[Federal Register Volume 61, Number 21 (Wednesday, January 31, 1996)]
[Proposed Rules]
[Pages 3334-3338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1867]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 21 / Wednesday, January 31, 1996 /
Proposed Rules
[[Page 3334]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 20
RIN 3150-AF44
Reporting Requirements for Unauthorized Use of Licensed
Radioactive Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to add a
new requirement for licensees to notify the NRC Operations Center
within 24 hours of discovering an intentional or allegedly intentional
diversion of licensed radioactive material from its intended or
authorized use. The proposed rule would also require licensees to
notify the NRC when they are unable, within 48 hours of discovery of
the event, to rule out that the use was intentional. The proposed rule
would require reporting of events that cause, or have the potential to
cause, an exposure of individuals whether or not the exposure exceeds
the regulatory limits.
DATES: Submit comments by March 1, 1996. Comments received after this
date will be considered if it is practical to do so, but the NRC is
able to assure consideration only for comments received on or before
this date.
ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, Attention: Docketing and Service
Branch. Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland, between 7:45 a.m. and 4:15 p.m. Federal workdays.
Documents related to this rulemaking may be examined at the NRC
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
For information on electronic communications please see the Electronic
Access discussion in the Supplementary Information section.
FOR FURTHER INFORMATION CONTACT: Mary L. Thomas, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC
20555-0001, telephone (301) 415-6230, e-mail [email protected]
SUPPLEMENTARY INFORMATION:
I. Background
Recently, the NRC responded to two incidents involving phosphorous-
32 (P-32) internal contamination of individuals at biomedical research
facilities. P-32 is widely used in research institutions, as are many
other radionuclides. Although these incidents both involved P-32, the
inherent issues of security and control of radioactive material apply
to all facilities using licensed material.
The first incident, involving a pregnant researcher, had been
reported to the licensee's radiation safety office. The contamination
was detected by the researcher's spouse, who worked with the researcher
at the licensee's facility, while performing a routine survey of the
lab. The licensee identified the radionuclide as P-32. In addition to
the researcher's contamination, further surveys performed by the
licensee identified P-32 contamination on the floor in front of a
refrigerator in an adjacent lounge and a contaminated water cooler in
the same building. Urine bioassays of other workers in the same
building identified approximately 25 additional individuals who had
low-level internal P-32 contamination.
The second incident, also involving internal contamination with P-
32, was discovered during a routine survey by the researcher. The
licensee performed urine bioassays and confirmed that the researcher
was internally contaminated with P-32. Both incidents are still under
investigation at this time.
These two recent incidents raise the following issues. First, the
current reporting requirements may not capture potentially intentional
events such as these if the events did not involve quantities of
material or potential exposures that exceeded the current regulatory
thresholds that trigger the requirements to file reports. Second,
prompt NRC attention to these types of events is needed to assure that
the appropriate corrective actions will or have been taken by the
licensee and to determine any need for the NRC to take action in
addition to any action taken by the licensee. Therefore, the NRC has
determined that a new reporting requirement is needed to address
incidents such as these.
II. Discussion of Proposed Rule Changes
The intent of the proposed rule is to provide the NRC with an early
notification of the intentional use of licensed radioactive material
for a purpose that is not authorized by the applicable NRC license or
the regulations. The rationale for such a requirement is that, even
though the potential exposures involved may not result in harm to an
individual, incidents involving intentional misconduct or a disregard
for safety requirements raise a great concern about the loss of control
of materials that could lead to potential harm. The NRC needs to have
the assurance that timely corrective action will be taken by the
licensee and needs to determine whether further NRC actions may be
appropriate. Further NRC action might be appropriate, for example, if
an individual is identified as having intentionally acted in violation
of the regulations and the individual has access to or is working with
other licensees and/or licensed materials.
A new section would be added (Sec. 20.2205) to require a licensee
to notify the NRC Operations Center within 24 hours after discovering
that licensed radioactive material was used for a purpose not
authorized by the applicable NRC license or regulations if the use
causes or has the potential to cause an exposure to an individual,
regardless of whether or not it exceeds the regulatory exposure limit
as identified in 10 CFR 20.2202, and if the use was intentional or the
licensee has received information that the use was allegedly
intentional. If the licensee cannot rule out that the use was
intentional, they must notify the NRC Operations Center within 48 hours
of discovery of the event. A separate telephone report under
Sec. 20.2205 would not be needed if a telephone report was made under
Secs. 20.2201 and 20.2202.
