Northwest Medical Isotopes NRC Facility License Application Summary

This report provides a comprehensive overview of the NRC license application process for Northwest Medical Isotopes (NWMI), a nuclear facility seeking to produce Mo-99. The report details the facility's mission, processes, and the regulatory framework under which it operates, including the Atomic Energy Act of 1954 and the Energy Reorganization Act of 1974, as well as licensing under 10 CFR 50. It outlines the two-step licensing process, the timeline of major events, and the issues encountered, such as target dissolver off-gas accidents, along with the corrective actions taken. The report also summarizes the correspondence between NWMI and the NRC, including meeting details and document submissions, and provides a summary of public feedback documented by the NRC. The facility's design and processes are described, including the use of Gold Standard for MO-99 production using the reactor fission method. This document highlights the importance of environmental safety, public safety, and regulatory compliance in the nuclear industry, providing a valuable resource for students and professionals alike. The report is contributed by a student to be published on the website Desklib, a platform which provides all the necessary AI based study tools for students.

Nuclear Rules and Regulations course

Table of Content
INTRODUCTION...........................................................................................................................3
Description of the facility and processes.....................................................................................4
Regulation the facility is being licensed under............................................................................4
One part or two-part license........................................................................................................5
Timeline of major events.............................................................................................................6
Issues encountered and corrective actions are taken...................................................................7
Summary of correspondence between the applicant and NRC...................................................8
Summary of any public feedback that has been documented by the NRC..................................8
Final Decision of the environmental report.................................................................................9
Final or current state of the license application...........................................................................9
CONCLUSION................................................................................................................................9
REFERENCES..............................................................................................................................10

INTRODUCTION
Nuclear power includes nuclear reactions which release nuclear energy for generating
heat. Nuclear power generated from nuclear fission, nuclear decay and nuclear fusion. In the
present time, large amount of electricity is generated from the nuclear power and nuclear fission
of the elements in the actinide series of the periodic table. Along with this, nuclear power is
popular low carbon power generation methods for producing electricity. On the other hand,
Nuclear regulation commission takes care of the nuclear plants and sites. The major purpose of
creating the NRC was to prevent people and environment from the nuclear power and related
subjects. Commercial nuclear power plants and other uses of the nuclear materials are regulated
by the NRC. In the context of the present file, Nuclear Power facility i.e. Northwest medical
Isotopes of the Columbia is taken into consideration. Northwest Medical Isotopes has just
received the permission of construction from NRC. The site selected for the facility is located
within the discovery ridge research park having 550 acres. The discovery ridge is a situation in
the central of Missouri. The report includes a description of the facility and related processes,
regulations related to the facility, issues encountered and their effective actions. Along with this,
the file consists of the final decision of environment report and state of the license application.
Different risks identified by the NRC in the facility are also explained in the report. The solution
for the risk has also discussed within the file.
Description of the facility and processes
The mission of NorthWest Medical Isotopes is to offer domestic, secure and reliable
supply for Mo-99 for the field of medical diagnostics. These facilities of the NRC will remover
the potential shortages of Mo-99 and lead to having a positive impact on the health of the

thousands of patients needing nuclear imaging procedures. The date issued for construction of
this nuclear facility is 9th May 2018. The first application of the respected facility was submitted
on 5th February 2015 and second on 20th July 2015. The government gives permission for
constructing the nuclear power plant with respect to improve the health conditions and other
factors regarding the nuclear procedures. Apart from this, the Northwest Medical Isotope will
use Gold Standard for producing the MO-99. The reactor fission method will be used by the firm
having low-enricehed uranium targets for recovering the Mo-99. Dissolution and purification
methods will be used in standard chemical processes in a Radioisotope production facility. The
selected process of Noth West Medical Isotope is well understood, reliable and predictable which
helps in extracting, purifying and producing the high activity Mo-99.
Commercial nuclear power plants and other uses of the nuclear materials are regulated by
the NRC. The various nuclear materials include nuclear medicine via licensing, inspection and
enforcement. The different processes handled by the commission under the nuclear power
include nuclear reactors, nuclear materials, radioactive waste, nuclear security and public
involvement. It provides a license of production and utilization facilities. With respect to the
Northwest Medical Isotopes, a notice of intent (NOI) was submitted to the US Nuclear
Regulatory Commission which intends for applying for a license under the 10 CFR 50 in order to
construct and operate an RPF. Different documents were submitted by the NWMI for providing
all the necessary information such as environmental safety, public safety and many more. It also
informs all individuals who are linked with any licensee, applicant, contractor, subcontractor,
components, equipment, materials and many more. The major purpose of applying for
regulations regarding the nuclear facility is to protect the environment and people from its
harmful impact. The process of nuclear power followed by the facility includes licensing,
inspection and enforcement in the context of the radiation protection, fire protection, developing
safety culture and many more. NRC follows values and morale will make any decision with
respect to safety, security and other environmental problems (Bernard, 2015).
Regulation the facility is being licensed under
The Northwest Medical Isotope facility of the Nuclear Regulatory Commission is being
licensed under the Atomic Energy Act of 1954 and Energy Reorganization Act of 1974. Both the
regulations are allowing nuclear power facility to collect information about the nuclear energy

