ML20216G004

Enforcement Actions: Significant Actions Resolved Material Licensees.Semiannual Progress Report,January-June 1999

ML20216G004
Person / Time
Issue date:	08/31/1999
From:	NRC OFFICE OF ENFORCEMENT (OE)
To:
References
NUREG-0940, NUREG-0940-PT03, NUREG-0940-V18-N1-P3, NUDOCS 9909270204
Download: ML20216G004 (150)

Text

1 NUREG-0940 Vol.18, No.1, Part 3 Material Licensees Enforcement Actions:

Significant Actions Resolved Material Licensees "3-Semiannual Progress Report January - June 1999 E

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AVAILABILITY NOTICE Availability of Reference Materials Cited in NRC Publications NRC publications in the NUREG series, NRC regu- NRC Public Document Room lations, and Title 10, Energy, of the Code of Federal 2120 L Street, N.W., Lower Level Regulations, may be purchased from one of the fol. Washington, DC 20555-0001 lowing sources: < http://www.nrc. gov /NR C/PDR/pdr1.htm >

1. The Superintendent of Documents

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U.S. Government Printing Office Microfiche of most NRC documents made publicly RO. Box 37082 available since January 1981 may be found in the Washington, DC 20402-9328 Local Public Document Rooms (LPDRs) located in

< http://www. access. g po. gov /su_ docs > the vicinity of nuclear power plants. The locations 202 - 512 -1800 cf the LPDRs may be obtained from the PDR (see l

previ us paragraph) or through:

2. The National Technical Information Service Springfield, VA 22161-0002 <http://www.ntc. gov /NRC/NUREGS/

<http://www.ntis. gov /ordernow> SR1350/V9/lpdr/html>

703 -487-4650 i Publicly released documents include, to name a 1 The NUREG series comprises (1) brochures few, NUREG-series reports; Federal Register no-(NUREG/BR-XXXX), (2) proceedings of confer- tices; applicant, licensee, and vendor documents ences (NUREG/CP-XXXX), (3) reports resultin9 and correspondence; NRC correspondence and 1 from international agreements (NUREG/lA-XXXX), internal memoranda; bulletins and information no-J (4) technical and administrative reports and books tices; inspection and investigation reports; licens-

[(NUREG-XXXX) or (NUREG/CR-XXXX)], and (5) ee event reports; and Commission papers and compilations of legal decisions and orders of the their attachments.

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tions, and non-NRC conference proceedings may Address: Office of the Chief Information Officer be purchased from their sponsoring organization.

Reproduction and Distribution Copies of industry codes and standards used in a Services Section substantive manner in the NRC regulatory process U.S. Nuclear Regulatory Commission are maintained at the NRC Library, Two White Flint Washington, DC 20555-0001 North, 11545 Rockville Pike, Rockville, MD E-mail: < DISTRIBUTION @nrc. gov >

20852-2738. These standards are available in the Facsimile: 301 - 415 - 2289 library for reference use by the public. Codes and A portion of NRC regulatory and technicalinforma- standards are usually copyrighted and may be tion is available at NRC's WorW VMe Web site: purchased from the originating organization or, if they are American National Standards, from-

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American National Standards institute All NRC documents released to the public are avail- 11 West 42nd Street able for inspection or copying for a fee, in paper, New York, NY 10036-8002 microfiche, or, in some cases, diskette, from the <http://www.ansl.org>

Public Document Room (PDR): 212- 642-4900

NUREG-0940 Vol.18, No.1, Part 3 Material Licensees Enforcement Actions:

Significant Actions Resolved Material Licensees Semiannual Progress Report January - June 1999 Manuscript Completed: August 1999 Date Published: August 1999 OITice of Enforcement U.S. Nuclear Regulatery Commission Wcshington, DC 20555-0001 bri as %73rfj 5gg,4*

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ABSTRACT I This comoitation summarizes significant enforcement actions that have been resolved during

the period (January - June 1999) and includes copies of letters, Notices, and Orders sent by the Nuclear Regulatory Commission to material licensees with respect to these enforcement actions. It is anticipated that the information in this publication will be widely disseminated to

! managers and employees engaged in activities licensed by the NRC, so that actions can be I

taken to improve safety by avoiding future violations similar to those described in this publication.

