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Memoranda (COMs and COMSECYs) > 1997 > COMSAJ-97-008 SRM
August 25, 1997
MEMORANDUM TO: L. Joseph Callan
Executive Director for Operations
FROM: John C. Hoyle, Secretary /s/
SUBJECT: STAFF REQUIREMENTS - COMSAJ-97-008 -
DISCUSSION ON SAFETY AND COMPLIANCE
The Commission has approved the attached discussion of safety and
compliance. This guidance should be incorporated in the
Enforcement Policy, Inspection Manuals, Project Managers
Handbook, and other staff guidance, as appropriate.
Attachment:
As stated
cc: Chairman Jackson
Commissioner Dicus
Commissioner Diaz
Commissioner McGaffigan
OGC
CIO
CFO
OCA
OIG
. 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
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 non-
compliance (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.
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