1

New processes at existing facilities are those that require a license amendment under

10 CFR 70.72 and are defined by NUREG-1520 as “system-level or facility-level design

changes to process equipment, process technology, facility layout, or types of licensed material

possessed or used. Generally, this definition does not include component-level design changes

or equipment replacement.”

June 2005

FCSS Interim Staff Guidance-04, Revision 0

Clarification of Baseline Design Criteria

Prepared by

Division of Fuel Cycle Safety and Safeguards

Office of Nuclear Material Safety and Safeguards

Issue

Additional clarification is needed of the staff guidance for Baseline Design Criteria (BDC)

information and level of detail expected in Title 10 of the Code of Federal Regulations (10 CFR)

Part 70 licensing submittals for new facilities and new processes at existing facilities.

Introduction

The purpose of this Interim Staff Guidance (ISG) is to provide guidance for the type of

information and level of detail that the staff expects for submittals from licensees/applicants to

address the BDC (when required). This ISG provides additional clarification and detail for the

Integrated Safety Analysis (ISA) Summary review guidance contained in Section 3.4.3.2(4)d. of

NUREG-1520, “Standard Review Plan for the Review of a License Application for a Fuel Cycle

Facility.” This ISG is expected to assist the U.S. Nuclear Regulatory Commission (NRC)

technical staff in conducting efficient reviews of licensee/applicant commitments for the

application of BDC to the design of new facilities and new processes,1

 at existing facilities.

Discussion

Section 70.64(a) of 10 CFR requires applicants and licensees to address and apply ten BDC in

the design of new facilities and new processes at existing facilities, and to maintain the

application of these criteria unless demonstrated as not needed in the ISA. Ten general criteria

are specified and are required to be addressed in the applicant/licensee submittal and applied

to the design. Their application is also required to be maintained by the licensee unless the ISA

demonstrates that a given item is not relied on for safety or does not require adherence to the

BDC.

Section 70.65(b)(4) of 10 CFR requires that the ISA Summary must contain information that

demonstrates the licensee’s compliance with the requirements of 10 CFR 70.64 for BDC, if

applicable.

The regulatory requirements for BDC were intended to identify standard design methods and

principles that should be applied, implemented, and maintained for the design of new facilities

and new processes at existing facilities. Appropriate commitments addressing the BDC should

assure that safety considerations and features are incorporated as the design is developed and
FCSS Interim Staff Guidance-04, Rev. 0 - 2 -

June 2005

not found to be needed or inadequate during the final design stage, construction, or operation. 

The appropriate implementation of BDCs should facilitate the licensee/applicant’s safety

program implementation and maintenance and the ISA demonstration of compliance with the 

performance requirements of 10 CFR 70.61.

Regulatory Basis

10 CFR 70.64(a) and 10 CFR 70.65(b)(4)

Technical Review Guidance

The guidance for the type of information and level of detail expected for submittals intended to

address the BDC are as follows:

General Guidance

• The licensee/applicant should discuss how the design process provides for and assures

incorporation of the BDC. Extensive or specific design features or details are not

required, but may be useful for illustration or example. Commitments to specific industry

consensus standards, codes, or management measures may be used to describe the

methods and controls for BDC that are to be (1) applied during the design and (2) used

to maintain the application of these criteria unless it is demonstrated that they are not

required by the ISA. 

• BDC commitments by reference to other commitments in the licensee/applcant’s

submittal, such as of its management measures, is encouraged as long as there is

sufficient clarity and specificity of commitment and application.

• Additional management programs or systems specifically for application or

implementation of BDC should not be needed provided that there are adequate specific

commitments in, and/or references to, the licensee/applicant’s management measures

or other programs or systems.

• The licensee/applicant should identify and discuss separately each baseline design

criterion as part of its submittal.

• The licensee/applicant should state clearly how the BDC are to be applied to the design

of the new facility or process and how the actual design provides for each specified

requirement.

• The licensee/applicant should confirm that the application of the BDC will be maintained,

unless the ISA demonstrates that a given item is not relied on for safety or does not

require adherence to the specified criteria. The controls to be applied for maintaining

the BDC, and for demonstration that a given item is not relied on for safety or does not

require adherence to the BDC should be described. Commitments in this area by

reference to other commitments in the applicant/licensee’s submittal, such as its
FCSS Interim Staff Guidance-04, Rev. 0 - 3 -

June 2005

management measures (e.g. quality assurance or configuration management systems)

may be acceptable provided that there is adequate clarity and specificity of

commitments.

