ML20217A094

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Notation Vote Disapproving W/Comment SECY-97-273 Re Staff requirements,SECY-96-221, Improving NRC Control Over & Licensee Accountability For,Generally & Specifically Licensed Devices
ML20217A094
Person / Time
Issue date: 03/17/1998
From: Mcgaffigan E
NRC COMMISSION (OCM)
To: Hoyle J
NRC OFFICE OF THE SECRETARY (SECY)
Shared Package
ML20217A044 List:
References
SECY-96-221-C, SECY-97-273-C, NUDOCS 9804220154
Download: ML20217A094 (4)


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NOT ATION VOTE l

1 i

RESPONSE SHEET l

TO:

John C. Hoyle, Secretary FROM:

COMMISSIONER MCGAFFIGAN

SUBJECT:

SECY-97-273 - STAFF REQUIREMENTS -- SECY-96-221 --

"lMPROVING NRC'S CONTROL OVER, AND LICENSEES' ACCOUNTABILITY FOR; GENERALLY AND SPECIFICALLY LICENSED DEVICES" Approved Disapproved

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Abstain Not Participating Request Discussion COMMENTS:

See attached comments.

+L SIGN JURE W U ()

Release Vote / Y/

/7

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DATE 1

Withhold Vote /

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Entered on "AS" Yes K No PSO4$0 ass 7S0c" CORRESPONDENCE PDR

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Commissioner McGaffiaan's Comments on SECY-97-273:

While I recognize that current resource constraints heavily influenced development of the options described in the paper for increased regulatory oversight of generally-licensed devices, I am concerned that the fundamental problem of lost or unaccounted for sealed sources and l

devices that have the potential to unnecessarily expose individuals is not fully addressed by the i

options before us. In arriving at my recommendations, I have also considered the earlier staff

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paper (SECY-96-221), discussions during the two public meetings in November 1996 and January 1998 with the staff and representatives of industry and the States, and the supplemental information provided via a memorandum from the Executive Director for Operations to the Commission dated February 5,1998.

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! offer the following comments on various elements of an enhanced regulatory program for the staff's consideration.

o WG recommendations on isotopes and qcantities - I support implementation of a l

registration program for the isotopes and quantities recommended by the WG since l

these sources / devices warrant increased regulatory oversight based on the potential for I

significant health, safety or environmental consequences associated with the loss of control of these sources. I recognize that the number of licensees that meet these criteria, and thus would be subject to increased regulatory control, is significantly larger than the number captured by any of the options discussed in the staff paper.

o The 1991-1993 rulemaking - I believe that finalizing the 1991-1993 rule as currently written is problematic for the following reasons. The rule: 1) applies to all generally-licensed sources / devices and thus will not capture the isotopes and activities recommended by the NRC/ Agreement State Working Group which represent certain generally-and spec'fically-licensed sources / devices; 2) does not impose fees on generallicensees needed to fund the registration program; 3) proposes a compatibility level 11, the public comments supported a compatibility level I and the staff currently proposes a category C (comparable to the former level ll); 4) would need to be modified

.to add requirements that appear necessary, such as permanent labeling of sources / devices; 5) contains requirements that the staff no longer supports, such as certain reporting requirements for vendors; and 6) contains costs assumptions that are no longer valid bewuse of the scope of the program is different and certain costs have i

increased. Because of the significant changes needed to the 1991-1993 rule, which would require re-noticing the rule for comment, I believe that it would be more efficient, less resource intensive and less confusing for licensees, industry and the Agreement States to draft an entiiely new rule to meet the current program objectives, o

Follow up of licensees - Where there is no response or discrepancies in the reported i

information are found, I believe that the following fundamental concepts should be integrated into the follow up procedures: 1) the extent of follow up should consider the risk to public health and safety that the source or device in question poses as well as the likelihood of finding the device; 2) considering the associated level of risk, there should be a point at which the follow up of certain low risk sources and devices is terminated; and 3) allinformation about lost sources should be made public in a timely manner. This approach will help prevent the expenditure of scarce resources in cases where there is a i

l point of diminishing return for the regulator, the industry and the public.

