ML20154S646

Notation Vote Approving with Comments & Edited Pages, SECY-98-199 Re Pr 10CFR31, Requirement for Those Who Possess Certain Industrial Devices Containing Byproduct Matls to Provide Requested Info

ML20154S646
Person / Time
Issue date:	09/25/1998
From:	Mcgaffigan E NRC COMMISSION (OCM)
To:	Hoyle J NRC OFFICE OF THE SECRETARY (SECY)
Shared Package
ML20154S601	List: ML20154S598 ML20154S612 ML20154S629 ML20154S646
References
FRN-63FR66492 AG06-1-018, SECY-98-199-C, NUDOCS 9810280043
Download: ML20154S646 (12)

Text

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NOTATION VOTE 1

1-l l RESPONSE SHEET l

l TO: John C. Hoyle, Secretary l FROM: COMMISSIONER MCGAFFIGAN

SUBJECT:

SECY-98-199 - PROPOSED RULE: 10 CFR PART 31 --

" REQUIREMENT FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIALS TO PROVIDE REQUESTED INFORMATION" Approved X Disapproved Abstain Not Participating COMMENTS:

See attached comments and edited pages.

l 3 ,

'l f 3 -

DATE U Entered on "AS" Yes X No l

?!Aaggpp,7g3gaa CORRESPONDENCE PDR 0l$/05f9OYb

, Commissioner McGaffinan's Comments on SECY-98-199:

i I approve the proposed rule to modify Part 31 for the purposes of explicitly requiring certain l

' general licensees (about 6,000 licensees in possessics of about 24,000 devices) to respond to NRC requests for information and I offer the following comments for the staff's consideration.

I am concerned about how long it may take to get the general license (GL) automated registration system in place. I worry about "the development of a state-of-the art (emphasis added) system to replace the current database and support a fully automated registration system." 'Ihere must be l

commercial-off-the-shelf (COTS) database software available that would meet most, if not all, of l our requirements for dealing with approximately 6,000 licensees and 24,000 devices. COTS software would also be easiest for interface with the States. I am surprised that the estimated cost of the project breaks the $500,000 threshold for full analysis under the Capital Planning and investment Control (CPIC) process.

I urge the staff to critically evaluate the program needs and see if there is a less expensive information technology alternative available. To the extent full CPIC analysis is still required, I am concerned that the CPIC process looms so large in the staff's thinking that the staffis unable to predict the implementation date for the automated registration system for the rule before us. I urge the Office of the ChiefInformation Officer to ensure that resources devoted to the CPIC analysis are " scaled to the size and complexity of the proposed IT investment" and do not impose "an undue burden on the NRC program staff"(as discussed in SECY-98 032).

Regarding the second more comprehensive rule--I urge the staff to involve the Conference of i

Radiation Control Program Directors and Agreement States early in the rulemaking process by I sharing the draft rule language at the earliest opportunity and including Agreement State and non-Agreement State representation on the Part 31 rule-writing team. This approach will help ensure timely resolution of such key issues as additional device labeling requirements and compatibility.

Regarding the GL program in general-while I support the " developmental" efforts currently underway in parallel-development of two rules, the related guidance and an automated registration system, I am concerned that there are no parallel " implementation" efforts between now and mid-to-late FY 2000. For example, it is my understanding that the staff plans to forward a letter to general licensees informing them of this proposed rule. Undoubtedly, some letters will be returned to NRC due to " addressee unknown," some licensees will notify NRC of a change of address, some licensees will indicate that they no longer possess the device (s) in question, etc. These responses could provide NRC with information that, in certain cases, warrants follow up by the staff. Follow up activities could range from a simple telephone contact to a limited scope inspection to confirm device and source identification, location and disposition. Failing to follow up in cases that potentially involve safety-significant information due to the unavailability of an automated registration system to compile and process that

information is not, in my opinion, an acceptable alternative. Therefore, I suggest that the staff be directed to make adequate resources available to triage the incoming information based on its safety significance, establish criteria for determining when, and what type of, follow up action is

