10 830 CFR

Question 1

Define Critical assembly

Answer 1

reactor

Question 2

Define Criticality. What is the contractor responsible for?

Answer 2

Criticality is the condition in which a nuclear fission
chain reaction becomes self-sustaining. A contractor responsible for a nuclear facility with fissionable material in a form and amount sufficient to pose a
potential for criticality is required to define their criticality safety program in their documented safety analysis.

Question 3

What is a Documented Safety Analysis (DSA)?

Answer 3

Documented safety analysis is a report that documents the adequacy of the analysis of a facility or activity to ensure that it can be constructed, operated, performed, maintained, shut down, and decommissioned safely and in compliance with applicable requirements.

Question 4

What form could the DSA be in?

Answer 4

Safety analysis report, a Basis for Interim Operation or BIO, a safety and health plan or HASP, or a combination of a safety analysis report and a hazard analysis report (HAR). This term is used in the new safety basis
requirements.

Question 5

What are Environmental restoration activities?

Answer 5

Environmental restoration activities are the processes by which contaminated sites and facilities are identified and characterized. It is also the process by which existing contamination is contained or removed.

Question 6

Are there the same rules for existing DOE nuclear facility versus new DOE nuclear facility?

Answer 6

This rule imposes different safety basis requirements in Subpart B for new facilities versus existing facilities. The first difference is related to the development of a preliminary documented safety analysis for new nuclear facilities, which is not required for existing nuclear facilities. The second difference is with respect to
schedules as specified in the rule.

Question 7

What is the time period for existing DOE nuclear facility versus new DOE nuclear facility?

Answer 7

Consider an existing DOE nuclear facility to be a DOE nuclear facility that is or has been in operation prior to April 9, 2001. New nuclear facilities are facilities, activities and operations that begin operations on or after April 9, 2000.

Question 8

What constitutes new DOE nuclear facility?

Answer 8

1) construction of new DOE facility which is intended tas a nuclear facility; (2) use of existing non-nuclear DOE facility to possess, use or store radioactive or fissionable material in such form and quantity that a nuclear hazard potentially exists; and (3) initial
possession, use, or storage of radioactive or fissionable material in such form and quantity that a nuclear hazard
potentially exists. Change from operation of a DOE nuclear facility to deactivation, decontamination, decommissioning, or environmental restoration to be a new DOE nuclear activity subject to the schedules for a new nuclear facility.

Question 9

Define Hazard controls

Answer 9

Hazard controls means measures to eliminate, limit, or

mitigate hazards to workers, the public, or the environment

Question 10

What five things do hazard controls include?

Answer 10

1) physical, design, structural and engineering features; (2) safety structures, systems and components; (3)
safety management programs; (4) technical safety requirements; and (5) other controls necessary to provide adequate protection from hazards.

Question 11

What is Low-level residual fixed

radioactivity?

Answer 11

Low-level residual fixed radioactivity is the radioactivity

remaining following reasonable efforts to remove radioactive systems, components, and stored materials

Question 12

What three categories could be Low-level residual fixed radioactivity be?

Answer 12

Surface contamination that remains fixed following chemical cleaning or some similar process;
· A component of surface contamination that can be picked up by smears; or
· Activated materials within structures.

Question 13

What are the definition permit values for low-level residual fixed radioactivity?

Answer 13

Smearable radioactivity must be less than the values defined for removable contamination by 10 CFR Part 835, Appendix D, Surface Contamination Values. results of the hazard analysis must show that no
credible accident scenario or work practices would release the fixed or activated components of remaining
radioactivity at levels that would prudently require the use of active safety systems, structures, or components to prevent or mitigate a release of radioactive materials.

Question 14

What is a major modification?

Answer 14

Major modification means a modification to a DOE nuclear facility that is completed on or after April 9, 2001 and which substantially changes the existing safety basis for the facility.

Question 15

What is expected if there is a major modification planned?

