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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: 

As the owner and operator of 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. 
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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, Safety and 

Health (ESH) and plant management production 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) Health Physics 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. 
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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 plant and process systems is complete, the equipment and systems 

undergo acceptance testing as in accordance with the QA Program and approved written 

procedures. Following successful completion of acceptance integrated equipment and systems

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

transferred from the Design and Construction DB Oorganization to the Plant Operation

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

COO/CFPD and the Startup Plant Manager ensure the development of a transition plan and an 

orderly, safe and thorough turnover to the IIFP COO/PM, Plant Engineering/Maintenance 

Manager and Operation/Technical Manager functions Plant Operation Organization. The turnover 

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

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

of modifications affecting the as-built plant. 
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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 ESH Manager and a QA Manager (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/CFPD is responsible, with delegated commensurate authority 

from the IIFP President, for managing the administration, ESH, QA, design, engineering, and 

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

the licensing, design and construction, initial startup, and procurement activities of the IIFP 

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 of the IIFP 

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 IIFP 

QA Coordinator and ESH Manager report to and support the COO/CFPD. 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 facility .The QA 

Coordinator also has a matrix reporting relationship to the corporate Regulatory Affairs/QA 

Director. During the DB phase, the ESH Manager has a matrix reporting relationship to the 

President/ CEO. These dual reporting relationships for the QA and ESH functions facilitate

objective audit, review, advisory and control activities.
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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 or 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 IIFP 

Facility (See also RAI OA-6A). The 2nd 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 continues to report to the 

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

changes to the COO/PM, the ESH Manager transitions to directly reporting to the IIFP COO/PM 

on ESH matters for the startup operations. The ESH Manager who has been reporting in a matrix 

role to the President/CEO now changes to reporting in the matrix role to the Regulatory 

Affairs/Quality Director (RAQD). The IIFP QA Coordinator likewise reports to the COO/CFPD 

during the design and construction stage, then transitions to reporting to the IIFP COO/PM. 

During the design and construction and the transition periods, Bboth the ESH Manager and QA 

Coordinator Managers have the responsibility and authority to elevate and report any ESH or QA 

unresolved concern to the IIFP President and to the parent corporate Regulatory Affairs/QA 

Director ESH and QA Managers, respectively. or directly to the INIS/IIFP President/CEO. All 

ESH and QA concerns will be followed through to resolution and documented. 
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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/PM) 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 
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regulatory compliance of the IIFP FEP/DUP Facilitycommercial facility. In the discharge of these 

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

• Quality Assurance, 

• Plant Management (Operations/Technical), 

• Plant Engineering/ and Maintenance, 

• Administration/Human Resources,

• Training, 

• Environmental, Safety and Health, and the 

• Facility Safety Review Committee (FSRC)/ALARA Committee 
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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 

IIFP/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/IIFP 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 IIFP 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 of INIS/IIFP 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 IIFP President reports directly to the INIS President 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 

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.
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OA-6 

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

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 IIFP 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: 

2.2.3 2.2.2 INIS/IIFP Regulatory Affairs and Quality Assurance DirectorINIS 

Corporate ESH and QA Managers 

The Regulatory Affairs and Quality Assurance Director (RAQD) is appointed by the INIS 

President/CEO and is responsible for ensuring development and communication of ESH and QA 

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

Director is responsible for establishing an IIFP system that will identify and evaluate potential or 

new regulatory requirements to determine applicability to the IIFP FEP/DUP Facility. The 

RAQD is also responsible for ensuring that effective audit, feedback, investigative and corrective 

action programs are in place both at the IIFP corporate and plant levels that will provide prompt 

response in preventing and correcting ESH related incidents. The RAQD provides advice, 

oversight and regulatory consultation in assisting the IIFP COO/PM, ESH Manager and the QA 

Coordinator in matters of regulatory compliance and ESH and QA programs objectives. The 

Regulatory Affairs and Quality Assurance Director shall have, as a minimum, a bachelor degree 
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in an engineering or scientific field and five years of related experience in chemical, radiological 

or nuclear facilities.

