Inteunatlnal Isotopes Jne.

May 3, 2011

ATTN: Document-Control Desk

U.S. Nuclear Regulatory Commission

Washington, DC 20555-0001

Subject: Submittal of Responses to Requests for Additional Information (RAI)

TAC L32739.

To Whom it May Concern,

The following document is provided as a response to the US Nuclear Regulatory Commission

RAIs pertaining to the International Isotopes Fluorine Products Inc. December 30, 2009

application to license a depleted uranium hexafluoride de-conversion and fluorine extraction

process facility.

(1) Official Responses to HunIian Factors RAIs

Please contact me by phone at 208 524-5300 or email at ijmiller2intisoid.com if you have any

questions regarding this letter or require additional information.

Sincerely,

John J. Miller, CHP

Radiation Safety Officer

JJM-201 1-31

Enclosure as Stated

cc: Dr. Matthew Bartlett

U.S. Nuclear Regulatory Commission

Mail Stop E2C40M

6003 Executive Blvd.

Rockville, MD 20852

4137 Commerce Circle, Idaho Falls, Idaho 83401

Phone: 208-524-5300, 800-699-3108 Fax: 208-424-1411

Website: www.intisoid.com

pAAoo I
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Official Responses to Human Factors RAls

10 CFR 70.61(e) requires a safety program to ensure that each IROFS will be available and reliable to

perform its intended function when needed. Many of these administrative IROFS and supporting

management measures rely on personnel activities to support the safety function (e.g., maintenance).

Staff guidance contained in NUREG- 1513, "Integrated Safety Analysis Guidance Document, " identifies

that for administrative controls (e.g., certain human actions), "... the man-machine interface for that

individual should be carefully designed." Given that the International Isotopes application contains

many IROFS that rely on human action, the human system interfaces and control systems associated with

these IROFS must be designed to adequately support operator task performance.

HF-1. Criterion A, Appendix E ofNUREG-1520 states that the applicant should appropriately identify

the personnel activities that are considered IROFS such that a reviewer can understand the

actions, human-system interfaces involved, and the consequences. ISA Table 4-3 contains the

Accident Sequence Summary and Risk Index for a number ofpotential events, many of which are

either labeled "operator error" or which appear to involve human action. However, the humansystem interfaces involved are not identified

a. Identify the human-system interfaces involved in the accident sequences that include human

actions, such that the impact on the IROFS can be evaluated

RESPONSE: A "what if' method was used for the accident and consequence analysis process of

the IIFP Process Hazard Analysis (PHA) and relied upon the considerable engineering and

operations experience of the ISA team. This approach generally leads to a conservative evaluation

with reference to safety significance as the participants consider "worst case" scenarios in the

"what if' PHA method. Human factors and human-system interface were considered as part of

the accident analysis review and discussion process. However, these considerations of human

factor aspects were not done at the level and structure of the current NUREG- 1520, Appendix E

because the accident analysis and PHA information used in developing the IIFP License

Application was conducted and completed prior to the revisions to NUREG- 1520, Revision I

Appendix E, criterion E.

The IIFP License Application (LA) will be revised as shown below in License Documentation

Impact number I to include the IIFP commitment to incorporate acceptable human factors

engineering standards and applicable requirements into the safety and design program. Because

the human factors and human-system interface (HSI) design supporting the IIFP safety analysis is

not at the detail design stage, information relative to human tasks, specific human-system

interfaces (HS Is) design or style guides, configuration of alarms, controls, displays and valve

alignment configurations are not yet available for evaluation. IIFP is committed to incorporate

acceptable human factors engineering standards, guidance and practices into the safety and design

program.

The basic Human Factors Engineering (1-FE) Implementation Plan (referred to as the Plan) is

being added to the IIFP Integrated Safety Analysis (ISA) Summary as shown below in the

License Documentation Impact number 2 below. The Plan has been renamed the "HFE

Implementation Plan" to replace the name "HFE Design Review Plan" that was submitted in the

response to the draft Human Factors RAIs. This title change is being made to better reflect that

human factors will be considered and developed beyond just the design aspects. Human factors

will also be addressed during development of operating procedures, personnel training and other

management measurement procedures involving Items Relied On For Safety (IROFS). The Plan

being incorporated into the ISA Summary identifies the IIFP program elements, describes the

basic processes by which these elements will be implemented and further assures IIFP

commitments to HFE consideration in the design and operation of the IIFP Facility. The

implementation process for each HFE element will be applied accordingly to ensure consideration

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of the HFE aspects for the IROFS structures, systems and components (SSCs) once those SSCs

are defined and prior to actual design and design review. The Plan and its elements will be

updated by the HFE/ISA team, approved by IIFP and reviewed by the affected design engineers

prior to beginning detail design of the IROFS SSCs. The HFE/ISA team authorization and

responsibilities are discussed in paragraph number 4 of the ISA Summary Section 4.6. Before

beginning that IROFS detail design, the Plan update will be made available for NRC staff review

including the identification of human-system interfaces involved in the IROFS, actions and

consequences of those human-interface actions, and a design review or style guide focused

toward a depleted uranium de-conversion facility.

License Documentation Impact (1): Section 3.2.5.8 of the IIFP LA will be revised by adding

the following to the end of the section.

Where IROFS involve human actions, human factors shall be considered, and human system

interfaces will be designed in accordance with applicable guidance provided in NUREG-0700,

"Human-System Interface Design Review Guidelines," Revision 2, May 2002, (USNRC, 2002a)

NUREG-07 11, "Human Factors Engineering Program and Review Model," Revision 2, February

2004 (USNRC, 2004), and NUREG- 1520, "Standard Review Plan for the Review of a License

Application for a Fuel Cycle Facility," Revision 1, Appendix E, "Human Factors Engineering for

Personnel Activities", May 2010 (USNRC, 2010).

License Documentation Impact (2): Renumber ISA Summary Section 4.6 "References" to

Section 4.7 "References." Add a new Section 4.6 "Human Factors Engineering and

Implementation" to the IIFP ISA Summary to read as follow.

4.6 Human Factors Engineerinig and Implementation

IIFP commits to following acceptable Human Factors Engineering (I-FE) guidance for personnel

activities identified as safety significant (involving IROFS). The Integrated Safety Analysis (ISA)

Summary will be used to identify those areas and to further determine whether an Item Relied on

for Safety (IROFS) has special or unique safety significance relative to human factors. Where

IROFS involve human actions, they will be evaluated further to consider potential consequences

of human related errors or failures. The goal of this application of HFE to personnel activities is

to ensure that the potential for human error in facility operations is addressed during the design of

the facility and during operating procedure development and personnel training to minimize

human error and resulting impacts and to provide means for detecting and correcting or

compensating for error.

IIFP intends to comply with HFE guidance provided in NUREG-0700. "Human-System Interface

Design Review Guidelines," Revision 2, May 2002, NUREG-071 1, "Human Factors Engineering

Program and Review Model," Revision 2, February 2004, and NUREG- 1520, "Standard Review

Plan for the Review of a License Application for a Fuel Cycle Facility," Revision 1, Appendix E,

"Human Factors Engineering for Personnel Activities, May 2010.

The Human Factors Engineering (HFE) Implementation Plan identifies the IIFP program

elements, describes the basic processes by which these elements will be implemented and further

assures IIFP commitments to HFE considerations in design and operation of the IIFP Facility.

The implementation process for each HFE element will be applied accordingly to ensure

consideration of the HFE aspects for the IROFS structures, systems and components (SSCs) once

those SSCs are defined and prior to actual design and design review.