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Requirements for Vendors - While the 1991-1993 rule did contain requirements for vendors, I support the staff's plans to incorporate new requirements for permanent labeling of sources / devices to foster prompt identification of lost sources / devices.

o Enforcement program - I fully support implementing an initial, short (perhaps one year) amnesty program for general licensees and the use of increased civil penalties for both specific and general licensees to provide incentives for complete reporting of sources and devices and due diligence by licensees. I believe that the increased civil penalties should be significantly greater than the costs of proper disposal or transfer of a source or device. Also, the paper states that the staff will examine having Agreement States implement enforcement policies at least as stringent as those implemented by NRC-l support this approach since it will further serve to enhance the effectiveness of this program.

o Fees - I preliminarily support the staff's preferred approach-Option 3--to apply a registration fee, per licensee, at the time of initial registration and annual re-registration of sources / devices since it is the least complex approach for applying fees to a class of licensees that has not historically been subjec'.to NRC fees. However, the proposed rule should solicit comment on other fee apuoaches such as applying a registration fee per device, as suggested by Commissior sr Dicus in her vote.

o Orphan sounes - I encouraga the staff to continue its efforts to more clearly define the roles and responsibilities of the Federal and State governments to address the problems associated with orphan sources. These efforts should include continued close coordination with the Conference of Radiation Control Program Directors to ensure that a similar regulatory framework is applied to sources / devices containing Atomic Energy Act (AEA) material and sources / devices containing naturally-occurring or accelerator-produced radioactive material. As the paper states, the role of each affected agency is particularly important in the post-emergency phase of an event involving a source / device. The current situation of making a non-licensed party, that finds itself in possession of a source / device, responsible for its proper disposal in accordance with all applicable requirements needs to be rectified since this situation is fundamentally unfair and it provides a disincentive for accurate and complete reporting of lost sources / devices.

Risk Assessment Study - I agree with the staff's approach for considering the results of o

the current risk assessment study in developin0 a restructured licensing and inspection program for certain materials uses. Since the risk study is scheduled to be completed this fall, the findings should also be considered when determining whether additional sources / devices should be subject to registration and follow up, and for performing the risk ranking necessary if a phase-in approach is used to reduce the initial resource surge l

associated with an increased regulatory program.

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Resources to support the program - I recognize that my recommendations regarding the revised regulatory program require significantly more resources to implement than i

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l any of the options discussed in the paper, and as such, it is an unbudgeted activity for the Office of Nuclear Materials Safety and Safeguards (NMSS). I agree with the comments of Commissioner Dicus that NMSS has been particularly hard hit during 1

recent budget decisions. Therefore, I believe that the Executive Council (EC) should l

identify resources from outside of NMSS to fully support the program described above.

l In summary, I believe that the staff should be directed to forward, for Commission approval, a l

timeline with specific milestones to: 1) draft a new rule to implement a registration and follow l

up program for the sources / devices identified by the NRC/ Agreement State Working Group and l

apply fees to generallicensees; 2) use the results of the materials risk assessment study to l

restructure the current licensing and materials programs; 3) implement an enforcement program that includes a short amnesty program for general licensees and increased civil penalties for both general and specific licensees; 4) make resources available from outside of NMSS to fully fund this program; and 5) continue its efforts to further address the orphan source issue. The staff should also be directed to provide an estimate of the resources l

needed to fully support this program and information on which program areas were identified by l

the EC as having available resources to support it.

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4 UNITED STATES 0*

1 NUCLEAR REGULATORY COMMISSION j

WASHINGTON, D C. 20555-0001 t

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April 13, 1998 OFFICE OF THE SECRETARY i

MEMORANDUM TO:

L. Joseph Callan Executive Director for Operations Jesse L. Funches Chief FinancialOfficer l

1 William M. Beecher, Director

(

Office of Public Affairs i

f 1

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l FROM:

Mnnette L. Vietti-Coo t g Secretary j

SUBJECT:

STAFF REQUIREMENTS - SECY-97-273 - STAFF REQUIREMENTS - SECY-96-221 "lMPROVING NRC'S CONTROL OVER, AND LICENSEES' ACCOUNTABILITY FOR, l

l GENERALLY AND SPECIFICALLY LICENSED DEVICES" l

l The Commission had disapproved the staff's recommendation and directs the staff take the l

following actions:

1.

Terminate the rulemaking on 10 CFR Part 31.5 that was initiated in 1991 except those l

provisions that will enable NRC to request information from certain generallicensees to l

provide the regulatory basis for initiation of a registration program in advance of the rulemaking described below. Those portions of the 1991 proposed rule should be l

l renoticed for public comment.

l (EDO)

(SECY Suspense:

8/21/98) 2.

Provide a set of milestones to the Commission for information for implementing the pI rulemaking described below. The milestones should be in lieu of the standard y

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rulemaking plan required by Management Directive 6.3, but should meet the l

requirement for coordination with Agreement States.

l (EDO)

(SECY Suspense:

8/21/98)

SECY NOTE: SECY-97-273 WAS RELEASED TO THE PUBLIC ON DECEMBER 2,1997.

THIS SRM AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

AkaN2201stS Hy.

. 3.