Answer 15

Because these changes have a significant effect on the
safety basis of a nuclear facility, we expect contractors to develop a preliminary documented safety analysis
that addresses these modifications and their impacts on the safety of the nuclear facility so DOE may review the proposed changes before they are implemented.

Question 16

What is expected before operation of a major modification?

Answer 16

Before operating the nuclear facility in the modified configuration or conducting modified operations, contractors must obtain approval of the upgraded safety basis from DOE and make any changes to the safety basis directed by DOE.

Question 17

Do major modifications need to be assessed under the USQ process of Subpart B?

Answer 17

Because contractors for major modifications must revise their safety basis documents to reflect the major modifications and obtain DOE approval of the revised safety bases prior to making the modification, they do not need to assess major modifications under the USQ process of Subpart B.

Question 18

Define Preliminary documented safety

analysis.

Answer 18

The preliminary documented safety analysis is the documentation prepared in connection with the design
and construction of a new hazard category 1, 2, or 3 DOE nuclear facility or a major modification to a hazard
category 1, 2, or 3 DOE nuclear facility. It is part of the safety basis requirements, and it serves as the principal safety basis for the DOE decision to authorize procurement, construction, or preoperational testing.

Question 19

Define Safety basis.

Answer 19

A safety basis for a DOE nuclear facility is documented in the documented safety analysis and the hazard controls for the nuclear facility.

Question 20

What happens if there is a potential change of the Safety Basis?

Answer 20

As changes are made or potential inadequacies of the safety analysis are discovered, contractors must perform USQ determinations. The results of the USQ determinations and any associated safety evaluations are part of the safety basis for the facility.

Question 21

Define Safety class structures, systems, and
components.

Answer 21

Safety class structures, systems, and components means structures, systems, or components, including portions of process systems, whose preventive or mitigative function is necessary to limit radioactive hazardous material exposure to the public, as identified by the safety analysis.

Question 22

Define Safety evaluation report or SER.

Answer 22

The SER is the documented safety evaluation performed by DOE on the safety basis documents for a facility that are developed by the contractor.

Question 23

What is included in a SER?

Answer 23

It includes the reasons for approving the safety basis and any conditions for approval. Contractors are required by the safety basis requirements to meet any conditions stated in the SER.

Question 24

Define Safety Management System (SMS).

Answer 24

Safety Management System means an integrated safety management system established consistent with the Department of Energy Acquisition Regulation (DEAR) in 48 CFR 970.5204– 2, Integration of Environment, Safety, and Health into Work Planning and Execution, or any successor regulation.
Additional information on SMS may be found in DOE Policy 450.4, Safety Management System Policy; DOE Guide 450.4–1A, Integrated Safety Management System Guide.

Question 25

Define Safety management program.

Answer 25

Safety management programs are programs designed to ensure a facility is operated in a manner that adequately protects workers, the public, and the
environment.

Question 26

What is required for contractors to define characteristics for within their Safety Management program?

Answer 26

Subpart B of the rule requires contractors to define the characteristics of the safety management programs for
the facility that are necessary for safe operations, including, where applicable, quality assurance, procedures, maintenance, personnel training, conduct of operations, emergency preparedness, fire protection, waste management, and radiation protection.
They may also include criticality safety
programs for nonreactor nuclear
facilities with fissionable material in a
form or amount sufficient to pose a
potential for criticality.

Question 27

Do contractors need to repeat or reinvent programs for the documented safety analysis?

Answer 27

Contractors may incorporate existing programs by reference into the documented safety analysis provided these programs are sufficient to provide adequate protection.

Question 28

What do contractors need to include to show evidence of existing programs for their DSA?

Answer 28

Contractors may need to include a copy of documents
that are incorporated by reference with the documented safety analysis when it is submitted to DOE for review and approval.

Question 29

Define safety significant structures, systems, and components.