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NUREG 0940, PART 3 lii

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CONTENTS Pace A B ST R ACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i ii I NT ROD UCTIO N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 SUMMARIES.............................................................3 MATERIAL LICENSEES A. CIVIL PENALTIES AND ORDERS Coriell Institute for Medical Research, Camden, New Jersey EA 9 9 -06 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 DMS Imaging, Inc., Bemidji, Minnesota E A 9 7- 1 8 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 March Metalfab, Inc., Hayward, California EA 98-5 2 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 3 I

Marshall Miller & Associates, Bluefield, Virginia EA 97-444 & 98-313 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 19 Materials Testing Laboratory, Inc., New Hyde Park, New York E A 9 9-0 37 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 3 0 NDT Services, Inc., Caguas, Puerto Rico E A 9 9 -01 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -3 4 Power inspection, Inc., Pittsburgh, Pennsylvania E A 9 5-02 5 . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 4 6 Special Testing Laboratories, Inc., Bethel, Connecticut E A 9 8-5 21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 6 3 Washington Hospital Center, Washington, DC E A 98 - 5 5 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 8 8 SEVERITY LEVEL 1. II. AND lli VIOLATIONS. NO CIVIL PENALTY Code Services, Inc., Madison, Alabama i E A 9 9-074 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......................B-1 DAS Consult, Inc., Columbus, Ohio EA 98-4 9 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B -6 I 1

l Depa1 ment of Interior, Bureau of Indian Affairs, Albuquerque, New Mexico EA98-471........................................................ ...... B-9 NUREG-0940. PART 3 v i

o Department of Veterans Affairs, Audie L. Murphy Memorial Veteran's Hospital -

San Antonio, Texas EA 98-481 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 1 3 Hartford Hospital, Hartford, Connecticut

. EA 98-575 .............................................................B-18 Material Testing Consultants, Inc., Grand Rapids, Michigan EA 99- 1 07 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 3 Materials Testing & Inspection, Inc., Boise, Idaho EA 9 8-52 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B 2 7 Medi-Physics, Inc., Livingston, New Jersey E A 9 9-09 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-31 Philadelphia Health and Education Corporation, Philadelphia, Pennsylvania j EA 99 -096 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-35 SibTech, Inc., Elmsford, New York EA 99- 1 2 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-41 Tulsa Gamma Ray, Inc., Tulsa, Oklahoma E A 98-4 7 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-47 United States Environmental Protection Agency, National Air and Radiation Environmental Laboratory, Montgomery, Alabama E A 98 -54 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5 2 United States Enrichment Corporation, Bethesda, Maryland EA 99-01 6 . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5 7 1'

XRI Testing, Troy, Michigan EA 98-507 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 61

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i NUREG-0940. PART 3 vi

ENFORCEMENT ACTIONS: SIGNIFICANT ACTIONS RESOLVED MATERIAL LICENSEES January - June 1999 INTRODUCTION This issue and Part of NUREG-0940 is being published to inform Nuclear Regulatory Commission (NRC) Material licensees about significant enforcement actions and their resolution for the first half of 1999. Enforcement actions are issued in accordance with the NRC's Enforcement Policy, published as NUREG-1600," General Statement of Policy and Procedure for NRC Enforcement Actions." Enforcement actions are issued by the Deputy Executive Director for Regulatory Effectiveness (DEDE), and the Regional Administrators. The Director, Office of Enforcement, may act foi se DEDS in thu absence of the DEDS or as directed. The NRC defines significant enforcement actions or escalated enforcement actions as civil penalties, orders, and Notices of Violation for violations categorized at Severity Level I, II, and 111 (where violations sre categorized on a scale of I to IV, with I being the most significant).

