ML18009B024

Scheduling Order

ML18009B024
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	01/09/2018
From:	Annette Vietti-Cook NRC/SECY
To:
SECY RAS
References
50-609-CP, Construction Permit Mndtry Hrg, RAS 54158
Download: ML18009B024 (6)

Text

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of NORTHWEST MEDICAL ISOTOPES, LLC Docket No. 50-609-CP (Medical Radioisotope Production Facility)

SCHEDULING ORDER On November 21, 2017, the Commission issued a notice that it would convene an evidentiary hearing at its Rockville, Maryland headquarters on January 23, 2018, pursuant to section 189a. of the Atomic Energy Act of 1954, as amended, to receive testimony and exhibits in the captioned proceeding.1 Todays Scheduling Order, issued pursuant to my authority under 10 C.F.R. § 2.346(a), (d), and (j), provides details covering matters such as the identification and swearing-in of witnesses, the process for admitting evidence, and the format of presentations.

Identification of Witnesses. To expedite the proceeding, all witnesses will be identified and sworn in at the beginning of the hearing. As a result, all witnesses should be present in the hearing room at that time. Witnesses should remain available for the entirety of the hearing.

Presentation Slides. Sets of presentation slides for each panel shall be served using the agencys E-filing system (see 10 C.F.R. § 2.304(g)), and also shall be transmitted via e-mail to Hearing.Docket@nrc.gov, no later than January 16, 2018.2 1

See Northwest Medical Isotopes, LLC; Notice of Hearing, 82 Fed. Reg. 56,276 (Nov. 28, 2017).

2 Northwest Medical Isotopes, LLC (NWMI) already filed its presentation slides using the agencys E-filing system. The slides also must be transmitted via e-mail as directed above.

Format and Time Allocations. The order of presentation panels and time allocations are reflected in the Scheduling Note for this proceeding, which will be transmitted separately.

Panelists should assume that the Commission is familiar with the content of their written testimony, including written responses to pre-hearing questions.

Admission of Evidence. Exhibits for this proceeding will be admitted after the witnesses are identified and sworn and before the panel presentations begin. To facilitate this process, no later than January 16, 2018, if they have not already done so, the NRC Staff and NWMI each shall pre-file all of the exhibits they intend to propose for admission into evidence at the hearing and provide to the Secretary a table listing these exhibits.3 The table should be formatted as follows:

Exhibit Number Panel Number/ Document Description/Title4 Sponsoring Witness(es)

All exhibits should be pre-filed in accordance with the requirements of our E-filing rules at 10 C.F.R. § 2.304(g). Other than witness lists, any documents pre-filed in advance of this 3

Any pre-filed exhibit that contains confidential or sensitive information should be filed separately in the agencys E-filing system using the non-public submission filing option and should include appropriate page markings.

4 The parties should include an ADAMS accession number to the extent one is available for the document (or portion of the document) that will be proffered. For any exhibit having a confidential/sensitive status that would preclude public disclosure, the listing information should be set forth in bold type. NWMI already has filed its exhibit table; it should re-file the table to reflect its non-public exhibit consistent with this direction.

Scheduling Order should be re-filed as exhibits.5 Only one copy of each item of documentary material should be offered as evidence in connection with this mandatory hearing, so the parties should coordinate as necessary. The Staff should include the construction permit application in its list of exhibits.6 Panel presentation slides should be included and identified as exhibits, and will be admitted into the record of the proceeding.

In cases of exhibits that are testimony, the sponsoring witness (or witnesses) shall provide a written certification containing the following information: that the identified testimony was prepared by the witness (or under the witnesss direction); that the written testimony is true and correct to the best of the witnesss information, knowledge, and belief; and that the witness adopts the identified testimony as his or her sworn testimony in the proceeding.7 Exhibits will be admitted at the hearing based on the exhibit tables and associated certifications, as applicable; the list of exhibits and any certifications will not be read aloud at the hearing. NWMI and the Staff will be offered the opportunity at the hearing to provide corrections, amendments, and additions to testimony or exhibits, or to object to the admission of 5

For example, the Commission has received the parties responses to the Commissions December 13, 2017, pre-hearing questions. NWMI already numbered its responses as exhibits; the Staff should re-file its responses as exhibits in accordance with this Scheduling Order.

Ex. NWMI-001, Response to NRC [ ] Public Pre-Hearing Questions Northwest Medical Isotopes, LLC Evidentiary Hearing (Dec. 29, 2017); Ex, NWMI-002, Response to NRC [ ] Non-Public Pre-Hearing Questions Northwest Medical Isotopes, LLC Evidentiary Hearing (Dec. 29, 2017); NRC Staff Responses to Commission Pre-Hearing Questions (Jan. 2, 2018); NRC Staff Responses to Non-Public Pre-Hearing Questions and Non-Public Response to Question 36 (Jan. 2, 2018).

