POLICY ISSUE

(Notation Vote)

November 18, 2004 SECY-04-0217

FOR: The Commissioners

FROM: Luis A. Reyes

Executive Director for Operations /RA/

SUBJECT: DISTRIBUTION OF EXEMPT MATERIAL - DATABASE, DOSE

LIMITS/CRITERIA, AND SECURITY ISSUES RELATED TO

RISK-INFORMING 10 CFR PARTS 30, 31, AND 32

PURPOSE:

To request the Commission’s approval that the information provided in this paper satisfies the

Commission’s current need and that the individual Issue Papers on the topics of the distribution

of exempt material database, dose/limits criteria, and security that Staff Requirements

Memorandum (SRM)-SECY-02-0196 directed staff to provide are no longer necessary.

BACKGROUND:

In SECY-02-0196, “Recommendations Stemming from the Systematic Assessment of

Exemptions from Licensing in 10 CFR Parts 30 and 40; and a Rulemaking Plan for RiskInforming 10 CFR Parts 30, 31, and 32,” dated November 1, 2002, staff recommended

regulatory changes as a result of a systematic assessment conducted by the staff on

exemptions from licensing, for both byproduct and source material. Staff also provided options

to make 10 CFR Parts 30, 31, and 32 less prescriptive and more risk-informed. In SRM-SECY 

02-0196, dated November 17, 2003, the Commission approved in part and disapproved in part

the recommendations and options that staff provided. In the SRM, the Commission also

directed that staff prepare Issue Papers on several topics, including: (1) a database for the 

CONTACT: William Ward, NMSS/IMNS

 (301) 415-7038
The Commissioners 2

distribution of exempt material, (2) the criteria and dose limits for exempt material, and (3) the 

replacement of exempt material quantities with a fraction of the TECDOC-1344 ’D’ values 

(’D’ values). 

On September 1, 2004, the Commission’s Materials Technical Assistants (TAs) requested

clarification from the staff regarding the Issue Papers discussed in SRM-SECY-02-0196. The

TAs commented that the Issue Papers on the database for the distribution of exempt material,

and the criteria and dose limits for exempt material may no longer be required because the

information that the above-referenced papers would have provided has been satisfied by other

means. This paper provides information and a recommendation regarding staff activities

applicable to the three Issue Papers requested by the Commission in SRM-SECY-02-0196.

DISCUSSION:

Distribution of exempt material database

Beginning in 1970, U.S. Nuclear Regulatory Commission (NRC) regulations have required that

exempt distribution licensees submit a report of the radionuclides and total quantities

distributed. Initially, the frequency was at least annually. Currently, these reports must be

submitted at least every five years. The Commission agreed with staff in SRM-SECY-02-0196

that the reporting requirements should be returned to annual reporting. The purpose of the

reporting, as stated in the 1965 Policy Statement on Consumer Products, is for NRC to monitor

the usage and re-evaluate the regulations should population exposure, due to exempt product

use, become a significant fraction of the permissible dose. The reported data provides the

NRC with a means to determine if previous analysis of the effect of those distributed

radionuclides on the public’s health and safety should be reexamined.

Reports are scanned into ADAMS upon receipt from the licensee. Pre-ADAMS reports are

available, mostly in hardcopy only. A considerable staff effort has been required on two

occasions in the past to evaluate the distribution of exempt quantities and verify that past

assumptions on use and disposal are still accurate. As discussed in SECY-02-0196, the staff

plans to develop or re-establish a database to make this information more readily available for

use in reviewing exempt-quantity thresholds or exempt material usage. Also, use of a database

would allow staff to verify that the reporting requirements are met and meaningful data is being

evaluated by the distributors as data is reported, rather than when a special evaluation occurs.

The resource savings that would be realized by the use of a database would more than

compensate for the modest staff effort needed to start-up and maintain it, especially in

consideration of the staff’s plans to require annual reporting, in the near future as part of the

implementation of SRM-SECY-02-0196. Staff understands that the Commission was

concerned that the creation of this database would require significant resources, possibly

similar to other recent large databases (e.g. the General License Tracking System (GLTS) and

Web-Based Licensing). However, staff believes that the exempt material database could be
The Commissioners 3

developed either as a small addition to the future Web-Based Licensing system, or as an

internal, MS-Access database. In either case, the resource requirements would be minimal and

could be included in ongoing work. The decision on whether or not information gathered on

exempt material distribution will be incorporated in the Web-Based Licensing effort will be made 

as part of Task 3 of the SafeSource software project. This decision is anticipated to occur in

the first two quarters of FY 2006.

Dose limits/criteria

In SRM-SECY-02-0196, the Commission directed staff not to move forward with revising the

exempt concentrations of 10 CFR 30.70 or the exempt-quantity thresholds of 10 CFR 30.71, at

this time. A specific Issue Paper on this topic would have included a general discussion of how

the staff would approach the issue in the future. Staff plans to reconsider whether to revise the

exempt-quantity thresholds in the future, after several national and international activities are

completed. These activities are discussed in SECY-04-0055, “Plan for Evaluating Scientific

Information and Radiation Protection Recommendations,” and approved by the Commission in

SRM-SECY-04-0055, dated May 13, 2004. Before formalizing plans to revise the exempt

concentrations and exempt-quantity thresholds, the staff will work with the Agreement States to

obtain their input. After obtaining Agreement State input, staff will submit its recommendations

to the Commission for its review and approval.