The purpose of the NRC Enforcement Program is to support the agency's safety mission in protecting the public and the environment. Consistent with that purpose, the NRC makes this NUREG available to all materials licensees in the interest of avoiding similar significant noncompliance issues. Therefore, it is anticipated that the information in this publication will be widely disseminated to managers and employees engaged in activities licensed by NRC.

A brief summary of each significant enforcement action that has been resolved in the first half of 1999 can be found in the section of this report entitled " Summaries." Each summary provides the enforcement action (EA) number to identify the case for reference purposes. The supplement number refers to the activity area in which the violations are classified in accordance with the Enforcement Policy.

Supplement 1 - Reactor Operations Supplement II - Facility Construction Supplement ll1 - Safeguards Supplement IV - Health Physics Supplement V - Transportation Supplement VI - Fuel Cycle and Materials Operations Supplement Vll - Miscellaneous Matters Supplement Vill - Emergency Preparedness Section A of this report consists of copies of completed civil penalty or Order actions involving materials licenseos, arranged alphabetically. Section B includes copies of Notices of Violation tnat were issued to materials licensees for a Severity Level I,11, or lll violation, but for which no civil penalties were assessed.

The NRC publishes significant enforcement actions taken against individuals and involving reactor licensees as Parts I and 11 of NUREG-0940, respectively.

NUREG-0940, PART 3 1

m SUMMAPIES A. civil PENALTIES AND ORDERS Coriell Institute for Medical Research, Camden, New Jersey Supplement Vil, EA 99-060 A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $4,400 was issued on June 2,1999 to emphasize the importance of continuously assuring a work environment that is free of any harassment, intimidation, or discrimination against those who raise safety concerns. The action was based on a Severity Level 11 violation of 10 CFR 30.7(a) for discrimination against one of its former employees for engaging in protected activities. The employee was terminated as a result of raising safety concerns to his management and the NRC regarding unnecessary exposure to employees from the use of phosphorus-32 in a laboratory. No credit was warranted for identification since the licensee did not identify the discriminatory actions. However, credit was j warranted for corrective actions which included: (1) preparation of a written policy 4 statement that indicated that employees are encouraged to identify safety concerns without fear of retaliation, (2) distribution of this policy to all employees, (3) meeting with 1 all supervisors to dhcuss the ALJ decision, and (4) meeting with all employees to I discuss the licensee's policy for identification and reporting of safety concerns. The l licensee responded and paid the civil penalty on June 23,1999 DMS Imaging, Inc., Bemidji, Michigan Supplements VI and Vil, EA 97-189 A Notice of Violation and Proposed imposition of Civil Penalty the amount of $2,500 was issued February 24,1998 to emphasize the importance of providing accurate and complete information to the NRC, procedural compliance, and prompt identification of violations. The action was based on a Severity Level lll problem which involved: (1) a supervisor del:ocrately directing a newly-hired technologist to conduct nuclear medicine activities before the technologist obtained the required perscnnel dosimetry, and (2) the supervisor subsequently directed two technologists to provide inaccurate information to an NRC investigator by telling them to state that the newly hired technologist did not handle radioactive material before he obtained the required dosimetry. Credit was not warranted for identification because NRC identified the violations, but credit was warranted for corrective actions which were prompt and comprehensive. The licensee responded and paid the civil penalty on March 18,1999.

March Metalfab, Inc., Hayward, California EA 98-529 A Confirmatory Order Prohibiting involvement in NRC-Licensed Activities (Effective immediately) was issued January 27,1999. The Order was based on an NRC investigation that concluded that two managers deliberately violated 10 CFR 72.11 which prohibits submission of incomplete or inaccurate information and 10 CFR 72.12, which prohibits deliberate misconduct that causes a licensee, contractor, or subcontractor to be in violation of any rule, regulation, or any term condition, or limitation of any license issued by the Commission. An NRC investigation concluded that the individuals deliberately made statements to the NRC and the prime contractor that were NUREG-0940. PART 3 3

inaccurate concerning internal welding of a spent fuel cask. The Order prohibits the licensee from engeging in NRC-licens3d activities for a period of five years.

