Reporting Requirements for Unauthorized Use of Licensed Radioactive Material

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]

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