ML20206E580
| ML20206E580 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1999 |
| From: | NRC |
| To: | |
| References | |
| NUREG-0750, NUREG-0750-V49-N02, NUREG-750, NUREG-750-V49-N2, NUDOCS 9905050169 | |
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NUREG-0750 Vol. 49, No. 2 Pages23-183 z 7, NOCLEARLREGULATORY -
. COMMISSION ISSUANCES February 1999' gyn REgy to U.S. NUCLEAR REGULATORY' COMMISSION
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I Available from 1 l
Superintendent of Documents -
U.S. Government Printing Office ]
RO, Box 37082 -
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A year's subscription consists of 12 softbound issues, 4 indexes, and 2-4 hardbound editions for this publication.
L l Single copies of this publication are available from
- National Technical information Service Springfield, VA 22161 l
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Errors in this publication may be reported to the l Office of the Chief Information Officer i l
U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 (301-415-6844) !
NUREG-0750 Vol. 49, No. 2 Pages23-183 NUCLEAR REGULATORY COMMISSION ISSUANCES February 1999 This report includes the issuances received during the specified period from the Commission (CLI), the Atomic Safety and Licensing Boards (LBP), the Administrative Law Judges (ALJ), the Directors' Decisions (DD), and the Decisions on Petitions for Rulemaking ,
(DPRM) l l
The summaries and headnotes preceding the opinions reported l herein are not to be deemed a part of those opinions or have any independent legal significance.
U S. NUCLEAR REGU'LATORY COMMISSION Prepared by the O# ice of the Chief Information Officer U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 (301-415-6844)
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ll COMMISSIONERS 1 l
Shirley A. Jackson, Chairman i Greta J. Dicus l Nils J. Diaz !
Edward McGaffigan, Jr. -
Jeffrey S. Merrifield I
G. Paul Bollwerk 111, Acting Chief Administrative Judge Atomic Safety & Ucensing Board Panel ,
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m CONTENTS Issuances of the Nuclear Regulatory Commission I
GENERAL PUBLIC UTILITIES NUCLEAR CORPORATION, et al.
(Ihree Mile Island Nuclear Station, Unit 1)
' Docket 50 289 MEMORANDUM AND ORDER, CLI-99-2, Rbruary ll,1999 . . .. . . . 23 HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101, Albuquerque, NM 87120)
Docket 40-8%8-ML MEMORANDUM AND ORDER, CLI-99-3. Ibbruary 11,1999 ...... 25 Issuances of the Atomic Safety and Licensing Boards AHARON BEN-HAIM, Ph.D.
- (Upper Montclair, New Jersey)
Docket IA 97-068 (ASLBP No. 97-731-01-EA)
(Order Superseding Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately))
INITIAL DECISION, LBP-99-4, Ibbruary 8,1999 . . . . . . . . . . . . . . . 55 HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101, Albuquerque, NM 8712.0) I Docket 40-8968-ML (ASLBP No. 95-706-01-ML)
(Re: Leach Mining and Milling License)
PARTIAL INITIAL DECISION, LBP-99-1, Rbruary 3,1999 . . . . . . . 29 ,
4 HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101, Albuquerque, NM 87120)
Docket 40-8968-ML (ASLBP No. 95-7%-01-ML)
(Re: Leach Mining and Milling License)
PARTIAL INITIAL DECISION, LBP-99-9, February 19,1999.... . 136 i
HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101 Albuquerque, NM 87120)
Docket 40-8968-ML (ASLBP No. 95-706-01-ML)
(Re: Leach Mining and Milling License)
PARTIAL INITIAL DECISION, LBP-99-10, February 19,1999. .. 145 ill
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INERNATIONAL URANIUM (USA) CORPORATION (Receipt of Material from Tonawanda, New York)'
Docket 40-8681-MLA-4 (ASLBP No. 98-748-03-MLA)
. (Re: Material License Amendment)
, INITIAL DECISION, LBP-99-5, February 9,1999. . . .......... 107
, ' INTERNATIONAL URANIUM (USA) CORPORATION l (Receipt of Additional Material from Tonawanda, New York)
Docket 40-8681-MLA-5 (ASLBP No. 99-758-02-MLA)
(Re: Material License Amendment) l MEMORANDUM AND ORDER LBP-99-8, February 19, 1999..... 131 IN'IERNATIONAL URANIUM (USA) CORPORATION (Receipt of Additional Material from Tonawanda, New York)
Docket 40-8681-MLA-5 (ASLBP No. 99 758-02-MLA)
. (Re: Material License Amendment)
MEMORANDUM AND ORDER, LBP-99-11, Itbruary 19, 1999.... 153 l
PRIVATE FUEL S*IDRAGE, L.L.C.
(Independent Spent Wel Storage Installation)
Docket 72-22-ISFSI (ASLBP No. 97 732-02-ISFSI)
- MEMORANDUM AND ORDER, LBP-99-3, Ibbruary 3,1999. . . . . . . 40 PRIVATE FUEL STORAGE, L.L.C.
(Independent Spent Rei Storage Installation)
Docket 72-22-ISFSI (ASLBP No. 97 732-02-ISFSI)
MEMORANDUM AND ORDER, LBP-99-6, February 17,1999... . I14 PRIVATE FUEL STORAGE, L.L.C.
(Independent Spent Rel Storage Installation)
' Docket 72-22-ISFSI (ASLBP No. 97-732-02-ISFSI)
MEMORANDUM AND ORDER, LBP-99-7, Ibbruary 18, 1999..... 124 SHIELDALLOY METALLURGICAL CORPORATION (Cambridge, Ohio Facility) -
Docket 40-8948-MLA (ASLBP No. 99-760-03-MLA) .
MEMORANDUM AND ORDER, LBP-99-12, February 23, 1999... 155 SPECIAL TESTING LABORATORIES, INC.
(Bethel, Connecticut) ,
j Docket 30-34318-EA (ASLBP No. 99-759-01-EA)
ORDER, LBP-99-2, February 3.1999 . . . . . . . . . . . . . . . . . . . . . . . . 38 1
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Issuances of Directors' Decisions INDIANA MICHIGAN POWER COMPANY (Donald C. Cook Nuclear Plant, Units 1 and 2)
Docket 50-315,50-316 (License Nos. DPR-58, DPR-74)
DIRECIDR'S DECISION UNDER 10 C.F.R. 6 2.2%,
DD-99-3, Itbruary 11,1999 ..................... 4 ......... 161 VERMONT YANKEE NUCLEAR POWER CORPORATION (Vermont Yankee Nuclear Power Station) !
Docket 50-271 (License No. DPR-28)
DIRECTOR'S DECISION UNDER 10 C.F.R. 6 2.206, DD-99-4, Ibbruary 10,1999 ..... ........................... 179 i
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f Commission Issuances Z
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Cite as 49 NRC 23 (1999) CLl-99-2 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION COMMISSIONERS: l Shirley Ann Jackson, Chairman Greta J. Dicus Nils J. Diaz Edward McGeffigan, Jr.
Jeffrey S. Merrifield in the Matter of Docket No. 50-289 OENERAL PUBLIC UTILITIES NUCLEAR CORPORATION, et al.
(Three Mile Island Nuclear Station, Unit 1) February 11,1999 In this license transfer application involving the "Ihree Mile Island Nuclear Station, Unit 1, the Commission rejects an intervention petition on the ground that it has failed to satisfy the requirements set forth in Subpart M for intenen-tion.
MEMORANDUM AND ORDER 1
This proceeding involves a license transfer application involving the Three I Mile Island Nuclear Station, Unit 1. The plant's operator (General Public I Utilities Nuclear Corporation, or "GPU") and owners (Metropolitan Edison ;
Company, Jersey Central itwer & Light Company and Pennsylvania Electric j Company) collectively seek the Commission's permission to transfer GPU's
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facility operating license to AmerGen Energy Company (AmerGen).
On January 11,1999, Mr. Camille " Bud" George of the Pennsylvania State House of Representatives submitted a letter asking us to " ensure that a federal hearing is held" on this application and "to ensure that Pennsylvanians are not put at risk by this facility." On January 22nd, Mr. George's office informed the I
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l Commission's Office of the Secretary ("SECY") by telephone that Mr. George
. had intended his letter to be both an intervention petition and a hearing request.
SECY responded that Mr. George had not satisfied the regulatory provisions
. governing requests for intervention and hearing in a Subpart M license transfer proceeding. See 63 Rd. Reg. 66,721 (Dec. 3,1998), to be codified at 10 C.F.R.
Part 2. Subpart M. Immediately following the phone call, SECY mailed Mr.
George's office a copy of Subpart M.
GPU and AmerGen, in their answers opposing Mr. George's intervention, argued that the procedural failures specified above were fatal to his requests.
Mr. George filed no reply to those answers but, on February lith, submitted a second letter which he says " amend [s], clarif[ies] and [ restate [s]" the content of his first letter.1 We agree with GPU and AmerGen that Mr. George has failed to satisfy the requirements set forth in Subpart M for intervention. Nothing in -
Mr. George's most recent correspondence convinces us otherwise. We therefore deny Mr. George's requests and dismiss this proceeding. The NRC Staff, of course, will review the license transfer application to ensure that all regulatory requirements are met and that the public health and safety are protected.2 IT IS SO ORDERED.
For the Commission ANNETTE L. VIETTI-COOK Secretary of the Commission Dated at Rockville, Maryland, this !Ith day of Rbruary 1999.
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Mr. George's second letter does not purport to be a reply pursuant to 10 C.F.R. 6 2.1307(b). However, even constnung it as such, the fding would still fait as being untimely and failing to reply (ce refer) to GPU's and AmerGen's Answers.
2 in our December 21st Federal Register Notice. we indscated that intervenuon pehuons and heanns requests i nunt be filed by January lith, but that. as an ahernative to requests for hearing and peutions to ime vene, persons wese also permitted to subnut wnnen comments to the Commission by January 20.1999 arger&ng die license .
transf t application. The Comnussion has received one comment, postmarked January 15th. from H E. Wilhamn. I Jr, We have refaned Gus conunent, as well as Mr. George's two letiers, to the NRC Staff for its consideration.
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FT Cite as 49 NRC 25 (1999) CLl-99-3 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION COMMISSIONERS:
l Shirley Ann Jackson, Chairman i Greta J. Dicus Nils J. Diaz Edward McGaffigan, Jr.
Jeffrey S. Merrifield in the Matter of Docket No. 40-8988-ML HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101, Albuquerque, NM 87120) February 11,1999 De Commission reviewed a petition from several Intervenors for interlocu-tory review of a Presiding Officer's Memorandum and Order denying requests to adjust schedules for various motions in the proceeding and to extend a deadline for written submissions. The Commission grants the petition insofar as it seeks an extension of the submission deadline and gives the Intervenors additional time. In all other respects, the petition is denied and the Commission does not alter the balance of the Presiding Officer's order.
RULES OF PRACTICE: TIME LIMITS FOR FILING Re Commission does not ordinarily review interlocutory orders denying extensions of time, but may do so in specific cases as an exercise of its general supervisory jurisdiction over agency adjudications.
RULES OF PRACTICE: TIME LIMITS FOR FILING he Presiding Officer possesses considerable authority to adjust general deadlines and procedures set out in the Commission's rules.
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i MEMORANDUM AND ORDER On February 4,1999, several Intervenors filed a petition for the Commis-sion's interlocutory review of the Presiding Officer's Memorandum and Order (Procedural Issues) issued earlier on the same day. In particular, the Presiding Officer denied (1) a request to adjust the schedule for motions for leave to reply and/or to request oral presentations, and (2) a request to extend the February 16 filing deadline for the next round of written submissions. Hydro Resources, Inc.
(HRI), has responded to the Intervenors' petition and urges the Commission to deny it.
We ordinarily do not review interlocutory orders denying extensions of time, but we do so here as an exercise of our general supervisory jurisdiction over agency adjudications. See Baltimore Gas & Electric Co. (Calvert Cliffs Nuclear Power Plant, Units I and 2), CL1-98-19, 48 NRC 132,134 (1998). The Presiding Officer's ruling of Rbruary 4 is consistent with the Commission's frequently expressed intention that this proceeding move to completion in an expeditious manner. In a recent decision in this case, issued on January 29 (CLI-99-1, 49 NRC 1 (1999)), the Commission - acting sua sponte
- vacated an earlier scheduling order from the Presiding Officer setting a March 5 briefing deadline and instead required the Intervenors to file their briefs by Rbruary 16. Nevertheless, it appears that, in this instance, the deadline set by the Commission's order may have unduly disrupted the expectations of the Intervenors given their reliance on the earlier scheduling order. As such, the Commission is extending the filing dead?ine for Intervenors' briefs to Rbruary I9,1999.
Our decision today to relax the deadline by no means suggests any dissat-isfaction with the Presiding Officer's handling of the matter. In light of the Commission's earlier direction, the Presiding Officer understandably refused to extend the Rbruary 16 deadline. We urge the Presiding Officer to continue his effort to move this proceeding forward expeditiously. Finally, as we have noted elsewhere (see Calvert Chffs,48 NRC at 134), the Presiding Officer possesses considerable authority to adjust general deadlines and procedures set out in our rules and we expect him to continue to exercise that authority if appropriate and consistent with our directives to resolve this case promptly.
For the foregoing reasons, we grant the petition insofar as it seeks an ex-tension to the Rbruary 16 filing deadline and give the Intervenors additional time, until February 19,1999. In all other respects, the petition is denied and the 26 I
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f-_ Commission does not alter the balance of the Presiding Officer's Rbruary 4 i' order.
For the Commission l ANNETE L. VIETTI-COOK
' Secretary of the Commission .
Dated at Rockville, Maryland, this lith day of Rbruary 1999.
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l Atomic Safety ,
and Licensing Boards issuances ATOMIC SAFETY AND LICENSING BOARD PANEL G. Paul Bollwerk lll,* Acting Chief Administrative Judge O
Vacant,* Deputy Chief Administrative Judge (Executive) 3 Frederick J. Shon,* Deputy Chief Administrative Judge (Technical) $
O Members Dr. George C. Anderson Dr. Harry Foreman Dr. Linda W. Little O Charles Bechhoefer* Dr. David L. Hetrick Dr. Frank F. Hooper Thomas S. Moore
- Thomas D. Murphy *
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Peter B. Bloch*
Dr. Robin Brett Dr. Charles N. Kelber* Dr. Harry Rein ..b.
Dr. James H. Carpenter Dr. Rchard F. Cole
- Dr. Jerry R. Kline Dr. Peter S. Lam
- Lester S. Rubenstein Dr. David R. Schink
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Dr. Thomas S. Elleman Dr. James C. Lamb Ill Dr. George F. Tidey O
- Permanentpanelmerrbars
Cite as 49 NRC 29 (1999) LBP-99-1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL Before Administrative Judges:
Peter B. Bloch, Presiding Officer Thomas D. Murphy, Special Assistant in the Matter of Docket No. 40-8968-ML (ASLBP No. 95-706-01-ML)
(Re: Leech Mining and Milling License)
HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101, Albuquerque, NM 87120) February 3,1999 Relief was denied concerning liquid waste disposal issues. The Presiding Officer determined that the licensing standard that must be met by Applicant is that there is adequate protection of public health and safety and adequate consideration of environmental issues related to waste disposal, both during operations and cleanup. 10 C.F.R. 5 40.32(c) and (d). He concluded that Intervenors had incorrectly relied on 10 C.F.R. 5 40.31(h) and on 10 C.F.R.
Part 40, Appendix A, which apply to mill tailings facilities "at sites formerly associated wia such milling."
INJECTION MINING OR IN SITU URANIUM SOLUTION MINING Section 40.31(h) and 10 C.F.R. Part 40, Appendix A, apply to mill tailings facilities "at sites formerly associated with such milling." They do not apply to injection mining for uranium, although Criteria 2 and 5A apply. Criterion 7 does not apply.
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l INJECTION MINING OR IN SITU URANIUM SOLUTION MINING This Decision includes a detailed description of an injection mining project.
PARTIAL INITIAL DECISION (Waste Disposal Issues)
'Ihis Decision determines the merits of the Written Presentations on Liquid Waste Disposal Issues filed on November 9,1998, by Eastern Navajo Din 6 ;
Against Uranium Mining (ENDAUM), the Southwest Research and Information Center (SRIC), Grace Sam, and Marilyn Morris (Intervenors).8 I have concluded that Intervenors' request for relief should be denied.
Intervenors erroneously rested a substantial portion of their argument on 10 C.F.R. 5 40.31(h) and on 10 C.F.R. Part 40, Appendix A, which apply to mill tailings facilities "at sites formerly associated with such milling." Although portions of Appendix A do apply to injection mining, Intervenors are incorrect in their assumption that the appendix is generally applicable to this project.
For reasons that will be discussed below, I have concluded that the licensing standard that must be met by HRI is that there is adequate protection of public j health and safety and adequate consideration of environmental issues related l
to waste disposal, both during operations and cleanup. 10 C.F.R. 5 40.32(c) and (d); National Environmental Policy Act of 1969, 42 U.S.C. 56 4321 et seq. (NEPA). HRI's waste products are far less hazardous than mill tailings I and its precautions for the treatment and disposition of wastes are adequate.
Intervenors have not raised any issues on which HRI has not carried its burden of demonstrating adequate protection of public health and safety and adequate consideration of environmental issues.
I. HACKGROUND: DESCRIPTION OF THE HRI PROJECT HRI has applied for and received a materials license to conduct in situ leach !
(ISL) mining on Sections 8 and 17 in Church Rock, New Mexico, and on I two sites in Crownpoint, New Mexico, " Unit 1" and "Crownpoint."2 HRI's I
Hydro Resources, Inc. OfR!), hied its " Response to Intervenors' Novernber 9,1998 Bnefs in opposinon to Apphcation for a Materials License with Respect to tipad Waste Disposal lasues" on Decenter 9.1998 OIRI Responne). The $tafr of the Nuclear Regulatory Conurussion (Staf0 hied sta *Responw to Intervenor Presentations on Liquid Waste IMposal Issues" on Decenter 16,1998 (Staff Respome) 2 HRI has been granted a heense (SUA 1508. January $ 1998)(License) to conduct isL nuning. It submitted its instial apphcation on Apnl 13, 1988, and proposed to mine un Secuan 8 in Onirch Rock. Hearing (Conunued) 30 l
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application proposes processing the uranium extracted from each site at its Crownpoint processing facility.)
l Solution mining produces different types of effluents that could be released to l the environment: (1) gaseous emissions and airborne particulates resulting from l the injection of groundwater enriched with dissolved oxygen and bicarbonate l
ions ("lixiviant") and from the drying of yellowcake, and (2) liquid waste asso-ciated with well field processing and aquifer restoration. " Final Environmental Impact Statement: To Construct and Operate the Crownpoint Uranium Solution Mining Project," NUREG-1508 (Febmary 1997) (FEIS) at 2-5, 6,14 and 16.
This Decision deals only with liquid effluents.
Some liquid waste occurs because HRI will inject lixiviant into rock forma-tions in which recoverable quantities of uranium oxide have been identified. De lixiviant will cause the uranium oxide to be dissolved. By operating "produc-tion wells" near the injection sites, HRI will withdraw somewhat more water from the formation than it has injected into it. His causes a " negative pres-sure" that causes the pregnant (i.e., uranium rich) lixiviant to flow toward the production wells, where it is pumped to the surface. Aboveground, the pregnant fixiviant is subject to three treatments. One removes the uranium oxide through ion exchange (using IX resin). Another ensures that radon gas will be kept un-der pressure so that the lixiviant may be safely reinjected into the underground formations without being discharged to the atmosphere. Still another treatment removes 99% of the radium from the production bleed, tvhich would be subse-quently treated and then disposed of by "an NRC-approved disposal method."
FEIS at 2-16.
After the uranium oxide is removed from the pregnant lixiviant through ion exchange, the ion exchange resin is subject to a chemical process, called elution or " stripping," which uses a chloride salt to replace the uranium oxide that was bound to the resin. The solution containing the uranium oxide is then dewatered, filtered, and dried in a vacuum drier to produce uranium oxide concentrate or yellowcake. The moisture from the drying chamber is filtered and condensed, reducing emissions almost to zero. FEIS at 2-9 to 2-12.
He production bleed contains radium,99% of which is removed from the process wastewater, Because 1% of the radium remains in the production bleed, retention ponds at injection mining sites are necessary. These ponds are designed i
I Record Accession Number (ACN) 8805200339, Apphcanon for Materials 1.icense (Apnl 13. 1988). HRI huer amended the appheation to include processmg m Crownpoint and numng at Section 17. Umt I and Crownpo nt. Consobdated operabons Plan. Rev. 2 0 (" cop Rev. 2 0"L at 2, Heanng Record ACN 9708210179 (August 15,1997). .See alw Hearing Record ACNs 8805200339 (Apphcauon for Matenals LJcenw. April 13, 1988),950908006s (Emirontental Assessnent of Umt 1, January 6.1992k 9211399381 (forwardang documents, includang Crownpoint project technical report, July 31.1992), and 9211300077 (Requests NE quaner of section 17 be included in Cburchrock numng project, septenter 28.1992).
3 COP Rev. 2.0 at 2. See also Heanng Record ACN 8811040138 GIRI changes location of the proposed Central Processing 1%cibty) (october 12, 1988).
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to promote evaporation and to control the byproduct material contained in the l production bleed. See FEIS, 5 2.1.1.5, at 2-12. During any injection mining l operations, HRI would be required to inspect the retention ponds, measure the i storage space left in the ponds (typically referenced as the " pond freeboard"),
i and check for evidence of any pond leaks. See id. see also HRI License l
Condition 10.5. 'Ihe retention ponds will have double synthetic liners to prevent any leaks. See FEIS 9 2.1.1.5, at 2-12; see also 52.3 of HRI's COP, at 29, providing a funher description of the liners to be used.
At the end of injection mining (also called ISL mining) operations, the radium-contaminated sludge at the bottom of the retention pond and any other l leftover byproduct material, will be transported off site for disposal at a licensed ,
facility. See FEIS 6 2.1.2.3, at 2-16 to 2-17. Injection mining does not produce !
any mill tailings. See Affidavit of Christopher A. McKenney, attached as Staff
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Exhibit 10 to "NRC Staff's Response to Motion for Stay, Request for Prior Hearing, and Request for Temporary Stay" 130. Indeed, no permanent onsite byproduct waste disposal is authorized by HRI's license. See HRI License i Condition 9.6.
HRI claims that this process is low risk. It asserts that there have been 25 years of ISL uranium mining in the United States with "no significant impacts '
to human health or the environment."' It asks that the Presiding Officer attach significance to the failure of Intervenors to cite any adverse incidents.
II. APPLICABLE LAW A. NRC Regulations ne principal regulatory standards governing this application for a license l are 10 C.F.R. 5 40.32(c) and (d), which mandate protection of the public health '
and safety. Generally speaking, a license may be granted if, "The applicant's proposed equipment, facilities and procedures are adequate to protect health and minimize danger to life or property." Ibr Intervenors to challenge successfully the HRI license, they must establish that HRI has failed to demonstrate the adequacy of its proposed equipment, facilities, and procedures. i l
- 1. Reliance on 10 C.F.R. f 40.31(h) and Part 40, Appendix A Re Intervenors erroneously rely on section 40.31(h), which refers generally to the provisions of Part 40, Appendix A, " Criteria Relating to the Operation of Uranium Mills and the Disposition of Tailings or Wastes Produced by the d
HRI Response at 2 an.9 & 10.
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h Extraction or Concentration of Source Material from Orcs Processed Primarily I
for Deir Source Material Content" (Appendix A). As we shall see, below,
- these regulatory provisions generally are not relevant to the inadequacy of HRI's license application. See SRIC Disposal Brief at 9-12; Morris Disposal Brief at l
2-4.
I On its face, section 40.31(h) sta?es that it applies "at sites formerly associated with such [ uranium or thorium] milling." Intervenors do not present any.
argument that explains why they believe the section applies to the HRI license even though the HRI site is not "formerly associated with such milling." He - 1 language of the section simply does not apply to the HRI site. De legislative history also strongly suggests that section 40.31(h) and Part 40, Appendix A, were designed to address the problems related to mill tailings and not problems related to injection mining. See Hydro Resources' Response at 9-16; Staff -
Response at 5-21.' He history of section 40.31(h) demonstrates that it does not apply to injection mining license applicants, and in implementing the general requirements of 10 C.F.R. 6 40.32 instead, the Staff properly applies only those Appendix A criteria that apply to injection mining.
- Similarly, Intervenors have argued that Part 40, Appendix A is generally applicable to ISL mining. It is not. %c principal purpose of Appendix .A relates to " sites formerly associated with such [ uranium or thorium] milling."
Hence, the criteria of Appendix A do not apply wholesale to the HRI license.
Specific criteria within Appendix A are applicable to this license only when they explicitly apply to ISL mining.
- 2. Applicability of P\ art 40, Appendir A Criteria Criterion 2 is the only one of the Appendix A criteria that references ISL mining.8 He Criterion SA provisions also are applicable to HRI's proposed operations because ISL mining operations generally use surface impoundments, and because such operations produce " byproduct material." See 10 C.F.R.
140.4, " Byproduct Material" definition; see also Staff's December 1997 SER at 29 (recognizing applicability of Criterion SA provisions to HRI's f roposed operations). De detailed basis for the Appendix A criteria, promulgated in 1980, are set forth in a Generic Environmental Impact Statement (GEIS). 45 Fed.
. Reg. 65,521,65,529 col.1 (Oct. 3,1980). De GEIS focused on the impacts of 8crierion 2, which the Intervenars do not Ascuss. stases in full as follows:
To avoid prohferation of small wane &sposal sites and thereby reduce perpetual surveillance obhgauona,
_ byproduct masenal from in sina extracuan operations. such as residues from solution evaporation or contaminated control processes. and wastes from small remote above ground entraction operations rnust be esposed of at existing large mill taihngs &sposal sites; unless, considenng the nature of the wastes, such as their volurne and specihc acovity, and the costs and environmental irnpacts of transporting the wastes to a large disposal aste. such offsite &sposal is demonstrated to be impruchcable or the advantages of onsne burial clearly outweigh the benefits of reducing the perpetual surven!!ance obligations.
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1 l conventional uranium milling operations, while giving limited consideration to the impacts of nonconventional uranium recovery processes such as ISL mining.
l See GEIS 61.2, " Scope of Statement," at 1 1 to 1-2.'
Intervenors have focused their attention on Criterion 7. However, Criterion 7A explains that the purpose of the required detection monitoring program is to detect " leakage of hazardous constituents from the disposal area." (Emphasis added.) I infer that this requirement applies to mill tailings, which are left in a " disposal area" and not to ISL mining. The definition of " disposal area,"
found in the beginning of Criterion 6, refers to an area of a site put aside for controlled, long-term storage of waste after a project is completed. That criterion is inapplicable here because there will not be any waste byproduct material permanently disposed of on this site.
Staff correctly states, at 19 of the Staff Response:
In arguing the applicability of Criterion 7A, Ms. Sam and Ms. Morris cite the 1995 " Staff Technical Position on Effluent Disposal at licensed Uranium Recovery Facihties (Effluent STP). See Morris Disposal Brief, at 4 n.l.10. and 10 n.6. The Effluent STP provides a general guide to the NRC staff in reviewing waste disposal proposals at both uranium mills and ISL facilities. See Effluent STP, at 1. As a result, its wording is neousarily broad.
Consistent with its status as a general guidance document, the wording of the applicable regulations controls for purposes of legal enforcenent. See id., at 2.
In license proceedings, guidance documents provide " guidance" but it is the agency's regulations, promulgated after notice and comment, that control.10 C.F.R. 5 2.1239(a).
Intervenors have argued that HRI's license application is deficient because it does not specify in detail the arrangements for surface impoundments. I reject this argument. HR1 complied with these regulations when it stated in the COP 2.0 that:
all CUP surface impoundnents will be equipped with two impermeable synthetic membrane liners: an inner 30 mit Hypalon lmer, or equivalent, and an outer liner 36 mils thick made of flypalon. or equivalent (1 mil = 0.001 inch). A space 4 to 5 inches thick between the two liners will contain sand. or some other (granular) porous medium, and a drainage network of open piping, forming an underdrain leak detection system. The (inner) liner will provide secondary containment for any leakage that may occur.
NRC recognized HRI's commitment in this regard in the SER:
HR1 has committed to using a double. lined, impermeable synthetic membrane for its waste retention ponds in accordance with 10 C.F.R. Part 40, Appendix A requirements, The liners O
la october 19so, secuan 40 31(h) and Part 40. Appendix A were pronmiguted in final form. ser 45 Fed.
Reg. ut 65.528 col.2. 65.529 col. At 65.529. the 1980 statement of Consideranons erroncously refers to "a new paragraph (g)" being added to 10 C.F R. I 40 31 The error is corrected at 46 red. Reg 13.497 (Feb 23.1981).
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I l will be separated by 4-5 inches of sand or equivalent medium, and a drainage network of open piping which forms an underdran leak detection system. The inner liner will provide secondary containment for any leakage that may occur. HRI states that it will conduct daily inspections for leakage, and that fluid found in the leak detection system will be cause for imrrediate corrective action, including notification of the NRC. I I
1 SER at 30. In addition the Staff has imposed License Condition 10.26, requiring 1 NRC acceptance of the adequacy of waste retention ponds prior to lixiviant injection. License SUA-1508 at 8. Intervenors have not persuaded me that these specifications are deficient.
- 3. Applicability of Part 20 On pages 29-37 of their brief. ENDAUM and SRIC claim that HR1 has failed !
to provide specific information and analyses in the license application required j by 10 C.F.R. 520.2002 for licensing waste disposal by land application, surface discharge, or deep-well injection "as HRI is already contemplating using these f
1 alternative methoda in some form." ENDAUM and SRIC Phase I Brief at 29-30.7 l As the SER points out, with respect to restoration water, "[clurrently, HRI would )
be limited to using either surface discharge (with appropriate State or rederal permits / licenses), brine concentration, waste retention ponds, or a combination of these three options to dispose of [restorationJ' waste water." SER at 26. HRI has not submitted an application to the Commission for deep-well injection, surface water discharge, or land application. Accordingly, it need not satisfy the section 20.2002 requirements at this time.
IIL NATIONAL ENVIRONMENTAL POLICY ACT (NEPA)
A. Analysis As the Staff argues, the FEIS has not been brought seriously into question by the arguments of the Intervenors. Page 30 of the Staff Response declares:
The 1997 FEIS contains over 250 pages of analysis, not including appendices. Even if all of the criticisms orfered by ENDAUM and SRIC regarding the FEIS (see SRIC Disposal Ilrief, at 38-53) were valid (which, as discussed below, they are not), their arguments would fall far short of estabhshing that the NRC failed to take the "hard look" required by the National Environmental Policy Act of 1969,42 U.S C. ll4321 et seg. (NEPA).
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7 ENDAUM and SRIC do not take issue with HRfs uw of evuporation as they adnut th.tt it is authonzed by 10 CJ R. Part 40. Appendas A. See ENDAUM and SRIC Phase I unef at 29 n.14.
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Although the SER states " process" water here, clearly, the staff intended to refer to " restoration" water. There are no plans for process waxer to be surface diw:harged.
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} Indeed. I have reviewed the F151S carefully and I am impressed by its attention to technical detail and its thoughtful consideration of environmental risks.
Intervenors have failed to demonstrate any significant deficiencies. I I am also convinced by the Staff's arguments, at 30-37, that Intervenors have made a variety of errors in characterizing the FEIS. 'Ihese errors include:
j e Mischaracterizing the FEIS's production bleed estimate, which consistently states that the bleed is 1% or 40 g.p.m. of water which is not returned to the aquifer.
See FEIS, { 4.3.1, at 4 26. In agreement with the FEIS, COP Figures 3.1-2 fn 3.1 1 both show a 40 g p.m. production bleed for various options of waste water treatment, e SRIC and ENDAUM, citing page 2-20 of the FEIS, state that 150-250 g.p.m. of water "would be withdrawn during groundwater sweep", and that after treatment.
"all those gallons would be re-injected [in]to the aquifer." SRIC Disposal 11rief, at
- 46. This misunderstanding may have been derived from FEIS pages 4-58 to 4-60, l estimating consumptive water volunws for each of the proposed ISL mining sites j singly, and in combination. At page 2-20, the 150 to 250 g p.nt flow is represented as an average 200 g.p.m. How in Figure 2.7. Neither the FEIS text on page 2-20, or Figure 2.7, states that restoration would result in reinjection of all withdrawn water.
Rather, the text on page 2-20 states that the permeate (clean water produced by j the re-crse osmosis treatment option) would be reinjected into the aquifer. Figure j
2.7 shows restoration flows for various restoration options, and shows that a 200 i g.p.m. restoration flow would produce 150 g p.m. of clean water (permeate), and 50 g.p.m. of waste water, e ENDAUM and SRIC state that the FEIS does not discuss evaporation ponds in terms of soil in pact from ground disturbance. See SRIC Disposal Brief, at 48.
However, impacts to soils from evaporation pond construction are described on pages 4-6 to 4-14 of the f1IIS, along with estimates of disturbed acreage for various alternatives.
- ENDAUM and SRIC incorrectly state that evaporation ponds are left out of the FEIS discussion on how ground water must be protected from the effects of pond ,
leakage. Comparc SRIC Disposal Brief, at 48 with Fels pages 4 25 to 4-26. See i aim HRI License Condition 10.5 (providing additional safeguards).
+ SRIC and ENDAUM erroneously state that evaporation ponds may overflow, nis is a misconception, as HRI License Condition 10.5 requires that enough space be left within each pond container (freeboard requirement) so that if a leak occurs in a pond, there will be enough space in other ponds so that the contents of the leaky j pond can be transferred to other ponds to prevent further leakage. l
- SRIC and ENDAUM incorrectly state that the FEIS only considered impacts for the 80 acres in Secticn 17 that might be used for land application disposal of hquid waste. However, as was stated on FEl$ page 4-11, the NRC Staff assumed that land application at the Church Rock site could occur on any of the four sections l
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but that no more that 640 acres would be affected. See aho HRI License Condition 11.R, which requires advance approval for land application; FEIS pages 4-7 and 4-10 to 11, 36 ,
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E ENDAUM and SRIC are incorrect in their concern about the significance of the omission of manganese ruolybdenum, and selenium from HRI's water quality data.
These elements have been measured and are either abnent or are present only in insignincant annunts. See Table 29-1 of HRI's response to RAI 29 (pregnant lixlviant data); see also HRI's December 9,1998 Eling. at $1.
- Contrary to SRIC and ENDAUM's arguments the FEIS gave adequate considera-tion to impacts on water fowl. See FEIS 14.73, at 4-91 to 4 92.
Intervenors' also presented overtopping concerns pertaining to rainfall, wind and wave action, and operator error. It is difficult to imagine how maximum rains in McKinley County, New Mexico, could result in overtopping, as the Prob-able Maximum Precipitation (PMP) is 8.9 inches. In any event, in accordance with License Condition 10.26(d), prior to injecting lixiviant at Churchrock, HRI must receive NRC acceptance that the waste retention ponds are designed to accommodate the Probable Maximum Flood. Ftr.ther, wind and wave action are covered by License Condition 10.26, which requires HRI to comply with NRC guidance which sets requirements with respect to these factors. Intervenors also have not sustained their concern that operator enor may cause overfilling of the ponds. HRI is committed to conduct operations so that pond freeboard is maintained and it has adopted proper Standard Operating Procedures (SOPS),
as stated in the COP Rev. 2 5 9.16 and as required by License Condition 9.8 COP Rev. 2 5 9,16, at 153-54; License Condition 9.8.
Order For all the foregoing reasons and upon consideration of the entire record in this matter, it is, this 3d day of February 1999. ORDERED that:
- 1. Eastern Navajo Dind Against Uranium Mining, the Southwest Research and Information Center, Grace Sam, and Marilyn Morris are denied relief with respect to their area of concern related to waste disposal issues.
- 2. This Decision is reviewable under 10 C.F.R. 6 2.1253, pursuant to the procedures set forth in 10 C.F.R. 66 2.786 and 2.763. The petition for review
- must be filed within 15 days of the service of this Decision.
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Peter B. Bloch, Presiding Officer l
ADMINISTRATIVE JUDGE !
Rockville, Maryland j
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I Cite as 49 NRC 38 (1999) LBP-99-2 1
UNITED STATES OF AMERICA i NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD !
Before Administrative Judges:
Thomas S. Moore, Chairman Thomas D. Murphy Dr. Peter S. Lam in the Matter of Docket No. 30-34318-EA (ASLBP No. 99-759-01-EA) l l
SPECIAL TESTING LABORATORIES, l INC. I (Bethel, Connecticut) February 3,1999 i
ORDER The NRC Staff and Special Testing Laboratories, Inc. (STL) by its Director, l Richard A. Speciale, have filed ajoint motion to tenninate this proceeding initi- I ated by the Staff's December 23,1998 immediately effective order suspending I STL/s material license. The Board's January 8,1998 Memorandum and Order sets forth the course of the parties' settlement negotiations in this proceeding. It ;
suffices to note that the parties have now agreed upon an immediately effective '
confirmatory order modifying STL's material license and rescinding the earlier Staff enforcement order.
The issuance of the confirmatory order settles the disputed issues between STL and the Staff. Although at this stage of the proceeding the record is necessarily limited, the terms of the confirmatory order clearly appear to be in the public interest and reasonable in light of the conduct charged in the original enforcement order. Because the parties agreed to the confirmatory order before the Board entered an order establishing a hearing date, however, a motion to terminate the proceeding is the appropriate vehicle to close the proceeding.
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! Compare 10 C.F.R. 52.203. Accordingly, the joint motion to terminate the proceeding is granted and the proceeding is terminated.
It is so ORDERED.
l THE ATOMIC SAFETY AND LICENSING BOARD Thomas S. Moore, Chairnun ADMINISTRATIVE JUDGE Thomas D. Murphy ADMINISTRATIVE JUDGE l Peter S. Lam ADMINISTRATIVE JUDGE Rockville, Maryland February 3,1999 l 39 i
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Cite as 49 NRC 40 (1999) LBP-99-3 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD Before Administrative Judges:
G. Paul Bollwerk, lit, Chaim1an Dr. Jerry R. Kline Dr. Peter S. Lam in the Matter of Docket No. 72-22-ISFSI {
(ASLBP No. 97-732-02-ISFSI)
PRIVATE FUEL STORAGE, LLC.
(Independent Spent Fuel Storage l Installation) February 3,1999 In this proceeding concerning the application of Private Fuel Storage, L.L.C.,
(PFS) under 10 C.F.R. Part 72 to construct and operate an independent spent fuel storage installation (ISFSI), the Licensing Board grants a late-filed intervention petition concerning a revised proposal to construct a rail spur that would be used to transport spent fuel shipping casks to the PFS facility.
RULES OF PRACTICE: INTERVENTION PETITION (PLEADING REQUIREMENTS)
. Absent some demonstration that separate consideration is required, a showing regarding the 10 C.F.R. 6 2.714(a)(1) cri:crie would be equally applicable to a late-filed intervention petition and any concurrently filed contentions.
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' RULES OF PRACTICE: INTERVENTION PETITIONS (S)(GOOD CAUSE FOR LATE FILING)
'Ihe first late-filing factor under section 2.714(a)(1)- good cause for filing late -is also the most important in the five-factor balance. See LDP-98-7,47 NRC 142,173 (1998).
RULES OF PRACTICE: INTERVENTION PETITION (S)
- (TIMELINESS)
Even though there is no Federal Register notice of an amendment application, the fact the amendment was placed in a local public document room (LPDR) created for a facility provides an enhanced opportunity for access to licensing information that should be taken into account in analyzing the timeliness of an intervention petition. It is reasonable to expect that, from time to time, those in the area of the facility who may have an interest in the proceeding, would visit the LPDR to check on its status. At the same time, nonparty status to a proceeding is a pertinent factor in assessing the frequency of such visits. A nonparty would not be expected to visit the LPDR as often as a party given the need to travel to the LPDR in order to see the files. With this in mind, one LPDR trip a month by a nonparty to monitor a proceeding seems reasonable.
RULES OF PRACTICE: NONTIMELY INTERVENTION PETITION (S) (BALANCING OF 10 C.F.R. 5 2.714(a)(1) CRITERIA)
Even with a finding that the first, and most important, section 2.714(a)(1) late-filing factor - good cause for late-filing - weighs in a petitioner's favor, the other four factors must be conidered to arrive at an assessment of the overall balance that accrues.
RULES OF PRACTICE: NONTIMELY INTERVENTION PETITION (S)(OTHER MEANS AND OTHER PARTIES TO PROTECT INTERVENORS' INTEREST)
Although winning United States Department of the Interior Bureau of Land Management (BLM) permission to use federal land to construct a rail spur involves a public process during which there is an opportunity for participation in an administrative hearing, there is a significant question about the degree to which this alternative forum might otherwise afford "a full hearing," see Detroit Edison Co. (Enrico Fermi Atomic Power Plant, Unit 2), ALAB-707,16 NRC 1760,1767 n.6 (1982), such that the second section 2.714(a)(1) factor - ~, .: e ,+ -
availability of other means to protect petitioner's interests - would constitute 4I
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[ > a substantial negative ingredient in the overall balance. When the NRC is the " lead agency" that will prepare an environmental impact statement (EIS) relative to a proposal to use federal land for a rail spur, BLM will act only in a cooperating role, providing comments on NRC's preliminary, draft, and final EIS, but not preparing its own EIS. Because any National Environmental Policy l
Act (NEPA) responsibilities relative to the rail spur have been assumed by the NRC, it is problematic whether the issue of NEPA compliance can (or should) be contested as part of any BLM review process, neutralizing any negative element this factor might bring to the balance. Compare Public Service Co. of New Hampshire (Seabrook Station, Units I and 2), CLI-78-1,7 NRC 1,26-27 (1978)(in NEPA analysis, NRC will not relitigate issues delegated to the Environmental Protection Agency).
RULES OF PRACTICE: NONTIMELY INTERVENTION PETITION (S)(OTHER MEANS AND OTHER PARTIES TO PROTECT INTERVENORS' INTEREST)
The fourth section 2.714(a)(1) factor - extent of representation of peti-tioner's interests by existing parties - clearly weighs in favor of a petitioner when no other party has raised a similar issue or even been successful in hav-ing a contention dealing with the same general subject matter admitted in the proceeding.
RULES OF PRACTICE: NONTIMELY INTERVENTION PETITION (S)(ASSISTANCE IN SOUND RECORD DEVELOPMENT)
When a petitioner identifies three of the witnesses it may utilize in the proceeding and, in the context of the affidavits supporting its petition and contentions, provides an outline of the testimony of one of those individuals, this affords at least some minimal support for acceptance of its petition under factor three - extent to which petitioner's participation may lead to development of a strong record. See LBP-98-29,48 NRC at 294 n.5.
RULES OF PRACTICE: NONTIMELY INTERVENTION PETITION (S) (DELAY)
Any broadening of the proceeding by the entry of new issues is offset to a considerable degree by the fact that admission is unlikely to result in any protracted delay becarse the case is still in its informal discovery phase, so that section 2.714(a)(1) factor five - broadening the issues or delaying the proceeding - is, at worst, a neutral element in the balance.
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I RULES OF PRACTICE: STANDING TO INTERVENE (NEPA)
In the NEPA context agency consideration of an action that would alter assertedly pristine public land without a discussion of alternatives seemingly I would constitute a sufficiently direct and concrete injury to an intervenor's legitimate interests under NEPA to provide standing to contest that action.
RULES OF PRACTICE: STANDING TO INTERVENE (REDRESSABILITY)
Argument that intervenor has failed to demonstrate a favorable decision likely will redress its injury, and so establish its standing, because even if land use application is rejected, BLM could grant a separate proposal for the land to some other entity misapplies the redressability standard. What intervenor seeks to gain from its challenge is to preclude the danger it perceives the applicant's proposal poses to the land in question. If, as a result of agency NEPA consideration of the applicant's proposal in this proceeding, the proposal is implemented in a way that is not inconsistent with the petitioner's asserted interest in the land, then the intervenor has won all it can expect from this proceeding and its potential injury has been redressed.
RULES OF PRACTICE: STANDING TO INTERVENE (FACTUAL 1 REPRESENTATION) l 1
While an affidavit indicating that an individual had " frequently visited, used, and enjoyed" an area and planned to do so " frequently in the future," could have been more specific about the number of times the individual traversed and otherwise used (and plans to use) the land in question, adoption of the term
" frequently" in this context demonstrates that individual's bond with the area is sufficiently concrete to establish his standing and, consequently, that of the organization he has authorized to represent his interests.
i RULES OF PRACTICE: STANDING TO INTERVENE (FACTUAL !
REPRESENTATION)
Precision regarding a standing showing that is based on actual physical contact (i.e., hiking, camping, etc.) with the object of the purported injury '
is of less concern than for a standing showing based on distance from the object in question (i.e., reside "x" miles from the facility). An ongoing presence via physical contact can be adequately conveyed with a general term such as
" frequently." General references regarding distance, however, will usually be ,
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MEMORANDUM AND ORDER (Granting Late Filed Intervention Petition)
In LBP-98-29,48 NRC 286 (1998), we denied requests by Intervenor State of Utah (State), Confederated Tribes of the Goshute Reservation (Confederated Tribes), and Ohngo Gaudadeh Devia (OGD) to admit late-filed contentions relating to the August 28,1998 license application amendment of Private Fuel Storage, L.L.C. (PFS). The application amendment in question moves wam 17 miles west the rail line that PFS proposes to construct to bring loaded spent fuel shipping casks from the Union Pacific mainline south to its planned 10 C.F.R. Part 72 independent spent fuel storage installation (ISFSI) located on the reservation of the Skull Valley Band of Goshute Indians (Skull Valley Band). Besides spawning these Intervenors' late-filed contention requests, that application also was the catalyst for the late-filed petition to intervene and supponing contentions of the Southern Utah Wilderness Alliance (SUWA) that is pending before the Licensing Board.
Ihr the reasons set forth below, we grant the SUWA intervention petition and accord it party status, finding that (1) a balancing of the late-filing criteria in 10 C.F.R. 5 2.714(a)(1) supports entertaining the petition and the accompanying contentions; (2) SUWA has established its representational standing to intervene; and (3) SUWA has proffered one litigable contention.
- 1. BACKGROUND The circumstances surrounding the August 1998 license application amend-ment that makes the so-called Low Junction rail spur the PFS preferred rail transportation scheme are described in LBP-98-29, 48 NRC at 289. In a November 18,1998 hearing request, Petitioner SUWA sought to intervene in this proceeding, either as of right or as a discretionary intervenor, to challenge that amendment. See [SUWA] Request for Hearing and Petition to intervene !