Answer 29

Safety significant structures, systems, and components means systems, structures, and components which are not designated as safety class systems, structures, and components, but whose preventive or mitigative function is a major contributor to defense in depth
(i.e., prevention of uncontrolled material release) and/or worker safety as determined from hazard analyses.

Question 30

Define Safety structures, systems, and

components

Answer 30

Safety structures, systems, and components are the combination of safety class systems, structures, and components and safety significant systems, structures, and components.

Question 31

Define Technical safety requirements.

Answer 31

Technical safety requirements are the limits, controls and related requirements necessary for the safe operation of a nuclear facility that are appropriate for the work and the hazards.

Question 32

What is included in Technical safety requirements?

Answer 32

Safety limits, operating limits, surveillance requirements, administrative and management controls, use and application provisions, and design features, as well as a bases appendix.

Question 33

Define the four criteria for an Unreviewed Safety Question (USQ).

Answer 33

if (1) the probability of the occurrence or the consequences of an accident or the malfunction of equipment important to safety previously evaluated in the documented safety analysis could be increased; (2) the possibility of an accident or malfunction of a different type than any evaluated previously in the documented safety analysis could be created; (3) a margin of safety could be reduced; or (4) the documented safety analysis may not be bounding or may be otherwise inadequate.

Question 34

When does a contractor need to use the USQ process?

Answer 34

If a situation involves a USQ, the contractor must use
the USQ process to determine if the change or the potential inadequacy of the documented safety analysis needs to be submitted to DOE for review and approval.

Question 35

Define Unreviewed Safety Question

Process.

Answer 35

The USQ process permits a contractor to make physical and procedural changes to a nuclear facility and to conduct tests and experiments without prior DOE approval, provided these changes do not explicitly or implicitly affect the safety basis of the
nuclear facility.

Question 36

What is the USQ process important to a contractor?

Answer 36

USQ process provides a contractor with flexibility needed to conduct day-to-day operations by requiring that only those changes and tests with potential to impact safety basis (and therefore safety of the nuclear facility) be brought to the attention of DOE.

Question 37

Define nuclear facility

Answer 37

Nuclear facilities include any related area, structure, facility, or activity to the extent necessary to ensure
proper implementation of the requirements established by Part 830. The nuclear facility may be on or off a DOE site. The facility may be wholly or partially owned or controlled by DOE.

Question 38

What Are the ‘‘Performance of Work’’ Requirements for a Safety Basis?

Answer 38

Contractors must perform work in accordance with the DOE-approved safety basis for a DOE hazard category
1, 2, or 3 nuclear facility. This includes prime contractors to DOE, subcontractors, and suppliers. The definition of ‘‘work’’ as applied to this rule is very broad and encompassing. It includes any defined task or activity
that may affect a safety basis for a facility.

Question 39

What Are the Requirements for Establishing a Safety Basis for a DOE Category 1, 2, or 3 Nuclear Facility?

Answer 39

The proper analysis of facility, operations, and activity hazards, the development of appropriate hazard
controls for the work to be conducted, and the performance of work consistent with the approved safety basis are necessary for work at nuclear facilities to be performed safely.

Question 40

What must a contractor do to properly establish a safety basis for a hazard category 1,2 or 3 nuclear facility?

Answer 40

A contractor must:
· Define the scope of work to be performed,
· Identify and analyze the hazards associated with the work,
· Categorize the facility consistent with DOE STD–1027,
· Prepare a documented safety analysis for the facility,
· Establish the hazard controls upon which the contractor will rely to ensure adequate protection of workers, the public, and the environment.

Question 41

Can a Facility Be Divided Into Compartments or ‘‘Segmented’’ for the Purpose of Facility Hazard Categorization?

Answer 41

If there are facility features that prevent hazards from one process, operation, or activity from interacting with those of another, contractors may be able to address the hazards separately. Therefore, in certain limited circumstances, contractors may be able to segment facilities (divide one facility into two or more facilities),
provided the radiological or nonradiological hazardous materials in one segment cannot interact with radiological or nonradiological hazardous materials in other segments.