Examples where a notification would be required include events
similar to the ones that precipitated this rulemaking as well as the
following types of events:
In an effort to add realism to an emergency drill, a drill
coordinator used Na-24 (a short-lived gamma emitter) without getting
permission from facility
[[Page 3335]]
management. The source was spread on the floor and participants tracked
through and spread the contamination. The drill participants were not
informed of this use of radioactive material. Workers had a potential
for uptake. This use of the isotope is for a purpose that is not
authorized by the license or regulations.
A worker was being surveyed for contamination as part of the
routine surveillance program at a licensed facility. A sealed radiation
source (used to response check radiation survey instruments) was found
in the worker's pocket. Apparently, someone had removed this strontium-
90 source from its storage place without authorization and deliberately
hidden it in the worker's pocket (in the change room) while the worker
was inside a contaminated area. The worker received a calculated dose
to the skin of approximately 20 rem.
In an effort to entrap a suspected thief who had been stealing
workers' valuables from a dressing/change room at a licensed facility,
health physics technicians fixed low levels of radioactive
contamination onto some dollar bills and left this contaminated money
in a wallet in an inviting manner to lure the suspected thief. While
this baiting activity did successfully lead to the apprehension of the
thief (alarmed the sensitive portal exit contamination monitor), this
use of licensed radioactive material was for a purpose that was not
authorized by the license or regulations.
A laboratory assistant, who had reported the vandalism of a
hematology laboratory, was found to have iodine-125 contamination on
her lab coat. Subsequent analysis also showed iodine-125 in her urine.
Consequently, the laboratory assistant confessed her responsibility for
the vandalism and the ingestion. This use of licensed radioactive
material was for a purpose that was not authorized by the license or
regulations.
Laboratory personnel were scanning samples for disposal when they
discovered that a post-doctorate researcher was radioactive. Later
analysis determined that the researcher was internally contaminated
with P-32. Surveys of the laboratory and surroundings revealed only one
instance of contamination, which was isolated to a food item. This use
of licensed radioactive material was for a purpose that was not
authorized by the license or regulations.
Examples of events that have occurred and that would not be covered
by this requirement include the following incidents:
In an effort to add realism to radiation worker training for
surveying materials, a qualified instructor used small, sealed
radioactive sources attached to objects that, when surveyed, provide
the trainee with realistic instrument responses. This controlled use of
radioactive materials had been properly reviewed by the facility health
physicist, conforms with the ALARA principle, and was part of a
documented, management approved training program. This use of licensed
radioactive material was used for a purpose that was authorized by the
license or regulations.
The routine loose surface contamination (smearable or swipe) survey
inside the radiologically controlled area at a licensed facility
revealed detectable loose surface contamination on the passageway floor
of an area not controlled as a contaminated area. The location, level,
and type of contamination leads the radiation protection staff to
conclude that it was likely that workers exiting the immediate worksite
had inadvertently tracked contamination outside the posted loose-
surface contaminated area into the unposted, ``clean'' passageway. The
contamination was determined not to be intentional.
A radiographer who intentionally fails to survey and subsequently
receives an overexposure while performing radiographic operations would
not be covered under this rule because radiography is a purpose
authorized by the license and regulations.
This reporting requirement is being proposed to ensure that the NRC
is made aware of any intentional or allegedly intentional activities
for a purpose not authorized by the applicable license or regulations
in order to take the necessary follow-up actions or to conduct
investigations in a timely manner. The NRC needs to have prompt
assurance that the licensee is taking the appropriate actions to assess
the consequences of the situation and to take the necessary steps to
reduce any likelihood that further exposures would occur. These actions
could consist of identifying the causes of the event, securing the
affected area and accounting for all licensed radioactive material,
surveying the area and the personnel working in that area, processing
the dosimetry worn by personnel working in that area, performing
bioassays of the personnel in the affected area, taking the appropriate
actions to prevent a recurrence of the event, and notifying law
enforcement agencies.