(Nov.18,1998) [ hereinafter SUWA Petition]. In its petition, SUWA describes itself as a nonprofit organization dedicated to identifying and protecting the
" wilderness character" of roadless areas under the jurisdiction of the United States Department of the Interior's Bureau of Land Management (BLM) until such time as Congress has an opportunity to designate those areas as wilderness j under the Wilderness Act of 1964,16 U.S.C. il 1131-1136, and the Federal Land Policy and Management Act of 1976 (FLPMA),43 U.S.C. Il1701-1784.
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Id. at 2-3. According to SUWA, in conjunction with an ongoing BLM rein-ventory of Utah wilderness areas, SUWA has conducted its own inventory of potential wilderness areas and has determined that the North Cedar Mountains area, through which a 3-mile portion of the Low Junction rail spur runs, should be designated as a potential wilderness area. In this vein, SUWA submitted two contentions, SUWA A and SUWA B, that assert a PFS failure to consider adequately the wilderness character of the North Cedar Mountains area in and near the Low Junction rail corridor in assessing the impacts of, and a possi-ble range of alternatives to, the PFS proposal in violation of the Wilderness Act, FLPMA, and the National Environmental Policy Act of 1969 (NEPA). See
. [SUWA] Contentions Regarding [PFS] Facility License Application (The Low Rail Spur) (Nov. 18,1998) [ hereinafter SUWA Contentions]. In its petition, SUWA also addressed the standards in 10 C.F.R. 5 2.714(a)(1) that govern late intervention, asserting its petition meets those late-filing standards.
Responses to these SUWA filings were submitted by Intervenor State, Appli-cant PFS, and the NRC Staff. The State supported intervention, asserting SUWA l
had met the standards for late-filed intervention and had provided admissible I contentions. See [ State] Response to Request for Hearing, Petition to Intervene and Contentions of [SUWA] (Dec.1,1998) [ hereinafter State Response]. PFS and the Staff, on the other hand, both asserted the SUWA petition should be denied in that (1) the SUWA hearing request did not merit admission under the section 2.714(a)(1) late-filing standards; (2) SUWA had failed to establish its uanding as of right; (3) SUWA had not made a case for permitting discretionary intervention; and (4) SUWA had failed to provide an admissible contention. See Applinnt's Answer to Petition to Intervene and Contentions of [SUWA] (Dec.1, l 1998) ihereinafter PFS Response]; NRC Staff's Response to [SUWA] Request !
for Hearing, Petition to Intervene, and Contentions Regarding [PFS] License '
- Application (The Low Rail Spur) (Dec.1,1998) [ hereinafter Staff Response].
In a reply to the PFS and Staff responses, SUWA declared that (1) it did meet the section 2.714(a)(1) standards for late filing so as to warrant admission of its ,
intervention petition and the accompanying contentions; (2) it should be admit-ted as party to the proceeding because it had established its standing as of right and as a matter of discretion; and (3) its contentions were admissible. See Reply
- of [SUWA] to Staff and Applicant Responses to SUWA's Petition to Intervene, Request for Hearing and Contentions (Dec. 8,1998) [ hereinafter SUWA Reply).
Thereafter, during a December 11,1998 videoconference, the Board entertained arguments from SUWA, the State, PFS, the Skull Valley Band, and the Staff concerning the SUWA petition and its contentions. See Tr. at 1050-165.
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l kL ANALYSIS A. Standards Governing Late-Filed Intervention Petitions, Standing, and Late Filed Contentions At this juncture, to gain admission as a party to this proceeding, SUWA must clear the following hurdles: (1) establish that its intervention petition and the accompanying contentions should be accepted even though late-filed; (2) show that it has established its standing to intervene, either (a) as of right, or (b) as a matter of discretion; and (3) show that its contentions meet the standards for admissibility. In prior decisions in this proceeding, we have outlined the various standards that govern these assorted aspects of our consideration of the admission of SUWA's petition and contentions. Among these are (1) the five criteria of 10 C.F.R. 5 2.714(a)(1) that govern the admission of late-filed intervention petitions and contentions;8 see LBP-98-7,47 NRC 142,167 (late intervention),182-83 (late-filed contentions), aff'd, CLI-98-13, 48 NRC 26 (1998); LBP-98-29, 48 NRC at 291 (late-filed contentions); (2) the requirements to establish standing as of right or discretionary standing, see LBP-98-7,47 NRC at 167-68; and (3) the standards for admission of contentions, see id. at 178-81; LBP-98-13,47 NRC 360, 365 (1998). We deal with these admission guideposts first as they apply to the SUWA intervention petition and then with respect to the accompanying contentions.
B. SUWA Intervention Petition
- 1. Late Filing Crueria DISCUSSION: SUWA Petition at 9-11; State Response at 13; PFS Response at 15-17; Staff Response at 4-7; SUWA Reply at 2-5; Tr. at 1050-54,1060-63, 1070-75, 1091-94, 1105-09.
RULINO: As we have noted before, see LBP-98-7,47 NRC at 173, the first late-filing factor - good cause for filing late -is also the most important in the balance. In this instance, SUWA declares that it first found out about the Low Junction rail corridor application amendment the second week of October 1998 and filed its petition and contentions some 6 weeks later. See SUWA Reply at 3; see also Tr. at i105-08. According to SUWA, it had good cause for taking 6 weeks of preparation before filing because of the time needed (1) to familiarize itself with the NRC regulatory process and the amendment, including generating maps to compare the Low Junction rail corridor with the areas in which it has an 3
Absent sonw dernonstration that separate consideradon is requin:d. a showing regarding the 10 CFR.
5 2.714(a)(1) csiteria would be equally apphcable to a late-hied intervenuon petition and any concurrendy Gled contenuons.
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The State agrees with SUWA's assertion. See State Response at 3. Both PFS and the Staff do not, albeit for somewhat different reasons. PFS asserts the 6-week period is too long given the nature of the amendment. See Tr. at 1061. The Staff's disagreement, on the other hand, is based not on the claimed l 6-week preparation period, which it indicates would be reasonable under the
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circumstances, but rather on the basis that SUWA, as an organization generally I interested in Utah areas such as that around the proposed PFS site, should have been more vigilant in learning of the amendment because (1) in early July 1998 PFS placed a letter in the docket of this proceeding indicating it planned to l file the Low Junction corridor amendment in late summer or early fall 1998; I and (2) the amendment was placed in the local public document room for this I proceeding in early September 1998. See Tr. at 1071-72. l We agree with the Staff that, under the circumstances here, the approximately )
45-day period SUWA used to prepare its intervention petition, while perhaps i approaching the outer boundary of " good cause," was not unreasonable. We l
do not agree, however, with the Staff's assessment of SUWA's vigilance in !
discovering the PFS application amendment. Although there was not a Federal Register notice of the amendment application, the fact the amendment was placed in a local public document room (LPDR) created in Salt Lake City, Utah, for the PFS facility provides an enhanced opportunity for access to licensing information that should be taken into account in analyzing the timeliness of SUWA's intervention petition. It is reasonable to expect that, from time to time, those in the area who may have an interest in the proceedin:., including SUWA, would visit the LPDR to check on its status. At the same time, the fact SUWA is not a party to this proceeding is a pertinent factor in assessing the frequency of such visits. By way of contrast, we would not expect a nonparty to visit the LPDR as often as a party given the need to travel to the LPDR, which is located in Salt Lake City on the University of Utah campus, in order to see the files. With this in mind, one LPDR trip a month by a nonparty to monitor this proceeding seems reasonable.2 Considering the circumstances here against this backdrop, although the July 1998 letter apparently was placed in the LPDR, it seemingly was not sufficiently 2
in this regard, we note that by the end of 1999 the agency hopes to implernent a paperless docunent control system under wtuch electronic versions of publically available beenung docunrnas would he placed on the agency's Internet Web site widun a Aort time efter the docunents are received. How such a system nught affect the unung analysis above. at least for those wnh internet acceu. is a question we need not resolve here 47
4 specific to prompt an intervention petition or contentions, particularly when it referenced the fact an actual amendment would be filed later. 'Ihe August 1998 amendmW itself thus is the appropriate trigger point for any intervention or contention.,,egarding the Low Junction rail corridor. Nrther, although the Staff declares the amendment was placed in the LPDR in early September, see Tr. at 1071, it has not provided a specific date. We thus will presume the August 28, 1998 amendment reached the LPDR within 2 weeks, or by the second week of September 1998. Further, we think it reasonable to count the 30 days within which SUWA would be expected to make an LPDR trip, and thus learn about the amendment, from the date the document is placed in the LPDR, or the second week of October 1998. As it turns out, this is the same time frame in which SUWA asserts it received notice of the amendment, albeit not from the LPDR, and began its 6-week period of petition preparation.
Consequently, taking into account both when SUWA learned of the amend-ment and the period it took to prepare and to file its hearing request, we conclude SUWA has demonstrated the requisite good cause for its late-filing.
Having found the first, and most important, late-filing factor weighs in SUWA's favor, we nonetheless must consider the other four factors to arrive at an assessment of the overall balance that accrues. Relative to factor two -
availability of other means to protect the petitioner's interests - we do not find the PFS and Staff assertions regarding a legislative remedy and the right to enmment on any NRC draft environmental impact statement (EIS) particularly compelling as alternative fora to protect SUWA's interests. See PFS Response at 16; Staff Response at 5 PFS, however, has suggested that SUWA does have ancther administrative arena, the BLM, within which to seek a protected wilderness designation for the portion of the Low Junction rail corridor about which it is concerned. Indeed, PFS apparently must win ELM permission to use the federal land upon which the Low Junction rail spur would be constructed, a public process during which there is an opportunity for participatioa in an administrative hearing. See Applicant's Reply to [ State] Response to NRC Staff Lead Agency Filing (Jan. 5,1999) at 3-5.
There is, however, a significant question about the degree to which this alternative forum might otherwise afford "a full hearing," see Detroit Edison Co. (Enrico Fermi Atomic Power Plant, Unit 2), ALAB-707,16 NRC 1760, 1767 n.6 (1982), such that this factor would constitute a substantial negative ingredient in the overall balance. As the Staff has made clear NRC is the " lead agency" that will prepare the EIS relative to the PFS proposal to use federal land for the Low 1metion rail spur. The BLM will act only in a cooperating role, providing comments on NRC's preliminary, draft, and final EIS, but not preparing its own NEPA statement. See Letter from Sherwin E. Turk, NRC Staff Counsel, to the Licensing Board (Dec, 16,1998) at 1-2. Given that any NEPA responsibilities relative to the Low Junction rail corridor have, in the first 48 i
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i 1 instance, been assumed by the NRC, it is problematic the degree to which the issue of NEPA compliance, a focus of the SUWA contentions, will be a matter that can (or should) be contested as part of any Department of the Interior review process, neutralizing any negative element this factor might bring to the balance.
Compare Public Service Co. of New Hampshire (Seabrook Station, Units 1 and 2), CLI-78-1,7 NRC 1,26-27 (1978) (in NEPA analysis, NRC will not relitigate issues delegated to the Environmental Protection Agency).
On the other hand, as the Staff notes, see Staff Response at 6, the fourth factor
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- extent of representation of petitioner's interests by existing parties - clearly j weighs in favor of SUWA because no other party has raised a wilderness issue t or, in fact, been successful in having a Low Junction rail corridor contention admitted in this proceeding. Thus, at best, the second and fourth factors negate each other in the balance.
As to factors three and five, which carry more weight among the four section 2.174(a)(1) non-good cause considerations, they are marginally positive (or at least not negative) clements in the balance. SUWA does identify three of the witnesses it may utilize and, in the context of the affidavits supporting the SUWA petition and contentions, provides an outline of the testimony of one of those individuals, Dr. Jim Catlin, thereby affording at least some minimal support for acceptance of its petition under factor three - extent to which petitioner's participation may lead to development of a stroug record. See LBP-98-29,48 NRC at 294 n.5. At the same time, any broadening of the proceeding by the entry of SUWA with its new " wilderness" issues is offset to a considerable degree by the fwt that admission is unlikely to result in any protracted delay because this ca.6e still is in its informal discov;ry phase, so that factor five
- broadening the issues or delaying the proceeding - is, at worst, a neutral element in the balance.
Accordingly, with good cause for lateness having been shown and the other l
four factors providing little, if any, counterweight, we conclude that a balancing of the five section 2.714(a)(1) factors favors entertaining the SUWA petition and !
the accompanying contentions despite their late filing. l
- 2. Standing DISCUSSION: SUWA Petition at 12-15; PFS Response at 5-14; Staff Re-sponse at 10-18; SUWA Reply at 6-11; Tr. at 1053-58,1063-69,1076-85, 1110-31.
RULING: Having gotten over the " late-filing" barrier, SUWA still must establish its standing to intervene. As presented by the parties, the dispute regarding standing centers on whether (1) SUWA as an organization has standing to intervene; and (2) SUWA has standing through its representation of the interests of one or more of its members. We see no need to address the first 49
l controversy, because, as we explain below, SUWA has fulfilled the qualifications for representational standing relative to its member, Dr. Jim Catlin.
Of the four showings required by an organization wishing to establish standing as the representative ofits members' interests, see CLI-98-13,48 NRC at 30 31, only one - whether one or more of its members would otherwise have standing to sue in his or her own right -is at issue here,5 Fufther, relctive to the three elements at play in this determination of Dr. Catlin's standing as the represented individual, see id. at 31, we consider only the first and third -
injury in fact and redressability - to be in serious question.d Regarding Dr. Catlin's injury in fact, both the PFS and the Staff assert that he has failed to establish that his injury is sufficiently concrete and particularized.
Both declare the asserted injury involved is not sufficiently concrete because it j does not inwlve a specific, tangible environmental harm. See PFS Response at J
8-11,13; Staff Response at 12. Additionally, both challenge the sufficiency of I Dr. Catlin's affidavit describing the injury to his personal interests, which states:
I have a personal interest in and have frequently visited, used and enjoyed the natural resources of the North Cedar Mountains and benches, including the section of this area that will be traversed by the proposed rail spur, for numy health, recreational, scientific, spiritual, educational, aesthetic, and other purposes and will do so frequently in the future. I have visited these areas, including the exact tract of land within the North Cedar Mountains area that will be traversed by the proposed rail spur, and have developed an ongoing and deep bond with the land and its wilderness character which I will continue to cultivate in the future. I frequently enjoyed and will, in the future with sone frequency, enjoy hiking, camping, birdwatching, study, contemplation, sohtude, photography, and other activities in and around the North Cedar Mountains roadless area, including the exact tract of land -
the bench of the North Cedar Mountains - over which the proposed rail spur will traverse.
I will be personally harmed and my health, recreational, scientific, spiritual, educational, aesthetic, informational, and other interests will be directly affected and irreparably harmed by a decision to allow construction and operation of the Low Rat! Spur and by other agency actions which may impact the North Cedar Mountains, includmg the exact tract of land -
the bench of the North Cedar Mountains - over which the proposed rail spur will traverse.
SUWA Reply, Second Declaration of Jim Catlin for Petitioner [SUWA] (Dec.
8,1998) at 4-5, According to PFS and the Staff, Dr. Catlin's use of the word
" frequently" to describe his past and future contacts with the Low Junction rail l
3 I Relauwe to repreventauonal standmg, neither PFS nor the Staff has contested whether (1) the interests SUWA seeks to protect are germane to its purpone, (2) the claim asserted or sehef requested requires an individual nendier to participate in the orgamration's adjudicatory challenge; or (3) the organization has denenstrated that at least one of its members upon which its standing rests has authorized it to represent his or her interests. Sec PFS l
Response at ll.Ih Staff Response at 12-15. Tr. ut 1063-69,1078-81. We likewise do not see these elements as i negating SUWA's representauonal standmg.
As the Staff notes, the causation elenent relauwe to Dr Cathn's purponed injury in fact appears to have been met. Sea Staff Response at 1314.
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g corridor is insufficiently particularized to establish the requisite concreteness for
' his asserted injury in fact, See Tr. at 1066-67, IM8-79, Relative to the PFS and Staff assertions about the concreteness of any purported environmental-related injury, we find the decision of the United -
States Court of Appeals for the Ninth Circuit in Idaho ConScrwation league
- v. Mumma, 956 F.2d 1508 (9th Cir.1992), instructive.8 Initially, we note the court's admonition that when " Congress is the source of the purportedly violated -
legal obligation, we look to the statute to define the injury." 14. at 1514. In this instance, SUWA in its contentions has based its claims on alleged violations of the Wilderness Act, FLPMA, and NEPA. As the Mumma court suggests. NEPA provides a procedural protection for potential intervenors by imposing an agency .
duty to consider all reasonable. alternatives before making a decision affecting the environment. In this NEPA context, even without the Wilderness Act or FLPMA, agency consideration of an action that would alter assertedly pristine public land without a discussion of alternatives seemingly would constitute a sufficiently direct and concrete injury to an intervenor's legitimate interests under NEPA to provide standing to contest that action. Consequently, with the provisions of the. Wilderness Act and FLPMA, which make it clear maintaining wilderness, and by implication the option to obtain a wilderness designation that results in such preservation, has more than nominal value, See 16 U.S.C.
61131(c) (wilderness defined as land "which is protected and managed so as to
. preserve its natural conditions"), agency action without sufficient consideration of alternatives that would preserve any designation potential is equally injurious to an intervenor's NEPA procedural interests so as to provide standing.'
As is specifically alleged in contention SUWA B, it is this NEPA interest in
. considering alternatives that Dr. Catlin and, as his representative, SUWA clearly want to protect. Accordingly, there is a concrete injury in fact in a proposal 5
As PFS noted, m Tr. at I116 17, at least one oder federal circuit has declined to follow the Mumnm decision.
See Sierra Cim6 y Robertson. 28 F.3d 753,759-60 (Bah Cir,1994). It did so, however, based on the fact the matwr under scrutiny in Messma was a proposed resource nuinagenent plan. as opposed to a siee-specine action.
See ht at 760. Here. of course, we are concetned with a proposed siw-speci6c action.
- Both PFS and the Staff nuuntan that de fact BLM previously dechnad to designate the area in queshon as potential " wilderness" area for further considersuon by congiens renders speculative any SUWA injury in losing the opportunity to have the land designaaed for proteccon. See PFS Response at 9; Staff Response at 12. As we -
have nosed. however, in the coneemt of NEPA, even absent de ILPMA statutory scheme. there would be a need to ::onsider the natural stase of the land and the alternahves. if any, that would be avslable to preserve that status.
This is perucularly so in an 6nstance when that natural staae will he irrevocably changed by the proposed project.
. Compare PFS Response, Exh. 3. at 17 (Utah BLM Simsewide Wilderness Final EIS) Ompact of not designaung Cedar Moumans wiki rness area is area would not receive prowetion but in foresacable future no developnent andcipawd that would affect wilderness values).
In this regard, the Staff also questions the sufhciency of SUWA's innerest in hght of the fact the proposed rail spur would only go through 3 rniles of the several thousand acre area idenutied by SUWA as wilderness. See Staff Response at $ a 6. see stvo PFS Response at 10. While this fact umy inAuence the consideration of alernatives, it is not disquahfying relative to SUWA's standing.
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v to take such an action without an adequate consideration of alternatives that accrues to SUWA as it acts as Dr. Catlin's representative.
l Because, as the Staff concedes, there is a chain of causation by which approval I of the PFS application will result in at least a small portion of the Low Junction rail Spur corridor becoming ineligible for protected " wilderness" designation under the Wilderness Act and FLPMA (at least as long as the rail line is in existence), see Staff Response at 14, this leaves only the matter of redressability, which can be promptly disposed of. The Staff makes the argument that SUWA has failed to demonstrate that a favorable decision likely will redress its injury, and so establish its standing, because even if PFS's application is rejected, the DLM could grant a separate proposal for the land to some other lessee. To adopt this reading, however, would misapply the redressability standard. What i SUWA seeks to gain from this challenge is to preclude the danger the PFS j proposal poses for the wilderness designation of the land in question. If, as a result of agency NEPA consideration of the PFS Low Junction rail spur in this proceeding, the PFS proposal is implemented in a way that is not inconsistent
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with SUWA's asserted interest in the land, then SUWA has won all it can expect from this proceeding and its potential injury has been redressed. We thus find the redressability requirement is not a bar to SUWA's representational standing.
Finally, we do not find convincing the PFS and Staff assertion that Dr. Catlin l has not shown sufficient contacts with the Low Junction rail corridor to establish !
a personal injury. Dr. Catlin, as was noted above, indicated in his affidavit that he had " frequently visited, used, and enjoyed" the area and planned to do so
" frequently in the future." As used in this context, the root term " frequent" is defined in the dictionary as meaning " habitual" or " persistent." Webster's Third New International Dictionary 909 (unabr.1976). While Dr. Catlin could have been more specific about the number of times he has traversed and otherwise I used (and plans to use) the Low rail corridor lands in question,7 his adoption of the term " frequently" in this context demonstrates that his bond with the area is sufficiently concrete to establish his standing and, consequently, that of his representative SUWA.
7 In ttus connectmn. we are considerably less concerned about precision regar&ng a standmg shommg that is based on actual physical contact 0 e.. julung, camping, etc.) with the object of the purported mjury, in tius case the low Juncimn ruil corndor, than we would be for a stanang showing based on & stance imm the object in question (Le. reside "x" nules from the facihtyt An ongenng presence via physical contact can be alrquately conveyed with a gercral term such as " frequently
- General references regar&ng & stance. however, will usually he inadequale to estabhsh the requisite concreteness see Atlas Corp. (Moab. Utah Tw;ihty). LEP-97-9,45 NRC 414. 426-27. af'd. CLI-97-8. 46 NRC 2I (1997) 52 l
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i Because we find that SUWA has established it has representational standing as of right, we need not reach the question of whether it should be admitted as a matter of discretion.8 i
C. SUWA Contentions SUWA A CONTENTION: The License Application Anendment fails to consider adequately the impacts of the tow Corridor Rail Spur and the associated fire buffer rene on the wilderness character and the potential wilderness designation of a tract of roadless Bureau of Land Management (BLM) land - the North Cedar Mountains - which it crosses. SUWA has deternuned, aAer significant analysis, that the North Cedar Mountains quahfies for and should he designated as wikierness under the Wilderness Act of 1964 and therefore should be preserved in its cunent natural state until the United States Congress has an opportumty to l evaluate the land for wilderness designation.
DISCUSSION: SUWA Contentions at 2-5; PFS Response at 18-23; Staff Response at 20-24; SUWA Reply at 11-14; Tr. at 1132-33,1136-41,1143-48, 1151-54, 1155-56.
RULING: Inadmissible in that this contention and its supporting bases lack adequate factual or expert opinion support; and/or fait properly to challenge the PFS application, as amended.
sUwA a l
CONTENTION: The License Apphcation Anzndment fails to develop and analyze a I meaningful range of alternatives to the Low Corridor Rail Spur and the associated fire buffer tone that will preserve the wilderness character and the potential wildemesa designation of a tract of roadless Bureau of Land Management (BLM) land -the North Cedar Mountains
- which it crus,ses.
DISCUSSION: SUWA Contentions at 5-6; PFS Response at 23-25; Staff Response at 24-25; SUWA Reply at 14-15; Tr. at 1133-35,1141-43,1148-51, i154-55. 1 RULING: As it seeks to explore the question of alignment alternatives to l the proposed placement of the Low Junction rail spur, admissible in that the l contention and its supporting basis are sufficient to establish a genuine dispute j adequate to warrant further inquiry.
8 We note, however, that given SUWA's showing of its strong, persistent concern for the local environnent, l
SUWA would be a much stronger candidate for discretionary staneng than penuoner Scientists for Secure Wasie '
Storage, a group we earher &sminned from ttus proceeding for havmg failed to estabhsh its stamhng as of nght or its eligsbihty for escretionary stan&ng See LBP-98-7,47 NRC at 175 78.
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II Ilh CONCLUSION '
Ihr the reasons given above, we find that Petitioner SUWA has established
. (1) its intervention petition should be entertained under a balancing of the late-filing criteria set forth in 10 C.F.R 12.714(a)(1); (2) it has representational standing as of right; and (3) it has proffered an admissible contention - SUWA B. Accordingly, SUWA is admitted as a party to this proceeding.
- For the foregoing reasons, it is, this third day of Ibbruary 1999. ORDERED, 1, 'Ihe November 18,1998 SUWA hearing request / intervention petition is i
Branted and SUWA is admirred as a party to this proceeding.
- 2. SUWA contention SUWA A is rejected as inadmissible for litigation in this proceeding.
j 3.- SUWA contention SUWA B is admitted for litigation in this proceeding and shall be considered as a Group III contention under the general schedule j
L for this proceeding, as revised on December 28,1998.
- 4. In accordance with the provisions of 10 C.F.R. 5 2.714a(a), as it rules ;
upon an intervention petition, this Memorandum and Order may be appealed to the Commission within 10 days after it is served.
THE ATOMIC SAFETY AND LICENSING BOARD' G. Paul Bollwerk,111 l
ADMINISTRATIVE JUDGE
{
]
Jerry R. Kline ADMINISTRATIVE JUDGE Peter S. Lam ADMINISTRATIVE JUDGE Rockville, Maryland Itbruary 3,1999
' Copies or this Menurandum and order were sent this dam by Internet e-nuut transnunnion to counsel for (1) de Appucant PFS,(2)Intervenors Skull Valley Band, oGD, Confederated Tribes. Castle Rock L.and and Livestock.
LC1 Skull Vahey Company. LJd., and the State;(3) Petitioner SUWA; and (4) the Staff.
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T Cite as 49 NRC 55 (1999) LBP-99-4 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD Before Adminletrative Judges:
Charles Bechhoefer, Chairman Dr. Jerry R. Kline Dr. Peter S. Lem in the Matter of Docket No. IA 97-068 (ASLBP No. 97-73101-EA)
(Order Superseding Order Prohibiting involvement in NRC-Licensed Activities (Effective immediately))
AHARON BEN-HAIM, Ph.D.
(Upper Montclair, New Jersey) February 8,1999
. The Atomic Safety and Licensing Board affirms, with modifications, an immediately effective Staff enforcement order, sustaining most of the substantive assertions of the order but reducing the proposed suspension from NRC-licensed activities from 5 years to 3 years and retaining other ancillary relief sought by the Staff, such as reporting requirements for future involvement in NRC-licensed activities.
ENFORCEMENT ACTIONS: UNLICENSED INDIVIDUALS Under 10 C.F.R. I 30.10, any contractor to a licensee, including a supplier or consultant, who knowingly provides to any licensee information or other things, may not engage in deliberate misconduct that causes or would have caused, if not detected, the licensee to be in violation of any NRC rule, regulation, order, or license condition.
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1 ENFORCEMENT ACTIONS: DELIBERATE MISCONDUCT ,
Deliberate misconduct means an intentional act or omission that the person - l knows would cause a licensee to be in violation of any NRC rule, regulation.
- order, or license condition. Deliberate is the same as intentional and does not include careless disregard.
REGULATIONS: CONTROL OF RADIOACTIVE MATERIAL l NRC regulations under 10 C.F.R. Part 35 require a byproduct materials licensee to appoint both a Radiation Safety Officer (RSO) and an Authorized ;
User, each with defined duties and responsibilities. An RSO or Authorized User may delegate the authority to carry out those duties and responsibilities but not the responsibility for ensuring that they are carried out.
REGULATIONS: CONTROL OF RADIOACTIVE MATERIAL A licensee must apply for and receive a license amendment before it changes RSOs.
I REGULATIONS: CONTROL OF RADIOACTIVE MATERIAL NRC regulations under 10 C.F.R. Part 35 require that a byproduct material licensee retain a record of the measurement of each dosage, includ:ng prescribed I dosage, of a photon-emitting radionuclide prior to medical use. Part 35 further I i requires a written directive, or explicit prescription, any time a dose of I-131 exceeding 30 microcuries is to be administered to a patient; or for any therapeutic l administration of a radiopharmaceutical. These activities must be performed by an Authorized User or designee.
ILNFORCEMENT ACTIONS: UNLICENSED INDIVIDUALS j (SANCTIONS); DELIBERATE MISCONDUCT (SANCTIONS) l 'Ihe Enforcement Policy, NUREG-1600, is NRC's policy for exercising its .
L authority to take action to enforce its regulatory requirements. The particular I sanction is determined on a case.by-case basis and involves discretion, based on specified factors that do not necessarily carry equal weight. Willful violations are of particular concern.
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E hPPEARANCES Aharon Ben.Hains, Ph.D., Montclair, New Jerey. pro se. assisted during prehearing phases by Everett van Kampen, Esq., Fairlawn, New Jersey.
Ann P. Hodadon, Esq., and Catherine L Marco, Esq., for the Nuclear
- Regulatory Commission Staff.
1 TABLE OF CONTENTS
)
OPINION (INCLUDING FINDINGS OF FACT) ...... ... . ...... 58
- 1. BACKGROUND AND INTRODUCTION . . . . . . . . . . . . . . . . 58 II. FINDINGS OF FACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 A. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... 60 B. The Staff's Order ......... ..-.. ... ..... ......... 61 C. Witnesses ....... ....................... ... ... 62 D. - The Licensee. Newark Medical Associates ..... . . 63 )
E. The NRC Inspection and Subsequent Licensing Actions . . 63 F. The 01 Investigation ....... ........... ..... ..... 65 G. The August 27.1997 Order . . . . ..... . . . . . . . . 65
- 11. Common Factual Findings . . . . . .. ... .. ....... . 66
- 1. The RSO Violation . . . . . . . . . . . . . . ... .... .. . 76
- 1. NRC Requirements . . . . . . . . . . . . . ...... . .. 76
- 2. Staff Claims . . . . . . . . . .................. .. 78
- 3. Staff Analysis . .... .... ................ ... 82
- 4. Summary of Findings ............ .. .... 83 J. The Authorized User Violation .. ....., .......... .. 83
- 1. NRC Requirements . . . . . . . . . . . . . . . . . . . . . . . 83
- 2. Performance by Dr. Ben-Haim of Functions of Authorized User . ................ .... ... .. 86
- 3. Board Analysis .. .. ................ . ..... 92
- 4. Summary of Findings on Authorized User Violation . 96 K. The Appendix K Violation . . . . . . . . . . . . . . . . . . . . . . . 96 111. SANCTION IMPOSED ...... ... . .. .........98 IV. CONCLUSIONS OF LAW . . . . . . . . . . . . . . . . . . . . . . . . . 104 V. ORDER .... ....... .... .. .. .. .... . . . .. ... 105 57
F-INITIAL DECISION (AfBrming Enforcement Order, with Modifications)
Opinion (Including Findings of Fact)
This proceeding involves the challenge of Aharon Ben-Haim, Ph.D., to the August 27,1997 " Order Superseding Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately)" (Order), issued by the Staff of ;
the Nuclear Regulatory Commission (Staff). 62 lid. Reg. 47,224 (Sept. 8, 1997). The Order prohibits Dr. Ben-Haim from any involvement in NRC-
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i licensed activities for 5 years from July 31,1997. ld. at 47,225. It also imposes various ancillary relief, including reporting requirements for future permitted j activities, l
Ihr the reasons described herein, we sustain most of the substantive assertions j of the Staff's Order. In particular, we conclude that Dr. Ben-liaim deliberately caused the Licensee, Newark Medical Associates (NMA), to be in violation of several of the Commission's requirements. We also conclude that the proposed 5-year prohibition against Dr. Ben-Haim is more severe than is warranted, taking into account all the facts and circumstances before us. We accordingly are modestly adjusting the length of the suspension, although retaining the other aspects of relief included in the Order.
I. BACKGROUND AND INTRODUCTION 1
I The Staff's August 27,1997 Order superseded in its entirety an order issued to Dr. Den-Haim on July 31, 1997. See " Order Prohibiting involvement in NRC-l. censed Activities (Effective Immediately) Pending Further Order," 62 Ivd. *hg 43,360 (Aug.13,1997). On August 19,1997, Dr. Den-Haim filed an ans! cr ta 6e initial order in which he requested a hearing and sought rescission of the immediate effectiveness of the order. Letter from Dr. Aharon Ben-Haim to Edward Jordan, Deputy Executive Director for Regulatory Effectiveness, dated August 19,1997. On September 8,1997, the Staff responded to Dr. Ben-Haim's answer to the initial order, treating it as applicable to the Superseding Order.
"NRC Staff's Response to Request to Set Aside immediate Effectiveness of Order Superseding Order Prohibiting involvement in NRC-Licensed Activities,"
dated September 8,1997.
On August 25,1997, this Atomic Safety and Licensing Board (Board) was established to preside in this proceeding. 62 Fed. Reg. 46,381 (Sept. 2,1997).
On September 11, 1997, we issued a " Memorandum and Order (Granting Request for Hearing and Scheduling Prehearing Conference)," in which we granted Dr. Den-Haim's request for a hearing and scheduled a prehearing 58
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conference to hear oral argument on the rescission of the immediate effectiveness of the Order and to establish hearing schedules. On September 15,1997, we issued a Notice of IIcaring. 62 Fed. Reg. 49,260 (Sept.19,1997).
At the September 18,1997 prehearing conference, we orally ruled to uphold the immediate effectiveness of the Order, based on the criteria set forth in 10 C.F.R. 5 2.202(c)(2)(i). Tr. 36. This ruling was memorialized by our Prehearing Conference Order (Denying Rescission and Establishing Schedules),
dated September 25,1997, LBP-97-15,46 NRC 60.
On September 30,1997, the Staff filed "NRC Staff's Motion for Delay of Proceeding" at the request of the United States Department of Justice (DOJ). The Staff's motion for a 120-day delay of the proceeding was based on the pendency of a criminal investigation concerning allegations of possible violations of federal criminal law by Newark Medical Associates (NMA), its owners and employees, including its consultant, Dr. Ben-liaim. The Staff's motion was supported by an affidavit from an Assistant United States Attorney in tne United States Attorney's Office for the District of New Jersey. By letter dated October 15, 1997 Dr. Ben-liaim offered no opposition to the Staff's motion.
By Memorandum and Order (Staff's Motion for Delay of Proceeding), dated October 22,1997, LBP-97-18, 46 NRC 234, we granted the Staff's motion, staying the proceeding for 120 days, until January 28,1998, and setting forth procedural requirements for further extension of the stay.
On January 28,1998, the Staff informed the Board that it would not seek to I extend the stay, based on DOJ's advice that, although a related investigation was I still continuing, it was not in the best interest of the government to extend the delay.8 On March 2,1998, after seeking a proposed schedule from the parties, '
we issued a " Memorandum and Order (Schedules for Proceeding),"in which we established a discovery and a hearing schedule. In accordance with that schedule, litigation went forward, with the filing of interrogatories and document requests, i and deposition discovery. Prior to the hearing, by Notice of Evidentiary Hearing dated April 20,1998,63 lbd. Reg. 20,434 (Apr. 24,1998), we set forth a number of technical hearing requirements, including the prefiling of lists of witnesses and documents to be utilized and the statements of qualifications of the parties' expert witnesses. Prior to the hearing, we also held several telephone prehearing conferences with the parties.
To assist the Board in developing an adequate record at the hearing, the Licensing Board, pursuant to 10 C.F.R. 5 2.722(a)(1), appointed Administrative Judge liarry Rein, who has expertise as a medical doctor, as its Special Assistant, to serve as a technical interrogator. 63 Ibd. Reg.18,458 (Apr.15,1998). 'lhe 8
0n April 23,1998. the Statiinforned the Board, as well as Dr BemHaim. that DOJ dechned prosecution in the matter of Newsk Medical Ainociates. The Doj had directly informed Dr Ben 41.um that he was not an investigative " target" by letter dated March 20,1998. Eth. BH 12.
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evidentiary hearing was held in Newark, New Jersey, from May 27,1998, to May 29,1998. Following the public hearing, on June 4,1998, the Board issued a
" Memorandum and Order (Telephone Conference,6/3/98; Proposed Findings),"
in which, to accommodate the schedule of Dr. Ben-liaim, we established August 14,1998, as the date by which the Staff would file its proposed findings; August 31,1998 (later extended until September 8,1998, at Dr. Ben-Haim's request),
as the date by which Dr. Ben-Haim's findings must be filed; and September 11, 1998 (later extended to September 21,1998, to accommodate Dr. Ben-Haim's extension), as the date for the Staff to file its reply findings. All proposed findings were timely filed.
II. FINDINGS OF FACT A. Introduction In setting forth our findings of fact in this proceeding, we must note first that Dr. Ben-Ilaim did not submit a conventional type of proposed findings, setting forth matters of record tending to prove his claims. Instead, he admitted three of the facts on which the Staff's proposed violations were founded. He further accepted " responsibility for his wrongdoing." He assured the Commission that "he will conduct license activities safely in the future" and expressed thanks to the NRC Staff for its professional handling of his case. He expressed his apology to Dr. Magdy Elamir, President of NMA, for having caused NMA to be in violation of NRC regulations. Finally, he sought to have his proposed findings considered as "a showing of cause to relax the order against" him.
('Ihe proposed findings were not signed.)
The Staff in its reply notes that Dr. Ben-Haim in his proposed findings does not dispute any of the findings set forth by the Staff. In these circumstances, we could, except with respect to the relief sought, adopt all of the Staff's Proposed Findings. The Staff further claims that Dr. Ben-Haim provides no support for his request that the penalty be relaxed (NRC Staff's Findings in Response to Dr. Ben-Haim's Proposed Findings, dated September 16,1998, at 2).
Because of the nature of Dr. Ben-Haim's Proposed Findings, we are adopting many of the Staff's Proposed Findings, subject to editing. But our obligation, of course, is to consider the entire record and not merely the content of various parties' proposed findings. See 10 C.F.R. 6 2.760(c) and, in particular, (c)(1).
Our findings reflect these requirements.
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i B. The Staff's Order The violations upon which the Superseding Order are based are set forth as follows (62 Fed, Reg. at 47,225):
10 CTR 30.10(aXI), (cXI) and (cX2) require, in part, that any contractor of a licensee not engage in deliberate misconduct that causes or, but for detection, would have caused, a licensee to be in violation of any rule, regulation, or order, or any term, condition, or limitation of any ;icense issued by the Commission; or any requirement, procedure, instruction, contract, purchase order or policy of a licensee.
- 1. 10 CFR 35.21 requires that a licensee appoint a Radiation Safety Officer responsible for implenenting the radiation safety program; and requires that the licensee, through the Radiation Safety Officer, ensure that radiatio's safety activities are being performed in accordance with approved procediares and regulatory requirements in the daily operation of the licensce's byproduct material program.
10 CFR 35.13 requires that a licensee apply for and receive a license anendnent before it changes Radiation Safety Ofhcers.
flyproduct Material License No. 29-30282-01, Condition 12 dated September 25,1996 states that the Radiation Safety Officer for this License is Gerard W. Moskowitz, M.D.
During the penod from November 1996 through Ibbruary 6,1997 Dr. Ben-Haim caused l Newark Medical Associates to be in violation of the requirements in Section III,A.1 above by performing the functions of the Radiation Safety Officer (RSO), even though he knew l that: (1) the RSO named on the license application and, subsequently, on the license, was I Gerard Moskowitz, M.D., and (2) he, Dr. Pen-Haim, was not the RSO named on the license application or the license.
- 2. 10 CFR 35.ll(a) and (b) permit an individual to use hcensed material for medical use only in accordance with a specific license issued by the Commission or under the supervision of an authorized user as provided in 10 CFR 35.25.
10 CFR 35.53(cX3) requires,in part, that the licensee retain a record of the neasurement of each dosage of a photon-emitting radionuclide prior to medical use to include, among other things, the prescribed dosage. Pursuant to 10 CFR 35 2: " Prescribed dosage" means the quantity of radiopharmaceutical activity as documented in a written directive or diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user; " Written directive" means an order in writing for a specific patient dated and signed by an authorized user; " Diagnostic clinical procedures manual" means a collection of written procedures that includes, among other things, where cach diagnostic pmcedure has been approved by ti.e authorized user and the radiopharmaceutical, dosage, and route of administration; and " Authorized user" neans a physician, dentist, or podiatrist who is (1) flourd certified by at least one of the boasds listed in Paragraph (a) of 10 CFR Part 35, sections 35.910, 35 920, 35.930, 35.940, 35 950, or 35 960, (2) identified as an authorized user on a Commission or Agreement State license that authorizes the nwdical use of byproduct material. or (3) identified as an authorized user on a permit issued by a Commission or Agreement State specific license of broad scope that is authorized to permit the medical use of byproduct material.
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Byproduct Malerial 1 lanse No. 29-30282-01, dated September 25,1996, states in Condition 13 that licensed matenal is only authonzed for use by, or under the supervision of, Gerard {
J W. Moskowitz, M.D.
Dyproduct Material Lianse Ne, 29-30282-01, dated September 25,1996, naquires in part.
in Condition 14, that the hcensee condact its program in accordance with the statenents,
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re preacntations, and procedures contamed in the Application dated Ibbruary 21,1996. This '
application, which was prepared by Dr. Ben-Haim, requires, in Item 10.6, **Ordenng and Receiving", that the beenhee follow procedures in Appendis K to Regulatory Guide 10.8, Revision 2. The procedures in Appendix K require, in part, that the Radiation Safety Officer 1
or a designee must authorize cach order for radioactive materials and ensure that the requested materials and quantities are authorized by the license for use by the requesting authorized
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user.
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During the period from November 19% through fthruary 6,1997, Aharon Ben-Haim, who is not a physician, caused Newark Medical Associates to be in violation of the requirements '
in Section Ill.A.2 above by prescribing, in writing, the radmpharmaceuticals and dosages to be ordered and administered to patients by technologists for bone scans and cardiac images (which are nedical uses), even though he knew that: (1) he was not an authonzed user nor under the supervision of an authonzed user; (2) he had prepared the Newark Medical Associates license application to specify the name of Gerard Moskowitz as the sole physician authorized user and Radiation Safety Officer; (3) Gerard Moskowitz, as the sole physician user named on the hcense, was the only individual who could presenbe a radmpharmaceutical and dosage for a technologist to administer to a patient; and (4) Gerard Moskowitz, as the Radiation Safety Officer named on the bcense, was the only individual w ho could authorize, or delegate to a technologist the authority to authorize, each order of byproduct material for nedical use.
1 C. Witnesses At the request of Dr. Ben-Haim, the parties were not required to use prefiled direct testimony of their witnesses but were permitted to present oral direct testimony, Both of them did so (although the Staff elected to file prepared testimony for one of its witnesses, Mr. R. Joseph DelMedico, ff. Tr. 659,2 and Dr. Ben-Haim elected to have his own prepared statement bound into the record as if read, ff, Tr. 786). All parties were required to prefile the statements i of qualifications for each of their expert witnesses. Memorandum and Order (Schedules for Proceeding), dated March 2,1998; Memorandum and Order (Telephone Conference, May 12,1998), dated May 13,1998.
In support of its Order, the Staff presented the testimony of nine individuals:
(1) Richard Gibson, Jr., the NRC Staff inspector who had conducted an inspection of NMA in January 1997 (Qualifications, ff. Tr. 73); (2) John D.
Kinneman, Chief of Nuclear Materials Safety Branch 2, Region I (Qualifications, ff. Tr. 75); (3) Dr. Barry Siegel, Professor of Radiology and Medicine / Director, 2
Citations to transynpts of the evidenuary heanng reflect corrected versions of thme transenpts 62
Division of Nuclear Medicine, Mallinckrodt Institute of Radiology, Washington University School of Medicine (Qualifications, ff. Tr. 358); (4) Ernest P.
Wilson, Senior Special Agent, Office of Investigations, Region I (Qualifications, ff. Tr. 516); (5) William J. Davis, Special Agent, Office of Investigations, Region I (Qualifications, ff. Tr. 540); (6) Dr. Gerard W. Moskowitz, the individual listed on NMA's license as the Radiation Safety Officer (RSO) and Authorized User (Qualifications, ff. Tr. 215); (7) Lubica Smoligova, an MRI technologist who ordered radiopharmaceuticals for NMA; (8) Marina Geylikman, a nuclear medical technologist who performed bone scans for NMA; and (9) R. Joseph DelMedico Senior Enforcement Specialist, Office of Enforcement (OE) (Qualifications, ff. Tr. 659).
Dr. Ben-Haim presented himself as a witness (Qualifications, B-H Exhs.
5-11). In addition, witnesses Marina Geylikman, Lubica Smoligova, and Dr.
Moskowitz had been designated as witnesses for both Dr. Ben-Haim and the Staff. See Memorandum and Order (Telephone Conference, May 12, 1998),
dated May 13,1998, at 3.-
D. The Licensee, Newark Medical Associates
- As of the date of hearing in this matter, Newark Medical Associates (NMA) was the holder of an NRC byproduct materials license issued on September 25, 1996. Tr. 77 (Gibson); Staff Exh.1 (NRC Materials License No. 29-30282-01).2 he license authorized the possession and use of byproduct material for imaging and localization procedures conducted at NMA's facility located at 810 Broad
. Street, Newark, New Jersey 07102. Staff Exh.1.
NMA's President, Dr. Magdy Elamir, signed NMA's February 21, 1996 application for its NRC license. Staff Exh. 2 (NRC Form 313, Application for ;
Material License, dated February 21,1996); Tr. 80 (Gibson). The license listed '
Gerard W. Moskowitz, M.D., as both the RSO and the Authorized User. Staff Exh.1,1112,13; Tr. 78 (Gibson).
E. 'Ihe NRC Inspection and Subsequent Licensing Actions i Mr. Richard Gibson conducted an inspection of NMA in Newark, New Jersey, in early 1997. It was an initial inspection of a new licensee. Tr. 77 (Gibson). ,
De purpose of the inspection was to assess the Licensee's compliance with the regulations and with the license conditions. Tr. 85 (Gibson). See also Staff Exh.
10 (Inspection Report No. 030-34086/97-001, dated September 5,1997).
3 As part of the setdenent of a companion cane. Dr. Magdy Elanur. President of NMA. agreed that NMA would rehnquish and surrender its byproduct materials hcense to the NRC. Magdy Dama. M D, (Newark, New Jersey).
LBP-98-2s 48 NRC 226 (1998L 63 l.