Draft a proposed rule to implement a registration and follow up program for the generally-licensed sources / devices identified by the NRC Agreement State Working Group, apply fees to these general licensees, and incorporate requirements for permanent labeling of sources / devices. The proposed rule should include the staff's preferred approach - Attachment item 11, Option 3 - to apply a registration fee, per licensee, at the time of initial registration and annual re-registration of sources / devices.

The staff should explore the possibilities, advantages, and disadvantages of other fee l

approaches such as pro-rating the fees, e.g., per device (fixed or sliding scale) or per license and provide recommendations to the Commission. Determine the extent to which application of the small business rule will affect the fees.

l (EDO/CFO)

(SECY Suspense:

12/31/98) 4.

Use the results of the rraterials risk assessment study to restructure the current licensing and materials programs. Consider the findings when determining whether additional sources / devices should be subject to registration and follow up, and for

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performing the risk ranking necessary if a phase-in approach is used to reduce the initial resource surge associated with an increased regulatory program. Review the basis of the general licenses for adequacy with respect to consideration of the consequences of off-site accidents, such as loss of shielding or melting in metal making furnaces. The staff should provide the technical basis document for ihs risk assessment together with recommendations on how to proceed.

(EDO)

(SECY Suspense:

12/31/98)

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5.

Include provisions in the registration program for follow up of cases where there are no l

responses or where discrepancies are found between responses and NRC records.

l Explore with vendors their willingness to voluntarily assist the NRC (and Agreement l

States)in the follow up effort. Develop follow up procedures which integrate the following fundamental concepts:

the extent of follow up should consider the risk to public health and safety that a.

the source or device in question poses as well as the likelihood of finding the l

j device; b.

considering the associated level of risk, there should be a point at which the follow up of certain low risk sources and devices is terminated; allinformation about lost sources should be made public in a timely manner.

c.

(EDO)

(SECY Suspense:

concurrent with effective date for final rule)

Implement an enforcement program that includes a short amnesty program for general 6.

licensees and increased civil penalties for both general and specific licensees for " lost" sources. The increased civil penalties should be significantly greater than the costs of proper disposal or transfer of a source or device. Work with Agreement States in i

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l l. implementing enforcement programs such that their policies, practices, and procedures l

have the same impact as NRC's enforcement program.

(EDO)

(SECY Suspense:

concurrent with effective date for final rule)

Provide an estimate of the resources needed to fully support this program. Preparation 7.

of this estimate should include:

Estimating resource needs for the various phases of the registration program o

including, in particular, the substantial" spike" of resources needed to carry out the follow up program.

Reviewing registration programs for generallicensees that have been o

implemented by Agreement States for applicability of concepts, and exploring the possibility of utilizing other Federal agency registration programs and off4he-i shelf commercial programs to minimize development and operating costs.

Exploring the possibility of contracting with the States to carry out this part of the o

program under authority of Section 274i of the Atomic Energy Act, as amended.

identifying, through the Executive Council, resources to support the expanded l

o program, and inform the Commission if other program areas need to be reduced.

The Executive Council should consider program areas outside of NMSS. The 1

Executive Council should also evaluate and inform the Commission of the impact of this change on the Strategic Plan, Strategic Goals, and specific programs.

(EDO)

(SECY Suspense:

12/31/98)

Continue efforts to further address the orphan sources. A guiding principle is that non-8.

liccasees who find themselves to be in possession of radioactive sources that they did not seek to possess should not be expected or asked to assume responsibility and cost for exercising control or arranging for their disposal. These efforts should inciude:

Consulting with DOE, EPA, FEMA and the States to define jurisdictions and o

regulatory responsibilities for addressing the orphan source problem, and continued close coordination with the Conference of Radiation Control Program Directors to ensure that a similar regulatory framework is applied to source / devices containing Atomic Energy Act (AEA) material and sources / devices containing naturally-occurring or accelerator-produced radioactive material.

The staff should aggressively pursue finalizing the MOU with DOE.

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Consider th5 pros and cons of establishing a contract program that would enable l

o licensees or DOE to take possession of and arrange for proper transfer or disposal of orphan sources and provide an estimate of the costs of such a program.

l (EDO)

(SECY Suspense.

12/31/98) if NRC funding is necessary for an orphan source recovery program, the staff o

should provide recommendations for funding the program including, as directed l

i by the Commission in its December 1996 SRM, " exploring with Congress the possibility of removing specific program costs from the NRC's user fee base l

(e.g., orphan source recovery fund)."

l (SECY Suspense:

12/31/98)

(CFO)

The Office of Public Affairs should issue a press release concerning the Commission's decision.

(OPA)

(SECY Suspense:

4/15/98) l Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA I

OlG Of' ice Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail) l PDR l

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