The reporting requirement is not based on an exposure threshold
because the NRC is concerned about any intentional unnecessary exposure
to workers or members of the public that could occur unless effective
corrective actions are promptly taken. It is recognized that, as a
licensee analyzes an event such as this, it may not be immediately
obvious whether the exposure was the result of an intentional use of
licensed material for a purpose not authorized by the applicable
license or regulations or was the result of an accident. A notification
to the NRC Operations Center would be required for any event that had
the potential for radiological exposure whenever the licensee cannot
promptly classify the exposure to be the result of either an operation
permitted under the license or an accident. Therefore, the NRC is
particularly interested in receiving comments on the proposed
requirement for licensees to inform the NRC within 48 hours of
discovery of the event that the licensee cannot rule out that the use
was intentional.
A medical administration to any individual is subject to the
regulations in part 35 and is specifically excluded from the scope of
Part 20 regulations. However, the administration of licensed
radioactive material to individuals outside the scope of Part 35's
definition of ``medical use'' is for a purpose not authorized by the
regulations and would therefore be reportable. An example of such a
situation would be the administration of material by one technician to
another technician to test their imaging skills.
The NRC has considered the impact on licensees from these new
requirements and has weighed them against the benefits. In those
instances where exposures of individuals cannot be ruled out as
resulting from operations permitted under the license or from
accidents, licensees will have to notify the NRC Operations Center.
Such events are expected to be rare. However, by reporting this
information early, the NRC will be able to assess promptly the
licensee's actions to prevent further exposures and possible harm to
other individuals, as well as determine whether it needs to be involved
in the matter. With this in mind, the NRC is specifically requesting
comments regarding the burden associated with the proposed reporting
requirement. Specifically, the NRC is interested in receiving an
estimate of the likely number of notifications licensees would have to
make of cases where they could not promptly rule out whether or not the
use was intentional.
[[Page 3336]]
III. Electronic Access
Comments on the proposed rule, 10 CFR part 20 Reporting
Requirements may be submitted electronically as indicated below.
Comments may be submitted electronically, in either ASCII text or
Wordperfect format (version 5.1 or later), by calling the NRC
Electronic Bulletin Board on FedWorld. The bulletin board may be
accessed using a personal computer, a modem, and one of the commonly
available communications software packages or directly via Internet.
Background documents on the rulemaking are also available for
downloading and viewing on the bulletin board.
If using a personal computer and modem, the NRC subsystem on
FedWorld can be accessed directly by dialing the toll free number: 1-
800-303-9672. Communication software parameters should be set as
follows: Parity to none, data bits to 8, and stop bits to 1 (N,8,1).
Use ANSI or VT-100 terminal emulation. The NRC rulemaking subsystems
can then be accessed by selecting the ``Rules Menu'' option from the
``NRC Main Menu.'' For further information about options available for
NRC at FedWorld consult the ``Help/Information Center'' from the ``NRC
Main Menu.'' Users will find the ``FedWorld Online User's Guides''
particularly helpful. Many NRC subsystems and databases also have a
``Help/Information Center'' option that is tailored to the particular
subsystem.
The NRC subsystem on FedWorld can also be accessed by a direct dial
phone number for the main FedWorld BBS: 703-321-3339; Telnet via
Internet: fedworld.gov (192.239.92.3); File Transfer Protocol (FTP) via
Internet: ftp.fedworld.gov (192.239.92.205); and World Wide Web using
the ``Home Page'': www.fedworld.gov (this is the Uniform Resource
Locator (URL)).
If using a method other than the NRC's toll free number to contact
FedWorld, the NRC subsystem will be accessed from the main FedWorld
menu by selecting ``F--Regulatory, Government Administration and State
Systems'' or by entering the command ``/go nrc'' at a FedWorld command
line. At the next menu select ``A--Regulatory Information Mall,'' and
then select ``A--U.S. Nuclear Regulatory Commission'' at the next menu.
If you access NRC from FedWorld's ``Regulatory, Government
Administration'' menu, you may return to FedWorld by selecting the
``Return to FedWorld'' option from the ``NRC Main Menu.'' However, if
you access NRC at FedWorld by using NRC's toll-free number, you will
have full access to all NRC systems, but you will not have access to
the main FedWorld system.
