International Isotopes Inc.

March 15, 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) Organization & Administration

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

questions regarding this letter or require additional information.

Sincerely,

John J. Miller, CHP

Radiation Safety Officer

JJM-2011-18

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
ORGANIZATION AND ADMINISTRATION

OA-1 Correct the typo in the first sentence of LA Section 2.1.2. This sentence indicates that the IIFP

management owns and operates the plant.

RESPONSE: Chapter 2 of the IIFP License Application, Revision A has been removed and will

be replaced with the Revision B of Chapter 2 in its entirety. In the revision the wording is

removed that indicates IIFP management is the owner and operator of the plant.

License Documentation Impact: The revised LA, Chapter 2 (Revision B) Section 2.1.2, first

paragraph will read as follows:

A• the-owncr . and epi.at.r . f the plant, IIFP management is responsible with delegated authority

from the INIS President/CEO for the design, engineering, construction, startup, operation,

maintenance, modifications, testing and final facility decommissioning.

Organization and Administration RAIs 

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Organization and Administration RAls Page 11
ORGANIZATION AND ADMINISTRATION

OA-2 The acronym Environmental Safety and Health (ESH) is used on LA Page 31 before it is defined

on LA Page 67. Ensure that ESH is defined at its first use.

RESPONSE: The acronym ESH will be defined at its first occurrence in Section 1.1.2.2,

subheading Process Offices/Laboratory of the IIFP License Application

License Documentation Impact: Section 1.1.2.2, subheading "Process Offices/Laboratory" of

the IIFP License Application (LA) Chapter 1 will be revised to clarify the subheading title and to

define the first occurrence of the acronym for ESH and to read as follows:

Process Offices/ and Laboratory

The Process Office Building is located adjacent to, and north of the DUF4 equipment access pad.

This building contains the offices for the engineering, technical, Environmental, Safe1y and

Health (ESHand plant management prdueetion supervisory staff. The north side of this building

contains the Laboratory that is furnished with work benches, equipment, analytical

instrumentation, fume hoods, containment devices and exhaust systems with vent streams exiting

to an outdoor scrubber on a containment pad just east of the Laboratory area. The Laboratory area

provides areas that receive, prepare, and store various samples as follows:

* Radiological Protection (Health Physics)HealfhiPhysi- s Lab for calibrating instrumentation

and counting samples,

* Chemical Laboratory for the analyses of process and product samples, and

* Environmental Monitoring Lab for the process of environmental/regulatory analysis.

Organization and Administration RAIs Page 12

Organization and Administration RA]s Page 12
ORGANIZATION AND ADMINISTRATION

OA-3. The last sentence on LA Page 2-4 indicates that the plant organization is responsible for system

maintenance. Clarify the intent of this sentence and define in the application what is meant by

the phrase 'plant organization. "

RESPONSE: After turnover from the Design and Construction organization structure shown in

Figure 2-1, the plant organization transitions to the Plant Operation Organization as shown in

Figure 2-2. The fourth paragraph in which the subject sentence appears will be rewritten to clarify

the intent of the plant organization during this turnover.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. The 4th paragraph of Section 2.1.3 of the

License Application Chapter 2 Revision B will read as follows:

When construction of the pla4t-facility and process systems is complete, the equipment and

systems undergo acceptance testing as in accordance with the QAProgram and approved written

procedures. Following successful completion of aeeeptance-integrated equipment and systems

testing and acceptance, the responsibilities for managing the facility equipment and systems are

transferred from the Design and Construction D40organization to the Plant Operation

Organization as shown in Figure 2-2 operating orga-ization by means of a transition plan. The

COO/GP-PD and the St H4up-Plant Manager ensure the development of a transition plan and an

orderly, safe and thorough turnover to the IIFP CO•O/P2M, Plant E..gineer.ing/Maintenanc.

Manager and Ope..ati.n/Teel.ical . anager fun.tions Plant Operation Organization. The turnover

includes the physical systems, corresponding design information, records of the facility, and asbuilt drawings. Following turnover, the Pplant Operation Organization is responsible for facility

safe operations, system-maintenance, configuration management (CM) and facility safety reviews

of modifications affecting the as-built plant.

Organization and Administration RAIs P ag e 13
ORGANIZATION AND ADMINISTRATION

OA-4. State whether the Quality Assurance (QA) Director mentioned in LA Section 2.1.2 is a member of

the IIFP organization or the International Isotopes Inc. (INIS) organization or both.

RESPONSE: Section 2.1.2 discusses the design and construction organization and Figure 2-1

shows the design and construction organizational structure for that organization. Figure 2-1 has

been revised to eliminate the matrix organization, particularly for the QA and ESH functions, to

show both a Corporate ESH Manager and a Corporate QA Manager in the INIS parent corporate

organization and also an IIFP ESH Manager and an IIFP QA Manager. When the IIFP positions

of IUP ESH and QA Managers are filled, any of the IIFP Facility ESH and QA responsibilities,

duties and authorities that were temporarily being performed by INIS Corporate staff will transfer

to the IIFP ESH and QA Managers. (identified in Revision A of the LA as the QA Coordinator)

for the IIFP Facility. Also see RAI OA-7A.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. Figure 2-1 of the License Application is

shown in the License Documentation Impact for response to RAI OA-7A and on the attached

rewrite (Revision B) of Chapter 2, "Organization and Administration." The supporting text for

Section 2.1.2 (new 7th paragraph) will be rewritten as follows:

As shown in Figure 2-1, the COO/C-FPD is responsible, with delegated commensurate authority

from the IIFP President, for managing the administration, ESI, QA. designengineering, and

training. The COO is also responsible for overseeing the supporting contractor functions during

the l icensing, design and construction, in;itial staup, and .IFP pracurement activities of thle 

Facility. Once the IIFP Engineering Manager is hired, the COO will delegate authority to the

Engineering Manager for providing day-to-day oversight of the Design and Build Contractor and

ensuring professional and/or contractor support is in place to perform any required Integrated

Safety Analysis and licensing documentation during the design and construction oftthe HIFP

Facility. Until the Engineering Manager position is filled, the COO (or the IIFP President if the

COO position is not yet filled) carries out these Engineering Manager responsibilities. The BF-P

QA Coordinator and ESH NManager report to and suppor the COO/CFPPI.• The INIS parent

company will provide the QA and ESH Management support to the IIFP COO during the

licensing and design phases of the project. Prior to start of construction activities IIFP will

establish full time IIFP Quality Assurance and ESH managers for the facilitv When the IIFP

positions of IIFP ESH and QA Managers are filled, any of the IIFP Facility ESH and QA

responsibilities, duties and authorities that were temporarily being performed by INIS Corporate

staff will transfer to the IIF.P ESH and QA Managers-The QA Coordinator also has a matrix

....... ing r.elatieniship to the corporate Regulat.... Affair'QA P.ire.to. During the DB phase, t

ESH '- anage has a matrix rprtn relationship to the P,.esidef.t/ CEO. These dual reportingIrelationships fort the QA .. n..d ESSH functions facilitate objective audit, r-eview,. advisorY' and

conitiol activities.

Organization and Administration RAIs P a g e 14
ORGANIZATION AND ADMINISTRATION

OA-5. The last sentence of the second full paragraph of LA Section 2.1.3 states, "During the design and

construction and the transition periods, both the ESH Manager and QA Coordinator have the

responsibility and authority to elevate and report any ESH o" QA unresolved concern to the

corporate Regulatory Affairs/QA Director or directly to the INIS/IIFP President/Chief Executive

Officer (CEO). " Add an additional commitment that all ESH and QA issues will be followed

through to resolution and documented

RESPONSE: The stated commitment will be added to the second paragraph of Section 2.1.3 of

the License Application

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. The second paragraph of Section 2.1.3 of

the License Application described the organizational relationship for ESH and QA functions

during the transition from the design and construction phase to the operations phase of the I1FP

Facility (See also RAI OA-6A). The 2 "d paragraph of Section 2.1.3 on the attached rewrite

(Revision B) has been rewritten as follows:

During this transition, the IIFP plant ESH and QA Managers entinues te report to the

COO/CFP-D for ESH and QA matters related to design and construction. As the COO/CFPD role

chianges to the COOý/P, the ESH Man.ger tran.itions to directly repe.:ing ESFP to the COO/PM

on ES. .matters fgr the stavtup operations. i The ESH-1an Manageruwho has been reporting in a matri

role to the PF PesidentdEO h e to repoting in the mfgatrix role to the Regulat•.y

Affair/Quality Di..e.t.r (RAQD). The IFP QA C.ordinFatri likewise repents to the COy/CFPD

dur-ing the design and construction stage, then tr-ansitions to reporting to the 11FP COO/P2M.

Durting the design and construcition Find thee t-ransition periods, Bboth the ESH Meana,-eirand QA

Ceordiatei- Managers have therespeo4hibilty-ai authority to elevate and report any ESH or QA

unresolved concern to the lIFP President. and-ý tor-pe~rate Regulatory Aff-air-sQA Direeter-,

respectively, or dir.ectl to . the NIS/II.P .. esident.. o The I.FP President is ultia

responsible for ESH, QA, and other safety-related issues. All ESH and QA concerns will be

followed through to resolution and documented.

Organization and Administration RAls dP a g e 15
ORGANIZATION AND ADMINISTRATION

OA-6. The management structure within the IIFP should be a standalone organization so that the

reporting structure is within the IIFP. Consistent with NUREG-1520, Section 2.4.3(1) & (2),

provide the following information:

A. The third paragraph on LA Page 2-6 indicates that the ESH and QA have authority and

responsibility to contact the INIS President/CEO (rather than the IIFP President/CEO)

directly, under certain circumstances. The INIS President/CEO position appears to be

outside the organizational structure of the IIFP. Consistent with NUREG-1520, 2.4.3(1) and

(2), revise the reporting requirements so that the ESH and QA report to an individual within

the corporate structure.

Section 2.1.4 indicates that the Chief Operations Officer (COO)/PM (Plant Manager) reports

to the INIS President/CEO. This individual appears to be outside the IIFP corporate

structure. Consistent with NUREG-1520, Section 2.4.3(2), revise the text in 2.1.4 to indicate

that the COO/Plant Manager reports to the IIFP President/CEO.

RESPONSE: The organization is structured as a stand-alone organization with the IIFP President

responsible for the entire organization and reporting to the parent corporation INIS Present/CEO

shown as Figure 2-2. See RAI OA-7A for revised figure.

The fifth paragraph of Section 2.1.4 of the License Application has been removed and the

reporting requirements. Eliminating the matrix reporting relationship for the QA and ESH

functions has been addressed in paragraph two of the IIFP LA Section 2.1.3. Both QA and ESH

Managers report directly to the IIFP COO. See license documentation impact in RAI OA-5.