The INIS Corporate ESH and QA Managers are appointed by the INIS 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.

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 IIFP 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 IIFP 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 IIFP 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 subsidiary 

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 correcting 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.

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 IIFP Corporate ESH and QA Managers.

2.2.112.2.7 IIFP Quality Assurance (QA) CoordinatorManager

The IIFP Quality Assurance Coordinator Managerat the facility is appointed by reports to the 

COO/PM with concurrence of the INIS RAQD. The QA Coordinator reports to the COO/PM, 

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

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

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

responsible for establishing and maintaining the IIFP QA Program. Line management and their 
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staff are responsible for ensuring implementation of the QA Program and compliance with the 

Program. The QA Coordinator Manager position is independent from operational and safety 

organizations. The Coordinator QA Manager has the responsibility and authority to elevate and 

report any ESH QA unresolved related concerns to the IIFP President and the Corporate QA 

Manager. The IIFP QA Manager is responsible to ensure that such QA concerns will be followed 

through to resolution and documentation. corporate management including the INIS 

President/CEO.

The IIFP QA Coordinator Manager also ensures and oversees the implementation and 

maintenance of the plant performance assessment and action tracking program relative to ESH 

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 

QA 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. 

2.2.108 IIFP Environmental, Safety and Health Manager 

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

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

but also has an reporting and interacting relationship with the RAQDall managers on matters of 

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

the ESH Manager has the authority and responsibility to elevate and report any ESH unresolved

concerns to the IIFP President and to the Corporate ESH Manager. The IIFP ESH Manager is 

responsible to ensure that such ESH concerns will be followed through to resolution and 

documentation. to up through IIFP management, and if not resolved to continue up through 

parent corporate management and including the INIS President/CEO. 

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

(RP), Licensing, ISA, Industrial Hygiene and Safety, Environmental Protection, Fire Protection, 

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

state, and local regulations and lawsrequirements. 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 

Shift SuperintendentPlant Manager and COO that such shutdowns are implemented in a safe and 
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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 IIFP Chief Operations Officer/Plant Manager 

The IIFP Chief Operations Officer/Plant Manager (COO/PM) is appointed by the INIS 

President/CEO, and is the individual with the overall responsibility for safety and operational 

activities at the New Mexico Facility. The COO/PM reports directly to the President/CEO. The 

responsibilities of the COO/PM are defined by IIFP policies, procedures, and instructions. The 

COO/PM is ultimately responsible for safety, control of operations, and protection of employees, 

the environment, emergency preparedness and response, and the public and any other accident 

consequences as related to the plant site and operations. The COO/PM also has responsibility for 

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

licenses. 

The COO/PM ensures proper selection of staff for the key positions including positions of the 

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

radiation protection committee. The COO/PM appropriately delegates specific responsibilities 

for implementing ESH and QA related programs to qualified line management and area 

managers.

The COO/PM shall be cognizant of the safety program as applied to the overall safety of the 

facility and shall have the authority to enforce the shutdown of any process or building. The 

COO/PM will also delegate facility shutdown authority to appropriate organizations and line 

managers. The COO/PM must approve restart of an operation that was shut down due to safety 

and/or regulatory concerns.

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, laboratory, 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 startup.

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 

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.
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The COO/PM shall have, as a minimum, 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 COO/PM 

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

IIFP Facility. 
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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 from 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 

As the owner and operator 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 INIS/IIFP approval and submittal the 

project.

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 is will being contracted to perform detailed design and 

construction of the IIFP Ffacility. 
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The design and build (DB) terminology is used synonymously with design and construction work 

as shown in Figure 2-1, “IIFP Project Design and Construction Organization.”