Marshall Miller & Associates, Bluefield, Virginia Supplement VI, EAs97-444 and 98-313 A Notice of Violation and Proposed imposition of Civil Penalties in the amount of $8,800 was issued January 29,1999 to emphasize the need for effective management oversight of licensed activities and in recognition of the seriousness of violations involving careless disregard. The action was based on two Severity Level ll problems involving: (1) numerous willful safety and training violations, including failure to lock and physically secure to prevent tampering of removal by unauthorized persons, a cesium-137 source, and (2) willful failure to maintain, and to provide to the NRC, complete and accurate records concerning training and radiation survey records. The violations were identified by the NRC and therefore, credit was not warranted for identification.

However, credit was warranted for corrective actions because the licensee took prompt and comprehensive corrective actions. The licensee responded and paid the civil penalties on February 25,1999.

Materials Testing Laboratory, Inc., New Hyde Park, New York Supplement VI, EA 99-037 i

l A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $2,750 )

was issued June 17,1999. The action was based on a Severity Levelill problem involving a licensee official who deliberately allowed, at least, one field technician to use a nuclear gauge without being properly certified and without wearing appropriate dosimetry. No credit was warranted for identification since the NRC identified the violation. Credit was warranted for corrective actions, since as part of its corrective actions the licensee demoted and reassigned the licensee official whose deliberate actions caused the problem.

NDT Services, Inc., Caguas, Puerto Rico EA 99-014 An Order Modifying License (Effective immediately) was issued January 15,1999. The action was based on the licensee's failure to provide adequate security and control of radiography devices in its possession. A prior NRC Order suspended the license because of a number of serious safety and compliance issues. NRC inspections on January 11 and 14,1999, determined that the radiography devices were being stored in a vacant building and not attended by a security guard, and that the building had been vandalized, including shearing of the locks that secured the devices. The Order requires immediate security measures, followed by the removal of the devices to a temporary safe storage location and transfer to an authorized recipient within 30 days.

Power Inspection, Inc., Pittsburgh, Pennsylvania Supplement Vil, Es95-025 A Notice of Violation and Proposed imposition of Civil Penalties in the amount of

$40,000 was issued February 18,1997. The action was based on a Severity Level I violation involves vendor-related issues, and was issued for four examples of a deliberate failure to provide to two NRC licensees complete and accurate information.

NUREG-0940. PART 3 4

The Severity Level I problem involved radiography-rclated issues and for deliberate failure to provide NRC complete and accurate information. The licensee responded on May 13,1997 denying involvement in the management of the company and protesting the civil penalties citing the conduct of others as being responsible for the violations. An Order imposing Civil Monetary Penalties in the amount of $40,000 was issued February 3,1998. The company has since dissolved and no payment of the civil penalties was made.

Special Testing Laboratories, Inc., Bethel, Connecticut EA 98-521 An Order Suspending License (Effective immediately) was issued December 23,1998.

The action was based on the findings of NRC inspections and an ongoing investigation which indicated that the licensee had deliberately violated NRC requirements by (1) directhg untrained individuals to use moisture density gauges, (2) not providing these individuals with the necessary dosimetry while they were using the gauges, and (3) making false statements to the NRC. The licensee responded on December 23,1998 requesting a hearing. On January 8,1999 the NRC sent a letter to the licensee agreeing to conditions that the Order may be modified. A Confirmatory Order Modifying License and Rescinding Order of December 23,1998 was issued on January 22,1999. ]

Washington Hospital Center, Washington, DC Supplement IV, EA 98-555 A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $5,500 was issued March 31,1999. The action was based on the loss of a nuclear pacemaker, which contained 2.8 curies of plutonium-238, when it was being prepared for shipment to a non-nuclear pacemaker company. Credit was warranted for identification and corrective actions, but the NRC decided to exercise enforcement discretion and issue a civil penalty for twice the base amount because (1) the loss of radioactive material, l l

which was shipped to an entity without verifying that the entity possessed an NRC license for receipt of such material, (2) the licensee's performance in this case was poor, and (3) the licensee's prior enforcement history had been particularly poor. The licensee responded and paid the civil penalty on April 27,1999, i l

