ML13149A015
| ML13149A015 | |
| Person / Time | |
|---|---|
| Site: | PROJ0786 |
| Issue date: | 05/24/2013 |
| From: | Bigles C I Coqui Radio Pharmaceuticals Corp |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| RIS 13-003 | |
| Download: ML13149A015 (3) | |
See also: RIS 2013-03
Text
U.S. Nuclear Regulatory
Commission
ATTN: Document Control Desk Washington, DC 20555-0001
May 24, 2013 Project No.: PROJ0786 Subject: NRC REGULATORY
ISSUE SUMMARY 2013-03, PRE-APPLICATION
COMMUNICATION
AND SCHEDULING
FOR MEDICAL RADIOISOTOPE
FACILITIES
INTENDING
TO PRODUCE MOLYBDENUM-99
Coqui Radio Pharmaceuticals
Corp. (Coqui) is providing
the Nuclear Regulatory
Commission (NRC) herein the voluntary
answers to the questions
set forth in the above-mentioned
April 24, 2013 communication.
If you have question or need additional
information, please contact me by telephone
at 787-685-5046
or by email at cbigles@coquipharma.com.
Sincerely, Carmen Irene Bigles Chief Executive
Officer / President Coqui RadioPharmaceuticals
Corp.Enclosure:
As stated Cc: Al Alexander, Senior Project Manager Steven Lynch, Project Manager Mary Adams, Sr. Env. Engineer Amy C. Roma, Hogan Lovells US LLP Alejandro
J. Valderrabano-Wagner
Board of Directors
of Coqui RadioPharmaceuticals
Corp.James Lewis, Lewis and Crawford US LLP
ENCLOSURE
(1)Coqui RadioPharmaceuticals
Corp.Design and Licensing
Submittal
Information
(1) How many applications
will be submitted
to the NRC? What NRC licensing actions will the application(s)
request? What will be the content of the application(s)?
Coqui RadioPharmaceuticals
Corporation (Coqui) anticipates
that it will submit applications
for both a construction
permit and an operating
license in a single submittal
per 10 CFR 2.105(c)for a Medical Isotope Production
Facility (MIPF), which will consist of two production
reactors and a radioisotope
processing
plant for the production
of molybdenum-99.
Coqui intends to submit its Environmental
Report for the requested
licenses prior to submitting
its license application.
(2) Under which part(s) of 10 CFR will the application(s)
request licenses?
In particular, will license applications
be submitted
under 10 CFR Part 50 for consideration
as a production
or utilization
facility or under 10 CFR Part 70 as a processing
facility?
Will an exemption
from any part of the regulations
be sought?Coqui's application
will be submitted
pursuant to 10 CFR Part 50. At this point, Coqui does not anticipate
the need to request any exemptions
from any part of the NRC regulations
when it submits its applications.
Coqui will also request a radioactive
materials
license, which will be requested
in its Part 50 reactor license applications.
(3) What consideration, if any, has been given to the applicability
of other parts of 10 CFR to the application(s)?
For example, a license for possession
of byproduct
material may be necessary
in accordance
with 10 CFR Part 30, "Rules of General Applicability
to Domestic Licensing
of Byproduct
Material." Coqui will also request authority
to possess and use the necessary
radioactive
materials
at the facility when it submits its Part 50 reactor license applications.
(4) When (month and year) will the NRC receive the application(s)
for review?Please provide the licensing
milestones
that have been established
for the development, submission, and review of the application(s).
Coqui intends to submit its Environmental
Report in November 2013 and its construction
permit and operating
license applications
in a single submittal
in March 2014. The Preliminary
Safety Analysis Report will follow NUREG 1537 acceptance
criteria for non-power
reactors.
The submission
date for the application
is subject to timely and successful
placement
of external funds and receipt of all board of director's
approvals.
Based on conversations
with the NRC staff, Coqui anticipates
that the NRC will issue the requested
construction
permit in March 2015 and the requested
operating
license in October 2016.
(5) Has a site been selected for each facility described
in the application(s)?
If so, please describe it.University
of Florida has allocated
a site in Alachua, Florida for the MIPF. In a December 7, 2012 communication
to the NRC, Coquf provided the NRC with the site assessment
for this location.(6) What design will be used for each facility?
What is the current status of the development
of the design(s) (i.e., conceptual, preliminary, or final)? Please provide a schedule for completing
the design(s).
The Coqui reactor is an INVAP reactor design. INVAP is the reactor designer and the general contractor
for the MIPF. The INVAP reactor design is conceptual, the development
of the preliminary
design supporting
the Preliminary
Safety Assessment
is associated
with the availability
of external funds.(7) Are vendors or consultants
assisting
in preparing
the application(s)?
If so, please describe their roles and responsibilities
in the design and licensing activities.
INVAP is the reactor designer and general contractor
for the project. Gresham Smith & Partners domestic design firm. Coqui has also engaged the law firm of Hogan Lovells to provide nuclear regulatory
licensing
counsel.White Papers and Technical
or Topical Reports (1) Are there current plans to submit white papers or technical
or topical reports related to design features, policy resolution, or technical
issues for review and approval?
If so, please describe and provide a schedule for submitting
the anticipated
report(s).
In May 2010, Coqui submitted
a first licensing
strategy document to the NRC about what class of license Coqui intends to apply for. In June 2012, Coqui submitted
a second licensing strategy document to the NRC, which provided for the NRC staff's review a Safety and Licensing
Plan for the technical
portions of the applications
that Coqui prepared with INVAP.Coqul does not anticipate
that it will submit any more white papers.