Paragraph two of Section 2.1.4 has been modified to clarify and that the COO reports directly to

the IIFP President. Additionally, a Plant Manager is established reporting to the COO. The

organizational charts are shown in the License Documentation Impact for RAI OA-7A.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. The organizational chart for the IIFP

Plant Operation Organization has been revised as shown in the License Documentation Impact

for RAI OA-7A. Paragraph 5 of Section 2.1.4 has been removed in the attached rewrite (Revision

B) of Chapter 2 and paragraph 2, Section 2.1.3 of the LA is revised as shown in the License

Documentation Impact shown in response to RAI OA-5.

License Documentation Impact: The attached rewrite (Revision B) of Chapter 2 of the License

Application explains the responsibilities of the parent corporate INIS and those of the subsidiary

entity IIFP with respect to the IIFP Facility. The subject paragraph of Section 2.1.4 (2nd

paragraph) has been rewritten to define that the COO reports to the IIFP President as follows:

The Chief Operations Officer/Plant Manager (COO/kPM) reports directly to the IIFP President

who, in turn reports to the INIS President/ CEO. The COO-and is responsible with delegated

authority from the IIFP President for the overall operation, maintenance, administration and

regulatory compliance of the IIFP FEP/DUP Facilitycommercial fa;cility. In the discharge of these

responsibilities, the COO/PM leads the activities of the plant, including the following functions:

Organization and Administration RAIs P ag e 16
ORGANIZATION AND ADMINISTRATION

* Quality Assurance,

" Plant Management (Operations/Technical),

* P-lantEngineering. and Maintenance,

• Administration/Human Resources,

* Training,

• Environmental, Safety and Health, and the

* Facility Safety Review Committee (FSRC)/ALARA Committee

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Organization and Administration RAIs P age 17
ORGANIZATION AND ADMINISTRATION

OA-6

B. The President/CEO is sometimes referred to as a member of the INIS and sometimes a

member of IIFP. The application indicates he is a member of both. Since this application is

for IIFP, ensure references to the President/CEO are consistent, e.g., a member of IIFP or

HFP/INIS.

RESPONSE: The organization chart has been revised to show both an INIS President and an

IIFP President for the Plant Operation Organization of the IIFP. The new position of the IIFP

President is described in Section 2.2.3, in a rewrite of Chapter 2 of the License Application

(Revision B). The key management position of the INIS President is still described in Section

2.2.1.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. The organizational chart for the IIFP

Plant Operation Organization has been revised as shown in Figure 2-2 in the attached rewrite

(Revision B) of Chapter 2 of the License Application. The chart is also shown in the License

Documentation Impact for RAI OA-7A. Section 2.2.1 describes the INIS President/CEO position

and Section 2.2.3 describes the IIFP President position as follows:

2.2.1 INIS/L1Z-t President and Chief Executive Officer

The INIS President and Chief Executive Officer (CEO) reports to, and receives policy direction

from, the INIS Board of Directors. The President/CEO is responsible for establishing policies and

providing overall direction and management of 4F-P-all corporate activities. The President/CEO

also ensures that policies for the ESH and QA Programs are maintained and transmitted to all

levels of management and implemented appropriately through approved written procedures. The

President/CEO ef •4NIS/IF-P shall have a bachelor's degree in a scientific field or business. At

least eight years of work experience is required with the proven ability in management of a

commercial chemical, radiological, or nuclear related facility, overall leadership qualities and the

commitment to safety, quality and regulatory compliance.

2.2.3 IIFP President

The I1FP President reports directly to the INIS President/CEO and is responsible for the

establishing policies and providing overall direction and management of all IIFP activities. The

President also ensures that policies for the ESH and QA Programs are maintained and transmitted

to all levels of IIFP management and implemented appropriately through approved written

procedures. The IIFP President shall have as a minimum a bachelor's degree in a scientific field

or business. At least five years of work experience is required with demonstrated proficiency in

management of a commercial chemical, radiological, or nuclear related facility, overall leadership

qualities, and a commitment to safety, quality, and regulatory compliance.

License Documentation Impact: The second full paragraph of Chapter 2, introductory section of

the License Application will be revised to add a clarifying statement to show who is ultimately

responsible for IIFP actions and will read of follows:

Organization and Administration RAIs 

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Organization and Administration RAJs Page 18
ORGANIZATION AND ADMINISTRATION

Once the facility (pla,,t) onstructien is com,•pleted, Tthe IIFP Chief Operations Officer/aant

Maiigei (COOAL-M) is delegated the authority by the IIFP President with the approval of the

INIS President/CEO has-everallfor the responsibilitiesy f4e-the IIFP Facility design, construction.

startup and operations- of the facility as well as safety and regulatory compliance of the Neew

Mexiee plan .The IIFP policy is to ensure and maintain a safe work place for its employees,

to protect the public relative to the operation of its plant, and to assure operational compliance

with the terms and conditions of the NRC license and applicable federal, state and local

regulations. The COO/PM reports directly to the President of IUFP who in turn reports directly to

the President/CEO an-d Chief .. .utiv0 O•f'•lr (CEO) of International Isotopes, Inc. (INIS). The

INIS President/CEO reports to the Board of Directors of INIS, and ensures corporate policies are

established, and that policy direction is communicated. Even though the IIFP COO has overall the

overall responsibility for safety and regulatoiw compliance, the IIFP President is ultimately

responsible for safety, securiN and protection of the environment.

Organization and Administration RAJs Page 19

Organization and Administration RAls Palge 19
ORGANIZATION AND ADMINISTRATION

OA-6

C. LA Section 2.2.3 states that the Regulatory Affairs and Quality Assurance Director (RA QD)

is appointed by the INIS President/CEO. This appears to indicate that the RAQD is an INIS

employee and not an IIFP employee. The section also states that the RAQD is responsible for

the ESH and QA policies. Consistent with NUREG-1520, Section 2.4.3(3), state in the LA

that the RAQD is an 1IFP employee. Clarify the reporting relationship and management

structure between RAQD, COO/Plant Manager, Quality Assurance Coordinator (QAC), and

ESH.

RESPONSE: The organizational chart for the Plant Operation Organization of the IIFP (Figure

2-2 ) has been revised to replace the position of the RAQD with both a Corporate QA Manager

and a Corporate ESH Manager reporting to the INIS President and CEO. The responsibilities for

these corporate positions are provided in Section 2.2.2.of the attached rewrite (Revision B) of the

IIFP LA Chapter 2.

The IIFP President reports to the INIS President/CEO. The IIFP COO reports to the IIFP

President. The IIFP Facility QA Manager (formerly QA Coordinator) and the ESH Manager each

reports to the IIFP COO. The responsibilities of these positions are described in the License

Application Revision B, Chapter 2 as shown below. Additionally, a Plant Manager reporting to

the COO has been added to the revised Figure 2-2. See the revised Figure 2-2 in the attached

rewrite of Chapter 2, Revision B of the License Application or in the License Documentation

Impact for RAI OA-7A.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. Figure 2-2 has been revised as shown in

the License Documentation Impact for RAI OA-7A or in attached rewrite of Chapter 2 of the

License Application (Revision B). Section 2.2.2 has been revised in the rewrite to describe the

INIS corporate ESH and QA functions. Sections 2.2.7 and 2.2.8 have been revised to describe the

IIFP QA and ESH Managers positions respectively. Section 2.2.9 has been revised in the Chapter

2 rewrite (Revision B) to describe the position of Plant Manager. Sections 2.2.2, 2.2.7, 2.2.8, and

2.2.9 have been rewritten read as follows:

2.-.32.2.2 I1NIS!IFP Regulatory Affairs and Q. uality Assu ranee Diretor• IS

Corporate ESH and QA Managers

The Regulatcry Affairs and Quality Assurance DireetOr (RAQD) is appointed by the P49S

PresdentCEOand is r-esponsible forf ensuring develepmenit and communication of ES" and QA

policies that will ensur-e safe oper-ation and meet the lieenses and peri euiments. The

Director- is responsible for establishing an 412P system that will identifyz and evaluate potentialo

nem, regulatory' requrmnst detcr~mine applicability to the IIFP FEP/DUP1 Facility. The

RAQD is also .esp.nsibl fori cnsuring that effe.tive audit, f.edba.k, investigative anda or.ective

action programs are in place . both .FP at the co.porate and plant levels that.will prv.ide prompt

resons inpreentngand correcting ESH related incidents. The RAQD pr-ovides advice,

ovc:-si tnd regulato-y .onsultation in assistin. g the IIP COO/P.M, ESH Manager and the QA

Coor.dinator. in matters of r.egulator' co..pliance arsd ESH4 and QA pro..gram..s objectives. The

Regulatory' Affairs and Quality Assur-ance Dir-ector shall have., as a miimm a baceloelr degree

in enineeingor a scientific field and five years of r-elated experiencee in chemical, radiologgical

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ORGANIZATION AND ADMINISTRATION

The IN IS Corporate ESH and QA Managers are appointed by the IN IS President/CEO and are

responsible for ensuring development and communication of the parent corporate ESH and QA

policies that will ensure safe operation and meet the licenses, permit, and product requirements.

During the early stages of the IIFP project, the INIS Corporate ESH and OA Managers

temporarily have duties that will later be fulfilled by the lIFP ESH and QA Managers,

respectively. When the positions of IIFP ESH and QA Managers are filled, any of the iIFP

Facility ESH and QA responsibilities, duties and authorities that were temporarily being

performed by INIS Corporate staff will transfer to the IUFP ESH and QA Managers.

The Corporate ESH Manager is responsible for initially establishing an IIFP system that will

identify and evaluate potential or new regulatory requirements applicable to the HJFP FEP/DUP

Facility. During the design and construction stages, the ESH Manager ensures that environmental

technical and licensing support. as requested by the COO or JlFP President, is provided. The

Corporate ESH Manager also provides technical support for the federal, State and local

environmental related permit application. A primary responsibility of the ESH Manager during

the design/construction stage of the project is to prepare responses and interact with the NRC for

Requests for Additional Information relative to the licensing review of the ILFP Environmental

Report.

The Corporate ESH Manager also provides support for ensuring that effective audit, feedback.

investigative and corrective action programs are in place across the parent and subsidiar

corporate organizations that will provide prompt response in preventing and correcting ESH

related incidents.

The Corporate QA Manager is responsible for the overall development and implementation of all

aspects of the corporate Quality Assurance Program. The Corporate QA Manager also provides

support for ensuring the QA policies, effective audit, investigative and corrective action programs

are in place across the parent and subsidiary corporate organizations that will provide prompt

response in preventing and conrecting Quality Assurance issues and events.

The Corporate ESH and QA Managers provide advice, oversight and consultation in assisting the

IIFP COO by providing support to the IIFP QA and ESH Managers in matters of regulatory

compliance and ESH and QA programs objectives.