For more information on NRC bulletin boards call Mr. Arthur Davis,
Systems Integration and Development Branch, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, telephone (301) 415-5780; e-mail
AXD3@nrc.gov.
IV. Enforcement Policy
In light of the purpose of this proposed rule, the NRC intends, if
this rule becomes final, to consider amending the NRC Enforcement
Policy, NUREG-1600, (60 FR 34381, June 30, 1995), to state that a
failure to meet 10 CFR 20.2205 may be considered a violation of
significant regulatory concern. Such a violation could be characterized
as a Severity Level III violation and be subject to an assessment of
civil penalties.
V. Agreement State Compatibility
This rulemaking will be a matter of compatibility between the NRC
and the Agreement States, thereby providing consistency of State with
Federal safety requirements. The NRC is considering whether Division 2
or 3 level of compatibility should be assigned. Comments are
specifically requested on the appropriate level of compatibility.
VI. Environmental Impact: Categorical Exclusion
The NRC has determined that this revised regulation is the type of
action described as a categorical exclusion in 10 CFR 51.22(c)(3)(ii),
recordkeeping requirements. Therefore, neither an environmental impact
statement nor an environmental assessment has been prepared for this
revised regulation.
VII. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). This proposed rule has been submitted to the Office of
Management and Budget for review and approval of the paperwork
requirements.
The public reporting burden for this collection of information is
estimated to average 20 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. The U.S. Nuclear Regulatory Commission is
seeking public comment on the potential impact of the collection of
information contained in the proposed rule and on the following issues:
1. Is the proposed collection of information necessary for the
proper performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of collection of information be minimized,
including the use of automated collection techniques?
Send comments on any aspect of this proposed collection of
information, including suggestions for reducing the burden, to the
Information and Records Management Branch (T-6F33), U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001; and to the Desk
Officer, Office of Information and Regulatory Affairs, NEOB-10202
(3150-0014), Office of Management and Budget, Washington, DC 20503.
Comments to OMB on the collections of information or on the above
issues should be submitted by March 1, 1996. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given to comments received after this date.
Public Protection Notification
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.
VIII. Regulatory Analysis
The NRC has considered the impact on licensees from these new
requirements and has weighed them against the benefits. Under the
proposed rule, the licensee would be required to report promptly to NRC
those instances in which exposures of individuals are intentional, are
alleged to be intentional, or in which intentional and unauthorized use
cannot be ruled out. These types of events are expected to be rare. By
reporting this information promptly, the NRC would be able to assess
quickly the licensee's actions to prevent further exposures and
possible harm to other individuals.
The NRC has considered three alternatives: (1) Take no action, (2)
amending each license, and (3) amend the regulations.
The first alternative is not acceptable because the NRC would not
be made aware promptly of any intentional or deliberate activities.
Thus, the NRC would not be able to take the necessary
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follow-up actions or to conduct investigations in a timely manner.
Under the second alternative, the only benefit of amending licenses
would be in the resources saved in promulgating a new regulation.
However, the costs to amend licenses for the more than 6,600 NRC
licensees could be much higher than the costs for amending the
regulation.
The third alternative would be acceptable because it would provide
regulations for prompt reporting of the affected events. The NRC needs
to have prompt assurance that the licensee is taking the appropriate
actions to assess the consequences of the situation and to take the
necessary steps to reduce any likelihood that further exposures would
occur. Furthermore, the rulemaking process involves public
participation and provides NRC the opportunity to consider any public
comments. The NRC believes that this benefit outweighs the costs to the
licensees if the proposed rule is adopted.
The costs to licensees of the proposed rule, if adopted, could be
estimated as follows: Based on the past experience, the occurrence of
events that would be affected by this rule is expected to be rare. The
number of such events is estimated at 20 per year. The NRC further
estimates that 20 hours would be required to determine the cause of the
event, prepare the report, complete management review, and make a
telephone call to the NRC Operations Center. The total estimated burden
to all licensees would be 400 hours per year. Assuming administration
and labor costs of approximately $116 per hour, the total cost would be
about $46,400 per year.
The NRC is requesting specific comments regarding the burden
associated with the proposed reporting requirement. Specifically, the
NRC is interested in receiving an estimate of the likely number of
events that must be reported under the proposed rule and the number of
events in which the licensee could not promptly rule out that the use
was intentional and unauthorized. Comments may submitted to the NRC as
indicated under the ADDRESSES heading.
