC has also decided that the exemption should be broader
than for just the oil and gas industry as there are other situations
where a similar health and safety issue may arise. The NRC has revised
Sec. 37.53(b) to provide flexibility for situations where the health
and safety requirements for a site prohibit the disabling of the
vehicle.
Comment C80: One commenter indicated that the terms ``mobile'' and
``portable devices'' are used differently in 10 CFR part 37 than
elsewhere in the regulations. The commenter stated that the NRC should
change the terminology or the requirements be changed to be applicable
to already defined mobile and portable devices.
Response: The NRC disagrees with the interpretation that the terms
``mobile'' and ``portable devices'' are used differently in 10 CFR part
37 than elsewhere in the regulations. The usage of the terms in 10 CFR
part 37 is in agreement with previously issued NRC guidance.
Specifically, the Increased Controls Question and Answer 159,
provides guidance for definitions for ``portable'' and ``mobile'' as
provided by the American National Standard for Gamma Radiography.
Comment C81: A few commenters suggested a change to the timing of
the program reviews. Commenters
[[Page 16985]]
suggested an annual frequency not to exceed 14 months between the dates
of the reviews, a timeframe of 15 months, a timeframe of 8 to 15
months, and language similar to Sec. 20.1101 of periodically (at least
annually). The commenters noted that this would provide some
flexibility to allow for circumstances beyond the control of the
workforce. One commenter noted that the program review could be
eliminated and included under Sec. 20.1101(c). One commenter stated
that the review should include a requirement for the licensee to
summarize those occasions where an unauthorized access resulted in
activation of the monitoring and detection systems, but the licensee's
assessment showed no actual or attempted theft or diversion of
radioactive material as such alarms could be indicative of a `probe' to
test or evaluate a licensee's response by a potential intruder.
Response: The NRC agrees with the comment and has revised the
language for the program review to be consistent with Sec. 20.1101.
The use of consistent terminology between the safety and security
programs should enhance the licensee's understanding of the
requirement. The NRC does not believe that it is necessary to add
additional detail on what must be included in the program review.
Comment C82: One commenter noted that Sec. 37.55 introduces the
term ``radioactive material security program'' which should be
clarified and consistently used in the regulations.
Response: The concept of the security program is introduced in
Sec. 37.41. The NRC believes that the term has been used consistently
in the regulations and that the concept is clear. The implementation
guidance contains information on the security program.
Comment C83: One commenter requested clarification on what
radioactive materials should be included in the security program
review.
Response: Part 37 only applies to category 1 and category 2
quantities of radioactive material. The security program review would
only address the security of the category 1 and category 2 quantities
of radioactive material.
Comment C84: One commenter indicated that the LLEA required it to
file Non-Residential Burglary Alarm Registrations for each room in
which an irradiator is housed (and to which they are expected to
respond in the event of an alarm). The commenter noted that the LLEA
has indicated that an LLEA response is deemed false if no evidence of
criminal activity is found, in which case a ``False Alarm Notice'' will
be served, including penalties escalating up to $4000 for requested
LLEA responses that are judged to be false. The commenter noted that
this places the licensee in a very bad position to attempt compliance
with this regulation and risk fines from the LLEA. The commenter noted
that there does not need to be evidence of criminal activity for the
licensee to perceive a threat to its facility, and appropriately
request LLEA response. The commenter requested that NRC conduct
outreach to the LLEA community with the intent of clarifying NRC's
expectations on this topic.
Response: Section 37.57 states that the licensee shall immediately
notify the LLEA after determining that an unauthorized entry was an
actual or attempted theft, sabotage, or diversion of a category 1 or
category 2 quantity of radioactive material. The NRC believes that such
an unauthorized entry would likely constitute criminal activity.
Furthermore, suspicious activity related to possible theft, sabotage,
or diversion of category 1 or category 2 quantities of radioactive
material would also constitute suspicion of criminal activity. When
coordinating with the LLEA, the licensee must explain that it will
request a timely armed response to any actual or attempted theft,
sabotage, or diversion of category 1 or category 2 quantities of
material.
Comment C85: One commenter requested that Sec. Sec. 37.41 and
37.49 be revised to reflect that a licensee is restricted in detection
and assessment by available technology and resources.
Response: The NRC does not believe the change is necessary. The
requirements do not specify a technology, and the licensee can change
the method used to meet the requirements whenever it wants, as long as
the plan is updated and training conducted on the revised plan.
Comment C86: One commenter expressed concern that the vocabulary
was not consistent with part 73 and that it was unclear exactly what
the rule required from a security standpoint in Sec. Sec. 37.41(b) and
37.49.
Response: The commenter is correct that the terminology between 10
CFR parts 73 and 37 may not be consistent. Part 37 does not have any
requirement for a design basis accident and pertains to less risky
materials. Part 37 applies to a different type of material and licensee
in most cases. The terminology used in 10 CFR part 37 is geared for a
materials licensee and not a reactor or fuel cycle facility. Guidance
for implementing 10 CFR part 37 is contained in the implementation
guidance.
Comment C87: One commenter stated that the proposed regulations, as
applied to Gamma Knife radiosurgery units, do not give sufficient
weight to engineered controls. The commenter felt that the greatest
risk was during source exchange, which only occurs every 5 to 7 years,
and not from someone obtaining access to the equipment overnight or on
a weekend. The commenter further stated the opinion that there is
almost no danger during the ordinary operation of the equipment to
treat patients.
Response: The NRC acknowledges that accessibility of a category 2
source(s) depends on the design of the device containing the source(s)
and the means used to gain access to and possibly remove the source(s).
However it is anticipated that an adversary will use whatever means is
available to gain access to and possibly remove a source. The category
2 designation has no basis in regard to the time it would take to
remove a source from the device in which it is contained. The security
program is designed to deny an adversary the opportunity to gain access
to a category 2 source. It is reasonable to expect that overnight and
weekend periods would provide an opportunity to an adversary.
Comment C88: One commenter stated that the requirement limiting
unescorted access to approved individuals would appear to preclude the
treatment of patients with a Gamma Knife radiosurgery unit since the
patient is required to be unescorted in the treatment room due to the
high radiation levels, and the treatment room would normally be
considered to be the security zone. The commenter noted that closed
circuit television is used to monitor the patient rather than line-of-
sight observation, and that this could be used in place of human escort
for those individuals needing entry to the treatment room.
Response: A patient undergoing treatment is considered to be an
escorted individual. Closed circuit television used to monitor the
patient meets the requirements of Sec. Sec. 37.45 and 37.47.
Comment C89: One commenter stated that for a Gamma Knife
radiosurgery unit, individuals subject to background investigations
should be defined as those who have the key or pass code for the
treatment room door and the ability to turn off the security system and
not the personnel who may need access to a patient on treatment day.
The commenter stated that individuals with the keys or pass code are
the ones that can enter a room and have access to the unit for a long
enough time, such as outside of normal treatment days, to
[[Page 16986]]
remove any or all of the radioactive sources.
Response: Gamma Knife radiosurgery is typically performed by a team
of individuals. The licensee has the option of escorting those team
members not authorized for unescorted access. For example, the licensee
may decide to grant unescorted access to authorized medical physicists
and have them provide escorted access for physicians, nurses,
technologists, etc.
Comment C90: One commenter noted that it is important that Gamma
Knife units secured behind electronically locked doors have a backup
door alarm which operates during a fire alarm. The commenter noted that
hospitals are increasingly adopting electronic locks for securing rooms
and that the fire code requires electronic locks to be disabled during
a fire alarm. The commenter noted that frequently the door alarm and
motion detector are tied into the same system.
Response: The licensee must meet the requirements of the rule. Any
additional alarms or other systems beyond those used to meet the
requirements are at the discretion of the licensee.
Comment C91: One commenter noted that since a Gamma Knife treatment
room has a single entrance that could be controlled by an assailant,
one or more panic alarm buttons, unobtrusively placed, should be
installed so that the staff could summon security without being
noticed. The commenter also suggested requiring use of a portal
radiation monitor tied into security at the exit.
Response: The use of duress/panic alarms could be used to enhance
the licensee's response plans and a radiation monitor can be used to
detect a situation where a source has been removed from a device. The
licensee can determine which methods it will use to comply with the
rule. Any additional alarms or other systems beyond those used to meet
the requirements are at the discretion of the licensee.
Comment C92: One commenter stated that additional security measures
addressing radioactive materials are not necessary in the refining or
petrochemicals industry due to the location, lack of accessibility,
source holder design, and currently applicable security requirements.
The commenter noted that the sources are continually monitored by
process control systems and there would be an immediate response, due
to process safety concerns, if they were to go off-line. The commenter
noted that most sources are contained within source holders bolted
individually to a process column or equipment and the source holders
are typically very large, heavy, cumbersome metal containers. The
commenter noted that to remove the source holders requires tools,
cranes, hoist or scaffold support because of their weight and position
on the process equipment. The commenter also noted that the sources are
not aggregated but are located within the various operating unit
locations scattered over several acres.
Response: Part 37 only applies if the material is aggregated such
that the total equals or exceeds the category 2 threshold. As with the
orders, the licensee can take measures such that the provisions do not
apply. For example, if a source holder is welded to the column and has
a cage around it, the NRC has determined that this is sufficient and
the sources would not need to be considered in aggregating the
material. Additional information has been added to the implementation
guidance to clarify what types of barriers would be sufficient.
Comment C93: One commenter noted that the type and configuration of
irradiators would render the probability of their use in an act of
terrorism as extremely unlikely. The commenter noted that they are
stationary, weigh in excess of 1000 pounds, and are secured within
segregated and separately locked facilities on a secure campus
requiring separate authorized keycard access to both the buildings
themselves and the irradiator rooms 365 days per year. The commenter
recommended that the NRC exempt irradiators from 10 CFR part 37.
Response: The NRC disagrees that irradiators should be exempt from
the requirements of 10 CFR part 37. The requirements are designed to
control access both to the radioactive material and to the irradiator
by controlling access to the security zone. The NRC has engaged the
expertise of national laboratories that have shown that these devices
may be vulnerable to theft, sabotage, or diversion under certain
scenarios. For this reason, and the possibility that the necessary
trained individual could be a malevolent insider, the NRC has
determined that certain additional security measures are necessary in
the current threat environment. Part 37 uses a layered, defense-in-
depth approach to enhance the security of radioactive material in
category 1 and category 2 quantities. No single measure can provide the
required security for this material. Therefore, a licensee must
implement all applicable 10 CFR part 37 requirements.
D. Transportation Security
Comment D1: In the proposed rule, the NRC specifically invited
public comment on several aspects of license and address verification.
Commenters were requested to provide information on: (1) Whether there
should be a requirement for verification of the license for transfers
of category 2 quantities of radioactive material or whether it would be
acceptable to wait for the system being developed before requiring
license verification for transfers of category 2 quantities of
radioactive material; (2) how the address verification might work for
shipments to temporary job sites and the ability of both licensees and
the Agreement States to comply with such a requirement; (3) the
frequency of the license verification, and (4) how the transferring
licensee would know if a license has been modified since the last check
and that the licensee is still authorized to receive the material.
Seventeen commenters provided responses to the specific questions on
this subject.
Of those that provided responses to the questions on license
verification, most commenters indicated that the current system for
license verification for category 2 quantities of radioactive material
is acceptable until the license verification is developed and ready for
implementation. A few commenters indicated that phone verification for
category 2 would be acceptable before the new system is available;
others indicated that the NRC should wait for the new system. One
commenter suggested that verification not be required for shipments
that result in a change of jurisdiction but not a change of licensee.
Most commenters did not support a requirement for address verification
for temporary jobsites, noting that in most cases the regulatory
authority will not know the address for a temporary site and that in
some cases there is no address. One State indicated that it did not
allow shipments to temporary jobsites. On the issue of frequency of
license verification (every transfer, annual, etc.), the response was
mixed; some noted that annual verification was adequate, some noted
that every transfer should be verified, some noted that every transfer
would be ok once the new system is available, some suggested
semiannual, and some felt that use of the National Source Tracking
System was sufficient. One commenter noted that amendments and
enforcement actions typically take a long time so the likelihood of a
license being modified after a copy is obtained by the transferor is
very small. The commenter indicated that there was no compelling reason
to take extra measures to verify that the license has
[[Page 16987]]
not been modified since that last check. Most commenters noted the
current practice was acceptable until the new license verification
system is up and running. One commenter suggested obtaining a written
statement from the receiving licensee RSO attesting to the current
amendment number.
In addition to those that responded to the specific questions, 18
commenters provided comments on this topic. One commenter noted that it
was unclear why additional work over and beyond the current
requirements in Sec. 30.41 is needed. Some commenters objected to the
need to verify a licensee's validity prior to shipment as it creates a
large burden on the licensee and the regulatory agency. At least one
commenter felt that the current method of obtaining a copy of the
receiving licensee's license via either fax or email was adequate to
verify the validity of a licensee. Commenters felt that, for companies
with which they do frequent business, verification was not necessary
and that having a copy of the license on file or verification within
the last year was adequate. Some commenters noted that verifying for
every shipment would take time and personnel and increase the cost of
doing business. One commenter indicated that they felt that it would
take half a day to process 30 orders using the system which is 4 times
the current time. Other commenters felt that that an annual check would
not be acceptable and the verification should occur close to the
shipping date. One commenter stated that a company should not be
required to verify a same company license in another State prior to
transfer between the same company but at different locations. Two
commenters requested clarification on the need to report shipments
within the same company but within different jurisdictions, such as
temporary jobsites in another State.
One commenter suggested that the verification requirement be
revised to allow for verification of the delivery address through the
receiving licensee's RSO or another individual specifically identified
on the license. The commenter pointed out that some licenses may list
the primary address but not individual buildings and that the delivery
(or dock) address may be different than the official building address
that is listed on the license. Commenters were opposed to including a
requirement to validate the address for transfers of category 2
quantities of radioactive material.
Commenters noted that it can be difficult to reach the regulator
and once reached that it may take the individual some time to look up
the license and verify the information. Commenters indicated that this
could result in delays and/or stopped shipments. As an alternative, one
commenter suggested that the regulatory agency could send a copy of an
amended license to ensure up to date and valid copies are on file.
One commenter recommended removing reference to the License
Verification System as it does not exist yet and another commenter
noted that the system would unlikely be operational when the final rule
is published. Several commenters expressed some concern over how well
the license verification system will work; some asked for clarification
on possible access to the system. One commenter recommended that the
verification provision should not be implemented until the system is
fully operational and demonstrated to be effective.
One commenter asked if the verification of license provisions
applied to exports. One commenter asked if these requirements would
replace the National Source Tracking System requirements.
One commenter noted that there is no need to document that a check
has been done as it can be covered under a procedure that the licensee
has in place for license checks and that adding additional
documentation just adds time and effort without value. One commenter
questioned what documentation was required for the transfer
verification.
Response: One of the recommendations from the Independent Review
Panel was that licenses be confirmed for all transfers of radioactive
material in risk-significant quantities. The NRC agrees with the
recommendation and believes that verification of the license before
transfer is an important component that enhances the security of the
material by validating the licensee's legitimacy. Use of the License
Verification System is a key component to allow 100 percent validation
of licenses before transfer of category 1 or category 2 quantities of
radioactive material. While some commenters felt that a fax or email
was adequate to verify the validity of a license, the NRC disagrees. An
individual can alter or tamper with a license to change the possession
limits or location of use, or even the person that received the
license. Currently, many licensees obtain copies of the license and
keep the copy on file. The problem with this method is that the license
could be amended or terminated and the licensee would not know that the
license was no longer valid. The License Verification System is being
developed to prevent these scenarios from occurring. Licensees are
required to use either the License Verification System or contact the
regulatory agency (NRC or Agreement State) to verify that a license is
valid before shipping category 1 or category 2 quantities of
radioactive material to a domestic company. For category 1 shipments,
the licensee must also verify that the shipping address is valid.
Transfers within the same company in a different State do not need to
be verified as the company knows what it is authorized to possess. The
rule language has been clarified to make this clear. Verification is
not required for imports and exports; the requirements of part 110
apply. The NRC agrees that the License Verification System (LVS) needs
to be fully functional before this provision of the regulations is
implemented. Although the NRC expects a timely startup of the LVS, this
provision of 10 CFR part 37 permits a separate compliance date that can
be changed if this startup is delayed.
The NRC does understand that it can be difficult to reach regulator
personnel and that there may be times when the system is down.
Therefore, the NRC has added a new provision that provides an
alternative so that licensees can still ship. If the licensee cannot
reach the regulator and the system is nonfunctional, the licensee will
be able to use certification from the receiving licensee that the
licensee is authorized to receive the requested radioactive material.
The licensee must follow-up by the end of the next business day to
confirm the license was valid.
The NRC has also changed the documentation requirement. The final
rule only requires documentation if the licensee conducts the
verification by contacting the license issuing authority (NRC or
Agreement State). The documentation can simply be a note to file or a
copy of an email response from the NRC or Agreement State. The license
verification system will keep the record of any verification conducted
using the system, therefore, the licensee is not required to keep
separate documentation. Documentation is important from an inspection
and enforcement aspect.
Comment D2: One commenter noted that the verification requirement
appears to duplicate the transfer requirements under Sec. 30.41. The
commenter noted that licensees should be exempted from Sec. 30.41 if
they have category 1 or category 2 quantities and follow 10 CFR part
37. The commenter noted that this is an example of an area where
industry and the NRC could constructively work together through
[[Page 16988]]
public meetings to find the most efficient and effective solution to
address NRC's concern. One commenter noted that the proposed
regulations should be consistent with existing NRC regulations related
to radioactive materials, should not duplicate any existing
requirements, and should not rely on the general statements of ``not
withstanding the requirements of any other regulations in this
chapter.''
Response: The verification requirements in Sec. 37.71 are in place
of the requirements in Sec. 30.41(d). The language has been revised to
make this clear. In addition, the NRC has added a provision to address
emergency situations where the License Verification System is down and
the licensee cannot reach the licensing authority.
Comment D3: One commenter objected to the preplanning and
coordination requirements in Sec. 37.75 stating that it would be
impossible to implement for category 2 sources for facilities that make
numerous shipments a day. The commenter noted that it would require a
dedicated individual to constantly communicate with customers and
carriers throughout the day for the 40-60 shipments and receipts that
occur during the day. The commenter noted that currently the customer
is told of the shipment date and method of shipment and that the
preplanning system takes advantage of the already understood arrival
times if using FedEx or similar. The commenter noted that the shipper
can review the FedEx confirmed deliveries each day (one central
location) which verifies receipt by the customer. The commenter noted
that this has been working very effectively, so there is no reason to
change to a much more burdensome method.
Response: It is not clear why the commenter believes that it will
need to constantly communicate with customers and carriers throughout
the day. The basic requirements are similar to the orders, with the
exception of establishing a no-later-than arrival time. The licensee
could easily establish the no-later-than arrival time as the close of
the business day on the expected arrival date. If the licensee is
already telling the customer the shipping information, the addition of
one additional piece of information does not present a large burden and
does not require the shipping licensee to conduct its business in a
different manner than it currently does. The NRC has revised the
language to clarify the coordination activities and has removed the
requirement that specified methods of sharing information to provide
licensees more flexibility. Information has been added to the
implementation guidance.
Comment D4: One commenter stated that in Sec. 37.75(a)(2)
alternate requirements should be added for those States who will not be
providing law enforcement escorts for the licensee to identify the
intended LLEA contacts it will use to summon an armed response should
there be an actual or attempted theft or diversion of the shipment.
Response: The NRC disagrees with the comment. Part 37 does not
require the use of escorts for shipments of category 1 or category 2
quantities of radioactive material; therefore, an alternate requirement
is not necessary.
Comment D5: Two commenters noted that in Sec. 37.75(a)(2)(i) the
term ``minimal delay'' is ambiguous and subject to interpretation. The
commenter recommended that the term be clarified or deleted.
Response: The NRC agrees with the comment and has removed the
requirement. While the purpose of the preplanning and coordination with
the State is to ensure minimal delays, the language is not necessary in
the rule itself.
Comment D6: Several commenters recommended removing the provisions
for preplanning and coordination activities with the Governors of each
State that the category 1 shipment will pass through. The commenters
noted that the advanced notification provided to the State by the
licensee provides sufficient time for the State to contact the licensee
if a revision to the route or additional State imposed controls, such
as escorts, are to be implemented. The commenters noted that Appendix A
of the regulatory analysis indicates that there had been zero event
notifications in the past 10 years regarding missing or lost material,
suspicious activities, theft, or diversion of category 1 materials and
questioned how additional coordination efforts that are not currently
required by the orders can be justified. The commenters noted that the
licensee would be unable to comply with the requirement to arrange for
positional information sharing when required by the State because, as
written, States would be authorized to dictate which position tracking
provider a carrier must utilize, or the State could request that the
carrier authorize the State to log into the carrier's tracking system.
This would result in additional costs as there are licensing and data
communication fees associated with tracking systems. One commenter
asked if the NRC has determined whether carriers are willing to share
their positional information real time. One commenter noted that this
requirement could provide a mechanism for a State to block the
transport of category 1 material through the State if the requesting
state official cannot log onto the tracking system. Another commenter
expressed concern over possible denial of a shipment through a State
due to tracking system incompatibility. The commenter noted that denial
of shipment could result in noncompliance with Federal interstate
transportation laws. The commenter noted that the licensee and carrier
are capable of determining safe havens along the route and that past
experience has shown that requesting a State to identify safe havens
has been fruitless. One commenter strongly agreed with the preplanning
and coordination requirements as both necessary and desirable. The
commenter urged the NRC to encourage States to coordinate with the
LLEAs and affected Tribes, including route and schedule information in
the shipment verification system, as it can help States monitor
shipments and the no-later-than arrival times. One commenter noted that
the coordination with the States is typically conducted by email and
that there is no discussion unless the State initiates one in response
to the licensee's notification. One commenter stated that there
shouldn't be any additional requirements for category 1 quantities that
might serve to dilute attention paid to highway route control
quantities (HRCQ). One commenter suggested including the Agreement
State program on the list for notification and preplanning coordination
for category 1 shipments. The commenter noted that the Governor's
designee is not always the Agreement State program director. One
commenter noted that the need to coordinate with all States for
transport will be very burdensome unless there is a tool to assist with
implementation.
Response: The NRC has determined that the requirement for
preplanning and coordination with each State for category 1 shipments
is necessary, but has removed several of the proposed elements.
The NRC believes that it is necessary to coordinate with the State
to determine whether the State plans to provide escorts. If the
licensee doesn't find out about the need for an escort until after the
advance notification is provided to the State, the licensee would
likely need to adjust the schedule and reissue the advance
notifications. Knowing upfront about the need for escorts is likely to
reduce the overall burden on the licensee and allow the licensee to
better plan the route for any shipment. The licensee is responsible for
identifying safe havens along the route. The licensee would provide
that
[[Page 16989]]
information to the State. If the licensee has difficulty identifying
safe havens, it may want to discuss this with the NRC, State police, or
other State contact. (See also response to Comment A11.)
The NRC agrees that the other elements of preplanning and
coordination are not necessary. It was not the intent that the State be
given direct access to the position monitoring system, only that the
state be provided information about the shipment's location upon
request. This provision is not included in the final rule. The NRC has
only retained what it believes are the minimum requirements for the
preplanning and coordination. The rule does not specify the method for
conducting the preplanning and coordination. The licensee can conduct
the preplanning and coordination by email.
The NRC will maintain the list of State contacts as it does for 10
CFR part 73 shipments. The list will be available on the NRC's Web site
at https://nrc-stp.ornl.gov/special/designee.pdf. The list will also be
published in the Federal Register on an annual basis, typically in
early July.
Comment D7: Some commenters objected to the requirement to
establish a no-later-than arrival time. One commenter pointed out that
the shipping licensee has no control over when a common carrier
delivers the material, noting that typically they know the day but not
an exact hour. The commenter felt that the requirement would result in
many unnecessary reports or an exaggeration of the time in order to
avoid making reports and noted that licensees are responsible enough
not to need a regulation that will burden them and ultimately be
subverted. Another commenter felt that the rule would be extremely
costly and time consuming to implement and impractical. The commenter
stated that the NRC should place the requirement on the carrier and not
the licensee, as the licensee has no control. Another commenter
suggested waiting until the end of the day, which was previously agreed
to, and send a report (NRC 748) into NSTS and hope that it gets put
into the system, maybe receiving confirmation that the reports were
received. Two commenters recommended allowing licensees to use the NSTS
as method to fulfill the notification requirement in Sec. 37.75(b) and
(c). One commenter supported the concept and suggested timeframes. One
commenter noted that a loss of material is an immediate notification
and that the rule as proposed places the licensee in a burdensome
position of devoting additional time, effort, and concern over movement
of material that is not completely in their control. The commenter did
agree that notification between the shipper and consignee is important
but felt no need for further restrictions or regulations in this area.