The IIFP President will approve the makeup and membership of a joint HFE/ISA team and

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delegate the authority to this team to carry out the responsibilities of: 1) identifying the humansystem interfaces relative to IROFS and evaluating actions and consequences involved, 2)

developing the specific information for updating the Plan prior to actual detail design of IROFS,

3) interviewing persons with technical, operational or maintenance experience in processes and

controls associated with facilities handling, processing or manufacturing UF6 UFE4 and uranium

oxide and related radiological or chemical hazards and 4) coordinating and communicating with

the design team, QA staff and the IIFP Facility project team to develop and implement criteria,

requirements. design review (style) guidance and findings of analyses derived from the Plan

implementation processes.

The HFE Implementation Plan will be developed in accordance with the nine elements of the

I-FE design process described in NUREG-1520, Rev.l Appendix E and will encompass all of the

following elements and their sub-elements:

Section 1.0 Identification of Personnel Activities (El)

Section 2.0 HFE Design Review Planning (E2)

Section 3.0 Operating Experience Review (E3)

Section 4.0 Functional Allocation Analysis and Task Analysis (E4)

Section 5.0 HSI Design, Inventory, and Characterization (E5)

Section 6.0 Staffing (E6)

Section 7.0 Procedure Development (E7)

Section 8.0 Training Program Development (E8)

Section 9.0 Verification and Validation (E9)

Brief descriptions as to how the elements of HFE provided in Appendix E of NUREG-1520 will

be implemented are provided in sections 4.6.1 through 4.6.9 of the ISA Summary.

The HFE design process to be used for the IIFP Facility is depicted in Figure 4-1.

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PLANT DESIGN

-, ~ IRENIFYOALS

- TAiJSEEAM -

E3; OPERATING EXPERIENCE.REVIEVA

CONCEPT DESIGN OF PROCESS CONTROL

ROOMS

• TASK DEFINITION

FUNCTION ALLOCATION

HUMAN & COMPUTER

• PERSONNEL ORGANIZATION

• CR LAYOUT

'ITh IDENTIFICATION OFE56N

E I FUNCTIONALALLOCATION

* ER STAFFING & QUALIFICATION

OPERATION TASK ANALYSIS

' NORMAL OPERATION

EMERGENCY OPERATION

E4TýAUAAYI

HUMAN SYSTEM INTERFACE DESIGN

• INFORMATION ALLOCATION

• DISPLAY & CONTROL

* PROTOTYPING

ES HUMAN SYSTEM ,INTERFACE DESIGN

Ri E7FPROCEURE DEVELOPMENT,

*1_

EVAROATION OF RIU DESIGN

VERIFICATION

S HAFE/HSI DESIGN VERIFICATION

TASE SUPPORT VERIFICATION

ISSUE RESOLUTION VERIFICATION

VALIDATION PART-TASE SIMULATOR]

* INTEGRATION SYSTEM VALIDATION

* PROCEDURE VALIDATION

F: 9%VRIFICATRION UVAUDATION

LR:TRAININGIPOGRAM

DEVELOP

M

EN

T

N APE ELEMEN!,OF NUR IEG IS21 I HFE DESIGN PROCESS

Figure 4-1 IIFP Facility Human Factors Engineeringi Design Process

4.6.1 Identification of Personnel Activities

The ISA Summary will be the guidance document used to identify personnel activities which are

safety significant. There are some IROFS which involve primarily human actions, namely the

Administrative Control (AC) and Enhanced Administrative Control (EAC) IROFS. Personnel

actions involved with these IROFS will be addressed primarily through training and procedures

as human-system interfaces (HSIs) for these IROFS are minimal and do not involve complex

equipment or systems. For Engineered Control (EC) and Passive Engineered Control (PEC)

IROFS, the equipment and systems are more complex and additional consideration is warranted.

IROFS boundar definitions of structures, systems and components (SSCs) are critical in the

identification of personnel activities and corresponding HSIs.

4.6.1.1 Identification of Personnel Activities - Implementation Actions

Members of the HFE/ISA team will review, consider and evaluate the IROFS to identify

personnel activities, human-systems interfaces, and consequences after the IROFS SSCs

boundaries are defined but prior to HSI design activities.

4.6.2 HFE Design Review Planning

4.6.2.1 Scope and Goal Identification

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The HFE program for the IIFP Facility will be developed in accordance with the nine elements

specified in Appendix E of NUREG-1520. Design goals will be used that assure the following are

accomplished:

* Critical personnel tasks are defined and accomplished within applicable time and

performance criteria.

• The anthropomorphic standards for the relevant population are defined and applied.

* HSIs, procedures, staffing/qualifications, training, management, and organizational variables

support a high degree of operating crew situational awareness.

" Allocation of functions accommodates human capabilities and limitations.

• Operator vigilance is maintained and distractions are minimized.

* Acceptable operator workload is met.

* Operator interfaces contribute to an error free environment.

* Error detection and recovery capabilities are provided.

* Control areas minimize stressors and fatigue while assuring adequate communication.

4.6.2.2 ISA Team and Oualifications

A single ISA team completed all aspects of the ISA activities. Team member qualifications were

consistent with guidance provided in NUREG 1520 (USNRC, 2002b). The ISA team was made

up of a diverse group of individuals with expertise in engineering, safety, safety analysis, and UF6

and general uranium chemistry. The team possessed expertise in the following range of

specialties, at a minimum:

" Facility and chemical process safety:

* Health physics and radiation protection:

* Chemical, mechanical, and electrical engineering:

* Plant operations and maintenance:

* Process hazards analysis:

o Safety analysis and risk assessment;

* UFs and chemical/nuclear processing: and

• Fire safety.

The ISA team members are trained, knowledgeable and experienced in a wide array of ISA

methods including hazards identification, process hazards analysis (PHA), and safety analysis and

risk assessment at various chemical/nuclear facilities. The team was ultimately responsible for the

methods and approach of the overall ISA development.

4.6.2.3 HFE Expertise Added to Project Team

An Engineer with experience in human factors engineering is being added to the ISA team

through the Design and Build Contractor. This arrangement and approach provide for the HFE

designated Engineer to become involved in reviews and updates of accident analyses and to

ensure continuity of HFE considerations by the design team as the project progresses. This

Engineer will be involved in the development and refinement of the I-FE Implementation Plan

that applies a structured approach to I-FE. The Engineer will work with the ISA team and the

design team to ensure that HFE and human-system interface (HSI) requirements are being met.

The Engineer being added to the IIFP project has more than 20 years of experience in

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engineering, design, and specification of instrumentation and control systems and equipment

including instrumentation of process systems, the preparation of specifications, logic and loop

diagrams, instrument lists, and system descriptions. The Engineer's expertise includes using good

Human Factors Engineering (HFE) practices. The Engineer's experience also includes

development of instruments and control criteria including HFE criteria and HFE references used

in nuclear power plants' control room designs such as EPRI NP-3659 (Kincaide, 1984). NUREG0700 and NUREG- 0711 as well as ANS/IEEE Standard 1023 (IEEE, 2004).

4.6.2.4 HFE Design Review Planning - Implementation Actions

During the design and construction stages of the facility, IIFP will rely heavily on the HFE

expertise of the Design and Build Contractor and the ISAIHFE team to accomplish the above

goals. Various aspects of personnel activities including the HSIs will be developed, designed, and

evaluated on the basis of a structured approach using HFE as depicted in the HFE Design Process

shown above. As the facility nears operating status, the staffing, training development, and

procedure development elements will be implemented by the IIFP team. The tracking and

maintenance of HFE elements will naturally transition to the Quality Assurance and

Configuration Management prorrams designed and maintained by IIFP personnel. In this way,

FIFE will be applied to any subsequent changes of equipment. controls, or systems affecting

IROFS and human-system interfaces.

The 1IFE Implementation Plan will be developed in accordance with the nine elements of the

HFE design process described in NUREG-1520, Rev. I Appendix E (USNRC, 2010) and

encompass the elements of Sections 1.0 through 9.0. The scope of the HFE Implementation Plan

includes the applicable Process Control Room, alarm and control instrumentation, and local

panels, supporting procedures, training, applicable operations, accident management, emergency

response management, maintenance, tests, inspection and surveillance interfaces (including

procedures), facility management, and facility personnel. The HFE design process implementing

the above elements will follow the NUREG 0711, 1.2.1(4) guidance and requirements.

