ML20203F586

Obtains Commission Approval to Revise NRC Enforcement Policy to Include Interim Policy on Exercise of Enforcement Discretion for Certain Violations of Requirements in 10CFR31 for Generally Licensed Devices Containing Byproduct Matl

ML20203F586
Person / Time
Issue date:	12/29/1998
From:	Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-98-303, SECY-98-303-01, SECY-98-303-1, SECY-98-303-R, NUDOCS 9902180195
Download: ML20203F586 (13)

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POLICY ISSUE (Notation Vote)

December 29.1998 SECY-98-303 EDB: The Commissioners FROM: William D. Travers Executive Director for Operations

SUBJECT:

INTERIM ENFORCEMENT POLICY REGARDING PROPOSED NEW REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL (10 CFR 31.5)

Purpose:

To obtain the Commission's approval to revise the NRC Enforcement Policy to include an interim policy on the exercise of enforcement discretion for certain violations of requirements in 10 CFR Part 31 for generally licensed devices containing byproduct material.

Backaround:

In SECY-98-199, the staff requested Commission approval to publish a proposed rule that would explicitly require persons who have received certain devices under a general license to provide the NRC with information about their possession and use of the devices. The intent of this new provision is to institute a registration and accounting system for generally licensed devices containing certain quantities of specific radionuclides.

The proposed rule states that the Commission intends to establish an interim enforcement O policy to provide that enforcement action normally will not be taken for violations of 10 CFR /

31.5 identified by a general licensee if appropriate corrective action is taken. This interim policy would remain in eeff' ct through one complete cycle of the registration program envisioned by the pg/f proposed rule.

The Commission approved publication of the proposed rule in the enclosed Staff Requirements Memorandum (SRM) (Encl.1) dated October 23,1998. In the SRM, the Commission directed the staff to develop the interim enforcement policy prior to the final rule, in the event that there is a need to " grant amnesty"in a specific situation identified as a result of the initial mailing of the proposed rule to general licensees for comment.

CONTACT:

James Lieberman, OE I 415-2741 i M/ p7 3; Rs]/ pin /c 9902180195 981229

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• i The Commissioners -

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. Discussion

• The staff proposes to amend the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, Rev.1, by adding Appendix D to the policy (Encl. 2).

Appendix D describes the interim enforcement policy that the NRC will follow to exercise l

enforcement discretion for violations identified as a result of the proposed new requirement that ,

persons licensed pursuant to the general license provision in 10 CFR 31.5 provide the NRC with information about the possession and use of their generally licensed devices. It addresses ,

violations that persons licensed pursuant to 10 CFR 31.5 discover and report now, as well as j during the initial cycle of the notice and response program contemplated by the proposed new l requirement. Under this interim enforcement policy, enforcement action normally will not be i taken for violations of 10 CFR 31.5 if they are identified by the general licensee, and reported to NRC if reporting is required, provided that the general licensee takes app.opnate corrective action to address the specific violations and prevent recurrence of similcr problems.

This change from the Commission's normal enforcement policy is inte.x$ed to remove the potential for the threat of enforcement action to be a disincentive far the licensee to identify deficiencies This approach is warranted given the limited NRC inspections of general licensees, it is intended to encourage general licensees to determine if applicable requirements have been met, to search their facilities to assure that sources are located, and to develop appropriate corrective action when deficencies are found.

Under this interim enforcement policy, enforcement action, including issuance of civil penalties and Orders, still will be considered where there is: (a) failure to take appropriate corrective action to prevent recurrence of similar violatons; (b) failure to respond and provide the information required by the notice and response program (if it becomes a final rule); (c) failure to provide complete and accurate information to the NRC; or (d) a willful violation, such as willfully disposing of generally licensed material in an unauthorized manner.

l Resources:

The resources required to implement this interim inforcement policy are included in the office's currently approved budget.

Recommendation:

The staff recommends that the Commission approve publication of Appendix D to the '

Enforcement Policy as enclosed.

Coordination:

The Office of the General Counsel has no legal objection to this paper. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has no objections. The  ;

Office of the Chief Information Officer has reviewed this paper and has no information j technology or information management concems.

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p-( O-o The Commissioners -

Notes:

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1. Appendix D to the Enforcement Policy will become effective upon publication in the Federa/ Register. Comments will be accepted for 30 days after publication, and will be considered prior to the next revision to the Enforcement Poiicy.

2. This change does not contain information collection requirements that are subject to the Paperwork Reduction Act.

3. The staff has determined that this is not a " major" rule as defined in the Small Business Regulatory Enforcement Fairness Act of 1996,5 U.S.C. 804(2).