Another commenter noted that the shipper currently sends an email
notification that has a receiving document attached to the message
noting when the shipment was received. The commenters believe that
licensees already effectively track the movement of sources without the
need to impose additional regulation. One commenter noted that category
1 shipments are often held up in States for inspection. Commenters
noted that common carrier delivery guarantees are not accurate to
within 4 hours. Commenters noted that the 2- and 4-hour timeframes
would result in numerous modifications to the time or ultra
conservative estimates. Several commenters suggested 24 hours as the
timeframe. One commenter noted that licensees routinely monitor the
status of shipments and notify the carrier and regulatory agency when
the shipment does not arrive within a reasonable timeframe. The
commenter stated that the regulations should specify what is required
and not how to achieve it. One commenter noted that the time of a
shipment will not be known for material that is transported by common
carrier as shippers like FedEx simply verify that a shipment will
arrive by a certain date, and often the only notice that a shipment
will be late is that it doesn't arrive by the end of the business day.
One commenter requested clarification that the no-later-than arrival
time applies only to domestic transfers, either within the definition
or in the guidance. One commenter noted that Sec. 37.75(b) requires
licensees to email or fax arrival times for shipments of category 2
material and that licensees must be made aware that the email must be
encrypted and faxes be made to an awaiting, known entity as was noted
in Regulatory Issue Summary 2005-31.
Response: The NRC continues to believe that the establishment of a
no-later-than arrival time is beneficial. The NRC notes that the orders
currently require the licensee to coordinate the expected arrival time
of the shipment and to initiate an investigation if the shipment has
not arrived by the expected arrival time. The provision for the no-
later-than arrival time actually provides the licensee with more
flexibility. The no-later-than arrival time allows for traffic delays
due to weather and other circumstances before an investigation is
initiated. The no-later-than arrival time for category 1 shipments has
been removed as the licensee is required to maintain continuous
communication capability. The no-later-than arrival time provision only
applies to domestic shipments. There is no requirement that email be
encrypted and faxes be made to an awaiting, known entity.
Comment D8: One commenter stated that Sec. 37.75(c) is a redundant
requirement as licensees are already required to input data into the
NSTS when shipping or receiving radioactive material. The commenter
noted that licensees are already required to initiate an investigation
if a shipment does not arrive and that there is no reason to require a
licensee to notify the shipper when the shipment occurs as it is
scheduled. The commenter noted that this would require a tremendous
amount of resources and is unnecessary as a licensee is already
required to notify the shipper if the shipment does not arrive. One
commenter requested clarification on whether Sec. 37.75(c) applied to
notify international shippers of receipt within 4 hours. One commenter
noted that the transferee licensee should notify the NRC (and the
License Verification System) and the host State when a shipment
arrives. The commenter indicated that the notification should
reasonably occur within 2 hours after arrival instead of the 4 hours
proposed in the rule. Another commenter objected to the need to confirm
a shipment with the shipper and noted that it was redundant to current
requirements for the NSTS. A commenter noted that if a notification
must be made when a shipment does not arrive that it doesn't make sense
to also require that a notification be made when and if it does arrive
and therefore it just adds burden without benefit. One commenter
recommended that the licensee should notify the NRC (and the License
Verification System) as well as the States affected when a shipment is
revised or cancelled. The commenter noted that the change should be
reported by the carrier company after communication/coordination with
the driver. One commenter objected to the requirement for the receiving
licensee to notify the shipping licensee within 4 hours of a package
arrival and recommended that the requirement be removed from the rule.
The commenter indicated that this would result in an undue cost and
would require licensees to have personnel on evenings, weekends, and
holidays to receive/send the information. One commenter asked why using
NSTS wasn't sufficient.
Response: The requirement in Sec. 37.75(c) to notify that a
shipment has
[[Page 16990]]
been received and the requirement to report to NSTS are not redundant.
The reporting to NSTS is a report to a system and does not notify the
shipping licensee that a source has been received. The shipping
licensee would need to access the system to see if the status of the
source has changed in order to determine if a shipment has been
received. The reporting to NSTS is by the close of the next business
day which means information on the receipt of the shipment might not be
available for several days and this would be too long for a shipment to
go missing without starting an investigation. Additionally, not all
shipments are reported to NSTS. When shipments don't arrive on time,
the shipping licensee needs to start an investigation to determine if
the material is missing or just delayed in shipment. The requirement to
confirm shipment is not new as it is a current requirement from the
orders. The notification provisions do not apply to international
shipments.
Comment D9: One commenter noted an inconsistency in the timeframes
for the receiving licensee to notify the shipping licensee no later
than 4 hours after the package arrives but that the shipping licensee
is to begin an investigation within 2 hours of a category 1 shipment
not arriving by the no-later-than arrival time.
Response: The NRC has removed the no-later-than arrival
requirements for shipments of category 1 quantities of radioactive
material because they are not needed with the communication and
monitoring requirements associated with these shipments. The provision
for no-later-than arrival time remains for category 2 shipments. The
arrival time and the no-later-than arrival time are not the same times.
The arrival time is the time the shipment actually arrives at the
facility. The no-later-than arrival time is the time established that
when a shipment has not arrived and an investigation will be started to
determine the whereabouts of the shipment.
Comment D10: Two commenters pointed out an editorial error in Sec.
37.75(d), noting that the reference to Sec. 37.75(a)(1) should be
Sec. 37.75(b).
Response: The NRC agrees with the comment and has made the
correction.
Comment D11: One commenter noted that it may not be possible to
provide the information for an advance notification before the
shipment. The commenter stated that the information is not available to
most licensees because carriers are not willing and may not be able to
provide the detailed information to licensees. The commenter noted that
for an import, a licensee may not have this information until the
shipment is in progress, or even when it is received. The commenter
noted that if it is assumed that this requirement is only applicable
from the point of customs clearance, then it may be practicable. The
commenter indicated that the regulation should specifically state that
it is applicable to the portion of the movement of shipments after
customs clearance. One commenter asked if NRC has coordinated with DOT
to determine if the advance notification is practicable. One commenter
noted that the activity levels are not available with much degree of
accuracy as the activity is often not measured until the shipment
arrives. One commenter noted that the shipper may not know when a
shipment will commence, cross State lines, and arrive. The commenter
also noted that the shipper may not know of schedule changes ahead of
time.
Response: The NRC understands that all of the information may not
be available at the time of the initial advance notification. Section
37.77(b) specifically states that the licensee must provide the
required information if available at the time of the notification. In
addition, Sec. 37.77(c) provides for revised notifications for
information that was not available at the time of the initial
notification and for instances where information changes. The commenter
is correct that the provisions only apply to the domestic portion of
the transport for both imports and exports. The requirements would
begin at the point of customs clearance for imports and end at the
border for exports. Section 37.73(d) and (e) notes that the provisions
only apply to the domestic portion of the shipment. Both sections have
been revised to address exports.
Although the NRC coordinates with DOT on a number of safety and
security matters of mutual interest, licensees have implemented advance
notification requirements for many years, and the practicability of
these notifications is no longer in serious question.
Comment D12: Two commenters recommended that the advanced
notifications to the Governor be made through the NRC's Operations
Center. The commenters noted that the licensee could simply provide the
advanced notification to the NRC's Operations Center with a list of
States affected and the NRC's Operations Center would then transmit the
advanced notification to the affected States. The commenters noted that
this would reduce the record retention and notification burden on the
licensee and would ensure consistency in how the States receive
notifications.
Response: The NRC disagrees with the comment. It is the licensee's
responsibility to notify the affected States. The need for the NRC's
Operations Center to notify affected States could interfere with its
primary responsibility to be available for response to events.
Additionally, for those shipments that are made by an Agreement State
licensee, the NRC would not be notified as the notification would go to
the Agreement State. The Agreement State will need to provide the
information to the NRC so that the NRC can share the information with
its Federal partners.
Comment D13: Two commenters recommended including an email address
and fax number for the NRC point of contact receiving the notification
in Sec. 37.77(a)(1). The commenters noted that the email address and
fax numbers should be readily available as most notifications are made
by email or fax.
Response: The NRC agrees with the comment and has included the
secure fax number and email address to submit the notifications to the
NRC.
Comment D14: Two commenters recommended removing the option in
Sec. 37.77(a)(2) to mail in notifications or require that
notifications not submitted by fax or email be sent via certified mail
or delivery service. The commenters noted that 7 days prior to the
shipment date may not be sufficient time to allow a notification
transmitted through the regular mail to reach the intended recipient.
Response: The NRC disagrees with the comment. The 7 days prior
notice requirement is consistent with the similar provision for advance
notifications for spent fuel shipments. Transmittal of the SGI-M
information must meet the requirements of Sec. 73.23. The licensee
always has the option of sending the notification earlier than
required. The NRC has revised Sec. 37.77(a) to clarify the procedures
for submitting the notifications.
Comment D15: Two commenters recommended increasing the notification
requirement in Sec. 37.77(a)(3) from 4 days to 7 days. The commenters
noted that the additional time would provide States enough time to
review and evaluate the details regarding the shipment and would
preclude the need to conduct the required preplanning and coordination.
The commenters noted that this advance notification process has been in
place and proven effective for the past 6 years. One commenter
recommended that ``other means'' in Sec. 37.77(a)(3) be defined or
clarified. The commenter assumed it meant by email or fax.
[[Page 16991]]
Response: The NRC disagrees with the comment. The NRC believes that
4 days provide sufficient time for the States to review and evaluate,
particularly since the licensee is required to conduct preplanning and
coordination with the States in addition to the advance notifications.
The timeframe is also consistent with the similar provision for advance
notifications for spent fuel shipments. No State that commented on the
rule indicated that additional time was necessary. Other means could
include fax or email, or delivery by messenger. Additional information
has been added to the implementation guidance.
Comment D16: Two commenters indicated that it was unclear what
information the point of contact, requested in Sec. 37.77(b)(7) for
the advance notifications, should be able to provide. The commenter
noted that ``current shipping information'' could imply that the point
of contact should be a person accompanying the shipment, or did it mean
someone who has information regarding the details of the notification.
Response: The point of contact would be someone that has
information regarding the details of the notification. It is not
intended to be a person accompanying the shipment. Additional
information has been added to the implementation guidance.
Comment D17: One commenter noted that the NRC should provide for
advance notification to Tribes for shipments that cross their
reservation. The commenter noted that this rule should be consistent
with the rule that the NRC promulgates for Tribal notifications.
Response: The NRC may consider providing advance notification of
these materials to Tribes in the future but does not currently plan to
include the provision.
Comment D18: Three commenters suggested changing the phrase
``movement control center'' to ``communication control center'' in
Sec. 37.79 to maintain consistency with the orders.
Response: The NRC disagrees with the comment. Although the orders
called the centers communication control centers, these centers are
typically called movement control centers. The terms refer to the same
function. The NRC is retaining the term movement control center to be
consistent with the term in 10 CFR part 73 as the centers serve the
same function.
Comment D19: One commenter noted that in the definition of
``movement control center'' various functions are combined and that
there is no value in requiring that they all be accomplished by one
entity as the functions may be accomplished by separate departments or
personnel.
Response: The movement control center definition does not require
that all of the functions be carried out by the same department or
personnel. It does require an operations center or base from which all
of the functions are handled. The primary purpose of the movement
control center is to have staff available that can immediately respond
to an emergency and coordinate the required response.
Comment D20: One commenter requested clarification in Sec.
37.79(c)(1)(ii) on the use of authentication and duress codes. The
commenter noted that it wasn't clear if there were two codes or if
there needed to be a strategy for the ``use'' and ``authentication'' of
duress codes.
Response: The NRC has revised the rule language to clarify that
there are two types of codes.
Comment D21: One commenter noted that redundant communications
systems are required but it was not clear if redundant position
location or tracking systems are necessary.
Response: The rule does not contain a requirement for a redundant
position location or tracking system.
Comment D22: One commenter noted that although a licensee can make
arrangements to ensure that personnel are trained and can audit the
carrier for compliance, it cannot ensure that personnel are trained as
required. One commenter objected to the requirement for licensees
providing training to entities beyond its control such as railroad
personnel. The commenter noted that the carriers already have training
and certification requirements under DOT. Two commenters recommended
allowing the licensee to provide current copies of normal and
contingency procedures in lieu of training as required by Sec.
37.79(c)(2). The commenter noted that it is not feasible to provide
``appropriate training'' to a group of individuals that the licensee
has no control over.
Response: The NRC agrees with the comment. The NRC agrees that it
is acceptable to provide copies of the normal and contingency
procedures in lieu of a formal training program. If this mechanism is
used, the licensee should have a signoff sheet associated with the
procedure that the individual would sign indicating that he or she has
read and understands the procedure. The NRC also agrees that the
licensee would be unable to dictate that railroad personnel undergo
training and follow the licensee's procedures. Railroads have their own
processes and procedures in place and would be required to follow them.
The NRC has removed the requirement for railroad shipments.
Comment D23: One commenter stated that the regulation must make it
clear that the requirements in Sec. 37.79 are only applicable from the
point of customs clearance.
Response: Section 37.73(d) and (e) makes it clear that the
provisions only apply during the domestic portion of the shipment. For
imports, the provisions begin at the point of customs clearance.
Comment D24: One commenter noted that Sec. 37.79 requires
licensees to use companies who use package tracking systems (for
category 2) and that it should be clarified that the package itself
should be accounted for and not simply the paperwork.
Response: The NRC believes that the regulations are clear that it
is the package that is being tracked and not the paperwork. No change
to the regulations is needed.
Comment D25: One commenter objected to the requirement to start an
investigation if a package does not arrive within 2 to 4 hours of its
designated arrival time. The commenter noted that weather, traffic,
etc. could affect delivery times and that starting an investigation
because a package did not arrive on time due to poor weather, etc is a
waste of time and resources with no foreseeable gains for security. The
commenter noted that the timeframe should allow some time for
investigation and suggested an 8- and 24-hour timeframes.
Response: The NRC agrees in part with the comment. The NRC has
clarified the text in Sec. 37.79(d) to remove reference to lost or
unaccounted for material. The requirement to establish a no-later-than-
arrival time for shipment of category 1 quantities has been removed as
the licensee is required to maintain constant communication capability.
The NRC has increased the timeframe for the no-later-than arrival time
for category 2 shipments to 6 hours.
Comment D26: One commenter stated that when shipping radioactive
material meeting the requirements of HRCQ and RAMQC the requirements
should include having two forms of communications available at all
times for reporting incidents and requesting assistance.
Response: The NRC agrees and included a requirement for redundant
communication capability for category 1 shipments (RAMQC) in the
proposed rule. The final rule in Sec. 37.79(a)(1)(ii) requires
licensees to ``Ensure that
[[Page 16992]]
redundant communications are established that allow the transport to
contact the escort vehicle (when used) and movement control center at
all times. Redundant communications may not be subject to the same
interference factors as the primary communication.'' Redundant
communications are required to mitigate an interruption, caused by
either natural events, such as storms, or deliberate actions, such as
signal jamming, that may cause communications to be lost on the primary
communication device. One or more additional communication devices must
be available to operate independently of the primary device, thereby
minimizing the possibility that whatever disabled the primary device
will impact the redundant devices. For category 2 shipments, the NRC is
not requiring a redundant means of communication.
The requirements for HRCQ shipments, other than the category 1
material, are beyond the scope of this rulemaking.
Comment D27: One commenter felt that the rule should be revised to
require the licensee to provide some level of armed security during
transport of HRCQ.
Response: The NRC disagrees and feels that the physical protection
measures in place are adequate without requiring the use of armed
security personnel. The licensees that ship category 1 quantities of
radioactive material by road would be required to have sufficient
protective measures which include: A movement control center that
maintains periodic position information from a location remote from the
activity of the transport vehicle or trailer and monitors shipments 24
hours a day, 7 days a week; redundant communications that would allow
the transport to contact an escort vehicle; and the ability to
communicate an emergency immediately to appropriate law enforcement
agencies that would provide an armed response. Since the appropriate
States are to be notified in advance of the shipment, the State may
decide to have armed escorts accompany the shipment within the State's
borders.
The requirements for HRCQ shipments, other than the category 1
material, are beyond the scope of this rulemaking.
Comment D28: One commenter suggested adding an exemption to Sec.
37.79 for shipments transported as Exclusive Use, in accordance with 49
CFR 173.441. The commenter noted that package tracking systems are
necessary when a carrier handles multiple consignments on single
vehicles and when packages traverse through delivery hubs. The
commenter noted that an exclusive use shipment removes the risk of lost
or misdirected packages and would provide the same level of control as
a package tracking system. The commenter noted that adding the
exemption would give the licensee the ability to transport their own
category 1 materials.
Response: The NRC disagrees with the comment and does not believe
that an exemption is appropriate for shipments transported as Exclusive
Use. The shipment should still have the same security measures applied
even if the shipment is in a dedicated truck. While it might remove the
risk of a misdirected package, it does not remove the possibility that
the material could be stolen during transport. The licensee is allowed
to transport its own category 1 or category 2 material under the rule.
Comment D29: One commenter was disappointed that the proposed rule
did not contain the requirement for GPS tracking for trucks carrying
category 2 quantities of radioactive material that was requested in
PRM-71-13 or, alternatively, for the rule to give Agreement States the
flexibility to be more stringent than NRC. The commenter was
disappointed that the NRC did not request comments on the issues raised
in the petition nor provided any further discussion or explanation for
not including the two recommendations in the proposed rule. The
commenter noted that NMED data shows that since the letter was sent,
another truck carrying radiography sources was stolen, and the
commenter further noted that it only takes one to become the terrorist
event. The commenter noted that GPS tracking is very inexpensive and an
easy way to help with rapid recovery should preventative measures fail
and that GPS tracking for category 2 sources should be required.
Response: The NRC reevaluated the need for requiring GPS tracking
for trucks carrying category 2 quantities of material. The NRC
continues to disagree with the comment. Tracking a truck can be
misleading as either the source or the device containing the source can
be removed and the GPS would provide no benefit. There is no easy
method of placing the GPS tracking mechanism on either the source or
device. While GPS could help with locating the truck, the source/device
may not still be on the truck. For devices in or on a vehicle, the
licensee is supposed to maintain control and have constant surveillance
of the material or use a method to disable the vehicle. The NRC
believes that these measures are adequate. As for the compatibility of
the provisions, the provisions need to remain compatibility B because
there are significant transboundary implications.
Comment D30: One commenter noted that the shipping requirements are
somewhat demanding with the authorized shippers having added
responsibilities. The commenter assumed that the Commission will
communicate with the shipping agencies accordingly. The commenter noted
that the addition of GPS capabilities combined with vehicle/trailer
alarms with remote features will be an added expense. Another commenter
asked how to find the approved carriers.
Response: The NRC is not sure what the commenter meant by
authorized shipper, but assumes that it refers to the licensee that is
shipping the material. The NRC is also uncertain what the commenter
meant by shipping agencies, but assumes that the term refers to common
carriers. Common carriers do not have any responsibilities under part
37 as the NRC does not regulate the carrier. It is each licensee's
responsibility to make sure that its shipments are compliant with the
regulations. The NRC believes that the requirements in subpart D are
necessary for the safe transport of category 1 and category 2
quantities of radioactive material. The regulations do not require the
licensee to use GPS or vehicle/trailer alarms during shipment of the
material. Alarms may be necessary, however, if the material is stored
in the vehicle or trailer while the vehicle is unoccupied. The NRC does
not approve the carriers.
Comment D31: One commenter stated that Sec. 73.35 is not clear on
what to include/exclude from the calculation for ``net weight.'' The
commenter indicated that if the ``net weight'' is intended to include
only the weight of the nuclear or radioactive material contained in the
irradiated fuel, then this should be clearly stated. The commenter
noted that calculation by ``exclusion'' may lead to wide variation in
interpretation.
Response: The rule addresses the irradiated reactor fuel weighing
100 g (0.22 lb) or less in net weight of irradiated fuel, exclusive of
cladding or other structural or packaging material, and that has a
total external radiation dose rate in excess of 1 Gray (100 rad) per
hour at a distance of 1 m (3.3 ft) from any accessible surface without
intervening shielding.
Comment D32: One commenter proposed an exemption for the
aggregation of packages that individually each contain less than a
category 2 quantity of material and were in a package with an external
volume
[[Page 16993]]
exceeding 1 cubic foot and with a mass exceeding 100 pounds. The
commenter noted that these parameters would present a practical,
individual barrier to theft. The commenter also suggested, as an
alternative, the addition of a specific activity threshold to the
category 2 table, and materials not exceeding the specified
concentration values (sum of fractions could be applied to packages
containing multiple radionuclides of interest) would be exempted from
the requirements.
Response: The NRC disagrees that the parameters described would
present a practical barrier to theft. The requirements do not allow an
individual licensee to aggregate less-than-category-2-quantity packages
of material to exceed category 2 limits for an individual shipment
unless the shipment complies with 10 CFR part 37 requirements. If two
or more packages, each containing less than a category 2 quantity, in
aggregate reach or exceed a category 2 quantity in a shipment from one
NRC licensee, the licensee would be required to meet applicable subpart
D requirements before shipping.
The NRC did consider specific activity and grants an exemption as
stated in Sec. 37.11(c), which states that licensees that possess
radioactive waste that contains category 1 or category 2 quantities of
radioactive material are exempt from the requirements of subpart B, C,
and D of 10 CFR part 37, unless the radioactive waste contains discrete
sources, ion-exchange resins, or activated material that weighs less
than 2,000 kg (4,409 lbs).
Comment D33: One commenter noted that category 1 rail shipments
should be by dedicated trains.
Response: The NRC disagrees with the comment. There is no security
or health and safety basis for requiring dedicated trains for rail
shipments of category 1 quantities of radioactive material.
Comment D34: The proposed rule contained a provision that would
require the licensee to have an NRC-approved monitoring plan to ensure
that no unauthorized access to the shipment takes place while the
shipment is in a railroad classification yard. The NRC specifically
sought comment on the feasibility of this requirement. Commenters were
requested to provide information on: (1) Whether surveillance of the
shipment could be accomplished while in the classification yard; (2)
whether the classification yard would allow an individual to accompany
a shipment while the shipment is held in the classification yard; and
(3) what precautions might be necessary from a personal safety
standpoint. Five commenters provided responses to the specific
questions on this subject.
Of the commenters that addressed the questions on the monitoring
plans for use in railroad classification yards, only one commenter gave
an answer other than unknown. The commenter noted that, due to
insurance and liability concerns, it was highly unlikely that the
classification yard would allow an individual to accompany a shipment.
The commenter noted that DOT regulations were sufficient for personal
safety from a radiological perspective.
In addition to those that addressed the specific questions, two
commenters provided comment in this area. One commenter indicated that
additional monitoring while the shipment is in a railroad
classification yard is an impractical and unenforceable requirement.
The commenter noted that the systems that are currently in place are
sufficient. One commenter stated that remote monitoring of the package
and not the railcar is necessary in a classification yard.
Response: The NRC has decided not to include the provision for an
NRC-approved monitoring plan for the time that a shipment is located in
a railroad classification yard. The NRC agrees that DOT regulations are
sufficient.
Comment D35: One commenter asked if the requirement for continuous
and active monitoring by licensees applies only to shipments carried by
the licensee. The commenter noted that real-time information is not
available to the licensee when a carrier is used.
Response: The continuous and active monitoring of category 1
shipments, whether by the licensee or by a carrier, is the
responsibility of the licensee. It is also the licensee's
responsibility to ensure that its carrier has the capabilities for
continuous and active monitoring. Any time a shipment is enroute, the
licensee must be knowledgeable of its whereabouts, which can be
verified by a phone call to the movement control center or other means
of communication. This provides licensees with flexibility to design
continuous and active monitoring systems that meet their unique
circumstances. A licensee may use a carrier or third-party
communications center in lieu of establishing one itself.
Comment D36: One commenter asked if FedEx's tracking system is
considered to be proven and reliable as they are the primary carrier of
radioactive material.
Response: The NRC does not prescribe a particular system for
tracking shipments. The NRC regulations describe the performance
characteristics for a method used for category 2 shipments and does not
endorse any particular company. The regulations require licensees to
use carriers that have an established package tracking system which is
a documented, proven, and reliable system routinely used to transport
objects of value. This gives licensees the flexibility to use tracking
systems that work within their organization. The package tracking
system must allow the shipper or transporter to identify when and where
the package was last located and when it should arrive at the next
point of control. The NRC does not object to the use of Federal
Express, as long as they continue to meet these requirements.
Comment D37: One commenter asked how the security provision must be
implemented when using a freight forwarder.
Response: Transportation security requirements will still apply to
shipments using a freight forwarder. The NRC expects licensees to
ensure that their shipments are received by the recipient in a timely
manner and that any suspicious, attempted, or actual acts against a
shipment would be quickly detected, assessed, and immediately reported
to law enforcement authorities.
Comment D38: One commenter questioned who would be responsible for
complying with the security requirements when a carrier aggregates the
material during transport or storage incidental to transport. The
commenter noted that it would be logical for the responsibility to be
with the carrier.
Response: Licensees are not responsible for packages that are
aggregated by the carrier as long as the individual licensee does not
exceed category 2 thresholds. The licensees are not responsible if the
carrier picks up radioactive material from multiple locations that, in
the aggregate, meet or exceed the category 2 threshold, since the
licensees have no knowledge of what the total quantity of material
might be in the shipment. The NRC does not regulate the carrier.