Specific Criteria Guidance

1. 10 CFR 70.64(a)(1), Quality Standards and Records 

• The licensee/applicant should state clearly how the design of the new facility or

process is developed and implemented in accordance with management

measures (see Section 11 of NUREG-1520 for additional guidance on

management measures). 

a. The submittal should address how appropriate management measures

are applied to the development and implementation of the design to

provide adequate assurance that the items relied on for safety (IROFS)

are adequate and available when called upon.

b. Reference to specific, definitive, and adequate commitments in other

parts of the submittal, such as management measures, industry

programs, or consensus standards may be sufficient.

• Information should be provided as to how appropriate records will be maintained. 

To avoid unnecessary duplication of information, the discussion could refer to

information contained elsewhere in the license/application pertaining to

applicable management measures. 

2. 10 CFR 70.64(a)(2), Natural Phenomena Hazards

• The licensee/applicant should state clearly how the design of the new facility or

process provides for adequate protection against natural phenomena with

consideration of the most severe documented historical events for the site (see

Section 3 of NUREG-1520. (Note: ISG-08, “Natural Phenomena Hazards,” is in

draft and may provide additional guidance in this area.)

• The discussion should specifically address how natural phenomena such as the

following were considered in the design of the plant:

a. Earthquakes and volcanoes;

b. Stream flooding (runoff, dam failures, downstream blockages);

c. Coastal flooding (hurricanes, tsunamis, seiches);

d. Winds including tornadoes;

e. Ice and snow loadings;

f. Temperature extremes.
FCSS Interim Staff Guidance-04, Rev. 0 - 4 -

June 2005

3. 10 CFR 70.64 (a)(3), Fire Protection

• The licensee/applicant should state clearly how the design of the new facility or

process provides for adequate protection against fires and explosions (see

Section 7 of NUREG-1520 for additional guidance on fire safety).

• If appropriate, the discussion should address how the design considered the

following:

a. The use of Fire Hazards Analyses in the ISA and pre-fire planning;

b. The facility design in regard to building construction, fire areas, life safety,

and ventilation;

c. Process fire safety including explosion protection;

d. Fire protection systems including detection and suppression;

e. Manual fire suppression capability.

4. 10 CFR 70.64(a)(4), Environmental and Dynamic Effects

• The licensee/applicant should state clearly how the design of the new facility or

process provides for adequate protection from environmental conditions and

dynamic effects associated with normal operations, maintenance, testing, and

postulated accidents that could lead to the loss of safety functions.

• The licensee/applicant should discuss how the design ensures that IROFS will

perform their safety functions under the environmental and dynamic service

conditions in which they will be required to function and for the length of time

their function is required. 

• The licensee/applicant should discuss how the design ensures that non-IROFS

will not prevent satisfactory accomplishment of safety functions of IROFS.

5. 10 CFR 70.64(a)(5), Chemical Protection

• The licensee/applicant should discuss how the design of the new facility or

process provides for adequate protection against chemical risks produced from

licensed material, facility conditions which affect safety of licensed material, and

hazardous chemicals produced from licensed material (see Section 6 of

NUREG-1520 for additional guidance on BDC for chemical process safety).

6. 10 CFR 70.64(a)(6), Emergency Capability

• The licensee/applicant should state clearly how the design of the new facility or

process provides for the emergency capability (see Section 8 of NUREG-1520

for additional guidance on emergency management) to maintain control of:

a. Licensed material and hazardous chemicals produced from licensed

material. The following should be discussed:
FCSS Interim Staff Guidance-04, Rev. 0 - 5 -

2

Essential utilities are the support systems that provide for the safety function of the

IROFS, e.g., power, air supply, ventilation.

June 2005

 ̃ How the site, facility, or process was designed to process and

store both licensed materials and hazardous chemicals either

produced from licensed material or used in the process. The

licensee/applicant may refer to its site-wide security plan, if

applicable.