This rule, if adopted, will be published in the Federal Register as
a final rule which would include an effective date for implementation
of the changes to allow licensees time to make the required changes.
The NRC intends to make the final rule effective 30 days after the
publication in the Federal Register. The NRC is also requesting
comments regarding the effective date.
IX. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the NRC certifies that this rule, if adopted, will not have a
significant economic impact upon a substantial number of small
entities. The proposed rule affects all licensees. The anticipated cost
of the proposed requirement is indicated in the Regulatory Analysis.
This cost would be incurred only by a licensee who is required to
report an event. The estimated cost of reporting a single event is
$2,320.
The potential gains in protection of the public health and safety
significantly outweigh the economic impact on small licensees. However,
the NRC is seeking comments and suggested modification because of the
widely differing conditions under which small licensees operate.
Any small entity subject to this regulation who determines that,
because of its size, it is likely to bear a disproportionate adverse
economic impact should notify the NRC of this in a comment that
indicates--
(a) The licensee's size and how the proposed regulation would
result in a significant economic burden upon the licensee as compared
to the economic burden on a larger licensee;
(b) How the proposed regulations could be modified to take into
account the licensee's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulations were modified as suggested by the
licensee;
(d) How the proposed regulation, as modified, would more closely
equalize the impact of NRC regulations or create more equal access to
the benefits of Federal programs as opposed to providing special
advantages to any individual or group; and
(e) How the proposed regulation, as modified, would still
adequately protect public health and safety.
X. Backfit Analysis
The NRC has determined that the proposed rule is not a backfit
under the backfit rule, 10 CFR 50.109. The NRC has determined that
recordkeeping and reporting requirements are not backfits.
List of Subjects in 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, Special nuclear material, Source material,
Waste treatment and disposal.
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. 553, the NRC is proposing to
adopt the following amendment to 10 CFR part 20.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
1. The authority citation for part 20 continues to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, (U.S.C.
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as
amended 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846).
2. In Sec. 20.1009, paragraph (b) is revised to read as follows:
Sec. 20.1009 Reporting, recordkeeping, and application requirements:
OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Secs. 20.1101, 20.1202, 20.1204, 20.1206, 20.1301,
20.1302, 20.1501, 20.1601, 20.1703, 20.1901, 20.1902, 20.1904, 20.1905,
20.1906, 20.2002, 20.2004, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105,
20.2106, 20.2107, 20.2108, 20.2109, 20.2110, 20.2201, 20.2202, 20.2203,
20.2204, 20.2205, 20.2206, and appendices F and G to 10 CFR part 20.
* * * * *
3. Section 20.2205 is added to read as follows:
Sec. 20.2205 Reports of unauthorized use of licensed radioactive
material.
(a) The licensee shall notify the NRC Operations Center by
telephone as soon as practical but not later than 24 hours after
discovering that--
(1) Licensed radioactive material was used for a purpose not
authorized by the applicable NRC license or regulations; and
(2) Such use listed in paragraph (a)(1) of this section causes, or
has the potential to cause an exposure to an individual, regardless of
whether or not it exceeds the regulatory exposure limit as identified
in 10 CFR 20.2202; and
(3) Such use listed in paragraph (a)(1) of this section was
intentional or the licensee receives information that the use was
allegedly intentional.
(b) The licensee shall notify the NRC Operations Center by
telephone as soon as practical but not later than 48 hours after
discovering that provisions (a)(1) and (a)(2) of this section have
occurred
[[Page 3338]]
and the licensee cannot rule out that the use was intentional.
(c) Reports made by licensees in response to the requirement of
this section must be made as follows:
(1) Licensees having an installed Emergency Notification System
shall make reports to the NRC Operations Center, and
(2) All other licensees shall make reports by telephone to the NRC
Operations Center (301-816-5100).
(d) Reporting events under Secs. 20.2201 and 20.2202 continue to
apply. A report is not required by paragraphs (a) or (b) of this
section if a notification has already been made under Secs. 20.2201 or
20.2202.
Dated at Rockville, MD, this 19th day of January 1996.
For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 96-1867 Filed 1-30-96; 8:45 am]
BILLING CODE 7590-01-P