Comment D39: One commenter suggested using a table to denote
applicability for the different types of shipments in Sec. 37.73 as
the paragraph format was confusing.
Response: The NRC has added a table to denote applicability for
different types of shipments to the implementation guidance.
Comment D40: One commenter indicated that synchronization of the
NRC and DOT requirements should be addressed. The commenter noted that
the rulemaking does not discuss the connection between the NRC and DOT
requirements on security and physical protection. The commenter noted
that
[[Page 16994]]
the rulemaking appears to regulate carriers even if only for security
purposes. The commenter felt that this situation could violate the
separation of responsibilities that the two organizations have and
will, at a minimum, create confusion among carriers. One commenter felt
that the rule should more closely align with the DOT requirements for
HRCQ shipments for routes used. One commenter asked if there has been
coordination between DOT and NRC regarding security during transport,
particularly in light of HM232F.
Response: The NRC shares responsibility for the safe and secure
transport of radioactive material with DOT and DHS. The NRC has a
Memorandum of Understanding (MOU) with DOT for safety and is currently
in the process of developing an MOU with DOE, DHS, and DOT on
transportation security to ensure that the agencies work together. The
Commission believes that it is necessary and appropriate to require
licensees to implement the proposed requirements, believes that the
issuance of security requirements for the transport of the material is
not a significant regulatory impediment, and believes that licensees
and carriers can successfully implement the requirements of both Title
49 and Title 10.
Comment D41: One commenter noted that the NRC's intent for
shipments of category 2 quantities of radioactive material is not clear
for licensees that are consignee, shipper, and consignor, as is the
case for the movement of most industrial radiography sources used in
the field. The commenter noted that this common situation should be
addressed for clarity either by inclusion or exclusion in the rule.
Response: The situation where a licensee is transporting its own
material is covered by Sec. 37.79(a)(2).
Comment D42: One commenter stated that the requirements placed on
licensees to coordinate with and to notify the LLEA for transport of
category I and category 2 quantities cannot be achieved by the licensee
alone, and thus seem unreasonable.
Response: The NRC disagrees with the comment. The rule does not
contain any provisions to coordinate with the LLEA for transport of
material. Licensees are required to notify the LLEA if a shipment of
category 1 materials is lost or missing. The NRC continues to believe
that this is an appropriate notification and sees nothing unreasonable
in the requirement.
Comment D43: One commenter (a State) noted that a number of
shippers are routing around States that charge fees for transportation
of HRCQ shipments of radioactive material and that this results in
longer transportation times and greater risk for shipment incidents
because of the additional transit time and miles traveled. The
commenter noted that because shipments of radioactive material are
being routed around the fee States, they are now traveling through
areas where there is little training and coordination of response to
radioactive material incidents increasing the risk and vulnerability.
The commenter suggested that language be added to require the shortest,
most direct, approved route for all HRCQ shipments and to prohibit
avoidance of States with transportation fees. The commenter further
suggested that licensees and shippers of HRCQ materials be required to
meet and preplan shipment routes with States on an annual basis to
ensure the States are ready to respond to incidents as needed.
Response: Routing of HRCQ material lies within the jurisdiction of
DOT's regulations and is beyond the scope of this rulemaking. For
category 1 shipments, the licensee is required to preplan and
coordinate with the States along the shipment route.
Comment D44: One commenter questioned why spent fuel was not
addressed in the rule.
Response: The rule does address transportation security of small
quantities (less than 100 grams) of irradiated fuel. Transportation
security of spent fuel is being addressed in a separate rulemaking. The
proposed rule was published for public comment on October 13, 2010; 75
FR 62695. Most of the licensees impacted by 10 CFR part 37 do not
possess spent fuel and large quantities of special nuclear material.
Security of special nuclear material and spent fuel security is
addressed in 10 CFR part 73 and in orders that were issued to specific
licensees possessing the material. Security for independent spent fuel
storage installations will be addressed in a future rulemaking.
Comment D45: One commenter noted that the link for Agreement State
contacts did not appear to work.
Response: The NRC has tested the link for Agreement State contacts
provided in the response to Q4 and it does take you to the Web page on
the Agreement States. From that location, you can access the State
transportation contacts. Part 37 contacts will not be added until just
before the rule is implemented.
Comment D46: One commenter stated that it is imperative that the
requirements for the transshipment of radioactive material be identical
to those for domestic shipments, and urged the NRC to work with other
Federal agencies to harmonize the regulations so that licensees and
their regulators at the Federal and State level follow consistent rules
for all shipments. The commenter suggested general licensing of
carriers as one way to resolve this issue. One commenter asked why
transuranic shipments were not addressed in 10 CFR part 37 and whether
these shipments fell under other security program requirements. Another
commenter asked what security requirements covered transshipments and
noted that it does not make sense to impose additional security on
licensees, if transshipments are not covered. Another commenter
recommended consistent regulations for transshipments, air shipments,
and water shipments regardless of the Federal authority and that the
standards for transshipments must be consistent with domestic
shipments. The commenter urged the NRC to provide leadership in
promoting consistency, perhaps via interagency agreement. The commenter
also recommended that the license verification system (licensees and
shipments by and among licensees) incorporate all RAMQC shipments,
regardless of the Federal authority under which they are made and that
the relevant information in the License Verification System be
appropriately shared with the State and local authorities involved in
enforcement.
Response: The NRC does not have any authority over transshipments
and does not regulate common carriers. However, the NRC has provided
copies of transportation security orders to companies that transship
category 1 quantities of radioactive materials. These companies have
agreed to voluntarily implement the security requirements for
transshipments. DHS has the overall lead for harmonizing transshipment
security, and the NRC has and will continue to work with other Federal
agencies on the security requirements for transshipments. The License
Verification System will be available to Agreement State personnel.
Comment D47: One commenter recommended that NRC work with the
States and law enforcement groups to determine effective ways to
support transport of category 1 and category 2 quantities of
radioactive material.
Response: The NRC did coordinate with the States. The Agreement
States were involved in both the development of the orders and
development of 10 CFR part 37. Law enforcement is not involved in the
routine transport of category 1 and category 2 quantities of
radioactive material. If a shipment is
[[Page 16995]]
lost or stolen, law enforcement would be contacted to assist.
E. Miscellaneous
Comment E1: One commenter wanted a clear, concise statement that
the requirements in 10 CFR part 37 supersede the Increased Control
Orders. The commenter suggested adding a second paragraph to Sec.
37.1.
Response: The NRC disagrees with the comment. A provision in the
rule is not necessary to note that the rule supersedes the orders. The
orders will be formally rescinded (withdrawn) on the effective date of
the final rule in each jurisdiction (Agreement State or NRC).
Comment E2: One commenter noted that the rule does not contain any
punitive provisions regarding situations where employees or outside
persons compromise safety and/or security. The commenter noted that
there are no provisions that can be cited in the event that a licensee
or an unlicensed person attempts to or gains unauthorized access,
breaches security systems, or otherwise compromises the security of
radioactive material.
Response: The NRC does not agree with the commenter's statement.
The proposed rule does contain punitive provisions for situations where
employees or outside persons compromise safety and/or security.
Specifically, Sec. 37.109 provides for criminal penalties. Section
37.109 of subpart G states that section 223 of the AEA provides
criminal sanctions for violations of any regulation issued under 161b.,
161i., or 161o., of the AEA. As stated in Sec. 37.109, all relevant
portions of this final rule have been issued pursuant to one or more of
sections 161b., 161i., or 161o. of the AEA. Further, there are other
applicable statutory provisions that provide punitive sanctions for
trespass and sabotage of nuclear facilities or fuel that could be
imposed on employees or outside persons who compromise safety and/or
security.
Comment E3: One commenter noted that the proposed rule fails to
provide descriptions in most sections to outline how the regulations
are applicable to a master materials licensee or a Federal agency. The
commenter felt that this lack of descriptions follows the pattern of
the previously issued increased controls and will likely result in
confusion during NRC compliance inspections at master materials
licensee facilities.
Response: A master material licensee and a Federal agency are still
a licensee and are treated the same as any other licensee. While a
master material licensee can issue permits within its organization for
the use of material, the permittees must still meet the requirements of
the license and the regulations. The NRC is not aware of any
implementation or inspection issues that have resulted from a licensee
being a master material licensee or a Federal agency.
Comment E4: Some States expressed concern that the proposed rule
would result in a potential increase in workload for the Agreement
State programs and that many States, particularly smaller States, may
have trouble accommodating the additional workload. Some of the
Agreement States also noted that the radiation control programs within
the States do not have the necessary expertise to handle what are
essentially ``law enforcement'' activities, nor will they likely be
able to hire additional staff to undertake these responsibilities. They
also noted that many of the proposed changes would impose duties that
are beyond traditional radiation control agency functions, and it is
likely that they would need to seek amendments to enabling legislation
to undertake the activities. One commenter stated that since the
regulatory activities formerly carried out under the NRC's Common
Defense and Security authority are being shifted to the Agreement
States because the rule is being issued under the NRC's Health and
Safety authority, the NRC should provide the funds necessary to pay the
direct costs incurred by the Agreement State governments in
implementing the regulation. One commenter (a State) indicated that NRC
must determine if funding will be provided to the States to increase
staffing levels to implement the rule or if other health and safety
programs should be cut.
Response: The NRC acknowledges that the rule will result in a
potential increase in workload for the Agreement State programs.
However, this is not unique to 10 CFR part 37. Any time the NRC issues
a rule that is a matter of compatibility for the Agreement States,
there will be an increased workload for the States. The State must
expend some effort to adopt the regulations and to include the
provisions in its inspection programs. These costs are addressed in the
regulatory analysis. The Agreement States will now need to conduct the
security inspections for those facilities in their State that were
issued orders under common defense and security and budget for those
inspections instead of being reimbursed by the NRC for conducting the
inspections. The NRC disagrees that the rule contains provisions that
are essentially ``law enforcement'' activities. The NRC assumes that
the commenters are referring to the regulatory agency approval of the
reviewing official. The NRC does not believe that this is a law
enforcement function, but in any case, regulatory agency approval of
the reviewing official has been removed and is not in the final rule.
As for the NRC paying the direct costs of increased staffing levels,
the NRC is not authorized to pay the salary costs for Agreement State
staff. The NRC can and will continue to pay for the necessary training
for Agreement State staff.
Comment E5: One commenter agreed with the proposed provisions to
remove the concept of sensitive information as used in the orders and
address information security in relevant sections of the proposed rule.
One commenter noted that placing all of the security requirements in
one chapter significantly enhanced their clarity. One commenter
supported the NRC decision to forgo conventional significant figure
conventions and list the actual curie activity equivalents to three
figures as many licensees use curies in their activities instead of
Becquerels. One commenter supported the general objective of the
rulemaking. Two commenters supported the approach to terminate the
orders coincident with the effective date of the rule in each
jurisdiction to avoid potential confusion and noncompliance. One
commenter expressed general support for the overall rulemaking and
suggested enhancements in the transportation security area. Several
commenters supported placing the security requirements in a rule
instead of in orders as it allows for public input and shows the
American population steps that are being taken to ensure their
security.
Response: No response necessary. Suggested enhancements were
considered as separate comments.
Comment E6: One commenter suggested that the NRC develop programs
and information packets to all involved (regulatory personnel, shipping
agencies, law enforcement agencies, Governors) so that everyone can be
on the same page.
Response: The NRC does have information on its Web site.
Information on radioactive material security can be found at https://www.nrc.gov/security/byproduct.html and information on radioactive
material transportation at https://www.nrc.gov/materials/transportation.html. These sites provide links to a variety of source
documents and specific NRC security enhancement activities, including
those on a Web page on current NRC radioactive
[[Page 16996]]
material security orders and requirements (https://www.nrc.gov/security/byproduct/orders.html) and a Web page on material transportation
regulations, guidance, and communications (https://www.nrc.gov/materials/transportation/regs-guides-comm.html). The NRC also routinely
participates in interagency efforts, such as the Task Force on
Radiation Source Protection and Security, where subjects of common
interest are discussed.
Comment E7: One commenter (a State agency that possesses
radioactive material subject to the rule) stated that the State would
not provide the additional funding necessary to implement the
requirements in 10 CFR part 37.
Response: Licensees are responsible for implementing and complying
with relevant regulations. A licensee may always request an exemption
from specific aspects of the requirements for its regulator to
consider.
Comment E8: One commenter stated that the phrase `Background Check'
was used inconsistently and seemed to mean different things in
different places. The commenter recommended reviewing the rule text for
consistent use of all terminology.
Response: The term ``background check'' is only used in the rule in
the context of the Bureau of Alcohol, Tobacco, Firearms, and Explosives
background checks. The term is used consistently in the rule. The NRC
tries to be consistent within the document, and any inconsistencies
identified have been corrected.
Comment E9: Three commenters addressed plain language in the rule.
One commenter suggested using ``you'' instead of ``licensee,'' pointed
out some long sentences, and noted some use of passive instead of
active voice. One commenter suggested rewriting the rule to address
these concerns. Another commenter noted that a single standard, clearly
spelled out in living room language, would better meet the need of all
licensees. One commenter noted that the rule did not meet the goal or
the intent of the President's directive.
Response: The NRC has considered the editorial changes and made
changes as appropriate.
Comment E10: One commenter noted that 10 CFR part 37 does nothing
to improve the security of radioactive materials that could be
introduced into the United States from foreign origins.
Response: The NRC's regulations only apply once the radioactive
material is in the U.S. The NRC does not have authority over material
in foreign countries.
Comment E11: One commenter noted that while the rule will help
protect the United States from terrorists, we should be thinking of the
environmental consequences.
Response: The NRC prepared an environmental assessment to support
the rulemaking.
Comment E12: One commenter suggested that the concept of what
category 1 and category 2 quantities are should be introduced earlier
in the summary and background sections to ensure that the distinction
between radioactive materials and category 1 and 2 quantities of
radioactive material is clear and that each term is used appropriately.
Response: The NRC disagrees with the comment. The summary notes
that the rule establishes security requirements for category 1 and
category 2 quantities of radioactive material and that the category 1
and category 2 thresholds are based on the IAEA Code of Conduct. The
NRC believes that the Statements of Consideration adequately describe
the material and are clear on what radioactive material is covered by
the rule.
Comment E13: One commenter noted that since few changes were made
by NRC as a result of Agreement States comments on the predecisional
draft of the proposed regulations, the NRC should make available to the
Director of the Office of Management and Budget (OMB) any written
communications submitted to the agency by State officials, including
State comments on the pre-decisional draft of 10 CFR part 37.
Response: The NRC made a number of changes in response to Agreement
State comments on the predecisional draft of the proposed rule. The NRC
did not make changes to the major issues on the reviewing official,
background investigation, and temporary jobsites, but specifically
invited comment on these issues in the proposed rule. Major differences
with the States were identified to the Commission as is common
practice. The NRC does not provide any comments to OMB, other than
comments on the information collection associated with the rule.
Comment E14: One commenter stated that the title of the rule should
also include a reference to the protection of information (SGI-M and
SUNSI). The commenter also stated that references to the protection of
information need to be made more consistent throughout the rule as most
sections and subsections only require implementation if individuals
have access to category 1 and category 2 quantities of radioactive
material. The commenter stated that those having access to safeguarded
or sensitive information also need to be included in the majority of
the sections in the rule, and the NRC should consider the inclusion of
10 CFR part 73 among the list of provisions of parts affecting
licensees in Sec. 37.1.
Response: The NRC disagrees with the comment. Part 73 contains the
physical protection requirements for special nuclear material as well
as requirements for protection of SGI. Reference to the SGI provisions
in 10 CFR part 73 were added to parts 30, 35, etc., as part of the SGI
rule that was published in the Federal Register on October 24, 2008; 73
FR 63546. References to 10 CFR part 73 are included at appropriate
locations in 10 CFR part 37. Section 37.1 contains the purpose of 10
CFR part 37 and does not include a reference to any affected provisions
of other NRC rules.
Comment E15: One commenter stated that the rule (and orders) moves
the emphasis for security away from engineered controls toward
administrative controls and that this goes against decades of NRC
safety policy and generally-accepted safety philosophy.
Response: The NRC disagrees with the comment. Part 37 contains a
mix of engineered controls and administrative controls.
Comment E16: One Agreement State expressed disappointment in what
was viewed to be the overly prescriptive content of the proposed rule
and the resurgence of issues that were previously discussed and agreed
upon as resolved in the orders. One Agreement State indicated that the
operational and practical understanding of the orders, together with
the knowledge of the effectiveness of the orders that the collective
Agreement States have gained during this time, should be taken into
consideration by the NRC. Other Agreement States noted disappointment
and concern that many concepts that were discussed at length during the
development of the orders and rejected by the orders working groups/
steering committees now appear in this proposed rule. They further
noted that they disagree with the new provisions and do not believe
that the added benefit warrants the significant resource burden that
would be incurred. One Agreement State felt that the rule contained too
many prescriptive items and was not adequately performance based. One
commenter noted that the knowledge and understanding that the Agreement
States have obtained during implementation of the orders should be
helpful to the NRC in improving the rulemaking.
[[Page 16997]]
Response: The rulemaking process is a more deliberative process
than what is used to develop an order. The 10 CFR part 37 working group
also had additional information to consider that included information
from lessons learned, implementation issues, inspection issues,
recommendations from other reviews, as well as the comments on the
preliminary rule language. In some cases the 10 CFR part 37 working
group and steering committee came to a different resolution than that
for the orders. Agreement State experience was utilized. There were
Agreement State representatives on the 10 CFR part 37 working group and
on the steering committee that brought their experience to the
discussions. In some areas where agreement could not be reached, the
NRC sought public comment on the issue to better inform the final
decision.
Comment E17: One commenter suggested that the NRC reconsider its
decision to use the same software developers for the verification
system as were used for the National Source Tracking System based on
the multiple continuing problems with the system.
Response: The comment is beyond the scope of the rulemaking.
Comment E18: Two commenters suggested that NRC conduct one or more
additional public workshops prior to submitting the draft final rule
and implementation guidance to the Commission for approval. The
commenters noted that the NRC could explain at the meeting how it
addressed and resolved the more significant or controversial topics
addressed by the public comments. The commenters noted that the
September 2008 workshop that NRC conducted on the Security and
Continued Use of Cesium-137 Chloride sources could serve as an
excellent model for such workshops. One commenter suggested holding
public meetings to discuss the regulatory analysis document and receive
insights and perspectives on its content.
Response: The NRC does not plan to hold any public meetings or
workshops on the 10 CFR part 37 final rule. The public was provided
opportunity to provide input on the rule and regulatory analysis during
the public comment period. The NRC considered the comments received and
made changes to the rule and supporting documents as appropriate.
Comment E19: Two commenters stated that continued stakeholder input
and involvement in the security area are essential and requested that
the NRC allow substantive opportunities to engage industry over the
next 4 years on the myriad of issues that the Congressionally mandated
Radiation Source Protection and Security Task Force is addressing as
all stakeholders continue to work collectively toward mutual safety and
security objectives.
Response: Continued stakeholder involvement in the security area is
beyond the scope of this rulemaking.
Comment E20: Two commenters noted that the NRC does not routinely
share the technical basis for rulemakings with stakeholders and
recommended that this become routine practice. The commenters noted
that providing the technical basis may have proven helpful for this
rule.
Response: Stakeholder involvement in regulatory basis development
is beyond the scope of this rulemaking. The decision to solicit
stakeholder input during the development of the regulatory (technical)
basis for a potential rule is decided on a case-by-case basis. The NRC
does obtain stakeholder input more routinely than it did a few years
ago. The NRC did obtain stakeholder input during the development of the
technical basis for the transportation security portion of this
rulemaking.
Comment E21: One commenter stated that the NRC should conduct
inspections to ensure that licensees are following the requirements and
that the focus on compliance verified by inspection should receive
greater emphasis instead of imposing additional administrative burdens
based on authorized use. Another commenter noted that the NRC must
ensure compliance through periodic inspections as is currently done.
Several commenters recommended that the NRC perform compliance audit
based reviews similar to what was done after the orders were
implemented. The commenter noted that the reviews were done with a
level of discretion and without citation as long as the licensee made
significant efforts to address the orders. One commenter requested that
the inspection frequency be modified to more closely coincide with the
risk.
Response: The NRC will conduct inspections to ensure that licensees
are complying with 10 CFR part 37 requirements. The inspections will be
conducted as part of the normal inspection program. The comment on
inspection frequency is beyond the scope of the rulemaking as the
inspection frequency is not set by the rule.
Comment E22: One commenter noted that a new licensee must have the
physical protection measures in place prior to a license being issued
and that this would be part of any prelicensing inspection. The
commenter noted that the agency should ensure implementation before
issuing a license.
Response: The NRC agrees that licensees should have the majority of
the provisions in place before the license is issued; some measures
could not be implemented until material is actually at the facility.
The NRC conducts prelicensing inspections before granting a license to
anyone that would be authorized to possess category 1 or category 2
quantities of radioactive material.
Comment E23: One commenter noted that certain materials licensees
would remain subject to the SGI requirements. The commenter recommended
that conforming changes to 10 CFR part 73 be included as part of the
regulation development under 10 CFR part 37, to ensure efficiency,
clarity, and help ensure compliance. The commenter noted that SECY-09-
0181 was silent on the timing of the future rulemaking to revise 10 CFR
part 73 to remove the SGI handling requirements for licensees subject
to 10 CFR part 37.
Response: The changes to 10 CFR part 73 to revise the SGI
requirements are beyond the scope of this rulemaking. The timing of any
potential changes to 10 CFR part 73 is unknown at this time.
Comment E24: One commenter noted that the rule could result in
institutions choosing to store materials, including waste, in separate
locations. The commenter noted that this could cause logistical
problems to keep track of the material and could inadvertently increase
the risk to the security of these materials.
Response: A licensee may choose to store radioactive materials, in
any form, in separate locations to avoid being subject to the proposed
security requirements. Such action would not conflict with the intent
of the proposed rule, which is to limit access to an aggregated
category 2 quantity of radioactive material listed in Table 1.
Aggregated, for purposes of this rule, means accessible by breach of a
single physical barrier.
Comment E25: One commenter made several comments related to a
change in the annual occupational radiation dose to a lower range and
how it would impact the licensee.
Response: These comments are beyond the scope of the rulemaking as
the proposed rule did not include any changes to the annual
occupational radiation dose. These comments appeared to be filed under
the wrong docket and were provided to the NRC working group that is
looking at possible changes to 10 CFR part 20.
[[Page 16998]]
IV. Discussion of Final Amendments by Section
Section 20.2201(c) Reports of Theft or Loss of Licensed Material
This section is revised to include a reference to the reporting
requirements in 10 CFR part 37 so that a licensee is not required to
file duplicate reports for the same event.
Section 30.6 Communications
This section is revised to include a reference to the new 10 CFR
part 37.
Section 30.13 Carriers
This section is revised to include 10 CFR part 37 in the list of
regulations that exempt common carriers.
Section 30.33 General Requirements for Issuance of Specific Licenses
Paragraph (a)(4) is revised to include a reference to the new 10
CFR part 37.
Section 32.1 Purpose and Scope
10 CFR part 37 is added to the list of 10 CFR parts that apply to
applications and licenses subject to this part.
Section 33.1 Purpose and Scope
10 CFR part 37 is added to the list of 10 CFR parts that apply to
applications and licenses subject to this part.
Section 34.1 Purpose and Scope
10 CFR part 37 is added to the list of 10 CFR parts that apply to
applications and licensees subject to this part.
Section 35.1 Purpose and Scope
10 CFR part 37 is added to the list of 10 CFR parts that apply to
applications and licenses subject to this part.
Section 36.1 Purpose and Scope
10 CFR part 37 is added to the list of 10 CFR parts that apply to
applications and licenses subject to this part.
Section 37.1 Purpose
This section establishes the purpose for the new 10 CFR part 37.
Section 37.3 Scope
This section establishes the scope of the proposed new 10 CFR part
37. These regulations apply to any person licensed by the NRC, who
possesses, uses, or transports an aggregated category 1 or category 2
quantity of radioactive material. Paragraph (a) establishes the
applicability for subpart B and C. Paragraph (b) establishes the
applicability for subpart D.
Section 37.5 Definitions
Definitions of the following terms that are included in this part
are identical to the definition of the term in other parts of this
chapter: Act, Agreement State, Becquerel, Byproduct material, Carrier,
Commission, Curie, Government agency, License, Lost or missing
material, Person, State, and United States. In addition, definitions
for the following terms are included in this Part: Approved
individuals, Access control, Aggregated, Background investigation,
Category 1 quantity of radioactive material, Category 2 quantity of
radioactive material, Diversion, Escorted access, Fingerprint Orders,
License issuing authority, Local law enforcement agency, Mobile device,
Movement control center, No-later-than arrival time, Reviewing
official, Sabotage, Security zone, Telemetric position monitoring
system, Trustworthiness and reliability, and Unescorted access.
Section 37.7 Communications
This section specifies where all communications and reports
concerning 10 CFR part 37 are to be sent.