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Prior to the January 29,1997 inspection, Mr. Gibson contacted the Licensee and spoke with Dr. Elamir. Mr. Gibson informed Dr. Elamit that he would bc l conducting an initial inspection and would like to meet with him or the RSO, Dr. Moskowitz. Dr. Ben Haim met inspector Gibson at the facility, and neither Dr. Elamir nor Dr. Moskowitz was there. Dr. Ben Haim advised Mr. Gibson that the Licensee normally conducts work on Saturdays and that Dr. Elamir had asked him to meet with Mr. Gibson at the inspxtion (which took place on a Wednesday). Tr. 86-87 (Gibson).
Following the inspection,' Mr. Gibson telephoned Dr. Moskowitz and in-l formed him about the inspection. Mr. Gibson reported that Dr. Moskowitz advised that he was not aware that he was listed as the RSO and Authorized User for NMA; that he was never at that facility; that he had not performed any of the responsibilitics of the RSO; and that he had not given his consent to be the RSO and Authorized User for NMA. Tr. 87-88 (Gibson).
A Confirmatory Action Letter (CAL) was issued to NMA on &bruary 6,1997, following Mr. Gibson's conversation with Dr. Moskowitz. He CAL documents NMA's 4,reement to immediately discontinue activities with byproduct material until such time as an amendment was filed and granted naming a new RSO and Authorized User. Tr. 89 (Gibson); Staff Exh. 4.
The CAL also provided that Dr. Den-Haim, NMA's consultant, would audit all aspects of the radiation safety program to determine compliance with NRC requirements and conditions of the license. Tr. 96 (Gibson); Staff Exh. 4.
Dr. Ben-Haim responded to the CAL by letter on Rbruary 14,1997, stating that he performed an audit of the setup and operations at NMA. Dr. Ben-Haim, in the letter, further stated that twenty-seven patients had received bone scans, that only Tc-99m MDp single doses of 25 mci had been ordered for bone scans, and that the date of the first delivery was October 19,1996. "R. 96 (Gibson);
Staff Exh. 5.
On February 6,1997, the same day as the CAL had been issued, NMA submitted a license amendment application to change the RSO and Authorized User on the license from Dr. Moskowitz to Dr. Romolo Maurizi. NMA also sought to add Dr. Ricardo Baldonado as an additional Authorized User. Tr. 96-
. 97 (Gibson); Staff Exh. 6. On February 7,1997, the Staff issued an amended license (Materials License Amendment No. 01), listing Dr. Maurizi as RSO and Authorized User. 'h.101-02 (Gibson); Staff Exh. 7.4 4
Tlw license amendnwns did not hst Dr. Baldonado as an additional Authorized Uner inanmuch as Dr Baldonado was a nedical doctor who already was an Auttunized User at another facihty and could act in that capacity at any facility. so lung as the facihty license listed at least one Autherned User of its own. Tr.103 (Kinneman).
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F. The 01 Investigation j
Special Agent Ernest P. Wilson, as part of his duties, conducted an investi-gation of NMA that originated from an allegation concerning the identification of the RSO and Authorized IJser at NMA. The case was initiated on Ibbruary 11, 1997, and the Report of Investigation (01 Report) was issued on July 23, 1997 Tr. 517 (Wilson); Staff Exh. 8 (OI Report, " Newark Medical Associates, P.A.: False Statement in License Application Concerning the Identification of the RSO and Authorized User," dated July 23, 1997). Special Agent William J. Davis assisted in the investigation. Tr. 519 (Wilson),541 (Davis).
As part of the investigation, many documents were reviewed and individuals interviewed, including Dr. Ben-Haim, Ms. Geylikman, Dr. Moskowitz, and Ms.
Smoligova. 'Iir. 517-19 (Wilson). In the 01 Report, which included thirty exhibits, Of concluded that Dr. Elamir and Dr. Ben-Haim both deliberately provided false information to the NRC in NMA's license application and that, after the license issued NMA operated in deliberate violation of its license. Tr.
522,537 (Wilson); Staff Exh. 8, at 23.
G. - The August 27,1997 Order he Staff's Order asserted that from November 1996 through libruary 6, 1997, Dr. Ben-Haim, in his role as contractor-consultant to the Licensee, NMA, aided and assisted the Licensee in continuing to conduct NRC-licensed activities even though NMA did not employ the Authorized User or the RSO named in the license application and on the NRC license, and the named individual did not serve in these capacities. 62 Fed. Reg. 47,224 (Sept. 8,1997). He Order stated that Dr. Ben.Haim's actions constituted violations of 10 C.F.R. 530.10
" Deliberate misconduct." /d. at 47,225.
The Order provides that Dr. Ben-Haim violated 10 C.F.R.130.10 by two ;
types of conduct: First Dr. Ben-Haim caused NMA to be in violation of the Commission's requirements by performing the functions of the RSO even though he knew that the RSO on the license application and the license was not Dr. Ben.
Haim but, rather, Dr. Gerard Moskowitz (hereinafter, RSO Violation). Second, l
Dr. Ben-Haim caused NM A to be in violation of the Commission's requirements by prescribing, in writing, the radiopharmaceuticals and dosages to be ordered and administered to patients by technologists for medical uses even though he knew that only Dr. Moskowitz could authorize or delegate the authority to authorize the ordering of byproduct material for medical uses (Authorized User Violation). The Order also provides that Dr. Ben-Haim caused NMA to be in violation of Appendix K of the license, which sets forth requirements regarding the ordering of radiopharmaceuticals. Id.
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As a result of these actions, the Staff concluded that Dr. Ben-Haim deliber-ately caused the Licensee to be in violation of NkC requirements. De Staff did not believe that, if Dr. Ben-Haim were permitted to be involved in NRC-licensed activities, reasonable assurance would exist that licensed activities could be con.
ducted in compliance with the Commission's requirements and that the health and safety of the public would be protected. Therefore, the Order concluded that public health, safety, and interest required that Dr. Ben-liaim be prohibited l from any involvement in NRC-licensed activities for 5 years. Id.
l Re Order further provides that the prohibition is applicable to Dr. Ben-Haim as an officer, employee, contractor, consultant, or other agent of a licensee and includes, but is not limited to: (1) any use of NRC-licensed materials; (2) l supervising licensed activities, including (but not limited to) hiring of individuals !
engaged in licensed activities or directing or managing individuals engaged in l licensed activities; (3) any involvement in radiation safety activities including (but not limited to) functions of an RSO; and (4) development of license )
applications, procedures and policies to meet license requirements, providing training to meet license requirements, and providing professional services to !
meet license requirements. 62 Fed. Reg. at 47,225-26.
He Order, among other things, additionally requir:s Dr. Ben-Haim to notify the NRC within 20 days of engaging in NRC licensed activities following his j 5-year prohibition of the name of the NRC or agreement-state licensee and i h> cation where licensed activities will be performed. This notification period runs for 5 years following Dr. Ben-Haim's resumption of licensed activities. Id.
at 47,226.
H. Common Factual Findings i Several factual findings are common to both of the categories of alleged vmlations. Principal among these are: (1) Dr. Den-Haim was a consultant to NMA; (2) Dr. Ben-Haim prepared the license application; (3) Dr. Moskowitz l never performed the role of RSO or Authorized User at NMA; and (4) Dr. Ben- !
Haim knew Dr. Moskowitz was not performing the role of RSO or Authorized User at NMA. The Board, therefore, addresses these findings first.
- 1. Dr. Ben-Haim was a consultant to NMA. He testified that he was an
! outside consultant to NMA (Tr. 787, 790), that he had known Dr. Elamir for about a week before becoming a consultant for NMA, and that he had far greater knowledge about nuclear materials than Dr. Elamir. Tr. 850-51.
Dr. Ben-Haim wrote a proposal to Dr. Elamir for his services on Ibbruary 15, 1996, and delivered it to Dr. Elamir in person. The proposal stated that
"[wle offer to obtain on your behalf in the shortest possible time your State and Federal Material Licenses" (with the term "we" referring to Dr. Ben-Haim). Tr.
821 (Ben-Haim); Staff Exh. 8,01 Exh. 7 at 1.
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The proposal also provided that "we will install your Hot Laboratory and establish the necessary Radiation Health procedures." Tr. 821 (Ben-Haim); Staff Exh. 8. 01 Exh. 7 at 1. Dr. Ben-Haim verified that the proposal stated that "we will prepare for State and NRC inspections," and "[w]e will assure continuous monitoring of the Laboratory in compliance with the regulations of the Nuclear Regulatory Commission." Tr. 822; Staff Exh. 8, O! Exh. 7 at 1.
The proposal also provides that:
We will train your staff, assist you in staffing requirements, perform all equipment tests.
such as Dow Calitrator constancy. accuracy. and hnearuy. assure that proper procedures are used in the handling of radioactive material. etc.
Staff Exh. 8. 01 Exh. 7 at 1; Tr. 822 (Ben-Haim). Significantly, the proposal did not offer to obtain the services of an RSO or Authorized User for NMA but only to " assist you in staffing requirements."
On February 20,1996, Dr. Ben-Haim and Dr. Elamir entered into a contract that provided, among other things, for Dr. Ben-Haim to supervise the NMA staff "in all aspects related to the safe use of radioisotopes" and to prepare NMA's NRC license. Staff Exh. 8, O! Exh. 7 at 2.
Based on the foregoing evidence, we find that Dr. Ben-Haim was NMA's consultant for the preparation of NMA's rnaterials license and for ensuring the safe use of radioactive material and compliance with the Cornmission's i
requirements. We also find that Dr. Ben-Haim held himself out to be well
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versed in the Commission's requirements and that he knew specifically that Dr. 1 Elamir did not have extensive knowledge in this area. Indeed, Dr. Ben-Haim's knowledge of the safe use of radioactive materials and understanding of the Commission's requirements were instrumental in his securing the consultantship l with NMA.
- 2. Dr. Den-Haim prepared the NRC heense application for NMA. Tr. 820, 823 (Ben-Haim); see Staff Exh. S-2. He testified that he is familiar with Form 313, Application for Materials License, that it is a one-page form, and that he filled out such a form for NMA. He also indicated that he prepared the supplemental pages that go with the form. ". 823-24 (Ben-Haim).
Dr. Ben-Haim acknowledged that the RSO and Authorized User in the license application was Dr, Moskowitz and only Dr. Moskowitz. Tr. 826. See Staff Exh.
'2. Dr. Ben Haim's testimony in this regard is consistent with that of Special Agent Wilson, who testified that Dr. Ben-Haim told the 01 investigators that he prepared the application and all the correspondance and required paperwork that needed to be submitted to the NRC. Tr. 527 (Wilson); see also Staff Exh.
l 8, OI Exh. 22 (interview of Dr. Ben-Haim). We reiterate that, as we previously found, the license issued to NMA to possess byproduct material provided that the RSO and Authorized User was Gerard W. Moskowitz. M.D. Staff Exh 1.
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i Dr. Ben-Haim was experienced in preparing NRC materials license appli-cations. IIe testified that he had experience with the NRC's regulations and considers them important in his consultant work; that he had experience in preparing NRC license applications; that he prepared five or so license applica-tions before preparing NMA's application; and that he knows what needs to go into an NRC license application. Tr. 820-22 (Ben-Haim). lie further testified that he makes it a practice to know the regulations and knew a licensee must have an RSO and an Authorized User. Tr. 823 (Ben-liaim).
Dr. Ben-liaim knew he could not be NMA's RSO. On May 3,1995, NRC Region I sent a letter to Dr. Ben-Haim, owner of Servicing Imaging Systems International, in response to an application for a byproduct materials license. Tr.
281 (Kinneman); Staff Exh.11. The letter stated that the submitted qualifications of Dr. Ben-Haim did not appear to satisfy the regulatory requirements at 10 C.F.R. 9 35.900 for him to be an RSO. The letter concludes: "Please submit evidence that Dr. Ben-Haim has completed the required training and experience.
If Dr. Ben-Haim has not, we recommend that you withdraw your request and reapply at a later date when a sufficient number of hours has been obtained."
Tr. 282 (Kinneman), Staff Exh. I1.
Mr. Kinneman testified that the Staff searched for files to assess whether Dr.
Ben-liaim had provided additional information and could not find any. As a result of the search, the Staff concluded that Dr. Ben-Haim had not submitted information that indicated that he meets the RSO requirements of 10 C.F.R.
5 35.900. Tr. 284-85 (Kinneman).
Based on the foregoing evidence, we find that Dr. Ben-Haim was experienced in preparing NRC license applications and prepared NMA's license application, including the supplemental information. The application provided that the RSO and Authorized User was Dr. Moskowitz and the license, which was based on the application, so specified. It is clear that Dr. Ben-Haim knew that Dr.
Moskowitz was NMA's only named RSO and Authorized User. Further, Dr.
Ben-Haim knew that he could not be NMA's RSO because the NRC had found his 1995 application to be an RSO to be deficient.
- 3. Dr. Moskowitz never performed the role of RSO or Authorized User at NMA. He testified that he did not know anything about NMA until libruary 6, 1997, when Mr. Gibson contacted him and he became aware that his name had been used in NMA's license application and subsequently on the license. Tr.
216, 223-24, 257 (Moskowitz); see Tr. 88 (Gibson). Dr. Moskowitz asserted that he was very concerned when contacted by Mr. Gibson and, in fact, that he was " horrified about the whole thing." 'h. 225. "It's like someone taking j my medical license, putting it on their wall, practicing medicine with my name and my license ." Tr. 224-25 (Moskowitz). When asked whether he ever delegated to Dr. Ben-liaim the duties of RSO and Authorized User at NMA, 4
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r-4 Dr. Moskowitz stated, "I never delegated that kind of responsibility to anyone."
Tr.217.
In response to questions posed by Dr. Ben-Ifaim, Dr. Moskowitz asserted: -
I was never invited to come see your facihty. I was never told where your facihty was, I was never shown a full fledged application that was subnutted to tre NRC 1 was never told that you had received a heense. I was never invited to cone over. Tr. 226.
At no time have you ever notified nw . . that I did not appear. You never invited ne. you never sent nw a letter stating that I was in any way asociated with the medical facihty. Tr.
259.
Dr. Moskowitz's testirnony in this regard is supported by all the witnesses that testified on this subject, except Dr. Ben-Haim. Mr. Wilson conducted two interviews of Dr. Moskowitz (on March 6 and April 22,1997) as part of the 01 investigation. Tr. 52123 (Wilson). At the first interview, conducted in Dr.
Moskowitz's office at the University of Medicine and Dentistry of New Jersey (UMDNJ), Dr. Moskowitz told Mr. Wilson that he had absolutely no affiliation with NMA, did not know Dr. Elamir, had never been to NMA, and did not have anything to do with NMA at all. Tr. 523. Dr. Moskowitz also provided a sworn statement to 01, which became part of Exhibit 15 to the 01 report. Tr.
524 (Wilson). See Staff Exh. 8, O! Exh.15. Dr. Moskowitz's sworn statement provides, in pertinent pait:
I have absolutely no affiliation to Newark Medical Anociates (NMA). Newark, NJ. and never have. I never nwt Dr. Magdy Elamir, M D., any technicians that work at NMA. or any consultants to NMA. I have never visited the NMA for any purpose and, to my recollection, was never aware that NMA or Dr. Elamir had used tny name as an RSO or Authorized User (AU) on the NRC license application or the license itself, since the issue was made known to ne by Mr. Gibson of the NRC on or about 2/6/97.
Staff Exh. 8. 01 Exh.15 at 3.
Ms. Smoligova had been employed as an MRI technician for Dr. Elamir at Newark Open MRI from June 1996 and ordered radiopharmaceuticals for NMA.
TY.124-25 (Smoligova). She testified that she did not know who Dr. Moskowitz was, that she never heard of Dr. Moskowitz, and that she never saw him. Further, that she did not know who the RSO and Authorized User for NMA were. Tr. l 126. See also Tr. 535,619 (Wilson); Staff Exh. 8. 01 Exh. 27. I Ms. Geylikman worked as a nuclear medical technologist at NMA on Saturdays. Tr.176; see Staff Exh. 8, O! Exh. 26. She testified that she never met Dr. Moskowitz and did not know who the Authorized User for NMA was.
"It 178. She had heard Dr. Ben-Haim mention Dr. Moskowitz's name but did not remember anything that he said about Dr. Moskowitz or the purpose for which his name was mentioned. Tr.186-87.
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Ms. Geylikman's testimony in this regard differs somewhat from that of Spe-cial Agent Wilson. Mr. Wilson interviewed Ms. Geylikman at liarlem Ilospital l in the Nuclear Medicine Department lie asked her about Dr. Moskowitz, and !
she replied that she did not know who Dr. Moskowitz was and further stated j
that 6he knew the name but only because of the NRC inspection. Tr. 531,532 l (Wilson).
j When Ms. Geylikman was asked whether she told 01 that she only knew of '
Dr. Moskowitz as a result of NRC's inspection, she stated, "It might be, I just don't remember right now. But then I stan to think and maybe I heard his name before, just once, like this." Tr.184-85. The Board considers that regardless i of whether Ms. Geylikman heard Dr. Moskowitz's name mentioned prior to the NRC inspection, it is clear that she did not see him at NMA or consider him to j
be NMA's RSO or Authorized User. !
Based on the foregoing evidence, we find that Dr. Moskowitz did not perform the role of RSO or Authorized User at NMA. lbrther, we find that Dr. Moskowitz j did not delegate the duties of the RSO or Authorized User to Dr. Ben-flaim or any other person.
- 4. Dr. Ben-liaim knew Dr. Moskowitz was not performing the role of RSO or Authorized User. The Staff argued that Dr. Ben-liaim knew that Dr. I Moskowitz was not performing the role of RSO or Authorized User because at no time did Dr. Ben-llaim see Dr. Moskowitz at NMA or have any communication with Dr. Moskowitz. Further, the Staff argued that Dr. Ben-Haim was aware that an essential record at NMA had not been reviewed by Dr. Moskowitz. Dr.
j Ben-liaim argued in defense that he met with Dr. Moskowitz at UMDNJ prior to listing him on NMA's license application, that he was candid at the NRC
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inspection and that Dr. Elamir provided assurances to him regarding Dr. Ben-l Haim's expressed concerns that Dr. Moskowitz had not been to NMA.
Concerning a meeting with Dr. Moskowitz, Dr. Ben-Haim testified that he 4 saw Dr. Moskowitz on February 16,1996, at UMDNJ, and that Dr. Moskowitz '
gave him his curriculum vitae (CV) and other papers in order to be included in NMA's license applict. tion r,s the Authorized User and RSO. Ben-Haim, ff.
Tr. 786, at 1; Tr. 797, 809 (Ben-Haim). Dr. Ben-Haim testified that he phoned Dr. Moskowitz using the phone number provided by Dr. Elamir, spoke with Dr.
Moskowitz, and made an appointment for February 16,1996, at 10:30 a.m. in his office in the Nuclear Medici m Laboratory H141, at UMDNJ. Ben-Haim, ff.
Tr. 786, at 1; Tr. 788 (Ben-Hann). Dr. Ben-Haim testified that "there was no other purpose to my visit than to receive from Dr. Moskowitz these papers."
Ben-Haim, ff. Tr. 786, at 1: Tr. 789,797. Dr. Ben-Haim testified that receipt of Dr. Moskowitz's papers is "a proof of his consent" to being named as the RSO and Authorized User in NMA's application for a materials beense. Ben-Haim, ff. Tr. 786, at 5. Dr. Ben-Haim indicated that no other person participated in the meeting, although an unidentified individual may have been present. Tr. 828.
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Dr. Ben-liaim admitted that Dr. Moskowitz did not specifically say that he wanted to be included in the application as the Authorized User and RSO. Tr.
795, 829-30. " lie didn't say, 'I will be the RSO.* . . We were talking about scans and he said, Tm going to read the bone scans."' Tr. 795. Dr. Ben-liaim testified that he equated the reader of the scans with the Authorized User. Tr.
854.11owever, when asked, "Other than handing you the CV, did he imply in any way, by words or body language, 'Yes, I will be the RSO' 7" Dr. Ben flaim answered, "No." Tr. 854.
Dr. Ben-liaim testified regarding his March 7,1997 interview with 01, in which the agents questioned him about his meeting with Dr. Moskowitz. At that interview, Dr. Ben-liaim could not remember the date of his meeting with Dr.
Moskowitz. Ben Ilaim, ff. 'Ir. 786, at 3. When asked if he had an appointment book, Dr. Ben-Ilaim stated that he took out his diary and came back to the two inspectors lie looked through the book in their presence and saw the entry on Rbruary 16,1996 Ben-flaim, ff. Tr. 786, at 3; Tr. 800. See also Ben-liaim Exh.1 (execrpt from Dr. Ben-liaim's diary). Dr. Ben-liaim, however, could not recall if anybody saw him write the note. 71. 830.
Dr. Ben-liaim's testimony is generally consistent with that of Special Agent Wilson, Mr. Wilson interviewed Dr. Ben-Haim at his residence in Upper Montclair, New Jersey. Tr. 527 (Wilson); see Staff Exh. 8,01 Exh. 22. Dr. Ben-liaim told Mr. Wilson that Dr. Elamir said that a Dr. Moskowitz of UMDNJ had expressed interest in doing outside work and, therefore, Dr. Moskowitz would serve as the RSO and Authorized User. Tr. 527 (Wilson). Dr. Ben-flaim told Mr. Wilso:: that he met with Dr. Moskowitz after calling and making an appointment with him. Tr. 528 (Wilson). Mr. Wilson testified that Dr. Ben-liaim retrieved a daily planner which had an entry for Rbruary 16,1996, that read, "l1-141, Dr. Moskowitz 10:30,982-6022." Tr. 528,554 (Wilson); see B-li Exh.1.
Dr, Moskowitz did not recall ever meeting Aharon Ben-liaim until the day )
of the hearing. Tr. 216-17 (Moskowitz). Upon cross-examination by Dr. Ben- l liaim (Tr. 217-27), when asked "And you've never seen me?", Dr. Moskowitz l
asserted, "[als far as I was concerned, the only time I've ever seen you is today."
]
7Y. 217.1)r. Moskowitz did not recall giving his CV and papers to anyone or l remember an Israeli coming and meeting with him. Tr. 220-21 (Moskowitz).
When asked specifically about his recollection of libruary 16,1996, Dr.
Moskowitz stated that he "would not have met somebody for an extended period of time to discuss anything on that liiday" because that was President's Day weekend, and he was going away and, therefore, liiday was a precious time to complete all the work he had to do. Tr. 217-18 (emphasis supplied).
When asked regarding a statement Dr. Moskowitz made to 01 that there was less than a 1% chance that he may have met with Dr. Ben-liaim at UMDNJ, Dr. Moskowitz clarified that his statement was made in the context that Dr.
71 4
Moskowitz may have met Dr. Ben-liaim at "another conference somewhere else in the hospital," but not in the context of negotiating a position as an RSO. Tr.
220,222; see Staff Exh. 8. 01 Exh.16 ("Moskowitz allowed that there was less than a 1% chance that he may have met with [Dr.] Ben-liaim at UMDNJ").
Dr. Moskowitz testified that the only face he could conceive of meeting was different from Dr. Ben liaim's. Tr. 231. Dr. Moskowitz stated that Dr. Ben-Haim has a " unique sort of facial appearance" and that Dr. Moskowitz should have remembered if he had seen him. Dr. Moskowitz conceded, however, that under the pressure of a rushed Friday, he may have given Dr. Ben-Haim a CV.
Tr.243.
Dr. Moskowitz did state that Dr. Baker of the UMDNJ might have given out his qualifications to a group with whom Dr. Baker, the Chairman of the Department of Radiology, was negotiating. Tr. 223. Dr. Moskowitz explained that Dr. Baker and his coordinator had his CV and they had given it out to different places for different purposes. 7Y. 222. Dr. Moskowitz testified that he did not know very much about the negotiations and was not privy to them. 71.
225. Dr. Moskowitz's testimony is consistent with Mr. Wilson's: Mr. Wilson l
{
testified that Dr. Moskowitz told the investigators that Dr. Baker would typically j hand out his CV. Tr. 524,599. 'Ihus, NMA could have received Dr. Moskowitz's CV without Dr. Ben-Haim's having obtained it from Dr. Moskowitt. Dr.
Moskowitz, however, did state that it is possible that he gave Dr. Ben-Haim his CV, although he does not recall. Tr. 232, 238-39, 243.
Dr. Moskowitz's testimony is generally consistent with that of Special Agent Wilson. Mr. Wilson and Mr. Davis interviewed Dr. Moskowitz a second time after 01 interviewed Dr. Ben-Haim in order to confront him regarding the j meeting that Dr. Ben-Haim spoke of. Tr. 525 (Wilson); see Staff Exh. 8, 01 !
Exh.16. Mr. Wilson testified that Dr. Moskowitz had no recollection that a meeting took place or of having provided his CV to Dr. Ben-Haim. 'IV. 525. Dr.
Moskowitz told the 01 investigators that, if he had been contacted by Dr. Ben-l Haim, he would have contacted Dr. Baker and made a note of the occurrence, j
because Dr. Baker could conduct negotiations for the university and not Dr. 1 Moskowitz. TV. 525-26. Dr. Moskowitz looked for documents relative to such a notation and did not find any. Tr. 526. Mr. Wilson testified that Dr. Moskowitz was "very adamant" that he had not met with Dr. Ben-Haim, but he did allow l that there was less than a 1% chance that he may have met Dr. Ben-Haim at l UMDNJ. "[H]e highly doubted it." Tr. 526 (Wilson).
! Mr. Wilson testified that the Office of Investigations believed Dr. Moskowitz l instead of Dr. Ben-llaim regarding the meeting because Dr. Moskowitz had no
! vested interest in the outcome. Tr. 538; see Staff Exh. 8 at 22. Mr. Wilson clarified that Dr. Moskowitz was not a subject or target of the investigation.
Tr. 559,639 (Wilson). Mr. Wilson opined that there was no potential for Dr.
Moskowitz to have gained financially regarding the resolution of whether he met 72
I with Dr. Ben-Haim. Mr. Wilson was not aware of any threat to Dr. Moskowitz that would be removed if the issue were resolved in his favci. Tr. 639 (Wilson).
Mr. Wilson added that Dr. Moskowitz was " antagonized that someone had used his name" and that Dr. Moskowitz felt like a victim and wanted answers.
Tr. 597. When asked if that showed some vested interest, Mr. Wilson said, "a little bit." 14.
Based on the above evidence, the Board is convinced that at no time prior to speaking with Inspector Gibson was Dr. Moskowitz aware that he was listed on either NMA's license or license application as the RSO or Authorized User.
Regarding Dr. Den-Haim's defense that he met Dr. Moskowitz at UMDNJ for the purpose of having Dr. Moskowitz listed on NMA's license application, however, we find that Dr. Ben-Haim did indeed travel to the UMDNJ, at the request of Dr. Elamir, to obtain Dr. Moskowitz's CV, but that at no time did Dr. Ben-Haim and Dr. Moskowitz discuss proposed service as an RSO or Authorized User. Our finding is based chiefly on the testimony of Dr. Ben-Haim, the copy of Dr. Ben-Haim's calendar in which he made a notation in the space for Ibbruary 16, 1996, regarding a meeting with Dr. Moskowitz at UMDNJ (B-H i Exh.1), together with our evaluation that Dr. Moskowitz had a motive for not remembering the alleged meeting: his position at UMDNJ was in danger and he did not want to get involved in a potential regulatory violation.
We disagree with the Office of Investigations' analysis that Dr. Moskowitz is more credible than Dr. Ben Hairn regarding the purported meeting. It is clear, l as the Staff asserts (Staff Proposed Findings 72, at 21) that Dr. Ben-Haim had a vested interest in stating that he met with Dr. Moskowitz that is evidenced by these very proceedings. 'Ihat is, Dr. Ben-Haim knew that, as the preparer of NMA's license application, he might be subject to some action if the license application were prepared fraudulently. On the other hand, Dr. Moskowitz, although concerned that someone had used his name improperly and desirous of having the matter set straight (as claimed by the Staff in Proposed Findings 72, at 21), knew it was against UMDNJ policy for him to be negotiating for extracurricular services and did not want to be connected with service for another organization, particularly one with alleged regulatory violations, without following proper UMDNJ channels. Indeed, Dr. Moskowitz admitted, at the time of the hearing, that he had not had tenure at UMDNJ and was not at that institution any longer. Tr. 243.
Although we are finding that a meeting between Dr. Moskowitz and Dr.
Ben-Haim did take place, we also find, as the Staff observes (Staff FOF 75, at 21-22), that the most that took place at the meeting was Dr. Moskowitz's handing his CV to Dr. Ben-Haim. As recounted by Dr. Ben-Haim (Tr. 795),
Dr. Moskowitz did not say that he would be the RSO or Authorized User on NMA's license, in fact, Dr. Ben-Haim admitted that, other than handing him the CV, Dr. Moskowitz did not imply in any way that he would be the RSO, 73 I
although he did equate Dr. Moskowitz's statement that he would read the scans with being the Authorized User. We find that the receipt of the CV and Dr.
Moskowitz's statement that he would interpret the scans is an inadequate basis for Dr. Ben liaim to conclude that Dr. Moskowitz would serve either as RSO or Authorized User for NMA.
Regarding Dr. Ben-liaim's defense concerning his attitude during the inspec-tion, Mr. Gibson testified that he asked Dr. Ben-Ifaim about Dr. Elamir and Dr.
Moskowitz's absence, and Dr. Ben-liaim informed him that the Licensee nor-mally conducted work on Saturday and that Dr. Elamir had requested him to be at the inspection. Th 87. Mr. Gibson asked Dr. Den-liaim if Dr. Moskowitz was ever at NMA, and Dr. Ben-Ilaim informed him that he did not know if Dr.
Moskowitz was ever there. Tr. 87 (Gibson). In that connection, however, Dr.
Ben-liaim maintained that he was never at the facility on Saturdays, when all nuclear work was performed, and thus did not know whether Dr. Moskowitz was there or not. Tr. 790 (Ben-11 aim).
On the day of the inspection, about an hour prior to the inspection, Dr.
Elamir asked Dr. Ben-Ilaim to be present. Ben-11 aim, ff. Tr. 786, at 2. When Mr. Gibson asked him who the RSO was. Dr. Ben-flaim advised "without any hesitation" that it was Dr. Moskowitz. Id. Dr. Den-liaim was not aware that Mr. Gibson had specifically asked for the RSO to be present at the inspection.
Ben-liaim, ff. Tr. 786, at 4.
We do not consider Dr. Ben-liaim's statement to Mr. Gibson that Dr.
Moskowitz was the RSO to be of much assistance to his defense. The issue is not whether Dr. Ben-IIaim knew that Dr. Moskowitz was the RSO named on the license but, rather, whether Dr. Ben-liaim knew that Dr. Moskowitz was not performing his role at NMA.
Dr. Ben-liaim testified that, after NMA's operations started, he was " con-vinced that Dr. Elami. was in contact with Dr. Moskowitz and had no way of knowing he was not." Tr. 790; see Ben-11 aim, ff. Tr. 786, at 1-2. liowever, Dr.
Ben-liaim admitted on cross-examination that he never saw Dr. Moskowitz at NMA. Th 838, 828-29. As of December 1996, Dr. Ben-liaim knew that Dr.
Moskowitz had not been to NMA. Tr. 839 (Ben-Ilaim). Dr. Ben-flaim further admitted that during the time NMA was in operation he had no communication with Dr. Moskowitz. Tr. 837.
Dr. Ben-liaim was concerned that Dr. Moskowitz had not been to NMA. Tr.
790, 839, 860 (Ben-11 aim). Specifically, in his direct testimony, Dr. Ben-liaim stated; I hadn't seen any signed - any signature of IDr. Moskowitz's! in the log book, and I had asked IDr. Elamir) apecihcally. I told him actually. 'This has to be signed. He has to review the procedures and I don't see anything.' Dr. Elamir nodded. Our encounters were very brief. So he nodded and said 'Okay. okay.'
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Tr. 790. Further, when asked by the Board whether he thought he "ought to see that there's an AU that's going to show up," Dr. Ben-llaim stated, "I was concerned about this." Tr. 860. Dr. Ben-Haim admitted that he expected to see some tangible evidence that an Authorized User and RSO had been to NMA.
Tr.801.
As part of his defense, Dr. Ben-Haim testified that in August 1996 he prepared a form regarding dose calibrator geometry correction for the Victorcen Dose Calibrator. Tr. 833. He indicated that he signed the form as the one who performed the calibration and that he left a place open for the RSO to sign. Tr.
834. Dr. Ben Haim added that the form actually shows the word "RSO" at the signature line, and Dr. Moskowitz did not sign it. Tr. 834-35. Dr. Ben-Haim admitted that he knew that Dr. Moskowitz had not signed the form. Tr. 838.
See Ben-Haim Exh. 4.
Dr. Ben-Haim testified that when he told Dr. Elamir that the procedures needed to be reviewed by an RSO, Dr. Elamir told him, "I have somebody else."
Tr. 862. When questioned by the Board as to why Dr. Ben-Haim did not advise Dr. Elamir that NMA needed a license amendment, Dr. Ben-Haim testified, "Somehow it did not click." Tr. 862. Dr. Ben Haim's testimony differs from what he said at his deposition. On cross-examination, Dr. Ben-Haim admitted that during his deposition he had said he asked Dr. Elamir why the RSO had not come in and signed, and that the extent of Dr. Elamir's response was merely to nod. Tr. 891-92.
Dr. Den Haim admitted that his only bases for assuming during the time NMA was in operation that Dr. Moskowitz was acting as Authorized User and RSO were (1) that Dr. Elamir told Dr. Ben-Haim that Dr. Moskowitz was the RSO and (2) that Dr. Moskowitz had given Dr. Ben-Haim his CV. Tr. 866.
Dr. Ben-Haim did not follow up to see to it that the RSO and Authorized User were functioning. He admitted, "I thought, 'Well, it's just the beginning.
Let's see how things develop. . I don't want to make waves.'" Tr. 863 (Ben-Haim).
Based on the above evidence, the Board finds that Dr. Ben-Haim knew, at least by December 1996 (see Tr. 839 (Ben-Haim)), that Dr. Moskowitz was not performing the role as RSO or Authorized User for NMA. Even though we conclude that a meeting with Dr. Moskowitz took place and Dr. Ben-Haim left that meeting believing that Dr. Moskowitz would be NMA's RSO and Authorized User, the Board rejects all inferences that Dr. Ben-Haim adhered to his belief that Dr. Moskowitz was acting as the RSO and Authorized User up until the NRC's inspection. We find it incredible that Dr. Ben-Haim, who saw no j evidence that Dr. Moskowitz had been to NMA, who had no communication with i Dr. Moskowitz, and who knew that an essential record had not been reviewed by Dr. Moskowitz, did not conclude that Dr. Moskowitz was not serving as NMA's RSO and Authorized User.
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i Dr. Ben-Haim's admitted concern that Dr. Moskowitz had not been to NMA, l and his conveyance of that concern to Dr. Elamir demonstrates that Dr. Ben- I l Haim knew, at least by December 1996, that something was wrong regarding l Dr. Moskowitz's fulfilling any of the required duties of the RSO. Dr. Elamir's
- purported response that he had "someone else" simply reinforces this conclusion. I l Thus, Dr. Ben-Haim clearly knew by December 1996 that Dr. Moskowitz was not acting as RSO and Authorized User.
- 5. Summary of Common Findings. In summary, we conclude the following:
(1) Dr. Ben-Haim was NMA's consultant for the preparation of NMA's materials license application and for ensuring the safe use of radioactive material and comphance with the Commission's requirements; (2) Dr. Ben-Haim knew that Dr. Moskowitz was named in the license application and on the license as NM4's only RSO and Authorized User: (3) Dr. Moskowitz did not perform the role of RSO or Authorized User at NMA and did not delegate the duties of the RSO or Authorized User to Dr. Ben-Haim; and (4) Dr. Ben-Haim knew, at least by December 1996, that Dr. Moskowitz was not performing the role of RSO ud Authorized User for NMA.
I. The RSO Violation
- 1. NRC Requirements The Order states that Dr. Ben-Haim violated 10 C.F.R. 6 30.10 by causing NMA to be in violation of 10 C.F.R. 99 35.21, 35.13 and NMA License Con-dition 12. These requirements were presented and explained by Mr. Kinneman, Mr. DelMedico, and Dr. Siegel. Dr. Siegel was offered by the Staff as an ex-pert witness. Tr. 356-57. We find Dr. Siegel qualified to testify as an expert regarding medical facilities that use nuclear material, such as NMA, and as an expert regarding application of the NRC's regulations.
Under 10 C.F.R. 9 30.10, a contractor to a licensee may not knowingly cause the licensee to be in violation of any Commission requirement. Tr.
486 (Kinneman). Specifically,10 C.F.R. 5 30.10 provides that any contractor, including a supplier or consultant, who knowingly provides to any licensee information or other things, may not engage in deliberate misconduct that causes or would have caused, if not detected, the licensee to be in violation of any rule, regulation, or orbr, or any term, condition, or limitation of any license issued by the Commi~4 v. Tr. 480,481 (Kinneman).
Deliberate misconduct by a person means an intentional act or omission that the person knows would cause a licensee to be in violation of any rule, 76 l
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' I regulaiion, or order, or arf term, condition, or limitation of art < v : ed I by the Commission. Tr. 480-81 (Kinneman); 10 C.F.R.130.1 c' B h: 's regard, Mr. fMMedico testified that deliberately is the same as men ac.
750. A question was raised regarding whether a finding of careles' 6 d of requirements, as discussed in NUREG-1600, could also apply in te w.
Tr. 701-02. Mr. De1 Medico answered that a violation of 10 C.F.L 90.10, as alleged here, requires a finding of deliberate misconduct and that careless disregard is not a violation of 10 C.F.R.130.10. Tr. 702-04,776.
Under 10 C.F.R. 6 35.21, a licensee must appoint an RSO who meets the specific responsibilities spelled out therein. Tr. 279 (Kinneman). These duties include: investigating overexposures, accidents, spills, losses, thefts; establish-ing and collecting in one binder (or file) written policies and procedures for authorizing the purchase of radioactive material; receiving and opening pack-ages; storing byproduct material; keeping an inventory; using byproduct ma-terial safely; taking emergency action if control of byproduct material is lost; performing periodic radiation surveys; performing checks of survey instrumen-tation; disposing of byproduct material; and training staff who work or frequent areas where byproduct material is used and stored. Tr. 280 (Kinneman); 10 C.F.R. I 35.21(b).
An RSO can instruct someone else to carry out the physical actions described in 10 C.F.R. I 35.21, but the RSO may not delegate the responsibility for ensur-ing that they are carried out. Tr. 279-80 (Kinneman); see 10 C.F.R. I35.21(a)
('The licensee, through the [RSO], shall ensure that radiation safety activities are being performed in accordance with . . regulatory requirements"). Neither l
may the RSO delegate the performance of assessments that the RSO is expected by virtue of training and experience to perform. Tr. 280 (Kinneman).
In the case of a medical facility, the individual in whom the responsibility for ordering byproduct material is embodied is the RSO. The RSO has the authority ;
to delegate that responsibility to an individual working under the RSO's direction i and supervision. The delegation is usually accomplished by a memorandum of delegation. Tr. 368-69 (Siegel).
Many of the activities of the RSO are carried out by a physicist or other consultant; however, in order for that to happen, the RSO must be active and must delegate those duties to the physicist or other person who carries them out.
'Ir. 290 (Kinneman).
Section 35.13(c) of the Commission's regulatkas provides that a licensee shall apply for and must receive a license amendracr.: before it changes RSOs.
10 C.F.R. 6 35.13(c). As previously noted, License Condition 12 of NMA's license states that the RSO for this license is Dr. Moskowitz. Staff Exh.1.
The Board finds that Dr. Ben-Haim's actions would constitute a violation of 10 C.F.R. 6 30.10 if he deliberately caused NMA to fail to appoint an RSO and have the RSO perform the duties delineated in 10 C.F.R. 9 35.21. In addition, 77
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! Dr. Ben-Haim would be in violation of 10 C.F.R. 5 30.10 if he deliberately caused NMA to change RSOs without a license amendment. Finally, Dr. Ben-l Haim would be in violation of 10 C.F.R. I 30.10 if he deliberately caused NMA to operate without Dr. Moskowitz as RSO. Aus, we find that NMA would be in violation of all three requirements if Dr. Ben-Haim performed the functions of the RSO without the delegation of the requisite authority by Dr. Moskowitz.
- 2. Staff Claims De Staff claims that Dr. Ben-Haim performed the functions of the RSO and admitted to OI that he was the de facto RSO. His occurred during a second interview of Dr. Ben-Haim by Special Agent Davis at NMA on April 22,1997, during which Dr. Ben-Haim discussed the role of the RSO, among other things.
Tr. 549 (Davis); see Staff Exh. 8, OI Exh. 23 (OI interview of Dr Ben-Haim).
He purpose of the second interview was to compare the doses of technetium-99m that were sent to NMA from Medi-Physics with the individual patient records. Tr. 542 (Davis). Dr. Ben-Haim went over the records with Mr. Davis and thoroughly explained what happens from the time a physician requests a bone scan until the time the procedure is performed. Tr. 543-44 (Davis).
During the conversation, Mr. Davis mentioned the RSO and the tone of the conversation changed: Dr. Ben-Haim questioned the reasons for Ol's many interviews. Tr. 545 (Davis). D . Ben-Haim stated to Mr. Davis, "So I might have made some mistakes . . I was here at NMA when I was needed I set it all up, this was just one job, I have many other things to do." Tr. 546 (Davis).
Mr. Davis testified that Dr. Ben-Haim informed him about the role of the RSO and additionally remarked that he was the de facto RSO. Tr. 549,550 (Davis).
Mr. Davis was absolutely certain that "Dr. Ben-Haim stated that in doing his work at NMA that he was the de facto RSO." Tr. 549,550 (Davis). At the end of the interview, Dr. Ben-Haim repeated that one of his mistakes was " acting as the de facto RSO." Tr. 550,580 (Davis).
Mr. Davis acknowledged on cross-examination that this was his first assign-ment at NRC's Region 101 office, and that a lot of things were new to him; however, he did not believe it was possible that he confused what was said.
Tr. 564-65. He " remembered specifically" that Dr. Ben-Haim told him that he acted as the RSO for NMA. Tr. 578-79. Mr. Davis testified that he did not have any preconceptions regarding Dr. Ben-Haim's role at NMA before the second interview. Tr. 584.
Further, Dr. Ben.Haim told Mr. Davis that he should have been the RSO; that he had applied to be certified for an RSO but that he was turned down. Tr. 577-
- 78. Mr. Davis understood that to mean that Dr. Ben-Haim should have been the RSO for NMA but was not. Tr. 601 (Davis). In that connection, Dr. Ben-Haim testified that the agent asked why he was not the RSO, and Dr. Ben-Haim replied J
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l l that he had applied for another facility and was rejected. "Therefore, I knew I could not be the RSO and did not apply." Tr. 804 (Ben-Haim); Ben-Haim, ff.
Tr. 786, at 4.
Dr. Ben-Haim denied having admitted acting as the de facto RSO for NMA.
He testified that he said he was a " Radiation Safety conscious consultant physicist." Tr. 798, 804; Ben-Haim, ff. Tr. 786, at 4. On cross-examination. Dr.
Ben-Haim again denied tc!!!ng Mr. Davis that he was acting as a de facto RSO.
He admitted, however, that he told Mr. Davis that there was an overlapping between the RSO and physicist's work and that "de facto [he was) doing [some of] the things that the RSO could do." Tr. 838 (Ben-Haim).
In light of the foregoing evidence, we find that the conversation of April 22, 1997, between Special Agent Davis and Dr. Ben-Haim occurred but incorporated details beyond those reported by Mr. Davis. We could not find in the record any substantial basis for attributing to Mr. Davis any bias that would discredit his ;
testimony. Neither do we find any substantial evidence of confusion on the part of Mr. Davis as to what was said. Therefore, we conclude that Dr. Ben-Haim admitted to 01 that he was the de facto RSO for NMA for certain activities.
More important, it appears that Dr. Ben-Haim in fact performed many of the duties of an RSO. He acknowledged that there may have been duties that he performed that may have overlapped with those of the RSO. These duties included " radiation safety, as far as anything that has to do with instrumentation, mainly the way wipe tests are conducted." Tr. 858-59. In addition, these overlapping duties were "[tjo make sure that nobody has access to a lab and is not exposed unnecessarily, none of the public" and " monitoring of the facilities, of the workplace, for the personnel." Tr. 859. When asked who was filling the functions of an Authorized User or RSO during the time NMA was in operation, 1
Dr. Ben-Haim stated, "[t]he overlapping functions that the physicist has to do, I was trying, to the best of my ability, to help with." Tr. 877 l Dr. Ben-Haim did perform several other activities at NMA: he performed l certain equipment tests, such as the accuracy, constancy, and geometry checks I for the dose calibrator (Tr. 815,831); he found a nuclear technician to work at ,
NMA (Tr. 835); he gave information to Ms. Smoligova regarding where to get technetium-99m and the specific radiopharmaceuticals and millicurie amounts that she should order (Tr. 835,840-41); he made sure the laboratory had a key and was kept locked (Tr. 836); he made sure the NRC license was posted (Tr.
836); he told NMA personnel to get personal monitoring badges in December 1996 (Tr. 837).
As set forth earlier, as part of his defense, Dr. Ben-Haim testified that he prepared a form for NMA's dose calibrator geometry correction check; that the geometry correction check, which only needed to be performed one time, was prepared prior to the start of NMA's operations; and that Dr. Ben-Haim performed the measurements, prepared the graphs, signed the form, and left the 79
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. I line blank where the RSO was to sign. Tr. 814-15, 834-35; BH Exh. 4. He did not sign that place of the form. Tr. 822. Dr. Ben-Haim did admit that to do so would have been blatantly false. Tr. 835. He also acknowledged that Dr.
Moskowitz had never delegated the authority of the Authorized User or RSO to him.'It 826.
Based on the foregoing evidence, the Board finds that Dr. Ben-Haim per-formed many of the functions of the RSO, even though he knew Dr. Moskowitz had not delegated this authority to him. Dr. Ben-Haim characterized these ac-tivities as overlapping functions that a physicist could do as well as the RSO.