The Corporate ESH and QA Managers shall have as a minimum a bachelor's degree in an

engineering or scientific field and five years of related experience in chemical, radiological or

nuclear facilities.

2A442.2.7 IIFP Quality Assurance (QACo ,rdinat"erManager

The IIFP Qalfity Assurance ree .. e- Managerat the facility is appointed by"reports to the

COO/P ith c..f th. INN RAQD. The QA Coer-dinatr repbrs to the sOO/PNt,

but also has an repeoting and-interacting relationship with the RAQDEngineering, Training, and

Plant Manager,amnd other IIFP facility managers, and INIS QA corporate staff, on matters of QA

policies, new QA requirements, and overall QA performance. The QA CerdiflatEif Manager is

responsible for establishing and maintaining the IWFP QA Program. Line management and their

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ORGANIZATION AND ADMINISTRATION

staff are responsible for ensuring implementation of the QA Program and compliance with the

Program. The QA Ceei'iinater Manager position is independent from operational and safety

organizations. The CGerdinatef QA Manager has thefespensibitity authority to elevate and

report any FS4-QA unresolved r-eh4ed-concerns to the lHFP President. The IIFP President is

ultimately responsible for QA. The IIFP QA Manager is responsible to ensure that such QA

concerns will be followed through to resolution and documentation. corporate manage.ment

including the INIS President'CEO.

The IIFP QA @ei-, . ater- Manager also-ensures and ...er.ee. the implementation and

maintenance of the plant perfcenc ffleiimt and aetion tr-acking prOgaram r-elative to ESH4

and QA~compliance with the program elements identified in Chapter 11 of the License

Application and the Quality Assurance Program Description, Appendix A of the License

Application. Those elements include the QA program: qualification and certification of

personnel, work control: design control: procurement document control; instructions, procedures,

and drawings; document control; control of purchased items and services: identification and

control of materials, parts, and components: control of special processes; test control; inspection;

control of measuring and test equipment; inspection, test, and operating status: control of nonconforming items; corrective actions: and audits/assessments.

The QA Manager has plant shutdown authority in matters relative to QA, and ensures through the

Plant Manager and COO that such shutdowns are implemented in a safe and orderly manner. The

Q.A Manager. or designee, must approve the restart of any operation shutdown by reasons of QA

matters or by the QA function.

The QA Coordinator- Manager shall have; as a minimum, a bachelor's degree in engineering,

science or related field and five years of quality -experience in the implementation of a QA

Program at a chemical, radiological or nuclear facility.

2.2.t408 IIFP Environmental, Safety and Health Manager

The IIFP Environmental, Safety and Health (ESH) Manager at the facility is appointed b- the

COO/PM with concurrence of the INIS RAQD. The ESH manager reports to the IIFP COOAPM,

but also has an-repoFting and interacting relationship with theAq•all managers on matters of

ESH policies, regulatory requirements, plant safety and environmental compliance. In addition,

the ESH Manager has the authority andresponsi[4ity to elevate and report any ESH unresolved

concerns to the ]1FP President. The I1FP President is ultimately responsible for ESH and other

safety-related issues. The IIFP ESH Manager is responsible to ensure that such ESH concerns

will be followed through to resolution and documentation. te tp through 1.l12D 12 ............ A

if not reselh'ed to ..... nu ......... up " .... 1 ... Ept cop .. rt . . ma ......a..~eft an ;nel,..Ang tile IN,

P'esident/CEO.

The IIFP ESH Manager has the responsibility to establish and oversee the Radiation Protection

(RP), Lieensing, 1S Industrial Hygiene and Safety, Environmental Protection, Fire Protection,

and Emergency Preparedness/Security programs to ensure compliance with applicable federal,

state, and local regulations and 4awsrequirements. Those programs are designed to ensure the

health and safety of employees and the public, as well as the protection of the environment. The

ESH Manager has plant shutdown authority in matters relative to ESH, and ensures through the

Organization and Administration RAIs P ag-e 112
ORGANIZATION AND ADMINISTRATION

Shift SuperfintendentPlant Manager and COO that such shutdowns are implemented in a safe and

orderly manner. The ESH Manager, or designee, must approve the restart of any operation

shutdown by reasons of ESH matters or by the ESH function.

The ESH Manager shall have- as a minimum- a bachelor's degree in engineering, science or

related field and five years of responsible assignments of ESH activities at chemical, radiological

or nuclear facilities.

2.2.9 1111' Chief Oper-ations Offiiccr!Plant Manager

The UIP Chief Opcrations Officer/Plant Maiiager (COO/PM) is appointed by the INIS

President/CEO. and is the individual with the averall r-esponsibility for safet and operaitional

actvitesat he ewMexico Facility. The COO/PM4 reports dir-ectly to the Pr-esidefiVCEO. The

!*cspons~l 1 Wtis or rue kLUU/IIYI~ are cierined byllf- I policies, proeeaures.. amid anstiucrins. The

COO/P2M is ultimately' responsible for safety, controel of operaitionS, anld protection Of emfployes

the envir-onmient, emer-gency preparedness and r-esponse, and the public and any, other acdn

conisequences, as related to the plant site and oper-ations. The COO)/PM also) has responsibility fo

regulateiy compliance with the facility NRC lic.ense. and other -t-eder'al, state and loal permits or

lieenses.

The COO0/.PM ensures pr-oper- selection o~f staff for the key positions including positions of the

Facility Safeaty and Review Committee and ALARA and approval of positions of the ALARA

r-adiation pr-otection cfiommittee. The COO/PM appropr-iately delegates specific responisibilities

for implemeniting ESH and QA .elated programs to qualified line management an.d area

fflalae!-

The COO/PM shall be cognizant of the sa• fet progran as, applied to the overall safety of the

fility and shall have the au.thority to enfoe• the shutdown of any pro.ess or building. The

COO/PM will also delegate facility shutdow.n authority to a.ppropriate organiza.io.s and line

manager-s. The COO/P2M must appro)ve restart o~f an operation that was shut down due to safety

and/or- regeulatory' oneeis.

The Plant Manager (PM) reports directly to the COO. The PM is responsible for implementing

safe practices, procedures and activities related to the operation of the production processes,

utilities, environmental protection and waste treatment systems. fire system, laborator, and

warehouses. The PM is responsible for the safe conduct and control of operations and protection

of employees. The PM also has responsibility for day to day regulatory and procedural

compliance associated with the facility operations. The PM is responsible for hiring and training

of qualified staff and operating personnel in the Plant Management organization.

During initial startup of the facility the Plant Manager is responsible for coordinating with the

Training Manager for developing safe and effective operating procedures and training program

plans. The PM is responsible for staffing of the operations organization, and for ensuring

operational readiness and acceptance testing plans, schedules, and documentation during staMtup.

The PM shall be responsible for application of the safety program to facility operations and shall

have the authority to enforce the shutdown of any process or building. The PM will also delegate

Organization and Administration RAls Page 113
ORGANIZATION AND ADMINISTRATION

facility shutdown authority to appropriate organizations and line managers. The PM. must approve

restart of an operation that was shut down due to safety and/or regulatory concerns.

The C-OOiPM shall have; as a minimumz a bachelor's degree and seven-five years of experience

in chemical, radiological, or nuclear related operations. The experience shall include senior

responsible assignments involving engineering or facility operations management. The C-@G/PM

shall be cognizant of the IIFP licensing documentation and the overall ESH requirements of the

IIFP Facility.

Organization and Administration RAIs 

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Organization and Administration RAls P a -e 114
ORGANIZATION AND ADMINISTRATION

OA-7. The organizational structures displayed in LA Figures 2-1 and 2-2 have a complex

interconnectivity ("matrix structure ") which is not well defined in LA Sections 2.1.2 and 2.1.4

Consistent with NUREG-1520, Sections 2.4.3(1) and 2.4.3(2), provide the following

information:

A. To demonstrate a clear, unambiguous set of management controls and communications

among organizational units, reduce the complexity of LA Figures 2-1 and 2-2 or expand the

explanations in 2.1.2 and 2.1.4, or both. This may involve reducing the level of detail in the

figures, focusing the explanation in the text to explain the groups responsible for the "design,

construction, and operation of the facility [NUREG-1520, 2.4.3(1)], "removing or explaining

dual reporting relationships, making the Figures layouts easier to read, etc. Any dual

reporting listed in the Figures should be explained in the text.

RESPONSE: The matrix structure has been omitted firom organizational charts (Figures 2-1 and

2-2) with the corresponding dual reporting text deleted in the LA Chapter 2 Revision B rewrite of

Sections 2.1.2 and 2.1.4.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the Revision B of Chapter 2 in its entirety. Sections 2.1.2 and 2.1.4 have been

rewritten to address the revised organizational charts eliminating the matrix structure and the text

to reflect the revised organizations. Sections 2.1.2 and 2.1.4 on the attached rewrite (Revision B)

have been rewritten as shown below:

2.1.2. IIFP Design and Construction Organizational Structure

A~s th• .... ne. and cper-ato"r of the plant, IIFP management is responsible with delegated authority

from the INIS President/CEO for the design, engineering, construction, startup, operation,

maintenance, modification, testing and final facility decommissioning.

In the early stages of the project concept, INIS hired a contractor to help develop the IIFP

FEP/DUP Project. The contractor has experience in uranium and fluorine technologies and

related commercial operations including the environmental, safety and health (ESH) aspects. The

contractor's scope of work included developing and managing early project activities and

preparing a conceptual design of the plant. The contractor was also hired to prepare the NRC

License Application and the Environmental Report for ,!N!SiIFP appreoval and submittal the

proiect.

The facility site evaluation and selection was conducted by INIS and its experienced contractors.

The selected site at Hobbs, New Mexico is described in the IIFP LA, Chapter 1.

A design and build (DB) contractor iswill being-contracted to perform detailed design and

construction of the I1FP Ffacility.

The design and build (DB) terminology is used synonymously with design and construction work

as shown in Figure 2-1, "IlFP Project Design and Construction Organization."

Organization and Administration RAls P a ,,e 115
ORGANIZATION AND ADMINISTRATION

As the project mives frion its develpeint and licenstuing phase. heP wil! hire a Chief Operations

OffieF iwho will take responsibility as the Chief Operaaions OfficerCoerectrespial Facility aPrwect

Direeted- ( tOO/CRD) during the DB phase of the Preject. Plans ar-e to have the pOO/CFPD

transitin ingte the COa Plant MaiiageF rale upen staftup of the FEctDUP Faeility operations.