Section 37.9 Interpretations
This section establishes that no interpretations of the meaning of
the regulations in 10 CFR part 37 by any officer or employee of the
Commission other than a written interpretation by the General Counsel
will be recognized as binding upon the Commission, unless specifically
authorized by the Commission in writing.
Section 37.11 Specific Exemptions
This section establishes that the Commission may grant exemptions
from the requirements of the regulations in 10 CFR part 37 that it
determines are authorized by law and that will not endanger life or
property or the common defense and security, and are otherwise in the
public interest. Paragraph (b) exempts an NRC licensee's activities
from 10 CFR part 37 to the extent that the activities are covered under
the physical protection requirements of 10 CFR part 73. Paragraph (c)
provides security measures for certain radioactive waste that contains
category 1 or category 2 quantities of radioactive waste.
Section 37.13 Information Collection Requirements: OMB Approval
Paragraph (a) specifies that the NRC may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. Paragraph (b)
lists those sections in 10 CFR part 37 that have approved information
collection requirements.
Section 37.21 Personnel Access Authorization Requirements for Category
1 or Category 2 Quantities of Radioactive Material
Paragraph (a) of this section establishes which licensees need to
comply with the requirements of subpart B of 10 CFR part 37.
Paragraph (b) establishes the general performance objective to
ensure that the individuals subject to the access authorization program
are trustworthy and reliable.
Paragraph (c)(1) establishes the individuals that are subject to
the access authorization program. Paragraph (c)(2) allows licensees to
not subject those individuals listed in Sec. 37.29(a) to the
investigation elements of the access authorization program. Paragraph
(c)(3) requires that licensees only approve those individuals whose job
duties permit unescorted access to category 1 or category 2 quantities
of radioactive material.
Section 37.23 Access Authorization Program Requirements
This section establishes the general requirements for the access
authorization program, such as the use of reviewing officials, informed
consent, personal history disclosure, determination basis, procedures,
the right to correct and complete information, and record retention.
Section 37.25 Background Investigations
This section establishes the elements of the background
investigation that are necessary before granting an individual
unescorted access to category 1 or category 2 quantities of radioactive
material. The scope of the initial investigation is the past 7 years.
This section also addresses reinvestigation and grandfathering of
individuals.
Section 37.27 Requirements for Criminal History Records Checks of
Individuals Granted Unescorted Access to Category 1 or Category 2
Quantities of Radioactive Material
Paragraph (a) establishes the general requirements for criminal
history records checks of individuals to be granted unescorted access
to category 1 or category 2 quantities of radioactive material.
Paragraph (b) prohibits a licensee from basing a final
determination to deny an individual unescorted access authorization
solely on the basis of certain information received from the FBI.
Paragraph (c) establishes the procedure for submitting fingerprint
records to the NRC.
[[Page 16999]]
Section 37.29 Relief From Fingerprinting, Identification, and Criminal
History Records Checks and Other Elements of Background Investigations
for Designated Categories of Individuals Permitted Unescorted Access to
Certain Radioactive Materials
This section provides relief from the fingerprinting and criminal
history records check requirements and the background investigation
requirements of this subpart for certain categories of individuals.
Section 37.31 Protection of Information
This section outlines the requirements for the protection and
release to authorized personnel of personal information collected by a
licensee during a background investigation.
Section 37.33 Access Authorization Program Review
This section outlines the requirements for an annual access
authorization program review to confirm compliance with the
requirements of subpart B of 10 CFR part 37 and for comprehensive
corrective actions to be taken in response to any nonconformance
identified by the review.
Section 37.41 Security Program
Paragraph (a) establishes the applicability of the security
program. Paragraph (a)(1) requires licensees that possess an aggregated
quantity of category 1 or category 2 quantities of radioactive material
to establish, implement, and maintain a security program. Paragraph
(a)(2) requires those licensees that are newly subject to subpart C,
upon application for modification of its license or an applicant
submitting a new application, to implement the requirements before
taking possession of an aggregated category 1 or category 2 quantity of
radioactive material. Paragraph (a)(3) requires any licensee that has
not previously implemented either the orders or subpart C to notify the
NRC at least 90 days before aggregating radioactive material to a
quantity that equals or exceeds the category 2 threshold.
Paragraph (b) establishes the general performance objective of the
security program.
Paragraph (c) establishes the program features that must be
addressed in the security program.
Section 37.43 General Security Program Requirements
Paragraph (a)(1) requires licensees to develop a written security
plan that addresses how the licensee will implement the security
program requirements. Paragraph (a)(2) requires the security plan to be
reviewed and approved by the individual with overall responsibility for
the security program. Paragraph (a)(3) allows a licensee to revise its
security plan to ensure effective implementation of the plan. Paragraph
(a)(4) requires the licensee to retain a copy of the current security
plan until the license is terminated and any security plan revisions
for 3 years.
Paragraph (b)(1) requires licensees to develop and maintain written
procedures for implementation of the security plan. Paragraph (b)(2)
requires the procedures to be approved by the individual with overall
responsibility for the security program. Paragraph (b)(3) requires the
licensee to retain a copy of the procedures for 3 years after the
procedure is no longer needed or upon termination of the license and
any revisions for 3 years.
Paragraph (c) requires licensees to conduct training and annual
refresher training on the security plan. Licensees are required to
maintain training records for 3 years from the date of the training.
Paragraph (d) requires licensees to protect the security plan,
implementing procedures, and the list of individuals that have been
approved for unescorted access from unauthorized disclosure. Licensees
are required to develop, maintain and implement written policies and
procedures for controlling access to, and for proper handling and
protection against unauthorized disclosure of, the security plan and
implementing procedures. Only individuals with a need-to-know and that
have been determined to be trustworthy and reliable should have access
to the protected information. The information protection procedures are
retained for 3 years after the document is no longer needed.
Section 37.45 LLEA Coordination
Paragraph (a) requires that a licensee attempt to coordinate with
an LLEA and specifies the types of information to be shared with the
LLEA.
Paragraph (b) requires the licensee to notify the NRC if the LLEA
isn't willing to participate in coordination activities or does not
respond to the coordination request.
Paragraph (c) requires the licensee to maintain records of its
coordination activities with any LLEA.
Section 37.47 Security Zones
Paragraph (a) requires licensees to establish security zones for
the use of category 1 or category 2 quantities of radioactive material.
Paragraph (b) requires the establishment of temporary security
zones, as necessary, to meet transitory or intermittent business
activities.
Paragraph (c) requires that security zones use physical barriers or
direct control of the security zone to allow unescorted access only to
approved individuals.
Paragraph (d) requires licensees to provide an approved individual
to maintain constant surveillance of sources in temporary security
zones or in a security zone in which a physical barrier or intrusion
detection system has been disabled to allow maintenance, source
receipt, preparation for shipment, source installation, or removal or
exchange of category 1 quantities of radioactive material.
Paragraph (e) requires individuals not approved for unescorted
access to be escorted by an approved individual when in a security
zone.
Section 37.49 Monitoring, Detection, and Assessment
Paragraph (a) requires the licensee to establish and maintain the
capability to continuously monitor and detect without delay all
unauthorized entries into the security zones.
Paragraph (b) requires the licensee to assess without delay each
actual or attempted unauthorized entry into the security zone.
Paragraph (c)(1) requires the licensee to maintain continuous
capability for personnel communication and electronic data transmission
and processing among site security systems.
Paragraph (c)(2) requires the licensee to provide alternative
capabilities for personnel communication and data transmission and
processing.
Paragraph (d) requires the licensee to respond without delay to any
actual or attempted unauthorized access to the security zone.
Section 37.51 Maintenance and Testing
This section requires licensees to implement a maintenance and
testing program to ensure that intrusion alarms, associated
communication systems, and other physical components of the systems
used to secure or detect unauthorized access to radioactive material
are maintained in operable condition, are capable of performing their
intended function when needed, and are inspected and tested for
operability and performance. The testing and maintenance are to be
conducted at the frequency recommended by the manufacturer or annually
if there is no manufacturer's recommended frequency. Licensees are
[[Page 17000]]
required to maintain the maintenance and testing records for 3 years.
Section 37.53 Requirements for Mobile Devices
This section requires licensees that possess mobile devices
containing category 1 or category 2 quantities of radioactive materials
to have two independent physical controls to secure the radioactive
material from unauthorized removal and to use a method to disable the
vehicle or trailer when the device is on a vehicle or trailer, unless
the site prohibits the use of a disabling mechanism due to health and
safety concerns.
Section 37.55 Security Program Review
This section requires licensees to conduct an annual review of the
security program. The licensee is required to document the results of
the review and any findings and keep the records for 3 years.
Section 37.57 Reporting of Events
Paragraph (a) requires licensees to immediately notify the LLEA of
any actual or attempted theft, sabotage, or diversion of category 1 or
category 2 quantities of radioactive material and to then notify the
NRC.
Paragraph (b) requires licensees to assess any suspicious activity
related to the theft, sabotage, or diversion of category 1 or category
2 quantities of radioactive material and to notify the LLEA as
appropriate and then notify the NRC.
Paragraph (c) requires licensees to submit a written report to the
NRC within 30 days of any report of actual or attempted theft,
sabotage, or diversion of radioactive material.
Section 37.71 Additional Requirements for Transfer of Category 1 and
Category 2 Quantities of Radioactive Material
Paragraphs (a) and (b) establish new requirements for licensees
transferring category 1 and category 2 quantities of radioactive
material. The licensee is required to verify the validity of the
license by using the license verification system or contacting the
license issuing authority.
Paragraph (c) provides an emergency method for when the licensee
can't reach the license issuing authority and the license verification
system is nonfunctional.
Paragraph (d) requires documentation to be maintained for 3 years.
Section 37.73 Applicability of Physical Protection of Category 1 and
Category 2 Quantities of Radioactive Material During Transit
This section establishes which requirements apply to licensees
shipping category 1 or category 2 quantities of radioactive material
and what requirements apply during the domestic portion of a shipment
that is imported from another country or exported to another country.
This section also allows the receiving licensee to arrange for the in-
transit physical protection of a shipment instead of the shipping
licensee as long as the agreement is in writing.
Section 37.75 Preplanning and Coordination of Shipment of Category 1 or
Category 2 Quantities of Radioactive Material
This section establishes the preplanning and coordination necessary
for a shipment of category 1 or category 2 quantities of radioactive
material.
Section 37.77 Advance Notification of Shipment of Category 1 Quantities
of Radioactive Material
This section establishes the requirements for advance notification
to the NRC and the governor of a State, or the governor's designee, of
the shipment of category 1 quantities of radioactive material that will
pass through or across the State.
Section 37.79 Requirements for Physical Protection of Category 1 and
Category 2 Quantities of Radioactive Material During Shipment
This section establishes the physical protection requirements for
shipments of category 1 and category 2 quantities of radioactive
material. Paragraph (a)(1) establishes the requirements for shipping a
category 1 quantity of radioactive material by road. Paragraph (a)(2)
establishes the requirements for a licensee that transports category 2
quantities of radioactive material by road. Paragraph (a)(3)
establishes the requirements for a licensee that uses a carrier for
shipping category 2 quantities of radioactive material.
Paragraph (b)(1) establishes the requirements for shipping category
1 quantities of radioactive material by rail. Paragraph (b)(2)
establishes the security requirements for shipping category 2
quantities of radioactive material by rail.
Paragraph (c) requires the shipping licensee to immediately conduct
an investigation of any shipment of category 2 quantities of
radioactive material that is lost or unaccounted for after the
designated no-later-than arrival time. It also requires the licensee to
conduct an investigation once it is determined that a category 1
shipment is lost or missing.
Section 37.81 Reporting of Events
This section establishes requirements for the shipping licensee to
make notifications upon the discovery that a shipment is lost or
missing and upon discovery of any actual or attempted theft or
diversion of a shipment, or suspicious activities related to the theft
or diversion of a shipment of either a category 1 or category 2
quantity of radioactive material. This section also establishes
requirements for notification upon recovery of a lost or missing
shipment. Written follow-up reports are required for notifications of
actual theft or attempted theft or diversion of a shipment.
Section 37.101 Form of Records
This section establishes the requirements for the storage and
protection of records required by this part.
Section 37.103 Record Retention
This section establishes the Commission's termination of the
license as the end point of the retention period for any record where a
specific retention period is not specified.
Section 37.105 Inspections
Paragraph (a) requires licensees to allow the Commission the
opportunity to inspect the materials and facilities subject to 10 CFR
part 37.
Paragraph (b) requires the licensee to make available for
inspection any records subject to 10 CFR part 37.
Section 37.107 Violations
Paragraph (a) of this section establishes that the Commission may
obtain an injunction or other court order to prevent a violation of the
AEA, Title II of the Energy Reorganization Act of 1974, as amended; or
a regulation or order issued under those Acts.
Paragraph (b) of this section establishes the violations for which
the Commission may obtain a court order for the payment of a civil
penalty imposed under Section 234 of the AEA.
Section 37.109 Criminal Penalties
This section establishes the sections in 10 CFR part 37 that are
issued under one or more of Sections 161b, 161i, or 161o and are
therefore subject to criminal sanctions for willful violation of,
attempted violation of, or conspiracy to violate the regulation.
[[Page 17001]]
Appendix A to 10 CFR Part 37--Category 1 and Category 2 Radioactive
Materials
Table 1 of this appendix establishes the radionuclides and
associated thresholds for category 1 and category 2 quantities of
radioactive material. The appendix also provides the methodology for
calculating the sum of fractions for evaluating combinations of
multiple radionuclides.
Section 39.1 Purpose and Scope
10 CFR part 37 is added to the list of 10 CFR parts that apply to
applications and licenses subject to this part.
Section 51.22 Criterion for Categorical Exclusion; Identification of
Licensing and Regulatory Actions Eligible for Categorical Exclusion or
Otherwise Not Requiring Environmental Review
Paragraph (c)(3) is revised to include 10 CFR part 37.
Section 71.97 Advance Notification of Shipment of Irradiated Reactor
Fuel and Nuclear Waste
Paragraph (b) is revised to delete the reference to shipments of
irradiated reactor fuel in quantities less than those subject to the
advance notification requirements of 10 CFR 73.37(f). Section 73.35
provides that such irradiated reactor fuel shipments be subject to the
same requirements that apply to shipments of category 1 radioactive
material, including the advance notification requirements.
Section 73.35 Requirements for Physical Protection of Irradiated
Reactor Fuel (100 Grams or Less) in Transit
A new section is added to 10 CFR part 73 to address the physical
protection requirements for shipments of irradiated reactor fuel
weighing 100 g (0.22 lb) or less in net weight of irradiated fuel,
exclusive of cladding or other structural or packaging material, which
has a total external radiation dose rate in excess of 1 Gray (100 rad)
per hour at a distance of 1 m (3.3 ft) from any accessible surface
without intervening shielding. The material is subject to the same
transportation security requirements as category 1 quantities of
radioactive material.
V. Criminal Penalties
For the purpose of Section 223 of the AEA, the Commission is
amending 10 CFR parts 20, 30, 32, 33, 34, 35, 36, 39, 51, 71, and 73
and adding new 10 CFR part 37 under one or more of Sections 161b, 161i,
or 161o of the AEA. Willful violations of the rule would be subject to
criminal enforcement.
VI. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register (62 FR 46517; September 3, 1997),
this final rule is a matter of compatibility between the NRC and the
Agreement States, thereby providing consistency among the Agreement
States and the NRC requirements. The NRC analyzed the final rule in
accordance with the procedure established within part III,
``Categorization Process for NRC Program Elements,'' of Handbook 5.9 to
Management Directive 5.9, ``Adequacy and Compatibility of Agreement
State Programs'' (a copy of which may be viewed at https://www.nrc.gov/reading-rm/doc-collections/management-directives/).
The NRC program elements (including regulations) are placed into
four compatibility categories (see the Compatibility Table in this
section). In addition, the NRC program elements can also be identified
as having particular health and safety significance or as being
reserved solely to the NRC. Compatibility Category A elements are those
program elements that are basic radiation protection standards and
scientific terms and definitions that are necessary to understand
radiation protection concepts. An Agreement State should adopt Category
A program elements in an essentially identical manner to provide
uniformity in the regulation of agreement material on a nationwide
basis. Compatibility Category B elements are those program elements
that apply to activities that have direct and significant effects in
multiple jurisdictions. An Agreement State should adopt Category B
program elements in an essentially identical manner. Compatibility
Category C elements are those program elements that do not meet the
criteria of Category A or B, but the essential objectives of which an
Agreement State should adopt to avoid conflict, duplication, gaps, or
other conditions that would jeopardize an orderly pattern in the
regulation of agreement material on a nationwide basis. An Agreement
State should adopt the essential objectives of the Category C program
elements. Compatibility Category D elements are those program elements
that do not meet any of the criteria of Category A, B, or C, above,
and, thus, do not need to be adopted by Agreement States for purposes
of compatibility.
Health and Safety (H&S) elements are program elements that are not
required for compatibility, but are identified as having a particular
health and safety role (i.e., adequacy) in the regulation of agreement
material within the State. Although not required for compatibility, the
State should adopt program elements in this H&S Category based on those
of the NRC that embody the essential objectives of the NRC program
elements because of particular health and safety considerations.
Compatibility Category NRC elements are those program elements that
address areas of regulation that cannot be relinquished to Agreement
States under the AEA or provisions of 10 CFR. These program elements
are not adopted by Agreement States. The following table lists the
parts and sections that have been created or revised and their
corresponding categorization under the ``Policy Statement on Adequacy
and Compatibility of Agreement State Programs.'' A bracket around a
category means that the section may have been adopted elsewhere, and it
is not necessary to adopt it again.
The Agreement States have 3 years from the publication of the final
rule in the Federal Register to adopt compatible regulations.
Compatibility Table for Final Rule
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
Part 20
----------------------------------------------------------------------------------------------------------------
20.2201(c).............................. Amend............... Reports of theft D............ D
or loss of
licensed material.
----------------------------------------------------------------------------------------------------------------
Part 30
----------------------------------------------------------------------------------------------------------------
30.6.................................... Amend............... Communications.... D............ D
[[Page 17002]]
30.13................................... Amend............... Carriers.......... B............ B
30.33(a)(4)............................. Amend............... General D............ D
requirements for
issuance of
specific licenses.
----------------------------------------------------------------------------------------------------------------
Part 32
----------------------------------------------------------------------------------------------------------------
32.1(b)................................. Amend............... Purpose and scope. D............ D
----------------------------------------------------------------------------------------------------------------
Part 33
----------------------------------------------------------------------------------------------------------------
33.1.................................... Amend............... Purpose and scope. D............ D
----------------------------------------------------------------------------------------------------------------
Part 34
----------------------------------------------------------------------------------------------------------------
34.1.................................... Amend............... Purpose and scope. D............ D
----------------------------------------------------------------------------------------------------------------
Part 35
35.1.................................... Amend............... Purpose and scope. D............ D
----------------------------------------------------------------------------------------------------------------
Part 36
36.1.................................... Amend............... Purpose and scope. D............ D
----------------------------------------------------------------------------------------------------------------
Part 37
----------------------------------------------------------------------------------------------------------------
37.1.................................... New................. Purpose........... ............. D
37.3.................................... New................. Scope............. ............. D
37.5.................................... New................. Definition Access ............. C
control.
37.5.................................... New................. Definition Act.... ............. D
37.5.................................... New................. Definition ............. C
Aggregated.
37.5.................................... New................. Definition ............. [B]
Agreement State.
37.5.................................... New................. Definition ............. B
Approved
individual.
37.5.................................... New................. Definition ............. C
Background
Investigation.
37.5.................................... New................. Definition ............. [A]
Becquerel.
37.5.................................... New................. Definition ............. [H&S]
Byproduct
Material.
37.5.................................... New................. Definition Carrier ............. [B]
37.5.................................... New................. Definition ............. B
Category 1
quantities of
radioactive
material.
37.5.................................... New................. Definition ............. B
Category 2
quantities of
radioactive
material.
37.5.................................... New................. Definition ............. D
Commission.
37.5.................................... New................. Definition Curie.. ............. [A]
37.5.................................... New................. Definition ............. C
Diversion.
37.5.................................... New................. Definition ............. B
Escorted access.
37.5.................................... New................. Definition ............. C
Fingerprint
Orders.
37.5.................................... New................. Definition ............. D
Government agency.
37.5.................................... New................. Definition License ............. D
37.5.................................... New................. Definition License ............. D
issuing agency.
37.5.................................... New................. Definition Local ............. C
law enforcement
agency.
37.5.................................... New................. Definition Lost or ............. [B]
missing material.
37.5.................................... New................. Definition Mobile ............. B
device.
37.5.................................... New................. Definition ............. B
Movement control
center.
37.5.................................... New................. Definition No- ............. B
later-than
arrival time.
37.5.................................... New................. Definition Person. ............. [C]
37.5.................................... New................. Definition ............. C
Reviewing
official.
37.5.................................... New................. Definition ............. C
Sabotage.
37.5.................................... New................. Safe haven........ ............. B
37.5.................................... New................. Definition ............. C
Security zone.
37.5.................................... New................. Definition State.. ............. D
37.5.................................... New................. Definition ............. B
Telemetric
position
monitoring system.
37.5.................................... New................. Definition ............. B
Trustworthiness
and reliability.
37.5.................................... New................. Definition ............. B
Unescorted access.
37.5.................................... New................. Definition United ............. D
States.
37.7.................................... New................. Communications.... ............. D
37.9.................................... New................. Interpretations... ............. D
37.11(a)................................ New................. Specific ............. D
exemptions.
37.11(b)................................ New................. Specific ............. D
exemptions.
37.11(c)................................ New................. Specific ............. B
exemptions.
37.13................................... New................. Information ............. D
collection
requirements: OMB
approval.
37.21(a)................................ New................. General........... ............. C
37.21(b)................................ New................. General ............. B
performance
objective.
37.21(c)................................ New................. Applicability..... ............. B
37.23(a)................................ New................. Granting ............. B
unescorted access
authorization.
37.23(b)(1), (2), (4), (5).............. New................. Reviewing ............. B
officials.
37.23(b)(3)............................. New................. Reviewing ............. C
officials.
[[Page 17003]]
37.23(c)................................ New................. Informed consent.. ............. B
37.23(d)................................ New................. Personal history ............. B
disclosure.
37.23(e)................................ New................. Determination ............. B
basis.
37.23(f)................................ New................. Procedures........ ............. C
37.23(g)................................ New................. Right to correct ............. B
and complete
information.
37.23(h)................................ New................. Records........... ............. C
37.25(a)................................ New................. Initial ............. B
investigation.
37.25(b)................................ New................. Grandfathering.... ............. C
37.25(c)................................ New................. Reinvestigations.. ............. B
37.27(a)................................ New................. General ............. B
performance
objective and
requirements.
37.27(b)................................ New................. Prohibitions...... ............. B
37.27(c)................................ New................. Procedures for ............. B
processing
fingerprint
checks.
37.29(a), (b)........................... New................. Relief from ............. B
fingerprinting,
identification,
and criminal
history records
checks and other
elements of a
background
investigations
for designated
categories of
individuals
permitted
unescorted access
to certain
radioactive
materials.
37.31(a)-(d)............................ New................. Protection of ............. B
information.
37.31(e)................................ New................. Protection of ............. C
information.
37.33(a), (b), (c)...................... New................. Access ............. C
authorization
program review.
37.41(a)................................ New................. Applicability..... ............. B
37.41(b)................................ New................. General ............. B
performance
objective.
37.41(c)................................ New................. Program features.. ............. C
37.43(a)................................ New................. Security plan..... ............. B
37.43(b)................................ New................. Implementing ............. C
procedures.
37.43(c)(1)-(c)(3)...................... New................. Training.......... ............. B
37.43(c)(4)............................. New................. Training.......... ............. C
37.43(d)(1)-(d)(8)...................... New................. Protection of ............. C
Information.
37.43(d)(9)............................. New................. Protection of ............. NRC
Information.
37.45(a), (b), (d)...................... New................. LLEA coordination. ............. B
37.45(c)................................ New................. LLEA coordination ............. C
(records).
37.47(a)-(e)............................ New................. Security zones.... ............. B
37.49(a)................................ New................. Monitoring and ............. B
detection.
37.49(b)................................ New................. Assessment........ ............. B
37.49(c)................................ New................. Personnel ............. B
communications
and data
transmission.
37.49(d)................................ New................. Response.......... ............. B
37.51................................... New................. Maintenance and ............. C
testing.
37.53................................... New................. Requirements for ............. B
mobile devices.
37.55(a), (b), (c)...................... New................. Security program ............. C
review.
37.57(a)................................ New................. Reporting of ............. C
events.
37.57(b)................................ New................. Reporting of ............. C
events.
37.71................................... New................. Additional ............. B
requirements for
transfer of
category 1 and
category 2
quantities of
radioactive
material.
37.71(a), (b) (c)....................... New................. Additional ............. B
requirements for
transfer of
category 1 and
category 2
quantities of
radioactive
material.
37.71(d)................................ New................. Additional ............. C
requirements for
transfer of
category 1 and
category 2
quantities of
radioactive
material.