4.6.3 Operating Experience Review (PER)

The IIFP ISA/FIFE team and the Design and Build Contractor will identify safety-related FIFE

events or potential events in past and existing facilities that are similar to the IIFP Facility. This

knowledge base will be used in identifying safety-related issues.

4.6.3.1 Review of HFE-Related Events - Implementation Actions

NRC and DOE event reports will be reviewed to identify potential safety issues especially as they

relate to HFE. Intemet searches of recognized databases (to include the DOE Office of Scientific

and Technical Information (OSTI) Information Bridge) will also be performed to find safety and

HFE related information.

4.6.3.2 HSI Technologry Review - Implementation Actions

Searches for relevant HFE events or potential events will focus not only on personnel actions

involved but also on HSI technology employed at these facilities so that the same issues can be

prevented in the IIFP Facility. It is recognized that improper design or euipment selection may

be a root cause of safet and HFE related issues.

4.6.3.3 Review of Similar Facilities - Implementation Actions

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Discussions will be held with personnel possessing a broad base of experience in uranium

processing and other manufacturing applications. Examples of this experience include using

autoclaves to feed UF 6, reacting UF6 to produce other products (de-conversion), producing and

handling UF 4 and uranium oxides, packaging fluorine products, using refrigeration systems and

cold traps, handling HF, and transporting UF 6, H4F, fluorine products, and radiological wastes.

Potential sources for such reviews include, but are not limited to, the DOE DUF 6 de-conversion

facilities in Paducah, Kentucky and Portsmouth, Ohio, the Areva EREF and Urenco USA

centrifuge enrichment facilities, and the Seciuoah Fuels Corporation depleted UF4 former plant

personnel. Other valuable resources which may be used include uranium conversion facilities

(UF 6 manufacturing), other uranium processing plants, and gas manufacturing and packaging

facilities.

4.6.4 Functional Allocation Analysis (FAA) and Task Analysis (TA)

4.6.4.1 Functional Allocation Analysis

Actual operating experience provides a good basis for determining personnel allocation to

accomplish necessary work tasks in a safe and efficient manner. IIFP will use Functional

Allocation Analysis to take advantage of human strengths and to avoid placing demands on

personnel which are not compatible with human capabilities.

4.6.4.2 Functional Allocation Analysis - Implementation Actions

The OER including Design and Build Contractor experience will be used to functionally allocate

personnel activities and to assign these activities to worker categories. The OER will be based

primarily on reviews of operations and experience at facilities involving UF6, UF4 and uranium

oxides and interviews about hazard and related controls with technical, operations, and

maintenance function workers with experience at such facilities. These reviews will also provide

a good basis for initial staffing requirements for both operations and maintenance personnel.

4.6.4.3 Task Analysis

Task analysis involves determining the re-quirements of personnel to successfully and safely

prform complex real-time control actions as part of the job assignments which result from

functional allocation. Task analysis is also used extensively in procedure development.

4.6.4.4 Task Analysis - Implementation Actions

Task analysis will include the scope, identification, and analysis of critical tasks focusing on

personnel demands in the performance of these tasks. The task analysis process will be used to

evaluate normal operations and also startup, shutdown, and emergency operations. Task analysis

results will be used to support the functional allocation and are a primary consideration in HSI

design as ways to best perform these tasks. Also, iob design issues are considered.

4.6.5 HSI Design, Inventory, and Characterization

The HSI design process uses inputs from the OER, the FAA, and the TA to translate function and

task requirements into HSI characteristics and functions. A structured methodology will be used

to identify and select the HSI approach. define the detailed design, and perform validation and

verification testing. The minimum inventory of HSIs, displays, alarms and control instruments for

each control process involving IROFS will be developed from structured review and evaluation

of the IROFS control function, the IROFS functional information and input derived from OER,

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FAA and TA results. The ISA Summary change control process that is implemented through the

IIFP configuration management measures will be the method of ensuring the inventory list is kept

up to date during design stage and later during facility maintenance. This structured methodology

and its results will be documented in accordance with requirements of the IIFP Quality Assurance

Program Description.

4.6.5.1 HSI Design - Implementation Actions

The HSI design will incorporate the FAA and the TA processes into the detailed design of safetysignificant HSI components (e.g. alarms, displays, controls, and operator aids) through the

systematic application of HFE. The work environment will also be considered to include Control

Room and remote shutdown area layouts, control panel and console design, control and display

device layout, and information and control interface design details. Extraneous controls and

displays will be identified through the above described process techniques and eliminated.

A structured, systematic approach will be applied to the human factors considerations for the

Process Control Room as well as local control stations or panels. This involves performing the

following for each:

" Task definition,

• Function allocation (human and computer: personnel organization),

* Layout of Process Control Rooms, local control stations,

* Functional Requirements Analysis and Function Allocation, and

* Staffing and Qualification

The Process Control Rooms will be designed based on the OER findings and the experience of

the HFE/ISA team and the proiect design engineers as applicable. The HSI will be based on

designs in similar facilities but modernized using the ergonomic and digital technology such as

Visual Display Units (VDU) integrated into work stations, soft controls, large panel displays,

adequate work surfaces, performance enhancing fumiture, etc. with the layouts being determined

based on the tasks of the operators. The number, location, spatial arrangements, sizes, and relative

positions of control consoles will be established using proven HFE principles, guidelines, and

experience gained from similar facilities and design review criteria derived from published

standards. Design review criteria and style guidance with consideration for human factors for

layouts, locations and configurations of alarms, displays and control instrumentation will be

developed for use by the design engineers prior to beginning actual Control Room and associated

instrumentation designs.

Ergonomics of the human-system interface will include determination of environmental

conditions (lighting, noise, ambient working temperatures, radiation, air quality, and humidity) in

the Process Control Rooms, and at local control stations. Designs will employ well-accepted

International Building Code (IBC) standards with consideration for the ergonomic design aspects.

Extraneous controls and displays will be identified during the Task Support Verification process.

Unnecessary HSI components will be identified for HSIs that are available in the HSI but are not

needed for any task. Unnecessar HSIs introduce clutter and can distract personnel for the

selection of appropriate HSIs. It is important to verify that the HSI is actually unnecessary. If an

HSI component has no associated personnel tasks because the function and task analysis was

incomplete, then any shortcomings in that analysis are identified and resolved.

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4.6.6 Staffing

While primary emphasis will be placed on sufficient staffing to operate the plant safely, the need

to operate the plant efficiently will also be a factor to be considered in the development of

staffing goals. The conceptual design team and the Design and Build Contractor have extensive

staffing experience in facilities where similar work is performed such as UF 6 cylinder handling

and feeding, drum handling and filling, chemical process operations, waste treatment operations,

radiation monitoring, and laboratory sampling and analysis.

4.6.6.1 Staffing - Implementation Actions

The OER, the FAA, and the TA are initially used to determine staffing requirements, and

consideration will be given to these requirements throughout the design process. Qualifications

for skilled positions will be established and candidates will be measured against those

qualifications in the selection of the workforce. The initial estimates of staffing requirements and

the acceptability of staffing goals will be evaluated throughout the design process as facility

layout and required worker activities are better defined. Categories of personnel will be based on

types of personnel activities and issues identified in the OER, the FAA and TA. HSI design,

procedure development, and verification and validation will be used to address staffing

considerations. Regulatory requirements will also be considered and may impact staffing.

4.6.7 Procedure Development

IIFP will incorporate HFE principles and criteria and design requirements into procedures that are

technically accurate, comprehensive, explicit, user-friendly, and validated. The elements of HFE

set forth in Appendix E of NUREG-1520 will be considered in procedure development.