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William D. Travers  !

Executive Director for Operations ,

Enclosures:

1. SRM dated October 23,1998 ,

2. FederalRegisternotice with Appendix D to the Enforcement Policy j l

DISTRIBUTION:

Commissioners OGC OCAA OIG OPA OCA CIO CFO EDO REGIONS SECY Commissioners' completed vote sheets / comments should be provided directly to SECY by c.o.b. Thursday, January 14, 1999.

Commission staff office comments, if any, should be submitted to the Commissioners NLT January 7, 1999, with an information copy to SECY. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

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f OEMAC- S98-199 P:ge 1 { . l n ,

Encl. 1  !

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October 23,1998  !

! MEMORANDUM TO: William D. Travers l Executive Director for Operations j Anthony J. Galante j Chief information Officer ,

FROM: John C. Hoyle, Secretary /s/

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 .

l lNFORMATION" l 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 attemative has been approved by the EC (if the project cost is over $500K) or the ClO (if the project cost is less than $500K).

(EDO) (SECY Suspense: 1/20/99)

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 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. i The OClO should ensure that resources devoted to the CPlO analysis are " scaled to the size

! and complexity of the proposed IT investment" and do not impose "an undue burden on the ,

l NRC program staff" (as discussed in SECY-98-032). )

l Full implementation of the registration program should commence no later than deployment of l 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 i rule to affected general licensees for information purposes, the staff should plan to " screen" any information received as a result of this mailing. Specifically, the staff should make available l

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f OEMAIL- S98199 Page 2 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 l 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 l significance. This process does not have to be an elaborate one but is intended to identify l those situations that, from a public health and safety perspective, warrant action. To complete I 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 licensees discussed above. Regardless of when the interim enforcement policy is implemented, the staff's plan should remain in effect through one complete cycle of the registration program. Also, the Federal Reaister should be revised accordingly.

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

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Attachment:

As stated i

1-l cc: Chairman Jackson Commissioner Diaz Commissioner McGaffigan i OGC

! CFO OCA OlG l OPA l

Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

PDR DCS 4

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[ OEMAll- S98-199 ~ P.!ge 3 l -

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< 4 Editorial Changes to Attachments to SECY-98-199 ,

Channes to the Federal Reaister Notice:  !

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

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- 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.' '!

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' Chanaes to the Reaulatory 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 j

' devices.'  ;

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

Channes to the Congressional 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'.

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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NUCLEAR REGULATORY COMMISSION

[NUREG - 1600, REV.1)

Policy and Procedure for NRC Enforcement Actions; interim Enforcement Policy for Generally Licensed Devices Containing Byproduct Material (10 CFR 31.5)

AGENCY: Nuclear Regulatory Commission.

ACTION: Policystatement.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, Rev.1, by adding Appendix D to the policy. This amendment describes the interim enforcement policy that the NRC will follow to exercise enforcement discretion for certain violations of requirements in 10 CFR Part 31 for generally licensed devices containing byproduct material. It addresses violations that persons licensed pursuant to 10 CFR 31.5 identify and correct now, as well as during the initial cycle of the notice and response program contemplated by the proposed new requirements published in the Federal Reaister on December 2,1998 (63 FR 66492), entitled

' Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested information".

DATES: This action is effective upon publication. Comments on this interim enforcement policy should be submitted within 30 days of publication in the Federal Reaister and will be considered by the NRC prior to the next revision of the Enforcement Policy.

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i ADDRESSES: Submit written comments to David L Meyer, Chief, Rules and Directives Branch, i Division of Administrative Services, Office of Administration, Mail Stop T6D59, U. S. Nuclear ,

Regulatory Commission, Washington, DC 20555. Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm, Federal workdays. Copies of j comments received may be examined at the NRC Public Document Room,2120 L Street, NW, ,

(Lower Level), Washington, DC. l FOR FURTHER INFORMATION CONTACT: James Lieberman, Director, Office of ,

Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001, (301) 415 2741.

SUPPLEMENTARY INFORMATION:

Background j in a separate action published in the Federal Reaister on December 2,1998 (G3 FR 66492), the NRC is proposing to amend its regulations in 10 CFR Part 31 to provide for more l frequent and timely contact between the NRC and users of certain industrial devices containing i byproduct material that are licensed pursuant to the general license provisions of 10 CFR 31.5.

The NRC is proposing this rule after concluding that there is a lack of awareness of NRC l

regulatory requirements on the part of the user of the generallicense (generallicensee). In addition, there is evidence of inadequate handling of and accounting for generally licensed j devices. Under the proposed rule, if finalized, the NRC intends to send notices to certain classes of persons licensed pursuant to me generallicense provisions of 10 CFR 31.5. These l

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notices would require recipients to provide information to the NRC, as requested, concerning j l products that they have received under the general license.