Figure 2 1 presents the ProjeCt wrgaization and lines of prammunications during the phatB 

While the project is in licensing, design, and construction phases the President of INIS will

continue to also act as the President of IIFP. One of the first positions that will be filled in the

UIP organization will be the Chief Operations Officer who will take direct responsibilit' and will

be delegated the comnmensurate authority by the IIFP President for all aspects of the project

inluin selecting additional UIP mnanagement staif. As the project moves into construction.

startup. and finally operations the COO will add appropriate management positions in order that

they gain knowledge of the plant at the appropriate stages and in order to put additional staff and

programs in place to support the safe operation of the facility. Figure 2-1 presents the planned

proiect organization during the project edsi n and construction phases of the project.

Revision A figure below is deleted and replaced with Figure 2-1 on following page

h.I. .l..Jill l I ...

Organization and Administration RAIs P a ~ e 116

Organization and Administration RAls 1P1ag,,e. 116
ORGANIZATION AND ADMINISTRATION

Figure 2-1 IIFP Project Design and Construction Organization

As shown in Figure 2-1, the COO/GF-PD is responsible, with delegated commensurate authority

from the lIFP President, for managing the administration. ESH, QA, cleignengineering, and

training. The COO is also responsible for overseeing the supporting contractor functions during

the licensing, design and construction, initial sta..up, and pro.urem..ent a;tivities of the IIFP

Facility. Once an IlFP Engineering Manager is hired, the COO will delegate authority to the

Engineering Manager for providing the day-to-day oversight of the Design and Build Contractor

and ensuring professional and contractor support is in place to perform any required Integrated

Safety Analysis and licensing documentation during the design and construction of the IIFP

Facility. Until the Engineering Manager position is filled, the COO (or the IlFP President if the

COO position is not vet filled) carries out these Engineering Manager responsibilities. The-HP

QA CoordinlatorF and ESH Manager-S repor~t to and suppei4 the COO/CFP1D.The INIS parent

company will provide the QA and ESH Management support to the I1FP COO during the

licensing and design phases of the proiect. Prior to start of construction activities lIFP will

establish full time Quality Assurance and ESH managers for the facility. When the positions of

H1FP ESH and QA Managers are filled, any of the IIFP Facility ESH and QA responsibilities,

duties and authorities that were temporarily being performed by INIS Corporate staff will transfer

to the I1FP ESH and QA Managers.The QA C•oeodinator also has a matrix r-eporting relatieonship

to the corperate Regulator~y Affair-s/QA Dir-ector. During the DB phase, the ESH4 Manager has a

matrix reporting . .elationship to .. the sident/ CEO. These dual reporting relationShipS for the QA

and ESH functions facilitate obj- ti.. audit, review, advisory and c.ntrol activities.

Organization and Administration RAls Page 117
ORGANIZATION AND ADMINISTRATION

During the DB phiase, the eninern and construction and related docuimentatietn ape eompltd

uitilizing qualified colntractors. Th- UP QA fuinction reviews the DB contractor qualified QA

proram in acor-dancee wAith the UIP QA (QAP). Approval o~f vendor-, DB contr-actor and sub

contractor- QAPs. where required by the UIP QA Program Plan (Q.APP) (I1F12, 2009a), shall be

obtained pr-ior to com iA with the DB Mnd rocE~urement w.or-k activtis

Procurement for the commercial plant project is generally performed by the DB Ceontractor, but

in some cases may be performed by IIFP or it-s-subcontractors. The IlFP QA function ensures that

evaluation and pre-approval of vendor qualification is performed where the procurement involves

IROFS as identified in the IIFP ISA Summary. This review and pre-approval is to ensure the

vendor quality assurance programs are in accordance with the requirements of the IIFP QA

Program. Likewise, the NINS-QA function ensures reviews of vendor performance in accordance

with the lIFP QAProgram, where the procurement involves QA Levels 1 and 2 systems,

structures and components as defined by the IIFP QA_Program documentation.

Configuration management (CM) and design modification safety reviews are discussed in Section

2.3.1.

Position descriptions of key management personnel in the design and construction organization

will be accessible to affected personnel and the NRC.

2.1.4. IIFP Operations Organizational Structure

The IIFP plant operations organizational structure and lines of communication are shown in

Figure 2-2. IWFP has responsibility for pre-o erational testing, startup, operation, and maintenance

of the FEP/DUP commercial plant Revision A figure below is deleted and replaced with Fiozure 2-2 on next pD

Revie m Cmmitut

SW Mat-i MArManger Ewaft 

EleneeteMaMamecer 1"b "Wedwattv

si •pe~msndets M."'Cl

I• gil rsStHygkm ~ Phamtnl

EYL 4.nr7FsFc~tf•

age

Organization and Administration RAls P ag-e 118
ORGANIZATION AND ADMINISTRATION

Figure 2-2 Plant Operation Organization

The Chief Operations Officer (COO/PM) reports directly to the IIFP President who, in turn

reports to the INIS President/ CEO. The COO is responsible with delegated authority from the

IIFP President for the overall operation, maintenance, administration and regulatory compliance

of the IJFP FEP/DUP ee-mmmeeiaFfacility. In the discharge of these responsibilities,_the

COO/P-M leads the activities of the project including the following finctions:

* Quality Assurance,

* Plant Management (Operations/Technical),

* Plant-Engineering/ and Maintenance,

" Administration/Human Resc, urces,

* Training,

* Environmental, Safety and Health. Training, and the

* Facility Safety Review Committee (FSRC)/ALARA Committee

Organization and Administration RAls P-1ag e 119
ORGANIZATION AND ADMINISTRATION

The responsibilities, authorities, and lines of communication of key management positions within

the plant organization are discussed in Section 2.2, "Key Management Positions, Responsibilities,

and Qualifications."

.In the Plant 1ic organization. r-elated to r-outine operations of the faeilit,.ý the HFP planit ES14

Manage.. and the plant QA Coo-rdinator beth r.eport to the COO, M. in a matrix. r.le, the ESH

Manager and the QA Coor-dinator. repor~t to the corpor-ate PUNQD. As part o~f the matrix roale., ths

managers interact with other ESH and QA activities and fiunctions in the ceerprate structure and

receive ESH4 and QA policy and technical standar gu...idan e f .. the .om corporate RAQD.

~Additieiially. the plant ES.H4 and QA managers have thc author-ity- and responsibility to dir-ectly

conitact the INIS Pr-esident'CEO wAith an),' ESH4 or QA conceems, respectively. These repor-ting

reiationships arc part of the independence assuralnce proevided by 11121 that concerns OF issues in

ESH4 or- quality cani be directly repor-ted and resolved in alignment with the corporate ESH4 and

Position descriptions for key management personnel in the operating organization will be

accessible to affected personnel and to the NRC.

Organization and Administration RAls ndage 120
ORGANIZATION AND ADMINISTRATION

OA-7

B. LA Sections 2.1.2 and 2.1.4 refer to a "matrix role "for reporting between organizational

structures. This phrase does not appear to be defined in the application and its implications

are unclear. Consistent with NUREG-1520, Section 2.4.3(2), define the phrase "matrix

role. " In the application, add a complete description of how the "matrix role" impacts the

organizational structure, such as reporting requirements, oversight, and reporting structure.

Define the key organizational positions within the matrix, and clearly indicate a subordinate

management structure. Provide a sufficient description of LA Figures 2-1 and 2-2, the

"matrix role, "to demonstrate that it provides "clear, unambiguous management controls

and communications [...] among organizations (NUREG-1520, Section 2.4.3(2)."

RESPONSE: The matrix role for reporting between organization structures has been deleted

from the organizational charts and from the text as explained in the License Documentation

Impact below:

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert the rewritten Revision B of Chapter 2 in its entirety. Sections 2.1.2 and 2.1.4 have

been rewritten to revise the organizational charts eliminating the matrix structure, and the text has

been revised to reflect the revised organization. See License Documentation Impact for RAI OA

7.A for the revised text and organization charts or see the revised Sections 2.1.2 and 2.1.4 in the

rewrite (redline version) of Chapter 2 of the License Application Revision B attached.

Organization and Administration RAIs 

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ORGANIZATION AND ADMINISTRATION

OA-7

C. The application indicates that the COO has responsibility for the design, engineering,

construction, startup, operation, maintenance, etc. However, the COO/Commercial Facility

Project Director (CFPD) (Design/Build (DB) phase) is not at the top of the Figure 2-1; nor is the

COO/Plant Manager (operations phase) at the top of Figure 2-2. In addition, several other

groups are parallel or above the COO for both phases. Consistent with NUREG-1520 2.4.3(1),

clearly indicate which individuals listed in LA Figures 2-1 and 2-2 are ultimately responsible for

overseeing the design, construction and operation of the facility.

If the COO/CFPD and COO/Plant Manager are in fact responsible for the design, engineering,

construction, startup, operation, maintenance, etc., provide a clear description in the text to

explain the relationship between the COO and other parallel and higher management individuals

represented in Figures 2-1 and 2-2. Describe what role these other groups play in overseeing the

design, construction and operation of the facility and how their authority interrelates with

parallel organizations.

RESPONSE:

Figure 2-1 has been revised with the IIFP President at the top of the IIFP organization and the

highest authority within IIFP. The IIFP President reports to the parent corporation INIS

President/Chief Executive Officer. The other management individuals in the parent corporation

that interrelate with the IWFP President are the Corporate ESH Manager and the Corporate QA

Manager. These parent corporate staff managers interrelate with the IWFP President by assisting

the IIFP COO and providing support to the IIFP ESH and QA management (See Section 2.2.2 of

the IIFP LA Chapter 2 Revision B attached). The COO reports directly to the IIFP President and

as such is delegated the line organization authority for the responsibility of managing the

administration, ESH, QA, engineering, training and supporting contractor functions during the

licensing, design and construction of the 1IFP Facility. Once the IIFP Engineering Manager is

hired the COO will assign responsibilities and delegate authority to the Engineering Manager,

who reports to the COO, for providing design authority and direct oversight of the Design and

Build Contractor and for ensuring professional and contractor support is in place to perform any

required Integrated Safety Analysis and licensing documentation.

Section 2.1.2 of the IIFP LA Chapter 2, "IIFP Design and Construction Organization Structure"

addresses the organization structure during the DB phase of the IIFP Project. Figure 2-1 addresses

that organizational structure. The roles and responsibilities of individual positions in managing

the design, construction and operation of the facility are discussed in response to RAI OA-7A

above.

The revised Figure 2-2 shows the same organizational structure during the plant operations phase.

A position of Plant Manager reporting to the COO was added to the Plant Operation Organization

chart. The responsibilities for the Engineering Manager, the COO, the Plant Manager, and the

IIFP President are delineated in Section 2.2, "Key Management Positions, Responsibilities, and

Qualifications."