Procedures may include generic technical guidance, plant and system operations, abnormal and

emergency operations, system or process testing (e.g. pre-operational, startup, and surveillance),

and alarm response.

Procedures are developed or modified through a formal process incorporating the change controls

described in Section 11.1.5 of the License Documentation (IIFP, 2009a). The procedures process

utilizes nine basic elements to accomplish procedure development, review, approval, and control.

These elements are Identification, Development, Verification, Review and Comment Resolution,

Approval, Validation, Issuance, Change Control, and Periodic Review. See Chapter 11 of the

License Application (IIFP, 2009a) for details of these elements.

4.6.7.1 Procedure Development - Implementation Actions

Production work aside from routine custodial and office duties will be governed by approved

procedures. Additionally, program requirements will be implemented via procedures, where

applicable. Procedures are necessary to provide consistent and reliable performance of site-wide

activities.

Applicable safety limits and IROFS will be clearly identified in the procedures. IIFP will

incorporate methodology for identifying, developing, approving, implementing, and controlling

operating procedures. Identifying needed procedures will include consideration of ISA results.

The method will ensure that, as a minimum:

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* Operating limits and IROFS are specified in the procedure.

* Procedures include required actions for off-normal conditions of production, as well as

normal production.

* Needed safety checkpoints are identified at appropriate steps in the procedure.

* Procedures are validated through field tests.

* Procedures are approved by functional managers responsible and accountable for the

operation.

* A mechanism is specified for revising and reissuing procedures in a controlled manner.

* The QA elements and CM program at the facility provide reasonable assurance that

current procedures are available and used at all work locations.

IROFS and other safety related items will be highlighted in work procedures, typically as

"cautions" and "warnings." Procedures will be developed and approved by the responsible

organizations. Employees will be trained on all procedures they follow as part of their work

assignments, and work procedures and supplemental safety related procedures are expected to be

located in the general work areas. Temporary work shall be performed under temporary work

orders or radiation work permits (RWPs).

Facility and process changes will require procedure updates in the form of revisions, and such

revisions shall be in place before restart of the operation can commence. Changes to safety

systems and safety basis documentation shall also be incorporated into respective procedures.

Employees will be retrained on the revised procedures before the restart of work.

4.6.8 Training Program Development

The principle objective of the IIFP training program system is to ensure iob proficiency of facility

personnel through effective training and qualification. The training program system is designed to

accommodate future growth and meet commitments to comply with applicable established

regulations and standards. Employees are provided with training to establish the knowledge

foundation and on-the-iob training (OJT) to develop work performance skills. Continuing training

will be provided, as required, to maintain proficiency in these knowledge and skill components,

and to provide further employee development.

4.6.8.1 Training Program Development - Implementation Actions

Training program development will address all personnel activities in the performance of job

tasks involving IROFS. It is anticipated that training will involve familiarization with procedures.

equipment, systems, controls, alarms. etc. The personnel will be trained in all areas involving

IROFS necessary to perform their job assignments safely and efficiently. The evaluation of

personnel knowledge and skill requirements will be a part of this process. It is intended that the

training program development will be coordinated with other activities of the 1FWE design process

and will be implemented in an effective manner consistent with human factors principles and

practices.

Qualifications and training requirements will be established for each functional type of work.

Qualifications will include minimum education, technical background, experience, etc., along

with physical skills needed to perform individual tasks. Employees will be provided formal

classroom training and on-the-iob training specific to their duties, as applicable. Workers shall

read, understand, and follow formal area procedures when performing work. Additionally,

workers shall understand and obey requirements in work orders, hot work permits, and radiation

work permits (RWPs) along with posted limits and controls. Job Task Analysis will be used to

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supplement training when tasks associated with IROFS are involved.

Job qualification will be indicated by successful completion of prescribed training, demonstration

of the ability to perform assigned tasks, and the maintenance of requirements established by

regulation. A graded approach to systematic training will be used that applies the level of detail

needed relative to safety. This graded approach incorporates methods to accomplish the analysis,

design, development, implementation, and evaluation of training.

Along with job specific training mentioned above, all employees will be given formal general

employee training and safety training, as needed. General worker training includes site access

information and an overview of site hazards, emergency alarms, and evacuation plans. Safely

training may include radiation worker training, hazards communication, and general health and

safety training. Training and qualification related documentation will be maintained as quality

records. Continuing training and continuous improvement will be an emphasis for the entire

workforce.

4.6.9 Verification and Validation (V&V)

4.6.9.1 HSI Task Support Verification

HSI task support verification will be a part of the HFE V&V process. The objective of task

support verification is to verify that the HSI provides all alarms, information, and control

capabilities and procedures required for personnel tasks. It verifies that all monitoring and

operating functions are available, and that all operational controls are both possible and

functional.

4.6.9.2 HSI Task Support Verification - Implementation Actions

The criteria for Task Support Verification come from task analyses of HSI requirements for

performance of personnel tasks that are defined for selected operational conditions. An example

of the criteria to be used is as follows:

i. General Methodology - The HSIs and their characteristics (as defined in the HSI

inventory and characterization) will be compared to the personnel task requirements

identified in the task analysis.

ii. Task Requirements Deficiencies - Human Engineering Discrepancies (HEDs) will be

identified when:

" An HSI needed for task performance (e.g., a required control or display) is not

available, or

" HSI characteristics do not match the personnel task requirements. e.g., a display

shows the necessary plant parameter but not the range or precision needed for the

task.

iii. Unnecessary HSI Components - An HED will be identified for HSIs that are available in

the operating area but are not needed for any task. Unnecessary HSIs introduce clutter

and can distract personnel for the selection of appropriate HSls. it is important to verify'

that the HSI is actually unnecessary.

If an HSI component has no associated personnel tasks because the function and task analysis

was incomplete, then any shortcomings in that analysis are identified and resolved.

4.6.9.3 HFE Design Verification

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HFE design verification is used to determine whether HFE has been used in the design HSI.

4.6.9.4 HFE Design Verification - Implementation Actions

HFE design verification will be performed to determine that each HSI identified for personnel

activity has HFE incorporated into the design. Deviations from accepted HFE principles and

guidelines will either be justified or documented for resolution.

4.6.9.5 Integrated System Validation

The HFE Program will include Integrated System Validation testing. "Integrated system

validation is the process by which an integrated system design (i.e., hardware, software, and

personnel elements) is evaluated using performance-based tests to determine whether it

acceptably supports safe operation of the plant. It is intended to evaluate the acceptability of those

aspects of the design that cannot be determined though such analytical means as HSI task-support

verification and FIFE design verification" (NUREG-07 ! 1).

4.6.9.6 Integrated System Validation - Implementation Actions

It is anticipated that the validation testing will be performed using a test bed that is a "part-task"

simulator. The part-task simulator is not a "full scope, high realism" simulator but one that will

provide a suitable representation of the Process Control Rooms and local control panels using

analytical means that will adequately validate and test the design. It will have a high degree of

physical, functional, data completeness, data content, and data dynamics fidelity. The part-task

simulator will also be used as a training tool as well as a design tool for developing new or

upgraded software.

These evaluations will be performed, where IFOFS are involved, by knowledgeable personnel to

perform task walkthroughs, reviews of task analysis and functional analysis findings, engineering

drawing reviews against field conditions, flow charting of procedural steps, operational task

charts, and analysis of simulator results. These techniques, where applicable, will be used to

validate the following (as a minimum):

" Validate the role of plant personnel,

* Validate staffing assignments,

• Validate each human ergonomic function,

* Validate specific personnel tasks,

* Validate that the integrated system performance is tolerant of failures, and

* Validate procedure adequacy, allocation, and fidelity.