B. SEVERITY LEVEL 1. II. AND lli VIOLATIONS. NO CIVIL PENALTY l Code Services, Inc., Madison, Alabama Supplement VI, EA 99-074 A Notice of Violation for a Severity Level lil violation was issued May 7,1999. The violation involved the failure of a radiographer's assistant to wear an alarm rate meter on February 16,1999, while performing radiographic operations at the NASA MSFC, an area under NRC jurisdiction. The violation was identified by the NASA Radiation Safety Officer. Discretion was exercised not to assess a civil penalty based, among other things, on the positive actions of the new management / ownership. The staff determined that the company's corrective actions were prompt and comprehensive and included among other actions (1) promptly conducting a mandatory safety meeting with the staff, (2) attending a meeting with the MSFC officials, (3) implementing a recovery plan with NUREG-0940. PART 3 5

goals to achieve and maintain compliance with regulatory requirements, and (4) issuing a follow-up letter to MSFC reiterating the company's commitment to safety and compliance.

DAS Consult, Inc., Columbus, Ohio Supplement VI, EA 98-492 A Notice of Violation and Termination of License was issued March 31,1999. The action was based on the unauthorized transfer of byproduct material. The severity level of the violation was increased to Severity Level ll because the violation was deliberate.

A civil penalty was not proposed because the licensee has suspended operation, divested itself of byproduct material, and requested termination of its license.

Department of Interior, Bureau of Indian Affairs, Albuquerque, New Mexico Supplement VI, EA 98-471 A Notice of Violation for a Severity Level lli was issued January 28,1999. The action was based on failures to: (1) adequately secure and restrict access to licensed materials, specifically three gauges, (2) store portable gauges in locked containers designed to prevent unauthorized or accidental removal of the sealed sources from their shielded positions, and (3) perform semi-annual source inventories. A civil penalty was not proposed because the licensee had not been the subject of escalated action in the past two years. The licensee also took corrective actions which includf d ensuring all gauges were secured in locked containers, ensuring that all storage fGcilities were locked when not in use, completing inventory of all portable gauges, conducting training on NRC requirements and creating a calendar of specific events to perform tasks such l as physicalinventories. I Department of Veterans Affairs, Audie L. Murphy Memorial Veteran's Hospital, San Antonio, Texas, Supplement VI, EA 98-481 A Notice of Violation for a Severity Level lli violation was issued on February 17,1999.

The action involved the unauthorized use of strontium-90 sealed sources to perform intravascular brachytherapy procedures on human subjects under a research protocol l on two occasions in March 1998. A civil penalty was not proposed because the licensee had not been the subject of escalated action in the past two years. Credit was warranted for corrective actions which included immediately suspending IVB research, returning the sealed sources to the rnanufacturer, and discussing NRC regulations and the hospital's license, regarding research on humans, with the hospital's radiation safety committee.

Hartford Hospital, Hartford, Connecticut Supplements IV and VI, EA 98-575 A Notice of Violation for a Severity Level ill violation was issued on February 5,1999.

The action involved (1) the failure to control and maintain constant surveillance of licensed material (3 to 6 milicuries of iodine-131 contaminated waste) that was in a l controlled or unrestricted area (an iodine-131 therapy patient's room) and that was not l in storage, (2) the failure to make surveys which would have prevented the iodine-131 contaminated waste from being removed from the patient's room, placed in the hospital's trash dumpster, and transported to the incinerator facility, and (3) the failure to NUREG-0940. PART 3 6

label the bag containing lodine-131 contaminated waste which would have prevented it from being removed from the patient's room. A civil penalty was not proposed because the licensee had not been the subject of escalated' enforcement in the past two years and they also took prompt and comprehensive corrective actions.

Material Testing Consultants, Grand Rapids, Michigan Supplements IV and V, EA 88-107  !