Dr. Ben-Haim, however, did not receive delegation from Dr. Moskowitz for any activities for which he would need a delegation from the RSO and Dr. Ben-Haim knew, at least by December 1996 that Dr. Moskowitz was not performing the duties of the RSO. By regulation, as explained above, the RSO is responsible for ensuring that these duties are carried out. Therefore, by engaging in activities, which included some functions of the RSO, he facilitated NMA's conducting operations without the involvement of the RSO named on the license. l Dr. Ben-Haim called our attention to the Dose Calibrator Geometry Corree-tion wherein he did not sign as the RSO for NMA. We do not give this evidence much weight in that it tends to prove not that Dr. Ben.Haim did or did not act as the RSO but rather that he knew he was not the RSO. The Staff need not show that Dr. Ben-Haim conducted RSO activities under a false claim that he was the RSO. 1 We find Dr. Ben-Haim caused NMA to fail to have the duties delineated in 10 C.F.R. 5 35.21 performed by the RSO, at least beginning in December 1996.
In addition, by acting as the de facto RSO, he caused NMA to change RSOs without the required license amendment. Finally, Dr. Ben-Haim caused NMA '
to operate without Dr. Moskowitz as RSO.
As noted earlier, Mr. Wilson conducted an 01 interview with Marina Geylik- i man at Harlem Hospital in the Nuclear Medicine Department. Tr. 531. Ms. Gey-likman had said her duties at NMA involved receiving deliveries of technetium-99m, performing surveys and wipe tests of the delivery container, and preparing the patients for injection of technetium-99m. Tr. 532. Ms. Geylikman told Mr.
Wilson that Dr. Ben-Haim set the procedures for those activities in place and explained the:n to her. Tr. 532 (Wilson). She described Dr. Ben-Haim as "her supervisor at [NMA] for the radioisotopes of technetium-99m and how to go about using those." Tr. 532, 612 (Wilson).
Mr. Wilson testified that he asked Ms. Geylikman if she knew who the RSO at Harlem Hospi tal was and she clearly knew who that person was. Tr. 532-33, 612-13. Mr. Wilson testified that Ms. Geylikman likened the RSO's duties at Harlem Hospital to what Dr. Ben-Haim did for NMA. Tr. 533. In case of an emergency, she was told by Dr. Ben-Haim to page him. She added that she had to page Dr. BerrHaim on several occasions. Tr. 538-39, 613 (Wilson). (Dr.
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' Ben-Haim, of course, claimed that he was not physically present at the facility on Saturdays, when Ms. Geylikman was performing her services. Tr. 790 (Ben-
. Haim).) The investigators understood Ms. Geylikman to mean that, if there was a problem regarding any of the procedures that Dr. Ben-Haim established, she would contact Dr. Ben-Haim. Tr. 561 (Wilson). Mr. Wilson testified that
! the focus of his questions revolved around nuclear medicine procedures "in
, context, she was discussing nuclear medicine procedures put in place by Dr.
- Ben-Haim, and she said when there were problems encountered, she paged him." Tr. 613; see also Tr. 591. According to Mr. Wilson, Ms. Geylikman did not state that the problems for which she was to call Dr. Ben-Haim were limited l to equipment problems. Tr. 640.
Ms. Geylikman testified that she came to NMA every Saturday when she was needed. Tr.176. She would perform a wipe test on the package, open the package, and measure the dose for the patient. She testified that the material came already premeasured in a syringe but that she had to measure it before
- injecting the patient. After injecting the patient, she would perform the scan and develop the film. Tr.177-78 (Geylikman).-
During her testimony, Ms. Geylikman stated that at NMA she considered Dr.
Ben-Haim to be "a supervisor,just regarding this machine." Tr.179. She said that Dr. Ben-Haim instructed her how to operate the machine and that it was the same machine that she had in West Orange where she previously worked with Dr. Ben-Haim. Id. Ms. Geylikman testified that no one at NMA explained
.to her the procedures for the scans because it is a common procedure for'each -
nuclear medicine facility. Tr.180. When asked if anyone instructed her on the wipe test, Ms. Geylikman replied that Dr. Ben-Haim showed her these things in West Orange, but not at NMA. Id. She testified that the forms, likewise, were the same as in West Orange and that she did not need any instruction. Tr.181.
Ms. Geylikman testified that most of the time she was alone at NMA when -
she performed her duties. Tr. 191. Ms. Geylikman testified that Dr. Ben-Haim told her to contact him' in the event of an emergency "if I could not, for example, do the scan, if the machine stopped . 4 . ." Tr.181. She
- acknowledged, however, that if there were an emergency with a patient, she
' would have to call a doctor. Id. When asked about her statements to 01, she did not recall her response to 01 "Maybe Ijust misunderstood [the questions) because Dr. Ben-Haim routinely did this in the West Orange office." Tr.184.
We find that the interview of Ms. Geylikman, as reported by Special Agent Wilson in his testimony and in the 01 Report, occurred as Mr. Wilson stated. We could not find in the record any substantial basis for attributing to Mr. Wilson any bias that would discredit his testimony. Neither do we find any substantial evidence of confusion on the part of Mr. Wilson as to what was said. We are somewhat mystified by the inconsistency between what Ms. Geylikman told 01
- and what she said in her testimony. While the record is devoid of any evidence of 81 I
l bias on the part of Ms. Geylikman, we find that Ms. Geylikman misunderstood what 01 was asking. We, therefore, accept what she testified under oath as the truth regarding her knowledge of Dr. Ben-Haim's activities. Nevertheless, we l find nothing in Ms. Geylikman's testimony that would alter our finding that Dr.
i i
Ben-Haim performed certain of the functions of the RSO at NMA without a 1
delegation from Dr. Moskowitz, the RSO named on the license.
The essence of Ms. Geylikman's testimony is that Dr. Ben.Haim did not instruct her on performing wipe tests or filling out the forms because Dr. Ben-Haim had instructed her in these matters in a separate facility. We find this inconsistent with Dr. Ben-Haim's own proposal to Dr. Elamir wherein he says ,
he will " assure continuous monitoring of the laboratory," " train your staff,"
and " establish the necessary radiation health procedures." Further, we find this l
possibly inconsistent with Dr. Ben-Haim's admission to 01 that he was the de facto RSO with respect to some functions and his testimony that he did many of the things the RSO could do. He had identified one such overlapping duty as
" radiation safety , , mainly wipe tests." Ibr these reasons, the preponderance )
of the evidence leads us to conclude that Dr. Ben-Haim performed certain of '
the duties of the RSO at NMA without a delegation from Dr. Moskowitz, the RSO named on the license.
- 3. StaffAnalysis l
Mr. Kinneman testified that Dr. Ben-Haim's actions caused the Licensee to be in violation of 10 C.F.R. 9 35.21. Tr. 280. Mr. Kinneman found it hard to conclude that Dr. Ben-Haim would not have realized in his position as a physicist that there should have been some evidence that the RSO gave Dr. Ben-Haim a delegation of authority and gave him some direction to do those RSO duties. Tr. t 293-94. Mr. Kinneman testified that Dr. Ben Haim was associated with NRC activities over a period of time, was involved with various communications with the NRC over a period of time, was apparently knowledgeable of what was going on at the facility even though not present at all times. Tr. 303. Mr. Kinneman testified that on balance it appeared that Dr. Ben-Haim and Dr. Elamir had or should have had the information they needed to conclude that NMA was not in )
compliance with the NRC's requirements and yet the activities continued. Tr. l 303. According to Mr. Kinneman, Dr. Ben-Haim reasonably should have known that the RSO did not exist because Dr. Ben-Haim did visit on some periodic basis, he had some contact with NMA, he is not unknowledgeable about how licensees operate, and, in fact, he was to advise the Licensee on such matters as compliance with the NRC's regulztions. Tr. 336. ;
'Ihe Board adopts the Staff's analysis as stated above, at least with respect to the period from December 1996 on, and concludes that Dr. Ben-Haim's actions in acting as NMA's RSO during the period from December 1996 through early 82
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February 1997 were intentional and, therefore, constituted a violation of 10 C.F.R. 6 30.10. In so doing, we emphasize our prior finding that Dr. Ben-l Haim, by virtue of his knowledge of the NRC's regulations and the fact that 4 he personally prepared NMA's license application, inciding the provisions
- involving the RSO, knew the requirements that he caused NMA to violate.
- 4. Summary of Findings In summary, we conclude: (1) Dr. Ben-Haim deliberately hvougnt about the use of licensed material at NMA even though he knew that the RSO named on
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the NMA license did not perform the duties delineated in 10 C.F.R. 6 35.21; l
. (2) Dr. Ben-Haim knew, at least by December 1996, that Dr. Moskowitz, the RSO named on the license, was not functioning as the RSO and that, therefore, a license amendment was required for NMA to continue to operate. Thus, Dr. j Ben-Haim deliberately caused NMA to operate without an RSO and without (
a license amendment to change the RSO; and (3) Dr. Ben-Haim deliberately caused NMA to operate without Dr. Moskowitz as RSO. Specifically, we find that Dr. Ben-Haim deliberately performed certain of the functions of the RSO, even though he knew Dr. Moskowitz had not delegated this authority to him.
Therefore, Dr. Ben-Haim violated 10 C.F.R. I30.10.
J. The Authorized User Violation
- 1. NRC Requirementi, He Order states that Dr. Ben-Haim violated 10 C.F.R. I30.10 by causing NMA to be in violation of 10 C.F.R. Il 35.53(c)(3),35.11(a) and (b), and NMA License Condition 13. These NRC requirements were presented and explained by Mr. Kinneman, Dr. Siegel, and Mr. DelMedico.
Mr. Kinneman testified that 10 C.F.R.135.53(c) requires that the Licensee retain a record of the measurement of each dosage, including prescribed dosage, of a photon-emitting radionuclide prior to medical use. Tr. 276; see 10 C.F.R 6 35.53(a) and (c). He prescribed dosage is defined in 10 C.F.R 6 35.2 and means the quantity of radiopharmaceutical activity as documented in (1) a written directive or (2) the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of an Authorized User. Tr. 276-77 (Kinneman); 10 C.F.R. 6 35.2.
Dr. Siegel testified that Part 35 requires a written directive, or explicit prescription, for two specific circumstances: (1) any time a dose of I-131 83
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n-exceeding 30 microcuries is to be administered to a patient; and (2) for any therapeutic administration of a radiopharmaceutical. Tir. 360-61,363.
' According to Mr. Kinneman, the diagnostic clinical procedures manual is a collection of written procedures that includes each diagnostic procedure that has been approved by the Authorized User. Tr. 277. Dr. Siegel also testified that the clinical diagnostic procedures manual is a compilation of the procedures performed in a laboratory that contains information about what drug is used for the test, what the dose of the drug is, the route of administration of that drug, and then all of the other details about how the test is performed; how long to
~
. wait after injection before imaging; what kind of camera to use; what kind of collimator to use; what specific pictures to take and in what specific sequence.
Tr.361.
Dr. Siegel testified that the NRC regulations require that the Authorized User must be the one who approves the procedures manual. Tr. 362, 363. %e Commission's regulations define a diagnosiic clinical procedures manual as a
" collection of written procedures that describes each method . . . by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiooharmaceutical, dosage, and route of administration." See 10 C.F.R. 9 35.2 (emphasis added). Dr. Siegel testified that it is not permissible for a physicist who is not a physician to put into effect a diagnostic clinical procedures manual without the approval of the Authorized User. Tr. 370-71.
Bus, a prescribed dosage has to be in a written directive, a diagnostic clinical procedures manual, or in any other written record from the Authorized User.
'The real key is that [it] has to be the authorized user that directs the dosage."
Tr. 277 (Kinneman). Dr. Siegel likewise testified,"the ultimate authorization to actually give [a] dose to a patient has to come from the authorized user." Tr.
430.
In response to whether it is permissible to administer a diagnostic radiophar-maceutical to a patient without a physician's prescription, Dr. Siegel testified that there is an implicit prescription that underlies the performance of all di-agnostic nuclear medicine procedures, that for the vast majority of diagnostic administrations an explicit written prescription is not required, and the directions can range from an oral instruction from the Authorized User to the technolo-gist to reliance on an implicit prescription contained in the clinical diagnostic procedures manual. Tr. 360, 361, 363. Dr. Siegel added that the procedures manual functions as the implicit prescription and that, based on the procedures established in a given laboratory, there may be authorization for the technolo-gists to perform the test in accordance with the procedures manual as if they had received an explicit written prescription from the Authorized User. Tr. 361-62.
Mr. Kinneman testified that " Authorized User" is defined in 10 C.F.R. 5 35.2 and means a physician, a dentist, or a podiatrist who meets the requirements that 84 -
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are specified in that regulation. Tr. 277. 'Ihe regulations in 10 C.F.R. I35.25 require that an Authorized User must provide supervision of employees or staff '
that carry out licensed activities. Tr. 287 (Kinneman); 10 C.F.R. 5 35.25. The Authorized User may instruct other people to carry out specific tasks, such as the
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administration of the radioactive material to the patient; however, the Authorized User must provide the supervision that is described in 10 C.F.R. 0 35.25. The licensee must require that the supervised individual follow the instructions of the supervising Authorized User. See Tr. 287 (Kinneman); 10 C.F.R. 0 35.25(a)(2).
Section 35.11(b) of the Commission's regulations provides that an individual may receive, possess, use, or transfer byproduct material in accordance with the regulations under the supervision of an Authorized User as provided in section 35.25, unless prohibited by license condition. An individual is prohibited from these activities except in accordance with a specific license or under the supervision of an Authorized User.10 C.F.R. 0 35.11(a) The Authorized User specifies what the dose to the patient is to be and that the Authorized User must authorize the person to order the radioactive material to be sent to the facility. Tr. 308 (Kinneman). While the RSO could order the material on behalf of the facility, the Authorized User must authorize the ordering of material for use in the patients. Thus, the RSO cannot direct the amount to give to each patient unless he is also the Authorized User. Tr. 310 (Kinneman). Therefore, according to Mr. Kinneman, even if Dr. Ben-Haim were the RSO, he would be precluded from authorizing the ordering of the dosage to give to a patient. Tr.
311.
Dr. Siegel testified that the physician who refers a patient for a diagnostic nuclear medicine procedure is not allowed to prescribe the dosage of radioactive material if the referring physician is not the Authorized User. Further, it would not be ordinary for a referring physician to specify the dose for a diagnostic procedure because the referring physician expects the test to be conducted properly -- the dose itself is not something the referring physician is concerned about. Tr. 378-80 (Siegel).
Dr. Siegel testified that it is not permissible for a technologist to rely i on the direction of a physicist in placing :he order for a specific amount i of a radiopt.armaceutical. Tr. 370. Dr. Siegel further testified that while a physicist may train a technologist in the ordering of the radiopharmaceutical, j the Authorized User and the RSO need to validate the instruction. Tr. 430-31, i
"Otherwise the physicist is, in fact, acting as the RSO and the AU." Tr. 431.
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As previously noted, NMA License Condition 13 provides that licensed i material is "only authorized for use by, or under the supervision of" the Authorized User, Dr. Moskowitz. Staff Exh.1. The Board finds that Dr.
Ben-Haim's actions would constitute a violation of 10 C.F.R. 5 30.10 if he deliberately caused NMA to fail to maintain a record of the measured amount of each prescribed dosage. That is, if he caused NMA to fail to maintain a 85 I
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record of the quantity of radioactive material prescribed by the Authorized User as required in 10 C.F.R. 5 35.53(c). Thus, we find that NMA would be in violation of 10 C.F.R. 6 35.53(c)(3) if Dr. Ben-Haim determined the dosage to be ordered and administered without the approval of the Authorized User.
Tne Board also finds that Dr. Ben-Haim would be in violation of 10 C.F.R.
5 30.10 if he deliberately caused NMA to allow NMA personnel to receive, possess, use, or transfer byproduct material without the supervision of the Authorized Usu. Finally, Dr. Ben Haim would be in violation of 10 C.F.R.
0 30.10 if he caused NMA to operate without Dr. Moskowitz as Authorized User. Thus, we find that NMA would be in violation of these two requirements if Dr. Ben-Haim performed the functions of the Authorized User without the supervision of Dr. Moskowitz.
- 2. Performance by Dr. Ben-Haim of Functions of Authorized User Ms. Smoligova testified that, every Thursday or Friday, she ordered tech-netium-99m for bone scans for the patients that came to NMA. Tr.125. Ms.
Smoligova further testified that NMA performed bone scans only on Saturdays.
Tr.127.
Ms. Smoligova testified that when she met Dr. Ben-Haim, Dr. Elamir asked her if she could order some things for him, such as paper towels, injections, or needies "whatever they're going to need." Tr.127-28. She testified that Dr.
Elamir asked her if she could help Dr. Ben-Haim with ordering what he needed for nuclear medicine but never told her that she would order nuclear materials.
Tr.133,138.
According to Ms. Smoligova, Dr. Ben-Haim told her to order the nuclear materials. See, e.g., Tr.139 (Q. "Who told you to order the nuclear materials 7' A. "Dr. Ben-Haim."), Tr.168 (Q. "Did I ask you to do the ordering?' A.
"Yes."), Tr.140,167. Ms. Smoligova testified that Dr. Ben-Haim asked her after operations started if she was ordering the radiopharmaceuticals for the patients, and she told him yes. Tr.147.
Ms. Smoligova identified P df Gxh. 8(a.) .as what Dr. Ben-Haim gave her regarding what she should ortL .:very 'Ihurslay or Friday for patients receiving scans. Dr. Ben-Haim gave her the document with the procedures and dosages written on it. Tr.128-29 (Smoligova).
Staff Exh. 8(a) is a handwritten document that states at the top half:
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l RADIOPtlARMACY:
MEDI-PliYSICS 1 800-242-8004 BONE SCAN - MDP - 25 mC llEART - MYOVIEW 2 SINGLE DOSES I X 8 rnCi i X 25 mci Staff Exh. 8(a). The bottom half contains telephone numbers and the name of the Licensee. /d.
Ms. Smoligova test.fied that Dr. Ben-Haim only gave her that one note and that he gave it to her prior to starting operations. Tr.136. The note was not wrinkled: "it was plain." Tr.144 (Smoligova).
Ms. Smoligova testified that Dr. Ben-Haim told her that she should check how many patients were scheduleo and, accordingly, how many bone scans she would need to order. Tr.129-30. Ms. Smoligova testified that the receptionist would tell her how many patients there would be. Tr. 141,142. Ms. Smoligova was certain Dr. Ben-Haim told her to order nuclear material for bone scans at 25 millicuries. She ordered the nuclear medicine because she was told to order the radiopharmaceuticals. Tr. 130.131 (Smoligova).
Ms. Smoligova testified that when she dialed the number she provided her name, Dr. Ben-Haim's name, the name and address of NMA, and the order.
Tr. 145, 153. The first few times she told them that she was calling for Dr.
Ben-Haim. Tr. 145,153 (Smoligova). On subsequent calls she just told them her name, the name and address of NMA, and the amount of unit doses needed for Saturday. She testified that she would say " bone scan, MDP 25 millicurie" and the amount of unit doses she needed. Tr.153-54. They also asked her the time the patient was due in for the procedure. Tr.154.
Ms. Smoligova's testimony is consistent with Dr. Siegel's statement that the procedure for ordering a radiopharmaceutical from a commercial nuclear pharmacy is simply to place a telephone call and request a dose. See Tr. 368, 410. Dr. Siegel testified that a radiopharmacy will not accept an order unless it has first been provided with a copy of a byproduct materials license. Tr. 368, 410.
Ms. Smoligova testified that Dr. Ben-Haim said that if there was a problem with the ordering she was to contact him. Tr.130. When asked if Dr. Ben-Haim told her he was in charge or in control, she testified that he was in charge of the ordering. Tr.160. When asked what she thought Dr. Ben-Haim's function was at NMA, she answered,"[als a supervisor of the place which was open for nuclear medicine, for patients to get bone scans." Tr.169.
Ms. Smoligova ordered the radiopharmaceuticals several times a month. Tr.
162 (Smoligova). She testified that she saw Dr. Ben-Haim "quite often, at least from the beginning every week," although she never saw him when patients 87
l were there, i.e., on Saturdays. Tr.169-70. Dr. Ben-Haim confirmed he was not .
at the facility on Saturdays.- Tr. 790.
- l. .Dr. Siegel and Mr. Kinneman testified regarding the characterization and import of Staff Exh. 8(a), which Dr. Ben-Haim wrote and gave to Ms. Smoligova.
Dr. Siegel testified that Staff Exh. 8(a) would be incomplete as a diagnostic
- procedures manual because not only does a diagnostic procedures manual have to specify the drug that is to be used for a particular test and the dosage
- - to be administered, but also the route of administration. Tr. 365, 367. Dr.
Siegel testified that even if the route of administration had been included in the L document, it would have been "the barest bones clinical diagnostic procedures 3
. manual one could conceive of." Tr. 367.' In fact Dr. Siegel testified that he never saw anything that could be properly characterized as a diagnostic procedures {
manual from NMA. Tr. 3%.
Dr. Siegel testified that if that paper were posted on the wall of a nuclear-medicine laboratory and there was nothing anywhere else in the laboratory that even looked remotely like a procedures manual or instructions, one might logically conclude that it was intended to be something like a procedures manual.
' Tr. 403. As for whether it would be considered less as a manual if kept in a
. drawer rather than being posted, Dr. Siegel did not think so, since the physical state of a manual could be variable: it could be posted on the wall; kept in a book on a shelf; kept in a drawer; or kept on a computer. Tr. 429 (Siegel).
Dr. Siegel testified that if the document was essentially the only informa-tion / instruction that had been provided to the ordering technologist and the nuclear medicine technologist who actually performed the studies, then the doc.
ument operationally represented the delegation of authority to order the radioac-tive materials, in which case it would put Dr. Ben-Haim in the position of having acted as the RSO. Tr. 397-98. Dr. Siegel testified that it also became the appar-ent set of instructions on how to perform the study, which put Dr. Ben-Haim in the position of having acted as the Authorized User. Tr. 398.
Dr. Ben-Haim testified that the piece of paper on which the information was written was " arbitrarily qualified as a prescription" by the Staff. He
- testified that there was no signature, no date, no name'of patient, it was not meant to be presented to a pharmacy or a doctor, it was not specific to one radiopharmaceutical. He characterized it as general information, as it might appear on any pamphlet, and did not engage anybody. Tr. 811; Dr. Ben-Haim, ff. Tr. 786, at 5. See also Tr. 813, Dr. Ben-Haim, ff. Tr. 786, at 6 ("it is information only").
Dr. Siegel did not consider the document to represent a prescription. Tr.
387. He testified that if the 25;millicurie dose were administered, based on Staff Exh. 8(a), one would conclude that it was the prescribed dose and that the person who wrote the document would have prescribed it. Tr. 365-66. The person who prepared the note would need to be an Authorized User. Tr. 366.
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Mr. Kinneman likewise characterized the docu' ment as "the closest thing that we have to a prescribed dosage" as defined in the regulations. Tr. 324. Dr. Siegel added that the physical status of the instructions regarding what doses to order and whether someone had written a telephone number on it is not relevant and does not render the instructions invalid. Tr. 380-81.
Regarding the characterization of Staff Exh. 8(a), we find that this document contains written instructions regarding the radiopharmaceuticals and dosages to be ordered and coministered to patients for medical uses. The Board does not find that this document is an explicit prescription, as one would typically receive from a doctor to be filled by a pharmacist; nor does the Board find that l it is a clinical diagnostic procedures manual, as defined in the Commission's regulations. We find, instead, that this document is an instruction on the quantity of radioactive material to be ordered. We also find that the physical status of the prescribed dosage in the instant situation has no relevance to its nature and effect. nat is, whether the document was wrinkled and was later annotated with extraneous information by Ms. Smoligova did not render it ineffectual in 4 conveying instructions regarding the dose of radioactive material to be ordered '
and administered. Indeed, Ms. Smoligova ordered radioactive material based on that document.
Ms. Smoligova's testimony, as set forth above, is fully consistent with the information she provided to Special Agent Wilson. When Mr. Wilson conducted an interview with Ms. Smoligova, she said that her duties were primarily magnetic resonance imaging duties and that she had one duty regarding nuclear 1
medicine: the ordering of radioisotopes on Friday so that they could be used on 1 Saturday. Ms. Smoligova further told Mr. Wilson that she took direction from l Dr. Ben-Haim on ordering the radioisotopes. Tr. 534-35 (Wilson). Further, she l told OI that Dr. Ben-Haim had given her something in writing to cause her to order the radioisotopes each and every week. Mr. Wilson received a copy of the document (Staff Exh. 8(a)) on the day of the interview. Tr. 535-36. Finally, Ms.
Smoligova informed OI that Dr. Ben-Haim told her if there were any prcblems or emergencies regarding her ordering duties she should contact him. Tr. 536-37 (Wilson).
Special Agent Wilson testified that, during Ol's first interview with Dr.
Ben-Haim, the O! investigators asked him how the technetium-99m was being ordered, and Dr. Ben-Haim "really couldn't answer them. He didn't have an answer of how it was being ordered." Tr. 530. During Dr. Ben-Haim's second interview, Mr. Davis showed Dr. Ben-Haim a copy of the document received from Ms. Smoligova (Staff Exh. 8(a)). According to Mr. Davis, Dr. Ben-Haim recognized the document and identified the top portion as his handwriting. Tr.
547.
Mr. Davis testified that they discussed the process of ordering the technetium-99m. Tr. 544. Mr. Davis testified that Dr. Ben-Haim said that a nurse or a 89 i
secretary from one of Dr. Elamir's businesses would call the receptionist at NMA and give the name of an individual who was scheduled to have a bone scan on Saturday, That name would be placed in a log and, at a later time, the order would be called into Medi-Physics by Ms. Smoligova. Tr. 544.
Mr. Davis testified that "in handing this document to Smoligova, Dr. Ben-Haim admitted to me.that he was giving her the authorization to order the
[ technetium-99m] when it was Lneeded." Tr. 547-48. Further, that Dr. Ben-Haim told him "the Authorized User on the license is the only individual that would be able to delegate this duty" and that the Authorized User on NMA's license .
was Dr. Moskowitz. Tr,548. Mr. Davis testified that Dr. Ben-Haim admitted
- that he had not received the authority to delegate from Dr. Moskowitz and that
. Dr. Ben-Haim told him,"It was impractical to always abide by the small rules."
Tr. 548,549 (Davis).
- Mr. Davis also testified that Dr. Ben-Haim stated that he " owed Dr. Elamir an apology" and that he was " aware that his actions were a mistake" and that he placed the Licensee in jeopardy. Tr. 548-49. Dr, Ben-Haim repeated at the end of the interview that one of his mistakes was " overseeing and delegating -
the authority to order the doses of [ technetium-99m]." Tr. 550, 580 (Davis).
'Ihese sentiments are consistent with those expressed by Dr; Ben-Haim in his proposed findings.
)
However, in his direct testimony, Dr. Ben-Haim stated that he did not admit to 01 giving Ms. Smoligova any authorization to order the radiopharmaceuticals.
Dr. Ben-Haim, ff. Tr. 786, at 3, 5. Dr. Ben-Haim testified he was not aware that his actions were a mistake and placed the Licensee in jeopardy and denied that he said that he owed Dr. Elamir an apology. Tr. 802; Dr. Ben-Haim, ff. Tr.
786, at 3.'
Dr. Ben-Haim testified that Ms. Smoligova received only one single piece of paper and not " notes" and that she did not take direction from Dr. Ben-Haim for ordering the Tc-99m. Tr. 803; Dr. Ben-Haim, ff. Tr. 786, at 4. Dr. Ben-Haim testified that Dr. Elamir designated Ms. Smoligova as the person in charge of ordering the radiopharmaceuticals from the pharmacy and that Dr. Elamir asked Dr. Ben-Haim to write down for her the pertinent information, which he did.
Tr. 808, 809; Dr. Ben-Haim, ff. Tr. 786, at 3, Si Dr. Ben-Haim testified that he "did not know that the Authorized User on
- the license is the only individual who, with respect to NMA, can delegate the ordering duty." Tr. 802. See also Tr. 802,853,854; Dr. Ben-Haim, ff. Tr. 786, -
at 3. Dr. Ben Haim testified that common practice, as documented in the 01 report of interview of John Carr, contradicts this. Tr. 802; Dr. Ben Haim, ff. Tr.
786, at 3. We do not find Dr. Ben-Haim's argument credible because he was familiar with the NRC's regulations and NMA's license: he held himself out in the medical community as having knowledge of the NRC's requirements; he compiled and prepared NMA's license application; and he made it a practice to
know the NRC requirements in his consultant work. Tr. 822-23. In addition, as more fully discussed below, Mr. Carr's statement to OI did not pertain to the requirements placed on NMA and, thus, is inapposite to any discussion of them.
John Carr, Ihcility Manager, MPI Pharmacy Services, Medi-Physics, Inc.,
told OI that, prior to filling NMA's first order for nuclear material, Medi-Physics requested that a copy of NMA's license be faxed to Medi-Physics. See Staff Exh. 8. 01 Exh. 25 (01 interview of John Carr). Mr. Carr told OI this was
" standard operating procedure for MPI."Id. Mr. Carr stated that NMA called in their orders on IViday, for Saturday delivery, and that the "only requirement MPI has, by law, before delivering Tc-99 to a customer, is that the customer prove it has a valid materials license." He added: "In this case, MPI was in possession of an NRC materials license for NMA that appeared to be legitimate." Id.
Dr. Ben Haim admitted he faxed a copy of the license on October 18, 1996, to Mr. Carr in order for NMA to be able to buy radioactive material.
'It 863-64. Dr. Ben-Haim testified that he had no doubt in his mind at the i time he sent Mr. Carr the license that there was an Authorized User and an RSO. Tr. 865. Upon cross examination, Dr. Ben-Haim testified that he wrote
" Radiopharmacy," "Medi-Physics," the 800 number, " bone scan," a nuclear diagnostic procedure, "MDP," and "25 millicuries" on the note he gave to Ms.
Smoligova. Tr. 840-41. See Staff Exh. 8(a). Dr. Ben-Haim also testified that he wrote " Heart," "Myoview," and "two single doses," "8 millicuries" and "25 millicuries." Tr. 841. Dr. Ben-Haim admitted he gave this information to Ms. Smoligova, although he objected to the characterization that they were instructions to her. Tr. 844. Dr. Ben-Haim admitted, however, that he knew she would use the information to order the radiopharmaceuticals. See Tr 844 (Q. "Isn't it a fact that you knew she would use this information to order the radiopharmaceuticals?" A. "Yes.").
Dr. Ben-Haim maintained that he did not tell her or authorize her to order the radiopharmaceuticals. Tr. 844. He added that, since he did not have the authority,"I could not authorize and did not authorize." Tr. 811; Dr. Ben-Haim, )
ff. Tr. 786, at 5. He also denied that he himself ordered the radiopharmaceuticals.
Tr. 844-45 (Q. "Well, did you order the radiopharmaceuticals?" A. "No, I did not."). However, following admission of Staff Exh.15, when asked by the Board whether he placed the first order, Dr. Ben-Haim testified: "No, I don't i remember if I placed the first order. It's possible, possible, but I did not give i my - John Carr knew me from - and I ordered from West Orange. He knew i me and there was a license and I thought at that time that I could order and I may have ordered. I don't recollect." Tr. 886 (emphasis added).
During his cross-examination, Dr. Ben-Haim was confronted with a letter dated October 17,1996. Tr. 846-49. Staff Exh.15. Dr. Ben-Haim admitted that it was a three-paragraph letter that he wrote and faxed to Dr. Elamir on 91
Ey l October 17,1996.' Tr. 847.- Dr. Ben-Haim admitted that he sent the letter two
! days before the first delivery of technetium-99m to NMA. Tr. 848.
l- Paragraphs two and three of the letter state:
!. 2. Please let ne know asap whether we have patients on Saturday. how many and what
. tests, so I may notify the technician and order the radiopharmaceuticals, j
' 3. ' We will have to decide who will place the orders and coordinate the logistics in the future.
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Staff Exh.15.
!- Dr. Ben-Haim testified that ."we" in the letter meant NMA and did not refer l to himself. Tr. 849, 870.. When asked,' "By 'we,' it means you and ElamirT' ~
L- Dr. Ben-Haim replied, "No, not me. I meant NMA. I didn't mean a person."
Tr. 870. When asked who would be speaking for the corporation Dr. Ben-Haim
!. . replied, "Elamir would decide." Tr. 870. Dr. Ben-Haim maintained that he was _
not the one who authorized the ordering and did not implement the ordering.
Tr. 884.
Dr. Ben-Haim admitted that, in paragraph 2 of the letter, it was his plan to l see to it that the radiopharmaceuticals were to be ordered and that, in paragraph I L 3, he was one of the people who was going to help decide the ordering process.
Tr. 850. He admitted that, in writing the letter, it was either his intent to order l
the radiopharmaceuticals or tell the technician to order the radiopharmaceuticals.
Tr.869. ;
Dr. Ben-Haim had only known Dr. Elamir about a week before he became l the consultant for NMA. He agreed that he had far greater knowledge about nuclear materials than Dr. Elamir had. Tr. 850. He also admitted that Dr. Elamir had little experience with NRC requirements. Tr. 826. Finally, Dr. Ben-Haim admitted that Dr. Moskowitz did not delegate the authority of the Authorized User or RSO to him. 'li. 826. 1
- 3. Boerst Analysis We find that the overwhelming weight of the evidence suppotts a finding L
that Dr. Ben-Haim directed Ms. Smoligova, an MRI technologist, to order a
, specific radiopharmaceutical in 25-millicurie-unit doses for nuclear diagnostic procedures. 'Ihe Board bases its finding on the testimony of Ms. Smoligova that l Dr. Ben-Haim gave her written instructions on how much radioactive material l to order, the specific radiopharmaceutical, and from what source, together with i .
her testimony that he told her to place the orders. Further, Dr. Ben Haim admitted that he knew that Ms. Smoligova would use the information to order the radiopharmaceuticals.
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Dr. Ben-Haim stated in his defense that he did not know the only individual who could delegate the ordering duty was the Authorized User. We do not accept that Dr. Ben-Haim, who was knowledgeable of the NRC's regulations !
and who personally put together the license application for NMA, was not aware j
of this requirement. Dr. Ben-Haim further stated that Ol's report of John Carr's interview contradicts the requirement. We find nothing in John Carr's interview ]'
that supports Dr. Ben-Haim's statement. Indeed, there is a difference between what a radiopharmacy must do to comply with state and federal requirements and
{
what a nuclear diagnostic facility must do to satisfy NRC requirements. Finally, we reject as circular reasoning Dr. Ben-Haim's assertion that, since he did not l have the authority to authorize the ordering, he did not authorize the ordering.
Certainly, he did not need to have the authority to order the material in order to cause the material to be ordered without the knowledge of, or direction from, the Authorized User, which is the essence of the 10 C.F.R. 5 30.10 violation.
The Board was also persuaded by the testimony of Special Agent Davis i regarding his interview with Dr. Ben-Haim on April 22, 1997. As previously noted, we find nothing in the record before us to suggest that Mr. Davis either was biased or (with respect to the Authorized User matter) misunderstood the conversation. We therefore find, despite Dr. Ben-Haim's protests to the I contrary, that he admitted to 01 that he authorized Ms. Smoligova to order j the radiopharmaceuticals, that he knew the Authorized User on the license was I the only person who could delegate that duty, and that Dr. Moskowitz had not delegated that duty to him. We also find that Dr. Ben-Haim told Mr. Davis that
"[i]t was impractical to always abide by the small rules" and that this was a true reflection of Dr. Ben-Haim's state of mind.
Finally, we find that Dr. Ben-Haim's October 17,1996 letter to Dr. Elamir sufficiently demonstrates Dr. Ben Haim's intent to bring about the ordering of radiopharmaceuticals. The record does not reflect whether, at the time that letter was written, Dr. Ben.Haim knew that there was no functioning Authorized User. The October 17,1996 letter issues instructions of the type an experienced l physicist would know an Authorized User would issue or approve, but it does I not reflect knowledge that NMA was operating without an Authorized User. In fact, the Staff's August 27,1997 Order did not include October 1997 during !
the period when either the Authorized User or RSO violations assertedly took j place.
In the October 17,1996 letter, Dr. Ben-Haim wrote that he needed to know the number of patients coming in on Saturday and the tests to be performed so that he might " notify the technician and order the radiopharmaceuticals." We find that, based on this information, he determined the 25-millicurie standard dosage (although not the dosage subsequently administered to each patient) and authorized its ordering and subsequent use. We do not accept his arguments that the letter means anything other than what it says.
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( Ms. Geylikman, the nuclear medicine technologist who performed the bone scans, testified that the radioactive material as it was ordered was always 25 millicuries and that it came in unit doses of 25 millicuries for each patient. Tr.
191-92. She stated that 25 millicuries is a standard dose for an injection and that she would be the one who would determine precisely how much to give the patient. Tr. 199-200. She added that it makes some difference if the person is large or small and that she knew how to adjust for the difference. Tr. 188,192.
Ms. Geylikman, however, also testified that she did not determine how much radioactive material to inject, but that each patient came with a doctor's order that said "what to do, what kind of scan to do, and how much is supposed to be." Tr.191,198-99. Ms. Geylikman clarified in response to our questioning that the doctors' orders did not specify the amount of radioactive material to i inject. In this regard, the Board asked whether, when the patients came to NMA )
bearing doctors' orders for bone scans, it was she who determined the amount l of radioactive material to inject. She replied, "Actually, yes. And the same at hospital, it's the same. We know the standard order, the standard dose between 20 and 25, maybe 22,23. It doesn't matter." Tr. 200.
The Board then asked, "And you made some record of [ dosage] for each . . ,
patient?"
Ms. Geylikman, replied, "Yes."
"And the amount?"
"Yes."
"But that would not be on a prescription as such?"
"No." Tr. 202.
Ms. Geylikman's clarification is consistent with Dr. Siegel's testimony that the referring physician would not likely specify the dose for a diagnostic procedure. See Tr. 378-80. With respect to altering doses, Dr. Siegel testified that it is not infrequent that nuclear medicine facilities have a procedure that says something to the effect that if a dose of 25 millicuries is specified, an acceptable dose is that number plus or minus 10%. Tr. 369. Further, that a facility would create a policy on what allowable dose ranges are and that in many facilities the allowable range is not in writing. Tr. 416-17; Tr. 370 (Siegel). He testified that a technologist is not authorized to determine the range, but that the only one who is authorized to write the prescription, which includes decisions about deviations from standard doses as specified in the clinical procedures manual, is the Authorized User. Tr. 370,374. The decision to use 10 millicuries,15 millicuries, or 20 millicuries is a decision made either on a patient-by-patient basis, by the Authorized User, or made on a laboratory-by-laboratory basis where they wish to be in the dose range. Tr. 373,374 (Siegel).
Dr. Siegel further testified that nuclear medicine technologists are not con-sidered licensed practitioners and would be unable to write a prescription and, therefore, would be unable to vary the dose based on their own medical judg-94 i
i ment (Tr. 375). He added that it is not permissible for a technologist to rely on the direction of a physicist who is not a physician in administering an amount to the patient (Tr. 370).
. Based on the above testimony of Ms. Geylikman, we find that she injected the radioactive material into the patients using 25 millicuries as a standard dose because the material was ordered in unit doses of 25 millicuries and that is how the nuclear pharmacy provided it. And they came in unit doses of 25 millicuries because Dr. Ben-Haim determined that dosage and had them ordered as such.
We find that Dr. Ben-Haim deliberately brought about the use of radioactive material at NMA without the authorization or involvement of the Authorized User.
Mr. Kinneman testified that as pan of his responsibilities he had to review the information contained in the 01 report and determine what actions needed to be taken as a result (Tr.107; see Staff Exh. 8). He reached his conclusions based on the OI report, and he assisted in preparing the order against Dr. Ben-Haim (Tr.107-08 (Kinneman)).
Mr. Kinneman viewed 10 C.F.R. I 35.53(c)(3) to have been violated when Dr.
Ben-Haim provided the information and direction to the individuals who actually did order the doses and who administered the doses to the patients (Tr. 278-79).
Stated otherwise, Dr. Ben-Haim directed the individual who ordered the dose, and the dose was waiting for the nuclear medicine technician to administer it to the patient (Tr. 327-28 (Kinneman)). Therefore, since there was no Authorized User, the activities had occurred in the absence of the Authorized User. Tr. 279 (Kinneman). Mr. Kinneman added that Dr. Ben-Haim should have known that there was no RSO or Authorized User at NMA (Tr. 445, 446). Mr. Kinneman concluded that there was intention to continue without the RSO and Authorized User (Tr. 448).
Mr. DelMedico testified that Dr. Ben-Haim violated 10 C.F.R.130.10 if he knew the instructions he was providing would bring about the possession of byproduct material at NMA and he knew that before NMA could possess byproduct material the approval of Dr. Moskowitz was needed. Tir. 683-84.
The Board adopts .t of the Staff's analysis. Dr. Ben-Haim was responsible for ordering byproduct material, and he knew that it would be administered without there being an Authorized User assigned to the facility. Dr. BerrHaim I was also aware of the normal doses that would be administered, bm he was not aware of the particular doses that would be administered to individual patients.
'Ihat amount was determined by the technician, Ms. Geylikman, and was based on her own past practice.
in short, we conclude that Dr. Ben-Haim's actions in determining the doses to j be ordered without the involvement of the Authorized User was intentional and, therefore, constituted a violation of,10 C.F.R. 6 30.10. His knowledge that doses in this general range would be administered to' patients without an Authorized 95
1 User also violates 10 C.F.R. i 30.10, even though he did not direct and was not l
aware of particular doses administered. In this regard, we emphasize our earlier i finding that Dr. Ben-Haim was knowledgeable and held himself out to have expertise in the NRC's requirements and that he personally read and prepared l NMA's license application. He, therefore, knew what the requirements were when he caused NMA to violate them.
- 4. Summary of Findings on Authorized User Violation in summary, we conclude that Dr. Ben-Haim caused NMA to be in violation of 10 C.F.R. 5 35.53(c)(3), by causing NMA to fail to maintain a record of the quantity of radioactive material prescribed by the Authorized User, through his actions of deliberately determining the dosages to' be ordered, and the general ranges of what would be administered to patients, without the Authorized User having prescribed any dosage. Since no Authorized User was involved in the determination of the dosage, there was no prescribed dosage as defined in 10 C.F.R. i35.2. That some records were kept, at the behest of Dr. Ben-Haim, is not in itself to be condemned - indeed, it may serve as an ameliorative factor even though those records were not prescribed by the Authorized User, as required. Thus, the records that NMA kept did not fulfill the requirements of 10 C.F.R. i 35.53(c)(3), which requires the record to include the " prescribed l
dosage." !
We also find that Dr. Ben-Haim intentionally cansed NMA to allow NMA personnel to receive, possess, use, and transfer byproduct material without the supervision of the Authorized User in violation of 10 C.F.R. Q 35.11(a) and (b).
Finally, we find that Dr. Ben-Haim intentionally caused NMA to operate without any Authorized User, a clear violation of NMA's license, if not from the start of operations, at least from December 1996 on. Therefore, we conclude that Dr. Ben-Haim violated 10 C.F.R. 5 30.10 by deliberately causing NMA to be in violation of the above requirements.
K. The Appendix K Violation We address separately that aspect of the Order that alleges that Dr. Ben-Haim caused NMA to be in violation of a provision of its license that sets forth both an RSO and an Authorized User responsibility. 'Ihis " Appendix K" violation touches upon both roles and, therefore, we elected to adtus it separately from those portions of our findings dealing specifically with the RSO and Authorized User violations.
Under Condition 16 of NMA's license, the Licensee is required to conduct its program in accordance with the " statements, representations, and procedures 96 1
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contained in the documents, including any enclosures, listed below." Staff Exh.1. One such document is the license application. Id. License Condition 16 incorporates the application as a part of the license,"as part of the requirements that the licensee must follow and as the basis for issuing the license." Tr. 82 (Kinneman).
Dr. Ben-Haim testified that he was familiar with the information in NMA's license application at supplemental item 10, Radiation Safety Program. He read item 10.6, which states: " Ordering and receiving. We will establish and implement a model guidance for ordering and receiving radioactive material that was published in Appendix K to Regulatory Guide 10.8, Revision 2." Tr.
824; see Staff Exh. 2. He also read Appendix K. Regulatory Guide 10.2, Re-vision 2 and attached it to NMA's license application. Tr. 824. See Staff Exh. 2.
Dr. Ben-Haim read paragraph number I under the heading, "Model Guidance."
Tr. 825. 'Ihat provision states:
The radiation safety offcer, RSO. or a designee must authorize each order for radioactive materials and ensure that the requested matenals and quanuties are authorized by the license for use by the requesting authorized user and that possession limits are not exceeded.
See Staff Exh. 2. ;
Under the NMA license, Appendix K, only the RSO or a designee may autho- !
rize each order for radioactive materials and ensure that the requested materials and quantities are authorized by the license for use by the requesting Autho-rized User and that possession limits are not exceeded. Tr. 285 (Kinneman).
See Staff Exh. 2. Mr. Kinneman testified that Dr. Ben-Haim's actions caused the Licensee to be in violation of this requirement because Dr. Ben-Haim pro-vided the direction to the individual who actually ordered the licensed material ,
by saying how much should be ordered and where it should be ordered from.
Tr.286.
Dr. Ben-Haim testified that Appendix K says that the RSO or a designee can order, but that it does not specify whose designee. Tr. 808-09. "I do not know that only the RSO or a designee of the RSO. It doesn't say that. It says or a designee." Tr. 808. Dr. Ben-Haim testified on cross-examination that he "was not sure by whom" and did not know what " designee" means. Tr. 825-26.
When asked whether he thought that designee meant Dr. Elamir, he stated that he "did not know," although he admitted that Dr. Elamir had little experience with NRC requirements. Tr. 826.
We are unconvinced that Dr. Ben-Haim did not know that designee meant anything other than a designee of the RSO. The subject of the sentence is clear and lends itself to no other rational interpretation. We therefore find that Dr.
Ben-Haim deliberately caused the Licensee to be in violation of a condition of its license and thus he violated 10 C.F.R. I 30.10. In making our finding, we 97 I
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agree with the Staff that NMA's license incorporates, by the terms of License Condition 16, all parts of NMA's license application, such that a violation of a provision in the applicatior constitutes a violation of the license.
III. SANCTION IMPOSED Mr. R. Joseph DelMedico, a Senior NRC Enforcement Specialist in the NRC's Office of Enforcement, described the rationale for the sanction imposed against Dr. Ben-Haim in the Staff's Order. DelMedico, ff. Tr. 659, at 1-13. He testified that the August 27,1997 Order was issued to Dr. Ben-Haim becau;e the NRC Staff concluded that he deliberately caused NMA to be in violation of NRC requirements and therefore violated 10 C.F.R. Q 30.10(a). This conclusion was based on the inspection repon and OI Report. DelMedico, ff. Tr. 659, at 7; Tr. 668.