4.6.9.7 HFE Issue Resolution Verification

The HFE Implementation Plan will be subject to the requirements of the Quality Assurance

Program Description (OAPD) and all HFE requirements and design documents will be controlled

under the design control provisions of the configuration management program and subiect to the

same change control as analysis, specifications, and drawings.

Additionally, a corrective action program is described in Chapter 11, Section 11.6 (IIFP, 2009a)

and in the OAPD (IIFP, 2009d), Section A. 15 of the IIFP License Application. This corrective

action program and the related implementation procedures include root-cause analysis of issues

related to Quality Assurance and Environmental Safety and Health. Consideration of human

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factors is one of the basic elements and integral parts of the root-cause analysis methodology.

When HFE issues arise, those will be incorporated into the corrective action program with a

commitment to follow through on the corrective action to resolution.

4.6.9.8 HFE Issue Resolution Verification - Implementation Actions

The check and review process will be performed by qualified, independent reviewers (other than

those who performed the design) as described in the QAPD. The results of 1iFE V&V activities

will be summarized in a summary report and any discrepancies will be identified in a Human

Engineering Discrepancy (HED) report. The HED report will also include the resolutions.

HFE will be included in the facility modification procedure as a review/evaluation activity for

any modifications that may impact Human-System Interfaces. Modifications affecting HSls may

be implemented for the following reasons:

* Obsolescence,

" Lack of spare parts,

* Lack of vendor support,

* New functionality requirements,

* Improved process performance,

* Enhanced operator performance, and

* Others.

If the assessment reveals that the modification affects HSI, the HFE process will be applied. This

approach to assessing modifications will be included in the HFE Implementation Plan.

License Documentation Impact (3): Renumber ISA Summary, Section 4.6 "References" to

Section 4.7 References" and revise or add references, as applicable for ISA Summary Chapter 4.

4.64.7 References

IIFP, 2009a. International Isotopes Fluorine Products, Inc., "Fluorine Extraction Process & Depleted Uranium De-conversion Plant (FEP/DUP) License Application. December 2009.

I1FP, 2009b. Internation Isotopes Fluorine Products, Inc., ""Fluorine Extraction Process & Depleted Uranium De-conversion Plant (FEP/DUP) Emergency Plan.2009.

IIFP, 2009c. International Isotopes Fluorine Products, Inc., ""Fluorine Extraction Process &

Depleted Uranium De-conversion Plant (FEP/DUP) Integrated Safety Analysis Summary,"

December, 2009.

IIFP, 2009d. International Isotopes Fluorine Products, ""Fluorine Extraction Process & Depleted

Uranium De-conversion Plant (FEP/DUP) Quality Assurance Program Description." December

2009.

IEEE, 2004. Institute of Electrical and Electronic Engineers, IEEE-1023. "IEEE Recommended

Practice for The Application of Human Factors Engineering to Systems, Equipment, and

Facilities of Nuclear Power Generating Stations and Other Nuclear Facilities." 2004.

Kincaide, 1984. Kincaide, R.G., and Anderson J., Electric Power Research Institute. "Human

Factors Guide for Nuclear Power Plant Control Room Development." EPRI/NP-3659, 1984

Human Factors RAI Official Responses

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USNRC, 2002a. U. S. Nuclear Regulatory Commission, NUREG-0700, "Human-System

Interface Design Review Guidelines," Revision 2, May 2002.

USNRC, 2002b. US Nuclear Regulatory Commission, NUREG-1520. "Standard Review Plan for

the Review of a License Application for a Fuel Cycle Facility.,"2002.

USNRC, 2004. U.S. Nuclear Regulatory Commission, NUREG-071 1, "Human Factors

Engineering Program and Review Model," Revision 2, February 2004.

USNRC, 2010. US Nuclear Regulatory Commission, NUREG- 1520. "Standard Review Plan for

the Review of a License Application for a Fuel Cycle Facility" Revision 1. Appendix E, "Human

Factors Engineering for Personnel Activities," May, 2010.

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HF-1

b. Clarify to what extent human factors considerations (e.g., task analysis, functional analysis,

operational experience reviews, and human reliability analysis) were incorporated into the

accident analysis and development of IROFs

RESPONSE: Personnel involved with evaluating the ISA accident scenarios used their many

years of plant operating experience in those evaluations. The ISA team conducted the PHA

accident analysis by organizing each of the processes into system and unit operations nodes based

on conceptual design of the IIFP Facility. Each node was reviewed by a team with relative

experience in safety analysis and actual operating experience of like, related or similar processes

to those being analyzed. Human tasks, potential for human errors, and functions of operating and

maintenance personnel were considered during the review discussions (for example, valve

alignment errors, drop of lifts by human actions during maintenance and response times to alarm

actions). However, the team did not use a formal structured or separate stand-alone documented

task analysis, functional analysis or human reliability analysis (See response to RAI HF-1(a)).

As part of the PHA "what if" analysis, the team members considered their operating experiences

and lessons learned in facilities involving processing and handling of UF 6, UF 4, uranium oxides

and fluorine compounds, but did not formally conduct and document a separate operational

experience review. Team members have been involved with various facets of plant and unit

operations and are familiar with actions and activities performed by operations and maintenance

personnel. The HFE Implementation Plan discusses the basis process that IIFP will use for

performing a more structured formal operational experience review prior to starting detail design

of IROFS structures, systems and components.

License Documentation Impact: Refer to RAI HF-W1(a) response.

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HF-2. NUREG-1520, Appendix E, part B(ii) states that the human factors engineering (HFE) Design

Review Plan should be implemented by an HFE Team with the appropriate composition,

experience, and organizational authority to ensure that HFE is considered in the design of human

systems interfaces (HSI) for personnel activities. Staff has reviewed the team composition

presented in Section 5.1 of the ISA. Human Factors expertise is not included in the expertise

listed

Describe the HFE experience/expertise of the ISA team, and clarify whether the HFE

responsibilities reside in an individual, a team, or the entire group.

RESPONSE: An Engineer with experience in Human Factors Engineering is being added to the

project through the Design and Build Contractor. This arrangement and approach provides for the

Engineer to become involved in reviews and updates of accident analyses and to ensure

continuity of HFE considerations by the design team as the project progresses through the

detailed design. This Engineer will be involved in the development of the FIFE Implementation

Plan that applies a structured approach to FIFE. This role will be filled early in the scope of work

of detail design and engineering once the Design and Build Contract is agreed and signed.

The Engineer being added to the IIFP project has more than 20 years of experience in

engineering, design, and specification of instrumentation and control systems and equipment

including instrumentation of process systems. The experience involved preparation of

specifications, logic and loop diagrams, instrument lists, and system descriptions. The Engineer's

expertise includes using good Human Factors Engineering (HFE) practices. The Engineer's

experience includes development of instruments and control criteria including HFFE criteria and

FIFE references used in Nuclear Power Plants (NPP) control room designs such as EPRI NP3659, NUREG-0700, & 0711 as well as ANS/IEEE Std. 1023.

License Documentation Impact: Section 5.1 of the IIFP ISA Summary will be revised as

follows:

" Facility and chemical process safety;

" Health physics and radiation protection;

* Chemical, mechanical, and electrical engineering&

* Plant operations and maintenance;

" Process hazards analysis;

* Safety analysis and risk assessment;

* UF6 and chemical/nuclear processing;

* Fire safety and

o Human Factors

License Documentation Impact: Table 5.1 of the IIFP ISA Summary will be revised as follows

to include HIFE experience:

Note : Add the following to bottom of Table 5.1:

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May 3, 2011

Design More than 20 years of experience in engineering, design, and specification of

Engineer instrumentation and control systems and equipment including instrumentation of process

with HFE systems, the preparation of specifications, logic and loop diagrams, instrument lists, and

experience system descriptions. Experience in Human Factors Engineering practices, control system

design, and instrumentation specifications and detail engineering. Experience and

development of HFE criteria, control room designs and 1IFE Implementation Plan or

including guidance provided NUREG 0700 and NUREG 0711.