37.73(a), (b), (d), (e)................. New................. Applicability of ............. D
physical
protection of
category 1 and
category 2
quantities of
radioactive
material during
transit.
37.73(c)................................ New................. Applicability of ............. B
physical
protection of
category 1 and
category 2
quantities of
radioactive
material during
transit.
37.75(a)-(d)............................ New................. Preplanning and ............. B
coordination of
shipment of
category 1 or
category 2
quantities of
radioactive
material.
37.75(e)................................ New................. Preplanning and ............. C
coordination of
shipment of
category 1 or
category 2
quantities of
radioactive
material.
37.77................................... New................. Advance ............. B
notification for
shipments of
category 1
quantities of
radioactive
material.
37.77(a)................................ New................. Procedures for ............. B
submitting
advance
notification.
37.77(b)................................ New................. Information to be ............. B
furnished in
advance
notification of
shipment.
37.77(c)................................ New................. Revision notice... ............. B
37.77(d)................................ New................. Cancellation ............. B
notice.
37.77(e)................................ New................. Records........... ............. C
37.77(f)................................ New................. Protection of ............. NRC
information.
37.79(a)................................ New................. Shipments by road. ............. B
37.79(b)................................ New................. Shipments by rail. ............. B
37.79(c)................................ New................. Investigations.... ............. B
37.81(a)................................ New................. Reporting of ............. B
events.
37.81(b)................................ New................. Reporting of ............. B
events.
37.81(c)................................ New................. Reporting of ............. B
events.
37.81(d)................................ New................. Reporting of ............. B
events.
37.81(e)................................ New................. Reporting of ............. B
events.
[[Page 17004]]
37.81(f)................................ New................. Reporting of ............. B
events.
37.81(g)................................ New................. Reporting of ............. C
events.
37.81(h)................................ New................. Reporting of ............. C
events.
37.101.................................. New................. Form of records... ............. C
37.103.................................. New................. Record retention.. ............. C
37.105.................................. New................. Inspections....... ............. D
37.107.................................. New................. Violations........ ............. D
37.109.................................. New................. Criminal penalties ............. D
Appendix A.............................. New................. Category 1 and 2 ............. B
thresholds.
----------------------------------------------------------------------------------------------------------------
Part 39
----------------------------------------------------------------------------------------------------------------
39.1.................................... Amend............... Purpose and scope. D............ D
----------------------------------------------------------------------------------------------------------------
Part 51
----------------------------------------------------------------------------------------------------------------
51.22(c)(3)............................. Amend............... Criterion for NRC.......... NRC
categorical
exclusion;
identification of
licensing and
regulatory
actions eligible
for categorical
exclusion or
otherwise not
requiring
environmental
review.
----------------------------------------------------------------------------------------------------------------
Part 71
----------------------------------------------------------------------------------------------------------------
71.97(b)................................ Amend............... Advance B............ B
notification of
shipment of
irradiated
reactor fuel and
nuclear waste.
----------------------------------------------------------------------------------------------------------------
Part 73
----------------------------------------------------------------------------------------------------------------
73.35................................... New................. Requirements for ............. NRC
physical
protection of
irradiated
reactor fuel (100
grams or less) in
transit.
----------------------------------------------------------------------------------------------------------------
VII. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has written this document to be consistent with the
Plain Writing Act as well as the Presidential Memorandum, ``Plain
Language in Government Writing,'' published June 10, 1998 (63 FR
31883).
VIII. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113), requires that Federal agencies use technical standards
that are developed or adopted by voluntary consensus standards bodies
unless the use of such a standard is inconsistent with applicable law
or otherwise impractical. In this final rule, the NRC is establishing
security requirements for the use of category 1 and category 2
quantities of radioactive materials. The NRC is not aware of any
voluntary consensus standards that address the subject matter of this
final rule. This action does not constitute the establishment of a
standard that establishes generally applicable requirements.
IX. Finding of No Significant Environmental Impact: Availability
Under the National Environmental Policy Act of 1969, as amended,
and the NRC regulations in subpart A of 10 CFR part 51, the NRC has
determined that this final rule, if adopted, would not be a major
Federal action significantly affecting the quality of the human
environment, and therefore an environmental impact statement is not
required for this rulemaking. The NRC has prepared an environmental
assessment and, on the basis of this environmental assessment, has made
a finding of no significant impact.
The implementation of the final rule's security requirements would
not result in significant changes to the licensee's facilities, nor
would such implementation result in any significant increase in
effluents released to the environment. Similarly, the implementation of
the final rule's security requirements would not affect occupational
exposure requirements. No major construction or other earth-disturbing
activities on the part of affected licensees are anticipated in
connection with licensees' implementation of the final rule's
requirements. The Commission has determined that the implementation of
this final rule is procedural and administrative in nature.
The determination of this environmental assessment is that there
will be no significant impact to the public from this action.
This conclusion was published in the environmental assessment that
was posted to the NRC's rulemaking Web site: https://www.regulations.gov
after publication of the proposed rule. No comments were received on
the content of the environmental assessment.
X. Paperwork Reduction Act Statement
This final rule contains new information collection requirements in
10 CFR part 37 that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). These requirements were approved by the
Office of Management and Budget (OMB), approval number 3150-0214. The
changes to 10 CFR parts 20, 30, 32, 33, 34, 35, 36, 39, 51, 71, and 73
do not contain new or amended information collection requirements.
Existing requirements were approved by the OMB, approval numbers 3150-
0014, 3150-0017, 3150-0001, 3150-0015, 3150-0007, 3150-0010, 3150-0158,
3150-0130, 3150-0021, 3150-0008, and 3150-0002.
The burden to the public for the information collections in 10 CFR
part
[[Page 17005]]
37 is estimated to average1.7 hours per response. This includes the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the information collection. Send comments on any aspect of these
information collections, including suggestions for reducing the burden,
to the Information Services Branch (T-5 F53), U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by Internet electronic mail
to INFOCOLLECTS.RESOURCE@NRC.GOV; and to the Desk Officer, Chad
Whiteman, Office of Information and Regulatory Affairs, NEOB-10202,
(3150-0214), Office of Management and Budget, Washington, DC 20503.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.
XI. Regulatory Analysis
The Commission has prepared a regulatory analysis on this final
regulation. The analysis examines the costs and benefits of the
alternatives considered by the Commission.
The analysis is available for inspection in the NRC's Public
Document Room, 11555 Rockville Pike, Rockville, Maryland 20852. The
analysis may also be viewed and downloaded electronically via the
Federal erulemaking portal at https://www.regulations.gov by searching
for Docket ID NRC-2008-0120.
XII. Regulatory Flexibility Certification
The NRC has prepared a regulatory analysis of the impact of this
final rule on small entities. The final rule will affect about 300 NRC
licensees and an additional 1,100 Agreement State licensees. Affected
licensees include laboratories, reactors, universities, colleges,
medical clinics, hospitals, irradiators, manufacturers and
distributors, well loggers, and radiographers, some of which may
qualify as small business entities as defined by 10 CFR 2.810. Based on
the regulatory analysis conducted for this action, the costs of the
rule for affected licensees are estimated to be between $358 million
and $488 million (7-percent and 3-percent discount rate over 20 years,
respectively) total. The average licensee will have a one-time cost of
approximately $23,375 and an annual cost of approximately $21,736 to
fully implement the final rule. The NRC believes that the selected
alternative reflected in the final rule is the least burdensome, most
flexible alternative that accomplishes the NRC's regulatory objective.
The Regulatory Flexibility Analysis is included as an Appendix to this
final rule.
XIII. Backfit Analysis
The NRC has determined that the backfit rule, which is found in the
regulations at 10 CFR 50.109, 70.76, 72.62, 76.76, and in 10 CFR part
52, does not apply to this final rule because this amendment would not
involve any provisions that would impose backfits as defined in 10 CFR
chapter I. Therefore, a backfit analysis is not required.
XIV. Congressional Review Act
In accordance with the Congressional Review Act of 1996, the NRC
has determined that this action is a major rule and has verified this
determination with the Office of Information and Regulatory Affairs of
OMB.
List of Subjects
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recordkeeping requirements, Source material, Special nuclear material,
Waste treatment and disposal.
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and recordkeeping requirements.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 33
Byproduct material, Criminal penalties, Nuclear materials,
Radiation protection, Reporting and recordkeeping requirements.
10 CFR Part 34
Criminal penalties, Packaging and containers, Radiation protection,
Radiography, Reporting and recordkeeping requirements, Scientific
equipment, Security measures.
10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 36
Byproduct material, Criminal penalties, Nuclear materials,
Reporting and recordkeeping requirements, Scientific equipment,
Security measures.
10 CFR Part 37
Byproduct material, Criminal penalties, Export, Hazardous materials
transportation, Import, Licensed material, Nuclear materials, Reporting
and recordkeeping requirements, Security measures.
10 CFR Part 39
Byproduct material, Criminal penalties, Nuclear material, Oil and
gas exploration--well logging, Reporting and recordkeeping
requirements, Scientific equipment, Security measures, Source material,
Special nuclear material.
10 CFR Part 51
Administrative practice and procedure, Environmental impact
statement, Nuclear materials, Nuclear power plants and reactors,
Reporting and recordkeeping requirements.
10 CFR Part 71
Criminal penalties, Hazardous materials transportation, Nuclear
materials, Packaging and containers, Reporting and recordkeeping
requirements.
10 CFR Part 73
Criminal penalties, Export, Hazardous materials transportation,
Import, Nuclear materials, Nuclear power plants and reactors, Reporting
and recordkeeping requirements, Security measures.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting
the following amendments to 10 CFR parts 20, 30, 32, 33, 34, 35, 36,
37, 39, 51, 71, and 73.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
0
1. The authority citation for part 20 continues to read as follows:
[[Page 17006]]
Authority: Atomic Energy Act secs. 53, 63, 65, 81, 103, 104,
161, 182, 186, 223. 234 1701 (42 U.S.C. 2073, 2093, 2095, 2111,
2133, 2134, 2201, 2232, 2236, 2273, 2282, 2297f), Energy
Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005 sec. 651(e), Pub. L. No. 109-58,
119 Stat. 549 (2005) (42 U.S.C. 2014, 2021, 2021b, 2111).
0
2. In Sec. 20.2201, paragraph (c) is revised to read as follows:
Sec. 20.2201 Reports of theft or loss of licensed material.
* * * * *
(c) A duplicate report is not required under paragraph (b) of this
section if the licensee is also required to submit a report pursuant to
Sec. Sec. 30.55(c), 37.57, 37.81, 40.64(c), 50.72, 50.73, 70.52,
73.27(b), 73.67(e)(3)(vii), 73.67(g)(3)(iii), 73.71, or 150.19(c) of
this chapter.
* * * * *
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
0
3. The authority citation for part 30 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 82, 161, 181, 182, 183,
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2231, 2232, 2233, 2236,
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42
U.S.C. 5841, 5842, 5846); Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. No.
109-58, 119 Stat. 549 (2005).
Section 30.7 also issued under Energy Reorganization Act sec.
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec.
2902 (42 U.S.C. 5851). Section 30.34(b) also issued under Atomic
Energy Act sec. 184 (42 U.S.C. 2234). Section 30.61 also issued
under Atomic Energy Act sec. 187 (42 U.S.C. 2237).
0
4. In Sec. 30.6, the introductory text of paragraph (a) is revised to
read as follows:
Sec. 30.6 Communications.
(a) Unless otherwise specified or covered under the regional
licensing program as provided in paragraph (b) of this section, any
communication or report concerning the regulations in parts 30 through
37 and 39 of this chapter and any application filed under these
regulations may be submitted to the Commission as follows:
* * * * *
0
5. Section 30.13 is revised to read as follows:
Sec. 30.13 Carriers.
Common and contract carriers, freight forwarders, warehousemen, and
the U.S. Postal Service are exempt from the regulations in this part
and parts 31 through 37 and 39 of this chapter and the requirements for
a license set forth in section 81 of the Act to the extent that they
transport or store byproduct material in the regular course of carriage
for another or storage incident thereto.
0
6. In Sec. 30.33, paragraph (a)(4) is revised to read as follows:
Sec. 30.33 General requirements for issuance of specific licenses.
(a) * * *
(4) The applicant satisfies any special requirements contained in
parts 32 through 37 and 39 of this chapter; and
* * * * *
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
0
7. The authority citation for part 32 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, sec. 651(e), Pub. L. No. 109-58, 119 Stat. 806-810 (42
U.S.C. 2014, 2021, 2021b, 2111).
0
8. In Sec. 32.1, paragraph (b) is revised to read as follows:
Sec. 32.1 Purpose and scope.
* * * * *
(b) The provisions and requirements of this part are in addition
to, and not in substitution for, other requirements of this chapter. In
particular, the provisions of part 30 of this chapter apply to
applications, licenses and certificates of registration subject to this
part, and the provisions of part 37 of this chapter apply to
applications and licenses subject to this part.
* * * * *
PART 33--SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT
MATERIAL
0
9. The authority citation for part 33 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005 sec. 651(e), Public Law 109-58, 119 Stat. 806-810 (42 U.S.C.
2014, 2021, 2021b, 2111).
0
10. Section 33.1 is revised to read as follows:
Sec. 33.1 Purpose and scope.
This part prescribes requirements for the issuance of specific
licenses of broad scope for byproduct material (``broad licenses'') and
certain regulations governing holders of such licenses. The provisions
and requirements of this part are in addition to, and not in
substitution for, other requirements of this chapter. In particular,
the provisions of parts 30 and 37 of this chapter apply to applications
and licenses subject to this part.
PART 34--LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY
REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
0
11. The authority citation for part 34 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork
Elimination Act sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
Atomic Energy Act of 2005 sec. 651(e), Pub. L. No. 109-58, 119 Stat.
806-810 (42 U.S.C. 2014, 2021, 2021b, 2111). Section 34.45 also
issued under Energy Reorganization Act sec. 206 (42 U.S.C. 5846).
0
12. Section 34.1 is revised to read as follows:
Sec. 34.1 Purpose and scope.
This part prescribes requirements for the issuance of licenses for
the use of sealed sources containing byproduct material and radiation
safety requirements for persons using these sealed sources in
industrial radiography. The provisions and requirements of this part
are in addition to, and not in substitution for, other requirements of
this chapter. In particular, the requirements and provisions of parts
19, 20, 21, 30, 37, 71, 150, 170, and 171 of this chapter apply to
applications and licenses subject to this part. This rule does not
apply to medical uses of byproduct material.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
0
13. The authority citation for part 35 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201, 206 (42 U.S.C. 5841, 5842, 5846); sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, sec. 651(e),
Public Law 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b,
2111).
0
14. Section 35.1 is revised to read as follows:
[[Page 17007]]
Sec. 35.1 Purpose and scope.
This part contains the requirements and provisions for the medical
use of byproduct material and for issuance of specific licenses
authorizing the medical use of this material. These requirements and
provisions provide for the radiation safety of workers, the general
public, patients, and human research subjects. The requirements and
provisions of this part are in addition to, and not in substitution
for, others in this chapter. The requirements and provisions of parts
19, 20, 21, 30, 37, 71, 170, and 171 of this chapter apply to
applicants and licensees subject to this part unless specifically
exempted.
PART 36--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
0
15. The authority citation for part 36 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 82, 161, 181, 182, 183,
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2273,
2282); Energy Reorganization Act secs. 201, 202, 206 (42 U.S.C.
5841, 5842, 5846); Government Paperwork Elimination Act sec. 1704
(44 U.S.C. 3504 note); Atomic Energy Act of 2005 sec. 651(e), Pub.
L. No. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b,
2111).
0
16. In Sec. 36.1, paragraph (a) is revised to read as follows:
Sec. 36.1 Purpose and scope.
(a) This part contains requirements for the issuance of a license
authorizing the use of sealed sources containing radioactive materials
in irradiators used to irradiate objects or materials using gamma
radiation. This part also contains radiation safety requirements for
operating irradiators. The requirements of this part are in addition to
other requirements of this chapter. In particular, the provisions of
parts 19, 20, 21, 30, 37, 71, 170, and 171 of this chapter apply to
applications and licenses subject to this part. Nothing in this part
relieves the licensee from complying with other applicable Federal,
State and local regulations governing the siting, zoning, land use, and
building code requirements for industrial facilities.
* * * * *
0
17. Part 37 is added to read as follows:
PART 37--PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2
QUANTITIES OF RADIOACTIVE MATERIAL
Sec.
Subpart A--General Provisions
37.1 Purpose.
37.3 Scope.
37.5 Definitions.
37.7 Communications.
37.9 Interpretations.
37.11 Specific exemptions.
37.13 Information collection requirements: OMB approval.
Subpart B--Background Investigations and Access Control Program
37.21 Personnel access authorization requirements for category 1 or
category 2 quantities of radioactive material.
37.23 Access authorization program requirements.
37.25 Background investigations.
37.27 Requirements for criminal history records checks of
individuals granted unescorted access to category 1 or category 2
quantities of radioactive material.
37.29 Relief from fingerprinting, identification, and criminal
history records checks and other elements of background
investigations for designated categories of individuals permitted
unescorted access to certain radioactive materials.
37.31 Protection of information.
37.33 Access authorization program review.
Subpart C--Physical Protection Requirements During Use
37.41 Security program.
37.43 General security program requirements.
37.45 LLEA coordination.
37.47 Security zones.
37.49 Monitoring, detection, and assessment.
37.51 Maintenance and testing.
37.53 Requirements for mobile devices.
37.55 Security program review.
37.57 Reporting of events.
Subpart D--Physical Protection in Transit
37.71 Additional requirements for transfer of category 1 and
category 2 quantities of radioactive material.
37.73 Applicability of physical protection of category 1 and
category 2 quantities of radioactive material during transit.
37.75 Preplanning and coordination of shipment of category 1 or
category 2 quantities of radioactive material.
37.77 Advance notification of shipment of category 1 quantities of
radioactive material.
37.79 Requirements for physical protection of category 1 and
category 2 quantities of radioactive material during shipment.
37.81 Reporting of events.
Subpart E--[Reserved]
Subpart F--Records
37.101 Form of records.
37.103 Record retention.
Subpart G--Enforcement
37.105 Inspections.
37.107 Violations.
37.109 Criminal penalties.
Appendix A to Part 37--Category 1 and Category 2 Radioactive Materials
Authority: Atomic Energy Act secs. 53, 81, 103, 104, 147, 148,
149, 161, 182, 183, 223, 234 (42 U.S.C. 2073, 2111, 2133, 2134,
2167, 2168, 2169, 2201a., 2232, 2233, 2273, 2282).
Subpart A--General Provisions
Sec. 37.1 Purpose.
This part has been established to provide the requirements for the
physical protection program for any licensee that possesses an
aggregated category 1 or category 2 quantity of radioactive material
listed in Appendix A to this part. These requirements provide
reasonable assurance of the security of category 1 or category 2
quantities of radioactive material by protecting these materials from
theft or diversion. Specific requirements for access to material, use
of material, transfer of material, and transport of material are
included. No provision of this part authorizes possession of licensed
material.
Sec. 37.3 Scope.
(a) Subparts B and C of this part apply to any person who, under
the regulations in this chapter, possesses or uses at any site, an
aggregated category 1 or category 2 quantity of radioactive material.
(b) Subpart D of this part applies to any person who, under the
regulations of this chapter:
(1) Transports or delivers to a carrier for transport in a single
shipment, a category 1 or category 2 quantity of radioactive material;
or
(2) Imports or exports a category 1 or category 2 quantity of
radioactive material; the provisions only apply to the domestic portion
of the transport.
Sec. 37.5 Definitions.
As used in this part:
Access control means a system for allowing only approved
individuals to have unescorted access to the security zone and for
ensuring that all other individuals are subject to escorted access.
Act means the Atomic Energy Act of 1954 (68 Stat. 919), including
any amendments thereto.
Aggregated means accessible by the breach of a single physical
barrier that would allow access to radioactive material in any form,
including any devices that contain the radioactive material, when the
total activity equals or exceeds a category 2 quantity of radioactive
material.
Agreement State means any state with which the Atomic Energy
Commission or the U.S. Nuclear Regulatory
[[Page 17008]]
Commission has entered into an effective agreement under subsection
274b. of the Act. Non-agreement State means any other State.
Approved individual means an individual whom the licensee has
determined to be trustworthy and reliable for unescorted access in
accordance with subpart B of this part and who has completed the
training required by Sec. 37.43(c).
Background investigation means the investigation conducted by a
licensee or applicant to support the determination of trustworthiness
and reliability.
Becquerel (Bq) means one disintegration per second.
Byproduct material means--
(1) Any radioactive material (except special nuclear material)
yielded in, or made radioactive by, exposure to the radiation incident
to the process of producing or using special nuclear material;
(2) The tailings or wastes produced by the extraction or
concentration of uranium or thorium from ore processed primarily for
its source material content, including discrete surface wastes
resulting from uranium solution extraction processes. Underground ore
bodies depleted by these solution extraction operations do not
constitute ``byproduct material'' within this definition;
(3)(i) Any discrete source of radium-226 that is produced,
extracted, or converted after extraction, before, on, or after August
8, 2005, for use for a commercial, medical, or research activity; or
(ii) Any material that--
(A) Has been made radioactive by use of a particle accelerator; and
(B) Is produced, extracted, or converted after extraction, before,
on, or after August 8, 2005, for use for a commercial, medical, or
research activity; and
(4) Any discrete source of naturally occurring radioactive
material, other than source material, that--
(i) The Commission, in consultation with the Administrator of the
Environmental Protection Agency, the Secretary of Energy, the Secretary
of Homeland Security, and the head of any other appropriate Federal
agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted
after extraction for use in a commercial, medical, or research
activity.
Carrier means a person engaged in the transportation of passengers
or property by land or water as a common, contract, or private carrier,
or by civil aircraft.
Category 1 quantity of radioactive material means a quantity of
radioactive material meeting or exceeding the category 1 threshold in
Table 1 of Appendix A to this part. This is determined by calculating
the ratio of the total activity of each radionuclide to the category 1
threshold for that radionuclide and adding the ratios together. If the
sum is equal to or exceeds 1, the quantity would be considered a
category 1 quantity. Category 1 quantities of radioactive material do
not include the radioactive material contained in any fuel assembly,
subassembly, fuel rod, or fuel pellet.
Category 2 quantity of radioactive material means a quantity of
radioactive material meeting or exceeding the category 2 threshold but
less than the category 1 threshold in Table 1 of Appendix A to this
part. This is determined by calculating the ratio of the total activity
of each radionuclide to the category 2 threshold for that radionuclide
and adding the ratios together. If the sum is equal to or exceeds 1,
the quantity would be considered a category 2 quantity. Category 2
quantities of radioactive material do not include the radioactive
material contained in any fuel assembly, subassembly, fuel rod, or fuel
pellet.
Commission means the U.S. Nuclear Regulatory Commission or its duly
authorized representatives.
Curie means that amount of radioactive material which disintegrates
at the rate of 37 billion atoms per second.
Diversion means the unauthorized movement of radioactive material
subject to this part to a location different from the material's
authorized destination inside or outside of the site at which the
material is used or stored.
Escorted access means accompaniment while in a security zone by an
approved individual who maintains continuous direct visual surveillance
at all times over an individual who is not approved for unescorted
access.
Fingerprint orders means the orders issued by the U.S. Nuclear
Regulatory Commission or the legally binding requirements issued by
Agreement States that require fingerprints and criminal history records
checks for individuals with unescorted access to category 1 and
category 2 quantities of radioactive material or safeguards
information-modified handling.
Government agency means any executive department, commission,
independent establishment, corporation, wholly or partly owned by the
United States of America which is an instrumentality of the United
States, or any board, bureau, division, service, office, officer,
authority, administration, or other establishment in the executive
branch of the Government.
License, except where otherwise specified, means a license for
byproduct material issued pursuant to the regulations in parts 30
through 36 and 39 of this chapter;
License issuing authority means the licensing agency that issued
the license, i.e. the U.S. Nuclear Regulatory Commission or the
appropriate agency of an Agreement State;
Local law enforcement agency (LLEA) means a public or private
organization that has been approved by a federal, state, or local
government to carry firearms and make arrests, and is authorized and
has the capability to provide an armed response in the jurisdiction
where the licensed category 1 or category 2 quantity of radioactive
material is used, stored, or transported.
Lost or missing licensed material means licensed material whose
location is unknown. It includes material that has been shipped but has
not reached its destination and whose location cannot be readily traced
in the transportation system.
Mobile device means a piece of equipment containing licensed
radioactive material that is either mounted on wheels or casters, or
otherwise equipped for moving without a need for disassembly or
dismounting; or designed to be hand carried. Mobile devices do not
include stationary equipment installed in a fixed location.
Movement control center means an operations center that is remote
from transport activity and that maintains position information on the
movement of radioactive material, receives reports of attempted attacks
or thefts, provides a means for reporting these and other problems to
appropriate agencies and can request and coordinate appropriate aid.
