Issue Date: 09/11/07 1 9900 SAFETY

 NRC INSPECTION MANUAL IRIB

Part 9900: Technical Guidance 

SAFETY & COMPLIANCE.TG 

 OPERATION – SAFETY AND COMPLIANCE 

A. PURPOSE 

The Commission has approved the attached discussion of safety and compliance. This 

guidance is incorporated into the NRC Inspection Manual for use by all NRC staff. [C1] 

B. SAFETY AND COMPLIANCE 

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 "adequate protection" as the standard of safety on which NRC 

regulation is based. 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 source, byproduct and special nuclear materials. 

The definition of compliance is much simpler. Compliance simply means meeting 

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 

assumptions used in underlying risk and engineering analyses remain valid. 

2. Adequate protection is presumptively 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 beyond 

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 
Issue Date: 09/11/07 2 9900 SAFETY

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 may 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 part of a pattern of noncompliance (i.e., the degree of pervasiveness) that can lead to the determination 

that licensee control processes are no longer adequate to ensure protection of 

the public health and safety. Based on the 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 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 

licensee focus on "safety versus compliance" debates. As the Commission 

states in its Principles of Good Regulation, "There should be a clear nexus 

between regulations and agency goals and objectives, whether explicitly or 

implicitly stated." 

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, the NRC should continue to refine its regulatory 

approach in a manner that enhances and reaffirms our fundamental safety 

objective. 

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 a consistent, credible 

regulatory approach--as applied to licensing, inspection, enforcement, performance 

assessment processes, and rulemaking. 

END 

 

Attachments: 

 1. Revision History Page
Issue Date: 09/11/07 Att1-1 

Attachment 1 - Revision History for 

Technical Guidance for Safety and Compliance 

Commitment Tracking Number 

Issue Date Description of Change Training 

Required 

Training Completion Date 

ComAcce

C1 Reference: SRM COMSAJ97-008 (ML003753992) 

09/11/07 CN 07-028 

Reactivation of identical TG inadvertently deleted from the Inspection Manual on March 9, 2007 (Change Notice 09-007). This TG is a Commission discussion of safety and compliance. 

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