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. Section 2.1.2 has been revised and is shown

in RAI OA-7A. Figure 2-1 has been revised in Section 2.1.2 as shown in License Documentation

Organization and Administration RAls P age 122
ORGANIZATION AND ADMINISTRATION

Impact for RAI OA-7A. Figure 2-2 has also been revised in Section 2.1.4 as shown in License

Documentation Impact for RAI OA-7A. The responsibilities for the IIFP President, the COO,

Engineering Manager, and the Plant Manager are delineated in Section 2.2.3, 2.2.4, 2.2.5. 2.2.9,

respectively, can be viewed in the attached rewrite for Chapter 2 of the License Application

Revision B.

Organization and Administration RAIs Page Z-- 123
ORGANIZATION AND ADMINISTRATION

OA-7

D. During the DB phase, LA Section 2.2.4 indicates that the COO/CFPD is ultimately responsible

for all activities, including QA. Sections 2.2.1-2.2. describe other management individuals who

are also responsible for these activities, e.g., Regulatory Affairs/QA Director or INIS/IIFP

President/CEO (LA Section 2.1.3, second full paragraph). Consistent with NUREG-1520,

2.4.3(2), clarify the management structure for the ESH and QA during the DB phase. During the

Operations phase, LA Figure 2-2 shows that the ESH and QA report to two separate managers.

Consistent with NUREG-1520, Section 2.4.3(1), clarify the management structure for the ESH

and QA during the Operations phase. Also clarify the role of the RAQD regarding the oversight

of the ESH and QA program.

RESPONSE: Section 2.2.4 of the LA Chapter 2 Revision A described the responsibilities of the

COO/CFPD. The COO/CFPD's responsibilities have been redefined in the attached rewrite of the

License Application Chapter 2 Revision B for the position of the COO.

The organizational charts for the Project Design and Construction (Figure 2-1) and for the Plant

Operation Organization of the IIFP (Figure 2-2 ) have been revised to replace the position of the

Regulatory Affairs/QA Director (RAQD) with both a Corporate QA Manager and a Corporate

ESH Manager reporting to the INIS President and CEO. In the revised figures, the IIFP President

reports to the INIS President/CEO, and the COO reports to the IIFP President see response and

license documentation impact for RAI OA-7A.

The management structure for the Corporate QA and ESH Managers and for the IIFP QA and

ESH managers is explained in response to RAI OA-6C above.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. Figure 2-1 and Figure 2-2 have been revised

as shown in the License Documentation Impact for RAI OA-7A or in attached rewrite of Chapter

2 of the License Application. See also responses and license documentation Impacts for RAIs

OA-6C and OA-8A view rewritten sections 2.2.1 through 2.2.8 in the attached Revision B of

Chapter 2 of the License Application.

Organization and Administration RA]s P a e 124
ORGANIZATION AND ADMINISTRATION

OA-8. LA Section 2.2 describes key organizational positions. The list of key positions in LA Figures 2-

1, 2-2 and Section 2.2 do not match. Consistent with NUREG-1520, Section 2.4.3(1), provide the

following information:

A. Some positions listed in LA Figures 2-1 and 2-2 are not described in LA Section 2-2. Conversely,

many of the key positions described in LA Section 2.2 are not listed in LA Figure 2-1 or Figure 2-

2, e.g., 2.2.5 Project Integrated Safety Analysis Lead, 2.2.6 Project Environmental Assessment

Lead, 2.2.12 Production/Technical Manager, 2.2.20 Fire Protection Lead, 2.2.22 Environmental

Lead, and 2.2.24 Records/Documents Lead. Although a description for each item listed in the

figures is not required, there does not appear to be a logical system for determining which items

are described and which are not. Consistent with NUREG-1520,Section 2.4.3(1), ensure that kev

positions listed in LA Figure 2-1 and Figure 2-2 have corresponding descriptions in LA Section

2.2. In response to this RAI, explain what logical criteria are used to determine which

management functions are described and which are not.

RESPONSE: Figure 2-1 and Figure 2-2 were revised in a rewrite to the License Application

Chapter 2. Section 2.2, "Key Management Positions, Responsibilities, and Qualifications," was

also revised to describe positions that have key management, supervisory or direct professional

responsibilities relative to ESH, Quality Assurance and safe operation of the IIFP Facility.

Positions shown in Figures 2-1 and 2-2 that are not described: 1) do not have supervisory or

management responsibilities for ESH or QA, for example the Administration managers or 2) are

not supervisors/managers, for example the operating crews and document control clerks.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. Figure 2-1 and Figure 2-2 have been revised

as shown in the License Documentation Impact for RAI OA-7A or in the attached rewrite for the

License Application Chapter 2. Sections 2.2 through 2.2.11 has been revised to include

descriptions of key (supervisory and management positions with ESH and QA responsibilities)

positions identified in Figures 2-1 and 2-2 in the attached rewrite of License Application Revision

B of Chapter 2.

Follow-up License Documentation Impact: Section 2.2.9.3 "Shift Superintendent", of Chapter

2, License Application Revision A will be revised to clarify the roles and responsibilities of the

Shift Superintendent as follows:

Each operating shift .IFP.s at the staffed with a Shift Superintendent, %4h0 is app.in.ted by th.e

Po.dutio•n/T.ehnieal Manager and appr.ved by the I.IFP COO/PM.. The Shift Superi..tendent

normally reports to the Production/TechInieal Manager. , but during declarAed emer i may a.t

ini the eapacity of the UIP COO/PM, as the Emer-gency' Director, until relieved by the GCOOPM-,

or designee. The r.ole and responsibilities of the Shift Su.perin•Atendent during dea•IAed em..ergen

are speeifically' stated in the UIP FEP/DUP Emeirgency Plan, latest revision (IIFP,. 2009b).

The Shift Superintendents report directly to the Plant Manager. A Shift Superintendent (SSP) is

assigned and scheduled for each work shift including weekends and holidays. The SSP when

scheduled on the back shift (afternoons, nights, holidays and weekends) has the role in

coordinating the IIFP Facility operational and maintenance tasks and support activities. This role

includes: 1) assuring coordination among work groups in the authorization of safety and

radiological permits, 2) arranging any additional or replacement qualified staff, as needed, for the

Organization and Administration RAls Page 125
ORGANIZATION AND ADMINISTRATION

work shift to suppolt planned and emerging work activities, 3) ensuring corrective response and

reporting for any abnormal events and 4) setting priorities and coordinating activities among the

various shift functional groups when emerging or unexpected task requirements arise. When the

SSP is scheduled to work on the day shift, he/she assists in emergency preparedness planning and

related training, supports the Plant Manager on special projects and assignments and attends

refresher training as needed. The Shift Super.intendent is r-esponisible for directing the day to day

oper-ation; A1n All shifts ineluiding the baek shift, weekend and holiday pcr-iods and frensrn

safe operations, andd the iddentificat~ion -and corec,-etion of -Any off normfal operating conditions. The

Shift Superintendent has the authority to stop work and shut down operations in a safe and

orderly manner in matters related to ESH or QA. Eah Sl.ift Superintendent directs assigne

personniel from the production, technical, ESI-, maintenance and support fractionis to provide

continuiy of safe and compliant oper-ations.

Additionally. the Shift Superintendent takes the lead role of the facility Emergency Director until

the Chief Operations Officer, or designee can assume that role in the event of an emergency.

Once relieved of the Emergency Director role, the SSP then fills the role of the Field Incident

Commander during the emergency event. The role and responsibilities of the SSP during declared

emergencies are specifically stated in the IIFP FEP/DUP Emergency Plan (EP), latest revision

(IIFP, 2009b).

The Shift Superintendent shall have; as a minimum; a bachelor's degree in an engineering or

scientific field, and a minimum of four years of responsible experience in supervising and

implementing chemical, radiological or nuclear-related operations programs. Educational

requirement may be substituted with relevant military and/or civilian work experience.

Organization and Administration RAIs Page 126

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ORGANIZATION AND ADMINISTRATION

OA-8

B. The individuals and positions listed in LA Section 2.2 do not appear to be listed in a logical

order consistent with the LA Figures 2-1 or 2-2, e.g., contractors from the DB phase are

listed after individuals who manage the operation phase (e.g., COO/Plant Manager).

Consistent with NUREG-1520, Section 2.4.3 (2-3), provide a logical order to the groups

listed in LA Section 2.2 so that management structure is easy to understand In response to

this RAI, provide the logic behind the ordering of groups described in Section 2.2, and

indicate how the ordering correlates with Figures 2-1 and 2-2. LA Sections 2.2.1 through

2.2.25 do not distinguish between the Design phase and the Operations phase. Provide some

method, e.g., in the title or by grouping, to distinguish which organizational groups are used

for design and which are used for operations.

RESPONSE: Figure 2-1 shows the organizational makeup of the IIFP during the Project Design

and Construction phase. The same organization makeup is used during the Operations phase

except that additional personnel are added during the transition from construction to operations.

The only organization in the project design and construction organization that does not transition

to the plant operations phase is the Design and Build Contractor owing to this being a temporary

position for design and construction of the IWFP Facility. In the rewrite to Chapter 2 of the License

Application (attached) the key management position (determined by responsibility for ESH, QA

and safe operation of the facility) descriptions in Section 2.2 have been logically organized in the

following order of discussion: 1) firstly, the parent corporate President/CEO and the parent

corporate staff that interact with the subsidiary IIFP organization are described; then 2) the IIFP

Facility organization is described beginning with the IIFP President, followed down the line

organization to the IIFP COO as a direct report to the IIFP President; 3) next the direct reports to

the IIFP COO are described beginning with the Engineering Manager followed by the direct

reports to the Engineering Manager down the line within the Engineering organization. The DB

Contractor is included in this reporting chain because of the oversight by the Engineering

Manager of the DB Contractor during design and construction and also because of the DB

Contractor's importance to safe design and construction of the facility; 4) then each of the other

direct reports to the COO are described beginning on the left side of the Figure 2-2 chart and then

following down the right side of the chart. As each position reporting to the COO is described

then each function or individual reporting to that management position is described in order down

the line within that respective organization.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. Key Management Positions, Responsibilities

and Qualifications have been revised in Section 2.2 of Revision B (redline version attached).

These are discussed in LA Chapter 2 Revision B in the logic order described in the Response

section above in relationship to the revised organizational charts shown in Sections 2.12 and 2.1.4

of Revision B.

Organization and Administration RATs P a g e I 27

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ORGANIZATION AND ADMINISTRATION

OA-8

C. The bulleted list in Section 2.1.4 on Pages 2-5 and 2-6 appears to match positions listed in

LA Figure 2-2. Ensure that the management positions listed in Figure 2-2 match the

positions contained in the bulleted list.

RESPONSE: The subject bulleted list does not include all the positions listed in Figure 2-2.

It has been revised to include the IIFP Facility functions where the IIFP COO provides

leadership and responsibility.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application,

Revision A and insert Revision B of Chapter 2 in its entirety. See response to RAI OA-6A for

revisions to Section 2.1.4 (2"d paragraph).