No-later-than arrival time means the date and time that the
shipping licensee and receiving licensee have established as the time
at which an investigation will be initiated if the shipment has not
arrived at the receiving facility. The no-later-than-arrival time may
not be more than 6 hours after the estimated arrival time for shipments
of category 2 quantities of radioactive material.
Person means--
(1) Any individual, corporation, partnership, firm, association,
trust, estate, public or private institution, group, Government agency
other than the Commission or the DOE (except that the Department shall
be considered a
[[Page 17009]]
person within the meaning of the regulations in 10 CFR chapter I to the
extent that its facilities and activities are subject to the licensing
and related regulatory authority of the Commission under section 202 of
the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill
Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear
Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the
Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat.
1842), any State or any political subdivision of or any political
entity within a State, any foreign government or nation or any
political subdivision of any such government or nation, or other
entity; and
(2) Any legal successor, representative, agent, or agency of the
foregoing.
Reviewing official means the individual who shall make the
trustworthiness and reliability determination of an individual to
determine whether the individual may have, or continue to have,
unescorted access to the category 1 or category 2 quantities of
radioactive materials that are possessed by the licensee.
Sabotage means deliberate damage, with malevolent intent, to a
category 1 or category 2 quantity of radioactive material, a device
that contains a category 1 or category 2 quantity of radioactive
material, or the components of the security system.
Safe haven means a readily recognizable and readily accessible site
at which security is present or from which, in the event of an
emergency, the transport crew can notify and wait for the local law
enforcement authorities.
Security zone means any temporary or permanent area determined and
established by the licensee for the physical protection of category 1
or category 2 quantities of radioactive material.
State means a State of the United States, the District of Columbia,
the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American
Samoa, and the Commonwealth of the Northern Mariana Islands.
Telemetric position monitoring system means a data transfer system
that captures information by instrumentation and/or measuring devices
about the location and status of a transport vehicle or package between
the departure and destination locations.
Trustworthiness and reliability are characteristics of an
individual considered dependable in judgment, character, and
performance, such that unescorted access to category 1 or category 2
quantities of radioactive material by that individual does not
constitute an unreasonable risk to the public health and safety or
security. A determination of trustworthiness and reliability for this
purpose is based upon the results from a background investigation.
Unescorted access means solitary access to an aggregated category 1
or category 2 quantity of radioactive material or the devices that
contain the material.
United States, when used in a geographical sense, includes Puerto
Rico and all territories and possessions of the United States.
Sec. 37.7 Communications.
Except where otherwise specified or covered under the regional
licensing program as provided in Sec. 30.6(b) of this chapter, all
communications and reports concerning the regulations in this part may
be sent as follows:
(a) By mail addressed to: ATTN: Document Control Desk; Director,
Office of Nuclear Reactor Regulation; Director, Office of New Reactors;
Director, Office of Nuclear Material Safety and Safeguards; Director,
Office of Federal and State Materials and Environmental Management
Programs; or Director, Division of Security Policy, Office of Nuclear
Security and Incident Response, as appropriate, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001;
(b) By hand delivery to the NRC's offices at 11555 Rockville Pike,
Rockville, Maryland 20852;
(c) Where practicable, by electronic submission, for example,
Electronic Information Exchange, or CD-ROM. Electronic submissions must
be made in a manner that enables the NRC to receive, read,
authenticate, distribute, and archive the submission, and process and
retrieve it a single page at a time. Detailed guidance on making
electronic submissions can be obtained by visiting the NRC's Web site
at https://www.nrc.gov/site-help/e-submittals.html; by email to
nrc.gov">MSHD.Resource@nrc.gov; or by writing the Office of Information
Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001. The guidance discusses, among other topics, the formats the NRC
can accept, the use of electronic signatures, and the treatment of
nonpublic information.
Sec. 37.9 Interpretations.
Except as specifically authorized by the Commission in writing, no
interpretations of the meaning of the regulations in this part by any
officer or employee of the Commission other than a written
interpretation by the General Counsel will be recognized as binding
upon the Commission.
Sec. 37.11 Specific exemptions.
(a) The Commission may, upon application of any interested person
or upon its own initiative, grant such exemptions from the requirements
of the regulations in this part as it determines are authorized by law
and will not endanger life or property or the common defense and
security, and are otherwise in the public interest.
(b) Any licensee's NRC-licensed activities are exempt from the
requirements of subparts B and C of this part to the extent that its
activities are included in a security plan required by part 73 of this
chapter.
(c) A licensee that possesses radioactive waste that contains
category 1 or category 2 quantities of radioactive material is exempt
from the requirements of subparts B, C, and D of this part. Except that
any radioactive waste that contains discrete sources, ion-exchange
resins, or activated material that weighs less than 2,000 kg (4,409
lbs) is not exempt from the requirements of this part. The licensee
shall implement the following requirements to secure the radioactive
waste:
(1) Use continuous physical barriers that allow access to the
radioactive waste only through established access control points;
(2) Use a locked door or gate with monitored alarm at the access
control point;
(3) Assess and respond to each actual or attempted unauthorized
access to determine whether an actual or attempted theft, sabotage, or
diversion occurred; and
(4) Immediately notify the LLEA and request an armed response from
the LLEA upon determination that there was an actual or attempted
theft, sabotage, or diversion of the radioactive waste that contains
category 1 or category 2 quantities of radioactive material.
Sec. 37.13 Information collection requirements: OMB approval.
(a) The U.S. Nuclear Regulatory Commission has submitted the
information collection requirements contained in this part to the
Office of Management and Budget (OMB) for approval as required by the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB has approved the information collection
requirements
[[Page 17010]]
contained in this part under control number 3150-0214.
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 37.11, 37.21, 37.23, 37.25, 37.27,
37.29, 37.31, 37.33, 37.41, 37.43, 37.45, 37.49, 37.51, 37.55, 37.57,
37.71, 37.75, 37.77, 37.79, and 37.81.
Subpart B--Background Investigations and Access Authorization
Program
Sec. 37.21 Personnel access authorization requirements for category 1
or category 2 quantities of radioactive material.
(a) General. (1) Each licensee that possesses an aggregated
quantity of radioactive material at or above the category 2 threshold
shall establish, implement, and maintain its access authorization
program in accordance with the requirements of this subpart.
(2) An applicant for a new license and each licensee that would
become newly subject to the requirements of this subpart upon
application for modification of its license shall implement the
requirements of this subpart, as appropriate, before taking possession
of an aggregated category 1 or category 2 quantity of radioactive
material.
(3) Any licensee that has not previously implemented the Security
Orders or been subject to the provisions of this subpart B shall
implement the provisions of this subpart B before aggregating
radioactive material to a quantity that equals or exceeds the category
2 threshold.
(b) General performance objective. The licensee's access
authorization program must ensure that the individuals specified in
paragraph (c)(1) of this section are trustworthy and reliable.
(c) Applicability. (1) Licensees shall subject the following
individuals to an access authorization program:
(i) Any individual whose assigned duties require unescorted access
to category 1 or category 2 quantities of radioactive material or to
any device that contains the radioactive material; and
(ii) Reviewing officials.
(2) Licensees need not subject the categories of individuals listed
in Sec. 37.29(a)(1) through (13) to the investigation elements of the
access authorization program.
(3) Licensees shall approve for unescorted access to category 1 or
category 2 quantities of radioactive material only those individuals
with job duties that require unescorted access to category 1 or
category 2 quantities of radioactive material.
(4) Licensees may include individuals needing access to safeguards
information-modified handling under part 73 of this chapter in the
access authorization program under this subpart B.
Sec. 37.23 Access authorization program requirements.
(a) Granting unescorted access authorization. (1) Licensees shall
implement the requirements of this subpart for granting initial or
reinstated unescorted access authorization.
(2) Individuals who have been determined to be trustworthy and
reliable shall also complete the security training required by Sec.
37.43(c) before being allowed unescorted access to category 1 or
category 2 quantities of radioactive material.
(b) Reviewing officials. (1) Reviewing officials are the only
individuals who may make trustworthiness and reliability determinations
that allow individuals to have unescorted access to category 1 or
category 2 quantities of radioactive materials possessed by the
licensee.
(2) Each licensee shall name one or more individuals to be
reviewing officials. After completing the background investigation on
the reviewing official, the licensee shall provide under oath or
affirmation, a certification that the reviewing official is deemed
trustworthy and reliable by the licensee. The fingerprints of the named
reviewing official must be taken by a law enforcement agency, Federal
or State agencies that provide fingerprinting services to the public,
or commercial fingerprinting services authorized by a State to take
fingerprints. The licensee shall recertify that the reviewing official
is deemed trustworthy and reliable every 10 years in accordance with
Sec. 37.25(b).
(3) Reviewing officials must be permitted to have unescorted access
to category 1 or category 2 quantities of radioactive materials or
access to safeguards information or safeguards information-modified
handling, if the licensee possesses safeguards information or
safeguards information-modified handling.
(4) Reviewing officials cannot approve other individuals to act as
reviewing officials.
(5) A reviewing official does not need to undergo a new background
investigation before being named by the licensee as the reviewing
official if:
(i) The individual has undergone a background investigation that
included fingerprinting and an FBI criminal history records check and
has been determined to be trustworthy and reliable by the licensee; or
(ii) The individual is subject to a category listed in Sec.
37.29(a).
(c) Informed consent. (1) Licensees may not initiate a background
investigation without the informed and signed consent of the subject
individual. This consent must include authorization to share personal
information with other individuals or organizations as necessary to
complete the background investigation. Before a final adverse
determination, the licensee shall provide the individual with an
opportunity to correct any inaccurate or incomplete information that is
developed during the background investigation. Licensees do not need to
obtain signed consent from those individuals that meet the requirements
of Sec. 37.25(b). A signed consent must be obtained prior to any
reinvestigation.
(2) The subject individual may withdraw his or her consent at any
time. Licensees shall inform the individual that:
(i) If an individual withdraws his or her consent, the licensee may
not initiate any elements of the background investigation that were not
in progress at the time the individual withdrew his or her consent; and
(ii) The withdrawal of consent for the background investigation is
sufficient cause for denial or termination of unescorted access
authorization.
(d) Personal history disclosure. Any individual who is applying for
unescorted access authorization shall disclose the personal history
information that is required by the licensee's access authorization
program for the reviewing official to make a determination of the
individual's trustworthiness and reliability. Refusal to provide, or
the falsification of, any personal history information required by this
subpart is sufficient cause for denial or termination of unescorted
access.
(e) Determination basis. (1) The reviewing official shall determine
whether to permit, deny, unfavorably terminate, maintain, or
administratively withdraw an individual's unescorted access
authorization based on an evaluation of all of the information
collected to meet the requirements of this subpart.
(2) The reviewing official may not permit any individual to have
unescorted access until the reviewing official has evaluated all of the
information collected to meet the requirements of this subpart and
determined that the individual is trustworthy and reliable. The
reviewing official may deny unescorted access to
[[Page 17011]]
any individual based on information obtained at any time during the
background investigation.
(3) The licensee shall document the basis for concluding whether or
not there is reasonable assurance that an individual is trustworthy and
reliable.
(4) The reviewing official may terminate or administratively
withdraw an individual's unescorted access authorization based on
information obtained after the background investigation has been
completed and the individual granted unescorted access authorization.
(5) Licensees shall maintain a list of persons currently approved
for unescorted access authorization. When a licensee determines that a
person no longer requires unescorted access or meets the access
authorization requirement, the licensee shall remove the person from
the approved list as soon as possible, but no later than 7 working
days, and take prompt measures to ensure that the individual is unable
to have unescorted access to the material.
(f) Procedures. Licensees shall develop, implement, and maintain
written procedures for implementing the access authorization program.
The procedures must include provisions for the notification of
individuals who are denied unescorted access. The procedures must
include provisions for the review, at the request of the affected
individual, of a denial or termination of unescorted access
authorization. The procedures must contain a provision to ensure that
the individual is informed of the grounds for the denial or termination
of unescorted access authorization and allow the individual an
opportunity to provide additional relevant information.
(g) Right to correct and complete information. (1) Prior to any
final adverse determination, licensees shall provide each individual
subject to this subpart with the right to complete, correct, and
explain information obtained as a result of the licensee's background
investigation. Confirmation of receipt by the individual of this
notification must be maintained by the licensee for a period of 1 year
from the date of the notification.
(2) If, after reviewing his or her criminal history record, an
individual believes that it is incorrect or incomplete in any respect
and wishes to change, correct, update, or explain anything in the
record, the individual may initiate challenge procedures. These
procedures include direct application by the individual challenging the
record to the law enforcement agency that contributed the questioned
information or a direct challenge as to the accuracy or completeness of
any entry on the criminal history record to the Federal Bureau of
Investigation, Criminal Justice Information Services (CJIS) Division,
ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as
set forth in 28 CFR 16.30 through 16.34. In the latter case, the
Federal Bureau of Investigation (FBI) will forward the challenge to the
agency that submitted the data, and will request that the agency verify
or correct the challenged entry. Upon receipt of an official
communication directly from the agency that contributed the original
information, the FBI Identification Division makes any changes
necessary in accordance with the information supplied by that agency.
Licensees must provide at least 10 days for an individual to initiate
action to challenge the results of an FBI criminal history records
check after the record being made available for his or her review. The
licensee may make a final adverse determination based upon the criminal
history records only after receipt of the FBI's confirmation or
correction of the record.
(h) Records. (1) The licensee shall retain documentation regarding
the trustworthiness and reliability of individual employees for 3 years
from the date the individual no longer requires unescorted access to
category 1 or category 2 quantities of radioactive material.
(2) The licensee shall retain a copy of the current access
authorization program procedures as a record for 3 years after the
procedure is no longer needed. If any portion of the procedure is
superseded, the licensee shall retain the superseded material for 3
years after the record is superseded.
(3) The licensee shall retain the list of persons approved for
unescorted access authorization for 3 years after the list is
superseded or replaced.
Sec. 37.25 Background investigations.
(a) Initial investigation. Before allowing an individual unescorted
access to category 1 or category 2 quantities of radioactive material
or to the devices that contain the material, licensees shall complete a
background investigation of the individual seeking unescorted access
authorization. The scope of the investigation must encompass at least
the 7 years preceding the date of the background investigation or since
the individual's eighteenth birthday, whichever is shorter. The
background investigation must include at a minimum:
(1) Fingerprinting and an FBI identification and criminal history
records check in accordance with Sec. 37.27;
(2) Verification of true identity. Licensees shall verify the true
identity of the individual who is applying for unescorted access
authorization to ensure that the applicant is who he or she claims to
be. A licensee shall review official identification documents (e.g.,
driver's license; passport; government identification; certificate of
birth issued by the state, province, or country of birth) and compare
the documents to personal information data provided by the individual
to identify any discrepancy in the information. Licensees shall
document the type, expiration, and identification number of the
identification document, or maintain a photocopy of identifying
documents on file in accordance with Sec. 37.31. Licensees shall
certify in writing that the identification was properly reviewed, and
shall maintain the certification and all related documents for review
upon inspection;
(3) Employment history verification. Licensees shall complete an
employment history verification, including military history. Licensees
shall verify the individual's employment with each previous employer
for the most recent 7 years before the date of application;
(4) Verification of education. Licensees shall verify that the
individual participated in the education process during the claimed
period;
(5) Character and reputation determination. Licensees shall
complete reference checks to determine the character and reputation of
the individual who has applied for unescorted access authorization.
Unless other references are not available, reference checks may not be
conducted with any person who is known to be a close member of the
individual's family, including but not limited to the individual's
spouse, parents, siblings, or children, or any individual who resides
in the individual's permanent household. Reference checks under this
subpart must be limited to whether the individual has been and
continues to be trustworthy and reliable;
(6) The licensee shall also, to the extent possible, obtain
independent information to corroborate that provided by the individual
(e.g., seek references not supplied by the individual); and
(7) If a previous employer, educational institution, or any other
entity with which the individual claims to have been engaged fails to
provide information or indicates an inability or unwillingness to
provide information
[[Page 17012]]
within a time frame deemed appropriate by the licensee but at least
after 10 business days of the request or if the licensee is unable to
reach the entity, the licensee shall document the refusal,
unwillingness, or inability in the record of investigation; and attempt
to obtain the information from an alternate source.
(b) Grandfathering. (1) Individuals who have been determined to be
trustworthy and reliable for unescorted access to category 1 or
category 2 quantities of radioactive material under the Fingerprint
Orders may continue to have unescorted access to category 1 and
category 2 quantities of radioactive material without further
investigation. These individuals shall be subject to the
reinvestigation requirement.
(2) Individuals who have been determined to be trustworthy and
reliable under the provisions of part 73 of this chapter or the
security orders for access to safeguards information, safeguards
information-modified handling, or risk-significant material may have
unescorted access to category 1 and category 2 quantities of
radioactive material without further investigation. The licensee shall
document that the individual was determined to be trustworthy and
reliable under the provisions of part 73 of this chapter or a security
order. Security order, in this context, refers to any order that was
issued by the NRC that required fingerprints and an FBI criminal
history records check for access to safeguards information, safeguards
information-modified handling, or risk significant material such as
special nuclear material or large quantities of uranium hexafluoride.
These individuals shall be subject to the reinvestigation requirement.
(c) Reinvestigations. Licensees shall conduct a reinvestigation
every 10 years for any individual with unescorted access to category 1
or category 2 quantities of radioactive material. The reinvestigation
shall consist of fingerprinting and an FBI identification and criminal
history records check in accordance with Sec. 37.27. The
reinvestigations must be completed within 10 years of the date on which
these elements were last completed.
Sec. 37.27 Requirements for criminal history records checks of
individuals granted unescorted access to category 1 or category 2
quantities of radioactive material.
(a) General performance objective and requirements. (1) Except for
those individuals listed in Sec. 37.29 and those individuals
grandfathered under Sec. 37.25(b), each licensee subject to the
provisions of this subpart shall fingerprint each individual who is to
be permitted unescorted access to category 1 or category 2 quantities
of radioactive material. Licensees shall transmit all collected
fingerprints to the Commission for transmission to the FBI. The
licensee shall use the information received from the FBI as part of the
required background investigation to determine whether to grant or deny
further unescorted access to category 1 or category 2 quantities of
radioactive materials for that individual.
(2) The licensee shall notify each affected individual that his or
her fingerprints will be used to secure a review of his or her criminal
history record, and shall inform him or her of the procedures for
revising the record or adding explanations to the record.
(3) Fingerprinting is not required if a licensee is reinstating an
individual's unescorted access authorization to category 1 or category
2 quantities of radioactive materials if:
(i) The individual returns to the same facility that granted
unescorted access authorization within 365 days of the termination of
his or her unescorted access authorization; and
(ii) The previous access was terminated under favorable conditions.
(4) Fingerprints do not need to be taken if an individual who is an
employee of a licensee, contractor, manufacturer, or supplier has been
granted unescorted access to category 1 or category 2 quantities of
radioactive material, access to safeguards information, or safeguards
information-modified handling by another licensee, based upon a
background investigation conducted under this subpart, the Fingerprint
Orders, or part 73 of this chapter. An existing criminal history
records check file may be transferred to the licensee asked to grant
unescorted access in accordance with the provisions of Sec. 37.31(c).
(5) Licensees shall use the information obtained as part of a
criminal history records check solely for the purpose of determining an
individual's suitability for unescorted access authorization to
category 1 or category 2 quantities of radioactive materials, access to
safeguards information, or safeguards information-modified handling.
(b) Prohibitions. (1) Licensees may not base a final determination
to deny an individual unescorted access authorization to category 1 or
category 2 quantities of radioactive material solely on the basis of
information received from the FBI involving:
(i) An arrest more than 1 year old for which there is no
information of the disposition of the case; or
(ii) An arrest that resulted in dismissal of the charge or an
acquittal.
(2) Licensees may not use information received from a criminal
history records check obtained under this subpart in a manner that
would infringe upon the rights of any individual under the First
Amendment to the Constitution of the United States, nor shall licensees
use the information in any way that would discriminate among
individuals on the basis of race, religion, national origin, gender, or
age.
(c) Procedures for processing of fingerprint checks. (1) For the
purpose of complying with this subpart, licensees shall use an
appropriate method listed in Sec. 37.7 to submit to the U.S. Nuclear
Regulatory Commission, Director, Division of Facilities and Security,
11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop TWB-05
B32M, Rockville, Maryland 20852, one completed, legible standard
fingerprint card (Form FD-258, ORIMDNRCOOOZ), electronic fingerprint
scan or, where practicable, other fingerprint record for each
individual requiring unescorted access to category 1 or category 2
quantities of radioactive material. Copies of these forms may be
obtained by writing the Office of Information Services, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, by calling 1-630-829-
9565, or by email to nrc.gov">FORMS.Resource@nrc.gov. Guidance on submitting
electronic fingerprints can be found at https://www.nrc.gov/site-help/e-submittals.html.
(2) Fees for the processing of fingerprint checks are due upon
application. Licensees shall submit payment with the application for
the processing of fingerprints through corporate check, certified
check, cashier's check, money order, or electronic payment, made
payable to ``U.S. NRC.'' (For guidance on making electronic payments,
contact the Security Branch, Division of Facilities and Security at
301-492-3531.) Combined payment for multiple applications is
acceptable. The Commission publishes the amount of the fingerprint
check application fee on the NRC's public Web site. (To find the
current fee amount, go to the Electronic Submittals page at https://www.nrc.gov/site-help/e-submittals.html and see the link for the
Criminal History Program under Electronic Submission Systems.)
(3) The Commission will forward to the submitting licensee all data
received from the FBI as a result of the licensee's
[[Page 17013]]
application(s) for criminal history records checks.
Sec. 37.29 Relief from fingerprinting, identification, and criminal
history records checks and other elements of background investigations
for designated categories of individuals permitted unescorted access to
certain radioactive materials.
(a) Fingerprinting, and the identification and criminal history
records checks required by section 149 of the Atomic Energy Act of
1954, as amended, and other elements of the background investigation
are not required for the following individuals prior to granting
unescorted access to category 1 or category 2 quantities of radioactive
materials:
(1) An employee of the Commission or of the Executive Branch of the
U.S. Government who has undergone fingerprinting for a prior U.S.
Government criminal history records check;
(2) A Member of Congress;
(3) An employee of a member of Congress or Congressional committee
who has undergone fingerprinting for a prior U.S. Government criminal
history records check;
(4) The Governor of a State or his or her designated State employee
representative;
(5) Federal, State, or local law enforcement personnel;
(6) State Radiation Control Program Directors and State Homeland
Security Advisors or their designated State employee representatives;
(7) Agreement State employees conducting security inspections on
behalf of the NRC under an agreement executed under section 274.i. of
the Atomic Energy Act;
(8) Representatives of the International Atomic Energy Agency
(IAEA) engaged in activities associated with the U.S./IAEA Safeguards
Agreement who have been certified by the NRC;
(9) Emergency response personnel who are responding to an
emergency;
(10) Commercial vehicle drivers for road shipments of category 2
quantities of radioactive material;
(11) Package handlers at transportation facilities such as freight
terminals and railroad yards;
(12) Any individual who has an active Federal security clearance,
provided that he or she makes available the appropriate documentation.
Written confirmation from the agency/employer that granted the Federal
security clearance or reviewed the criminal history records check must
be provided to the licensee. The licensee shall retain this
documentation for a period of 3 years from the date the individual no
longer requires unescorted access to category 1 or category 2
quantities of radioactive material; and
(13) Any individual employed by a service provider licensee for
which the service provider licensee has conducted the background
investigation for the individual and approved the individual for
unescorted access to category 1 or category 2 quantities of radioactive
material. Written verification from the service provider must be
provided to the licensee. The licensee shall retain the documentation
for a period of 3 years from the date the individual no longer requires
unescorted access to category 1 or category 2 quantities of radioactive
material.
(b) Fingerprinting, and the identification and criminal history
records checks required by section 149 of the Atomic Energy Act of
1954, as amended, are not required for an individual who has had a
favorably adjudicated U.S. Government criminal history records check
within the last 5 years, under a comparable U.S. Government program
involving fingerprinting and an FBI identification and criminal history
records check provided that he or she makes available the appropriate
documentation. Written confirmation from the agency/employer that
reviewed the criminal history records check must be provided to the
licensee. The licensee shall retain this documentation for a period of
3 years from the date the individual no longer requires unescorted
access to category 1 or category 2 quantities of radioactive material.
These programs include, but are not limited to:
(1) National Agency Check;
(2) Transportation Worker Identification Credentials (TWIC) under
49 CFR part 1572;
(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background
check and clearances under 27 CFR part 555;
(4) Health and Human Services security risk assessments for
possession and use of select agents and toxins under 42 CFR part 73;
(5) Hazardous Material security threat assessment for hazardous
material endorsement to commercial drivers license under 49 CFR part
1572; and
(6) Customs and Border Protection's Free and Secure Trade (FAST)
Program.
Sec. 37.31 Protection of information.
(a) Each licensee who obtains background information on an
individual under this subpart shall establish and maintain a system of
files and written procedures for protection of the record and the
personal information from unauthorized disclosure.