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2 indicated based on the information received and the potential public health and safety risk associated with the device, and perform limited scope inspections when indicated. Disposition of the information collected during these follow up activities should be based on its safety significance. For example, the information may yield an allegation that would warrant additional )

, follow up, or if the information is administrative in nature it could simply be retained for entry i into the existing general license data base or the yet-to-be developed automated registration

{

j l system. To complete this approach, the staff should consider developing the interim enforcement policy prior to the final rule-as currently planned by the staff-in the event that there is a need to

" grant amnesty"in a specific situation identified as a result of the initial mailing to general l licensees discussed above. Regardless of when the interim enforcement policy is implemented, I '

I agree with the staff's plan that it remain in effect through one complete cycle of the registration program. Also, the Federal Register notice should be revised accordingly.

I also suggest edits to the Federal Renister notice, Regulatory Analysis, letters to Congress and the press release as indicated on the attached pages.

. p -

[7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR Part 31 RIN 3150 - AG06 Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule, 9 ed -

pSS

SUMMARY

The Nuclear Regulatory Commission (NRC) poses amending its prto/

regulations add an explicit requirement that general licensees wh use certain measuring, gauging, or controlling devices that contain byproduct material provide :he NRC with information conceming these devices. The NRC intends to use this provision to request information concerning devices that present a comparatively higher risk of exposure to the public or property damage.

l The proposed rule is intended to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.

DATES: Submit comments by (Insert date 75 days after publication date). Comments received after this date will be considered if it is practical to do so, but the Commission is ab!e to ensure consideration only for comments received on or before this date.

, general license is meant to simplify the licensing process so that a case-by-case determination 4

of f% adequacy of the radiation training or experience of each user is not necessary.

There are about 45,000 general licensees under 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. In the past, the NRC has not contacted

generallicensees on a regular basis because of the relatively small radiation risk posed by

1 these devices and the very large number of general licensees. eb However, there have been a number of occurrences where generally licensed devices containing radioactive material have not been properly handled or properly disposed of. In some cases, this has resulted in radiation exposure to the public and contamination of property.

For example, when a source is accidentally melted in a steel mill, considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust, can re. cult.

j Because of these incidents, the NRC conducted a 3-year sampling (1984 through 1986) 1 j of generallicensees to assess the effectiveness of the generallicense program and to determine whether there was an accounting problem with generally licensed device users and, i if so, what action could be taken. The sampling revealed several areas of concem regarding the use of radioactive material under the generallicense provisions of 10 CFR 31.5. The NRC

, concluded that - (1) Many generallicensees are not aware of the appropriate regulations on i

the part of the generallicensee and; (2) Generally licensed devices are inadequately handled and accounted for.

1

, Approximately 15 percent of all general licensees sampled could not account for all of

{ their generally licensed devices. The NRC concluded that these problems could be remedied j by more frequent and timely contact between the general licensee and the NRC.

i i

4 i

1

.Q, The io cah o k O M '"oS .

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1. The identification of devices, such as the manufacturer, model and serial numbers;

2. The persons responsible for compliance with the regulations; and

3. The disposition of the devices.

While the proposed rule would apply to all 10 CFR 31.5 general licensees (about I

45.000), the NRC would only contact, for purposes of registration, approximately 6000 general licensees, possessing about 24,000 devices. This estimate is based on the criteria recommended by the working group for determining which sources should have increased oversight. Requests for information would be sent to generallicensees who are expected, based on current NRC records, to possess devices containing at least 370 MBq (10 mci) of cesium-137,3.7 MBq (0.1 mci) of strontium-90, 37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain americium-241). The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density, or chemical composition in petrochemical and steel manufacturing industries. The requests will include the information contained in NRC records conceming the possession of these devices. The licensees will be asked to verify, correct, and add to that information. The NRC records are based on information provided to NRC by distributors under 10 CFR 32.52(a) and from general licensees as required by 10 CFR 31.5(c)(8) or (9). If a general licensee no longer possesses devices meeting the criteria, it would be expected to provide information about the disposition of the devices previously possessed. Errors in current NRC records conceming these general licensees could be the resu't of: (1) errors made in the quarterly reports of manufacturers or initial distributors, (2) general licensees not reporting transfers, or (3) errors made by NRC or its contractors in recording transfer information.

