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Page Title: Conditions of Approval cont'd
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There is insufficient information to document the conclusion that there is
reasonable assurance of adequate protection of the worker, the public, and the
The DSA does not meet the regulatory requirements of 10 CFR Part 830 and
does not have an approved exemption in accordance with 10 CFR Part 820,
Subpart E.
Significant issues were identified during the acceptance review that would
prevent conducting a successful technical review.
The base information contained in the DSA is insufficient to describe the
activities, processes, or systems to enable the hazard analyst to identify a
complete set of hazards for the covered facility/activity/program.
The Hazard Analysis (HA) is incomplete (e.g., there are missing hazards; the
response is incomplete, unavailable, or misapplied).
The Accident Analysis (AA) is incomplete (e.g., a scenari o does not bound the
hazard from the HA, there are incorrect calculations supporting the AA
Conditions of approval cannot be used to allow the facility/activity/program to be outside
of the approved safety basis or to be inconsistent with la w or other requirements.
Examples of situations where conditions of approval would be appropriate for DSAs are
 the use of a fire watch where a fire barrier is needed per the safety analysis but
it has not yet been installed and
 the use of personal protective equipment (e.g., respiratory protection) to mitigate
the any exposure to workers doing glovebox repackaging operations for a
defined period until an design correction identified in the DSA can be completed.
Fundamentally, the DSA must demonstrate that proposed activities have been thoroughly
described and analyzed, and that the hazards have been adequately identified. The DSA
must establish the linkage between the individual hazards identified and the final control
set that addresses each hazard. The functions of the controls that are relied upon for
safety must be clearly documented and demonstrated to be adequate for the bounded
hazards that they are intended to address. The selected controls must be documented
as capable of providing the credited safety functions, and appropriately captured in the
technical safety requirements. The DSA, TSRs, SER and conditions of approval should
provide an acceptable safety envelope for the facility/activity/program. While individual
instances of a shortcoming in one of these areas, such as the need for an additional
control, may be addressed in a condition of approval, a fundamental weakness in the
processes used to perform the hazard analysis and accident analysis would render the
DSA unacceptable.

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