 ̃ Controls on the interface of hazardous chemicals with the licensed

material process safety program.

b. Evacuation of onsite personnel. The following should be discussed:

 ̃ What criteria were used in the design of the facility to allow

personnel to evacuate, e.g., time, dose, ease of egress.

c. Onsite emergency facilities and services that facilitate the use of

available offsite services. The following should be discussed:

 ̃ What offsite services will be needed in an emergency at the

facility;

 ̃ What criteria was used to design the facility to detect accidents;

 ̃ What criteria was used to design the facility to alert facility staff of

an accident;

 ̃ What criteria was used to design the facility to notify and coordinate with both onsite and offsite personnel;

 ̃ What criteria was used to design the facility to allow for the

transportation of personnel to onsite and offsite facilities or

locations.

7. 10 CFR 70.64(a)(7), Utility Services

• The licensee/applicant should state clearly how the design of the new facility or

process provides for the continued operation of essential utility services2

. 

• The licensee/applicant could include design features such as the following as

possible methods to ensure continued operation of essential utilities:

a. For large essential electrical loads - a diesel generator with automatic

start on loss of normal electrical supply supported by periodic functional

testing, periodic battery checks, and configuration control;

b. For small essential electrical loads - an uninterruptible power supply

(UPS) supported by periodic functional testing, periodic battery checks,

and configuration control.
FCSS Interim Staff Guidance-04, Rev. 0 - 6 -

June 2005

8. 10 CFR 70.64(a)(8), Inspection, Testing, and Maintenance

• The licensee/applicant should state clearly how the design of the new facility or

process provides for adequate inspection, testing, and maintenance of IROFS to

ensure their availability and reliability to perform their function when needed (see

Section 11 of NUREG-1520 for additional guidance on management measures).

• The licensee/applicant could include design features for IROFS such as the

following as possible methods to provide adequate inspection, testing, and

maintenance to ensure their availability and reliability:

a. The capability for periodic test and inspection to assess the operability

and performance of IROFS;

b. The capability to test the functions of IROFS such as active engineered

controls as a completed functioning system and under appropriate design

conditions.

c. The capability to perform needed maintenance actions or to identify

system or component maintenance needs to assure availability of IROFS

features that are relied upon in the ISA to meet the 10 CFR 70.61

performance criteria.

9. 10 CFR 70.64(a)(9), Criticality Control

• The licensee/applicant should state clearly how the design of the new facility or

process provides for criticality control (see Section 5 of NUREG-1520 for

additional guidance).

• The discussion should identify how the following were considered in the design:

a. Subcriticality under normal and abnormal conditions;

b. Criticality accident alarm system;

c. Implementation of double contingency.

• The licensee/applicant could indicate its preference in the selection of controls

such as:

a. Engineered over administrative controls;

b. Favorable geometry design;

c. Two-parameter control.

10. 10 CFR 70.64(a)(10), Instrumentation and Controls

• The licensee/applicant should state clearly how the design of the new facility or

process provides for the inclusion of instrumentation and control systems to

monitor and control the behavior of IROFS.
FCSS Interim Staff Guidance-04, Rev. 0 - 7 -

June 2005

• The licensee/applicant could include the following design features as possible

methods to monitor the behavior of IROFS:

a. Failure detection diagnostics.

b. Information read-out in the control room or locally for variables (e.g.,

temperature, pressure) used in active engineered and augmented

(sometimes referred to as enhanced) administrative controls.

c. Bypass indication for IROFS intentionally rendered inoperable more often

than annually.

• The licensee/applicant could include in the design features such as the following

to control the behavior of IROFS:

a. Manual initiation of each individual active engineered control ensuring

that all associated safety actions occur at the system level with a minimal

amount of manual controls/circuitry.

b. Completion of a safety function once it has been initiated (seal-in

capability).

c. System restoration requiring deliberate operator action (for example, a

valve closed as a result of an automatic safety actuation should not reopen automatically when the safety signal is restored; it should remain

closed until re-opened by manual action).

d. Indication to the operator that a safety action has been initiated

Recommendation

This ISG should be utilized as additional guidance in conjunction with that in Section

3.4.3.2(4)d. of NUREG-1520.

References

U.S. Code of Federal Regulations, Title 10, Energy, Part 70, “Domestic Licensing of Special

Nuclear Material.”

U.S. Nuclear Regulatory Commission (U.S.) (NRC). NUREG-1520, “Standard Review Plan for

the Review of a License Application for a Fuel Cycle Facility.” NRC: Washington, D.C.

March 2002.

Approved: ______/RA/____________ Date: _June 9, 2005

 Robert C. Pierson, Director 

 Division of Fuel Cycle Safety

 and Safeguards, NMSS