Organization and Administration RAIs 

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ORGANIZATION AND ADMINISTRATION

OA-9. Several of the key management positions described in LA Section 2.2 need additional descriptions

to understand their responsibilities. Consistent with NUREG-1520, Section 2.4.3(3) provide the

following information:

A. LA Section 2.2.1 indicates the President/CEO's credentials must include proven ability in

management, leadership qualities, and a commitment to safety, etc. These items are not

quantifiable. Consistent with NUREG-1520, Section 2.4.3(3), provide the minimum quantifiable

criteria required for the President/CEO such as: the number of years of experience in

management, the years and type of demonstrated leadership, and the number of years and type of

education. (Note: If there aren't specific criteria, specify in response to the RAI why this is

acceptable.)

RESPONSE: The subject sentence in Section 2.2.1 has been revised to provide quantifiable

criteria required for the INIS President/CEO. In addition, key positions described in Section 2.2,

including new Section 2.2.3 for the IIFP President have been reviewed to ensure that the

minimum quantifiable criteria required for the positions have been incorporated in the position

descriptions.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. See response to RAI OA-6B license

documentation impact for rewrites of Section 2.2.1 and 2.2.3.

Organization and Administration RATs PaQe 129

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ORGANIZATION AND ADMINISTRATION

OA-9

B. In LA Section 2.2.4, first paragraph, the first few sentences describe the role of the

CO0/CFPD. The remainder of the paragraph shifts to a focus on Configuration

Management (CM). Consistent with NUREG-1520, Section 2.4.3 (1-3), modify the

paragraph so that it defines the role of the CO0/CFPD rather than provide a discussion of

the CM and other items. If CM is an integral role of the CO0/CFPD, provide additional

description of the CO0/CFPD's CM role. Separate the remainder of the paragraph which

focuses on the QAC, ESH Manager and the President/CEO or clarify how these positions

impact the responsibility of the CO0/CFPD.

RESPONSE: The CM discussion and other items have been removed from Section 2.2.4 and

it has been rewritten to focus on describing the responsibility/role and qualification of the

COO.

License Documentation Impact: Section 2.2.4 has been rewritten as shown below to delete

the description of CM and to provide the description for the COO.

2.2.4 Chief Operations Officer and Commercial F.-ility Project Dirceto.

The Chief Operations Officer wh. will be the Comr. .reial Facility Prject Diretr

(COO/CFPD) dur.ing the DB proEjeC;t phase is selected by the N4-IS/IIFP President/CFG-. In the

role of COO/CF-PD, he/she is responsible for managing the design, detailed engineering,

construction, pre-startup, procurement, configuration management (CM), quality assurance,

ESH, subcontracting, project control and records. ModAifi.ations• resulting from designfi and

engnerig haiiges are roontroelled through CM4. The change maniagement is coeordinated with

the IS A andý 10esi~ Hupo grouHp for technfical review and analysis, documentation and~/or

lieensing amenidmennts, whiere r.equir.ed. Wher.e mo.difications involve e.isting ;o. new. 1ROFS,

the ISA documentation. and any licensing amenidment r-equir-e the r-eview and approeval, at a

minimum, of the QA Coordinatr, ES4 M .anager. and COO/CFP.D. hi addition, any licensing

amendment r-equires the approval of the PNIS/IIEP President'CEO, eir designee, prior- to

sub mitti ng the amendment to the NRC.

The COO is the individual with the overall responsibility for safety and operational activities

of the FEP/DUP Facility. The responsibilities of the COO are defined by IIFP policies,

procedures, and instructions. The COO is responsible for the safe conduct and control of

operations. and protection of employees. The COO also has responsibility for regulatory

compliance with the facility NRC licenses and other federal, state, and local permits or

licenses. The COO ensures proper selection of staff for the key positions including positions

for the Facility Safety Review and ALARA Committees.

The COO/GFP-D shall have the authority to enforce the shutdown of any construction or prestart activity. The COO&CFP-D will also delegate facility shutdown authority to appropriate

organizations and line managers. The COO/GF-PD must approve restart of any activity that

was shut down due to safety and/or regulatory concerns.

The COO/CF-PD shall have; as a minimum; a bachelor's degree in a scientific field and seven

five years of experience in chemical, radiological, or nuclear related operations. The

Organization and Administration RAls Page 130
ORGANIZATION AND ADMINISTRATION

experience shall include senier-responsible assignments involving engineering and either

project management or facility operations management. The COO/C.FP-D shall be cognizant

of the IIFP licensing documentation and the overall ESH and OA requirements of the facility

design and construction.

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ORGANIZATION AND ADMINISTRATION

OA-9

C. The QAC description in LA Section 2.2.11 contains the following sentence. "The IIFP QA

Coordinator also ensures and oversees the implementation and maintenance of the plant

performance assessment and action tracking program relative to ESH and QA. " Provide a

brief description of the "plant performance assessment" and "action tracking program" so

individuals unfamiliar with these programs understand their purpose. In addition, the QAC

description contains a sentence which states, "The QA Coordinator shall have, as a

minimum, a bachelor's degree in engineering, science or related field and five years of

quality experience in the implementation of a QA Program at a chemical, radiological or

nuclear facility. " Clarify what is meant by "quality experience. "

RESPONSE: The subject sentence referring to the plant performance assessment and action

tracking program has been deleted in the rewrite to Chapter 2 of the License Application.

Since these are only two of the elements for which the QA Manager has responsibility, the

sentence was replaced by expanding Section 2.2.6 to explain all those elements of the QA

program under the IIFP QA Manager's responsibility. Additionally, the word "quality" in

"quality experience" was deleted since the experience required is in the implementation of a

QA Program.

Facility performance assessment and the corrective action program are described in Sections

2.3.5 and 2.3.6 of the LA Chapter 2. These programs are further described in Sections 11.5

and 11.6 of the IIFP LA Chapter 11.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application,

Revision A and insert Revision B of Chapter 2 in its entirety. Section 2.2.11 (now 2.2.7) of

the License Application was rewritten to rename the QA Coordinator as the IIFP Quality

Assurance (QA) Manager, and to include all the quality elements for which the QA Manager

is responsible, and to show the experience required for the QA Manager. The rewrite of

former Section 2.2.11 (now 2.2.7) can be viewed in the license documentation impact of RAI

OA-6C or in the attached rewrite of Chapter 2 of the License Application, Revision B.

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ORGANIZATION AND ADMINISTRATION

QA-10. The description of the transition from DB contractor to operations must demonstrate adequate

planning and staffing. Consistent with the NUREG-1520, Section 2.4.3 (4), provide the following

information."

A. LA Section 2.1.3 states that the Engineering and Maintenance Manager and the Operation and

Technical Manager may serve as the Startup Manager. This appears to be inconsistent with the

description in Section 2.2.8 "Startup Manager, "which indicates a dedicated individual will be

assigned to the position. Consistent with NUREG-1520, Section 2.4.3(4), clarify whether the

Startup Manager is a standalone position or whether the role is filled by other managers for a

limited time. If multiple individuals serve as the Startup Manager, explain how this transition

takes place and its implication for who has authority over the startup of operations.

RESPONSE: The Startup Manager has been deleted as a key management position in Section

2.2. Section 2.1.3 of the License Application has been rewritten to delete reference to the Startup

Manager. The Plant Manager will take a lead role with authorization and support from the Chief

Operations Officer in the transition from the design and construction phase to the operations

phase of the IIFP Facility.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. Chapter 2 has been rewritten to eliminate the

position of the Startup Manager in Section 2.2 and to clarify the roles during the transition from

construction to operations in Section 2.1.3. Section 2.1.3 in the attached License Application

(Revision B) will be rewritten to read as follows:

2.1.3 Transition from Design and Construction to Startup and Plant Operations

WhlqenPrior to the end of construction appfoaehe , the focus of the organization will shift from

design and construction to initial startup and operation. At an appropriate time during

construction, IIFP will supplement and expand the initial organization structure to include a Plant

Manager (PM) and other management positions and disciplines necessar to ensure readiness of

the facility for safely starting and effectively transitioning from construction activities to

operating activities. These additional positions will be hired well in advance of the scheduled

startup of operations, and may serve in interim organizational roles during the construction phase

of the project. Prior to completing construc..tion, UP will staffd.e fac.ility oper-ating or.ganization

to en:;ture readiness of the ficility t:r saf~ely starting anld eff-ectively tr-ansitioninig f

constiuttion activities to oper-ation activities. The persons thatwill take the riesponsibilities- of

Want Eng . .ineer.ing and Maintenan. e aUnager. and the Operation and Technic l Manager ar hired

wvell in advancee of the scheduiled star~t tip of operations;, and may ser-ve in DB or-ganiizationial roales,,

such as the Startup Manager. until the transition froem DB to fitcility operation.

During this transition, the IIFP plant ESH and OA Managers eonti•nue5to-report to the

COO/-,FP-D for ESH and QA matters related to design and construction. As the COO/CFPD role

enlangeS to Hie ýu~-AJWW-A, tile ELSA mvanager* tfansitions to Eairecty reporting to the UFT WýU/V

on ESH matter:; for- the startup oper-atien:;. The ESH M~anager who has; beeni reporting in a mati

role to the Pi-esident/CEO noew chianges torpr ini the matr-ix role to the Regulatory,

Affai!rs/Ouality Director (R,6OD). The H.FP QA Coor-dinator- likewise reports to the COO/CFP2D

durinig the design anid con: t i stage, then tran.Sitions L• r ng to the II21 COO/PM.

Organization and Administration RAIs IPa-e• 133
ORGANIZATION AND ADMINISTRATION

Dr,,ing the deSign an.d cn4.t.u.tiO. an; d the trasitioln pi. , Bboth the ESH Managei-and QA

Cear-dinatetr Managers have therespensibiliyaf authority to elevate and report any ESH or QA

unresolved concern to the IIFP President. an4 to cerperate Regulator.y Affali:s/QA Dife.to.

respectively, Or dirft •.to the INIS/IIFP Preside.. t,/CEO The IIFP President is ultimately

responsible for ESH, QA, and other safety-related issues. All ESH and QA concerns will be

followed through to resolution and documented.

This reporting authority of the ]IFP relationship fr- the planit ESH and QA managers is

intentionally structured to provide significant continued focus on the ESH goals and stop-work

authority during design, construction and transition periods when the operating organization is

not yet fully implemented.