As the project moves from its development and licensing phase, IIFP will hire a Chief Operations 

Officer who will take responsibility as the Chief Operations Officer/Commercial Facility Project 

Director (COO/CFPD) during the DB phase of the Project. Plans are to have the COO/CFPD 

transition into the COO/Plant Manager role upon startup of the FEP/DUP Facility operations. 

Figure 2-1 presents the Project organization and lines of communications during the DB phase. 

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 

IIFP organization will be the Chief Operations Officer who will take direct responsibility and will

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

including selecting additional IIFP management staff. 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 

project organization during the project design and construction phases of the project.

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

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Figure 2-1 IIFP Project Design and Construction Organization 

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

from the IIFP President, for managing the administration, ESH, QA, design,engineering, and 

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

the licensing, design and construction, initial startup, and procurement activities of the IIFP 

Facility. Once an IIFP 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 IIFP President if the 

COO position is not yet filled) carries out these Engineering Manager responsibilities. The IIFP 

QA Coordinator and ESH Managers report to and support the COO/CFPD. 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 Quality Assurance and ESH managers for the facility. The QA Coordinator 

also has a matrix reporting relationship to the corporate Regulatory Affairs/QA Director. During 

the DB phase, the ESH Manager has a matrix reporting relationship to the President/ CEO. These 

dual reporting relationships for the QA and ESH functions facilitate objective audit, review, 

advisory and control activities.

During the DB phase, the engineering and construction and related documentation are completed 

utilizing qualified contractors. The IIFP QA function reviews the DB contractor qualified QA 
ORGANIZATION AND ADMINISTRATION 

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programs in accordance with the IIFP QA (QAP). Approval of vendor, DB contractor and subcontractor QAPs, where required by the IIFP QA Program Plan (QAPP) (IIFP, 2009a), shall be 

obtained prior to commencing with the DB and procurement work activities. 

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

in some cases may be performed by IIFP or its subcontractors. The IIFP 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 INIS QA function ensures reviews of vendor performance in accordance 

with the IIFP QA Program, 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. IIFP has responsibility for pre-operational testing, startup, operation, and maintenance 

of the FEP/DUP commercial plant. Revision A figure below is deleted and replaced with Figure 2-2 on next page
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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 IIFP FEP/DUP commercial Ffacility. In the discharge of these responsibilities, the

COO/PM leads the activities of the project including the following functions: 

• Quality Assurance, 

• Plant Management (Operations/Technical), 

• Plant Engineering/ and Maintenance, 

• Administration/Human Resources,

• Training,

• Environmental, Safety and Health, Training, and the 

• Facility Safety Review Committee (FSRC)/ALARA Committee 

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.”
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In the plant line-organization, related to routine operations of the facility, the IIFP plant ESH 

Manager and the plant QA Coordinator both report to the COO/PM. In a matrix role, the ESH 

Manager and the QA Coordinator report to the corporate RAQD. As part of the matrix role, those 

managers interact with other ESH and QA activities and functions in the corporate structure and 

receive ESH and QA policy and technical standards guidance from the corporate RAQD. 

Additionally, the plant ESH and QA managers have the authority and responsibility to directly 

contact the INIS President/CEO with any ESH or QA concerns, respectively. These reporting 

relationships are part of the independence assurance provided by IIFP that concerns or issues in 

ESH or quality can be directly reported and resolved in alignment with the corporate ESH and 

QA commitment. 