Mr. DelMedico testified that the Enforcement Policy, NUREG-1600, is the Commission's policy for exercising its authority to take actions to enforce its regulatory requirements. DelMedico, ff. Tr. 659, at 4. See Staff Exh.13. In his view, according to the Enforcement Policy, enforcement actions may be taken against individuals in situations including deliberately causing a licensee to be in violation of NRC requirements, and recognizing a violation of procedural requirements and deliberately not taking corrective action. DelMedico, ff.
Tr. 659, at 5. According to the Enforcement Policy, section VIII, orders to unlicensed individuals may include provisions that would prohibit involvement in NRC-licensed activities for a specified period of time and require the person to tell a prospective employer or customer engaged in licensed activities that the person has been subject to an NRC order. Id. at 7. He Enforcement Policy, section VIII, further states that the particular sanction to be used for enforcement actions involving individuals should be determined on a case-by-case basis. Id.
at8.
Factors for deciding whether to issue an enforcement action to an unlicensed individual (such as Dr. Ben-Haim) are set forth under section Vill of the Enforcement Policy. Id. at 5. These factors are:
- 1. The level of the individual within the organization.
- 2. He individual's training and experience as well as knowledge of the potential consequences of the wrongdoing.
- 3. The safety consequences of the misconduct.
- 4. The benefit to the wrongdoer, e.g., personal or corporate gain.
- 5. He degree of supervision of the individual, e.g., how closely the individual is monitored or audited, and the likelihood of detection.
- 6. The employer's response, e.g., disciplinary action taken.
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j 7. The attitude of the wrongdoer, e.g., admission of wrongdoing, accep-tance of responsibility.
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- 8. 'Ihe degree of management responsibility or culpability.
- 9. Who identified the misconduct.
DelMedico, ff. Tr. 659, at 5-6; Staff Exh.13 (NUREG-1600), at 18. l Mr. DelMedico identified the following factors that were considered in I formulating the enforcement action against Dr. Ben Haim:
1 Aharon Ben-Haim is a consultant who had contracted with the licensee to prepare for State
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and NRC inspections, assure continuous monitoring of the laboratory in compliance with NRC regulations, and assure that proper procedures were used in the handimg of radioactive material. It was apparent to the NRC Staff that Aharon Ben-Haim occupied a position of specialized knowledge, trust, and authority in the eyes of INMA]. as well as any otler licensees for whom he might consult. This gave Aharon Ben-Haim the opportunity to have broad induence over the degree of NRC compliance at such facilities.
Aharon Ben-Haim had experience in NRC comphance matters. In fact, he himself prepared i the NRC license application with commitments to follow a number of procedures that he later caused the licensee to violate. l Since Aharon Ben-Haim was a consultant as opposed to an employee, his misconduct was j unlikely to receive a significant response from the licensee, such as demotion, probation. l or firmg for cause. Presumably, if the licensee terminated Aharon Ben 4taim's consulting l
contract he could still go on to consult at other facilities without the type of detailed check j on previous employment that would occur for the hiring of an employee.
l There was tangible gain to Aharon Ben Haim from his misconduct because the licensee's continued operation, even though it did not have a radiation safety officer or authorized user, would allow Aharon Ben-Haim to continue to earn consulting fees.
The underlying licensee violations caused by Aharon Ben-Hairn's conduct continued in 3
duration from October 19.1996 through January 25.1997. '
. Aharon Ben-Haim's attitude toward the non-compliances caused by his actions was that it was " impracticable to always abide by the small rules."
DelMedico, ff. Tr. 659, at 9-10.
According to Mr. DelMedico, if the factors weigh against an individual, consideration is given to increasing the sanction for that individual; and if they weigh in favor of an individual, consideration is given to reducing the sanction based on that factor. Tr. 728-29. These factors do not necessarily carry equal weight. Tr. 729 (DelMedico).
Regarding the gain Dr. Ben-Haim was expected to receive from engaging in this particular misconduct Mr. DelMedico found tangible gain because the Licensee's continued operation allowed Dr. Ben-Haim to continue to carn consulting fees. Tr. 693. In particular, Dr. Ben-Haim's agreement with NMA provided for a yearly fee of $16,000 payable quarterly at the beginning of each quarter. Tr. 693 (DelMedico); see Staff Exh. 8. 01 Exh. 7 at 2. When asked 99 i'
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by the Board whether the Staff's deliberation was influenced by the fact that there were no safety consequences of Dr. Ben-Haim's deliberate misconduct, Mr. DelMedico testified that the Staff was concerned with the potential safety consequences of an individual who could influence a wide number of licensees, and that the Staff was more concerned with potential safety consequences than actual safety consequences. Tr. 722.
Mr. DelMedico testified on cross-examination that the most important factor is the attitude of the wrongdoer. Tr. 729-30. Regarding this factor, he stated that the Commission has addressed the issue of attitude as follows:
The Commission believes that in addressing the issue of future involvement of an individual in licensed activity, where safety is crucial, it is proper to consider the individual's attitude I toward compliance with safety practices and regulations. Recognition and admission of past errors indicates a more positive attttude than continuing denial or hostility, and thus enhances the Commission's reasonable assurance that licensed activities will be conducted in a manner that protects public heahh and safety. Flowever attitude is only one factor and is not controllbg in the overall determination of appropriate action. i DelMedico, ff. Tr. 659, at 11; see Staff Exh.14, at 40,676.
In the opinion of Mr. DelMedico, the second important factor is the severity level of the underlying violations. Tr. 730. The violations that were caused by Dr. Ben-Haim's actions would be categorized at Severity Level 11 under section l IV of the Enforcement Policy. DelMedico, ff. Tr. 659, at 9. 'Ihe severity level of the violations, however, is one consideration of many. Tr. 755. Other factors l would have been whether Dr. Ben-Haim engaged in deliberate misconduct at another facility or whether the deliberate misconduct was self-reported to the NRC. Tr. 731 (DelMedico).
We find that the Staff considered factors appropriate in determining the sanction to be imposed against Dr. Ben-Haim. But it appears not to have considered, or at least to have de-emphasized, other relevant factors that we ;
regard as worthy of consideration in this case. ;
In particular, we are guided (as was the Staff) by the importance the j Commission places on the individual's attitude toward compliance with the Commission's requirements. We believe that the evidence supports a finding that Dr. Ben-Haim displayed a cavalier attitude toward compliance with the Commission's requirements and that he considered that it was " impractical to always abide by the small rules." We observed during the course of the hearing that Dr. Ben-Haim was not forthcoming in all aspects of his testimony, and we determined that his attitude to that extent falls short of what is required of a consultant to NRC licensees and applicants providing advice regarding compliance with NRC requirements. For example, we find that portions of Dr.
Ben-Haim's testimony were staccessfully impeached when he was confronted with his October 17, 1996 letter. He had testified that he did not authorize 100
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the ordering of radioactive material and that his involvement in this regard was l minimal. Yet, the letter that he wrote to Dr. Elamir, which conveys a sense of urgency, shows that he was an active and knowing participant in the ordering i of radiopharmaceuticals and, in fact, was the initiator of this activity. '
'Ihe letter does not, on its face, reflect whether Dr. Ben-Haim knew at that time whether Dr. Moskowitz was acting as RSO and Authorized User. Nor does l
the record reflect how Dr. Elamir responded to the letter or, indeed, whether he j informed Dr. Ben-Haim on the stams of the RSO or Authorized User. Thus, we do not regard the letter as evidence of willful violation on the part of Dr.
Ben-Haim.
We also agree with the Staff that it was appropriate to consider that Dr.
Ben-Haim occupied a position of authority in the eyes of NMA and other entities for whom he may have consulted. Further, Dr. Ben-Haim was not a l person unfamiliar with the Commission's requirements - indeed, he prepared I the application for the very Ikense that he caused NMA to violate. The Board finds that the Staff correctly took these factors into account, as well as those i
pertaining to the tangible gain to Dr. Ben-Haim from the violations, and the fact that as a consultant, his conduct might otherwise go unchecked.
Under the Enforcement Policy, section IV.C. willful violations, which include deliberate violations, are of particular concern to the Commission because its I regulatory program is based on licensees and their consultants acting with !
integrity; and thus deliberate violations cannot be tolerated by the Commission. j DelMedico, ff. Tr. 659, at 9; Staff Exh.14. The Commission relies on the i licensee and its contractors and its employees to conduct their operations with integrity and in complete compliance with NRC regulations. It is a matter of trust. Tr. 690 (DelMedico). To this end, Mr. DelMedico testified that "it only takes once - one time of deliberate misconduct for the Commission to ;
lose confidence in the ability of the individual to conduct licensed activities in l compliance with Commission requirements." Tr. 719.
Mr. DelMedico further explained that there is a serious question as to how, in the absence of having an inspector there daily or some other form of continuous l
audit, the Commission can possibly have confidence that an individual who l engaged in deliberate misconduct, even if only one time, would not do the same thing another time, either at the same facility or at another one. Tr. 715-
- 16. The Order against Dr. Ben-Haim concluded that the NRC could not have confidence that licensed activities could be conducted safely and in compliance with NRC requirements if Dr. Ben-Haim were to be permitted to be involved in licensed activities. DelMedico, ff. Tr. 659, at Il-12. We agree with the Staff's assessment in this regard and find that the Commission has made it clear that it cannot tolerate willful violations, even if committed only once.
Mr. DelMedico testified that the sanction in this case was established with a view to three specific goals: (1) protection of the public health and safety by 101 I
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b l prohibiting a person who has been known to engage in deliberate misconduct from involvement in NRC-licensed activities; (2) deterring other individuals from engaging in deliberate misconduct that involves licensed activities; and (3) rehabilitation of the individual. De1 Medico, ff. Tr. 659, at 11-12. In 1
his view, the duration of a sanction against an individual who has engaged j in ' deliberate misconduct should be chosen with the intent that the sanction 1 will restore the Commission's confidence in that individual's ability to conduct
, licensed activities with integrity.and candor at the end of the sanction period.
! DelMedico, ff. Tr. 659, at 13.
According to Mr. De! Medico, a 5-year suspension from licensed activities is a sufficient time such that, should Dr. Ben-Haim decide to become involved in licensed activities in the future, he will appreciate the importance of strict compliance with all Commission requirements. DelMedico, ff. Tr. 659, at 13.
This was the same period initially sought against Dr. Elamir, for essentially the same enunciated rationale, but with respect to whom the Staff later settled for a 3 year suspension. Magdy Elamir, M.D., LBP-98-25,48 NRC 226.
'Ihe Board recognizes that the Staff applied appropriate factors in assessing its proposed penalty against Dr. Ben-Haim but believes that other factors also need be considered. In the first place, Dr. Ben-Haim's conduct resulted in no safety consequences, only the potential for such consequences. One of the explicit relevant factors identified by Mr. DelMedico - the third factor included in Part VIII of NUREG-1600, Staff Exhibit 13 at 18 - was thus apparently de-emphasized in the Staff's assessment.
Further, it is unclear to us whether Dr. Ben-Haim's knowledge of the violations commenced prior to December 1996. Even though at that time Dr.
Ben Haim was fully aware of the RSO and Authorized User violations, he should not, in our view, be charged with knowing, intentional violations prior to that date. We note that Mr. DelMedico evaluated the intentional conduct as I commencing as early as October 19,19% (DelMedico, ff. Tr. 659, at 10) but l do not believe the record supports an intentional violation prior to December i 1996. Thus, the two documents (Staff Exhs. 8(a) and 15) that the Staff relies
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on to demonstrate intentional violations at the time they were written (October '
1996) do not, in our opinion, demonstrate a wilfulness or intent to violate NRC regulations at the time the documents were written.
Further, the Staff has given no credence to Dr. Ben-Haim's acknowledgment of and apologies for his wrongdoing. Though late in coming, we believe that Dr.
- Ben-Haim's acknowledgement and apologies set forth in his proposed findings are worthy of some recognition.
Finally, the Staff did not give adequate consideration to factor 8 outlined by Mr. DelMedico, the degree of management culpability in the violations. Even though Dr. Elamir was not technically knowledgeable in radiological matters, it was clearly his business responsibility to hire an RSO and Authorized User.
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here is no record that he ever did so, although he apparently advised Dr. Ben-
' Haim that he was negotiating for an RSO ('n. 440 (Kinneman),527 (Wilson)).
Further, only Dr. Elamir could know with certainty that there was no RSO in the employ of NMA but there is no record that he ever explicitly informed Dr.
Ben-Haim of that critical fact. It was the Staff position that Dr. Ben-Haim had the duty to infer that there was no functioning RSO present. However, such inferences require information, and inferences adverse to an employer require a 4 high degree of certainty. Nevertheless, Dr. Ben-Haim made such an inference sometime in December 1996 and approached Dr. Elamir. However, according to uncontradicted testimony, Dr. Elamir was unresponsive. Thus, Dr. Ben-Haim decided,' wrongfully'as it turned out, not to'"make waves" and to let the matter pass. ' From that point on, we find that he willfully permitted and acquiesced in the continued operation of NMA contrary to NRC regulations. Perhaps he should have acted more decisively with Dr. Elamir; however, Dr. Ben-Haim was not a company officer and did not have the authority to order operations to cease. Dus, it appears that Dr. Ben-Haim's culpability was to some degree -
subordinate to Dr. Elamir's and accordingly less serious than asserted by the ,
Staff, even though still deserving of sanction. f Moreover, it appears that Dr. Ben-Haim was compromised by Dr. Elamir at the inspection conducted by the Staff on January 29, 1997. He Staff had
, informed Dr. Elamir prior to the inspection that it wanted either Dr. Elamir or the RSO to be present at the inspection. Dr. Elamir requested Dr. Ben Haim to attend but there is no record to reflect that Dr. Ben-Haim was informed that he was appearing in the place of the RSO that was requested. Given that situation, it is small wonder that the Staff came to believe that Dr. Ben-Haim had arrogated
.the role of RSO to himself. We find that appearance resulted from the actions or omissions of Dr. Elamir and was not evidence in itself that Dr. Ben.Haim knowingly acted as RSO.
In addition, the Staff has compared Dr. Ben-Haim's violations with those
- for Severity Level II, which under the Enforcement Policy are applied both
' to the imposition of orders (as here) and to the assessment of civil penalties.
NUREG-1600 (Staff Exh.13). With respect to civil penalties, the Enforcement Policy states that the gravity of the violation is the primary consideration but
. that " ability to pay" may also be considered: "it is not the NRC's intention that
' the economic impact of a civil penalty be so severe that it puts a licensee out of business." NUREG-1600, citing 60 Fed. Reg. at 34,387.
l Similar considerations may be applied to suspension orders. Given the I circumstance that Dr. Ben-Haim was age 65 when the Order was issued and would be age 70 at the end of the 5-year suspension, the suspension sought by the Staff could very well be practically equated to a death sentence against further involvement in nuclear activities. (An order barring further participation could have been, but was not, sought.) )
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8eyond that, the Commission has clearly . indicated that the length of a suspension is discretionary. Mr. DelMedico testified that penalties in cases such as this could range anywhere from "no action at all" to a 10-year suspension (Th 699.)
Comparing the proposed 5-year suspension of Dr. Ben-Haim with the 3-year suspension recently approved by the Staff and sanctioned by a Licensing Board comprised of the same Administrative Judges as this one with respect to Dr.
Elamir - see LBP-98-25, supra 5- the 5-year period of time for the proposed suspension of Dr. Ben-Haim is excessive. The following additional factors must also be taken into account: (1) Dr. Ben ilaim's age - 65 at the onset of the suspension (see Exhs. BH-6, BH-8); (2) his admission of his mistakes and his apology set forth in his propose <1 findings; (3) the fact that the violations resulted in no safety consequences (only the potential for such consequences); (4) the fact that the willful and intentional violations did not commence prior to December 1996; and (5) the fact that Dr. Ben-Haim's violation was at least influenced by Dr. Elamir. Bastd on these additional factors, we find that only a 3-year prohibition fiom NRC-licensed activities is appropriate and justified, coupled with the teporting requirements imposed by the Staff (which we do not modify) for any NRC-licensed activities performed for 5 years following expiration of the suspension. The suspension of Dr. Ben-Haim will expire July 31,2000. i l
IV. CONCLUSIONS OF LAW The Board has considered all of the evidence presented by the parties pertaining to the Staff's Order prohibiting Dr. Ben-Haim's involvement in NRC-licensed activities. Based upon a review of the entire record in this proceeding and the proposed findings of fact and conclusions of law submitted by the parties, and based on the findings of fact set forth herein, which are supported I by reliable, probative and substantial evidence in the record, the Board has decided all matters in controversy and reaches the following conclusions, i
Based on the foregoing findings of fact, the Board finds that Dr. Ben-Haim caused NMA to be in violation of the following Commission regulations: 10 C.F.R. il E ! '(a) and (b), 35.13,35.21,35.53(c)(3). The Board also finds that Dr. Ben-Haim caused NMA to be in violation of License Conditions 12,13, and 16. We find that these actions were deliberate on the part of Dr. Ben-Haim,
! for the period beginning in December 1996, and, thus, he violated 10 C.F.R.
! 30.10.
5 9'e acknowledge, however. Giat de 3-year suspension of Dr. Elanur was protably based in part on the fact that there was a settlenwnt anumg de parues in that proceeding but aho note Gutt the fact of nettienent shmdd have httle to do with de trust that de Comnussion may be able to place in de indmdual.
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I l t Based on those violations and the testimony and documentary evidence submitted in this proceeding, the Board finds that the Staff has sufficiently met its burden of proof (except with respect to the length of the proposed suspension) and has shown by a preponderanc; of the evidence that the Order should be sustained (but modified to reduce the suspension from 5 to 3 years). Under the Order, the Staff also has discretion to reduce further the suspension, upon request by Dr. Ben-Haim.
V. ORDER On the basis of the foregoing opinion, including findings of fact, conclusions of law, and the entire record, it is, this 8th day of February 1999. ORDERED:
- 1. The Staff's August 27,1997, " Order Superseding Order Prohibiting in-volvement in NRC-Licensed Activities (Effective Immediately)," is MODIFIED and, as so modified SUSTAINED.
3 . This initial Decision is effective immediately and, in accordance with 10 U.F.R. 9 2.760 of the Commission's Rules of Practice, shall become the final action of the Commission forty (40) days from the date of its issuance, unless any party petitions for Commission review in accordance with 10 C.F.R. 5 2.786 or the Commission takes review sua sponte. See 10 C.F.R. 9 2.786.
- 3. Within fifteen (15) days after service of this Decision, any party may seek review of this Decision by filing a petition for review by the Commission i
- on the grounds specified in 10 C.F.R. 5 2.786(b)(4). The filing of the petition for l review is mandatory for Dr. Ben-Haim to exhaust his administrative remedies 1 before seeking judicial review.10 C.F.R. 5 2.786(b)(2).
- 4. The petition for review shall be no longer than ten (10) pages and shall contain the information set forth in 10 C.F.R. 6 2.786(b)(2). Any other party i may, within ten (10) days after service of a petition for review, file an answer supporting or opposing Commission review. Such an answer shall be no longer than ten (10) pages and, to the extent appropriate, should concisely address the l
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I matters in 10 C.F.R.12.786(b)(2).' A petitioning party shall have no right to reply, except as permitted by the Commission.
THE ATOMIC SAFETY AND LICENSING BOARD - 1 Charles Bechhoefer, Chairman ADMINISTRATIVE JUDGE ,
i Dr. Jerry R. Kline I ADMINISTRATIVE JUDGE Dr. Peter S. Lam 4
.. ADMINISTRATIVE JUDGE
)
Rockville, Maryland February 8,1999
[ Appendix A has been omitted from this publication but can be found in the NRC Public Document Room,2120 L Street, NW, Washington, DC 20555.]
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! j Cile as 49 NRC 107 (1999) LBP-99-5 4
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL Before Administrative Judges:
Peter B. Bloch, Presiding Officer Richard F. Cole, Special Assistant in the Metter of Docket No. 40-8681-MLA-4 (ASLBP No. 98-748-03-MLA)
(Re: Material License Amendment)
CORPORATION (Receipt of Material from Tonewanda, New York) February 9,1999
'Ihe Presiding Officer affirmed the grant of a license to Applicant to receive Ashland 2 material from Tonawanda, New York. He rejected the argument of the State of Utah that "the Amendment does not comply with Commission Guidance because the material is not byproduct material and must therefore be disposed of at an appropriate facility rather than being subject to ' sham disposal.'" Instead, .
the Presiding Officer reasoned that the material being received by IUSA is !
ore because it "is processed primarily for its source material content when the extraction of source material is the principal reason for processing the ore.
Under those circumstances, the material falls within the NRC's jurisdiction over the uranium fuel cycle."
BYPRODUCT MATERIAL: ORE; 42 U.S.C. 5 2014e(2)
Under 42 U.S.C. 5 2014e(2) the phrase " processed primarily for its source material content" should be given its natural meaning. The adverb "primarily" modifies the verb " processed." Therefore, ore is processed primarily for its' 107 f
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source material content when the extraction of source material is the principal i
reason for processing the ore. Under those circumstances, the material falls within the NRC's jurisdiction over the uranium fuel cycle.
BYPRODUCT MNTERIAL: ORE; ALTERNATE FEED GUIDANCE ne Proposed Position and Guidance on the Use of Uranium Mill feed Ma- I terial Other Than Natural Orcs,57 Fed. Reg. 20,525,20,533 (1992) (" Alternate I Feed Guidance") makes it clear that if source material is extracted from a ma-terial at a licensed uranium mill, then the material is considered to be " ore,"
providing that it does not contain hazardous waste and that it is processed so that a useable product, uranium, is extracted from it.
INITIAL DECISION (Denying the Relief Requested by the State of Utah)
The State of Utah's Written Presentation pursuant to 10 C.F.R. 6 2.1233 is titled, "Brief in Opposition to International Uranium (USA) Corporation's Source Material License Amendment," December 7,1998 (Brief). This brief and the responses to it' form the basis for the determination of whether the State's concerns should be sustained or dismissed. !
He license amendment Utah complains of, Amendment 6, allows the Interna-tional Uranium (USA) Corporation (IUSA) to process as an alternate feedstock at its mill certain uranium-bearing material from the Ashland 2 site located in Tonawanda, New York. The Ashland 2 site is administered by the Army Corps of Engineers ("USACE") under the Department of Energy's (" DOE's") l Termerly Utilized Sites Remedial Action Program (FUSRAP).2
)
The State's principal argument is that the Amendment does not comply with Commission guidance because the material is not byproduct material and must therefore be disposed of at an appropriate facility rather than being subject to
" sham disposal" It maintains that "Ile.(2) byproduct material requires that the ore be ' processed * *
- primarily for its source material content' and thus would not permit . . . sham disposals." (Emphasis in original.) Brief at 4-5, citing 3
The International Uranium (USA) Corporauon's (IUSA) Reply was hied on January 19.1999, and the Staff of the U.S. Nuclear Regulatory Comnussion's (staf0 Reply was filed on January 29.1999.
2 The FUsRAP program was established by the Atomic Energy Comminion (AEC")in 1974. to clean up and control radioactive contamination at sites associated with actmues that were previously carned out on behalf of the Manhattan Engineenng Dir.rict. its successor the AEC. and other related encues during the early days of the nation's nuclear progrant See generally U.S. Department of Energy. The Formerly Utaned Surs Remednal Actwn Program fFUSRAP): Building Stakeholder Partnershups to Achirn Effernw Cleanup. DoEKM4)233
, (April 1995).
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j Proposed Position and Guidance on the Use of Uranium Mill Fred Material Other l
Than Natural Ores,57 Fed. Reg. 20,525,20,533 (1992) (" Proposed Guidance"). I I conclude that the State misconstrues the Atomic Energy Act, which defines j
- as byproduct materials "the tailings or wastes produced by the extraction or .
concentration of uranium or thorium from any ore processed primarily for its source material content." Atomic Energy Act of 1954 as amended,42 U.S.C.
52014e(2).
Re State interprets " processed primarily for" to require a test of motive or
(
1 purpose. It argues that the IUSA is processing this material primarily for the fee it is being paid for receiving the material and it attempts to show that the fee exceeds the amount of money that will be recovered by extracting uranium '
from the material.
While the State's argument has some superficial appeal, the phrase " processed primarily for its source material content" should be given its natural meaning.
The adverb "primarily" modifies the verb, " processed." Therefore, ore is processed primarily for its source material content when the extraction of source material is the principal reason for processing the ore. Under those i circumstances, the material falls within the NRC's jurisdiction over the uranium i fuel cycle.3 Accordingly, when the extraction of uranium is the principal reason l that ore is processed, it meets the test of this section and is byproduct material.*
If, on the other hand, the material were processed primarily to remove some other substances (vanadium, titanium, coal, etc.) and the extraction of uranium was incidental, then the processing would not fall within the statutory test and it would not be byproduct material within the meaning of the Atomic Energy Act.
That is, the adverb, "primarily," applies to what is removed from the material by the process and not to the motivation for undertaking the process. J This reading is consistent with the Uranium Mill Tailings Radiation and Control Act of 1978, as amended (UMTRCA),2(b)(2),42 U.S.C. 6 7901, which j states that a purpose of that Act is 1
to regulate mill tailings dunng uranium or thorium ore processing at active mill operations and after tennination of such operations in order to stabilize and control such tailings in a safe !
t and environmentally sound manner and to minimize or climinate radiation health hazards to i
l the public.
Moreover, the legislative history of the definition of byproduct material incorpo-l rated into Section lle(2) of the Atomic Energy Act shows that it was intended j l to focus on the nuclear fuel cycle. NRC Chairman, Joseph M. Hendrie, testified: l i
3 3re Chairman Hendrw's renurks on p.110.
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'Tlete are two reasons to remove uranium: the value of the naterial that is removed and the reduced expense i of disposing or the materud. Ordmarily. material processed at a nuc! car fuel cycle facihty would be considered I to he proccued pnmanly to remove uramum.
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[T]he intent of the language is to keep NRC's regulatory authority primarily in the field of the nuclear fuel cycle. Not to extend this out into such things as phosphate mining and perhaps even limestone mining, which are operations that do disturb the radium-bearing crust of the Earth and produce some exposures, but those activities are not connected with the nuclear fuel cycle.
Uranium Mill Tailings Radiation Control Act of1978: Hearings on H.R.11698, H.R.12229, H.R.12938, H.R.12535, H.R.13049, and H.R.13650 Before the Subcomm. on Energy and Power of the House Comm. on Interstate and Foreign Commerce, 95th Cong.143-44 (1978)(statement of Joseph N. Hendrie, Chairman of Nuclear Regulatory Commission).
'Ihis definition of byproduct material reaches a sound practical result in this case. The State of Utah describes the transaction in this case, at 6-8 of its Brief, as follows:
The Ashland 2 material is located on a U.S. Army Corps of Enginect's ("USACE" or
- Corps") Formerly Utilized Site Remedial Action Program ("FUSRAP'*) site at Tonawanda.
New York. ICF Kaiser is the Corps' prine contractor for the cleanup of the IUSRAP Tonawanda site. As discussed in Mr. Herbert's Testimony, the State obtained a copy of ICF Kaiser's request, price analysis, and suminary of waste disposal alternatives submitted to the Corps in support of the award of a contract to IUSA "for material handling and disposal services" for the Ashland 2 mate ial. See Exhibit 3 attached to Mr.11erbert's testimonyf] According to ICF Kaiser's Price Analysis, ICF Kaiser conducted a market survey to " determine the firms who regularly provide material handling and waste disposal services." All the firms identified, with the exception of IUSA, are pertmtted as waste disposal facilities (Lc., Envirocare, Envirosafe, Laidlaw, and Waste Control Specialists).
Under the contract, ICP Kaiser will pay transportation costs to deliser the Ashland 2 matenal to the White Mesa mill. IUSA will collect a material handling and disposal fee of $90/ cubic yard of Ashland 2 rnaterial received at the mill. lUSA initially estimated that the Ashland 2 material would contain a maximum of 25.000 dry tons. Ilowever, IUSA has now informed the State that the amount of Ashland 2 material it will receive will be as much as 45.000 cubic yards. lierbert Testimony at 6. Based on this latest estimate of the amount of material IUSA will receive, the material handling and disposal fees total $4,050.000. lierbert Testimony at 9. Additionally, Mr. IIerben used the current market price of yellowcake and various estimatu of Ashland 2's uranium concentration to calculate possible value of uranium thra could be processed from the Ashland 2 material. Without waste-spectfic density data, Mr.
llerbert used the assumption that the density of the Ashland 2 matenal nnges from 80 to 100 lbs/ cubic foot. Ilerbert Testimony at 6.
8 The State han independently obtauned a copy of the signed contract between IUSA and ICF Kaiser. IUSA has aswrted to tie State that this contract thould be treated as conhdential. As the informauon in the contract is not inconsistent with the infornmuon that ICF Kaiser presented to the Corps, the state will forego, for now, introducing the IUSA-ICF Ksuser contract into evidence in this proceedmg. However, IUSA has itnelf disclosed contract cost informanon to NRC in the Ashland 2 hceme anendment request See Attachment 3 thereto WSACE Value Engmeering I*rupusalfor Ashland I and Ashtund 2).
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l The range of potential uranium values, based on weight percent of uranium-238 listed in s Tonawanda PUSRAP documents, is as follows:
Value Density ' Uranisun Centent
$ 68,040 80 lbs/ cubic foot 0.008 percent
$ 85,050 100 lbs/ cubic foot 0.008 percent
$221,130 80 lbs/ cubic foot 0.026 percent
$276,413 100 lbs/ cubic foot 0.026 percent
$493,290 80 lbs/ cubic foot 0.058 percent
$616,613 j 100 lbs/ cubic foot 0.058 percent
]
Herbert Testimony at 8. Thus, the gross value imm uranium extraction - which does not take into account the costs of extracting the material - ranges from $68,000 to a little more -
i than $600,000 depending on the actual density of the naterial and its total uranium content. '
id.
I conclude that the scenario presented by the State of Utah is a good practical argument for permitfing the milling of uranium contained in the Ashland 2 ]
l materials. First, IUSA produced the lowest bid for recycling these materials.
Why? As the State of Utah has explained,IUSA would remove some uranium from the materials and would make at least a small profit on that activity, Second, from an environmental standpoint, it is preferable to extract uranium before burying waste materials that contained it. Third, even the State of Utah projects a net profit from the milling activity, Hence, it is reasonable to predict that the milling will actually occur Since the milling will occur, it is not a l " sham" as the State has argued, It is real.'
Here is the way that IUSA expressed this same point on page 55 of its Reply:
1 IUSA will be recycling obstantial quantities of a valuable material. As already discussed,
! even based on the conservative numbers calculated by the State, IUSA is hkely to recover between 8,000 to 70,000 pounds cf uranium from its processing of the Ashland 2 material.
In all likelihood, if IUSA were not pnwessing the Ashland 2 material this substantial quantity of valuable uranium would be lost to disposal. Recovering and recychng such a substantial quantity of valuable uranium is an important benefit, and provides an additional justification for IUSA's certification.7 This was perceived to be a benefit by USACE, the l agency administering remediation of the Ashland 2 site, which is one of the reasons why i
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6 lt seems to me that the only " sham" that stops material from being bypmduct matenal is if it is not actually nulled. If it is nulled, then it is not a sham. I 7 '
Indeed, as EPA has noted, recycling can be legitimate and beneficial even ifit is not profitable. See generally 63 red. Reg. at 28.556.
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i IUSA was chosen by USACE and committed contractually to process the Ashland 2 rnaterials for the recovery of uranium;8 Second, by recovering uranium from the Ashland 2 material,IUSA's processing makes the material less radioactive, thereby reducing the hazards associated with its ultimate disposition and, in effect, making it safer for disposal. This was also perceived to be a benefit by the USACE and hence is another reason that IUSA was chosen to and contractually committed to process the Ashland 2 materials for the recovery of uranium; Third, tecycling the Ashland 2 material provides a benefit to the government, and therefore to the pub!!c at large, by allowing the FUSRAP prograrn to reduce its inventones of unwanted materials and accomplish environment clean up in a manner that is environmentally sound, that is cost efficient, and that allows for the recovery of a valuable product that would otherwise be disposed; .
iburth, the Ashland 2 materials are lle.(2) byproduct materials that originated from conventional ores and are therefore chenucally, radiologically and physically similar to the existing Mill tailings and should be expected to be able to be processed for the recovery of uranium at the Mill; and, Finally, IUSA has a history of successfully extracting uranium from alternate feed materials and has developed credibihty with the NRC, not only for being technically competent, but also for fulfilling its proposals to recover uranium from alternate feeds.
He Alternate Iked Guidance is not supportive of the position, taken by the State of Utah, that material is to be considered byproduct only if the primary economic motivation is to remove uranium rather than to dispose of waste, Ihr example, on page 4 of its Brief, the State quotes the following out of context:
the potential of converting niatenal that would have to be disposed of as (Low level Radioactive Waste ("LLW")] or mixed waste into ore, for processing and disposal as Ile.(2) l byproduct material. The possibility of converting such wastes to Ile.(2) byproduct material
! can be very attractive to owners of such material. An owner of such material could pay a null operator substantially less to process it for its uranium content and dispose of the resulting Ile (2) byproduct matenal than to dispose of the material as waste at an appropriate facility, s Thus, in its value engineenng proposal for disposition of the Ashland 2 natenal, the USACE specihcally hated among the advantages associated with IUSA's processing of the natenal.
ADVANTAGES
- 1. Conforms to Congressional and regulatory nmndates which encourage uw of recychng.
l 2. Reduces rmlicachvity of the nmterial to he disposed of.
l 3. Recycles uranium and other minerals.
- 7. Actual cost savings for treatment and disposal versus cost of direct dnposal can only be greater than projected in this pmposal, dependmg upon the actual content of recoverable uranium or eller nunerals found in the waste stream.
See t/SACE Vulme Engmeenna Pmpmal Proposal & C-II, onginally included with IUS A's beense amendment upphcation, by letter from Michelle R. Rehmann to Joseph 1 Holonich (May 8.1998). ISee IUSA Responw, Exh.7) t l
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. Proposed Position and Guidance on the Use of Uranium Mill Red Material Other 'Ihan Natural Orcs, .57 Rd. Reg. 20,525, 20,533 (1992) (" Alternate Red Guidance").
I find the interpretation of the State of Utah to be misleading because this
- same Alternate Red Guidance, at 20,532-33, makes it clear that if source material is extracted from a material at a licensed uranium mill, then the material is considered to be " ore," providing that it does not contain hazardous waste' and that it is processed so that a useable product, uranium, is extracted from it. Accordingly, I conclude that IUSA meets the requirements of statute and r guidance. It is not involved in a sham. It is milling ore and its license was
- j. appropriately granted to it.m l
ORDER Br all the foregoing reasons and upon consideration of the entire record in this matter, it is, this 9th day of Rbruary 1999. ORDERED that:
, 11 The relief requested by the State of Utah in its December 7,1998,"Brief L in Opposition to International Uranium (USA) Corporation's Source Material i License Amendment"is denied.
- 2. This Decision is reviewable under 10 C.F.R. 5 2.1253, pursuant to the procedures set forth in 10 C.F.R. 56 2.786 and 2.763. The petition for review
, must be filed within 15 days of the service of this Decision.,
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Peter B. Bloch, Presiding Officer ADMINISTRATIVE JUDGE Rockville, Maryland -
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'The State of Utah has satashed itself that the Ashland 2 natenal does not contain Imzardous waste. Utah Brief at 3. The adequacy of the Staff's safety review is irrelevant. Curators of the University of Missoort CLI-951, I~ 41 NRC 78,121 (1995).
l "The State has failed to show any rnalerial respect in which the Staff's environnental review of this license amendrnent was dehcient. The assertion that the state's regulations rnay be nere stnngent than the NRC's does
. not dernonstruee the inadequacy of the environtnental review.-
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Cite as 49 NRC 114 (1999) LBP-91Hi UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD Before Administrative Judges:
G. Paul Bollwerk,111, Chairman Dr. Jerry R. Kline Dr. Peter S. Lam .
I in the Matter of Docket No. 72-22-ISFSI i (ASLBP No. 97 732-02-ISFSI) t i
PRIVATE FUEL STORAGE, LLC. I (Independent Spent Fuel Storage installation) February 17,1999' j l
in this proceeding concerning the application of Private Fuel Storage, L.L.C.
(PFS), under 10 C.F.R. Part 72 to construct and operate an independent spent fuel storage installation (ISFSI), the Licensing Board approves a notice of withdrawal, with prejudice, submitted by Intervenors Castle Rock Land and Livestock, L.C., and Skull Valley Company, Ltd., and denies the request of Intervenor State of Utah to adopt their contentions as late-filed.
RULES OF PRACTICE: WITHDRAWAL OF INTERVENOR With an intervenor's approved exit from a proceeding, those admitted con-tentions for which it is the sole sponsor also depart. Acconfingly, in the absence of prior timely adoption by anotner intervenor, those contentions can be pre-served for further consideration only if an intervenor shows that the issues are admissible under the late-filing standards of 10 C.F.R. 9 2.714(a)(1). See Hous-son Lighting & Power Co. (South Texas Project, Units 1 and 2), ALAB-799,21 NRC 360,382-83 (1985).
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RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (GOOD CAUSE FOR LATE FILING) l Although the Appeal Board in the South Texas proceeding was concerned that a blanket stricture on the later adoption of a withdrawing party's contentions would complicate litigation and settlement by encouraging " nominal" contention co-sponsorship at a proceeding's outset, see ALAB-799,21 NRC at 384, that consideration is not implicated when, as is apparent from its previous late-filed pleading seeking to adopt all other Intervenors' contentions, an Intervenor sought early on to impose those complexities in this proceeding and failed to make the appropriate arguments. Under the circumstances, no reason exists to provide a second bite at the apple, especially when the Intervenor's ultimate justification is based on no more than the " trusted others to vigorously pursue" line of argument rejected in South Texas. See id. at 382-83.
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (GOOD CAUSE FOR DELAY)
A failure to demonstrate good cause for late-filing requires there be a
" compelling showing" regarding the other four late-filing factors.1.BP-98 7, 47 NRC 142,208 (1998).
1 RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (OTHER MEANS AND OTHER PARTIES TO PROTECT INTERVENORS' INTERESTS; ASSISTANCE IN SOUND RECORD DEVELOPMENT; DELAY)
Late-filing factors two and four - availability of other means to protect the petitioner's interests and extent of representation of petitioner's interests by other ,
l parties - are accorded less weight in the balance than factors three and five - l assistance in developing a sound record and broadening the issues / delaying the proceeding. See LBP-98-7,47 NRC at 208; see also LBP-98-29,48 NRC 286,-
294 (1998).
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (DELAY)
Late-filing factor five - broadening the issues / delaying the proceeding -
clearly does not weigh in favor of admission when the contentions otherwise !
l would not be part of the proceeding because of the sponsoring intervenor's withdrawal. See South Texas, ALAB-799,21 NRC at 382 (rejecting argument i
applicant will not be prejudiced if required to litigate previously admitted l
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contentions of withdrawing intervenor because applicant already knew those issues would be explored).
MEMORANDUM AND ORDER (Approving Notice of Withdrawal and Denying Request to Adopt Contentions as Late Filed)
- Applicant Private Fuel Storage, L.L.C. (PFS), has requested agency autho-rization to construct and operate a 10 C.F.R. Part 72 independent spent fuel storage installation (ISFSI) on the Utah reservation of the Skull Valley Band of Goshute Indians (Skull Valley Band). Pending with the Licensing Board is the December 21,1998 notice of Intervenors Castle Rock Land and Livestock, L.C., and Skull Valley Company, Ltd. (Castle Rock), declaring their intent to withdraw from this proceeding convened to adjudicate various Intervenor con-cerns about the PFS application. In response to that notice, intervenor State of Utah (State) has requested that it be permitted to litigate two of the three con-tentions for which Castle Rock has had sole responsibility as well as all portions of those Castle Rock contentions that previously were consolidated with other Intervenors' issues by the Licensing Board. Applicant PFS opposes the State's request in toto, while the NRC Staff accepts it in part and opposes it in part.
For the reasons set forth below, we accept the Castle Rock notice of withdrawal, with prejudice, and dismiss all the Castle Rock unconsolidated ,
contentions and portions of the consolidated contentions.
L BACKGROUND j i
On December 21,1998, Castle Rock filed a notice of withdrawal, declaring .
that they "hereby voluntarily and with prejudice withdraw from this proceed- )
ing . . . " Notice of Withdrawal of [ Castle Rock) (Dec. 21.1998) at 1. In the letter accompanying that request, Castle Rock asked that the Board approve the withdrawal notice. See Letter from Bryan T. Allen, Counsel for Castle Rock, to the Licensing Board (Dec. 21,1998) at 1. The Board permitted party com-ments on the Castle Rock withdrawal notice, and the State PFS, and the Staff responded.
Regarding the Castle Rock contentions, or portions of contentions, admitted by the Board in LBP-98-7, 47 NRC 142 (1998), the State declared that notwithstanding the Castle Rock departure from this proceeding, it wished to pursue (1) two of the three Cutie Rock contentions - Castle Rock 17 and 20
- that were admitted but not consolidated with other Intervenor contentions; and (2) all facets of the seven contentions that contained consolidated portions 116 l
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of Castle Rock contentions. See [ State] Response to Castle Rock's Notice of 1 q
1 Withdrawal (Jan. 5,1999) at I [ hereinafter State Response]. According to the i State, most of the Castle Rock contentions are " inextricably intertwined" with the State's contentions so as to preclude any dissection of their contentions from the other parties' issues. Nonetheless, for those that are not, the State asserted -
it meets the late-filing criteria of 10 C.F.R. 9 2.714(a)(1) so as to permit their ,
adoption now.- 14. .. .
(
' PFS and the Staff contended that with Castle Rock's withdrawal, all three
- unconsolidated contentions and different portions of the seven consolidated con-tentions should be dismissed. See Applicant's Response to Notice of Withdrawal
- of [ Castle Rock] (Jan. 5,1999) [ hereinafter PFS Response]; NRC Staff's Re-sponse to Castle Rock's Notice of Withdrawal (Jan. 5,1999) [ hereinafter Staff Response]. PFS sought dismissal of portions of five consolidated contentions
- Utah F/ Castle Rock 7/ Confederated Tribes F; Utah K/ Castle Rock 6/ Con-federated 'IYibes B; Utah O/ Castle Rock 8 and 10; Utah S/ Castle Rock 7; and
- Utah T/ Castle Rock 10,12, and 22 - while the Staff declared that parts of only three - Utah F/ Castle Rock 7/ Confederated Tribes F; Utah O/ Castle Rock 8 and'10; and Utah T/ Castle Rock 10,12, and 22 - should be excised. See PFS Response at 5-9; Staff Response at 4 5. In addition, PFS declared that any State attempt to have the admitted Castle Rock contentions (or portions thereof) '
remain in the proceeding under the late-filed contention criteria of 10 C.F.R.
- 9 2.714(a)(1) should be rejected. See PFS Response at 9-10.
In simultaneous reply filings submitted on January 15,1999, the State, PFS, and the Staff offered their positions concerning the earlier party filings. With regard to the consolidated contentions, the State asserted those issues should be left as specified in LBP-98 7 because of the way the Board initially structured the proceeding, the amount of resources the State has devoted to the case in reliance on its current structure, and the implications that can be drawn from
- uncoupling the consolidated contentions. See [ State] Reply to NRC Staff's and ' Applicant's Responses to Castle Rock's Notice .of Withdrawal (Jan.15, 1999) at 2-4 [ hereinafter State Reply). Alternatively,' the State maintained it ;
should be permitted to litigate the Castle Rock consolidated contentions, as j well as the u'nconsolidated contentions, as late-filed because they independently j are admissible under the section 2.714(a)(1) criteria. See id. at 4-13. PFS, {
on the other hand, declared the Castle Rock consolidated and unconsolidated contentions identified in its initial filing should be dismissed because the State's attempt to retain them in this proceeding is impermissibly late-filed. See
~ Applicant's Reply to [ State] Response to Castle Rock's Notice of Withdrawal 1 (Jan.15,1999) [ hereinafter PFS Reply]. With one minor revision, the Staff j maintained its position regarding the dismissal or retention of the Castle Rock )
consolidated and unconsolidated contentions. See NRC Staff's Reply to [ State] l I '117 l l
q-a
Response to Castle Rock's Notice of Withdrawal (Jan. 15,1999) [ hereinafter Staff Reply].
II. ANALYSIS With Castle Rock's exit from this proceeding, which we approve, those admiued contentions for which it is the sole sponsor also depart. Accordingly, in the absence of prior timely adoption by another intervenor, those contentions can be preserved for further consideration only if an intervenor shows that the issues are admissible under the late-filing standards of 10 C.F.R. 6 2.714(a)(1).
See Houston Lighting & Power Co. (South Texas Project, Units 1 and 2), ALAB-799,21 NRC 360,382-83 (1985). We have described and applied those criteria in several other instances in this proceeding. See LBP-99-3,49 NRC 40,46 (1999) (citing cases).
With the exception of contention Castle Rock 21, the State now seeks to preserve all of Castle Rock's admitted contentions, whether those issues stand akme or have been consolidated with another party's contentions. Neither PFS nor the Staff contest the fact that two of the seven consolidated contentions -
Utah AA/ Castle Rock 13 and Utah DD/ Castle Rock 16'- should remain intact as State contentions. We now redesignate those issues as Utah AA and Utah DD. As to the others, however, in addition to considering the State's arguments about the scope of certain consolidated contentions, each Castle Rock contention the State seeks to preserve must be judged in accordance with the late-filing standards of section 2.714(a)(1).
A. Unconsolidated Contentions - Castle Rock 17 and Castle Rock 20 DISCUSSION: State Response at 10-15; PFS Response at 9-10; Staff Re-sponse at 10-15; State Reply at 2-3; PFS Reply at 2-6; Staff Reply at 4-8.
RUUNG: Relative to factor one - good cause for late-filing - we are unable to find that the State has made the showing needed to place this important factor on the admissibility side of the section 2.174(a) balance.
The State (unlike Intervenor Confederated Tribes of the Goshute Reservation (Confederated Tribes), see iq/ra p.120) did not initially express a " shared I
- concern" with Castle Rock about certain of their issues, a factor the South Texas Appeal Board found significant in concluding that a subsequent attempt to adopt other contentions of a departing intervenor was not supported by good cause.