Security

The Commission suggested the staff might compare the current exempt-quantity thresholds

listed in 10 CFR 30.71, Schedule B (Schedule B), with the ’D’ values used to determine the

thresholds for security considerations of certain radionuclides, and provide a discussion of the

pros and cons for replacing the Schedule B values with a small fraction of the ’D’ values. Staff

believes, however, that such an approach would not serve the underlying basis for exemption,

namely that the exempt activity poses only a negligible cancer risk should a member of the

public be exposed to gamma radiation emitted by the source or should the activity become

airborne. The ’D’ values, on the other hand, are based on a different health end-point, namely

death from one of the acute radiation syndromes. Using a specified fraction of the ’D’ values as

a basis for determining exempt quantities would not necessarily provide the intended level of

protection against the risk of cancer from exempt sources or, conversely, may be excessively

conservative in the case of some radionuclides.

The basis for the quantities of byproduct material authorized for exempt distribution was derived

from or based on one of two radiological criteria. First, since inhalation was considered the

most likely means of exposure, the quantity was calculated that would result in the maximum

permissible concentration (MPC) in air for members of the public (International Commission on

Radiological Protection, Publication 2 (ICRP 2)). Second, for each gamma-emitting

radionuclide, the quantity that would produce a radiation level of 1 milliroentgen (mR)/hour at a

distance of 10 cm (3.9 in.) from a point source was calculated. Then, the smaller of the two

quantities was adopted as the quantity in Schedule B.

The radioactive material restrictions described above made it unlikely that any individual would

inhale (or ingest), or otherwise be exposed, to more than a very small fraction of any radioactive

material being used. Therefore, it was considered highly improbable that any member of the
The Commissioners 4

public would receive more than a small fraction of the recommended limits for the public at the

time the exemption was developed. Staff believes these criteria continue to be a reasonable

basis for determining exempt quantities; however, the exposure scenarios need to be

re-evaluated for adequacy and the exempt quantities may need to be recalculated using current

dosimetric models and quantities after several national and international activities are

completed, as discussed above.

CONCLUSIONS:

Staff will continue with the development of a database for the distribution of exempt material

reports. This database will likely be either an addition to the Web-based licensing system, or

an MS-Access database. Staff agrees with the Commission TAs that a specific Issue Paper on

this topic would not be useful because creating such a database does not require a significant

allocation of resources.

The staff will consult with the Commission as a continuation of the rulemaking process before

formalizing plans to revise the exempt-quantity thresholds. This will include obtaining

Agreement State input prior to informing the Commission. Staff agrees with the Commission

TAs that a specific Issue Paper on exempt quantity dose limits/criteria would not be useful at

this time since no changes are currently being proposed by staff. 

Risk-informing the exempt-quantity thresholds will involve reviewing many criteria. These

include the adoption of new radiation protection standards, and the likely exposure scenarios

for normal and accidental use of these materials, which can result in quite different relative risks

for the various radionuclides than the risk resulting from the malicious use scenarios considered

in the security arena. These criteria will be considered by the staff in coordination with the

various stakeholders and the Agreement States.

RECOMMENDATION:

The staff recommends that the Commission approve the staff’s submission of this paper in lieu

of the individual Issue Papers on the topics of the distribution of exempt material database,

dose/limits criteria, and security, as directed by SRM-SECY-02-0196.

COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objections.

/RA/

Luis A. Reyes

Executive Director

 for Operations 
The Commissioners 4

re-evaluated for adequacy and the exempt quantities may need to be recalculated using current

dosimetric models and quantities after several national and international activities are

completed, as discussed above.

CONCLUSIONS:

Staff will continue with the development of a database for the distribution of exempt material

reports. This database will likely be either an addition to the Web-based licensing system, or

an MS-Access database. Staff agrees with the Commission TAs that a specific Issue Paper on

this topic would not be useful because creating such a database does not require a significant

allocation of resources.

The staff will consult with the Commission as a continuation of the rulemaking process before

formalizing plans to revise the exempt-quantity thresholds. This will include obtaining

Agreement State input prior to informing the Commission. Staff agrees with the Commission

TAs that a specific Issue Paper on exempt quantity dose limits/criteria would not be useful at

this time since no changes are currently being proposed by staff. 

Risk-informing the exempt-quantity thresholds will involve reviewing many criteria. These

include the adoption of new radiation protection standards, and the likely exposure scenarios

for normal and accidental use of these materials, which can result in quite different relative risks

for the various radionuclides than the risk resulting from the malicious use scenarios considered

in the security arena. These criteria will be considered by the staff in coordination with the

various stakeholders and the Agreement States.

RECOMMENDATION:

The staff recommends that the Commission approve the staff’s submission of this paper in lieu

of the individual Issue Papers on the topics of the distribution of exempt material database,

dose/limits criteria, and security, as directed by SRM-SECY-02-0196.

COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objections.

/RA/

Luis A. Reyes

Executive Director

 for Operations

ML042580308 * See previous concurrences

OFC MSIB MSIB MSIB OGC OSTP IMNS

NAME WWard* THarris* TEssig* STreby* PLohaus* PHolahan for*

CMiller

DATE 9/21/04 9/22/04 9/21/04 9/21/04 9/22/04 9/22/04

OFC Tech Ed NSIR NMSS DEDMRS EDO 

NAME EKraus* MWeber* MFederline for*

JStrosnider

MVirgilio LReyes

DATE 9/15/04 10/22/04 10/22/04 11/17/04 11/18/04

OFFICIAL RECORD COPY