License Documentation Impact: Table 5.2 of the IIFP ISA Summary will be revised to include a

column for Human Factors Engineering and will include a Human Factors Engineer as a team member of

the ISA team.

Table 0-1. ISA Team Members PHA Qualifications

M'',

- I-

•C

Team Member Role(s) z E 42

Ron Green Team Leader X X X

Carol Mason Safety Analyst, Chemical X X X Process Safety

Tammy Wheeler Safety Analyst, Health Physics X X

Daniel Theisen Safety Analyst, Environmental Safety I _X

Mike Balmert Facility safety, PHA X X

Andy O'Connor Fire safety X

Chemical, meehanial, and

Jim Thomas Olcftrical engineefifg; plant X X X

operations and maintenance; UF 6

and chemical-nuclear processing

Quality Assurance,

Don Chumbler Environmental Safety, Radiation X X X

Protection

Tommy Thompson Fire Hazard Analyst X X

Gary Holland UF 6 and chemical-nuclear x

processing

To be Added Human Factors Engineer X

Human Factors RAI Official Responses

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License Documentation Impact: Section 3.2.7 of the IIFP LA will be updated as follows to include

HFE:

* Nuclear facility safety,

* Radiological safety,

* Process hazards analysis,

* Safety analysis and risk assessment,

" Fire safety,

* Chemical process safety,

* Operations and maintenance, and

o ISA methods-, and

* Human Factors.

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HF-3. NUREG-1520, criterion E describes the HSI design, inventory and characterization:

ISA Section 2.1.4.1 contains multiple references to alarms, displays or controls to be contained in

one or more control rooms in the facility. The descriptions provided are very high level. It is

unclear whether human factors has been or will be considered in their design. There is not a

description of these control rooms with respect to functions controlled, alarms, communications

requirements, displays or staffing, nor is there a description of the HFE/HSI analysis that will

determine the requirements for these systems or a commitment to implement a program to

incorporate HFE into the design of the control room(s). Per the guidance provided in NUREG1520, Criterion E:

a. Clarify whether there is a single control room for each process building or another

arrangement (e.g., multiple control rooms in a single building for different aspects of the

process).

Note: Reference to ISA Summary Section 2.1.4.1 appears to be incorrect.

RESPONSE: The fifth paragraph of Section 2.4 of the ISA Summary provides a general

description of the Control Rooms (CR). The current concept is that three (3) Control Rooms will

be provided to support the major processes and one (1) control area is provided to support the

supporting utilities. The Control Rooms will be located in the following areas:

* DUF 4 Process Building, (the DUF 4 process and autoclave operations are controlled in this

CR);

* FEP Process Building, (this building has its own process joint CR for the SiF 4 and BF3

processes);

* AHF Staging Containment Building and Fluoride Products Trailer Loading Building share a

CR, (Neither of these buildings contain licensed material and does not affect areas containing

licensed material).

In addition, a control area will be provided in the Utilities Building for monitoring and controlling

the steam boiler system, air compressors and other utility supply equipment.

The Process Control Rooms will all have the appropriate monitoring, recording, alarm

notification and control instrumentation to provide the latest relevant information to the operators

that allow for control of the processes.

In the conceptual design, other supporting utilities will be controlled by local instrumentation and

control panels as appropriate that are usually provided as part of packaged systems. These include

utilities or supporting processes in the following buildings:

* Decontamination Building,

0 Fire Pump House,

" Water Treatment Building,

* Main Switchgear Building,

" Environmental Protection Process Building.

The details of the Process Control Rooms have not yet been developed and will be subject to

locations where licensed materials are involved or licensed materials may be affected. Concepts

will be based on experience of the ISA team with information from similar projects that will be

upgraded using modem digital control and information systems and subject to the HFE

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Implementation Plan.

License Documentation Impact: The fifth paragraph of ISA Summary Section 2.4, referred to

in the response above will be revised as follows for clarification of the locations of the facility

Control Rooms (see RAI GI-6B), see also License Documentation Impact in HF- 1(a). Also, a

discussion is added on the process of how the control instrumentation, alarms, etc. will be

determined to provide relevant information and response to the Control Room Operator.

Process Control Rooms are provided, including apprpFiate monitoring, recording, alarm

notification and control instrumentation. During the detail design of Control Room alarms,

displays, and control instrumentation, the design review (style guide) and the standards criteria

developed from the 1-FE Implementation Plan will be used as guidance for the design engineers

in the consideration of human-system interfaces and human factors The guidance will be

developed prior to beginning detail design of affected Control Room instrumentation. The

affected Control Room alarms, displays and control instrumentation will be determined from: 1)

the reviews and evaluations of the IROFS, 2) the tasks that involve human interaction relative to

IROFS functions and responses including development of written procedures and operator aids,

3) the functional analysis of the IROFS structures, systems and components and how those

functions involve human tasks in support or response of the function, 4) evaluation of the alarm,

readout, display and instrumentation interface with the Operator for effective and accurate

communications and 4) the consequences of human action responses relative to an IROFS SSC

functionality.

A Control Room is.-and-are located in the DUF4 Process Building-. The DUF6 Autoclave

Building is controlled from the DUF4 Process Building. The FEP Process Building1 has its own

process joint Control Room for the SiF4 and BF3 processes.and Tthe AHF Staging Containment

Building and the Fluoride Products Trailer Loading Building share a Control Room (Neither of

these buildings contain licensed material and does not affect areas containing licensed material).

Likewise, one control area is located in the Utilities Building for monitoring and controlling the

steam boiler system, air compressors and other utility supply equipment. Control Room areas and

electrical and instrument rooms are typically of concrete block construction with concrete or

metal roofs. Ceiling assemblies and fire walls separate these areas from production areas of the

facilities. Process Control Rooms, where routinely occupied by workers, have environments

maintained for comfort and safety. Control Rooms located in process areas, where uranium or

hazardous chemicals are processed, stored or handled, have separate heating, ventilation and air

conditioning (HVAC) systems. The Control Rooms are maintained at a slight positive pressure

with respect to the surrounding areas and are provided with low pressure alarms to notify

occupants should a loss of pressure inside a Control Room occur.

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HF-3

b. State the minimum list of alarms, displays, and HSIs that will be provided for each of the

control rooms. Provide the basis for this minimum inventory (e.g., derivation from task

analysis, etc.)

RESPONSE: Anticipated displays, alarms and HSIs have been considered during the conceptual

stage of the design by the ISA team members. Team members have experience in these types of

process systems. The basis for the concepts is from team member past experience with similar

process plants. A conceptual listing will be used as a preliminary starting point of the design for

the systems and subsystems. Each display and supporting instrumentation and controls involving

IROFS will be developed, designed, and implemented using a structured approach as detailed in

the WFE Implementation Plan (See Section 4.6.5 of the revised ISA Summary discussed in RAI

HF-l(a) above). The HSI design will incorporate the functional allocation analysis and task

analysis process into the detailed design of safety-significant HSI components (e.g., alarms,

displays, controls, and operator aids) through the systematic application of HFE.

License Documentation Impact: None

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HF-3

c. Describe how human factors will be considered in the layout of the control rooms and

considerations for ergonomics for the development of the control rooms. The design should

provide the overall work environment including lighting, noise control, control panel and

console design, etc. Describe the commitment to apply human factors to the HSI.

RESPONSE: A structured, systematic approach will be applied to the human factors

considerations for the Process Control Rooms as well as local control stations or panels. This

involves performing the following for each:

* Task definition;

* Function allocation (human and computer; personnel organization);

" Layout of Process Control Rooms and local control stations;

* Functional requirements analysis and functional allocation; and

" Staffing and qualifications.