See ALAB-799,21 NRC at 383-84 & n.106. Instead, the State in this instance waited until approximately one month later te seek to adopt these Castle Rock contentions (as well as the contentions of all other Intervenors), albeit without addressing the late-filing standards, which was a defect we later found warranted 118 l
l I
r rejection of its request. ' See ! BP-98-7, 47 NRC at 163,182. Despite these differences, however, the result here is the same as in South Texas.
Acknowledging the South Texas Appeal Board's concern that a blanket stricture on the later adoption of a' withdrawing party's contentions would:
complicate litigation and settlement by encouraging " nominal" contention co-sponsorship at a proceeding's outset, see ALAB-799, 21 NRC at 384, in this instance that consideration is not implicated. As is apparent from its previous late-filed pleading seeking to adopt all intervenor contentions, the State sought carly on to impose those complexities in this proceeding. Having failed to make the appropriate arguments at that time, we see no reason it now should have a -
second bite at the apple, especially when its ultimate justification is based on no more than the " trusted others to vigorously pursue"line of argument rejected in South Texas. See id. at 382-83.
As we have observed elsewhere, a failure to demonstrate good cause for late-filing requires there be a " compelling showing" regarding the other four late-filing factors. LBP-98-7,47 NRC at 208. As the Staff has noted, see Staff Reply at 7 factors two and four - availability of other means to protect the petitioner's -
interests and extent of representation of petitioner's interests by other parties -
generally favor late admission of these contentions. These criteria, however, are accorded less weight in the balance than factors three and five - assistance in J
developing a sound record and broadening the issues / delaying the proceeding.
See LBP-98-7,47 NRC at 208; see also LBP-98-29,48 NRC 286,294 (1998).
In this instance, the State's showing relative to factor three provides perhaps only minimal support for accepting these contentions. See id. at 208-09. On the other
~ hand, factor five clearly does not weigh in favor of admission, given that, as they now stand, these two issues otherwise would not be part of this proceeding.
See South Texas, ALAB-799, 21 NRC at 382 (rejecting argument applicant will not be prejudiced if required to litigate previously admitted contentions of withdrawing intervenor because applicant already knew those issues would be explored).
Thus, even with the modest support afforded by factors two, three, and four, the State has not made the compelling showing required to overcome t!te lack of good cause for its late-filing. *lhe State's request to permit it to litigate contentions Castle Rock 17 and 20 therefore is denied.
l H. Consolidated Contentions I 1. Utah E/ Castle Rock 7/ Confederated Tribes F DISCUSSION: State Response at 5,6-10; PFS Response at 6; Staff Response at'4-5; State Reply at 4-6; Staff Reply at 10-11.
l 119 p
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RULING: As the Staff correctly points out, see Staff Response at 4 &
n.6, the Board previously ruled that Confederated Tribes had properly adopted Castle Rock 7, although in doing so we failed to acknowledge that portions of that contention had been admitted and consolidated with this issue statement.
Compare LBP-98-7, 47 NRC at 215 wifh id. at 237. As a consequence, all portions of this consolidated cc:.t:ntion remain in this proceeding. The i contention is redesignated as contention be.h E/ Confederated Tribes F.
- 2. Utah K/Casde Rock 6/ Confederated Tribes B DISCUSSION: State Response at 5,7-10; PFS Response at 6-7; Staff Re-sponse at 4-5; State Reply at 8-12; PFS Reply at 8-15: Staff Reply at 14-15.
RUUNG: Initially, we find unpersuasive the State':s consolidated contention-related arguments regarding inextricable intertwining, lead party status, and maintaining the status quo.8 The first point is not borne out by a careful review of the contentions, the second does not account for the separate status each party retains under the " lead party" scheme,2 and the third does not account for the general Commission policy of encouraging settlements.
As a consequence, based on a review of the admitted portions of these consolidated contentions and their supporting bases, absent a State showing it bas met the late-filing standards relative to Castle Rock 6, this contention is now limited to the activities affecting the PFS facility or the Rowley Junction intermodal transfer point (ITP) specified in our ruling on Utah K,' and the ;
concern about wildfires specified in Confederated Tribes B. Further, upon l balancing the late-filing standards, for the reasons we have noted already, see l supra pp. I18-19, we find the State lacks good cause for late-filing. Nor, for j the reasons we speciSed earlier, see supra p. I19, does a balancing of the other four factors produce the " compelling showing" necessary to overcome the lack of good cause.
I Nor do we hnd persumive the asserted contrary authority in the Licensing Board decision in Georgia Power Co. (Vogtle Electric Generating Plam. Umts I and 2), LBP-94-22,40 NRC 37, 39 (1994), relied upon by the State, see State Renpome at 7-8, given that (1) the carher Licensing flourd case relied on for the Fogtle standard l dealt wHh the adnussion or a contenoon in the context of a mouon to reopen the record, a sigmhcantly different i concept; and (2) the State's failure to make a convincing unchness argument so as to nret the Vogtle standard.
2 in estabintung the " lead party" procedure, me made it clear that while consultauon and accommodation should be the norm between the lead party and any other parues mvolved with a consolidated contention. it is possible for a nonlead party that disagrees wuh a lead party to bring disputes to the Board's attenuon, See LBP-98-7. 47 NRC at 243 n.29.
3 As we declared in LBP-98-7,47 NRC at 190. this would encompas relative to (1) the PFS facihty. those ,
acuvities at or emanatmg from the Tekoi Rocket Engine Test facihty. Dugwsy Proving Ground, Salt Lake City l' Internanonal Airport, Hill Air force Bae, and the Utah Test ak,d Training Range; or (2) the Rowley Junction TrP, those acuvines at or emanatang from the facihues specahed above, or hazardous nviterials that pass through the ITP from the imdlaw Al'rUS humdous waste incinerator. the Envirocare low-level radioactive and mixed waste landhlt, or Imdlaw's Chve Humdous Wate Facihty and Grassy Mounuun hazardous waste landhil.
120 l
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The State's request to litigate the admitted portions of Castle Rock 6 that were consolidated with the admitted portions of Utah K and Confederated Tribes B f
thus is denied and the scope of the consolidated contention is limited as specified above. This contention is redesignated as Utah K/ Confederated Tribes B.
- 3. Utah O/ Castle Rock 8 and 10 j i
DISCUSSION: State Response at 6,7-10; PFS Response at 7; Staff Response at 5; State Reply at 6-7; PFS Reply at 9-15; Staff Reply at 10-15.
)
)
RULING: As we have previously indicated, see supra p.120, we find
{
unpersuasive the State's consolidated contention-related arguments regarding
)
inextricable intertwining, lead party status, and maintaining the status quo. '
Further, based on a review of the admitted portions of these contentions and their supporting bases, absent a State showing it has met the late-filing standards relative to Castle Rock 8, paragraph one of this consolidated content ion encompasses only routine facility operations, thereby excluding firefighting activities. And with respect to the late-filing standards, for the reasons we already have noted, see supra pp.118-19, we find the State lacks good cause for late-filing. Nor, for the reasons we specified earlier, ser supra p.119, does a balancing of the other four factors produce the " compelling showing" necessary to overcome the lack of good cause.
Accordingly, the State's request to litigate the admitted portion of Castle Rock 8 concerning firefighting activities that was consolidated with the admitted portions of Utah O is denied. Paragraph one of that contention is revised as follows:
l 1. Contaminant pathways from the Applicant's sewer / wastewater systems; routine i facility operations; and construction activities.
)
Further, this contention is redesignated as Utah O.
1
- 4. Utah S/ Castle Rock 7 DISCUSSION: State Response at 4, 7-10; PFS Response at 7-8; Staff Re- j sponse at 4-5; State Reply at 12-13; PFS Reply at 8-15; Staff Reply at 10-15.
! RULING: We find the portion of contention Castle 7 at issue, i.e., paragraph l c, is within the ambit of contention Utah S, so there is no need to revise this j contention, other than to redesignate it as Utah S.*
- To the ericia PiS has a concern about tne viability of this contenuon relauve to spern nuclear fuel disposal costs and offsite transportanon radiological accidents, see PF5 Renponne at 8 n.12,it remains free to seek summary disposinon on such matters. See LDP-98-10,47 NRC 288. 295 n.10 (1998) 121
- 5. Utah T/ Castle Rock 10, 2,22 DISCUSSION: State Response at 5, 7-10; PFS Response at 8-9; Staff Re-sponse at 4-5; State Reply at 7; PFS Reply at 9-15; Staff Reply at 8-15.
RULING: Initially, we find unpersuasive the PFS and Staff arguments seek-ing dismissal of those portions of the consolidated contention concerning the Utah Groundwater Protection Rules and the Utah Division of Air Quality Rules, which appear to be relevant to the air and water quality authorizations ultimately at issue in paragraphs four and five of the contention.
In connection with the other matter at issue regarding this contention, we once again find unpersuasive the State's consolidated contention-related arguments regarding inextricable intertwining, lead party status, and maintaining the status quo. See supra p.120. Further, based on a review of the admitted portions of these contentions and their supporting bases, absent a State showing it has met the late-filing standards relative to Castle Rock 12, this contention is revised to excise the portion of paragraph six regarding the Skull Valley Band's Clean Water Act (CWA) permitting authority. That paragraph should now read as follows:
- 6. The Applicant's analysis of other required water permits lacks specificity and does not satisfy the requirements of 10 C.F.R.151.45 in that the Applicant merely states that it "might" need Army Corps of Engineers and State approvals in connection with any Clean Water Act (CWA) Section 404 dredge and fill permit for wetlands along the Skull Va' ey transportation corridor; and PFS will be required to consult with the Stc.;e on the effects of the intermodal transfer site on the neighboring Timpic Springs Wildlife Management Area.
I Relative to the late-filing standards, for the reasons we already have noted, see supra pp. I18-19, we find the State lacks good cause for late-filing relative to the Skull Valley Band's CWA permitting authority. Nor, for the reasons we specified earlier, see supra p.119, does a balancing of the other four factors produce the " compelling showing" necessary to overcome the lack of good ,
cause.5 Accordingly, the State having failed to establish it has met the late-filing standards in connection with portion of paragraph six regarding the Skull Valley Band's Clean Water Act (CWA) permitting authority, the scope of that paragraph is limited as set forth above. We redesignate this contention as Utah T.
S We aho note that the language in the PTS en ironmental report (ER) regarding the Skull Valley Barurs CWA authonty that apparently was the focus of this Castle Rock concern is not in the most recent ER revision. Coinpare
[Pril Environmental Report ifor! Private Fuel Storage facihty at 9.14 (sev. O June 1997) with id. at 9.1-7 (rev.
I Aug.1998).
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l' IIL CONCLUSION
' With Castle Rock's withdrawal, with prejudice, from this proceeding,'its L admitted contentions and its contentions admitted as part of a consolidated
- -issue statement, but which now have no other sponsor, are no longer litigable.
Although the State attempts to have these contentions admitted as late-filed under the 10 C.F.R. 6 2.714(a)(1) criteria, we find its efforts are unavailing. As l a result, we dismiss from this proceeding all Castle Rock contentions, including portions of otherwise consolidated contentions that are attributable solely to Castle Rock.'
Ibr the foregoing reasons, it is, this 17th day of Ibbruary 1999 ORDERED that:
- 1. The December 21,1998 notice of withdrawal of Intervenor Castle Rock
- . ' is accepted and approved, with prejudice.
l 2. He following contentions are dismissed from this proceeding: Castle Rock 17; Castle Rock 20; Castle Rock 21.
- 3. He following contentions are revised as set forth in Section 11 above:
Utah E/ Castle Rock 7/ Confederated Tribes F; Utah K/ Castle Rock 6/Confed-erated Tribes B; Utah O/ Castle Rock 8 and 10; Utah S/ Castle Rock 7; Utah l- T/ Castle Rock 10,12,22; Utah AA/ Castle Rock 13; Utah DD/ Castle Rock 16.
l l
THE ATOMIC SAFETY AND I
LICENSING BOARD 1 G. Paul Bollwerk,111
- ADMINISTRATIVE JUDGE Peter S. Lam ADMINISTRATIVE JUDGE Rockville, Maryland L Itbruary 17,1999
'Having modified the titles of certain contenbons,in a separate iuuarn:e today we revise the general achedule for this proceethng to reflect those changes. See Ucensing Board order (Revised General Schedule)(Feb.17 l
' 1999) at 1 (unpubbshed). j
' Copies of tius Memorandum and Order were sent this date by Internet e mail transmission to counsel for (1) the Applicant PF5;(2)Intervenor Skull Valley Band. Ohngo Gaudadeh DeWa, Confederated Tribes. Castle Rock.
Southern Utah Wilderness Alhance. and the State; and (3) the Staff.
I Judge Khne was unavailable to participare in hnal deliberations regarding, or to sign, this Msnurandum and Oder.
l 123 l
r-Cite as 49 NRC 124 (1999) LBP-99-7 f
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION l
ATOMIC SAFETY AND LICENSING BOARD Before Administrative Judges:
I G. Paul Bollwerk, Ill, Chairman .
Dr. Jerry R. Kilne Dr. Peter S. Lam in the Matter of Docket No. 72-22-ISFSI (ASLBP No. 97-732-02-ISFSI) i PRIVATE FUEL STORAGE, LLC.
(Independent Spent Fuel Storage installation) February 18,1999 ~
In this proceeding concerning the application of Private Fuel Storage, L.L.C.
(PFS), under 10 C.F.R. Part 72 to construct and operate an independent spent fuel storage installation (ISFSI), the Licensing Board denies an Intervenor request to amend contentions concerning the validity of the Applicant's physical security plan (PSP) as the PSP relies on the local county sheriff's office to exercise law enforcement authority at the PFS ISFSI located on the reservation of the Skull Valley Band of Goshute Indians.
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (GOOD CAUSE FOR LATE FILING) j l
Having received a copy of an agreement concerning the provision of local law j enforcement services for a Native American tribe's reservation where a proposed j ISFSI is to be located, the Intervenor was under an obligation, particularly once the Licensing Board indicated the agreement had some relevance to the proceeding, to act promptly to uncover any additional problems with the pact.
When there apparently were no complex scientific or technical analysis involved, 1
124 i
the more than 2 month period the Intervenor took to inquire was too long for it to claim that good cause existed for its late-filed request to submit additional
~ issues.
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (GOOD CAUSE FOR DELAY)
A failure to demonstrate good cause for late filing requires there be a
" compelling showing" regarding the other four late-filing factors. LBP-99-6, 49 NRC 114,119 (1999).
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (OTiiER MEANS AND OTHER PARTIES TO PROTECT INTERVENORS' INTERESTS; ASSISTANCE IN SOUND RECORD DEVELOPMENT; DELAY)
Late-filing factors two and four - availability of other mee.ns to protect the -
petitioner's interests and extent of representation of petitioner's interests by other parties - are accorded less weight in the balance than factors three and five -
assistance in developing a sound record and broadening the issues / delaying the proceeding. Id.
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (ASSISTANCE IN SOUND RECORD DEVELOPMENT)
I With regard to late-filing factor three - assistance in developing a sound record - when legal issues are a focal point of a late-filed contention, the need for an extensive showing regarding witnesses and testimony may be less compelling. See LBP-98-29,48 NRC 286,301 n.18 (1998).
RULES OF PRACTICE: NONTIMELY SUBMISSION OF CONTENTIONS (DELAY)
Late-filing factor five - broadening the issues / delaying the proceeding -
clearly does not support an intervenor's request to amend its security contentions when litigation regarding a local law enforcement agency's legal obligations under an agreement to provide law enforcement services to a Native American tribe is likely significantly to broaden and delay the proceeding by raising a substantive challenge to the agreement, as opposed to the essentially procedural challenge to its adoption protocols that already is before the Licensing Board, i
125
+
as well as the possibility of having to await the outcome oflegal actions in other judicial forums.
MEMORANDUM AND ORDER (Denying Motion to Aniend Security Contentions)
As part of its challenge to the pending application of Priva~ N1 e orage, L.L.C. (PFS), for authorization to construct and operate a 10 C.hx. Part 72 independent spent fuel storage installation (ISFSI) on the Utah reservation of the Skull Valley Band of Goshute Indians (Skull Valley Band), Intervenor State
-of Utah (State) prtviously sought and gained admission of several contentions regarding the adequacy of the physical security arrangements for the PFS facility.
See LBP-9817,48 NRC 69, granting reconsideration of LBP-98-13,47 NRC 360 (1998). In particular, the Board admitted portions of contentions Security-A, Security-B, and Security-C on the issue whether a June 1997 cooperative law enforcement agreernent [(CLEA)] that pernuts the Tooele County sheriff's office to exercise law enforcernent author 4ty on the Skull Valley Hand reservation has been properly adopted by Tooele County, thereby allowing the county sheriff's ofLcc to fulfill its role as the designated [ local law enforcement agency (tLEA)J for the PFS facility.
LBP-98-17, 48 NRC at 71. The State now seeks to amend these admitted contentions to permit litigation of a new questica regarding the participation of the Tooele County sheriff's office in responding to i.'cidents at the PFS facility, a request both PFS and the NRC Staff oppose.
Ibr the reasons that follow, we deny the State's security contentions amend-ment request.
I. BACKGROUND The State's motion, which was submitted to the Board on December 17 1998, is footed on a December 2,1998 letter from the Tooele County Attorney that is attached to the State's pleading. See [ State] Motion to Amend Security Contentions (Dec. 17,1998), Exh. 3 [ hereinafter State Motion]. Responding to an October 14,1998 written inquiry from the Executive Director of the State's Department of Environment Quality about the extent of the assistance Tooele County will render for law enforcement on the Skull Valley Band reservation, see id., Exh. 2, in that letter the Tooele County Attorney stated:
126 1
l do not believe Tooele County is obligated to provide law enforcernent protection to
[PFS] and their proposed storage site. Tooele County patrols areas as requested by Skuli 1 Valley Tribal governinent. If they desire to include the [PFS] site we will have to revise the CLEA and negotiate to provide this service. At the time the CLEA was signed there was no discussion or conternplation that [PFS] would be part of the agreenent. Moreover, the county has not yet entered into any agreernent that has any bearing on locating the PFS j storage facility on the reservation.
l M, Exh. 3 at 1.-
According to the State, this statement by the Tooele County Attorney, who approved the existing CLEA as to form, establishes that PFS cannot satisfy the requirements of 10 C.F.R. 6 73.51(d)(6) and 10 C.F.R. Part 73, App. C, 63.d, which respectively require that an ISFSI applicant must (1) show a documented liaison with a designed LLEA to permit timely response to unauthorized penetration activities; and (2) provide a listing of available ,
LLEAs, as well as a description of their response capabilities and criteria and
[
a discussion of working arrangements or agreements for communication with j such LLEAs. Because the December 2 letter shows that Tooele County will not j provide law enforcement protection to the PFS facility under the existing CLEA, the State asserted it has (1) raised an additional admissible legal challenge; (2) added substance to the already admitted basis for contention Security-C !
regarding LLEA response time; and (3) provided support for broadening the bases of admitted contentions Security-A and Security-B concerning security ,
force staffmg, equipment, and training. See State Motion at 5-6. Finally, the j State asserted that in connection with its proposed amendment of contentions Security-A, Security-B, and Security-C, it fulfills the five late-filing criteria of 10 C.F.R. 6 2.714(a)(1), j Both PFS and the Staff opposed the PFS motion in pleadings filed December l 29, 1998. PFS declared the State's motion should be rejected because (1) it j failed to establish a balancing of the section 2.714(a)(1) standards support late- l filed admission of its new assertions; and (2) the State's amended contentions would advocate stricter requirements than those imposed by the agency's reg-ulations. See Applicant's Answer to (State] Motion to Amend Security Con- l tentions (Dec. 29,1998) at 1 [ hereinafter PFS Response]. On the second point, PFS maintained that section 73.51(d)(6) requires only that the LLEA be able to respond to unauthorized activities at the PFS site, not patrol or provide pre-ventative protection. Because assistance of the latter type is the subject of the Tooele County Attorney's December 2 letter, PFS argued that the State is seek-ing impermissibly to amend the existing contentions on a basis that goes beyond l the requirements of the existing regulations. See id. at 8-10. For its part, the j Staff challenged the State's request, arguing it (1) had not met its burden under the section 2.714(a)(1) late-filing criteria; and (2) failed to provide authorita-tive support for its new challenge to the facial validity of the existing CLEA 127 l
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L
y
!' as it vests the Tooele County sheriff's office with jurisdiction to undertake law enforcement activities on the Skull Valley Band reservation. See NRC Staff's Response to [ State] Motion to Amend Security Contentions (Dec. 29,1998) at 311 [ hereinafter Staff Response].
IL ANALYSIS Because the State once again is seeking to interpose new matters into this proceeding, it must meet the five-factor balancing test found in 10 C.F.R.
62.714(a)(1). And as before, we look first to the imponant factor of good cause for late filing. In this instance, the bone of contention posited by PFS and the Staff is not the amount of time the State took to lodge its motion after receiving the Tooele County Attorney's letter, which was less than 2 weeks. or even the nearly 2 months it apparently took Tooele County officials to answer the State's information inquiry. At issue instead is the amount of time the State took to request the information in the first instance. The State's letter, dated October 14,1998, was posted some 4 months after the CLEA was first provided by PFS at a June 17,1998 prehearing conference, see Tr. at S-15 to S-16, and more than 2 months after this Board admitted the CLEA-related issue on reconsideration.
The precipitating event for a late-filed contention often is a subject of some dispute. For present purposes we will assume the State had no reasonable basis for looking further into the CLEA until we granted its reconsideration request in our August 5,1998 issuance. Even in this posture, however, we are unable to find the State's unexplained 2-month delay ir. directing questions to county officials has any legitimate justification that w'>uld provide good cause for its late filing. Having received a copy of the CLEA, the State was under an obligation, particularly once we indicated that agreement had some relevance to this proceeding, to act promptly to uncovu any additional problems with that pact. In this instance, which apparently did not involve any complex scientific or technical analysis, we find the more than 2-month period the State took to inquire too long for it to claim that good cause existed for its late filing.
With this failure to demonstrate good cause for late filing comes the re-quirement that the State make a " compelling showing" regarding the other four late-filing factors. See LDP-99-6,49 NRC 114,119 (1999). As to factors two and four - availability of other means to protect the petitioner's interests and extent of representation of those interests by other parties - we find, as the Staff suggests, see Staff Response at 5-6, that they weigh in the State's favor. They are, however, accoided less weight in the balance than the other two criteria. Id.
Looking to factor three -- assistance in developing a sound record - because legal issues are a focal point of the State's motion, the need for an extensive showing regarding witnesses and testimony may be less compelling. See LBP-128 l
7
- . ~
l g
!' 98-29,48 NRC 286,301 n.18 (1998). At the same time, the State seeks to use this matter as a vehicle to gain fu.ther consideration of previously rejected factual
_ contentions regarding the adequacy of security. force staffing and equipment, L . albeit without the requisite evidentiary proffer regarding these elements, thereby l- diluting somewhat the support factor three provides on the admission side of
- the balance.
Finally, factor five - broadening the issues / delaying the proceeding -
-c' learly does not support the State's request to amend its security contentions.
l . Litigation regarding the Tooele County sheriff office's legal obligations under l the CLEA is likely significantly to broaden and delay this proceeding, raising as l it does a substantive challenge to the agreement, as opposed to the essentially procedural challenge to its adoption protocols that is now before the Board, as well as the possibility of awaiting the outcome of legal actions in other judicial forums, in sum, even with the modest support afforded by factors two, three, and four,
! the compelling showing needed to overcome the lack of good cause under factor l' one is lacking. He State's request to amend several of its security contentions therefore must be denied.8 IIL CONCLUSION In seeking to amend its security contentions to introduce questions regarding the validity of the CLEA as it provides that Tooele County will afford law
. enforcement services on the Skull Valley Band's reservation, Intervenor State of Utah has failed to demonstrate that the five factors governing late admission of contentions under 10 C.F.R. 62.714(a)(1) support entertaining those revisions.
We thus reject the State's motion to amend.its security contentions.
~
I Having found that under a balancing of the section 2.714(aXI) late-fihns factors the State's amendment request simuld not be entertained, we need not reach the question of its admissibihty. Nonetheless, we note that even
- if it had net those crieria, we would not be inchned to perrmt the amendment given (1) tie import of section l 73.51(dX6)'s reference to LLEA response"; and (2) the failure of the statements in Tooele County Attorney's leteer to call into question our previous pronouncement that "nottung on the face of the cooperative agreement j gives un cause to question its vahdity as it provides [ law enforcement] jurindaction on the Skuu Valley Band's
[
senervation for the designated t1EA." LBP-98-13. 47 NRC at 370 n.9.
Nevertheless, with the CLEA's provisions regarding yearly review and eermination. see State Monon. Exh.1.
at 3. the potential exists for further developments that muy call into quescon the substance of t1EA jurisdiction, see Staff Response at 10. Nothing in our ruling today precludes party requests for the admission of appropriate issues if future events warrant.
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Ibr the foregoing reasons, it is, this 18th day of Rbruary 1999, ORDERED that the December 17,1998 motion of the State to amend its security contentions is denied.
j THE ATOMIC SAFETY AND l
LICENSING BOARD 2 I
G. Paul Bollwerk, III ,
ADMINISTRATIVE JUDGE i
1 Peter S. Lam ADMINISTRATIVE JUDGE l I
I' Rockville, Maryland l Rbruary 18,1999
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1 2 Copies of this Menarandum and Order were sent this date by Internet e-nmit transmission to counsel for (1) the Apphcant PFS; (2) Intervenors Skull Valley Band. ohngo GadJadeh Devia. Confederated Tribes of the Goshute Reservation. Southern Utah Wilderness Alliance, and the State; and 0) the Staff.
. Judge Khne was unavailable to participate in final dehberations regarding. or to sign, this Memorandum and Order.
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4 Cite as 49 NRC 131 (1999) LBP-99-8 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL Before Administrative Judges:
Peter B. Bloch, Presiding Offcer Richard F. Cole, Special Assistant l
In the Matter of Docket No. 40-8681 MLA-5 (ASLBP No. 99 758-02-MLA)
(Re: Material License Amendment)
CORPORATION (Receipt of Additional Material from Tonawands, New York) February 19,1999 A hearing was denied to three public Petitioners because they had failed to demonstrate that the proposed action will cause them " injury in fact."
RULES OF PRACTICE: IIEARING REQUIRES INJURY IN FACT The Presiding Officer explains that in our democratic system of government, we rely on elected officials to represent our interests. It is only when we suffer a particularized injury or " injury in fact" that we may challenge a governmental action in an administrative proceeding.
MEMORANDUM AND ORDER (Dismissing Certain Petitions) 1 On December 29, 1998, the Presiding Officer issued an order authorizing Petitioners Ken Sleight, Navajo Utah Commission, and the Concerned Citizens 131
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of San Juan County (CCSJC) to file amended petitions in response to objections to their petitions raised by International Uranium (USA) Corporation (IUSA) and the NRC Staff (Staff). Memorandum and Order (Amended Petitions to i Intervene), served December 29, 1998, citing NRC Staff Notice of Intent to I Participate and NRC Staff Response to Requests for Hearing Filed by Ken Sleight, Navajo Utah Commission, Concerned Citizens of San Juan County, dated December 17,1998, at 4-9.
Specifically, the Presiding Officer stated that "it was important non-sovereign petitioners show that they will suffer personal injury or environmental effect, given the many miles that separate them from the IUC site." Order at 1-2.
In response to a request by CCSJC, in an e-mail, dated January 5,1999, the Presiding Officer extended the deadline for filing amended returns to a receipt date of January 15, 1999.
In a filing dated January 12, 1999, served by first class mail on that date, CCSJC filed an amended petition.' Concerned Citizens of San Juan I County Response to NRC and IUSA Opposition to Petition, dated January 12, I 1999 (Amended Petition). None of the other Petitioners filed the authorized j response. Ihr the reasons stated below, I have determined that none of the l nongovernmental petitioners has shown a particularized injury. Accordingly, all l the nongovernmental petitions are dismissed.
In our constitutional, representative government, the first line of defense of any citizen is that the legislature and the government officials elected or appointed to execute the laws will act reasonably and with due respect for private rights. In addition, citizens have been given the right to intervene in formal or informal proceedings when they are personally aggrieved by a governmental action. His additional protection is available onl> when there is a personal grievance.
It is fundamental that any person or group intervening in a Commission proceeding must demonstrate that the proposed action will cause " injury in fact" to its interests and that those interests are arguably within the " zone of interests" protected by the statutes governing the proceeding. E.g., Georgia Power Co.
(Vogtle Electric Generating Plant, Units 1 and 2), CLI-93-16,38 NRC 25,32 (1993); Public Service Co. of New Hampshire (Seabrook Station, Unit 1), CLI-91 14, 34 NRC 261, 266 (1991), citing Metropolitan Edison Co. (Bree Mile Island Nuclear Station, Unit 1), CLI-83-25,18 NRC 327,332 (1983).
He ameuded petition filed by CCSJC does not show an injury to its organizational interests and does not identify a member, by name and address, who will tuffer injury as a result of the proposed amendment. See Houston Lighting and Power Co. (South Texas Project, Units I and 2), ALAB-549,9 I
Wlule the Staff did not receive this 6hng unul January 19,1999, and the wrvice list indicates that a copy was served or the ofhce of the Secretary, the 3rdi has addressed the snents of CCSJC's amended hhng.
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T NRC 644,646-47, ag'g, LBP 79-10,9 NRC 439,447-48 (1979). In addition, CCSJC has not shown that a named member (with standing in at, individual capacity) has authorized the organization to represent his or her interests in the proceeding. Id.; Houston Lighting and Power Co. (Allens Creek Nuclear Generating Station, Unit 1), ALAB-535, 9 NRC 377, 393-94, 3% (1979);-
Babcock and Wilcox Co. (Pennsylvania Nuclear Services Operations, Parks _
Township, Pennsylvania), LBP-94-4, 39 NRC 47,50 (1994). Gene Stevenson, the Bluff Water Manager who signed the petition and the amended petition, has not shown that he is authorized to file a request for hearing on behalf of the organization.2
. The surface and drinking water concerns discussed further in the amended petition, see, e.g., Amended Petition at 2-4, indicate that CCSJC has grievances
. about the operation of the White Mesa Mill in general, particularly that the mill "is not required to apply for a Utah groundwater permit," id. at 3. CCSJC does not particularize an injury stemming from the proposed amendment. Such concerns fall short of demonstrating that the organization or its members will suffer distinct and palpable harm as'a result of the proposed amendment.
See Three Mile Island, CLI-83-25,18 NRC at 333, citing Transnuclear Inc.
(Ten Applications for Low Eniici,/ Urr.nium Exports to EURATOM Member Nations), CLI-77-24, 6 NRC 525,531 (1977) (a " generalized grievance" shared in substantially equal measure by all or a large class 6 9izens will not result in distinct and palpable harm to support standing); It e~.at6nal Uranium (USA)
Corp. (White Mesa Uranium Mill), CLI-98-6, 47 NRC 116, i17 (1998) (a petitioner must show an injury that is " distinct and palpable, particular and concrete, as opposed to being conjectural or hypothetical"), citing Steel Co. v.
- Citizensfor a Better Environment, _ U.S. _,118 S. Ct,10'13,1016 (1998);
Warth v. Seldin, 422 U.S. 490, 501, 508, 509 (1975); Sequoyah Fuels Corp.
(Gore, Oklahoma Site), CLI-94-12,40 NRC 64,72 (1994).
In essence, because CCJSC has failed (1) to show a harm that is' distinct and apart from that caused by the initial licensing and continued operation of the facility, see Energy Fuels Nuclear, Inc., LBP-94-33, 40 NRC 151,153-54 (1994), and (2) to show organizational standing based on an injury to its -
organizational interest or to a member (identified by name and address) who has authorized the filing of : 0 tetition on his or he, behalf, its petition is denied.
CCSJC foiled to particulaw an injury on which its standing might be based.
With;;spect to the other Petitioners, application of the standards for inter-vention (in the context of the action challenged) indicates that Mr. Sleight and
- the NUC also do not have standing to intervene as parties to the proceeding.
. Each has failed to demonstrate that, as a result of the amendment, it will likely ;
l- j f ;
. 2see Detroir FJhem Co. (Enrico Fermi Atomic Power Plant. Unit 2) LBP-7s-37. 8 NRC 575 $83 (1978h see !
aho Georgis Power Co. (Vogtle Electric Generating Plant, Umts I and 2). LBP.90w29,32 NRC 89,92 (1990).
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i suffer injury that is " distinct and palpable, particular and concrete, as opposed to being conjectural or hypothetical." See White Mesa, CLI-98-6,47 NRC at i17, citing Steel Co. v. Citizens for a Better Environment,118 S. Ct. at 1016; Warth v. Seldin,422 U.S. at 501,508,509; Sequoyah Fuels Corp., CLl-94-12,
/0 NRC at 72. They have not shown a harm that is distinct and apart from that caused by the initial licensing and continued operation of the facility. See Energy Fuels ivuclear, LBP-94-33, 40 NRC at 153-54. They were invited 'o cure this weakness in their petitions but they failed to amend their petitions to establish standing.
While Mr. Sleight mentions the processing and storage of material from the Ashland I (as well as the Ashland 2) site, the injuries claimed stem from general concerns about operations at White Mesa and general objections to nuclear-related activities in the region and its perceived effect on his business, his other activities in the region, the local economy, and cultural resources.
Such general " injuries" are not caused by the contested license amendment and are not sufficient to support standing. See Cleveland Electric Illuminating Co.
(Perry Nuclear Power Plant, Unit 1), CLI-93-21, 38 NRC 87,95 n.10 (1993)
(standing requires more than general interests in the cultural, historical, and economic resources of a geographic area), citing Sierra Club v. Morton, 405 U.S. 727, 734-35 (1972). Moreover, Mr. Steight's claims of harm from the processing of the Ashland I material are speculative since he does specify a credible means by which the proposed action could direct!y harm him, and thus, he fails to describe an injury that is " distinct and palpable from his general concerns about the continued operation of the facility. See White Mesa, CLI 6,47 NRC at i1718; Sequoyah fuels Corp., CLI-94-12,40 NRC at 72; Energy fuels Nuclear, LBP-94-33,40 NRC at 153-54.
He Navajo Utah Commission of the Navajo Council states that it is a local governing body designated by the Intergovernmental Relations Commission (IGR) of the Navajo Council that, by resolution, has "the authority to review all matter affecting the communities in the seven chapter areas of Utah, making appropriate recommendations to, and requests of, the Navajo Nation and other pertinent agencies." NUC Petition at 1, ne NUC is located in Montezuma Creek which is approximately 40 miles from White Mesa. While Native Americans have a unique relationship with the federal government, they must satisfy NRC requirements for standing in order to be admitted as a party to an NRC proceeding. Ilydro Resources, Inc. (2929 Coors Road, Suite 101, Albuquerque, NM 87120), LDP-98-9,47 NRC 261,272 (1998), citing Umerco Minerals Corp., LBP-94-18, 39 NRC 369 (1994). He resolution and the comments in the petition amount to a generalized grievance concerning the operation of the White Mesa mill and do not identify a distinct and palpable harm from the proposed hcensing action. See Threr Mile Island, CLI-83-25,18 NRC at 333. The fear of nuclear materials and concerns about 134
i the cumulative impacts of nuclear activities and testing unrelated to the proposed amendment cannot provide a basis for standing in this proceeding. In addition, NUC has not identified (by name and address) the particular Navajo people who have authorized NUC to represent their interests and who will likely be harmed as a result of the proposed amendment See South Texas, ALAB-549,9 NRC at 646-47. Moreover, NUC has not shown that the milling to be authorized by the proposed amendment will result in tailings that are more hazardous than that already authorized under the license. See International Uranium (USA)
Corp. (White Mesa Uranium Mill), LBP-97-14,46 NRC 55,56 (1997), aff'd, CLI-98-6,47 NRC 116,117 (1998). Therefore, the NUC Petition is denied.8 ORDER For all the foregoing reasons and based on the entire record in this matter, it is, this 19th day of February 1998, ORDERED
- 1. The Petitions for a Hearing filed by Ken Sleight, the Concerned Citizens of San Juan County (CCSJC) and the Navajo Utah Commission (NUC) of the Navajo Utah Council of San Juan County are dismissed.
- 2. Appeals of this Order may be filed pursuant to 10 C.F.R. 62.1205(o).
Any appeal must be filed within ten (10) days of service of this Order and may be taken by filing and serving upon all parties a statement that succinctly sets out, with supporting argument, the errors alleged. At y other party may support or oppose the appeal by filing a statement within fifteen (15) days of the service of the appeal brief.
Peter B. Bloch, Presiding Officer ADMINISTRATIVE JUDGE Rockville, Maryland I
lf the NUC can dernonstrate that it is a recognized governrnental entity the Prenading Ofheet could exercise his discrenon and allow NUC adrnission as a 10 CF lt. 6 2.12ti(b) participant if another intervenuun peuuan were granted.
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r Cite as 49 NRC 136 (1999) LBP-9S9 UNITED STATES OF AMERICA j NUCLEAR REGULATORY COMMlSSION ATOMIC SAFETY AND LICENSING BOARD PANEL I
l Before Administrative Judges:
l Peter B. Bloch, Presiding Officer Thomas D. Murphy, Special Assistant in the Matter of Docket No. 40-8968-ML (ASLBP No. 95-706-01-ML)
(Re: Leach Mining and Milling License) l HYDRO RESOURCES, INC. '
(2929 Coors Road, Suite 101, Albuquerque, NM 87120) February 19,1999 ,
1 After examining the steps taken by the Staff and Applicant to comply with NHPA and NAGPRA, the Presiding Officer found them in compliance with the requirements of those acts. He concluded that Intervenors failed to present i regulatory standards and to show how they had been violated. He also concluded l that it is permissible to segment a project for NHPA purposes when the project is plarned to be performed over an extended period of time.
NHPA: FINDING OF NO EFFECT When no hi!. toric properties are found, after an agency properly documents and notices a finding that a project will have no effect on historical properues, the government agency "is not required to take further steps in the section 106 process." 36 C.F.R. I 800.4(d). In this regard, it is important that local historic preservation departments, including the New Mexico State Historic Preservation Department ("NMSHPD") and the Navajo Nation Historic Preservation Depan-ment ("NNHPD"), responded to NRC Staff consultation requests with letters 136 i
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r concurring with the conclusion of NRC Staff that there would be "no effect" on allcultural resources within the parcels.
. NATIVE AMERICAN GRAVES PROTECTION AND REPATRIATION ACT (NAGPRA): NONGOVERNMENTAL PROJECT NAGPRA applies only to the disposition of Native American cultural items
" excavated or discovered on federal or tribal lands." It does not apply to privately owned lands, even if the owner engages in federally licensed activity.
NATIONAL ENVIRONMENTAL POLICY ACT (NEPA): CULTURAL RESOURCES PLAN Intervenors failed to show a deficiency in the Staff's Cultural Resources Management Plan. Hence, their NEPA claims are without merit.
PARTIAL INITIAL DECISION (Issues Related to the National Historic Preservation Act (NHPA) and the Native American Graves Protection and Repatriation Act (NAGPRA) and Cultural Resources)
This is the second in a series of planned Partial Initial Decisions (PIDs). The issues covered by this Decision involve allegations that the Nuclear Regulatory Commision's Staff (Staff) failed to follow NHPA and the NAGPRA in issuing the license (SUA-1508) to HRI. Intervenors ENDAUM and SRIC assert that the Staff failed to identify adequately historic properties eligible for the National
- Register and traditional cultural properties. In addition, Intervenors allege the Staff violated NHPA by authorizing activity on Sections 8,12 and 17 before the section 106 review is complete,' Intervenors nlm contend that the Staff failed to comply with the NAGPRA by not receivie; ancurrence from the appropriate Native American tribes. Finally, ENDAUM and SRIC allege that the FEIS fails to address impacts on cultural resources.
Many of the issues covered in this PID are not new to this case. In LBP-98-5,47 NRC 119,124-25 (1998), the Presiding Officer in this case revoked 3 "Briefin opposition to Hydrc Resources, Inc.'s Application for Matenals 13 cense wuh Respect to: Compliance with the National Historic Preservation Act, Nauve Arnerican Graves Prmeetion and Repatriation Act and Related Cultural Resource 1 sues," 6ied by Eastern Navajo Dind Against Uraniura Mining (ENDAUM) and the Southwest Research and Infornution Center (SRIC) on Decernber 7,1999 (Brief). Hydro Resources, Inc. (HRI), 6ted a Response on January 11.1999 (HR1 Response) and the Staff of the Nuclear Regulatory Comnussion (Staf0 Sled a response on January 19.1999 (Staff Responie),
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a temporary stay and denied a stay, The merits of those issues were similar to those asserted here. In order to avoid plowing old ground, let us set forth what was already said about these issues:
' De brunt of the irreparable harm I%:itioners allege is that the NRC has issued a liconae to HRI to conduct mining activities without having complied with the provisions of section 106 of the National Histone Preservation Act. Because of this noncompliance, Phtitioners allege that construction activities will ineparably harm cuhural resources that -
have gmat meaning and importance in the history and day-to<tay lives of the various Indian people of the region. . However. Petitioners' motion, legal citations, and accompanying
' affidavits largely ignore HRI's phased approach to compliance with NHPA i106 in its mining dev-lopment. FWtitioners are silent on the acceptainlity of the phased approach in complying with the requirements of the NHPA. Applicant's approach is to complete cultural resource inventories and preservation plans on various sections of the developme it prior to each section being developed instead of the whole inventory being cornpleted on the whole development before nuaing i = In essence, Petitioners argue that HRI fails to comply with the NHPA unless the whole resource inventory and protection plan is established before any mining developawnt can begin. However, for the purposes of meeting the Commission's requirements for a stay, tie focus is not on methodology but on whether construction activities could wreak actual damage on cuhural resources that have not been inventoried and adequately addressed in mining plans. It is this type of damage the NHPA was intended to prevent. Applicant's arguments and support af6 davits establish at this stage
- of the proceeding that Applicant's phased approach to compliance with the terms of section 106 of the NHPA ensures that actual damage will not occur.
Applicant and NRC Staff adequately address the appropriateness of the phased approach to compliance with section 106 of the NHPA with regard to cuhural resources. HRI states that it may only begin activities at Section 8 of its Church Rock properties, and it is prohibited from proceeding with mining activities at other locations until it completes a full-scale restoration dernonstration at Section 8. Staff proffers evidence that resource inventories have been conducted on the only area Applicant can mine in the immediate future. Staff Exhibit 2 at 159-60. Moreover, as noted above, section 9.12 of the HRI license requires the NRC to Gnd that all disturbances associated with the proposed development will le completed in compliance with the National Historic Preservation Act of 1966 and the Archeological Resources Protection Act of 1979.
The weight of the evidence of record at this point clearly favors Applicant. First, phased compliance with section 106 of the NHPA does not appear to violate the statute. Staff has offered evidence that this approach to compliance with the NHPA has been successfully employed at other mining projects, and Petitioners have not demonstrated a Icgal or practical bar to this approach. Second, the State Estoric Preservation Of6cer and the Navajo Nation Historic Preservation Department have agreed to this approach of phased compliance, and other interested parties have not objected. Third, there appears from the affidavits to be no
' disagreement that the only parcel ofland that Apphcant may develop under the conditions of its NRC heense has been satisfactonly inventoried and is in compliance with the NHPA. In short, Petitioners have failed to make a strong showing at this juncture that they are likely to prevail on the merits. Having failed in its attempt to demonstrase that it is likely to succeed on the merits, it becomes mandatory for Petitioners to demonstrate the threat of irreparable injury from the Staff's licensing action for the grantmg of a stay. '
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De Nuclear Regulatory Commission also visited this legal territory in CLI-98-8, 47 NRC 314, 323-24 (1998). - In its opinion, the Commission stated
[(footnotes omitted)]:
[WJe are not convinced by Petitioners' argunent that the NRC and HRI are prohibited from taking a "phaud review" approach to complying with the NHPA - the legal position that fanns the foundation of Petstioners' NHPA arguments regarding severe, immediate, and irreparable injury. The statute itself contains no such prohibition, federal case law suggests none, and the supporting regulations are ambiguous on the matter, even when read in the light most favorable to Ittitioners.
In footnote 17, the Commission refers to 36 C.F.R. 6 800.3(c), which states:
Thning. Secuon 106 requires the Agency Official to complete the section 106 process prior to . . the issuance of any license or permit. The Council [on Historic Preservationi does not interpret this language to bar an Agency Official from . . authorizing non-destructive planning activities preparatory to an undertaking before complying with section 106 or to prohibit phaned compliance at different stages in planning.
Rese earlier statements in this case were issued in the context of determining a stay motion and should, at the very least, be understood and addressed by a party that disagrees.
I. NHPA AND RELATED ISSUES Intervenors argue, based in part on the testimony of three expens - Dr.
Klara B. Kelley, Mr. William A. Dodge, and Mr. Abie Itancisco - that HRI's license application fails to satisfy federal law and regulations governing national histotic sites, Native American graves and funerary objects, and related cultural resources. . Hey also argue that the Final Environmental Impact Statement (NUREG-1508; Hearing Record ACN 9703200270) (FEIS) fails to adequately address the impact of the projects on cultural properties.
My analysis of these arguments has disclosed serious flaws. In one important instance, Intervenors cite a portion of a regulation and inexplicably omit to mention that a part of the regulation differs from their position.2 In another instance, Intervenors' witness criticizes the difference in research methods among the studies relied on by HRI but does not provide a legal standard against which the adequacy of these studies may be found wanting.3 In still another instance, which is typical of other criticisms that they level, Intervenors criticize 2
Brief at 11, citing 36 C F.R. 5 800.3(c) without explaining that it does not bar phased cornpliance with the provisions of the Act.
3 Bnef at 15.
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HRI and the Staff for not following "the standard practice for compliance with
' federal and tribal cultural resources laws" but they do not cite a regulation l requiring that kind of compliance
- Indeed, it is a general fallacy of the brief '
that it points to " defects" that Intervenors' experts believe they have found but it does not argue persuasively that the HRI and Staff studies have failed to meet an identified regulatory standard.
Nor have Intervenors described in detail the planning steps taken by HRI and the Staff, who argue that they complied step-by-step with regulatory directions, and shown why those steps were insufficient.
ENDAUM and SRIC ignore the regulatory authority for phased compliance, even though the Commission has already spoken to this issue. On page 3 of their brief, they cite 36 C.F.R. I800.3(c) as requiring the completion cf "the section 1% process" before a license is issued. They do not mention the second sentence of section '800.3(c), which authorizes " phased compliance" and appears to create some problems for their case. Accordingly, Intervenors have not stated why the second sentence should be interpreted, distinguished, or ignored in order to sustain Intervenors' opposition to phased compliance.
