ML14295A337

Shine Medical Technologies, Inc. - Response to Request Regarding 10 CFR 50.95(b)

ML14295A337
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/02/2014
From:	Lynch S T Research and Test Reactors Branch B
To:	Jim Costedio SHINE Medical Technologies
Lynch, Steve 415-1524
References
Download: ML14295A337 (4)

Text

December 2, 2014

James Costedio Licensing Manager SHINE Medical Technologies, Inc. 2555 Industrial Drive

Monona, WI 53713

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, INC. - RESPONSE TO REQUEST REGARDING 10 CFR 51.95(b)

Dear Mr. Costedio,

By letter dated August 20, 2014 (SMT-2014-029, Agencywide Documents Access and Management System Accession No. ML14232A738), SHINE Medical Technologies, Inc. (SHINE) asked the U.S. Nuclear Regulatory Commission (NRC) staff to provide guidance regarding the necessary information to satisfy Title 10 of the Code of Federal Regulations (10 CFR) Section 51.95(b), "Initial operating license stage."

The requirements of 10 CFR 51.95(b) direct the NRC staff to prepare a supplement to the final environmental impact statement, updating the environmental review conducted during the review of the construction permit application.

The NRC staff is currently preparing an environmental impact statement evaluating the information provided in the environmental report submitted as part of SHINE's construction permit application for a medical radioisotope production facility. In the future, should SHINE submit an operating license application, the NRC staff would need to supplement the final environmental impact statement with any significant new information.

In order for the NRC staff to meet the requirements of 10 CFR 51.95(b), applicants for operating licenses covered by 10 CFR 51.20, "Criteria for and identification of licensing and regulatory actions requiring environmental impact statements," must comply with the provisions of 10 CFR 51.53(b), "Postconstruction environmental reports, operating license stage." Under 10 CFR 51.53(b), an operating license applicant must submit with its application a separate document entitled "Supplement to Applicant's Environmental Report - Operating License Stage." In this supplement, the applicant shall:

discuss the same matters described in §§ 51.45, 51.51, and 51.52, but only to the extent that they differ from those discussed or reflect new information in addition to that discussed in the final environmental impact statement prepared by the Commission in connection with the construction permit.

Thus, the supplemental environmental report is not a complete resubmittal of the environmental report. Rather, in accordance with 51.53(b), the supplemental environmental report should discusses only different and/or new information that has become available since the publication of the final environmental impact statement. Therefore, it is not necessary for the applicant of an operating license to provide information that is unchanged since the publication of the final

environmental impact statement. As required by 51.95(b), the NRC staff will use the information provided in the supplemental environmental report to prepare a supplement to the final environmental impact statement.

In general, when preparing the supplemental environmental report, an applicant should follow the same guidance on form and content that it used to prepare the initial environmental report submitted as part of its construction permit application. As applied to SHINE, the applicant should follow the guidance provided in "Interim Staff Guidance Augmenting NUREG-1537, Part 1, 'Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content,' for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors," Chapter 19 (ADAMS Accession No. ML12156A069) to prepare a supplemental environmental report that discusses only different and/or new information that has become available since the publication of the final environmental impact statement.

If you have any questions, please contact me at Steven.Lynch@nrc.gov or 301-415-1524.

Sincerely,

/RA/

Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch

Division of Policy and Rulemaking Office of Nuclear Reactor Regulation

Docket No. 50-608

cc: See next page cc:

Rilla Hamilton National Nuclear Security Administration, NA-212 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585

Cheryl Rogers Supervisor

Radiation Protection Section

Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659

Amanda Cushman Environmental Analysis and Review Specialist State of Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711

Dr. Thomas Newton Chair National Organization of Test, Research, and Training Reactors

138 Albany Street Mail Stop MITNRL-NW12 Cambridge, MA 02139

Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy

1326 Putnam Avenue Janesville, WI 53546

Alfred Lembrich 541 Miller Avenue Janesville, WI 53548

Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546

ML12156A069) to prepare a supplemental environmental report that discusses only different and/or new information that has become available since the publication of the final environmental impact statement.

If you have any questions, please contact me at Steven.Lynch@nrc.gov or 301-415-1524.

Sincerely,

/RA/

Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch

Division of Policy and Rulemaking Office of Nuclear Reactor Regulation

Docket No. 50-608

cc: See next page

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