The Process Control Rooms will be designed based on the experience of the HFE/ISA team and

the project design engineers as appropriate. The HSI will be based on similar process plants

(involving UF 6 and uranium materials) which are already known; such as the Paducah Gaseous

Diffusion Plant, a commercial conversion plant, centrifuge enrichment facilities and the SFC

conversion and de-conversion plants. IIFP will use the past experiences coupled with modernized

and ergonomic technologies such as Visual Display Units (VDU) integrated into work stations,

large panel displays, adequate work surfaces, etc. with the layouts being determined by the tasks

of the operators. The number, location, spatial arrangements, sizes, and relative positions of

control consoles will be established using proven HFE principles, guidelines, and experience

gained from similar facilities. The design process will follow the program steps as described in

the HFE Implementation Plan. Design review criteria and (style) guidance will be developed

prior to actual detail design and used by the design engineers for the control room, panels, and

instrumentation layouts (See RAI HF-I(a) License Documentation Impact, ISA Summary Section

4.6.5.1 above).

Determination of Control Room environmental conditions and ergonomics is also discussed in the

added Section 4.6.5.1 of the IIFP ISA Summary.

License Documentation Impact: See RAI HF-I(a).

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HF-3

d. Describe how the design process excludes the development of extraneous controls and

displays.

RESPONSE: Extraneous controls and displays will be identified and addressed during the Task

Support Verification process (See Section 4.6.9 of the revised ISA Summary as described in

response to RAI HF-l(a) above. Unnecessary HSI Components will be identified for HSIs that

are available in the HSI but are not needed for any task. Unnecessary HSIs introduce clutter and

can distract personnel for the selection of appropriate HSIs. It is important to verify that the HSI

is actually unnecessary.

If an HSI component has no associated personnel tasks because the function and task analysis

was incomplete, then any shortcomings in that analysis will be identified and resolved.

License Documentation Impact: See RAI HF- 1 (a).

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HF-4. NURE G-1 520, Appendix E, criterion B(iii) states that a structured approach to HFE should be

included in the HFE Design Review. It also states the HFE Design Review should identify

appropriate goals and scope to ensure that HFE practices and guidelines are implemented

during design, construction and operation of the facility

Staff has not found a discussion of the structured approach to HFE. Although, quality assurance

section A. 3.1.3.3 does describe the factors required for the design analyses of documents. , the

scope and goals of the HFE process do not appear to be defined in the application.

a. Consistent with NUREG-1520, Appendix E, criterion B (iii) provide the goals and scope of

the HFE Design Review and program.

RESPONSE: An HFE Implementation Plan will be developed that addresses the review elements

ofNUREG- 1520 Rev. 1, "Standard Review Plan for the Review of a License Application for a

Fuel Cycle Facility", APPENDIX E, "Human Factors Engineering for Personnel Activities". The

HFE Implementation Plan will provide design goals to ensure that:

* Critical personnel tasks are defined and accomplished within applicable time and

performance criteria,

* The anthropomorphic standards for the relevant population are defined and applied,

* HSls, procedures, staffing/qualifications, training, management, and organizational variables

support a high degree of operating crew situational awareness,

* Allocation of functions accommodates human capabilities and limitations,

* Operator vigilance is maintained and distractions are minimized,

* Acceptable operator workload is met,

* Operator interfaces contribute to an error free environment,

* Error detection and recovery capabilities are provided, and

* Control areas minimize stressors and fatigue while assuring adequate communication.

The HFE Implementation Plan will be developed in accordance with the nine elements of the

LFE design process described in NUREG-1520, Rev. I Appendix E and encompass all of the

following elements and their sub-elements.

Element I (E l) Identification of Personnel Activities

Element 2 (E2) HFE Design Review Planning

Element 3 (E3) Operating Experience Review

Element 4 (E4) Functional Allocation Analysis and Task Analysis

Element 5 (E5) HSI Design, Inventory, and Characterization

Element 6 (E6) Staffing

Element 7 (E7) Procedure Development

Element 8 (E8) Training Program Development

Element 9 (E9) Verification and Validation

The scope of the HFE Implementation Plan includes all Process Control Rooms and local panels,

supporting procedures, training, all operations, accident management, emergency response

management, maintenance, test, inspection and surveillance interfaces (including procedures),

facility management and facility personnel.

License Documentation Impact: See RAI HF-I(a).

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HF-4

b. Per NUREG-1520, Appendix E, criterion E: Explain the process used to incorporated HFE

into the design of the human system interfaces (HSIs), alarms, and communications systems

that support the Process Control Rooms to support the operator in controlling the facility

under normal and abnormal/emergency conditions.

RESPONSE: As stated in the response to HF-l(b), the process used to incorporate HFE into the

design of HSIs will include the techniques and processes described in the IIFP ISA Summary

revised Section 4.6, "Human Factors Engineering Implementation Plan". The tools and

techniques of this Plan will be developed and employed by personnel with extensive design and

operating expertise and experience in plants of similar designs to that of the IIFP. The conceptual

design and safety analysis teams have many years of combined experience where similar systems

and human systems interfaces are involved. Team members have been involved with many facets

of plant operations involving uranium hexafluoride and uranium materials and are familiar with

actions and activities performed by operations and maintenance personnel. They have gained that

experience in the daily performance of their actual job duties as well as in response to emergency

situations where non-routine activities are performed. The process that will be used to continue

the incorporation of HFE into design of the HSIs, alarms, etc, is described in the response to HF4(a) and included in the IIFP ISA Summary as Section 4.6.

License Documentation Impact: See RAI HF- 1(a).

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May 3, 2011

HF-5. NUREG-1520, Appendix E, criterion C (i, ii and iii) states that a review of HFE related events

and operational experience in existing facilities should be conducted. This review should

include operator interviews, surveys, and analysis of the HSIfor relevant events. While the INIS

facility may be somewhat unique in application, experience should be drawn from related

facilities, e.g., chemical plants and nuclear facilities.

a. Clarify what, if any, HFE related events from existing chemical and nuclear facilities were

evaluated and used to inform the INIS application. Describe to what extent operator

interviews/surveys on existing HSI technology were conducted and incorporated into the

facility design and IROFS. Identify the types offacilities that were evaluated. Define how

the information derived from operational experience reviews will be used to inform other

aspects of the design.

RESPONSE: The process used to incorporate HFE into the design will be to rely heavily on the

expertise of personnel with extensive plant operating experience in processes of similar and/or

almost identical designs to that of the IIFP. The conceptual design team and the Design and Build

Contractor have experience in facilities where similar work is performed. The Team will review

HFE programs as part of the Plan discussed in response to RAI HF-I(a) and the revised ISA

Summary Section 4.6 described in that response. This will include interviews with experienced

persons that have worked or are working in facilities such as DUF6 Processing (Paducah &

Portsmouth), the AREVA enrichment facility, Urenco USA, the commercial uranium conversions

plants, the Paducah Gaseous Diffusion Plant and the Sequoyah Fuels Corporation (SFC) former

conversion and de-conversion plants.

License Documentation Impact: See RAI HF- 1 (a).

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HF-5

b. The use of task analysis which underlies the development of the IROFS involving human

factors is not discussed. Section 2.3.3 of the Licensing Application (LA-IFP-O01 Revision A)

uses the term "Job Task Analysis ". Define this term and provide a description of the

methods used to perform it. Define the techniques used to perform the task analysis, the

techniques to identify and analyze critical tasks, how the personnel demands in tasks were

identified, and how job design analysis was conducted.

RESPONSE: See RAI HF- I (a)

License Documentation Impact: See RAI HF-I(a) License Documentation Impact; ISA

Summary revised Sections 4.6.8.1 and 4.6.9.2).

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HF-5

c. The basis for the functional allocation analysis and the functional requirements analysis

which underlies the development of HSIs and the definition of the tasks to be performed at the

facility is not apparent. Define how operational experience was used to inform the functional

requirements analysis. Define how the task analysis interacts with the functional analysis.