(b) The licensee may not disclose the record or personal
information collected and maintained to persons other than the subject
individual, his or her representative, or to those who have a need to
have access to the information in performing assigned duties in the
process of granting or denying unescorted access to category 1 or
category 2 quantities of radioactive material, safeguards information,
or safeguards information-modified handling. No individual authorized
to have access to the information may disseminate the information to
any other individual who does not have a need to know.
(c) The personal information obtained on an individual from a
background investigation may be provided to another licensee:
(1) Upon the individual's written request to the licensee holding
the data to disseminate the information contained in his or her file;
and
(2) The recipient licensee verifies information such as name, date
of birth, social security number, gender, and other applicable physical
characteristics.
(d) The licensee shall make background investigation records
obtained under this subpart available for examination by an authorized
representative of the NRC to determine compliance with the regulations
and laws.
(e) The licensee shall retain all fingerprint and criminal history
records (including data indicating no record) received from the FBI, or
a copy of these records if the individual's file has been transferred,
on an individual for 3 years from the date the individual no longer
requires unescorted access to category 1 or category 2 quantities of
radioactive material.
Sec. 37.33 Access authorization program review.
(a) Each licensee shall be responsible for the continuing
effectiveness of the access authorization program. Each licensee shall
ensure that access authorization programs are reviewed to confirm
compliance with the requirements of this subpart and that comprehensive
actions are taken to correct any noncompliance that is identified. The
review program shall evaluate all program performance objectives and
requirements. Each licensee shall periodically (at least annually)
review the access program content and implementation.
(b) The results of the reviews, along with any recommendations,
must be
[[Page 17014]]
documented. Each review report must identify conditions that are
adverse to the proper performance of the access authorization program,
the cause of the condition(s), and, when appropriate, recommend
corrective actions, and corrective actions taken. The licensee shall
review the findings and take any additional corrective actions
necessary to preclude repetition of the condition, including
reassessment of the deficient areas where indicated.
(c) Review records must be maintained for 3 years.
Subpart C--Physical Protection Requirements During Use
Sec. 37.41 Security program.
(a) Applicability. (1) Each licensee that possesses an aggregated
category 1 or category 2 quantity of radioactive material shall
establish, implement, and maintain a security program in accordance
with the requirements of this subpart.
(2) An applicant for a new license and each licensee that would
become newly subject to the requirements of this subpart upon
application for modification of its license shall implement the
requirements of this subpart, as appropriate, before taking possession
of an aggregated category 1 or category 2 quantity of radioactive
material.
(3) Any licensee that has not previously implemented the Security
Orders or been subject to the provisions of subpart C shall provide
written notification to the NRC regional office specified in Sec. 30.6
of this chapter at least 90 days before aggregating radioactive
material to a quantity that equals or exceeds the category 2 threshold.
(b) General performance objective. Each licensee shall establish,
implement, and maintain a security program that is designed to monitor
and, without delay, detect, assess, and respond to an actual or
attempted unauthorized access to category 1 or category 2 quantities of
radioactive material.
(c) Program features. Each licensee's security program must include
the program features, as appropriate, described in Sec. Sec. 37.43,
37.45, 37.47, 37.49, 37.51, 37.53, and 37.55.
Sec. 37.43 General security program requirements.
(a) Security plan. (1) Each licensee identified in Sec. 37.41(a)
shall develop a written security plan specific to its facilities and
operations. The purpose of the security plan is to establish the
licensee's overall security strategy to ensure the integrated and
effective functioning of the security program required by this subpart.
The security plan must, at a minimum:
(i) Describe the measures and strategies used to implement the
requirements of this subpart; and
(ii) Identify the security resources, equipment, and technology
used to satisfy the requirements of this subpart.
(2) The security plan must be reviewed and approved by the
individual with overall responsibility for the security program.
(3) A licensee shall revise its security plan as necessary to
ensure the effective implementation of Commission requirements. The
licensee shall ensure that:
(i) The revision has been reviewed and approved by the individual
with overall responsibility for the security program; and
(ii) The affected individuals are instructed on the revised plan
before the changes are implemented.
(4) The licensee shall retain a copy of the current security plan
as a record for 3 years after the security plan is no longer required.
If any portion of the plan is superseded, the licensee shall retain the
superseded material for 3 years after the record is superseded.
(b) Implementing procedures. (1) The licensee shall develop and
maintain written procedures that document how the requirements of this
subpart and the security plan will be met.
(2) The implementing procedures and revisions to these procedures
must be approved in writing by the individual with overall
responsibility for the security program.
(3) The licensee shall retain a copy of the current procedure as a
record for 3 years after the procedure is no longer needed. Superseded
portions of the procedure must be retained for 3 years after the record
is superseded.
(c) Training. (1) Each licensee shall conduct training to ensure
that those individuals implementing the security program possess and
maintain the knowledge, skills, and abilities to carry out their
assigned duties and responsibilities effectively. The training must
include instruction in:
(i) The licensee's security program and procedures to secure
category 1 or category 2 quantities of radioactive material, and in the
purposes and functions of the security measures employed;
(ii) The responsibility to report promptly to the licensee any
condition that causes or may cause a violation of Commission
requirements;
(iii) The responsibility of the licensee to report promptly to the
local law enforcement agency and licensee any actual or attempted
theft, sabotage, or diversion of category 1 or category 2 quantities of
radioactive material; and
(iv) The appropriate response to security alarms.
(2) In determining those individuals who shall be trained on the
security program, the licensee shall consider each individual's
assigned activities during authorized use and response to potential
situations involving actual or attempted theft, diversion, or sabotage
of category 1 or category 2 quantities of radioactive material. The
extent of the training must be commensurate with the individual's
potential involvement in the security of category 1 or category 2
quantities of radioactive material.
(3) Refresher training must be provided at a frequency not to
exceed 12 months and when significant changes have been made to the
security program. This training must include:
(i) Review of the training requirements of paragraph (c) of this
section and any changes made to the security program since the last
training;
(ii) Reports on any relevant security issues, problems, and lessons
learned;
(iii) Relevant results of NRC inspections; and
(iv) Relevant results of the licensee's program review and testing
and maintenance.
(4) The licensee shall maintain records of the initial and
refresher training for 3 years from the date of the training. The
training records must include dates of the training, topics covered, a
list of licensee personnel in attendance, and related information.
(d) Protection of information. (1) Except as provided in paragraph
(d)(9) of this section, licensees authorized to possess category 1 or
category 2 quantities of radioactive material shall limit access to and
unauthorized disclosure of their security plan, implementing
procedures, and the list of individuals that have been approved for
unescorted access.
(2) Efforts to limit access shall include the development,
implementation, and maintenance of written policies and procedures for
controlling access to, and for proper handling and protection against
unauthorized disclosure of, the security plan and implementing
procedures.
(3) Before granting an individual access to the security plan or
implementing procedures, licensees shall:
(i) Evaluate an individual's need to know the security plan or
implementing procedures; and
(ii) If the individual has not been authorized for unescorted
access to
[[Page 17015]]
category 1 or category 2 quantities of radioactive material, safeguards
information, or safeguards information-modified handling, the licensee
must complete a background investigation to determine the individual's
trustworthiness and reliability. A trustworthiness and reliability
determination shall be conducted by the reviewing official and shall
include the background investigation elements contained in Sec.
37.25(a)(2) through (a)(7).
(4) Licensees need not subject the following individuals to the
background investigation elements for protection of information:
(i) The categories of individuals listed in Sec. 37.29(a)(1)
through (13); or
(ii) Security service provider employees, provided written
verification that the employee has been determined to be trustworthy
and reliable, by the required background investigation in Sec.
37.25(a)(2) through (a)(7), has been provided by the security service
provider.
(5) The licensee shall document the basis for concluding that an
individual is trustworthy and reliable and should be granted access to
the security plan or implementing procedures.
(6) Licensees shall maintain a list of persons currently approved
for access to the security plan or implementing procedures. When a
licensee determines that a person no longer needs access to the
security plan or implementing procedures or no longer meets the access
authorization requirements for access to the information, the licensee
shall remove the person from the approved list as soon as possible, but
no later than 7 working days, and take prompt measures to ensure that
the individual is unable to obtain the security plan or implementing
procedures.
(7) When not in use, the licensee shall store its security plan and
implementing procedures in a manner to prevent unauthorized access.
Information stored in nonremovable electronic form must be password
protected.
(8) The licensee shall retain as a record for 3 years after the
document is no longer needed:
(i) A copy of the information protection procedures; and
(ii) The list of individuals approved for access to the security
plan or implementing procedures.
(9) Licensees that possess safeguards information or safeguards
information-modified handling are subject to the requirements of Sec.
73.21 of this chapter, and shall protect any safeguards information or
safeguards information-modified handling in accordance with the
requirements of that section.
Sec. 37.45 LLEA coordination.
(a) A licensee subject to this subpart shall coordinate, to the
extent practicable, with an LLEA for responding to threats to the
licensee's facility, including any necessary armed response. The
information provided to the LLEA must include:
(1) A description of the facilities and the category 1 and category
2 quantities of radioactive materials along with a description of the
licensee's security measures that have been implemented to comply with
this subpart; and
(2) A notification that the licensee will request a timely armed
response by the LLEA to any actual or attempted theft, sabotage, or
diversion of category 1 or category 2 quantities of material.
(b) The licensee shall notify the appropriate NRC regional office
listed in Sec. 30.6(a)(2) of this chapter within 3 business days if:
(1) The LLEA has not responded to the request for coordination
within 60 days of the coordination request; or
(2) The LLEA notifies the licensee that the LLEA does not plan to
participate in coordination activities.
(c) The licensee shall document its efforts to coordinate with the
LLEA. The documentation must be kept for 3 years.
(d) The licensee shall coordinate with the LLEA at least every 12
months, or when changes to the facility design or operation adversely
affect the potential vulnerability of the licensee's material to theft,
sabotage, or diversion.
Sec. 37.47 Security zones.
(a) Licensees shall ensure that all aggregated category 1 and
category 2 quantities of radioactive material are used or stored within
licensee-established security zones. Security zones may be permanent or
temporary.
(b) Temporary security zones must be established as necessary to
meet the licensee's transitory or intermittent business activities,
such as periods of maintenance, source delivery, and source
replacement.
(c) Security zones must, at a minimum, allow unescorted access only
to approved individuals through:
(1) Isolation of category 1 and category 2 quantities of
radioactive materials by the use of continuous physical barriers that
allow access to the security zone only through established access
control points. A physical barrier is a natural or man-made structure
or formation sufficient for the isolation of the category 1 or category
2 quantities of radioactive material within a security zone; or
(2) Direct control of the security zone by approved individuals at
all times; or
(3) A combination of continuous physical barriers and direct
control.
(d) For category 1 quantities of radioactive material during
periods of maintenance, source receipt, preparation for shipment,
installation, or source removal or exchange, the licensee shall, at a
minimum, provide sufficient individuals approved for unescorted access
to maintain continuous surveillance of sources in temporary security
zones and in any security zone in which physical barriers or intrusion
detection systems have been disabled to allow such activities.
(e) Individuals not approved for unescorted access to category 1 or
category 2 quantities of radioactive material must be escorted by an
approved individual when in a security zone.
Sec. 37.49 Monitoring, detection, and assessment.
(a) Monitoring and detection. (1) Licensees shall establish and
maintain the capability to continuously monitor and detect without
delay all unauthorized entries into its security zones. Licensees shall
provide the means to maintain continuous monitoring and detection
capability in the event of a loss of the primary power source, or
provide for an alarm and response in the event of a loss of this
capability to continuously monitor and detect unauthorized entries.
(2) Monitoring and detection must be performed by:
(i) A monitored intrusion detection system that is linked to an
onsite or offsite central monitoring facility; or
(ii) Electronic devices for intrusion detection alarms that will
alert nearby facility personnel; or
(iii) A monitored video surveillance system; or
(iv) Direct visual surveillance by approved individuals located
within the security zone; or
(v) Direct visual surveillance by a licensee designated individual
located outside the security zone.
(3) A licensee subject to this subpart shall also have a means to
detect unauthorized removal of the radioactive material from the
security zone. This detection capability must provide:
(i) For category 1 quantities of radioactive material, immediate
detection of any attempted unauthorized removal of the radioactive
material from the security zone. Such immediate detection capability
must be provided by:
(A) Electronic sensors linked to an alarm; or
(B) Continuous monitored video surveillance; or
[[Page 17016]]
(C) Direct visual surveillance.
(ii) For category 2 quantities of radioactive material, weekly
verification through physical checks, tamper indicating devices, use,
or other means to ensure that the radioactive material is present.
(b) Assessment. Licensees shall immediately assess each actual or
attempted unauthorized entry into the security zone to determine
whether the unauthorized access was an actual or attempted theft,
sabotage, or diversion.
(c) Personnel communications and data transmission. For personnel
and automated or electronic systems supporting the licensee's
monitoring, detection, and assessment systems, licensees shall:
(1) Maintain continuous capability for personnel communication and
electronic data transmission and processing among site security
systems; and
(2) Provide an alternative communication capability for personnel,
and an alternative data transmission and processing capability, in the
event of a loss of the primary means of communication or data
transmission and processing. Alternative communications and data
transmission systems may not be subject to the same failure modes as
the primary systems.
(d) Response. Licensees shall immediately respond to any actual or
attempted unauthorized access to the security zones, or actual or
attempted theft, sabotage, or diversion of category 1 or category 2
quantities of radioactive material at licensee facilities or temporary
job sites. For any unauthorized access involving an actual or attempted
theft, sabotage, or diversion of category 1 or category 2 quantities of
radioactive material, the licensee's response shall include requesting,
without delay, an armed response from the LLEA.
Sec. 37.51 Maintenance and testing.
(a) Each licensee subject to this subpart shall implement a
maintenance and testing program to ensure that intrusion alarms,
associated communication systems, and other physical components of the
systems used to secure or detect unauthorized access to radioactive
material are maintained in operable condition and are capable of
performing their intended function when needed. The equipment relied on
to meet the security requirements of this part must be inspected and
tested for operability and performance at the manufacturer's suggested
frequency. If there is no suggested manufacturer's suggested frequency,
the testing must be performed at least annually, not to exceed 12
months.
(b) The licensee shall maintain records on the maintenance and
testing activities for 3 years.
Sec. 37.53 Requirements for mobile devices.
Each licensee that possesses mobile devices containing category 1
or category 2 quantities of radioactive material must:
(a) Have two independent physical controls that form tangible
barriers to secure the material from unauthorized removal when the
device is not under direct control and constant surveillance by the
licensee; and
(b) For devices in or on a vehicle or trailer, unless the health
and safety requirements for a site prohibit the disabling of the
vehicle, the licensee shall utilize a method to disable the vehicle or
trailer when not under direct control and constant surveillance by the
licensee. Licensees shall not rely on the removal of an ignition key to
meet this requirement.
Sec. 37.55 Security program review.
(a) Each licensee shall be responsible for the continuing
effectiveness of the security program. Each licensee shall ensure that
the security program is reviewed to confirm compliance with the
requirements of this subpart and that comprehensive actions are taken
to correct any noncompliance that is identified. The review must
include the radioactive material security program content and
implementation. Each licensee shall periodically (at least annually)
review the security program content and implementation.
(b) The results of the review, along with any recommendations, must
be documented. Each review report must identify conditions that are
adverse to the proper performance of the security program, the cause of
the condition(s), and, when appropriate, recommend corrective actions,
and corrective actions taken. The licensee shall review the findings
and take any additional corrective actions necessary to preclude
repetition of the condition, including reassessment of the deficient
areas where indicated.
(c) The licensee shall maintain the review documentation for 3
years.
Sec. 37.57 Reporting of events.
(a) The licensee shall immediately notify the LLEA after
determining that an unauthorized entry resulted in an actual or
attempted theft, sabotage, or diversion of a category 1 or category 2
quantity of radioactive material. As soon as possible after initiating
a response, but not at the expense of causing delay or interfering with
the LLEA response to the event, the licensee shall notify the NRC's
Operations Center (301-816-5100). In no case shall the notification to
the NRC be later than 4 hours after the discovery of any attempted or
actual theft, sabotage, or diversion.
(b) The licensee shall assess any suspicious activity related to
possible theft, sabotage, or diversion of category 1 or category 2
quantities of radioactive material and notify the LLEA as appropriate.
As soon as possible but not later than 4 hours after notifying the
LLEA, the licensee shall notify the NRC's Operations Center (301-816-
5100).
(c) The initial telephonic notification required by paragraph (a)
of this section must be followed within a period of 30 days by a
written report submitted to the NRC by an appropriate method listed in
Sec. 37.7. The report must include sufficient information for NRC
analysis and evaluation, including identification of any necessary
corrective actions to prevent future instances.
Subpart D--Physical Protection in Transit
Sec. 37.71 Additional requirements for transfer of category 1 and
category 2 quantities of radioactive material.
A licensee transferring a category 1 or category 2 quantity of
radioactive material to a licensee of the Commission or an Agreement
State shall meet the license verification provisions listed below
instead of those listed in Sec. 30.41(d) of this chapter:
(a) Any licensee transferring category 1 quantities of radioactive
material to a licensee of the Commission or an Agreement State, prior
to conducting such transfer, shall verify with the NRC's license
verification system or the license issuing authority that the
transferee's license authorizes the receipt of the type, form, and
quantity of radioactive material to be transferred and that the
licensee is authorized to receive radioactive material at the location
requested for delivery. If the verification is conducted by contacting
the license issuing authority, the transferor shall document the
verification. For transfers within the same organization, the licensee
does not need to verify the transfer.
(b) Any licensee transferring category 2 quantities of radioactive
material to a licensee of the Commission or an Agreement State, prior
to conducting such transfer, shall verify with the NRC's license
verification system or the license issuing authority that the
transferee's license authorizes the
[[Page 17017]]
receipt of the type, form, and quantity of radioactive material to be
transferred. If the verification is conducted by contacting the license
issuing authority, the transferor shall document the verification. For
transfers within the same organization, the licensee does not need to
verify the transfer.
(c) In an emergency where the licensee cannot reach the license
issuing authority and the license verification system is nonfunctional,
the licensee may accept a written certification by the transferee that
it is authorized by license to receive the type, form, and quantity of
radioactive material to be transferred. The certification must include
the license number, current revision number, issuing agency, expiration
date, and for a category 1 shipment the authorized address. The
licensee shall keep a copy of the certification. The certification must
be confirmed by use of the NRC's license verification system or by
contacting the license issuing authority by the end of the next
business day.
(d) The transferor shall keep a copy of the verification
documentation as a record for 3 years.
Sec. 37.73 Applicability of physical protection of category 1 and
category 2 quantities of radioactive material during transit.
(a) For shipments of category 1 quantities of radioactive material,
each shipping licensee shall comply with the requirements for physical
protection contained in Sec. Sec. 37.75(a) and (e); 37.77;
37.79(a)(1), (b)(1), and (c); and 37.81(a), (c), (e), (g) and (h).
(b) For shipments of category 2 quantities of radioactive material,
each shipping licensee shall comply with the requirements for physical
protection contained in Sec. Sec. 37.75(b) through (e); 37.79(a)(2),
(a)(3), (b)(2), and (c); and 37.81(b), (d), (f), (g), and (h). For
those shipments of category 2 quantities of radioactive material that
meet the criteria of Sec. 71.97(b) of this chapter, the shipping
licensee shall also comply with the advance notification provisions of
Sec. 71.97 of this chapter.
(c) The shipping licensee shall be responsible for meeting the
requirements of this subpart unless the receiving licensee has agreed
in writing to arrange for the in-transit physical protection required
under this subpart.
(d) Each licensee that imports or exports category 1 quantities of
radioactive material shall comply with the requirements for physical
protection during transit contained in Sec. Sec. 37.75(a)(2) and (e);
37.77; 37.79(a)(1), (b)(1), and (c); and 37.81(a), (c), (e), (g), and
(h) for the domestic portion of the shipment.
(e) Each licensee that imports or exports category 2 quantities of
radioactive material shall comply with the requirements for physical
protection during transit contained in Sec. Sec. 37.79(a)(2), (a)(3),
and (b)(2); and 37.81(b), (d), (f), (g), and (h) for the domestic
portion of the shipment.
Sec. 37.75 Preplanning and coordination of shipment of category 1 or
category 2 quantities of radioactive material.
(a) Each licensee that plans to transport, or deliver to a carrier
for transport, licensed material that is a category 1 quantity of
radioactive material outside the confines of the licensee's facility or
other place of use or storage shall:
(1) Preplan and coordinate shipment arrival and departure times
with the receiving licensee;
(2) Preplan and coordinate shipment information with the governor
or the governor's designee of any State through which the shipment will
pass to:
(i) Discuss the State's intention to provide law enforcement
escorts; and
(ii) Identify safe havens; and
(3) Document the preplanning and coordination activities.
(b) Each licensee that plans to transport, or deliver to a carrier
for transport, licensed material that is a category 2 quantity of
radioactive material outside the confines of the licensee's facility or
other place of use or storage shall coordinate the shipment no-later-
than arrival time and the expected shipment arrival with the receiving
licensee. The licensee shall document the coordination activities.
(c) Each licensee who receives a shipment of a category 2 quantity
of radioactive material shall confirm receipt of the shipment with the
originator. If the shipment has not arrived by the no-later-than
arrival time, the receiving licensee shall notify the originator.
(d) Each licensee, who transports or plans to transport a shipment
of a category 2 quantity of radioactive material, and determines that
the shipment will arrive after the no-later-than arrival time provided
pursuant to paragraph (b) of this section, shall promptly notify the
receiving licensee of the new no-later-than arrival time.
(e) The licensee shall retain a copy of the documentation for
preplanning and coordination and any revision thereof, as a record for
3 years.
Sec. 37.77 Advance notification of shipment of category 1 quantities
of radioactive material.
As specified in paragraphs (a) and (b) of this section, each
licensee shall provide advance notification to the NRC and the governor
of a State, or the governor's designee, of the shipment of licensed
material in a category 1 quantity, through or across the boundary of
the State, before the transport, or delivery to a carrier for transport
of the licensed material outside the confines of the licensee's
facility or other place of use or storage.
(a) Procedures for submitting advance notification. (1) The
notification must be made to the NRC and to the office of each
appropriate governor or governor's designee. The contact information,
including telephone and mailing addresses, of governors and governors'
designees, is available on the NRC's Web site at https://nrc-stp.ornl.gov/special/designee.pdf. A list of the contact information is
also available upon request from the Director, Division of
Intergovernmental Liaison and Rulemaking, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001. Notifications to the
NRC must be to the NRC's Director, Division of Security Policy, Office
of Nuclear Security and Incident Response, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001. The notification to the NRC may
be made by email to RAMQC_SHIPMENTS@nrc.gov or by fax to
301-816-5151.
(2) A notification delivered by mail must be postmarked at least 7
days before transport of the shipment commences at the shipping
facility.
(3) A notification delivered by any means other than mail must
reach NRC at least 4 days before the transport of the shipment
commences and must reach the office of the governor or the governor's
designee at least 4 days before transport of a shipment within or
through the State.
(b) Information to be furnished in advance notification of
shipment. Each advance notification of shipment of category 1
quantities of radioactive material must contain the following
information, if available at the time of notification:
(1) The name, address, and telephone number of the shipper,
carrier, and receiver of the category 1 radioactive material;
(2) The license numbers of the shipper and receiver;
(3) A description of the radioactive material contained in the
shipment, including the radionuclides and quantity;
(4) The point of origin of the shipment and the estimated time and
date that shipment will commence;
[[Page 17018]]
(5) The estimated time and date that the shipment is expected to
enter each State along the route;
(6) The estimated time and date of arrival of the shipment at the
destination; and
(7) A point of contact, with a telephone number, for current
shipment information.
(c) Revision notice. (1) The licensee shall provide any information
not previously available at the time of the initial notification, as
soon as the information becomes available but not later than
commencement of the shipment, to the governor of the State or the
governor's designee and to the NRC's Director of Nuclear Security,
Office of Nuclear Security and Incident Response, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001.
(2) A licensee shall promptly notify the governor of the State or
the governor's designee of any changes to the information provided in
accordance with paragraphs (b) and (c)(1) of this section. The licensee
shall also immediately notify the NRC's Director, Division of Security
Policy, Office of Nuclear Security and Incident Response, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001 of any such changes.
(d) Cancellation notice. Each licensee who cancels a shipment for
which advance notification has been sent shall send a cancellation
notice to the governor of each State or to the governor's designee
previously notified and to the NRC's Director, Division of Security
Policy, Office of Nuclear Security and Incident Response, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001. The licensee shall
send the cancellation notice before the shipment would have commenced
or as soon thereafter as possible. The licensee shall state in the
notice that it is a cancellation and identify the advance notification
that is being cancelled.
(e) Records. The licensee shall retain a copy of the advance
notification and any revision and cancellation notices as a record for
3 years.
(f) Protection of information. State officials, State employees,
and other individuals, whether or not licensees of the Commission or an
Agreement State, who receive schedule information of the kind specified
in Sec. 37.77(b) shall protect that information against unauthorized
disclosure as specified in Sec. 73.21 of this chapter.
Sec. 37.79 Requirements for physical protection of category 1 and
category 2 quantities of radioactive material during shipment.