and evaluate its negative impact on the US and other countries of the world. With respect to the
regulations, the Atomic Energy Act 1954 amend the Atomic Energy Act of 1946. It includes
laws and regulations for the development, regulation, and disposal of the nuclear materials in the
United States. The act has made possible for the government to provide permission to the private
firms for gaining technical information i.e. restricted data regarding nuclear energy production.
With the help of this act, the Northwest Medical Isotope is able to exchange information with the
foreign nations as part of Atoms for the peace program. Under the respected regulation, NCR is
able to evaluate the ways of controlling and managing the nuclear technology used by the facility
(Simpson, 2016).
On the other hand, the Energy Reorganization Act of 1974 has created the Nuclear
Regulatory Commission in the United States. The act is responsible for development and
production of the nuclear weapons and safety regulations of the individuals. It is the duty of
Energy Research and Development Administration for developing and producing the nuclear
weapons, promoting the nuclear energy and related work and assigning it to the NRC. The
Northwest Medial Isotope is also working under this regulation for promoting the use of Mo-99
for the medical purpose. The regulation also provides protection for the employees,
whistleblowers, individuals who raise the nuclear safety concerns and many more (Reyes and
et.al., 2016).
Apart from this, the nuclear facility has received the license for construction under 10
CFR 50 of the NRC. Under the regulations, it is the prime duty of the nuclear facility to use the
resources effectively without damaging any environmental factor. The promotion of the nuclear
products and services also need to be done in the friendly and effective manner by considering
the environmental and individual safety.
One part or two-part license
The licensing process of Nuclear facility i.e. Northwest Medical Isotopes is of two steps.
The applications of the nuclear facility include a safety review, an environmental review and
anti-trust review. The application for a license is reviewed by the NRC staff members for
identifying if plant design meets all the necessary and applicable regulations. The two part
license includes a review of the design of the nuclear part, emergency plan, plant operations, and
responses of the plant to the hypothetical accidents and many more (Sklyar, 2016). It is

necessary that the document includes sufficient information for accepting it and starting a
detailed review.
All the documents and correspondence regarding the nuclear facility are stored in the
document management system of the agency which is a safe and secure method of storing the
information. After the completion of the review by NRC, a Safety Evaluation Report is issued to
the person having information regarding the anticipated effect of the safety. After this, the
Advisory Committee on Reactor Safeguards provides advice on the reactor safety. Along with
this, the National Environmental Policy Act conducts environmental reviews for evaluating the
impact regarding the environment and its benefits. Atomic Energy Act needs a public hearing
before providing permission for construction of a northwest medical isotope (Capps, 2015).
Timeline of major events
The timeline of the major events included in the facility of Northwest Medical Isotope
includes the following:
Date Procedure
5th February 2015 Date of Part 1 of application submittal
20th July 2015 Date of Part 2 of application submittal
9th May 2018 Date of Construction permit issued
The below table represents the key milestones in the schedule that NRC has developed
for the review of the application provided by Northwest medical isotopes.
Milestones Time period
Application Tendered
Receipt of environmental report
Receipt of preliminary safety analysis report
2/2015-A
7/2015-A
Application Review
Acceptance of part 1 application
Acceptance of part 2 application
6/2015-A
12/2015-A
Environmental Review Schedule
Environmental Site Audit
Enviornmental scoping meeting
Issurance of supplemental request for additional
information
NUREG publication of draft environmental impact
Draft Environmental impact statement public
09/2015-A
12/2015
01/2016
12/2016-T AND 10/2016-A

meeting
NUREG Publication of final environmental impact
12/06/2016-T AND 12/06/2016-A
05/2017-T AND 05/2017-A
Safety Review Schedule
Issurance of a request for information on
preliminary safety analysis
Completion of the draft safety evaluation report
Advisory Committee of reactor safeguards
Subcommittee Meeting
Completion of safety evaluation report
NUREG Publication of safety evaluation report
08/2016—T
09/2016—A
06/2017—T
06/2017—A
07/2017—A
08/2017—A
09/2017—A
11/2017—A
TBD
Hearing
A mandatory hearing for permitting the
construction application
01/23/2018-A
License
Decision on construction permit
05/03/2018-A
Issues encountered and corrective actions are taken
There are various Generic Issues identified by the NRC which are as follows:
Target Dissolver Off-gas Accidents with Radiological consequences: This issue includes the
evaluation of the target dissolver offgas accidents which results to radiological exposure threats
to both employee and the people. This problem includes the loss of efficiency in context to
iodine removal unit due to the process upset or failure of the equipment at the time of the
dissolution of irradiated targets. In this initial stage of the problem, there are chances of relapse
of iodine generated from the single dissolution of the four research reactor targets at 8 hour post
irradiation. This issue can enhance and convert into a disaster resulting in a release of iodine to
the environment with duration of 2 hours. According to the NRC, the issue is big and needs a
proper solution. With respect to this, the safety and associated functions are identified by the