Nor does Intervenor acknowledge that Alan Downer, the NNHPD Director, agreed that incremental NHPA review of HRI's project in 5-year segments was I appropriate,8 and he committed the NNHPD to reviewing reports on Navajo l traditional cultural properties (TCPs) as those reports were submitted.6 Nor is the testimony of William A. Dodge, a witness for ENDAUM and SRIC, helpful. He lays out his view of the law but does not provide insight into the proper treatment of the regulatory approval for " phased compliance." Brief at Attachment 2, generally.
As I have said, Intervenors' Brief does not explain what official action was taken by the NRC and what regulations apply to that action. Ibr example, the NRC argues that it followed a process that is authorized by the regulations and that is different from the one believed to be applicable by SRIC and ENDAUM.
As the Staff explained on pages 7-8 of the Staff Response (January 19, 1999):
ENDAUM's and SRIC's analysis of the NHPA regulations fails to consider 36 C.F.R.
I 800.4(d) and 36 C.F.R. 6 800.5(b). The first of these provisions applies when no historic properties are found. and states that after properly documenting and noticing such a finding.
the government agency "is not required to take further steps in the section 106 process." 36 C.F.R. 5 800.4(d). The latter provision applies when historic properties are present. but it is found that the undertaking will have no effect on such properties. In this situation, after properly documenting and noticing such a finding, the government agency is not required to "id. at 16.
S letter dated October 31.1996 (NNHPD Response); Appendix C to ills NUREG-1508.
'As ducussed infra. after the Fels was pubbshed in February 1997, the Museum of New Mexico's Of6ce of Archar.> logical Studies authored a report (MNM Report), encerpts of which (at 15 22 and 159-61) were attached to the Staff's Stay Respone as Exhibit 2.
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I take any further steps in the section 106 process unless the SHPO " objects within 15 days of receiving such notice." 36 C.P.R. I 800.5(b).7 Y
i As HRI states, HRI RcSponse at 4,6,7-8:
NRC Staff completed the Section 106 process with respect to Church Rock Section 8 and concluded that operations would have "no effect'* on "any district, site, building, structure, or object that is included in or eligible for inclusion in the National Register." See Letter
- frorn J. Ilotonich, Chief Uranium Recovery Branch, NRC to Lynne Sebastian, State Itistoric Preservation Officer, NM (May 20,1998). To reach this determination, the Staff adequately identified historic propetties considered cligible for inclusion in the National Register of Ilistoric Places and considered the effect of Section 8 operations on historic properties in conruttation with the affected tribes, pueblos, and organizations.8
[TJwo reports are relevant to Church Rock Section 8: Ernest C, Decenti Sr/s report ("the Becenti Report")' and Blinman, Cultural Resources Inventory ofFwposed Uranium Solution Entraction and Monitorrng facilities at the Church Rm k Site and Proposed Surface irrigation Facihties North of the Crown point Sae, McKinley County, New Mexico ("MNM Report").IU The Becenti Report is only one page in length with attachments and has been incorporated into the MNM report in its entirety. See MNM Report.
As indicated in the consultation letter from NRC Staff to Lynne Sebastian, New Mex-ico State }{istoric Preservation Officer ("SllPO"), "no traditional cultural properties were identified at or near any of the project areas," i.e., Sections 8,17, and 12. See Letter from J. Holonich, Chief, Uranium Recovery Brech, NRC to Lyrme Sebastian, State Ifis-toric Preservation Officer, NM (May 20,1998) at 1. Importantly, both the New Mex-ico State liistoric Preservation Department ("NMSilPD") and the Navajo Nation litstoric Preservation Department ("NNiiPD") responded to NRC Staff consultation requests with letters concurring with the conclusion of NRC Staff that there would be "no effect" on all cultural resources within the parcels.H Both the consultation request and the MNM Report 7
in Mr. Dodge's desenption of the "Secuon 106 four step comphance process," he too onuts any reference to 36 C.F R. I 800 4(d). See Dodge Tenurnony at 7-9. In his one-sentence desenption regarding 36 C.F.R I 800.5(b)(id.
at 8), he fails to rnention that the NHPA process may be concluded absent any objecuon snade by the SHPO, and later seems to assume that the NHPA section 106 process always pmgresses to step four consultations. Comrary to Mr Dodge's statements there, the NHPA regulauons require that a memorandum of agreement be entered into by the consulung parues only when it is found that an undertaking will have adveru effects on historic propertses.
See id at 17; see 36 C.F.R. I800 5(e)(4). Here, no such finding has been made a
Although, as referenced above, Intervenors IWDAUM and SRIC assert that NRC Staff failed to " adequately take imo account the Project's effect on lustaric propernes in consultation with the affected tribes, pueblos, and organizanons." pursuant to the Presicbng Officer's September 22.1998 Order, Intervennrs may only raise isrves concerning Church Rock Secuan 8 at this ume See September 22 Order at 2. Thus, HRI has focused its response on issues peruumng to Church Rock Section 8.
'Becenti Report, letter from Mark Pelizza, HRI, to J. Holonich, NRC, Attachnent 6. Hearing Record ACN 9605080097 (May 3, t996).
"Heanng Record ACN 9704140!40 (Apnl 4.1997).
U See Bhnman AItidavit 13(; see Heanng File, Vol.11 (State Respone, June 3,1999 Navajo Nanon Response, June 24,1999).]
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ruuke it clear that no traditional cultural properties were found within Church Rock Section 8.12 Thus, NRC Staff did consider the presena of non Navajo TCPs but found none based on the MNM Report and response to consultation requests. Moreover, since no traditional cultural properties were identified and since eligible archeological sites will be avoided,83 the concurrence of the NMSHPO and NNHPO as to "no effect" completes consultation on both archeological and traditional cultural property resources, see Blinman Affidavit at.15; thus, the "no effect" deterrnination applies to both the archeological and traditional cultural property resources.
I am persuaded that the concurrence of the NMSHPO and NNHPO as to "no effect" completes consultation on both archeological and traditional cultural property resources and that HRI and the Staff have fulfilled their NHPA responsibilities. Intervenors have not demonstrated that there is a defect in the NRC's proof of compliance with 36 C.F.R. I 800.4(d)." I do not accept by Mr. Dodge's testimony that the NRC letters included in Appendix B to his testimony were limited in scope; the letters contain a finding of "no effect."
Dodge Testimony at 26, Appendix B.
'Ihis phase of the licensing proceeding has been limited specifically to issues affecting either the issuance of the entire license or " operations at Church Rock Section 8 or with respect to the transportation or treatment of materials extracted from Section 8." Memorandum and Order (Scheduling and Partial Grant of Motion for Bifurcation), September 22,1998 (unpublished) at 2-3.
Since " phased compliance" is permitted under 36 C.F.R. I800.3(c), the scope of the NHPA issue is limited to Church Rock related questions. Intervenors appear at times to have made arguments that are broader than the subject matter U
Notably, the complete report of the archeological and tradinonal cuhural property inventory resuhs from the HRI pmject was provided to all concerned tnbes concurrent with the NMSHPD and NNHPD review in compliance with the NHPA Section 106 process. See Bbnman Affidavit at 14. No comments, requests for more information, or requests for rnure time were received either wittun the comment penod or since, /d.
83 HRI's beense conuuns Con &uon 9.12 wiuch states:
Before engaging in any construction acovity not previously assessed by the NRC, the bcensee shall conduct .e cultural resource invenmry. All disturbances associated with the proposed development will be completed in comphance with the Nanonal Histaric Preservauon Act of 1966, as amended, and its implemenung regulabons 06 CFR Part 800), and the Archaeological Resources Prosecuon Act of 1979, as amended, and its implemen6ng reguladons (43 GR Part 7).
In order to ensure that no unapproved disturbance of cultural resources occurs, any work resulting in the discovery of previously unknown cultural arufacts shall cease. The arufacts shall be inventoried and evaluated in accordance with 36 CFR Pad 800. and no esturbance shall occur untal the hcensee has received wntien authonzauon to proceed fmm the State and Navajo Nadon Historic Preservadon offices.
License No. SUA-1508, Hearing Record ACN 9801160066. Thus. in the event of a discovery of a TCP, HRI will halt work resulting in the escovery unul it receives wrinen authonzation to proceed from the SHPo and the NNHPo.
N The responses of NMSHPD and NNHPD make the attacks on the credibihty of Mr. Becenti moot. Bnef at 19 22. Even were that not true, Intervenors have failed to cite a standard for determining at Gus time that the Decenti Report should be ignored. On the rnents, based on HRTs defense of Mr. Decenti, HRI Response at 8-13. I am convinced of his creetulity. Nor does Intervenors' witness, Mr. Evancisco,6fter rnaienally from the findings of Mr. Becenti; the &fferences are primanly spintual or theok>gical, as Mr. reancisco does not idenufy any specific cuhural resouices.
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! .of this portion of the ' case. In any event, they have not raised serious doubts
. that the NRC failed to comply with NHPA with respect to the Church Rock site or the portion of the Crownpoint site on which effluents from the Church Rock site will be treated.
II. ' NAGPRA ISSUE i
Despite Intervenors claims under NAGPRA, that act does not apply to this case. It applies only to the disposition of Native American cultural items
" excavated or discovered on federal or tribal lands.". federal lands are defined '
as " land other than tribal lands which are controlled or owned by the United -
States.". 25 U.S.C. I 3001(5). Neither Section 8 nor the land on which Section 8 fluids will be processed is either tribal land or federal land. Hence, NAGPRA -
- is' inapplicable and the Intervenors claims under NAGPRA fail."
IIL ^ NEPA' ISSUE I also conclude that Intervenors' NEPA claims are without' basis. He key j
question here is whether the Staff, in the FEIS, adequately considered cultural issues. De FEIS discusses cultural resource impacts, as summarized in SRIC's l
brief at 52-53.' Subsequently, the MNM report was completed, distributed for l comment,' and concurred in by the SHPO. See p.141, above. . Then the Staff l issued a license. I conclude that the license contains conditions that demonstrate l
attention to this area of concern.
In the FEIS, the NRC Staff recommended that HRI implement a final cul-tural resources management plan for all mineral operating lease areas and other lands affected by license activities pursuant to National Historic Preservation Act l106 review and consultation processes. FEIS at 4-111,4-112. The NRC j
' Staff's recommended cultural resources management plan would include archae- !
ological and traditional cultural property surveys of lease areas, identification j of protection areas where human activity would be prohibited, and archaeolog- l ical testing before subsurface disturbance occurs. The plan would also include ;
^
archaeological monitoring during ground disturbing construction, drilling, and operation activities. Both the FEIS and the license require that if unidentified cultural resources or human remains are found during project activities, the ac- I
'tivity would cease, protective action and consultation would occur, and artifacts and human remains would be evaluated for their significance. Id. HRI agreed
' Usection 10 4(b) of 43 CER., which applies to inadvenent discoveries of "hunun remains, funerary objects.
sacred objects. or objects of cultural putnmony," is apphcable.
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to these recommendations. FEIS at 4-111, NRC License SUA 1508 0 9.12; see also COP Rev. 2.0 at 23. Moreover, for the reasons discussed at length above, there were no " deficiencies" in the section 106 process for Church Rock Section 8; Intervenors merely refuse to accept the " phased review" of the project that is permitted by law, ORDER For all the foregoing reasons and upon consideration of the entire record in this matter, it is, this 19th day of February 1999, ORDERED that:
- 1. He relief requested by Eastern Navajo Dind Against Uranium Mining (ENDAUM) and the Southwest Research and Information Center (SRIC) in their joint "Brief in Opposition to Hydro Resources, Inc.'s Application for Materials License with respect to: Compliance with the National Historic Preservation Act, Native American Graves Protection and Repatriation Act and Related Cultural Resource Issues," December 9,1999, is denied.
- 2. His Decision is reviewable under 10 C.F.R. 6 2.1253, pursuant to the procedures set forth in 10 C.F.R. 66 2.786 and 2.763. The petition for review ;
must be filed within 15 days of the service of this Decision.
Peter B. Bloch, Presiding Officer ADMINISTRATIVE JUDGE Rockville, Maryland i
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l Cite as 49 NRC 145 (1999) LBP-99-10 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL Before Administrative Judges:
Peter B. Bloch, Presiding Officer Thomas D. Murphy, Special Assistant in the Matter of Docket No. 40-8968-ML (ASLBP No. 95-706-01-ML)
(Re: Leach Mining and Milling License)
HYDRO RESOURCES, INC.
(2929 Coors Road, Suite 101, Albuquerque, NM 87120) February 19,1999 Relief is denied because Intervenors failed to show that the .NRC's licensing action violated any NRC regulatory requirements. Performance-based licensing, as reflected in the Staff's actions in issuing a license to Applicant, is valid. There is no need for the Commission to approve a regulation explicitly approving performance &. red licensing.
PERFORMANCE BASED LICENSING: HEARING RIGHTS Since' Applicant's license requires that an amendment be sought if he sub-sequently seeks to vary the terms of this license, which contains many detailed conditions, there is no loss of public hearing rights.
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P PERFORMANCE-BASED LICENSING: EXTENSIVE LICENSING RECORD Dat there is an extensive record resulting from interaction between Applicant and Staff in no way affects the validity of the license.
PERFORMANCE BASED LICENSING: EXTENSIVE LICENSING RECORD; LICENSE CONDITIONS It is permissible to impose licensing conditions that are contained in a license and, in addition, to incorporate in the license by reference promises made by Applicant in the course of lengthy discussions with the Staff.
PARTIAL INITIAL DECISION (Performance Based Licensing Issues)
His third Partial Initial Decision (PID) covers performance-based licensing issues, which were raised by the Eastern Navajo Dind Against Uranium Mining (ENDAUM), the Southwest Research and Information Center (SRIC), and Grace Sam and Marilyn Morris (Sams) (collectively, Intervenors).' j There are many issues raised by the Intervenors, but on careful analysis the ]
issues appear to be either irrelevant or incorrect. Issues covered by this Decision l involve allegations that performance-based licensing (PBL) violates the Atomic Energy Act (AEA), the NRC regulations, and the Administrative Procedure Act (APA). Intervenors allege that the AEA does not authorize PBL, that the NRC doesn't authorize PBL by policy or regulation, that the AEA requires license amendments to be approved by the NRC, and that notice and hearing requirements of the AEA are violated. ES Brief at 10-18; Sams Brief at 4-9.
This Decision also considers Intervenors' claim that the National Environmental Policy Act (NEPA) is violated. ES Brief at 18-21. Finally, the Intervenors contend that, in violation of the APA, the PBL license condition issued by the ,
Staffis arbitrary and capricious, consists of many documents filed over a decade, J
and therefore creates substantial doubt as to the actual license terms. ES Brief !
at 21-29. i Intervenors challenge the validity of what they call " performance-based !
licensing" but they are inconsistent in what they consider to be covered by that term. Ibr example, ENDAUM and SRIC challenge the incorporation in the I
ENDAUM and SRIC nled their bnef on December 7.1998 (Es Brief) and the Sams filed on Decernber 11.
1998 (sams Brief). Hydro Resources. Inc. (HRI) hied its responac on January 1 t,1999, and the Staff of the Nuclear Regulatory Comnussion (stafr) Bled its response on January 19,1999.
146 f
license, by reference, of the provisions contained in the HRI license application and they describe this as a part of performance-based licensing and as creating ambiguity and confusion. Id at 2. Adopting a different line of argument, the Sams Brief challenges the validity of section 9,4 of the license, which permits HRI to make certain limited changes in its operations "without prior NRC review or approval," In their Brief, at 3, the Sams characterize their objection to section 9,4 as follows:
It permits llRI to make changes in its facilities, processes, or standard operating procedures, without obtaining prior NRC approval, so long as the changes are consistent with NRC regulations, the Consolidated Operations Plan, Revision 2.0 (" COP") [ Notebook No.10.3, Acc. No. 9708210179, 8/15/97), the Final Environrnental Impact Statement to Construct and Operate the Crownpoint Uranium Solution Mining Project, Crownpoint, New Mexico, NUREG-1508 ("FEIS") [ Notebook No.10, Acc. No. 9703200270. 2/28/97]), and the Safety Evaluation Report ("SER") [ Notebook No.10.3, Acc. No. 9709050033,8/28/97]. Materials License SUA 1508 at 2.2in the event a desired change does not meet this condition, llRI must seek NRC approval for the change by submitting an application for a license amendment.
Id. Perhaps most critically, LC 9.4 imbues HRI with the authority to determine whether its desired change complies with the aforementioned condition. It states in relevant part:
If any of these conditions are not rnet for the change, test, or experiment under consideration, the licensee is required to submit a license amendment application for NRC review and approval. The licensee's determinations as to whether the above conditic,os are met will be made by a Safety and Environmental Review Panel (SERP). All such determinations shall be documented, and the records kept until license termination. All such determinations shall be reported annually to the NRC, pursuant to LC 12.8. The retained records sha!! include written safety and environmental evaluations, made by the SERP, that provide the basis for determining whether or not conditions are met.
j i
Intervenors also argue that performance-based licensing denies the public its I right to a hearing on a license " amendment,"2 42 U.S.C. 6 2239(a)(1)(A); 10 C.F.R. 6 2.1205, 'Ihey overlook the fact that the very condition that concerns them requires that HRI seek a license amendment if it wishes to change any provision of its license or of the documents that control its license.
Intervenors have not persuaded me that the NRC has done anything improper with the carefully crafted definition of amendment contained in section 9.4 of HRI's license. (ML SUA-1508, at 2-3.) My study of this language demonstrates that the license has been carefully thought through so that HRI might make ,
low-risk changes in its mode of operation without advance approval but may not j alter its license or make high-risk changes in its operations. I conclude that the 2
Note that these te,ms provide that HRI may not wry any crmdahm rif its licew without applying for an amendrnent.
'sams Bnef at 5. Es Brief at 1618.
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r definition is a very sensible interpretation of" amendment,"4 and Intervenors have not identified any authority that persuades me that it is an improper definition to use in interpreting the applicable regulations,10 C.F.R. Il 2.1201(a),2.1205, and 40.44. It is also consistent with the following language, from a case cited to me by Intervenors, approving an analogous practice for nuclear power reactors:
The Commission has issued regulations specifically allowing a licensee to modify its facilities without NRC supervision, unless the modification is inconsistent with the license or involves an "unreviewed safety question." 10 C.F.R. 9 50.59(aXI). If the proposed change is inconsistent with the license, or does involve an unreviewed safety question . . the licensee must apply to the Commission for a license amendment.
Citizens Awareness Network v. United States Nuclear Regulatory Commission, 59 F.3d 284, 287 (1st Cir.1995). Nor have Intervenors directed me to any definition of " amendment" that would indicate that this license condition is improper.8 Intervenors do not identify any regulatory provisions that prohibit per-formance-based licensing (PBL). They argue that there is "nothing in either the Atomic Energy Act or its implementing regulations that authorizes the issuance of performance-based source material licenses." ES Brief at 10. Literally speaking, they are correct in that assertion. However, the assertion that PBL is not adopted in the regulations is irrelevant. There is no requirement of law that there be a regulation adopting performance-based licensing. What is required is i that the Staff continue to conform to the existing regulations in the administration of any licensing regime, including PBL.
ENDAUM and SRIC have presented some specific arguments concerning the j alleged inadequacy of the license because of PBL. For ex:unple, they contend that future mining cannot be conducted on Section 17 of HRI's Church Rock site 4 because that mining would contaminate the restored, postmining groundwater quality in the adjoining Section 8. Brief at 27 n.22. This and other specific arguments may or may not have merit. They are not, however, properly part of this Partial Initial Decision.
Intervenors have many specific concerns in this case and they have been permitted to make written presentations concerning the inadequacy of this license in these different areas. If this license is inadequate, they have the opportunity to demonstrate that with respect to specific substantive issues. 'Ihere is no need to litigate those same issues in this Partial Initial Decision, which covers 8
ser Sann Brief at 8-9. ES Brief at 1618.
5 in Saa h r obispo Wrhersfor reace v. NRC,781 E2d 1287.1312 tD C. Cir.1984), the Court found that the extension of the term of a low-power operaung license for a nuclear power plant was an " amendment." In that case, the term of the amendment was stated in the license. Hence, the amendment changed a term of the hcense.
Under the HRI license. such a change also would be an amend nent.
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i intervenors' PBL concerns. Thie decisions on the other concerns should cast additional light on whether or not the PBL clause creates potentially unsafe or environmentally unsound conditions. If specific defects in the license are shown, j then those defects can be remedied or the license can be invalidated. See ES Brief at 25-29.
Intervenors are critical of the record upon which the NRC Staff based its licensing determination. Rey describe the record as follows:
IIRI filed its original license application in the spring of 1988, and has amended it a number of times. Between 1992 and 1997, IIRI aho submitted a large number of reports, i analyses, and responses to NRC comments, in support of its license application. (citation omitted). During this period, the NRC Staff requested additional information from HRI on 99 discrete issues in at least six rounds of requests. These Requests for Additional Information (hereinafter "RAls") cover a broad range of health and safety and environmental issues, such as ground water restoration standards. historic sites and cultural resources. In response, !!RI subnutted thousands of additional pages of new data and explanatory information. NRC Staff's reviews of IIRl's responses to RAls aho generated requests for clarification, in response to which HRI repeatedly revised and supplemented its responses.' I I conclude that the Intervenors' complaints about the record are in error. The huge record is testament to the years-long process of HRI submitting relevant information, NRC Staff casting a critical eye on that information and requesting supplementary information, HR1 submitting the requested supplementary infor-mation, and NRC Staff carefully scrutinizing that information, until the Staff was satisfied that all requirements had been met. After reviewing these many submissions by HR1 over a 10-year period, NRC Staff imposed some license conditions and determined that HRI's license application satisfied the require-ments for a license. I am not persuaded that there is anything wrong with this process or with its outcome.
Intervenors also argue that LC 9.4 (the PBL license condition) provides HRI virtual carte blanche to " unilaterally" modify its license in any manner it might see fit and that NRC somehow abdicates its responsibility to safeguard public health and the environment by issuing a license containing such a condition.
One need only read LC 9.4 in conjunction with LC 9.3 to see that this is not so.
License Condition 9.3 makes clear that "[W]henever the licensee uses the word 'will' or 'shall' in the aforementioned licensee documents" (i.e., the materials listed in Attachment A to the License Application and the COP Rev.
2), it denotes an enforceable license requirement.' Rus, among HRI's forty-nine submittals listed in Attachment A, there are extensive commitments, the i many " wills" and "shalls." Pursuant to LC 9.3, these constitute enforceable l l
'Sce ENDAUM and SRIC Brief at 21.
7 Source Matenal Ucense sUA-1$08.1.C 91 149 1
P license requirements. The performance-based License Condition 9.4 expressly states that the only changes, tests, or experiments allowable under the PBL must not conflict with any specifically stated license requirement.' The number and breadth of express requirements in HRI's license restrict application of PBL to a very few' discrete, operational changes.
Not only must any changes not conflict with any license requirements, but such changes cannot result in any " degradation in the safety or environmental commitments made in the" COP Rev. 2.0 or the approved reclamation plan.'
In addition, such changes must be " consistent with NRC's findings in NUREG-1508, the Final Environmental Impact Statement (, , .) and the Safety Evalu-I stion Report. . . ."' . _ .
Whether any ~ proposed operational change satisfies the license condition would have to be determined by HRPs three-member Safety and Environmental Review Panel (" SERP"). All such determinations must be documented and .
reported annually to the NRC. Intervenors argue that this " cedes" to HRI the authority to determine whether an amendment is necessary to safeguard human
- health, safety, and the environment. Sams Brief at 4. To the contrary, I have concluded that this process does not cede power to HRI since the NRC continues -
to have an important regulatory role. NRC may, after an annual review or an
' inspection, determine that the change did not satisfy the condition (and in fact required a license amendment) and bring an enforcement action against HRI.'
Furthermore, contrary to Intervenors' assertion that HRI's license "does not set forth most of the conditions that must be met by HRI" in its proposed mining and milling operation in Church Rock and Crownpoint, New Mexico ("the mining operations"),5 I find that the license clearly sets fonh important license conditions. In addition, there is nothing wrong with incorporating additional requirements in the license by reference to identified documents. HRI's license specifically binds it to the commitments and specifications contained in its application and the FEIS, SER, and COP filed in support of the application.
Intervenors also argue that HRI's license leaves HRI's operation practically unregulated. 'Ihis is far from the truth. License Condition 9.3 provides:
. The licensee shall conduct operations in accordance with all commitments, representations, and statements made in its license application submitted by cover letter dated April 25.1988 (as supplemented by the license submittals listed in Attachment A), and in the Crownpoint Uranium Project Consolidated Operations Plan (COP). Rev. 2.0, dated August 15. 1997
- except where superseded by license conditions contained in this license. Whenever the 8
- 14. LC 9 4(AX2).
'14. LC 9.4(AX3).
D ENDAUM and SIUC Brief at I.
150
l t licensee uses the words "will" or "shall"in the aforementioned licensee documents, it denotes an enforceable license requirement."
HRI must conduct its operations "in accordance with all commitments, repre-sentations, and statements made in its license application" as supplemented by the forty-nine documents referenced in Attachment A to the license application plus HRI's Crownpoint Uranium Project Consolidated Operations Plan (" COP")
Rev. 2.0.
I conclude that HRI has carried its burden of proof because none of Inter-
' venors' arguments cast serious doubt on the validity of HRI's license within the scope of this PID. Hence, with respect to all arguments made within the scope of this PID, I conclude that the license was properly issued to HRI pursuant to 10 C.F.R. 5 4032, which provides:
An application for a specific license will be approved if:
(a) The application is for a purpose authorized by the Act; and (b) The applicant is qualified by reason of training and expenence to use the source material for the purpose requested in such manner as to protect health and minimize danger to life or property; and (c) The applicant's proposed equipnent, facilities and procedures are adequate to protect health and minimize danger to life or property; and (d) The issuance of the license will not be inimical to the common defense and security or to the health and safety of the public; and 4 (c) In the case of an application for a heense . . to possess and use source . . material for uranium milling . or for the conduct of any other activity which the Commission determines will significantly affect the quality of the environment the Director of Nuclear l j
Material Safety and Safeguards or his designee. before commencement of construction of the plant or facility in which the activity will be conducted . . has concluded, after weighing the environmental, economic, technical and other benefits against environnental costs and considenng available alternatives, that the action called for is the issuance of the proposed i license, with any appropriate conditions to protect environmental values.
)
10 C.F.R. 6 40.32.
ORDER For all the foregoing reasons and upon consideration of the entire record in this matter, it is, this 19th day of February 1999, ORDERED that:
- 1. He relief requested by Eastern Navajo Dine Against Uranium Mining (ENDAUM) and the Southwest Research and Information Center (SRIC) in their joint "Brief in Opposition to Hydro Resources, Inc.'s Application for Materials H Source Materials ticense sVA-1508,if 9.3.
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4 .
License with respect to: Performance Based Licensing Issues," December 7, 1998, is denied.
- 2. This Decision is reviewable under 10 C.F.R. 5 2.1253, pursuant to the procedures set forth in 10 C.F.R. il2.786 and 2.763.' A petition for review must be filed within 15 days of the service of this Decision.
Peter B. Bloch, Presiding Officer ADMINISTRATIVE JUDGE Rockville, Marylan' d l
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4 Cite as 49 NRC 153 (1999) LBP-9911 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL Before Administrative Judges:
Peter B. Bloch, Presiding Officer Richard F. Cole, Special Assistant in the Matter of Docket No. 40-8681 MLA-5 j (ASLBP No. 99-758-02-MLA)
(Re: Material Lleense Amendment)
CORPORATION (Receipt of Additional Material from Tonawanda, New York) February 19,1999 A hearing was denied to a Petitioner that based its standing on economic-competitor injuries that are not associated with any environmental harm associ-ated with the proposed licensing action.
MEMORANDUM AND ORDER (Dismissal of Envirocare)
On December 7,1998, Petitioner Envirocare of Utah, Inc. ("Envirocare")
filed a Request for Hearing cha.,4. ring the Nuclear Regulatory Commission's
("NRC") amendment of International Uranium (USA) Corporation's ("IUSA")
Source Material License SUA-1358 to allow for the receipt and " processing" of uranium-bearing material from the Ashland 1 site (Formerly Utilized Sites Remedial Action Program, "FUSRAP") near Tonawanda, New York. In its Request for Hearing, on pages 12, Envirocare states that it disagrees with prior Commission decisions but it acknowledges that Quivira Mining Co.
153 l
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]
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}; (Ambrosia Lake Facility, Grants, New Mexico), CLI-98-il,48 NRC 1 (1998) l and International Uranium (US4) Corp. (Receipt of Material from Tonawanda, New York), CLI-98-23,48 NRC 259 (1998) may well affect its standing in this case. Envirocare states, on page 2 of its Request, that:
.. While its appeals are pending, Envirocure hoseby Ales this request. in good faith, to preserve its right to participate as a g arty in a hearing on IUSA's latest license ~ '
^ application.
l Because the Request bases Envirocare's standing on economic-competitor injuries that are not associated with any environmental harm associated with l the proposed licensing action and that are therefore not cognizable under the i National Environmental Policy Act or the Atomic Energy Act, I am convinced that this case is on all fours with the cases with which Envirocare has cited and ' ,
which it contests. Accordingly, the Request for a IIcaring is dismissed.
- Peter B. Bloch, Presiding Officer -
ADMIN 1ETRATIVE JUDGE l Rockville, Maryland l
r 154 l
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r Cite as 49 NRC 155 (1999) LBP-99-12 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL Before Administrative Judges:
G. Paul Bollwerk, Ill, Presiding Officer Thomas D. Murphy, Special Assistant in the Matter of Docket No. 40-8948-MLA (ASLBP No. 99-760-03-MLA)
SHIELDALLOY METALLURGICAL CORPORATION (Cambridge, Ohio Facility) February 23,1999 In this proceeding concerning the application of Shieldalloy Metallurgical Corporation (SMC) to amend the 10 C.F.R. Part 40 license for its Cambridge, Ohio facility to authorize SMC to possess radioactive slag, the Presiding Officer denies a petition for leave to intervene, finding that the Petitioners lack standing as of right.
RULES OF PRACTICE: INTERVENTION i Intervention in NRC licensing adjudications, whether formal or informal, generally arises in one of three ways: (1) an individual seeks to intervene on his or her own behalf; (2) an organization seeks to intervene to represent the interests of one or more of its members; or (3) an organization seeks to intervene on its own.
l RULES OF PRACTICE: INTERVENTION PETITION (PLEADING l REQUIREMENTS)
When an individual seeks to intervene on his or. her own behalf, that person must establish that (1) he or she will suffer a distinct and palpable injury in I
155 l
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1 fact within the zone of interests arguably protected by the statutes governing the l
. proceeding (e.g., the Atomic Energy Act, the National Environmental Policy Act of 1%9); (2) the injury is fairly traceable to the challenged action; and (3) l the injury is likely to be redressed by a favorable decision. See Atlas Corp.
(Moab, Utah Facility), LBP-97-9,45 NRC 414,423, ag'd, CLI-97-8,46 NRC )
2I (1997).
RULES OF PRACTICE: STANDING TO INTERVENE (FACTUAL REPRESENTATIONS) )
In order to establish the factual predicates for the various standing elements, when legal representation is present, it generally is necessary for the individual to set forth any factual claims in a sworn affidavit. See id. at 427 n.4.
MEMORANDUM AND ORDER (Denying Petition to Intervene) .
By letter dated December 21,1998, attorney Michael Bruce Gardner requests an informal adjudicatory hearing to contest a request by Shieldalloy Metallurgi-cal Corporation (SMC) to amend the 10 C.F.R. Part 40 source materials license for its Cambridge, Ohio facility. In the petition, Mr. Gardner claims he is act- !
ing on behalf of unnamed persons residing in Guernsey County, Ohio, whose i interests are affected by that amendment. Both SMC and the NRC Staff oppose this hearing request, asserting there has been no demonstration of standing and a failure to show the areas of concern specified in the petition regarding the SMC amendment are germane to the subject matter of this proceeding.
The Presiding Officer concludes the petition fails te establish standing to intervene. 'Ihe hearing request thus is dismissed.
I. BACKGROUND In a notice issued November 17, 1998, the NRC Staff indicated it was considering issuing a license amendment to Source Material License No. SMB-1507, which authorizes Licensee SMC to possess radioactive slag that resulted from previous alloy production processes conducted at its Cambridge facility. As described in the notice and SMC's September 14,1998 amendment request, the license revision would (1) allow SMC to take possession of slag and associated soil that was gathered from offsite locations in 1997 and is currently kept in roll-off containers at a temporary staging area at SMC's Cambridge facility; 156 l
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and (2) permit SMC to remove this offsite slag / soil from the containers and transfer it to an existing slag pile on the SMC facility. Sec 63 Rd. Reg. J 64,976,64,976 (1998); NRC Staff Notice of Intent to Participate and NRC Staff I
- Response to Request for Hearing Filed by Michael Bruce Gardner (Jan. I 1,1999) unnumbered Attachment 1, at unnumbered p. 7 (Auxlier & Associates, Inc.,
l Environmental Report (July 24,1998) at 3) [ hereinafter Staff Answer]. Prior l owners of the Cambridge facility apparently sold or gave away the offsite slag l for use as fill material, primarily in the 1980's. See Staff Answer, unnumbered j.
. Attachment 1, at unnumbered p. 5 (Environmental Report at 1). !
~ By a timely hearing petition filed on December 21,1998, purportedly act-
.ing on behalf of certain unname.d citizens of Guernsey County, Ohio, attorney i j Michael Bruce.Gardner asserted that the requested amendment should be dis.
L allowed as (1) violating various Ohio state statutory and regulatory provisions and NRC require.ments in 10 C.F.R. Part 61; (2) increasing the costs of proper -
disposal of offsite radioactive slag from the Cambridge facility that was not l . accounted for in the amendment; and (3) increasing the public health and safety i risk from needless handling of radioactive material. See Dec. 21,1998 Letter from Michael Bruce Gardner to NRC Secretary at 1-2 [ hereinafter Petition].
On December 30,1998,'this Presiding Officer and the Special Assistant were appointed to consider the December 21,1998 hearing request. See 64 Rd. Reg.
l- 915 (1999).
! In a December' 31, 1998 answer to the petition, SMC declared that the
!- unnamed Guernsey County citizens Mr. Gardner purported to represent lacked l~ standing as of right and had failed to specify areas of concern that were germane to the subject matter of this materials license amendment proceeding. See Answer to Michael Bruce Gardner Request for Hearing Regarding Docket No.
40-8948, [SMC] License Number SMB-1507 (Dec. 31,1998) at 1-3. In its January 11, 1999 answer, besides declaring it wished to be a party to this proceeding in accordance with 10 C.F.R. 5 2.1213, the Staff asserted the petition had failed to demonstrate standing or germane areas of concern. See Staff l
. Answer at 12-15.
l In a January 14,1999 issuance, the Presiding Officer provided Mr. Gardner with an opportunity to respond to the SMC and Staff answers and allowal
< for SMC and Staff replies to that response. - See Presiding Officer Order l (Schedule for Wrther Filings Regarding Hearing Request) (Jan. 14,1999) at i
I (unpublished). Mr. Gardner did so on February 5,1999, declaring the proposed amendment would (1) affect the aesthetic, recreational, environmental, and economic interests of certain unnamed Guernsey County citizens; and (2) violate various provisions of Ohio and federal law, including the Comprehensive j Environmental Response, Compensation, and Liability Act of 1980 (CERCLA),
42 U.S.C.159601-9657 and 10 C.F.R. Part 61. See Unnamed Citizens of
- l. Guernsey County's Joint Reply to Answers of NRC Staff and [SMC] to Request 157 i
e p
e ,.
- for Hearing (Rb. 5,1999) at 6-18 [ hereinafter Response]. 'mereafter, in replies
- filed on Rbruary 12 and 22,1999, respectively, both the Staff and SMC again
~ declared that the December 21,1998 petition should be dismissed for failing eid:: to establish the requisite standing or to specify germane areas of concern.
See NRC Staff Response to " Unnamed Citizens of Guernsey County's Joint Reply to Answers of NRC Staff and [51vtCJ to Request for Hearing"(Rb; 12 1999) at 2 [hereinafte Staff Replyt Reply of [SMC] to " Unnamed Citizens" Joint Reply to Request for He:. ring Filed by Michael Bruce Gardner (Rb. 22,. t
'1999) at 2-6.8 l
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- II. ANALYSIS .
Intervention in NRC licensing adjudications, whether formal or informal, generally arises in one of three ways: (1) an individual seeks to intervene on his or her own behalf; (2) an organization seeks to intervene to represent the interests of one or more ofits members; or (3) an organization seeks to intervene
. on its own. In this instance, it is apparent that only the first type of intervention is at issue. See Response at 16 (" Organizational standing is not at issue here.
Citizens are unorganized in that respect and asseft only their own legal rights are adversely affected.") '
When an individual seeks to intervene on his or her own behalf, that person must establish that (1) he or she will suffer a distinct and palpable injury in fact within the zone of interests arguably protected by the statutes governing the proceeding (e.g., the Atomic Energy Act, the National Environmental Policy Act of 1%9); (2) the injury is fairly traceable to the challenged action; and (3) the injury is likely to be redressed by a favorable decision. See Atlas Corp.
(Moab, Utah Facility), LBP-97-9,45 NRC 414,423, ag'd, CLI-97-8,46 NRC 21 (1997). Wrther, in order to establish the factual predicates for these various elements, when legal representation is present, it generally is necessary for the individual to set forth any factual claims in a sworn affidavit. See id. at 427 n.4.
In connection with these standards, the intervention petition is deficient on
-several counts. Although the petition makes various claims about purported injuries, the only specific factual assertion it contains is that there are "two in-dividuals' who own real property within a mile of the SMC facility known to I
on Itbruary 16. 1999, the Staff nctihed the Presiding Of6cer and the other puticipants that, in accordance !
with 10 C.F.R.12.1205(m), notwith tanding the pendency of the December 21. 1998 hearing petition it h.ad
- decided to issue the requested amendment. Sea lib. 16.1999 Letter from John W.N. Hickey, NRC office of Nuclear Maserials safety and Safeguards to James Valenti, SMC.
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o contain radioactive slag from the SMC facility.8 Response at 14. 'Iheir injury, it asserts, relates to the failure of the amendment to permit these individuals to place the slag now on their property on the SMC slag pile, thereby injuring their economic interests by requiring them to dispose of their slag at a substantially greater cost. Putting aside the question of whether this purported interest falls within applicable zone of interests, but see, e.g., international Uranium (USA)
Corp. (Receipt of Material from Tonawanda, New York), CLI-98-23,' 48 NRC 259, 264-65 (1998) (economic interests, unlinked to any radiological harm, inadequate to provide basis for standing), this claim must also fail because (a) it is not supported by the requisite sworn statement affirming any of the factual assertions upon which it rests; (b) it lacks the requisite concreteness to establish an injury in fact; and (c) it is not likely that a favorable decision in this instance would redress the alleged injurious effects to the interest in question. On the latter point, the Presiding Officer's authority in this proceeding relative to the SMC amendment application is to determine whether to permit the material now on site to be moved from the containers to the slag pile. Consequently, action by the Presiding Officer to grant or deny the requested amendment simply will not afford the relief the petition purports to seek so as to redress the alleged injury.8 flaving failed to establish the requisite standing as of right,' the petition must
. be dismissed and this proceeding is terminated.
III. CONCLUSION Because it fails to establish the requisite standing as of right, the December '
21,1998 petition filed by Michael Bruce Gardner, Esq., seeking to challenge 2
The pension also describes various purported injuries to aesthetic, recreational. and environmental interests
- that will occur if the anendment is granted. including visual blight and contaminated runoff into nearby streams.
' See Response at 12-14. As we note below, however, the pention contains no veri 6ed claim to these injuries from individual who had indicated an intent to become a party to this proceeding.
. angBy the same token. the linuted scope of the amendment request raises a serious ques 6on wtetter,in accordance we.h 10 C.F.R. I 2.1105(h), the areas of concern specaned in the pection are indred germane to the subject matter -
of this proceeding.
4 Ahhough these is sons cuesdon whether consideradon of &screnonary stan&ng under the standards in Portland Gencial Electric Co. (Pebble springs Nuclear Power Plant. Units I and 2) CU-76 27,4 NRC 610,614-17 (1976),
is appropriate when there is no intervenor with standmg as of right, see Envarocare of Urah. Inc., L.BP 92-8. 35
' NRC 167, is3 (1992). the peudon is so woefuny de6cient relative to the various factors that must be considered for escretionary standing that it would n W pass muster under that analysis either.
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ths %/ J-x 14,1998 SMC request for a license amendment authorizing the movement of onsite slag material is denied.8 Ibr the foregoing reasons, it is, this 23d day of libruary 1999,' ORDERED that:
' 1, .'Ihe December 21,1998 request for a hearing filed by Michael Bruce Gardner is denied and this proceeding is dismissed. '
~
- 2. In accordance with the provisions of 10 C.F.R. I2.1205(o), as it rules
, upon a hearing request, this Memorandum and Order may be appealed to.
the Commission by filing an appeal statement that succinctly sets out, with
- supporting arguments, the errors alleged. To be timely, an appeal statement must be filed within 10 days after this Memorandum and Order is served (i.e.,
on or before Wednesday, March 10,1999).
BY 'ihT, PRESIDING OFFICER 5 G Paul Bollwerk,III
- ADMINISTRATIVE JUDGE Rockville, Maryland -
.c - Ibbmary 23,1999 Putting aside de stan&ng denciencies nord above. the f.etition here is also suspect because o' the consider.tle uncertamy about Mr. Owdner's role relative to the petioon. He has not clained to te intervening on his own behalf. but rather on behalf of h "chems." Petition at I. Yet. despite the Presi&ng of6ceri exp.icit directive to enter a notice of appesance confornung with the reqmrenents of 10 C.F.R.12.713(b). which would include a staaenes identifying exactly whom te is representing. re Presi&ng ofhcer Memorandum and order (iniual Prehmannsonder)(Jan. 4.1999) at 2 3 (uppuhhshed). up to this pois Mr. Gudner has failed to do so.
If Mr. Gardner seeks to appeal this dianussal deternundios to the Comnvasion he should endeavur to clanfy this nenne: of chant authonration by entering an appropnase apperance with whatever ad&uonal explananon is needed.
' Copies of this Memurandom and Order were sent dus due to counsel for Applicant SMC and to Michael
. Bruce Gudner, Esq., by Internet e-mail transmission; and to counsel for the Staff by e-mail through the ager.cy's wide area network systent 160
@~ , _ .
t Directors' '.
- Decisions Under .,
10 CFR 2.206 (n Z -
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4 Cite as 49 NRC 161 (1999) DD-99-3 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION Samuel J. Collins, Director in the Matter of Docket Nos. 50-315 50-316 (License Nos. DPR-58 DPR-74)
INDIANA MICHIGAN POWER COMPANY (Donald C. Cook Nuclear Plant, Units 1 and 2) February 11,1999 On October 9, IW7, the Union of Coa ned Scientists (UCS or Petitioner) submit;ed a petition pursuant to 10 C.F.R. e 2.206 requesting that the operating license for Donald C. Cook Nuclear Plant, Units I and 2, be modified, revoked, or suspended until there is reasonable assurance that plant systems are in conformance with design- and licensing-bases requirements. The petition from UCS was submitted because of the inspection findings from the AE team inspection performed by the NRC in August-Segunber 1997.
In addition, the UCS requested a public hearing on this issue be held in the Washington D.C. area.
On January 12,1998, a meeting was held with the UCS and additional issues
, were raised by the UCS concerning the D.C. Cook Nuclear Plant. The UCS summarized these in a January 12, 1998 letter to the NRC. Following is a summary of the concerns that were evaluated under the section 2.206 process and included in the Director's Decision on the October 9,1997 UCS petition:
(1) ice condenser issues; (2) 10 C.F.R. 5 50.59 process issues; (3) scope of the Licensee's review of eng; ,eering calculations and the NRC assessment of that review; (4) missing or inaccurate net positive suction head calculations for safety-related pumps; and (5) accuracy of the Licensee's Ibbruary 6,1997 161
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respon:.e to the NRC request for additional information pursuant to 10 C.F.R.
I 50.54(f).
He NRC granted the petition request concerning the informal public hearing.
On August 19,1998, an informal public hearing was held with the UCS and the L6 for the purpose of gathering information and to provide clarification of the issue s raised in the petition.
He D9ector of the Office of Nuclear Reactor Regulation has determined that
'the request to prevent operation of the units at D.C. Cook until there is reasonable assurance that significant noncompliances have been identified and corrected-
, - so that systems are in conformance with their design-basis and licensing-basis requirements has been satisfied, ne regulatory oversight actions being taken by the NRC will provide reasonable assurance that systems at D.C. Cook will be in conformance with their design bases and licensing bases, thus meeting the request made in the petition, and eliminates the need to modify, suspend, or revoke the licenses at D.C. Cook.
DIRECTOR'S DECISION UNDER 10 C.F.R. I2.206 I. INTRODUCTION On October 9,_1997, Mr. David A. Lochbaum submitted a petition to the Executive Director for Operations of the U.S. Nuclear Regulatory Commission (NRC) pursuant to section 2.206 of Title 10 of the Code of Federal Regulations (10 C.F.R. 9 2.206). The petition was submitted on behalf of the Union of Concerned Scientists (UCS or Petitioner) and requested that the operating licenses for the Donald C. Cook Nuclear Plant, Units 1 and 2 (D.C. Cook) be
, modified, revoked, or suspended to prevent operation of the units until there is reasonable assurance that significant noncompliances have been identified -
and_ corrected so that systems are in conformance with their design-basis and licensing-basis requirements. The Petitioner also requested that a public hearing into this matter be held in the Washington, D.C. area before the first unit at D.C. Cook is authorized to restart. De Petitioner indicated that the basis for his request was derived from a completed NRC architect / engineering' (AE) design inspection at D.C. Cook. Findings by the NRC during the AE inspection led to the Licensee declaring the emergency core cooling system (ECCS) inoperable at both units at D.C. Cook. As a result, the Licensee shut down both units in accordance with their Technical Specifications (TS). As stated in the petition, the systems reviewed during the AE inspection were the same systems that i
NRC Inspection Report (IR) No. S315, S31687201. November 26,1997.