(a) Shipments by road. (1) Each licensee who transports, or
delivers to a carrier for transport, in a single shipment, a category 1
quantity of radioactive material shall:
(i) Ensure that movement control centers are established that
maintain position information from a remote location. These control
centers must monitor shipments 24 hours a day, 7 days a week, and have
the ability to communicate immediately, in an emergency, with the
appropriate law enforcement agencies.
(ii) Ensure that redundant communications are established that
allow the transport to contact the escort vehicle (when used) and
movement control center at all times. Redundant communications may not
be subject to the same interference factors as the primary
communication.
(iii) Ensure that shipments are continuously and actively monitored
by a telemetric position monitoring system or an alternative tracking
system reporting to a movement control center. A movement control
center must provide positive confirmation of the location, status, and
control over the shipment. The movement control center must be prepared
to promptly implement preplanned procedures in response to deviations
from the authorized route or a notification of actual, attempted, or
suspicious activities related to the theft, loss, or diversion of a
shipment. These procedures will include, but not be limited to, the
identification of and contact information for the appropriate LLEA
along the shipment route.
(iv) Provide an individual to accompany the driver for those
highway shipments with a driving time period greater than the maximum
number of allowable hours of service in a 24-hour duty day as
established by the Department of Transportation Federal Motor Carrier
Safety Administration. The accompanying individual may be another
driver.
(v) Develop written normal and contingency procedures to address:
(A) Notifications to the communication center and law enforcement
agencies;
(B) Communication protocols. Communication protocols must include a
strategy for the use of authentication codes and duress codes and
provisions for refueling or other stops, detours, and locations where
communication is expected to be temporarily lost;
(C) Loss of communications; and
(D) Responses to an actual or attempted theft or diversion of a
shipment.
(vi) Each licensee who makes arrangements for the shipment of
category 1 quantities of radioactive material shall ensure that
drivers, accompanying personnel, and movement control center personnel
have access to the normal and contingency procedures.
(2) Each licensee that transports category 2 quantities of
radioactive material shall maintain constant control and/or
surveillance during transit and have the capability for immediate
communication to summon appropriate response or assistance.
(3) Each licensee who delivers to a carrier for transport, in a
single shipment, a category 2 quantity of radioactive material shall:
(i) Use carriers that have established package tracking systems. An
established package tracking system is a documented, proven, and
reliable system routinely used to transport objects of value. In order
for a package tracking system to maintain constant control and/or
surveillance, the package tracking system must allow the shipper or
transporter to identify when and where the package was last and when it
should arrive at the next point of control.
(ii) Use carriers that maintain constant control and/or
surveillance during transit and have the capability for immediate
communication to summon appropriate response or assistance; and
(iii) Use carriers that have established tracking systems that
require an authorized signature prior to releasing the package for
delivery or return.
(b) Shipments by rail. (1) Each licensee who transports, or
delivers to a carrier for transport, in a single shipment, a category 1
quantity of radioactive material shall:
(i) Ensure that rail shipments are monitored by a telemetric
position monitoring system or an alternative tracking system reporting
to the licensee, third-party, or railroad communications center. The
communications center shall provide positive confirmation of the
location of the shipment and its status. The communications center
shall implement preplanned procedures in response to deviations from
the authorized route or to a notification of actual, attempted, or
suspicious activities related to the theft or diversion of a shipment.
These procedures will include, but not be limited to, the
identification of and contact information for the appropriate LLEA
along the shipment route.
[[Page 17019]]
(ii) Ensure that periodic reports to the communications center are
made at preset intervals.
(2) Each licensee who transports, or delivers to a carrier for
transport, in a single shipment, a category 2 quantity of radioactive
material shall:
(i) Use carriers that have established package tracking systems. An
established package tracking system is a documented, proven, and
reliable system routinely used to transport objects of value. In order
for a package tracking system to maintain constant control and/or
surveillance, the package tracking system must allow the shipper or
transporter to identify when and where the package was last and when it
should arrive at the next point of control.
(ii) Use carriers that maintain constant control and/or
surveillance during transit and have the capability for immediate
communication to summon appropriate response or assistance; and
(iii) Use carriers that have established tracking systems that
require an authorized signature prior to releasing the package for
delivery or return.
(c) Investigations. Each licensee who makes arrangements for the
shipment of category 1 quantities of radioactive material shall
immediately conduct an investigation upon the discovery that a category
1 shipment is lost or missing. Each licensee who makes arrangements for
the shipment of category 2 quantities of radioactive material shall
immediately conduct an investigation, in coordination with the
receiving licensee, of any shipment that has not arrived by the
designated no-later-than arrival time.
Sec. 37.81 Reporting of events.
(a) The shipping licensee shall notify the appropriate LLEA and the
NRC's Operations Center (301-816-5100) within 1 hour of its
determination that a shipment of category 1 quantities of radioactive
material is lost or missing. The appropriate LLEA would be the law
enforcement agency in the area of the shipment's last confirmed
location. During the investigation required by Sec. 37.79(c), the
shipping licensee will provide agreed upon updates to the NRC's
Operations Center on the status of the investigation.
(b) The shipping licensee shall notify the NRC's Operations Center
(301-816-5100) within 4 hours of its determination that a shipment of
category 2 quantities of radioactive material is lost or missing. If,
after 24 hours of its determination that the shipment is lost or
missing, the radioactive material has not been located and secured, the
licensee shall immediately notify the NRC's Operations Center.
(c) The shipping licensee shall notify the designated LLEA along
the shipment route as soon as possible upon discovery of any actual or
attempted theft or diversion of a shipment or suspicious activities
related to the theft or diversion of a shipment of a category 1
quantity of radioactive material. As soon as possible after notifying
the LLEA, the licensee shall notify the NRC's Operations Center (301-
816-5100) upon discovery of any actual or attempted theft or diversion
of a shipment, or any suspicious activity related to the shipment of
category 1 radioactive material.
(d) The shipping licensee shall notify the NRC's Operations Center
(301-816-5100) as soon as possible upon discovery of any actual or
attempted theft or diversion of a shipment, or any suspicious activity
related to the shipment, of a category 2 quantity of radioactive
material.
(e) The shipping licensee shall notify the NRC's Operations Center
(301-816-5100) and the LLEA as soon as possible upon recovery of any
lost or missing category 1 quantities of radioactive material.
(f) The shipping licensee shall notify the NRC's Operations Center
(301-816-5100) as soon as possible upon recovery of any lost or missing
category 2 quantities of radioactive material.
(g) The initial telephonic notification required by paragraphs (a)
through (d) of this section must be followed within a period of 30 days
by a written report submitted to the NRC by an appropriate method
listed in Sec. 37.7. A written report is not required for
notifications on suspicious activities required by paragraphs (c) and
(d) of this section. In addition, the licensee shall provide one copy
of the written report addressed to the Director, Division of Security
Policy, Office of Nuclear Security and Incident Response, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001. The report must set
forth the following information:
(1) A description of the licensed material involved, including
kind, quantity, and chemical and physical form;
(2) A description of the circumstances under which the loss or
theft occurred;
(3) A statement of disposition, or probable disposition, of the
licensed material involved;
(4) Actions that have been taken, or will be taken, to recover the
material; and
(5) Procedures or measures that have been, or will be, adopted to
ensure against a recurrence of the loss or theft of licensed material.
(h) Subsequent to filing the written report, the licensee shall
also report any additional substantive information on the loss or theft
within 30 days after the licensee learns of such information.
Subpart E--[Reserved]
Subpart F--Records
Sec. 37.101 Form of records.
Each record required by this part must be legible throughout the
retention period specified by each Commission regulation. The record
may be the original or a reproduced copy or a microform, provided that
the copy or microform is authenticated by authorized personnel and that
the microform is capable of producing a clear copy throughout the
required retention period. The record may also be stored in electronic
media with the capability for producing legible, accurate, and complete
records during the required retention period. Records such as letters,
drawings, and specifications, must include all pertinent information
such as stamps, initials, and signatures. The licensee shall maintain
adequate safeguards against tampering with and loss of records.
Sec. 37.103 Record retention.
Licensees shall maintain the records that are required by the
regulations in this part for the period specified by the appropriate
regulation. If a retention period is not otherwise specified, these
records must be retained until the Commission terminates the facility's
license. All records related to this part may be destroyed upon
Commission termination of the facility license.
Subpart G--Enforcement
Sec. 37.105 Inspections.
(a) Each licensee shall afford to the Commission at all reasonable
times opportunity to inspect category 1 or category 2 quantities of
radioactive material and the premises and facilities wherein the
nuclear material is used, produced, or stored.
(b) Each licensee shall make available to the Commission for
inspection, upon reasonable notice, records kept by the licensee
pertaining to its receipt, possession, use, acquisition, import,
export, or transfer of category 1 or category 2 quantities of
radioactive material.
Sec. 37.107 Violations.
(a) The Commission may obtain an injunction or other court order to
[[Page 17020]]
prevent a violation of the provisions of--
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended;
or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a
civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of--
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of
the Atomic Energy Act of 1954, as amended:
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the
sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under
the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under
Section 186 of the Atomic Energy Act of 1954, as amended.
Sec. 37.109 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act. For purposes of section 223,
all the regulations in this part 37 are issued under one or more of
sections 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in this part 37 that are not issued under
sections 161b, 161i, or 161o for the purposes of section 223 are as
follows: Sec. Sec. 37.1, 37.3, 37.5, 37.7, 37.9, 37.11, 37.13, 37.107,
and 37.109.
Appendix A to Part 37--Category 1 and Category 2 Radioactive Materials
Table 1--Category 1 and Category 2 Threshold
The terabecquerel (TBq) values are the regulatory standard. The
curie (Ci) values specified are obtained by converting from the TBq
value. The curie values are provided for practical usefulness only.
----------------------------------------------------------------------------------------------------------------
Category 1 Category 1 Category 2 Category 2
Radioactive material (TBq) (Ci) (TBq) (Ci)
----------------------------------------------------------------------------------------------------------------
Americium-241................................... 60 1,620 0.6 16.2
Americium-241/Be................................ 60 1,620 0.6 16.2
Californium-252................................. 20 540 0.2 5.40
Cobalt-60....................................... 30 810 0.3 8.10
Curium-244...................................... 50 1,350 0.5 13.5
Cesium-137...................................... 100 2,700 1 27.0
Gadolinium-153.................................. 1,000 27,000 10 270
Iridium-192..................................... 80 2,160 0.8 21.6
Plutonium-238................................... 60 1,620 0.6 16.2
Plutonium-239/Be................................ 60 1,620 0.6 16.2
Promethium-147.................................. 40,000 1,080,000 400 10,800
Radium-226...................................... 40 1,080 0.4 10.8
Selenium-75..................................... 200 5,400 2 54.0
Strontium-90.................................... 1,000 27,000 10 270
Thulium-170..................................... 20,000 540,000 200 5,400
Ytterbium-169................................... 300 8,100 3 81.0
----------------------------------------------------------------------------------------------------------------
Note: Calculations Concerning Multiple Sources or Multiple
Radionuclides
The ''sum of fractions'' methodology for evaluating combinations
of multiple sources or multiple radionuclides is to be used in
determining whether a location meets or exceeds the threshold and is
thus subject to the requirements of this part.
I. If multiple sources of the same radionuclide and/or multiple
radionuclides are aggregated at a location, the sum of the ratios of
the total activity of each of the radionuclides must be determined
to verify whether the activity at the location is less than the
category 1 or category 2 thresholds of Table 1, as appropriate. If
the calculated sum of the ratios, using the equation below, is
greater than or equal to 1.0, then the applicable requirements of
this part apply.
II. First determine the total activity for each radionuclide
from Table 1. This is done by adding the activity of each individual
source, material in any device, and any loose or bulk material that
contains the radionuclide. Then use the equation below to calculate
the sum of the ratios by inserting the total activity of the
applicable radionuclides from Table 1 in the numerator of the
equation and the corresponding threshold activity from Table 1 in
the denominator of the equation. Calculations must be performed in
metric values (i.e., TBq) and the numerator and denominator values
must be in the same units.
R1 = total activity for radionuclide 1
R2 = total activity for radionuclide 2
RN = total activity for radionuclide n
AR1 = activity threshold for radionuclide 1
AR2 = activity threshold for radionuclide 2
ARN = activity threshold for radionuclide n
[GRAPHIC] [TIFF OMITTED] TR19MR13.000
PART 39--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL
LOGGING
0
18. The authority citation for part 39 continues to read as follows:
Authority: Atomic Energy Act secs. 53, 57, 62, 63, 65, 69, 81,
82, 161, 181, 182, 183, 186, 223, 234 (42 U.S.C. 2073, 2077, 2092,
2093, 2095, 2099, 2111, 2112, 2201, 2231, 2232, 2233, 2236, 2273,
2282); Energy Reorganization Act secs. 201, 202, 206 (42 U.S.C.
5841, 5842, 5846); Government Paperwork Elimination Act sec. 1704
(44 U.S.C. 3504 note).
0
19. In Sec. 39.1, paragraph (a) is revised to read as follows:
Sec. 39.1 Purpose and scope.
(a) This part prescribes requirements for the issuance of a license
authorizing the use of licensed materials including sealed sources,
radioactive tracers, radioactive markers, and uranium sinker bars in
well logging in a single well. This part also prescribes radiation
safety requirements for persons using licensed materials in these
operations. The provisions and requirements of this part are in
addition to, and not in substitution for, other requirements of this
chapter. In particular, the provisions of parts 19, 20, 21, 30, 37, 40,
70, 71, and 150 of this chapter apply to applicants and licensees
subject to this part.
* * * * *
[[Page 17021]]
PART 51--ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC
LICENSING AND RELATED REGULATORY FUNCTIONS
0
20. The authority citation for part 51 continues to read as follows:
Authority: Atomic Energy Act sec. 161, 1701 (42 U.S.C. 2201,
2297f); Energy Reorganization Act secs. 201, 202, 211 (42 U.S.C.
5841, 5842, 5851); Government Paperwork Elimination Act sec. 1704
(44 U.S.C. 3504 note). Subpart A also issued under National
Environmental Policy Act secs. 102, 104, 105 (42 U.S.C. 4332, 4334,
4335); Pub. L. 95-604, Title II, 92 Stat. 3033 3041; Atomic Energy
Act sec. 193 (42 U.S.C. 2243). Sections 51.20, 51.30, 51.60, 51.80.
and 51.97 also issued under Nuclear Waste Policy Act secs. 135, 141,
148 (42 U.S.C. 10155, 10161, 10168). Section 51.22 also issued under
Atomic Energy Act sec. 274 (42 U.S.C. 2021) and under Nuclear Waste
Policy Act sec. 121 (42 U.S.C. 10141). Sections 51.43, 51.67, and
51.109 also issued under Nuclear Waste Policy Act sec. 114(f) (42
U.S.C. 10134(f)).
0
21. In Sec. 51.22, the introductory text of paragraph (c)(3) is
revised to read as follows:
Sec. 51.22 Criterion for categorical exclusion; identification of
licensing and regulatory actions eligible for categorical exclusion or
otherwise not requiring environmental review.
* * * * *
(c) * * *
(3) Amendments to parts 20, 30, 31, 32, 33, 34, 35, 37, 39, 40, 50,
51, 52, 54, 60, 61, 63, 70, 71, 72, 73, 74, 81, and 100 of this chapter
which relate to--
* * * * *
PART 71--PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL
0
22. The authority citation for part 71 continues to read as follows:
Authority: Atomic Energy Act secs. 53, 57, 62, 63, 81, 161,
182, 183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, 2111,
2201, 2232, 2233, 2273, 2282, 2297f); Energy Reorganization Act
secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear
Waste Policy Act sec. 180 (42 U.S.C. 10175); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, Pub. L. No. 109-58, 119 Stat. 594 (2005). Section 71.97
also issued under sec. 301, Pub. L. 96-295, 94 Stat. 789 790.
0
23. In Sec. 71.97, the introductory text of paragraph (b) is revised
to read as follows:
Sec. 71.97 Advance notification of shipment of irradiated reactor
fuel and nuclear waste.
* * * * *
(b) Advance notification is also required under this section for
the shipment of licensed material, other than irradiated fuel, meeting
the following three conditions:
* * * * *
PART 73--PHYSICAL PROTECTION OF PLANTS AND MATERIALS
0
24. The authority citation for part 73 continues to read as follows:
Authority: Atomic Energy Act secs. 53, 147, 161, 223, 234, 1701
(42 U.S.C. 2073, 2167, 2169, 2201, 2273, 2282, 2297(f), 2210(e));
Energy Reorganization Act sec. 201, 204 (42 U.S.C. 5841, 5844);
Government Paperwork Elimination Act sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119
Stat. 594 (2005).
Section 73.1 also issued under Nuclear Waste Policy Act secs.
135, 141 (42 U.S.C, 10155, 10161). Section 73.37(f) also issued
under sec. 301, Pub. L. 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).
0
25. A new Sec. 73.35 is added to read as follows:
Sec. 73.35 Requirements for physical protection of irradiated reactor
fuel (100 grams or less) in transit.
Each licensee who transports, or delivers to a carrier for
transport, in a single shipment, a quantity of irradiated reactor fuel
weighing 100 grams (0.22 pounds) or less in net weight of irradiated
fuel, exclusive of cladding or other structural or packaging material,
which has a total external radiation dose rate in excess of 1 Gray (100
rad) per hour at a distance of 1 meter (3.3 feet) from any accessible
surface without intervening shielding, shall follow the physical
protection requirements for category 1 quantities of radioactive
material in subpart D of part 37 of this chapter.
Dated at Rockville, Maryland, this 8th day of March, 2013.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
Note: This Appendix Will Not Appear in the Code of Federal
Regulations.
APPENDIX A TO THIS FINAL RULE--REGULATORY FLEXIBILITY ANALYSIS FOR THE
AMENDMENTS TO 10 CFR PARTS 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71,
AND 73 (PHYSICAL PROTECTION OF BYPRODUCT MATERIAL)
I. Background
The Regulatory Flexibility Act (RFA), as amended 5 U.S.C. 601 et
seq., requires that agencies consider the impact of their
rulemakings on small entities and, consistent with applicable
statutes, consider alternatives to minimize these impacts on the
businesses, organizations, and government jurisdictions to which
they apply.
The U.S. Nuclear Regulatory Commission (NRC) has established
standards for determining which NRC licensees qualify as small
entities (10 CFR 2.810). These size standards were based on the
Small Business Administration's most common receipts-based size
standards and include a size standard for business concerns that are
manufacturing entities.
Description of the Reasons That Action by the Agency Is Being
Considered
The NRC has long participated in efforts to address radioactive
source protection and security. The terrorist attacks of September
11, 2001, heightened concerns about the use of risk-significant
radioactive materials in a malevolent act. Such an attack is of
particular concern because of the widespread use of radioactive
materials in the United States by industrial, medical, and academic
institutions. The theft or diversion of risk-significant radioactive
materials could lead to their unauthorized use in a radiological
dispersal device or a radiological exposure device.
Commission regulations provide requirements for the safe use,
transport, and control of licensed material. A licensee's loss of
control of risk-significant radioactive material, whether it is
inadvertent or through a deliberate act, could result in significant
adverse impacts that could reasonably constitute a threat to the
public health and safety or the common defense and security of the
United States. After the attacks of September 11, 2001, the
Commission determined that certain licensed material should be
subject to enhanced security provisions and safeguarded during
transport, and that individuals with unescorted access to risk-
significant radioactive material should be subject to background
investigations. For additional information see the Discussion
portion of the Statements of Consideration (SOC).
Succinct Statement of the Objectives of, and Legal Basis for, the
Final Rule
The objective of this rule is to establish generically
applicable security requirements for the protection of category 1
and category 2 quantities of radioactive materials possessed by
certain NRC and Agreement State licensees. These security
requirements are similar to the requirements imposed on these
licensees through the NRC's applicable previously-issued security
orders. The NRC has determined that it is preferable to regulate
through rulemaking rather than order because notice and comment
rulemaking is an open and transparent process that facilitates
public participation. In developing the final rule, the NRC
considered, among other things, the various orders, lessons-learned
during implementation, the recommendations from the Independent
Review Panel and the Materials Working Group, and stakeholder
comments. The rule also considered a petition for rulemaking
submitted by the State of Washington. For additional information see
the Discussion portion of the SOC. The authority citation sections
of the final rule contain the statutory authority for the rule.
[[Page 17022]]
Description of and, Where Feasible, an Estimate of the Number of
Small Entities to Which the Final Rule Will Apply
The final rule would affect about 300 NRC licensees and about
1,100 Agreement State licensees. This includes a wide range of
licensees, including pool-type irradiator licensees; manufacturer
and distributor licensees; medical facilities with gamma knife
devices; self-shielded irradiator licensees (including blood
irradiators); teletherapy unit licensees; radiographers; well
loggers; broad scope users; radioisotope thermoelectric generator
licensees; and licensees that ship or prepare for shipment category
1 or category 2 quantities of radioactive material. Some of these
licensees would be considered small entities. In fiscal year 2008,
about 26 percent of materials licensees qualified as small entities.
Using the same percentage, approximately 364 of the licensees that
will be affected by the rule would be considered small entities.
Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Final Rule, Including an Estimate of
the Classes of Small Entities That Will Be Subject to the
Requirements, and the Type of Professional Skills Necessary for
Preparation of Reports and Records
Licensees will be required to: (1) Develop procedures for
implementation of the security provisions; (2) develop a security
plan that describes how security is being implemented; (3) conduct
training on the procedures and security plan; (4) conduct background
investigations for those individuals permitted access to category 1
or category 2 quantities of radioactive material; (5) coordinate
with local law enforcement agencies (LLEAs) so the LLEAs would be
better prepared to respond in an emergency; (6) conduct preplanning
and coordination activities before shipping radioactive material;
and (7) implement security measures for the protection of the
radioactive material. Licensees will be required to promptly report
any attempted or actual theft or diversion of the radioactive
material. Licensees will be required to keep copies of the security
plan, procedures, background investigation records, training
records, and documentation that certain activities have occurred.
For additional information on the requirements, see the SOC or the
final rule text. No special skills are necessary for the preparation
of reports or records.
On average, a licensee would have a one-time cost of
approximately $23,375 and an annual cost of approximately $21,736 to
fully implement the final rule. Much of this cost would result from
the requirements to have procedures, conduct training, and to
develop a security plan. Although not required by the various
orders, many licensees may have developed procedures and conducted
training that may require only minor revisions; if so, the actual
cost may be lower. Additional large costs are the annual program
review and the maintenance and testing of the security-related
equipment. The program review is important for licensees to review
the effectiveness of the program and to ensure that requirements are
being implemented. Maintenance and testing is essential to ensure
that the equipment is operational and available when needed. More
information on the cost of the rule is contained in the Regulatory
Analysis.
Identification, to the Extent Practicable, of All Relevant Federal
Rules That May Duplicate, Overlap, or Conflict With the Final Rule
Several U.S. Government programs involve fingerprinting and an
FBI identification and criminal history records check. These include
the National Agency Check; Transportation Worker Identification
Credentials in accordance with 49 CFR 1572; Bureau of Alcohol,
Tobacco, Firearms, and Explosives background check and clearances in
accordance with 27 CFR 555; Health and Human Services security risk
assessments for possession and use of select agents and toxins in
accordance with 42 CFR 73; Hazardous Material security threat
assessment for hazardous material endorsement to commercial drivers
license in accordance with 49 CFR 1572; and Customs and Border
Protection's Free and Secure Trade Program. Any individual that has
favorably undergone the background investigation required by these
programs would be relieved from the fingerprinting and FBI criminal
history records check element of the final rule as long as the
licensee has appropriate documentation. Any individual who has an
active Federal security clearance would also be relieved assuming
appropriate documentation is provided.
The Department of Transportation requires security plans for the
transport of highway route control quantities of radioactive
material in accordance with 49 CFR 172.800. This provision covers
only a small portion of the category 1 and category 2 quantities of
radioactive material covered by the rule.
The NRC is not aware of any other relevant Federal rules that
may duplicate, overlap, or conflict with the final rule.
Description of any significant alternatives to the final rule
that accomplish the stated objectives of applicable statutes and
that minimize any significant economic impact of the final rule on
small entities, including alternatives considered, such as: (1)
Establishment of differing compliance or reporting requirements or
timetables that take into account the resources available to small
entities; (2) clarification, consolidation, or simplification of
compliance and reporting requirements under the rule for small
entities; (3) use of performance rather than design standards; and
(4) any exemption from coverage of the rule, or any part thereof,
for such small entities.
As noted earlier, some of the licensees that would be impacted
by the final rule are small businesses. The rule would impose the
minimum requirements that the NRC believes are necessary to
adequately protect the public health and safety and the common
defense and security. Therefore, the NRC could not generically grant
relief to small entities to allow them to implement less effective
measures. The final rule provides some flexibility in the particular
measures that a licensee can choose to employ. Licensees affected by
the rule have already implemented the bulk of the rule's
requirements in response to various orders.
[FR Doc. 2013-05895 Filed 3-18-13; 8:45 am]
BILLING CODE 7590-01-P