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These projected savings would not be entirely attributable to implementation of the rule, but also to the planned increase in inspection and enforcement efforts.

1 4.2 Costs of Proposed Alternative The proposed amendment to 10 CFR 31.5 resu n costs to general licensees and to the 3 Commission. There also are costs to the Commission associated with the rulemaking process.

4.2.1 Costs of Revisions to 10 CFR 31.5 to General Licensees Registration process: .

The revision requires general licensees to respond to requests from the NRC to verify information related to their generallicenses. This information can help the NRC confirm that the general licensees still possess and are in control of their generally licensed devices containing byproduct materials and are meeting the general license conditions imposed by the Commission's regulations. The NRC plans to send a request for verification to each general licensee who has received a generally licensed device meeting the criteria developed by the working group and should still be in possession of it according to the Commission's records.

The cost to industry would entail a small annual administrative cost to each of approximately 6000 general licensees. The General License Study found that the average time required to locate and verify license conditions for all devices in the possession of a general licensee was approximately 30 minutes. The general licensees included in the registration requirement as proposed in this rule have fewer devices per licensee on average, so we estimate an average time of 20 minutes per response. Assuming that the cost to industry for staff time is $50/hr, the annual cost of this step is estimated as:

Cost = 1/3 hour / licensee x $50/ hour x 6000 licensees = $100,000 15 1

l j ,

contractual work which have been used to support this rulemaking have already been performed and dealt with a broader range of issues. These costs are considered outside the scope of this analysis. Development costs within the scope of this analysis are the costs of proceeding with this specific action and consist mainly of the costs of the effort of NRC professional staff members expended in developing this rule.

NRC implementation costs are those " front end" costs necessary to effectuate the proposed action. They may arise from the necessity of developing procedures and guidance to assist licensees in complying with the final action. These costs do not include the cost to the NRC of improving and maintaining a computerized directory of deviceg#% ie creidarad ne S

% 7 a-sunk.csts.1/ Although the computer database must be updated in order to implement this rule, i

and this will be done in a way to particularly accommodate a registration process, the database must be updated if it is to provide a reasonable information base for inspection and enforcement and regulatory actions related to 10 CFR Part 31 generallicensees. Additional costs related to accommodating the registration process are expected to be a small fraction of the overall costs for the update and are not estimated here.

The total development and implementation corts for this rule and associated guidance preparation is estimated as: $189,000 (1 % professional staff year x $126,000).

5 DECISION RATIONALE lt is recommended that this action be adopted because it represents a reasonable i

means for the Commission to fulfill its obligation to protect public health and safety, property, and the environment. It would better ensure that certain generallicensees are aware of those requirements with which they must comply and provide the information on the location, use, and disposition of generally licensed devices needed to confirm the efficacy of the generallicense 21 1

Flexibility Act (Pub.L.96-534). However, the economic impact on these entities would not be significant.

In Section 4.2.1 of this analysis, it was estimated that the cost of responding to the Commission's verification requests to general licensees would total about $100,000/yr.

It is estimated that there are approximately 24,000 devices in the possession of the Commission's generallicensees which will come under the registration requirement. The i

average cost to the general licensee per device per year is about $4.00. Therefore, the action would not have a significant economic impact on small entities.

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[y ~=% '4 UNITED STATES y

g 2 j NUCLEAR RE2ULATORY COMMISSION

, WASHINGTON, D.C. 20seH001

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j The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, h Me/.

i Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate 1 Washinrton, a DC 20510 Dear Mr. Chairman.

i Enclosed for the information of the Subcommittee is a cc.,y of a Notice of Proposed Rulemaking to be published in the Federal Reaister soon. The U.S. Nuclea egulatory , , , b, j g. ,

l Commission (NRC) is proposing to amend 10 CFR Part 31 to Mexpli quiremordthat ,) NE C' certain generallicensees who possess devices containing byproduct materiaPp c'eid; N"O Ch' N N information conceming devices that they have received for use under a general license C UQ,