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the Licensee had reviewed earlier as part of its design-basis documentation reconstitution program. His review did not identify any deficiencies concerning equipment operability. Herefore, the Petitioner asserted that the D.C. Cook design-basis documentation reconstitution programs lacked the necessary rigor and focus to identify potential design-related operability issues. The Petitioner further asserted that deficiencies in the Licensee's design control programs may also be responsible for similar issues in safety systems that have not been examined by the NRC. On the basis of this potential, the Petitioner also requested that the NRC increase the inspection scope at D.C. Cook.
On December 9,1997, the NRC acknowledged receipt of the petition and informed the Petitioner that the petition had been assigned to the Office of Nuclear Reactor Regulation (NRR) to prepare a response and that action on the ;
specific concerns raised in the petition would be taken within a reasonable time, i By letter dated January 12, 1998, the Petitioner submitted an addendum to I the petition. The addendum raised additional issues concerning D.C. Cook l and provided additional information concerning the petition. In addition, the addendum raised concerns dealing with the section 2.206 process, the NRC inspection process, and generic concerns with ice condenser containments. On February 23,1998, the NRC acknowledged receipt of the additional information and informed the Petitioner that the specific concerns related to the D.C. Cook plant and the petition would be considered in the Director's Decision. Further, the NRC informed the Petitioner that the concerns not directly applicable to !
the requests in the petition would be evaluated and transmitted in separate correspondence. By letters dated July 10 and December 28, 1998, the NRC sent the Petitioner the status of the review of these issues not related to D.C. i Cook or the petition. I II. DISCUSSION A. Request To Mcdify, Revoke, or Suspend the Operating Licenses fer D.C. Cook Nuclear Plant, Units 1 and 2 he Petitioner based his request on the fact that the NRC had recently completed an AE design inspection at D.C. Cook and the inspection identified a i number of issues concerning design and procedural controls, safety evaluations, use of engineering judgment, adequacy of op:rability determinations, temporary modifications, and consistency between the updated Final Safety Analysis Report (UFSAR) and the TS. The Petitioner asserted that the Licensee's design control programs were inadequate and there was the potential that similar issues could exist in other safety-related systems that the NRC had not inspected. The Petitioner requested that the units at D.C. Cook be prevented from operating until such time that there is reasonable assurance that significant noncompliances t
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' have been identified and corrected. The Petitioner stated in the petition that the
' system certification process used at the Salem Nuclear Generating Station and the Millstone Nuclear Power Station would provide 2uch reasonable assurance.
On September 8 and 9,1997, the Licensee shut down both Unit I and Unit -
2, respectively, because of inspection findings made by the NRC during the AE
' inspection. These findings led the, Licensee to question the operability of the ,
ECCS. Upon further investigation, the Licensee determined that the ECCSs in both units were incperable and, in accordance with the TS, the Licensee shut down both units. By letter dated September 18, 1997, the Licensee identified several issues and corrective actions it would take preceding restart of either.
unit at D.C. Cook. By letter dated September 19.-1997, the NRC issued a confirmatoiy action letter (CAL) confirming that nine specific issues from the Licensee's September 18,1997 letter would be addressed by the Licensee before a unit at D.C. Cook would be restarted. In addition, the NRC recognized that the
- AE inspection was a limited-scope inspection and that the inspection findings were substantial. For this reason, the NRC confirmed that the Licensee, before restart of a unit at D.C, Cook, would perform an assessment to determine whether the type of inspection findings discovered during the A E inspection ' existed in other safety-related systems and whether they affected system operability. ,
By letters dated December 2, December 24, and December 31,1997, the Licensee responded to the CAL in these letters, the Licensee described the-
~ corrective actions, the root-cause analysis, and the reasons why the units at D.C.
Cook were ready to restart. The NRC held public meetings with the Licensee on December 10 and December 22,1997, and Januaty 8,1998, to discuss the j
Licensee's CAL responses. )
'Ihe petition raised concerns involving the Licensee's design control program rond requested that a public hearing be held in the Washington, D.C. area before restarting either unit at D.C. Cook. The NRC Staff reviewed the petition
' thoroughly and determined that no new information was provided concerning D.C. Cook. The NRC Staff came to this conclusion because the Petitioner based his concerns on the Licensee's design control program deficiencies that were identified in the NRC AE inspection. A CAL had been issued which confirmed ;
that the Licensee would bound the problems discovered by the AE insnecdon and implement adequate corrective actions before restarting either unit at D.C. Cook,
- Therefore, following the guidelines contained in NRC Management Directive i (MD) 8.11. " Review Process for 10 C.F.R. 2.206 Petitions," the NRC Staff came to the conclusion that new information was not provided and a hearing was not warranted. ,
.In a telephone converration on January 5,1998, the NRC Petition Manager informed the Petitioner that new information was not provided h the petition and, in accordance with MD 8.11, a public hearing would not be granted. By letter dated Janusy 6,1998, the Petitioner protested the NRC's decision not to )
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hold a public hearing concernir g the petition. In that letter, the Petitioner stated that information concerning ice condenser issues was presented to the NRC 1
- Inspector General's Office and since D.C. Cook's containment operability relies on an ice condenser system this constituted new information. The Petitioner also stated that the petition was developed and submitted in haste because NRC Region III officials indicated that the Licensee was planning to restart a unit at D.C. Cook in mid-October 1997 and *.he Petitioner wanted to submit the petition before the first unit at D.C. Cook was restarted. For this reason, the petition had not been fully developed and additional information would be forthcoming. On
' the basis of concerns that the Petitioner raised in the January 6,1998 letter, and the assenion that the Petitioner potentially had new information, the NRC held a public meeting with the Petitioner on January 12,1998. During the meeting, the Petitioner raised general concerns about the section 2.206 process and addressed the following six specific concerns covering a broad range of issues: i
- 1. ice condenser concerns,
- 2. 10 C.F.R. 6 50.59 Safety Evaluation process, ,
- 3. engineering calculations, !
- 4. net positive suction head (NPSH) calculations,
- 5. Licensee's response to the CAL,
- 6. NRC inspection process.
By letter dated January 12,1998, the Petitioner issued an addendum to the petition documenting the issues discussed during the January 12,1998 public meeting. By letter dated February 23,1998, the NRC acknowledged the receipt of the addendum. Issues I through 5, as they relate to D.C. Cook and the petition, are discussed individually in Sections II.B through II.F of this Director's Decision. As stated above, all issues raised in the addendum not related to D.C.
Cook or the petition are being evaluated and will be addressed independent of the section 2.206 process in separate correspondence. l
'Ihe NRC Staff reviewed the new information provided in the addendum j according to the guidelines of MD 8.11 and concluded that the additional l information presented in the January 12, 1998 addendum met the criteria for holding an informal public hearing. As a result, the NRC granted the Petitioner's request for an informal public hearing. On August 19, 1998, an informal public hearing was held at NRC headquarters in Rockville, Maryland. Both the Petitioner and the Licensee made presentations at the hearing. The hearing gave the Petitioner an opportunity to clarify the issues raised in the petition and i the addendum. During the het. ring, the Petitioner reported being pleased with the NRC oversight activities at D.C. Cook. Further, the Petitioner indicated he would like to see a Millstone-scale civil penalty issued to the Licensee to ensure that the Licensee will maintain the proper safety culture in the future.
During the hes. ring, the Petitioner also requested that the NRC investigate the potential that 6e Licensee's December 2,1997 letter contained material false 165
statements concerning the readinew of a unit at D.C. Cook to restart. This issue
) has been referred to the NRC Region III office for resolution and the results will be forwarded to the Petitioner under a separate cover..
In an effort to assess the effectiveness of the Licensee's corrective actions and the readiness of the units at D.C, Cook to restart, NRC performed an inspection of the CAL issues. ~ The results of the inspection are documented in NRC Inspection Report (IR) No. 50-315, 50-316/98004. The team of
- inspectors reviewed the nine specific issues identified in the CAL and considered them adequately addressed. The inspection team concluded that the short-term l
assessment items were appropriate and bounded the AE inspection concerns.
However, as described in the NRC July 30,1998 letter to the Licensee, the CAL remains open pending the resolution of concerns involving the adequacy !
of th: Licensee's assessment to determine whether the type of issues discovered duririg the AE inspection existed in other safety related systems. By letter dated January 15,1998, the Petitioner requested a ' copy of the inspection report, even if it was a preliminary version subject to revision, at least I business day before l
closing the CAL. In the NRC's February 23,1998 letter, the request to release the draft inspection report was denied. As stated in the February 23, 1998 letter,-it is not NRC policy to release draft predecisional information. This ~
. policy is intended to prevent improper influences and ensure that predecisional
- information, or contemplated enforcement actions, are not compromised by a premature release. In accordance with MD 8.11, once the petition was received, the Petitioner was placed on distribution for correspondence between the NRC .
and D.C. Cook. The Petitioner has subsequently received a copy of the IR.
The NRC expanded the scope of inspections of the D.C. Cook facility based on findings of the resident inspector staff, concerns that came to the NRC's
. attention regarding the ice condenser issues emanating from the AE inspection, and information brought to our attention by the Petitioner. 'Ihis expanded scope of inspection satisfied the request in the petition. From November 1997 until April 1998, the NRC performed inspections of the containment (IR No. 50-315, 50-316/97017), ice condenser (IR No. 50-315, 50-316/98005), hydrogen mitigation systems (IR No. 50-315,50-316/98009), and the design-basis (IR No, 50-315, 50-316/98004). The inspections identified that NRC requirements had l been violated. 'Ihe apparent violations were discussed at a public predecisional i enforcement conference held at the NRC Region 111 office on May 20,1998, with video viewing by the NRC headquarters staff, the Petitioner, and other members of the public in the NRC headquarters offices located in Rockville, Maryland.
During the predecisional enforcement conference, the Licensee admitted to all the apparent violations that formed the basis for the conference, described its assessment of the root causes, and presented its proposed corrective actions to address these issues. The Licensee stated that a root cause for many of 166 e
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these apparent tiolations' was ti e failure to establish and communicate adequate performance standards. _
- As documented in the irs, extensive degradation of the design of each unit's 3 ECCS, ice condenser, refueling water storage tanks (RWSTs), and containment 1 sumps impaired the ability of the barriers (fuel cladding and containment) to
. prevent fission product release to the environment in the event of a design-
- basis loss-of-coolant accident (LOCA). With regard to the fuel cladding barrier, deficiencies were identified involving (1) a large quantity of fibrous materials -
within containment which would likely have clogged the ECCS sump screens
. in the recirculation mode, (2) a' single-failure ECCS vulnerability, and (3) the insufficient amount of water available in the ECCS sump which represents a challenge to cool the fuel post LOCA. With regard to the containment barrier, the effects on the degraded ice condenser from blocked ice-bed flow passages, missing ice segments, and ice basket damage represented a serious challenge I
to the ability of the ice condenser to perform its intended function to condense 1 steam and suppress containment pressure. Dese conditions seriously impaired the safety function of the ECCS and the containment. Further, beyond the
. specific systems addressed by this enforcement action, two additional systems related to the containment, the hydrogen ignition and containment spray systems, were also degraded during the same period and, following analysis, the Licensee declared these systems inoperable.
' During the informal public hearing, the Petitioner requested that the NRC issue a." Millstone" scale2 civil penalty for the violations of NRC requirements at D.C. Cook. The violations were collectively categorized in accordance with the NRC Enforcement Policy (NUREG-l&X6 as a Severity Level 11 violation.
This severity level was warranted for the I-cadth and number of the violations
. that, taken in total, resulted in a lack of reasonable assurance that following a design-basis accident, the ECCS and containment would have performed their
' intended functions.
On October 13, 1998, the NRC issued the Notice of Violation and asso-ciated proposed civil penalty to the Licensee. Accordingly, after considering the information obtained during the informal public hearing ar.d predecisional enforcement conference, and after consultation with the Commission, the NRC Staff chose to exercise discretion pursuant to Section VII.A.1 of the NRC En-forcement Policy and ressecsed a penalty in the amount of $500,000. Specifically.
the escalated civil penalty reflected the consideration of the poor performance by the Licensee, the duration of the problems,'the adverse impact on the ECCS and the containment, and the NRC's concerns regarding the violations. The i
purpose of the enforcement action was to emphasize the need for (1) taking 2 on December 10.1997, the NRC issued Enforcenent Action EA 96 34 to Northeast Unlitws which included Severity level H wiohmans and a s2.1 nulhou civil pensity.
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timely and effective corrective actions for identified deficiencies, (2) effective l surveillance testing and for plant personnel to challenge and investigate discrep-ancies identified during surveillance activities, (3) rigorous safety evaluations to determin whether changes to the plant or procedures constitute unreviewed -
safety questions, (4) maintaining the plant's design and licensing bases, and (5) a strong self-assessment prograin. He NRC Staff would have proposed a largef civil penalty had it not been for the Licensee's decision to take comprehensive corrective actions and a commitment to keep the facility shut down until these problems are resolved.
Compliance with regulations, license conditions, and TS, and operation of a facility in accordance with the licensing basis is mandatory. However, the NRC also recognizes that plants will not operate trouble-free.2 This is clearly
. articulated in Criterion XVI. Appendix B, Part 50, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." Criterion XVI states that "[m]easures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected." The appropriate response to an identified deficiency can and should vary, depending on the safety significance of the deficiency.
The conduct of NRC ragulatory oversight at the D.C. Cook site is based on the recognition that it is the Licensee's responsibility to comply with its license and Safety requirements and to take corrective actions when deficiencies are identified. Thus, the Licensee must detefmine that a unit is in conformance with applicable NRC regulations, its license conditions, its UFSAR, and that applicable licensing commitments have been met before a unit is ready to restart. The Licensee's conformance with NRC regulations, license conditions, and licensing commitments is fundamental to the NRC's confidence in the safety of licensed activities. In short, the Licensee has the primary responsibility for i the safe operation of its facilities.
{
By letter dated March 7,1998, the Licensee docketed the D.C. Cook Nuclear j
- Plant Restart Plan (Restart Plan). De Restart Plan is the principal program )
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The NRC's regulations for protecton of public heahh and safety embrace the philosophy of defense-in-depth, which supports the identincanon and coneccon of degraded or nonconforrrung conditions previously discussed.
Bnctly stated, this philosophv (1) reqmres the upphcation of conservauve codes and standards to estabhsh substantial safety mrgms in the design of nuclear plants; (2) requires high quahty in the design. construction, and operation of nuclear plants to reduce the hkchhood of malfunctions, and pronmies the une of autonatic safety system actuation features; (3) recognizes that equipment can fail and operators can make mistakes and therefore, requires redundancy in safety systems and crunponents to reduce the chances that malfuncuons or nustakes will lead to accidents that release 6ssion products from the fuel and (4) recognizes that,in spite of these precautions, serious fuel damage accidents can happen and, therefore, requires contamment sauctures and safety features to nutigate the release of 6ssion products. In the unhkely event of an offsile fission product renceae, emergency plans are in place to provide reasonable assurance that protective accons can and win be taken to protect the populauon around nuclear power plants. These emergency plans are coordinated wah local and state officials and the lederal Emergency Management Agency.
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- to provide reasonable assurance that weaknesses at the D.C. Cook units are identified and appropriate corrective actions are implemented. He Restart Plan includes efforts to understand and correct the licensing- and design-bases issues
-that, in part, led to the Licensee shutting down both units at D.C; Cook and the NRC taking escalated enforcement action. Revision 4 of the Restart Plan -
- was submitted by the Licensee on December 16,1998. De Licensee's Restart Plan included system readiness reviews for the most risk-significant systems at D.C. Cook. He reviews included evaluation of the UFSAR and TS design requirements, surveillance tests for the system, a review of design modifications, and a review of temporary modifications.
- De NRC, in an effort to' assess the effectiveness of the system readiness reviews, scheduled a safety system functional inspection (SSFI) on the auxiliary feedwater (AFW) system. De Licensee requested permission to conduct and -
subsequently conducted the SSFI, using independent contractors. The NRC provided oversight of the Licensee's SSFI through an inspection team. De NRC IR No. 50-315, 50-316/98017 associated with the oversight of the Licensee's SSFI was issued on January 28,1999. -In a public meeting on October 22, 1998, the Licensee presented the preliminary findings from the SSFL De SSFI identified a number of issues, including findings that questioned the operability of the AFW system under certain accident conditions. Dese findings had not been identified by the Licensee's AFW system readiness review. In a public meeting on December 22,1998, the Licensee stated that enhancements would
. be made to the system readiness review process and a more thorough review of the most risk-significant systems would be performed before restart of a unit at D.C. Cook.' nese changes will be incorporated into the Licensee's Restart
- Plan.
nrough the implementation of the Restart Plan, the Licensee has documented
- a large number of deficiencies that vary in scope and safety significance for each unit. He Licensee has identified deficiencies that must be corrected before restart.'In its continuing review of the Licensee's corrective act,ons,' the
- NRC will determine whether the Licensee has appropriately scheduled safety-significant items for completion before restart and whether the decision to defer selected corrective actions until after restart is appropriate for each unit. He results of these efforts will be documented in NRC irs.
De NRC has developed a comprehensive and multifaceted oversight process to provide reasonable assurance that the Licensee has identified necessary issues and implemented required corrective actions. Because of the extent of issues 3
discovered at D.C. Cook; the NRC has chosen to use the guidelines contained in NRC Inspection Manual Chapter (MC) 0350, " Staff Guidelines for Restart Approval" to conduct the oversight of the Licensee's corrective actions. MC 0350 establishes the guidelines for approving the restart of a nuclear power plant after a :;hutdown resulting from a significant event, a complex hardware problem, j l
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or serious management' deficiencies. The primary objective of the guidelines in MC 0350 is to ensure that NRC's restart review efforts are appropriate for
' the individual circumstances,' are reviewed and approved by the appropriate NRC management levels, and provide objective measures of restart readiness.
' In accordance with MC 0350, a restart panel has been established. Members include senior managers from both NRC Region 111 and the NRR offices. De NRR project manager and the senior resident inspector are also on the panel.
The panel meets internally to discuss restart issues on a weekly basis, and holds meetings approximately monthly with the Licensee to discuss the Licensee's corrective actions and schedules. The monthly meetings with the Licensee are
. noticed and are open to the public.
By letters dated July 30 and October 13, 1998, the NRC forwarded to the -
Licensee the Case-Specific Checklist for D.C. Cook in accordance with the MC 0350 guidelines. De checklist specified the activities the NRC considers necessary to be addressed before the restart of a unit at D.C. Cook. De items l-- - on the list were derived from the NRC's review of inspection activities, the CAL, and the Licensee's Restart Plan; As new issues emerge the Case-Specific Checklist will be changed, and new issues necessary to be addressed before restart will be added to the list.
B. Ice Condenser Concerns
!~ In the addendum, the Petitioner identified problems in the configuration and testing of the ice condenser at the Watts Bar Nuclear Power Plant.' The addendum l specifically identified problems with the inlet bay doors, floor upheaval, and ,
L ice basket components The addendum also stated that those problems , vere T l known, but were not properly reported by the Watts Bar Licensee (the Tennessee l' Valley Authority), the D.C. Cook Licensee (Indiana Michigan Power Company),
the McGuire Licensee (Duke Power), and the vendor (Westinghouse). De.
Petitioner questioned if the Watts Bar ice condenser problems were valid and if they applied to the D.C. Cook facility, in the NRC's Itbruary 23, 1998 acknowledgment letter, the Petitioner was informed that the specific concerns l'
regarding ice condenser issues at D.C, Cook would be addressed in the Director's
' Decision. All other issues concerning ice condensers at other facilities and the vendor will be reported on in separate correspondence. By letters dated July 10 and December 28,1998, the Petitioner was informed of the review status of these issues.
As a result of concerns with the ice condensers at the D.C. Cook facility, the NRC Region III office initiated an inspection of the ice condensers. The Peti-tioner's concerns raised in the addendum were incorporated into that inspection.
In addition to the concerns raised in the addendum, the inspection also reviewed
. activities associated with the surveillance test program of the ice condensers, the 170
corrective actions performed on the ice condensers, and how the Licensee main-tained the design-basis documentation concerning the ice condensers. He find-ings of the inspection were documented in NRC IR No. 50-315,50-316/98005.
He inspectors determined that the overall material condition of the ice condensers was poor and some of the concerns raised by the Petitioner were confirmed. De issues raised in the addendum concerning the inlet bay doors and the floor upheaval were not substantiated. De team inspected the doors of the ice condensers and found them to be functional but in poor material condition.
In addition, the team identified deficiencies in the design-basis testing of the inlet bay doors. He team also inspected the ice condenser floor sections, which have the potential to heave and prevent the bay doors from operating properly. No signs of floor upheaval or degradation were detected. Concerning the issue of deficiencies of ice basket components, the team identified defective and damaged ice baskets. Examples include the following: (1) dented and buckled ice basket webbing, (2) missing sheet metal screws used to couple the ice baskets together,
- 0) loose and miscing U-bolt nuts on lower ice basket assemblies, (4) separated ice baskets, and (5) failed fillet welds at the ice basket bottom holddown bar. He team inspection identified twenty-nine apparent violations of NRC requirements.
As stated in Section II.A of the Director's Decision, these violations were part of the overall enforcement action taken by the NRC.
In the addendum, the Petitioner raised the concern that the Licensee was aware of the deficiencies with the ice condenser and did not properly report the deficiencies. While the Licensee's staff had knowledge of some of the inspection issues, it was not apparent that the Licensee was aware of the significance of those issues until they were discovered by the NRC and followed up by the Licensee during the inspection. Contributing to the Licensee's failt.re to recognize the significance of those issues was the breakdown of the corrective action program. As stated in Section ll.A. these issues were a part of the overall enforcement action. Therefore, the problems the Licensee's staff identified with the ice condenser were not properly resolved or reported by the Licensee.
Following the inspection, the Licensee has submitted several LERs repor<ing on ,
the deficiencies identified with the ice condenser in accordance with 10 C.F.R. l l 5 50.73. In addition, on July 30,1998, the Licensee issued a report in accordance with 10 C.F.R. Part 21 informing the NRC of potential defects with failed fillet welds at the ice basket holddown bar.
In March 1998, the Licensee decided to completely melt out the ice con-densers of both units to allow thorough inspections and comprehensive repairs of the ice condensers. Following the mettout of the ice condensers, the Licensee discovered foreign material in the ice baskets. Some material appeared to be l from the original construction. Also, the Licensee identified damage to the ice baskets and other ice condenser components. De restoration of the ice con-denser has been incorporated into the Licensee's Restart Plan. The Licensee i 171 I
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i chose to repair damaged components and reinspect the ice condensers to ensure that corrective actions have been adequately implemented and the material con-dition of the ice condensers has been returned to its original design basis. In 3
addition to the physical repairs to the ice condenser, the Licensee has reviewed 1 the ice condenser surveillance program and intends to complete revised ice con-denser surveillance tests to ensure that the ice condensers are operable and will perform their intended function. )
Resolution of the ice condenser problems is an item on the MC 0350 Case- l Specific Checklist and the Licensee's corrective actions are monitored by the I MC 0350 restart panel. Corrective actions implemented by the Licensee will be inspected before the restart of a unit at D.C. Cook, l
l C. 10 C.F.R. 6 50.59 Safety Evaluation Process During the AE inspection, the NRC inspectors identified problems with the 10 C.F.R. 5 50.59 process at D.C. Cook. In the addendum, the Petitioner
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raised a concern that the Licensee's section 50.59 safety evaluation preparation process was " bad" and that a thorough enough review of old section 50.59 ofety evaluations had not been performed. Further, the Petitioner questioned if safety evaluations prepared using the " Lad" section 50.59 process potentially could mean that unidentified safety problems remain at D.C. Cook. ,
Ibliowing the AE inspection, the Licensee initiated corrective actions to ad- {
dress the section 50.59 issues identified during the AE inspection. The Licensee assessed the section 50.59 process in December 1997. De Licensee reviewed section 50.59 screenings and unreviewed safety question determinations per-formed between January 1996 and September 1997. He Licensee identified sev-eral administrative or procedural problems. The Licensee's assessment did not identify issues that would have an impact on the technical conclusions reached in ar.y safety evaluation prepared in accordance with the section 50.59 process.
To evaluate'the corrective actions taken by the Licensee following the AE inspection, the NRC performed an inspection of the section 50.59 process at D.C. Cook. The inspectors reviewed procedure and design change safety evaluations The team did not identify any safety evaluations per%J by the Licensee using the "old" section 50.59 process that resulted in a safety sy tem j
! operability concern, or where the change would have resulted in an unrev ewed j safety question determination. The inspection did, however, identify arparent j violations of section 50.59 concerning the failure to perform safety eve'uations for proposed changes to the plant design basis. The violations resaltui from the Licensee's failure to recognize that implemented changes constiteted a change to the plant's design basis as described in the UFSAR. Violatins were also l identified pertaining to the adequacy of safety evaluations. The mspection made l it evident that weakness still existed in the Licensee's section 50.59 program and 1
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substantiated the concerns raised in the addendum with the Licensee's section 50.59 process. The specific details of the findings are contained in IR No. 50-315, 50-316/98004.
As a result of the inspection findings from both the AE inspection and IR No. 50-315, 50-316/98004, the Licensee has performed three additional self-assessments of the effectiveness of its section 50.59 program. The Licensee's
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review sample was selected from a population of section 50.59 safety evaluations beginning in the 1980s. As a result of the deficiencies identified through these self-assessments, the Licensee committed to implement a number of programmatic changes to improve the section 50.59 process at D.C. Cook.
Further, the Licensee has committed to perform enhanced system readiness reviews as stated above. These commitments have been incorporated into the Licensee's Restart Plan and will be implemented before restart of a unit at D.C.
Cook.
Inspections to date of the Licensee's section 50.59 process have not identified any safety evaluations performed by the Licensee that resulted in safety system operability corcerns. However, the Licensee's enhanced system readiness reviews may discover section 50.59 safety evaluations that are inadequate and that may result in safety system operability concerns. Because of the nature and ;
number of section 50.59 violations, the NRC placed the section 50.59 process on the MC 0350 Case-Specific Checklist. Corrective actions taken by the Licensee will be inspected by the NRC Staff before restart of a unit at D.C. Cook to ensure that the section 50.59 program implementation at D.C. Cook provides !
adequate assurance of safety.
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D. Engineering Calculations In the addendum, the Petitioner identified concerns involving engineering ;
calculations at D.C. Cook. The Petitioner questioned whether the population of I calculations, reviewed by the Licensee as pan of the corrective actions taken i in response to inspection findings from the AE inspection, was a representative sample. In addition, the Petitioner questioned whether the NRC was satisfied with corrective actions taken by the Licensee in response to the calculation weaknesses identified by the NRC during the AE inspection.
The NRC inspected the corrective actions taken by the Licensee in this area. The NRC inspection findings were documented in NRC IR No. 50-315, 50-316/98004. The inspection concluded that the older calculations (early 1970 vintage) appeared to satisfy their intended purpose; however, problems still existed with calculations at D.C. Cook and the initial corrective actions implemented by the Licensee had been unsuccessful in bounding the problem.
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n-i On the basis of the inspection findings, the Licensee chose to expand the scope of engineering calculations to be reviewed to determine the quality, level
, of detail, completeness, and accuracy of the calculations before restart of a _
unit. De Licensee expanded its review to include a significant sample of the -
calculations for the most risk-significant systems. The Licensee's expanded review identified a number of deficiencies in engineering calculations. As a result of these deficiencies, the Licensee has committed to corrective actions to change the calculation preparation procedure and to train all calculation preparers, verifiers, and approvers on the ne procedures.
In summary, because of the extent of the problems with engineering calcula-l tions and design control at D.C. Cook, the MC 0350 restart panel incorporated this issue into the Case-Specific Checklist. Before restart of a unit at D.C. Cook, the NRC will evaluate corrective actions taken by the Licensee to assess whether the Licensee has been successful in correcting the weakness in the engineering calculation program at D.C. Cook and that the calculation adequacy provides reasonable assurance of safety.
. E. Net Positive Suction Head (NPSH) Calculations in the addendum, the Petitioner etated that from the time the petition was submitted on October 9,1997, until the time the Licensee responded to the CAL j . on December 2,1997, the Petitioner received concerns from an individual at D.C. Cook indicating problems with NPSH calculations. He alleged problems l- involved both missing and inaccurate calculations. The Petitioner questioned if l safety related pumps at D.C. Cook have adequate NPSH as shown by quality l calculations.
I in response to the concerns raised in the addendum, the NRC Staff requested by letter dated June 8,1998, that the Licensee provide (1) the NPSH calculations for all safety-related pumps, (2) a description of the calculation technique, and (3) all assumptions used in the calculations. By letter = dated July 22, July 31, and August 5,1998, the Licensee provided the requested information.
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%e NRC Staff reviewed the NPSH calculations for each safety-related pump at D.C. Cook. - With the exception of the containment spray (CTS) and the residual heat removal (RHR) systems, the NRC found that the calculations submitted by the Licensee supported adequate NPSH for the safety-related pumps. For the CTS and RHR systems the values used for the pump run-out flows in the UFSAR did not match the values used in the NPSH calculations.
Because of the inconsistencies in the values used for the pump run-out flows, the NRC was unable to determine whether the NPSH calculations of record for the CTS and RHR systems demonstrated adequate NPSH for the pumps in
. these systems; By letter dated January 7,1999, the NRC informed the Licensee
, of the inconsistencies discovered during the review of the NPSH calculations.
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- Further, the letter requested the Licensee to provide revised NPSH'ca culations addressing the inconsistencies in the CTS and RHR systems' NPSH calculations, and show that adequate NPSH is available for the safety-related pumps in these systems. In addition, the issue of adequate NPSH for safety-related pumps will be monitored by the VC 0350 restart panel. He Licensee's resolution of the issue will be reviewed'and evaluated by the NRC..
In summary, the Petitioner stated that there were missing and inaccurate
' NPSH calculations for safety-related pumps at D.C. Cook.~ Upon request, the Licensee provided _the NPSH calculation for all safety-related pumps at D.C.
Cook. The Licensee's response demonstrated that there were NPSH calculations for all safety-related pumps at D.C. Cook. When the calculations were reviewed
.by the NRC, inconsistencies were discovered in values documented in the UFSAR and those used in the NPSH calculations. Hese concerns have been identified and transmitted to the Licensee. De Licensee's corrective actions
. will be monitored through the MC 0350 process to ensure appropriate actions are taken.
F. Licensee's Response to the CAL In the addendum, the Petitioner raised a concern about the credibility of the Licensee's response to the CAL. He Petitioner stated that since the Licensee's {
libruary 6,1997 response to the NRC'e October 9,1996,10 C.F.R. 6 50.54(f) )
- request for design-basis information was not accurate, based on the AE inspec- j tion finding, he could not see how the Licensee's response to the CAL could be accurate.
Following the Licensee's response to the CAL, the NRC performed additional inspections at D.C. Cook, documented in IR Nos. 50-315, 50-316/98004; 50-315, 50-316/98005; and 50-315, 50-316/98009. De findings of these inspections clearly showed that the Licensee's actions to bound the scope of engineering problems in response to the CAL were too narrowly focused and were not sufficient to address the broad array of problems concerning the design-basis and licensing-basis issues that existed at D.C. Cook.
. De Petitioner's concern in the addendum (that the Licensee's response to the CAL failed to assure the NRC that corrective actions were adequate) has been substantiated. De inspection findings from early 1998 indicated that the CAL response did not bound the design-basis and licensing-basis issues at D.C. Cook.
As indicated in Section ll.A of the Director's Decision, the NRC took escalated enforcement' action against the Licensee. In response to the violations and various programmatic breakdowns at D.C. Cook, the Licensee made a decision in early 1998 to perform a comprehensive assessment to provide reasonable assurance of plant system readiness, programmatic readiness, functional area readiness, and containment readiness before restart of either unit. De Licensee's 175
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primary mechanism to implement each of the plant assessment programs is the D.C. Cook Nuclear Plant Restart Plan. He Restart P11n was submitted in March 1998, and Revision 4 of the Restart Plan was do;;keted on December 16, 1998. As stated above, the NRC is using the guidelines in MC 0350 to oversee the Licensee's corrective actions and the readiness of a unit to restart.
As additional problems or concerns are identified during the implementation of the Restart Plan, appropriate adjustments will be made to the Restart Plan and the Case-Specific Checklist.
IIL NRC RESPONSE TO REQUESTED ACTION A. Request To Modify, Revoke, or Suspend the Operating Licenses for D.C. Cook, Units 1 and 2 ;
he Petitioner requested that the operating licenses for D.C. Cook, Units I and 2 be modified, revoked, or suspended to prevent operation of the units until there is reasonable assurance that significant noncompliances have been identified and corrected so that systems are in conformance with their design- <
basis and licensing-basis requirements. In addition, the petition requested that I the NRC broaden the inspection scope at D.C. Cook following the AE inspection.
The NRC's regulatory oversight actions taken thus far at D.C. Cook, in part, fulfill the actions requested in the petition. The regulatory oversight actions at i D.C. Cook are broad and comprehensive and will ensure that there is reasonable assurance of safety prior to restart of either unit.
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Inspection findings at D.C. Cook following the AE inspection verified that l the corrective actions implemented by the Licensee as described in the CAL i response were too narrowly focused and did not fully address the design- !
basis and licensing-basis issues. The NRC increased inspections at D.C. Cook j identified a number of violations of NRC requirements, and as a result, took I appropriate enforcement action against the Licensee as stated above. While the enforcement action did not modify, suspend, or revoke the operating licenses of j the D.C. Cook facilities, it did emphasize the serious nature of the violations, J the duration of the problems, and the Licensee's poor performance.
The Licensee has developed an integrated Restart Plan. The plan provides l . the framework to be used by the Licensee to identify, evaluate, and correct l issues. The NRC regulatory oversight at D.C. Cook is following the guidelines of MC 0350 as discussed above. His approach focuses the correct level of management atter. tion as well as resources on significant issues to be verified before restart of a unit at D.C. Cook. In addition, this approach allows the NRC the flexibility to change the focus of the oversight as different significant issues emerge. In the Licensee's effort to identify and correct issues, new issues will continue to emerge. As a result, the Licensee will be expected to modify the 176
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Restart Plan to ensure that corrective actions, to resolve the emergent issues, are implemented in a timely manner. He MC 0350 restart panel will review these changes to the Restart Plan to ensure that the Licensee has taken appropriate corrective actions. j He Petitioner's request to suspend, modify, or revoke the licenses at D.C. J Cook, Units 1 and 2 has not been granted at this time. He current regulatory oversight at D.C. Cook is sufficient, and provides reasonable assurance that before restart of a unit at D.C. Cook the Licensee will have identified and corrected issues so that the safety systems at D.C. Cook will be in compliance with their design-basis and licensing-basis requirements.
B. Request To Hold a i ublic Hearing on the Issues Raised in the Petition Before Restart of a Unit at D.C. Cook De Petitioner requested that a public hearing into the issues raised in the petition be held in the Washington, D.C. area before the first unit at D.C. Cook is authorized to restart. As discussed above, this request was granted. On August 19,1998, an informal public hearing was held at the NRC headquarters in Rockville, Maryland. Both the Petitioner and the Licensee made presentations during the hearing. He hearing gave the Petitioner an opportunity to clarify the j issues raised in the petition and the addendum. ;
l C. Issues Raised in the Addendum -
As discussed in Sections II.P through II.E of this Director's Decision, each of the actions requested by the Petitioner in the addendum has been granted in that the Licensee is taking additional corrective actions to ensure that each
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issue raised in the addendum will be resolved before restart of a unit at D.C. I Cook, and the NRC will verify that the Licensee's corrective acticns have been .
effective. Eact of the issues raised in the addendum will be reported on in a future inspection report.
IV. CONCLUSION He NRC has determined, for the reasons given in the preceding discussion, that the request to prevent operation of the units at D.C. Cook until there is reasonable assurance that significant noncompliances have been identified and corrected so that systems are in conformance with their design-basis and licensing-basis requirements has been satisfied. The regulatory oversight actions being taken by the NRC as stated above will provide reasonable assurance that systems at D.C. Cook will be in conformance with their design basis and 177
rv licensing bases, thus meeting the request made in the petition, and eliminates the need.to modify, suspend, or revoke the licenses at D.C. Cook. The request
' to hold a public hearing into the issues raised in the petition and addendum in the Washington, D.C. area before the first unit at D.C. Cook is authoriud to restart has been granted. Action has been taken on each concern identified in the addendum, as stated above.
As provided for in 10 C.F.R. 5 2.206(c), a copy of this Decision will be filed with the Secretary of the Commission for the Commission's review. This Decision will constitute the final action of the Commission 25 days after issuance
'unless the Commission, on its own motion, institutes review of the Decision at that time.
FOR THE NUCLEAR REGULATORY COMMISSION Samuel J. Collins, Director Office of Nuclear Reactor Regulation l Dated at Rockville, Maryland, this lith day of itbruary 1999.
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Cite as 49 NRC 179 (1999) DD-99-4 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION Samuel J. Collins, Director in the Matter of Docket No. 50-271 l (lJeonse No. DPR-28) {
VERMONT YANKEE NUCLEAR POWER CORPORATION l '
(Vermont Yankee Nuclear Power Station) February 10,1999 l
l By Director's Decision dated Ibbruary 10, 1999, the Director, Office of Nuclear Reactor Regulation, has acted on a petition for action under 10 C.F.R. 62.206 received from Michael J. Daley on April 9,1998, concerning the Vermont Yankee Nuclear Power Station (VYNPS).
The petition requested that the U.S. Nuclear Regulatory Commission (NRC) .
t issue an order requiring that the Licensee's administrative limits, which were in effect at the time and precluded VYNPS from operating with a torus water .
temperature above 80"F or with a service. water injection temperature greater i than 50 F, shall remain in force until certain conditions are met. The conditions listed include a complete reconstitution of the licensing basis for the maximum torus water temperature, submittal to the NRC of a technical specifications (TSs) amendment request establishing the correct maximum torus water temperature, and completion of NRC's review of the amendment request.
As a basis for the request, the Petitioner raised concerns about the Licensee being unable to demonstrate an ability to either justify the operational limits for the maximum torus water temperature or to maintain operations within existing 1 administrative limits (torus water temperature is critical to the proper functioning of the containment). The Petitioner asserted that since 1994, events have caused the Licensee to question VYNPS's maximum torus water temperature limits four times, leading to the self-imposed administrative limits previously noted.
The Petitioner stated that the NRC must move from a " wait and see" posture 179 1
? to active intervention, with immediate imposition of the order recommended by the Petitioner as a first step.
On _May 13,1998, the Director of the Office of Nuclear Reactor Regulation concluded that issuing an immediate order imposing the Licensee's administra-
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- tive limits that were in effect at the time was unnecessary. This aspect of the
- petition was denied since the Licensee took appropriate actions to determine Ithe proper limit on torus water temperature, sought a TS amendment to impose
- the correct torus water temperature, and administratively implemented the limit
- while the NRC reviewed the analysis in support of the TS amendment. The ,
additional conditions associated with the request have been completed includ- i ing establishing the correct licensing basis for the maximum torus temperature, submittal of a TS amendment request establishing the correct maximum torus water temperature limit, and completion of the NRC review of the amendment request. The NRC has concluded that the appropriate limit for maximum torus temperature is 90'F, making the limits requested in the petition unnecessary.
' Accordingly, the Staff has addressed the issues raised by the Petitioner and has completed its actions relating to the petition.
I DIRECTOR'S DECISION UNDER 10 C.F.R.12.206 l L INTRODUCTION By' a petition submitted pursuant to 10 C.F.R. 6 2.2% on April 9,1998, Michael J. Daley, on behalf of the New England Coalition on Nuclear Pollution, Inc. (Petitioner), requested that the U.S. Nuclear Regulatory Commission (NRC) take immediate action with regard to the Vermont Yankee Nuclear Power Station (VYNPS) operated by the Vermont Yankee Nuclear Power Corporation
'(Licensee or Vermont Yankee).
The Petitioner requested that the NRC issue an order requiring that the
- Licensee's administrative limits, which were in effect at the time and precluded VYNPS from operating with a torus water temperature above 80 F or with a - i service water injection temperature greater than 50 F, shall remain in force until certain conditions are met. The conditions listed include a complete reconstitution of the licensing basis for the maximum torus water temperature,.
submittal to_the NRC of a technical specifications (TSs) amendment request establishing the correct maximum torus water temperature, and completion of NRC's review of the amendment request.
On May 13,1998, the Director of the Office of Nuclear Reactor Regulation informed the Petitioner that he was denying the request for immediate action at l
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! VNYPS, that the petition was being evaluated under 10 C.F.R. 5 2.206 of the Commission's regulations, and that action would be taken in a reasonable time.
1 De NRC Staff's review of the petition is now complete. Ibr the reasons -
i set forth below, the Petitioner's remaining requests have been appropriately ad-l '. dressed. De conditions associated with the Petitioner's request have been com-
" pleted, including establishment of the correct licensing basis for the maximum
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- torus temperature, submittal of a TS amendment request establishing the correct i maximum torus water temperature limit, and ccmpletion of the NRC's review of the amendment request.
i IL~ BACKGROUND In support of these requests, the Petitioner raised concerns about the Licensec being unable to demonstrate an ability to either justify the operational limits for -
the maximum' torus water temperature or to maintain operations within existing administrative limits (torus water temperature is critical to the proper functioning of the containment). The Petitioner asserted that since 1994, events have caused l the Licensee to question VYNPS's maximum torus water temperature limits four times,' leading to the self-imposed administrative limits previously noted.
The Petitioner stated that the NRC must move from a " wait and see" posture to active intervmtion, with immediate : 7 position of the order recommended by l the Petitioner as a first step. _
(. De Staff notes that the limits proposed by the Petitioner were in effect at L ' VYNPS on an interim basis while the Licensee determined the correct maximum
[* torus water temperature limits since it was determined that the TS limit of 100*F was incorrect. The Licensee subsequently completed the analysis and determined
- that the correct limit for the maximum torus water temperature is 90 F. His administrative limit was then established at 90 F and a TS amendment request was submitted to establish this as the maximum torus water temperature.
. IIL DISCUSSION l A's indicated in the May 13 letter, Petitioner's request for immediate action was denied. Although the NRC identified concerns regarding the Licensee's
- _ handling of the torus water temperature issue in the past, as evidenced by the
- NRC's enforcement action (Notice of Violation and Proposed Imposition of Civil Penalty of $55,000 dated April 14,1998), there was insufficient basis for j concluding that the limits proposed by the Petitioner must be imposed on the !
Licensee while the NRC reviewed the associated TS amendment request. The NRC took several actions in this area, including performing a design inspection 181 i
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and conducting several meetings with the Licensee on this issue. The NRC concluded that the Licensee's actions to resolve this issue were acceptable.
In May and June 1997, the NRC performed a design inspection to evaluate the capability of selected systems to perform their intended safety function as described in design-basis documentation. Also, the NRC assessed the Licensee's adherence to its design and licensing basis for selected systems, and the consistency of the as-built configuration and system operations with the '
final safety analysis report. The team concluded that although some concerns were identified, the systems evaluated were capable of performing their intended ,
functions and the design engineers had excellent knowledge and capabilities. l The report findings were documented in NRC Inspection Report Number 50-271/97-201, which was provided with our May 13 letter to the Petitioner.
One of the concerns identified during the design inspection was associated with the Licensee's previous handling of the torus water temperature issue and resulted in enforcement action being taken on April 14, 1998, because of a failure to (1) properly translate the design basis of the plant into specifications, l procedures, and instructions and (2) promptly correct design deficiencies once they were identified. However, credit was warranted for corrective actions ;
because NRC considered the Licensee's actions, once the violations were identified, to be prompt and comprehensive.
At the NRC's request, several public meetings were conducted to discuss issues, including the Licensee's analysis to determine the appropriate torus water temperature limit. As a result of discussions with the Licensee during public meetings on March 5, March 24, and April 7,1998, the NRC concluded that the Licensee was taking the appropriate actions to resolve this issue and to ensure that the appropriate maximum torus water temperature was specified in the TS and administratively controlled while the TS amendment was being reviewed by the NRC. During the April 7 meeting, the Licensee committed to submit the TS amendment request to limit the torus water temperature to 90 F, which is an input value to the containment analysis calculations, before restart. The calculations supporting the amendment request were subjected to the Licensee's formal quality process for ensuring accuracy and completeness and provided additional assurance that the 90 F limit is correct. The more restrictive administrative limits (80 F torus water temperature and 50 F service water injection water temperature) were put in place by the Licensee, while the ;
detailed analysis was perforraed to verify that 90 F was the correct limit.
The Licensee proposed a TS amendment to establish a maximum torus water temperature limit of 90 F by letter dated May 8,1998, as supplemented on July 10 and October 2,1998. The NRC reviewed the Licensee's analysis and concluded, for the reasons specified in the safety evaluation, that the appropriate maximum torus water temperature is 90 F. Therefore, imposition of the more restrictive administrative limits specified in the petition are not necessary.
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iv. CONCLUSION l
' The NRC Staff has' evaluated the information provided by the Petitioner as its basis for the actions requested. As indicated in the May 13 letter to the Petitioner, the NRC has concluded that issuing an immediate order, as requested, was unnecessary since the Licensee took appropriate actions to determine the
. proper limit on torus water temperature, sought a TS amendment to impose the correct torus water temperature, and administratively implemented the limit while the NRC reviewed the analysis in support of the TS amendment. Although the NRC denied Petitioner's request to take immediate action to issue an order
- imposing certain limits on VYNPS, the conditions associated with the request
' have been completed, including establishment of the correct licensing basis for the maximum torus temperature, submittal.of a TS amendment request establishing the correct maximum torus water temperature limit, and completion - 4
' of the NRC's review of the amendment request.
Since the conditions listed in the petition have been met and the NRC had previously addressed Petitioner's immediate request for imposition of an order, all actions associated with the request are complete. For the reasons contained in I the safety evaluation, we have concluded that the appropriate limit for maximum : f' torus water temperature is 90 F, making the limits requested in the petition -
unnecessary. Accordingly, the Staff has addressed the issues raised by the Petitioner and has completed its actions relating to the petition.
' As provided in 10 C.F.R.12.206(c), a copy of this Decision will be filed with the Secretary of the Commission for the Commission's review. This Decision will constitute the final action of the Commission 25 days after issuance unless the Commission, on its own motion, institutes review of the Decision within that time.
FOR THE NUCLEAR REGULATORY COMMISSION l j
i Sc.muel J. Collins, Director
- Office of Nuclear Reactor Regulation Dated at Rockville, Maryland, this 10th day of February 1999, 183 i
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