NWMI and NRC for handling the consequences of the accident. The staff analyzes the target
dissolver offgas on the basis of preliminary design for identifying the safety requirements.
With respect to the corrective actions, NWMI re-design the dissolver and implemented all the
necessary equipments for developing safety environment for the workers and public as well. The
plant added pressure relief device and pressure relief tanks for handling the realease of iodine
which can affect the environment and health of the public. Apart from this, Dissolver offgas
iodine removal unites and dissolver offgas primary absorber units are implemented by the
NWMI.
Summary of correspondence between the NWMI and NRC
In the context of the hearing file of a nuclear facility, within 30 days of the issuance of
the order granting requests for hearing to interfere the NRC file it in the docket. Later, present
the file to the presiding officer and make available to the parties. It is necessary for NRC to
make the file available for NWMI either in the form of hard copies or making the file available at
the website. It is also important to make the hearing file available for the public inspection and
copying at the website of the NRC. It is also necessary to have all the documents important for
hearing like application if there is any and any amendment to that application, statement of NRC
environment impact, etc. Apart from this, the meeting is conducted by NRC with NWMI for
discussing the application and providing them with with the necessary information. The
applicant can also communicate with the NRC through e-mail. For getting the license, NWMI
fills the application form and attach the needed documents. Later proper review and analysis of
the documents make NRC decide whether to accept the application or not (Diya and Officer,
2015).
Summary of any public feedback that has been documented by the NRC
NRC conducts meetings for the public for hearing their issues and informing them about
the nuclear facility and its impact. The firm has provided public meeting feedback forms to the
people for knowing their perceptions regarding their decision of constructing NWMI. The
feedback form shows input from a variety of stakeholders who attended the meeting. From the
analysis of the feedback forms, NRC found that 79% of the public has understood the meeting
subject regarding nuclear facility and measures for safety. Along with this, the people also get
sufficient opportunity for asking questions or expressing their views. Firstly the people were not

satisfied with the construction of Nuclear plant due to the emission of radiations which can affect
the environment and health of the people. But after proper discussion, informing public about the
processes and procedures, informing about the safety concerns and measures taken, etc people
get agreed and allowed NRC to construct the NWMI. According to the feedback, NRC
represents that people are also satisfied with the decision taken for the construction of NWMI.
The NRC also shows that most of the respondents are satisfied with the personnel of the
company who participated in the meeting. This feedback analysis represents that people are
satisfied with the meeting and new nuclear plant conducted by the NRC for their welfare and
development (Marcus, 2015).
Final Decision of the environmental report
The environment report of NRC includes proper analysis of the factors which considers
and balances the environmental effect of the proposed action. The report of NWMI consists of
the factors which can affect the environment and public via chemical reactions, different gases
and many more. The report of the facility also represents the impact of the alternatives to the
proposed action and alternatives present for decreasing or avoiding the adverse impact on the
environment. Cumulative impacts of the activities to be authorized with the help of construction
permit; authorization or combined license are added into the report. All the necessary and
important documents are attached to the facility to their environmental report for providing all
the necessary information to NRC. It is necessary to balance the activities for maintaining the
environment safety and security. Any commitments regarding the irreversible and irretrievable
resources which are included in the proposed activity are added in the report. Thus, the final
decision on the environmental report is evaluated after analyzing all the necessary factors which
can affect the environment and its safety (McGuire, 2015).
Final or current state of the license application
The licensing process of NRC provides applicant permission to conduct any activity like
construction, operation of the fuel and commercial reactors, site, design, close waste disposal
sites and many more. In context to this, Northwest Medical Isotope applied for a license under 10
CFR 50 for taking permission of constructing a nuclear plant at Columbia. The applicant
provides application two times to the NRC. Along with this, various reports including safety
report, environmental report, etc were provided by the firm to the NRC. The final state of license

application includes analysis of all the documents, the purpose of the activities proposed by the
facility and in the end accepting the proposal and screening it effectively. In the end, the senior
authority accepts the proposal provided by the NWMI for constructing a nuclear power plant.
The nuclear facility has gained the license under NRC on 5th March 2018 (No and DPR, 2018).
CONCLUSION
From the above, it is concluded that the Nuclear Regulatory Commission plays an
essential role in producing nuclear materials and keeping the environment safe from them.
Permission of constructing nuclear power plants is provided by the NRC after proper analysis
and screening of the documents. The firm makes sure that the purpose of applicant is for the
development, welfare and growth of the nation and society as well. There are various facilities
permitted by the NRC. The government regulations also conduct the risk analysis for examining
present and future threats and suggesting the appropriate solutions to them. Northwest Medical
Isotope has received the permission for starting the construction at Columbia on 5th Feb 2018.
The purpose of this facility is to remove the shortage of Mo-99 and dealing the health issues of
the patients needing nuclear energy for treatment. With respect to this, Northwest Medical
Isotope followed all the procedures of NRC for taking permission of construction of the nuclear
power plant. Various documents including security and safety report, environmental report,
different applications and many more are provided by the facility to the NRC for proper
screening. In the end, the firm gets a license from NRC after proper analysis of their application
and documents.

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