-requcetcd by NoC+This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclide@ih*4 Se pi+wl we A r he< cd hb "

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his amendment would allow C to account or devices that have been distributed for use under the general license an educe the potential for incidents that could result in unnecessary N*I '

radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.

s Sincer *y,

's s

Dennis K. Rathbun, Director

. . Office of Congressional Affairs

Enclosure:

Federal Reaister Notice MC b's d5e<v d &

h W.C d in N 'es *

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• e, .r a (l - \, e us d &

• n '*s cc: Senator Bob Graham g, m g, , 4,, 6dba & W.y o s a A d, -d e t . ..

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NRC PROPOSES CHANGES TO REGULATIONS FOR DEVICES CONTAINING RADIOACTIVE MATERIAL 4 3I The Nuclear Regulatory Commission is proposing to amend its regulation goveming 4 the use of radioactive material in certain measuring, gauging and controlling devices to explicitly require censees who possess the devices to provide information to NRC upon request. >

Companies and individuals are permitted to use the devices under an NRC ' general license," which means that they need not have a specific license issued to a named individual or organization with specific license conditions and requirements. A generally licensed device usually consists of radioactive material contained in a sealed source within a shielded container.

The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of radiation training or experience of each user is not necessary.

There are about 45,000 general licensees under the Commission's general license program; they possess about 600,000 devices containing radicactive material. In the past, these generallicensees have not been contacted by the NRC on a regular basis because of the relatively srnall radiation risk posed by the devices and the very large number of general licensees. However, inere have been a number of instances in which generally licensed devices have not been properly handled or properly disposed of, which has resulted in radiation y exposure to the public and contamination of property.

A three-year NRC sampling of general licensees showed that approximately 15 percent of those surveyed could not account for all of their devices. The NRC believes this situation could be addressed by more frequent and timely contact between the generallicensees and the NRC.

l lc 2

While the Atomic Energy Act gives NRC the authority to request appropriate information from licensees, the Commission has not previously included in its regulations an explicit provision in this regard for generally licensed devices. .

The NRC proposes to use the new requirements for neral licensees to establish a x registration system. This system would cover generally licensed measuring, gauging and controlling devices with quantities of certain radioactive materials posing a higher risk to public l

l safety or of property damage if the device were lost than would other generally licensed devices. The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density or chemical composition in industries such gp g u, 9 am t h e <r. u n fon*W} ,68 as petrochemical and steel manufacturing. 3 y , ,p j ,g,c,3 s, Il c. . vM j,j, i The proposed revisions would require the affected licensees to respond to NRC ,r #

l requests for information within 30 days, in most cases.

Interested persons are invited to submit comments on the proposed changes within l 75 days after publication of a Federal Register notice on this subject, expected shortly. Written l comments should be mailed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff. Comments may l also be submitted via the NRC's interactive rulemaking web site at l

~ http://www.nrc. gov /NRC/ rule.html.

l

._. ___m.. _. . __..__.__ _ ._._._. - _._ __.___ _ _ _ ._ ___ __

' l p tfo UNITED STATES 8 o NUCLEAR REGULATORY COMMISSION a

{ j WASHINGTON. D.C, 20555-0001

# October 23, 1998 OFFICE OF THE SECRETARY MEMORANDUM TO

William D. Travers Executive Director for Operations Anthony J. Galante ChiefI tion Officer FROM: John dl W

'hicretary

SUBJECT:

STAFF REQUIREMENTS - SECY-98-199 - PROPOSED RULE:

10 CFR PART 31 ' REQUIREMENT FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIALS TO PROVIDE REQUESTED INFORMATION'

' The Commission has approved publication of the proposed rulemaking for 10 CFR Part 31.5 with the changes indicated in the attachment.

(EDO) (SECY Suspense: 11/20/98)

The staff should provide the Commission with its best estimate of the schedule and milestones necessary to complete the automated registration system once the business case has been completed and reviewed by the information Technology Business Council, and the recommended altemative has been approved by the EC (if the project cost is over $500K) or the CIO (if the project est is less than $500K).