Define how functional analysis was conducted to avoid overloading human capabilities and

to take advantage of human strengths.

RESPONSE: See responses to HF-I(a) and HF-5(a), above.

License Documentation Impact: See RAI HF-1 (a) License Documentation Impact.

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May 3, 2011

HF-6 NUREG-1520, Appendix E, criterion F indicates that discussion of staffing should be included in

the applicant's approach to the HFE Design Review. Further, development of management

measures for IROFS as well as the potential impact of human error on administrative IROFS is a

function of staffing, workload, training, skills and experience. ISA Summary Section 4.2.3 states

that personnel qualifications will include minimum education, technical background, experience,

etc., along with physical skills needed to perform individual tasks.

Clarify how the requisite number of staff will be identified and how the requisite qualifications of

personnelfor each activity will be determined (with respect to functional requirements and task

analysis).

RESPONSE: Consideration will be given to staffing requirements throughout the design process

with a formal review and evaluation of each element of the HFE Implementation Plan. While

primary emphasis will be placed on sufficient staffing to operate the plant safely, the need to

operate the plant efficiently will also be a factor and will also be considered in the development

of staffing goals. The conceptual design team has extensive staffing experience in facilities where

similar work is performed such as UF6 cylinder handling and feeding, drum handling and filling,

chemical process operations, waste treatment operations, radiation monitoring, and laboratory

sampling and analysis. Regulatory requirements will also be considered and will definitely impact

staffing requirements.

Qualifications for skilled positions will be established and candidates will be measured against

those qualifications in the selection of the workforce. The initial estimates of staffing

requirements and the acceptability of staffing goals will be evaluated throughout the design

process as plant layout and required worker activities are better defined (See the RAI HF-I(a)

License Documentation Impact revision to IIFP ISA Summary Section 4.6.6 and its subsections).

License Documentation Impact: See RAI HF-I(a).

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May 3, 2011

HF- 7. NUREG-J1520, Appendix E, Criterion I, sub-criteria i through v, provide detailed guidance on the

need for Validation and Verification (V& V). This ensures the design incorporates human factors

into the HSI in a manner that enables the successful completion ofpersonnel activities. The V& V

is needed to confirm, prior to operational deployment, that the design incorporates HFE to HSI

in a manner that ensures IROFS will be available and reliable.

The Quality Assurance Plan, Section A. 3.1.3.4 provides discussion of the design verification

program but does not discuss validation of the design with respect to human factors

requirements. The inclusion of V& V of the human factors engineering in design V& V in this

process is not clear.

a. Clarify whether V& V of the human factors engineering of the facility is included in the design

verification plan. If it does not, please provide justification.

RESPONSE: The V&V plan will be subject to the requirements of the QA Program and all HFE

Plan requirements and design documents will be controlled under the design control provisions of

the Configuration Management Program and subject to the same change control as analysis,

specifications, and drawings. The IIFP commitment that the V&V plan will be subject to the QA

program requirements is included in the ISA Summary Section 4.6 (see 4.6.9.7) described in the

License Documentation Impact of the RAt HF-l(a) response.

The check and review process will be performed by qualified, independent reviewers (other than

those who performed the design) as described in the QA Program Description (QAPD). The

results of HFE V&V activities will be summarized in a summary report, and any discrepancies

will be identified in a written report and will include resolutions of the discrepancies.

License Documentation Impact: See RAI HF-I(a).

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HF-7

b. Clarify that the design verification process includes task support verification. If it does not,

provide justification.

RESPONSE: Task support verification will be a part of the HFE V&V process. The objective of

task support verification is to verify that the HSI provides all alarms, information, and control

capabilities and procedures required for personnel tasks. It verifies that all monitoring and

operating functions are available, and that all operation controls are viable. The response to this

RAI has been incorporated into the IIFP ISA Summary Section 4.6. See RAI HF-I(a)

License Documentation Impact: See RAI HF-I(a).

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Official Responses to Human Factors RAIs

May 3, 2011

HF- 7

c. Clarify that the design verification process includes integrated system verification with

respect to human factors, as defined in NUREG-1520. If not, provide justification.

RESPONSE: IIFP believes the question refers to "system validation" and not "verification" to be

consistent with NUREG-l 520. The -IFE Implementation Plan will include Integrated System

Validation testing. "Integrated system validation is the process by which an integrated system

design (i.e., hardware, software, and personnel elements) is evaluated to determine whether it

acceptably supports safe operation of the facility. It is intended to evaluate the acceptability of

those aspects of the design that cannot be determined though such analytical means as HSI tasksupport verification and HFE design verification" (NUREG-071 1).

See the IIFP ISA Summary revised Section 4.6.9.6 discussed in RAI HF-I(a) response for a

description of the process.

License Documentation Impact: See RAI HF-I (a).

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HF- 7

d Clarify whether HFE issues are also addressed by the corrective action program. If not,

provide justification.

RESPONSE: A corrective action program is described in Chapter 11, Section 11.6 and in the

Quality Assurance Program description, Section A.1 5 of the IIFP License Application. This

corrective action program and the related implementation procedures include root-cause analysis

of issues related to Quality Assurance and Environmental Safety and Health. Consideration of

human factors is one of the basic elements and integral parts of the root-cause analysis

methodology. When HFE issues arise, those will be incorporated into the corrective action

program with a commitment to follow through on the corrective action to resolution.

The IIFP corrective action program is an integral part of the IIFP Quality Assurance Program

(QAP) and is included in the HFE Implementation Plan through the QAP (See response to RAI

HF-I(a), License Documentation Impact revision to ISA Summary Section 4.6.9.7.).

License Documentation Impact: See RAI HF-l(a).

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Official Responses to Human Factors RAts

HF- 7

e. Provide a description of the methods to be used in the Human Factors V& V process.

RESPONSE: The V&V portion of the HFE Implementation Plan is described in HF-7, parts (a)

through (d), above.

License Documentation Impact: See RAI HF-1 (a) License Documentation Impact for revised

IIFP ISA Section Summary 4.6 and subsections relative to V&V process.

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HF- 7

f Describe how issues identified in the V& Vprocess are included and resolved.

May 3, 2011

RESPONSE: See response to HF-7(a) above. Issues are identified as Human Engineering

Discrepancies (HED) and are documented, tracked, and resolved.

License Documentation Impact: See RAI HF-I(a) License Documentation Impact for revised

IIFP ISA Summary Section 4.6 and subsections relative to V&V process.

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HF- 7

g. Section 11.1.5.3 of the License Application states that human factors will be considered in

evaluating a modification. Describe the issues, methods, techniques or processes that will be

used to consider human factors with respect to a plant modification.

RESPONSE: The following license documentation impact will be added to LA Section 1I. 1.5.3

as new paragraphs and all other paragraphs will shift down in number accordingly.

License Documentation Impact:

HFE will be included in the facility modification procedure as a review/evaluation activity for

any modifications that may impact Human System Interfaces. Modifications affecting HSI and

human factors may be implemented for the following reasons:

" Address obsolescence,

* Lack of spare parts,

* Lack of vendor support,

" New functionality requirements,

* Improve process performance,

* Enhance operator performance,

* Others.

If the assessment reveals that the modification affects HSI, the HFE process will be applied.

Guidelines will be provided that will address the modification for efficient design characteristics,

licensing issues, and operation and maintenance considerations, as a minimum. One efficient way

to address these issues is by imposing a checklist that addresses such ergonomic areas as:

information display: user interfaces: controls (hard/soft), alarms: procedures; communications:

workstations; maintenance; and configuration management; among others.

This approach to assessing modifications will be included in the HFE Implementation Plan.

Detail design and engineering have not begun for the IIFP Facility and a level of detail is not

available for including specific actions, design or style guides, inventory lists, Control Room

displays and other details of task analysis, operating experience reviews and specifics of the V&V

process.

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