6 If, due to its size, the application is too large to mark and file through the E-filing system as directed in this order, the Staff may, in the alternative, provide in its exhibit list the ADAMS accession number for the package of each part of the application and provide the application on compact disc to the Office of the Secretary.

7 This certification may be notarized, or may be submitted in the form of an unsworn declaration consistent with 28 U.S.C. § 1746.

particular exhibits, during the process of admitting exhibits. The exhibit tables and certifications will become part of the record of the proceeding.8 Exhibits should be labeled and numbered consecutively beginning with exhibit number one, formatted as NRC-001, NRC-002, or NWMI-001, NWMI-002, etc. Exhibit numbers should be placed in the upper right hand corner of the first page of the exhibit. A separate cover sheet should be used for an exhibit only if there is no space on the first page of the exhibit into which the number can be legibly placed.9 Multi-page exhibits should be numbered consecutively so that they can be readily referred to at the evidentiary hearing.

Post-hearing Responses to Follow-up Questions. If, at the hearing, Commissioners ask any questions that cannot be fully answered at the hearing itself, or expressly pose follow-up questions to be answered in writing, the Staff and NWMI, as appropriate, may file supplemental 8

Provided the exhibits are properly pre-filed using the agencys E-filing system, it should not be necessary for the parties to provide the Commission or the representative for the other party with any paper copies of their pre-filed evidentiary materials. Nonetheless, the parties should have available at the hearing one properly marked copy (paper or electronic, at each partys discretion) of each pre-filed document for use in the event that there are any operational issues.

In addition, if a party must submit any new testimony or exhibits at the hearing, or revise any pre-filed testimony or exhibits at the hearing, that party must provide at that time a properly marked electronic copy of any such documents, along with enough properly marked paper copies of any such documents for distribution to the representative for the other party, all Commission members (two copies each), and the Secretary of the Commission (three copies).

9 If a party needs to provide a revised version of a previously pre-filed exhibit, the exhibit should be re-filed with -R following the numbering sequence. For example, if exhibit NRC-005 must be revised, the revised exhibit would be labeled NRC-005-R. If this exhibit must again be revised, it would be labeled NRC-005-R2. If a party needs to break a document into several segments to ensure it does not exceed the agencys guidance on recommended file size for submissions (see NRC, Guidance for Electronic Submissions to the NRC, Rev. 6.1, at 15-16 (May 27, 2011) (ADAMS accession no. ML13031A056)), each of the segments should be labeled by adding a letter directly following the exhibit number to reflect the relationship of each part of the exhibit to the other parts. For example, if NRC Staff exhibit NRC-005 must be submitted in multiple parts, each portion should be assigned a different exhibit number:

NRC-005A, NRC-005B, NRC-005C, etc.

responses to such questions no later than February 6, 2018, unless the Commission sets a different deadline for responses.

General Information. The Office of the Secretary of the Commission will contact the parties regarding logistics related to the hearing.

IT IS SO ORDERED.

For the Commission NRC SEAL /RA/

Annette L. Vietti-Cook Secretary of the Commission Dated at Rockville, Maryland, this 9th day of January, 2018.

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of )

)

NORTHWEST MEDICAL ISOTOPES, LLC )

) Docket No. 50-609-CP

)

(Medical Radioisotope Production Facility) )

)

(Mandatory Hearing) )

CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing SCHEDULING ORDER have been served upon the following persons by Electronic Information Exchange.

U.S. Nuclear Regulatory Commission U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication Office of the Secretary of the Commission Mail Stop: O-16B33 Mail Stop: O-16B33 Washington, DC 20555-0001 Washington, DC 20555-0001 ocaamail@nrc.gov hearing.docket@nrc.gov U.S. Nuclear Regulatory Commission Carolyn Haass Office of the General Counsel Chief Operating Officer Mail Stop: O-14A44 Northwest Medical Isotopes, LLC Washington, DC 20555-0001 22500 Hope Dale Avenue Mitzi Young, Esq. Parker, CO 80138 Jeremy Wachutka, Esq. carolyn.haass@nwmedicalisotopes.com Catherine Scott, Esq.

Catherine Kanatas, Esq.

John Tibbetts, Paralegal mitzi.young@nrc.gov jeremy.wachutka@nrc.gov catherine.scott@nrc.gov catherine.kanatas@nrc.gov john.tibbets@nrc.gov

[Original signed by Herald M. Speiser ]

Office of the Secretary of the Commission Dated at Rockville, Maryland, this 9th day of January, 2018