(EDO) (SECY Suspense:

n 1/20/99) jfJ r

The staff should continue to work closely with the Office of the Chief Information Officer (OClO) to ensure that the automated registration system is developed in a timely manner, in order to fi control the costs of the automated system, the staff should critically evaluate the program needs.

In evaluating attematives, the staff should explore options such as commercial-off-the-shelf registration software and registration software available from the States or other govemment agencies that would be sufficiently capable of meeting the basic information capture, recording, and response requirements of the device registration program. The OClO should ensure that resources devoted to the CPIC analysis are ' scaled to the size and complexity of the proposed IT investment" and do not impose 'an undue burden on the NRC program stafr (as discussed in SECY-98-032).

Full implementation of the registration program should commence no later than deployment of the automated registration system. In the interim, the staff should take the following steps to address potential safety significant situations. Since the staff plans to forward the proposed rule to affected general licensees for information purposes, the staff should plan to " screen" any

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, information received as a result of this mailing. Specifically, the staff should make available resources to triage the incoming information based on its safety significance, establish simple criteria for determining when, and what type of, follow up action is commensurate with the potential public health and safety risk associated with the device, and perform limited scope inspections when indicated. Follow up activities could range from a simple telephone contact to a limited scope inspection to confirm source identification, location and disposition. Disposition of the information collected in such follow up activities should also be based on its safety significance. This process does not have to be an elaborate one but is intended to identify those 1 situations that, from a public health and safety perspective, warrant action. To complete this l approach, the staff should consider developing the interim enforcement policy prior to the final rule-as currently planned by the staff-in the event that there is a need to " grant amnesty" in a specific situation identified as a result of the initial mailing to general licensees discussed above.

Regardless of when the interim enforcement policy is implemented, the staffs plan should l remain in effect through one complete cycle of the registration program. Also, the Federal ,

Reaister should be revised accordingly. l Regarding the second more comprehensive rule - the staff should involve the Conference of Radiation Control Program Directors and Agreement States early in the rulemaking process by l

sharing the draft rule language at the earliest opportunity and including Agreement State and j

non-Agreement State representation on the Part 31 rule-writing team. This approach will help ,

ensure timely resolution of such key issues as additional device labeling requirements and compatibility. l

Attachment:

l 1

As stated cc: Chairman Jackson Commissioner Diaz Commission:r McGaffigan OGC CFO OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

PDR DCS l

l

, Editorial Changes to Attachments to SECY-98-199 Channes to the Federal Raaister Notice:

! 1. On page 1, paragraph 1, line 2, change 'use' to ' possess.'

2. On page 4, first full paragraph, line 3, insert ' exposure' after ' radiation.'

3. On page 8, after item 3, insert a new item as follows: '4. The location of the devices.'

Chances to the Raoulatorv Analysis:

1. In page 15, in item 4.2, line 1, add an 's' to ' result.'

2. On page 21, first full paragraph, lines 4-5, delete the remainder of the sentence after

' devices.'

3. On page 24, last paragraph, line 3, delete the 's' on ' licensees.'

Chanoes to the Conoressional Letters:

1. In paragraph 1, line 3, replace ' add an explicit requirement' with ' explicitly require.' In line 4, replace ' provide NRC with' with ' respond to NRC requests for.' In lines 5-6, delete

'as requested by NRC.' in the last line, add 'that are primarily used in commercial and industrial applications' after ' radionuclides'.

l 2. In paragraph 2, add a new first sentence as follows: 'NRC has observed a number of instances in the past where generally-licensed devices have not been properly handled or disposed of.' In line 2, insert 'there by' after 'and.'

Chanoes to the Press Release:

! 1. On page 1, paragraph 1, line 1, insert 'in Part 31' after ' regulations.' In line 3, delete the first 'the.'

2. On page 1, paragraph 3, line 6, insert ' unnecessary' before ' radiation.'

3. On page 2, paragraph 2, line 1, insert 'certain' before ' general.' Add a new sentence to the end of the paragraph as follows: 'About 6,000 general licensees possessing about 24,000 devices will come under the registration requirement.'

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