When construction of the plant and process systems is complete, the equipment and systems

undergo acceptance testing as in accordance with the QAProgram and approved written

procedures. Following successful completion of aeeeptanee integrated equipment and systems

testing, and acceptance, the responsibilities for managing the facility equipment and systems are

transferred from the PB-Desigzn and Construction Oorganization to the Plant Oeperationing

Oorganization as shown in Figure 2-2 by means of a transition plan. The COO/GFP-D and the

-S-a4tPlant Manager ensure the development of a transition plan and an orderly, safe and

thorough turnover to the IIFP COO/PM- , Plant Engiiiee• . /r ;.Maintenanee Man.ager an

Operation/Technical Managerfunet.ionsPlant Operation Organization. The turnover includes the

physical systems, corresponding design information, records of the facility, and as-built drawings.

Following turnover, the Pplant Operation 0organization is responsible for facility safe operations,

system-maintenance, configuration management (CM) and facility safety reviews of

modifications affecting the as-built plant.

The design basis for the facility is maintained during the transition from construction to

operations through the CM Program described in LA Chapter 11; "Management Measures."

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ORGANIZATION AND ADMINISTRATION

OA-10

B. The second full paragraph of LA Section 2.1.3 indicates that the ESH reports to a different

manager after the transition from the DB phase to the Operations phase. Based on LA Figures 2-

1 and 2-2, the entire management structure changes during this transition. Consistent with

NUREG-1520, Section 2.4.3(4), clarify why only the ESH is called out specifically in Section

2.1.3; and describe the transitions for all key managers. Also, introduce new key organizations

created for the Operations phase and provide a description of the new positions in LA Section

2.2. Provide an overview of how the positions listed in Figure 2-1 will be transitioned to the

positions in Figure 2-2, similar to the description provided for the COO.

LA Section 2.2.2 describes the Chief Financial Officer (CFO). This position does not appear in

LA Figure 2-2. Consistent with NUREG-1520, Section 2.4.3 (2), clarify what happens to the

CFO in the transition from DB to organization.

RESPONSE: Figures 2-1 and 2-2 have been revised as a result of a rewrite to Chapter 2 of the

License Application. Figure 2-1 portrays the organizational makeup of the IIFP during the Project

Design and Construction phase. The same organization makeup is used during the Operations

phase, except that additional personnel are added during the transition from construction to

operations. All the organizations in the project design and construction organization transition to

the plant operations phase except for the Design and Build Contractor. Section 2.1.3 has been

rewritten to clarify the transition from construction to operations and to clarify that both ESH and

QA have the authority to elevate unresolved ESH and QA concerns to the IIFP President. See

License Documentation Impact for RAI OA-1OA. Section 2.2 has been rewritten to include

position description for the key positions. See License Documentation Impact for RAI OA-8A.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. See License Documentation Impact for RAI

OA-8A for the rewrite of key position descriptions (Section 2.2) to be viewed in the attached

Chapter 2, of the License Application, Revision B. See License Documentation Impact for RAI

OA- 1 OA for the rewrite of Section 2.1.3 to clarify roles during the transition between construction

and operations phases. See License Documentation Impact for RAI OA-7A for the revised

organization charts (Figures 2-1 and 2-2).

Organization and Administration RAIs Page 135

Organization and Administration RAls P age 135
ORGANIZATION AND ADMINISTRATION

OA-1 0

C. LA Section 2.1.3, fourth paragraph, references two separate plans, the Quality Assurance

Plan and the Transition Plan. The purpose and use of these plans is not well defined.

Consistent with NUREG-1520, Section 2.4.3(4), clarify whether the plans will ensure that

IROFS, equipment, procedures, etc., are in place and functioning safely, efficiently, and are

tested. This paragraph also indicates acceptance testing of the system will be conducted

before final operations. Summarize the things that will be tested (e.g., safety equipment,

procedures, process equipment, etc.) and what criteria will be used to determine the items are

ready for operations. Clarify which individuals/functions are responsible for overseeing the

testing and which manager ultimately decides items are ready for operations. State whether

an integrated systems test will be preformed prior to operations.

RESPONSE: The Transition Plan will be developed following the requirements of the QA

Program Description (QAPD) of the License Application and will include the same elements of

the QA Program. Section 2.1.3 has been rewritten to reflect only the Transition Plan.

Requirements for pre-operational testing were added to the QAPD for Test Control (See License

Documentation Impact for RAI QAPD-1). The Transition Plan, which will include an integrated

equipment and systems test, will follow the requirements of Test Control of the QAPD.

License Documentation Impact: Remove Chapter 2 of the IWFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. Section 2.1.3 has been rewritten to reflect

only the Transition Plan, acceptance testing in accordance with QA program requirements, and

completion of integrated equipment and systems testing. See the License Documentation Impact

for RAI OA- 1 OA for the rewrite of Section 2.1.3.

Test control requirements were added to the Quality Assurance Program Description (Appendix

A to the License Application) as shown below and as in the License Documentation Impact for

RAI QAPD-1:

A.11 Test Control

A.11.1 General

A system is established for design verification testing. acceptance testing, pre-operational and

operational testing, and post-maintenance testing of IROFS. This system provides measures to

ensure that this testing is completed satisfactorily.

Requirements for the certification of personnel who perform design verification testing.

acceptance testing, pre-operational and operational testing, and post-maintenance testing of

IROFS are identified.

A.11.2 Responsibilities

Engineering is responsible for providing technical criteria for testing. evaluation of test results,

and resolution of deficiencies identified from these tests.

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ORGANIZATION AND ADMINISTRATION

Line managers are responsible for the conduct of testing activities under their cognizance which

are in accordance with procedures consistent with these requirements.

A.14.3 Requirements

Tests required for conformance verification of an item or computer program to specified

requirements and to demonstrate satisfactory performance for service are planned and executed.

Characteristics to be tested and test methods to be employed are specified.

Test results are documented and their conformance with acceptance criteria is evaluated.

Tests required to collect data, such as for siting or design input, shall be planned, executed,

documented, and evaLluated.

Tests include design verification tests, acceptance tests, pre-operational and operational tests, and

post-maintenance tests. Planning for tests may include mandatory hold points, as required.

Test policies, plans, and/or procedures contain the following information, as appropriate:

* Test purpose or objectives, responsibilities, characteristics to be tested, hold points, and

test methods to be employed:

" References and related documents:

" Provisions for ensuring prerequisites for a given test have been met, to include, as

applicable, calibrated instrumentation, appropriate equipment. trained personnel,

condition of test equipment and the item to be tested, and provisions for data acquisition;

* Adequate instrumentation is available and suitable environmental conditions are

maintained:

• Provisions for documenting and evaluating the test results for conformance with

acceptance criteria; and

" Qualifications for test personnel.

In lieu of test policies, plans, and procedures, appropriate methods of related documents rsuch as

American Society for Testing and Materials (ASTM), external manuals, maintenance

instructions, or approved drawings] may be used. Such documents must include adequate

instructions to ensure the required quality of work.

Test records contain the following information:

• Item tested: test date;

" Tester or data recorder;

* Type of observation;

* Test policy, plan, procedure, or reference;

" Results and acceptability;

" Actions taken in connection with any deviations noted; and

* Person evaluating the results.

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ORGANIZATION AND ADMINISTRATION

OA-1 0

D. The last paragraph on Page 2-4 states, "...physical systems, corresponding design information,

records of the facility and as-built drawings, "will be turned over to the

Engineering/Maintenance Manger and Operations/Technical Manager. LA Section 2.1.3 does

not specify who these responsibilities will be transferred foiom. Also, these responsibilities do not

appear to be described in the DB Organization in LA Section 2.1.2. Consistent with NUREG

2.4.3(1), clarify if these are key organizational responsibilities in the DB phase. Ensure that key

organizational responsibilities are consistently described and transitioned throughout LA

Sections 2.1.2, 2.1.3, and 2.1.4.

RESPONSE: Earlier in subject paragraph of Section 2.1.3 prior to the subject sentence, it states

that the systems are transferred from the DB organization. Section 2.1.3 was rewritten to

generalize this transition from the DB organization to the IIFP organization. Responsibilities for

the DB organization have been added to Section 2.2.

License Documentation Impact: Remove Chapter 2 of the IIFP License Application, Revision

A and insert Revision B of Chapter 2 in its entirety. See the License Documentation Impact for

RAI QA 1 OA for the rewrite for Section 2.1.3 which shows the generalized transition from the

design and build phase to the operations phase. Section 2.2 has been rewritten as shown in the

License Documentation Impact for RAI QA-8A and includes the key management position of the

Design and Build Contractor Section 2.2.6 as shown below:

2.242.2.6 Design and Build Contractor

The Design and Build DUB)Contractor DBIG-)-is selected by the 1NIS4/1- President/CEO, and

approved by the INIS Board of Directors. The DB Contractor, under a formal approved written

contract with IIFP, is responsible for performing the detailed design, engineering, procurement

and construction of the IIFP FEP/DUP ptahtFacility. The DBC Contractor assigned manager is

the lead-official representative of the design/build contract.-; In the initial design phase the DB

Contractor will and-reports directly to the COO/GpP-D. Once the Engineering Manager position is

filled the DB Contractor shall report directly to the Engineering Manager. The DB Contractor

coordinates and-works Y4th-on the project and @M---controls aeeerds-subcontractors,

inspections, and startup functions to ensure a safe design, construction, acceptance testing and

turnover to the IIFP Plant Operating-Operation Organization.

During the detailed design, construction and startup stage of the project, the DB Contractor will

also ensure, as part of the written contract, that design meets all the applicable federal, state and

local codes and standards.

The approved DB Contractor shall have; as a minimum; a demonstrated safe record of experience

in design, engineering, procurement and construction of chemical, radiological or nuclear

facilities at project complexity levels equivalent with that of the IIFP Project. The DB Contractor

shall also have the professional and trade craft capabilities of either performing or subcontracting

(with IIFP approval) for design, engineering, procurement, construction and support of

acceptance testing for the plant process equipment, systems and facility infrastructure.

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ORGANIZATION AND ADMINISTRATION

OA (No number) New Follow Up Question

The staff has confirmed that the revised application addresses all the acceptance criteria in NUREG1520, Chapter 2, except possibly for the fifth bullet on page 2-3 (under criteria for existing facilities).

For completeness, please clarify how this 51h bullet has been addressed in the application (ESH

implemented via written and approved procedures)

RESPONSE: The fifth bullet of the criteria states, "The activities that are essential for effective

implementation of the ESH functions are documented in formally approved, written procedures,

prepared in compliance with a formal document control program." Chapter 11, "Management

Measures," of the License Application and the "Quality Assurance Program Description" (Appendix

A of the License Application) address this bullet as follows:

11.1.4 Document Control

Procedures are established which control the preparation and issuance of documents such as manuals,

instructions, drawings, procedures, specifications, design documents, procurement documents and

supplier-supplied documents, including any changes. Procedures are established to control the lifecycle of documents that pertain to the CM function. Measures are established to ensure documents,

including revisions, are adequately reviewed, approved, and released for use by authorized personnel.