For further information regarding these proposed new requirements, the reader is

- referred to the Statements of Consideration that accompany the proposed rule. As noted i

therein, the NRC anticipates that general licensees may discover violations of NRC regulatory

- requirements as a result of the proposed new requirement to respond to notices and provide j information as requested. For example, general licensees who have not had contact with the NRC for many years may have failed to test for leakage of radioactive material from the generally licensed device, maintain the labe'c affixed to the device, or comply with the instructions and precautions in the labels. Additionally, general licensees may discover I

violations when copies of the proposed rule are mailed to them. For example, a general licensee that has changed its address of business may have abandoned or improperly '

transferred a generally licensed device during the process of moving. Under the cur' rent NRC Enforcement Policy published in NUREG-1600, Rev.1., such violations normally would result in enforcement action.

Scope This interim enforcement policy addresses violations that persons licensed pursuant to 10 CFR 31.5 ' discover and report before, as well as during, the initial cycle of the notice and response program contemplated by the proposed rule described above. It will remain in effect I

through at least July 1,2000, by which time it is expected that one complete cycle'of the notice and response program will be completed. However, any delays in completing the first cycle of s

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notice and response will be taken into account, and the effective time period of this interim enforcement policy will be lengthened accordingly. >

Under this interim enforcement policy, enforcement action normally will not be taken for violations of 10 CFR 31.5 if they are identified by the general licensee and reported to the NRC, if  !

I reporting is required, provided that the general licensee takes appropriate corrective action to address the specific violations and prevent recurrence of similar problems. This chenge froin the Commission's normal enforcement policy is to remove the potential for the threat of enforcement action to be a disincentive for the licensee to identify deficiencies. This approach is warranted given the limited NRC inspections of general licensees. This approach is intended to encourage general licensees to determine if applicable requirements have been met, to search their facilities to assure that sources are located, and to develop appropriate corrective action when -

deficiencies are found. Under this intet;n enforcement policy, enforcement action, including issuance of civil penalties and Orders, may be taken where there is: (a) failure to take appropriate corrective action to prevent recurrence of similar violations; (b) failure to respond and provide the information required by the notice and response program (if it becomes a final rule),  ;

(c) failure to provide complete and accurate information to the NRC; or (d) a willful violation, such as willfully disposing of generally licensed material in an unauthorized manner.

Paperwork Reduction Act This policy statement amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements have been

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l 1 submitted to the Office of Management and Budget (OMB) for review and approval under OMB

- number 3150-0016, Public Protection Notification if an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

Small Business Regulatory Enforcement Fairness Act in accordance with the Small Business Regulatory Enforcement Fairness Act of igg 6, the NRC has determined that this action is not a " major" rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

Accordingly, the NRC Enforcement Policy is amended by adding Appendix D as follows:

GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS l

Appendix D:. Interim Enforcement Policy for Generally Licensed Devices Containing Byproduct Material (10 CFR 31.5)

I This Appendix sets forth the interim enforcement policy that the NRC will follow to

- exercise enforcement discretion for certain violations of requirements in 10 CFR Part 31 for j

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o-generally licensed devices containing byproduct material. It addresses violations that persons licensed pursuant to 10 CFR 31.5 identify and correct now, as well as during the initiel cycle of the notice and response program contemplated by the proposed new requirements published in the Federal Reaister on December 2,1998 (63 FR 66492), entitled " Requirements for Those Who Possess Certain industrial Devices Containing Byproduct Material to Provide Roquested information".

Exercise of Enforcement Discretion Under this interim enforcement policy, enforcement action normally will not be taken for violations of 10 CFR 31.5 if they are identified by the general licensee, and reported to the NRC l if reporting is required, provided that the general licensee takes appropnate corrective action to 1

address the specific violations and prevent recurrence of similar problems.

Exceptions Enforcement action may be taken where there is: (a) failure to take appropriate corrective action to prevent recurrence of similar violations; (b) failure to respond and provide the information required by the notice and response program (if it becomes a final rule); (c) failure to provide complete and accurate information to the NRC; or (d) a willful violation, such as willfully I

~ disposing of generally licensed materialin an unauthorized manner. Enforcement sanctions in I

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7 these cases may include civil penalties as well as Orders to modify or revoke the authority to possess radioactive sources under the general license.

Dated at Rockville, Maryland, this day of ,1999.

For the Nuclear Regulatory Commission.

Annette Vietti-Cook, Secretary of the Commission I

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