ML20246G996

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Announcement 114 Advising That Commission Approved Important Discussion of Safety & Compliance Which Will Be Incorporated Into Enforcement Policy,Insp Manuals,Project Managers Handbook & Other Staff Guidance,As Appropriate
ML20246G996
Person / Time
Issue date: 12/05/1997
From: Callan L
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
NRC
Shared Package
ML20246G984 List:
References
NUDOCS 9803250119
Download: ML20246G996 (2)


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UNITED STATES a;I NUCLEAR REGULATORY COMMISSION

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ANNOUNCEMENT NO. 114 DATE:

December 5, 1997 T0:

ALL NRC EMPLOYEES

SUBJECT:

DISCUSSION OF SAFETY AND COMPLIANCE Recently, the Commission approved an important discussion of safety and compliance (Attachment 1).

It is being incorporated into the Enforcement Policy. Inspection Manuals. Project Managers Handbook and other staff guidance, as appropriate. Copies also will be sent to NRC licensees.

I view this document as a fundamental reference which provides a concise discussion of the relationship between compliance and safety.

I expect all

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regulatory staff to read this document so that this very important relationship is thoroughly understood.

L. Jo h Callan Executive Director for Operations

Attachment:

SRM dated 8/25/97 9803250119 980313 PDR STPRG ESGMD PDR

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UNITED STATES f

NUCLEAR REGULATORY COMMISSION e

y WASHINGTON, D.C. 20555-0001

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August 25, 1997 CrFICE OF THE SECRETARY I

MEMORANDUM TO:

L. Joseph Callan Execu v

Di ector for Operations i

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i FROM:

Joh

. Hoy

, Secretary

SUBJECT:

STAFF REQUIREMENTS - COMSAJ-97-008 -

DISCUSSION ON SAFETY AND COMPLIANCE l

l The Commission has approved the attached discussion of safety and i

compliance.

This guidance should be incorporated in the Enforcement Policy, Inspection Manuals, Project Managers j

l Handbook, and other staff, guidance, as appropriate.

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Attachment:

l As stated cc:

Chairman Jackson t

l Commissioner Dicus i

Commissioner Diaz Commissioner McGaffigan OGC CIO CFO l

OCA i

OIG l

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Safety and Como11ance i

k As commonly understood, safety means freedom from exposure to danger, or protection from harm.

In a practical sense, an activity is deemed to be safe if the perceived risks are judged to be acceptable. The Atomic Energy Act of 1954. as amended, establishes "ade on which NRC regulation is based. quate protection" as the standard of safety In the context of NRC regulation safety means avoiding undue risk or, stated another way, providing reasonable assurance of adequate protection for the public in connection with the use of l

source, byproduct and special nuclear materials The definition of compliance is much simpler.

Lumpliance si' ply means meeting m

applicable regulatory requirements.

What is the nexus between compliance and safety?

1.

Safety is the fundamental regulatory objective, and compliance with NRC requirements plays a fundamental role in giving the NRC confidence that safety is being maintained. NRC requirements, including technical specifications, other license conditions, orders, and regulations, have been designed to ensure adequate protection--which corresponds to "no undue risk to public health and safety"--through acceptable design, construction, operation, maintenance, modification, and quality assurance measures.

In the context of risk-informed regulation.

compliance plays a very important role in ensuring that key assuuW1ons

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i used in underlying risk and engineering analyses remain valid.

2.

Adequate protection is oresumotively assured by compliance with NRC requirements. Circumstances may arise, however, where new information reveals, for example, that an unforeseen hazard exists or that there is a substantially greater potential for a known hazard to occur.

In such situations, the NRC has the statutory authority to require licensee action above and teyond existing regulations to maintain the level of protection necessary to avoid undue risk to public health and safety.

3.

The NRC has the authority to exercise discretion to permit continued operations--despite the existence of a noncompliance--where the noncompliance is not significant from a risk perspective and does not.

in the particular circumstances, pose an undue risk to public health and safety. When non-compliances occur, the NRC must evaluate the degree of risk posed by that non-compliance to determine if specific immediate action is required. Where needed to ensure adequate protection of public health and safety, the NRC m;y demand immediate licensee action, up to and including a shutdown or cessation of licensed activities.

In addition in determining the appropriate action to be taken, the NRC must evaluate the non-compliance both in terms of its direct safety and regulatory significance and by assessing whether it is ) art of a pattern of non-compliance (i.e.

the degree of pervasiveness) tlat can lead to the determination that licensee control 3rocesses are no longer adequate to ensure protection of the public healt1 and safety. Based on the

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NRC's evaluation, the appropriate action could include refraining from taking any action, taking specific enforcement action. issuing orders, or providing input to other regulatory actions or assessments, such as

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. increased oversight (e.g., increased inspection).

4.

Where requirements exist that the NRC concludes have no safety benefit.

the NRC can and should take action, as appropriate, to modify or remove such requirements from the regulations or licenses.

Requirements that are duplicative, unnecessary. or unnecessarily burdensome can actually have a negative safety impact. They also can tend to create an inappropriate NRC and i1censee focus on " safety versus com 11ance" debates. As the Commission states in its Principles of Go d Regulation.

'There should be a clear nexus between regulations and agency goals and

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objectives, whether explicitly or implicitly stated."

l 5.

Since some requirements are more important to safety than others. the Commission should use a risk-informed approach wherever possible when adding, removing, or modifying NRC regulations, as well as when applying NRC resources to the oversight of licensed activities (this includes enforcement).

Based on the accumulation of operating experience and the increasing sophistication of risk analysis, t1e NRC should continue to refine its regulatory ap3 roach in a manner that enhances and reaffirms our fund mental safety o]jective.

s These principles attempt to describe the nexus between compliance and safety.

The misperception that compliance and safety are somehow incompatible or unrelated arises when the principles just outlined are not understood or are wrongly applied. When understood and applied correctly the result should be

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a consistent, credible regulatory approach--as applied to licensing, inspection. enforcement, performance assessment processes, and rulemaking.

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To:

Paul lehaus. Deputy Director O

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NRC State Programs 3

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301-41 $-3502 N

Phone:

Pages:

Cover page only Date:

January 9.1998

Subject:

Definition of Standards Tenn Slessage:

Paul. I understand from a conversation 1 just had with Joel Lubenau that the NRC still uses the tenn 'perfonnance based standard'?

It is my impression (from my standards development experience at the NRC) that a peribnnance based standard specifies the goal to be achieved without specifying the panicular method that must be used.

Hon ever. my client (Neutron Products. Inc.. a hlaryland licensee) is much in need of an o#icial definition. If you have one that he can use and or reference would you be willing to fax or E-mail it to me (see below).

Although I haven't seen you in 10 years or more i remember you well.

Best uishes ibr a successibl 199R Bob Alexander From R E Alexander The Alexander Corporation 13131 Matese Lane Fairfax, VA 22033 703-6318878 voice 703-631-8642 f ax alexand@comstor net i

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