[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]



 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  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.

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

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 
AXD[email protected].

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 

[[Page 3337]]
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