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

accessible to affected personnel and to the NRC. 
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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.
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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 IIFP President are the Corporate ESH Manager and the Corporate QA 

Manager. These parent corporate staff managers interrelate with the IIFP 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 IIFP 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 
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in RAI OA-7A. Figure 2-1 has been revised in Section 2.1.2 as shown in License Documentation 

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. 
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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. 
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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 key 

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. 
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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 IIFP 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. 
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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 (2nd paragraph). 
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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. 
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OA-9

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

COO/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 COO/CFPD rather than provide a discussion of 

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

description of the COO/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 COO/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 Facility Project Director 

The Chief Operations Officer who will be the Commercial Facility Project Director

(COO/CFPD) during the DB project phase is selected by the INIS/IIFP President/CEO. In the 

role of COO/CFPD, 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. Modifications resulting from design and 

engineering changes are controlled through CM. The change management is coordinated with 

the ISA and licensing support group for technical review and analysis, documentation and/or 

licensing amendments, where required. Where modifications involve existing or new IROFS, 

the ISA documentation and any licensing amendment require the review and approval, at a 

minimum, of the QA Coordinator, ESH Manager and COO/CFPD. In addition, any licensing 

amendment requires the approval of the INIS/IIFP President/CEO, or designee, prior to 

submitting 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/CFPD shall have the authority to enforce the shutdown of any construction or prestart activity. The COO/CFPD will also delegate facility shutdown authority to appropriate 

organizations and line managers. The COO/CFPD must approve restart of any activity that 

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

experience shall include senior responsible assignments involving engineering and either 

project management or facility operations management. The COO/CFPD shall be cognizant 

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

design and construction. 
ORGANIZATION AND ADMINISTRATION 

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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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OA-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 

When Prior to the end of construction approaches, 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 necessary 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 construction, IIFP will staff the facility operating organization 

to ensure readiness of the facility for safely starting and effectively transitioning from 

construction activities to operation activities. The persons that will take the responsibilities of 

Plant Engineering and Maintenance Manager and the Operation and Technical Manager are hired 

well in advance of the scheduled start up of operations, and may serve in DB organizational roles, 

such as the Startup Manager, until the transition from DB to facility operation.

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

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

changes to the COO/PM, the ESH Manager transitions to directly reporting to the IIFP COO/PM 

on ESH matters for the startup operations. The ESH Manager who has been reporting in a matrix 

role to the President/CEO now changes to reporting in the matrix role to the Regulatory 

Affairs/Quality Director (RAQD). The IIFP QA Coordinator likewise reports to the COO/CFPD 
ORGANIZATION AND ADMINISTRATION 

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during the design and construction stage, then transitions to reporting to the IIFP COO/PM. 

During the design and construction and the transition periods, Bboth the ESH Manager and QA 

Coordinator Managers have the responsibility and authority to elevate and report any ESH or QA 

unresolved concern to the IIFP President and to the parent corporate Regulatory Affairs/QA 

DirectorESH and QA Managers, respectively or directly to the INIS/IIFP President/CEO. All 

ESH and QA concerns will be followed through to resolution and documented. 

This reporting authority of the IIFP relationship for the plant 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 QA Program and approved written 

procedures. Following successful completion of acceptance integrated equipment and systems

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

transferred from the DB Design and Construction Oorganization to the Plant Ooperationing

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

StartupPlant Manager ensure the development of a transition plan and an orderly, safe and 

thorough turnover to the IIFP COO/PM, Plant Engineering/Maintenance Manager and 

Operation/Technical Manager functionsPlant Operation Organization. The turnover includes the 

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

Following turnover, the Pplant Operation Oorganization 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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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 and to 

the parent corporate ESH or QA Managers, respectively. See License Documentation Impact for 

RAI OA-10A. 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-10A 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 

Organization and Administration RAIs Page | 34

OA-10 

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 IIFP 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-10A 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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Line managers are responsible for the conduct of testing activities under their cognizance which 

are in accordance with procedures consistent with these requirements.

A.11.3 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 evaluated.

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 [such 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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OA-10 

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 from. 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 10A 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: 

2.2.72.2.6 Design and Build Contractor 

The Design and Build (DB) Contractor (DBC) is selected by the INIS/IIFP 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 plantFacility. 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/CFPD. Once the Engineering Manager position is 

filled the DB Contractor shall report directly to the Engineering Manager. The DB Contractor

coordinates and works with on the project and CM, controls and records, 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.