Question 42

When can facilities not be compartmentalized?

Answer 42

The safety basis for each segmented facility must demonstrate that the hazards cannot interact with
radiological or nonradiological hazardous materials in other segments of the physical structure. If the hazardous materials could be transported to other segments by common confinement systems or the lack of other physical barriers, the facility cannot be segmented for purposes of this rule.

Question 43

Is the Contractor Required To Incorporate Changes Directed by DOE Into the Safety Basis?

Answer 43

Yes. As stated in 830.202(c)(1), the contractor must incorporate in the safety basis for the facility, any changes, conditions, or hazard controls directed
by DOE.

Question 44

How Often Is the Contractor Required To Update the Documented Safety Analysis?

Answer 44

Each year, the contractor responsible for a DOE hazard category 1, 2, or 3 nuclear facility must update the
documented safety analysis to reflect all changes to the nuclear facility, the hazards, and the work. The updated documented safety analysis must be
submitted to DOE. If there were no changes to the nuclear facility or its activities or operations that affected the documented safety analysis over the
previous year, the contractor may instead send DOE a letter confirming that there were no changes.

Question 45

When Must a Contractor Use a USQ Process To Evaluate if a Situation Involves a USQ?

Answer 45

For DOE hazard category 1, 2, or 3 nuclear facilities may make physical and procedural changes
to a nuclear facility without DOE approval, provided those changes do not implicitly or explicitly affect the safety basis of the facility. USQ process is also used to assess newly discovered situations that might involve a potential inadequacy of the safety basis.

Question 46

What are the two USQ process steps?

Answer 46

The contractor must first determine whether
a situation involves a USQ. If it does, the contractor must inform DOE and then perform an evaluation to determine whether the existing safety basis is adequate to bound the situation.

Question 47

What are the conditions that exist and require a contractor to go through the USQ process?

Answer 47

· A temporary or permanent change in the facility as described in the existing documented safety analysis,
· A temporary or permanent change in the procedures as described in the existing documented safety analysis,
· A test or experiment not described in the existing documented safety analysis, or
· A potential inadequacy of the documented safety analysis is discovered for which the safety analysis
may not be bounding or may be otherwise inadequate.

Question 48

What are the steps that the contractor must do if the conditions are met to go through USQ process?

Answer 48

In this case, the contractor must (1) take action to place
the facility in a safe condition, (2) notify DOE of the situation, (3) perform a USQ evaluation, and (4) submit the USQ evaluation to DOE and obtain its
approval prior to removing any operational restrictions previously imposed.

Question 49

What is the first situation that involves a USQ (1 of 3)?

Answer 49

· the probability of the occurrence or the consequences of an accident or the malfunction of equipment important to safety previously evaluated in the facility documented safety analysis could be increased,

Question 50

What is the second situation that involves a USQ (2 of 3)?

Answer 50

· the possibility of an accident or malfunction of a different type than any evaluated previously in the facility documented safety analysis could be
created.

Question 51

What is the second situation that involves a USQ (3 of 3)?

Answer 51

· a margin of safety could be reduced.

Question 52

What is other situation that involves a USQ?

Answer 52

A situation also involves a USQ if there is a potential inadequacy of the safety analysis.

Question 53

What Is a USQ Summary and How Often Must a Contractor Submit It to DOE?

Answer 53

Each year, when the contractor submits its updated documented safety analysis to DOE, the contractor must also submit a report which summarizes
all situations for which the contractor performed a USQ determination since the prior submission. The report must summarize the results of those determinations.

Question 54

What Are ‘‘Safe Harbor’’ Methods?

Answer 54

Safe harbor methods are methods which we have already determined to be acceptable for use. The safe harbor methods are based on many years of experience with the types of facilities to which they may be applied.