Document control procedures require documents to be transmitted and received in a timely manner at

appropriate locations including the location where the prescribed activity is to be performed.

Controlled copies of these documents and their revisions are distributed to and used by the persons

performing the activity.

Superseded documents are destroyed or are retained only when they have been properly labeled.

Indexes of current documents are maintained and controlled.

Document control is implemented in accordance with procedures. A document management system is

used both to file project records and to make available the latest revision (i.e., the controlled copy) of

design documents. The system provides a record copy of the current controlled document, and

personnel are trained to use this system to retrieve controlled documents. The system is capable of

generating indices of controlled documents, which are uniquely numbered (including revision

number). Controlled documents are maintained until cancelled or superseded. Cancelled or

superseded documents are maintained as a record, currently for the life of the project or termination

of the license, whichever occurs later. Hardcopy distribution of controlled documents is provided

when needed in accordance with applicable procedures (e.g., when an electronic document

management system is being used but is not available).

Document control encompasses those documents that are relied on for safety, e.g. the ISA. all

procedures that pertain to IROFS, procedures involving training, QA, maintenance, audits and

assessments, emergency operating procedures, emergency response plans, system modification

documents, assessment reports, and others that the applicant deems part of CM. See Section 11. 1.1. I,

"Scope of Structures, Systems. and Components." for a general accounting of the documents subiect

to configuration management during design, construction, and operations of the IIFP Facility. A more

detailed listing of documents tinder configuration control during design is provided in Section 11.1.2,

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"Design Requirement" and Section 1I 1.1 .3, "Configuration Management Controls on the Design

Requirements." Documentation under CM during construction is delineated in Section 11.1.5.2

below. Similarly, Section 11.1.5.3 provides a discussion of documentation under CM during the

operations phase.

11.4 Procedures Development and Implementation

IIFP utilizes a hierarchy of policies, plans, and procedures to document management expectations and

commitments, as well as to provide instructions and guidance to IIFP personnel. Policies and plans

are upper tier documents that define and describe senior management expectations and guidelines for

safe operation of the IIFP Facility and compliance with state and federal regulations, permits and

licenses. Procedures are used to ensure implementation of the requirements set forth in policies and

plans.

All activities involving IROFS and QA level 1 and 2 items (See Seetio-subsection 11.8.42.2) are

conducted in accordance with approved procedures. As noted throughout this document, procedures

are used to control IROFS activities to ensure the activities are carried out in a safe manner and in

accordance with regulatory requirements.

11.4.1 Type of Procedures

Procedures are categorized as management control procedures or operating procedures/instructions.

Management control procedures describe administrative and general practices approved and issued by

management at a level appropriate to the scope of the practice. These procedures direct and control

activities across the various organizational functions, and assign finctional responsibilities and

requirements for these activities. Operating procedures provide specific direction for task-based work

and are used to directly control process operations at the work place.

Compliance with IlFP procedures is mandatory. If any aspect of a procedure is unclear or incorrect as

written, personnel shall safely stop the operation and/or activity and contact management. The

operation and/or activity shall not restart until corrective action has been taken. If a situation is not

defined in the procedure content or an unexpected response is obtained, management notification is

also required.

Generally, four types of plant procedures are used to control QA Level 1 and 2 activities: operating

procedures, management control (administrative) procedures, maintenance procedures, and

emergency procedures. Procedures may also be used to control other plant and administrative

activities.

11.4.1.2 Management Control (Administrativel Procedures

Administrntive Management control procedures deal with policy or programs and administrative

systems, provide programmatic requirements, and do not normally involve manipulation of

equipment. Administiative Management control procedures are used to perform activities that support

production i-and control process with IROFS and/or hazardous chemicals incident to the processing of

licensed material. Site-wide safe work practices (such as lockout/tagout. confined space entvy.

exclusion area requirements, radiation or hot work permits. industrial safety, and environmental

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ORGANIZATION AND ADMINISTRATION

issues) apply to workers, visitors, contractors, and vendors. These management control procedures;

include4+gwmanagement measures such as the following:

* Configuration management;

e Industrial Safety, radiation safety, chemical safety, and fire safety;

* Quality Assurance;

" Design control;

* Plant personnel training and qualification;

* Audits and assessments;

* Incident investigations;

* Record keeping and document control;

* Reporting; and

* Procurement

Procedures for construction will be an integral part of the procedures of the Design and Build (DB)

contractor chosen by IIFP. The DB contractor will use those procedures during the construction

phases of the flFP Facility.

Additionally, criticality safety procedures will not be applicable for the IIFP Facility since the facility

will only process depleted Uranium.

11.4.2.5 Approval

Following the resolution of review comments, procedures are approved. Approval authority rests with

the responsible manager. Managers ensure that necessary training or required reading is completed

prior to procedure implementation.

11.4.4 Topics to be Covered in Procedures

Activities defined in Section 11.4.1, "Types of Procedures," are the minimum activities to be covered

b ycontrolled documents. Maintenance activities listed below may be covered by approved written

procedures, documented work instructions, or drawings; whichever is appropriate to the

circumstance. 'rhe list below is not intended to be all-inclusive, as many other activities carried out

during operations may be covered by procedures not included in the list. Similarly, this listing is not

intended to imply that procedures need to be developed with the same titles as those in the list. This

listing provides guidance on topics to be covered rather than specific procedures.

MANAGEMENT CONTROL (ADMINISTRATIVE) PROCEDURES

1. Configuration Management

2. Maintenance, with the Following Additional Procedures:

" Maintenance Modifications

* Work Control Procedures

• Control of Measuring and Test Equipment

3. Training and Qualifications Procedures

Organization and Administration RAIs P a g e I 41

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ORGANIZATION AND ADMINISTRATION

4. Procedures Development and Implementation

5. Audits and Assessments Procedures, Including

" Audits

" Certification of Audit Personnel

* Management Assessments

6. Incident Investigations and Corrective Actions Management

7. Records Management and Document Control

8. Other Quality Assurance Elements

* Organization

* Quality Assurance Program

* Design Control

* Procurement Document Control

* Supplier Qualification

" Instructions, Procedures, and Drawings

* Document Review

* Continuous Inprovement

* Control of Purchased Items and Services

" Identification and Control of Items

* Inspection

* Test Control

" Control of Special Processes

" Control of Nonconforming Items. Materials, and Components

* Inspection, Test, and Operating Status

" Quality Assurance Records

9. Environmental, Safety, and Health Procedures

* Hazard Commlunication Program (HAZCOM)

" Fire Prevention Plan

* Energy Control (Lock/out/Tag/out)

* Respirator Program

" Confined Space Entry

* Exposure Control Plan (Bloodborne Pathogens Program)

* Fall Protection

" Chemical Hygiene Plan (Laboratory Safety Program)

" Hazardous Waste Operations and Emergency Response (HAZWOPER)

* Process Safety Management

* Radiation Protection

* Environmental Protection

* Spill Control Response

10. Fire Protection Procedures

11. Nonradiological/Radioactive Waste Management Procedures

12. Laboratory Analytical Procedures

13. Security Procedures

11.8.5 Instructions, Procedures, and Drawings

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Activities affecting the availability or reliability of IROFS are prescribed by and accomplished in

accordance with documented specifications, requirements, procedures, instructions, and drawings of a

type appropriate to the circumstances. These documents include or reference appropriate acceptance

criteria for determining that prescribed activities have been satisfactorily accomplished. Standard

guidelines for the format, content, review, and approval processes for documents are established. (See

Section 11.4 "Procedures Development and Implementation" and LA Appendix A.5.1. "Instructions,

Procedures. and Drawings.").

Adherence to policies and procedures is mandatory. In the case of conflict or error involving a

procedure, the activity in question shall be placed in a safe condition and the procedure shall be

corrected or changed before proceeding to implement the procedure.

11.8.6 Document ControlRccords Managemcnt

A document control and i'eccrdS managerneit system is established for IROFS and related activities

and services within the scope of the QAP-QA program. This system ensures that documents and4

recerds-defining the performance of quality :elated aetivitiesmanageement measures are controlled so

only current and correct information is available at the location where the activity is performed prior

to commencing the work. See Section 11.7. "Records Management and Document Control" and LA

Appendix A.6, "Document Control."

The Quality Assurance Program Description (Appendix A of the License Application) addresses this

bullet as follows:

A.5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS

A.5. 1 General

The requirements for instructions, procedures, and drawings are applied to quality and process-related

activities and services. Measures are in place to ensure that activities affecting quality are prescribed

by documented procedures, drawings, and instructions, appropriate to the circumstances, and are

accomplished in accordance with these documents. These documents also include quantitative and

qualitative acceptance criteria to ensure that important operation evaluations which may affect IROFS

have been satisfactorily accomplished.

A.5. 3 Requirements (2nd paragraph only)

Written procedures shall be prepared, reviewed, approved, implemented, and maintained in

accordance with the IIFP document control process.

A.64 DOCUMENT CONTROL AND RECORDS MANACEMENT

A.64.1 General

A document control and rFcorcds managcment system is established to maintain policy, procedure,

work instruction and any other documentation which relates to the activities and services provided by

IIFP. This system ensures that documents mid -eeerds-defining the performance of process and

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quality-related activities are controlled so only current and correct information is available at the

location where the activity is performed prior to commencing the work.

A.64.2 Responsibilities

The Records Manager has the overall responsibility for the development and implementation of the

records management and document control system.

Managers are responsible for (1) identifying documents to be included in the controlled document

system; (2) ensuring instructions, procedures, drawings, and other specified documents are reviewed

for adequacy and approved for release; (3) complying with document distribution requirements; and

(4) ensuring these documents are maintained and used by personnel performing the prescribed

activity.

A.64.3 Requirements for Document Control

Procedures for the control of document preparation, review, approval, and issuance are established to

ensure the following:

* Identification of documents to be controlled and their specified distribution,

* Identification of assignments of responsibility for preparing, reviewing, approving, and

issuing documents, and

* Review of documents for adequacy, completeness, and correctness prior to approval and

issuance.

Drawings depicting as-built conditions, including changes, and related documentation are prepared in

a timely manner and accurately reflect the actual design.

Document controls used to specify the current revision and any changes to instructions, procedures,

specifications, drawings, and procurement documents are identified. This document control system

has provisions for updating and for distribution to predetermined personnel.

Except for minor changes, changes to documents are reviewed and approved by the same

organization that performed the initial review and approval or are delegated to other qualified

organizations. The reviewing organization has access to pertinent background data or information

upon which to base their approval.

Minor changes to documents, such as inconsequential editorial corrections do not require that the

revised documents receive the same review and approval as the original documents. The review and

approval for minor changes are specified in procedures.

Obsolete or superseded documents are removed and/or replaced in a timely manner.

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