A Notice of Violation for a Severity Level ill violation was issued June 25,1999. The action involved the loss of a moisture-density gauge which fell from a truck during transport on a public highway. A civil penalty was not proposed because the licensee had not been the subject of escalated enforcement in the past two years and they also took prompt and comprehensive corrective actions: (1) a safety review meeting was held i with all authorized users to discuss the incident and to review, security, control and I transport procedures, (2) the operator was reprimanded and placed on probationary work status for three months, and (3) management increased its supervision of licensed activities to emphasize the importance of maintaining control of licensed material.

Materials Testing & Inspection, Inc., Boise, Idaho Supplement IV, EA 98-527 A Notice of Violation for a Severity Level ll1 violation was issued January 28,1999. The action involved two portable gauges left unlocked and unsecured overnight in the bed of a pickup truck parked in a residential driveway, and then in a residential garage the following day and night. A civil penalty was not proposed because the licensee had not been the subject of escalated enforcement in the past two years and they also took prompt and comprehensive corrective actions which included (1) having an independent consultant audit the licensee's portable nuclear gauge program at the Boise, Idaho office and sharing the results with other offices, (2) disciplining the responsible individual, and (3) briefing the licensee's Idaho Falls personnel on the specifics of the incident and the license and procedural requirements.

Medi-Physics, Inc., Livingston, New Jersey Supplements IV and VI, EA 99-093 A Notice of Violation for a Severity Level 111 violation was issued June 17,1999. The action was based on three violations involving the failure to ensure that the package offered for shipment to Brick Hospital was proper for the contents to be shipped, in that a gasket and absorbent pad were missing in the primary shielding container. The other violations involved the failure to properly label the package, and ensure radiation and contamination levels at the package surface were within the regulatory limits. A civil penalty was not proposed because the licensee had not been the subject of escalated enforcement in the past two years and they also took prompt and comprehensive corrective actions which included (1) use of additional packaging to minimize the potential for damage to glass containers during transport, (2) full inspection of the existing inventory of all such glass containers, with plans to eventually discontinue use of such containers, (3) additional training of all pharmacy sie members responsible for transportation of radioactive material, and (4) a review of this event with all staff, as well as with management of all of the licensee's other facilities.

NUREG-0940. PART 3 7

Philadelphia Health and Education Corporation, Philadelphia, Pennsylvania Supplement VI, EA 99-096 A Notice of Violation for a Severity Level ill violation was issued May 11,1999. The action was based on a violation involving the use of licensed material by an unauthorized individual in 1996. A civil penalty was not proposed because the hcensee had not been the subject of escalated enforcement in the past two years and the licensee took prompt and comprehensive corrective actions which included (y immediately shutting down the laboratory and investigating the incident, (2) prohibiting l the authorized user from conducting experiments until an investigation was completed, l (3) training of the laboratory staff to emphasize their responsibilities for safe use of l radioactive material, and (4) review of the operations of other laboratories for similar i problems. 1 SibTech, Inc., Elmsford, New York Supplement VI, EA 99-123 l

l A Notice of Violation for a Severity Level lli violation was issued May 21,1999. The action was based on an Ol investigation which concluded that the company imported and transferred byproduct material both domestically and internationally from 1993-1995 without a license, and distributed byproduct material to others from 1995-1998. A civil  ;

penalty was not proposed because the company had not been the subject of escalated l enforcement in the past two years and the company took prompt and comprehensive l corrective actions which consisted of filing an application to possess and use such I materialin the State of Connecticut.

l Tulsa Gamma Ray, Inc., Tulsa, Oklahoma

' Supplement IV, EA 98-475 I

l l

A Notice of Violation for a Severity Level lil violation was issued February 25,1999. The action was based on the failure of the licensee to limit the annual occupational dose to an adult industrial radiographer to 5 rems. The radiographer received 5.64 rems total effective dose equivalent for calendar year 1998. A civil penalty was not proposed because the licensee had not been the subject of escalated enforcement in the past two years and the licensee took corrective actions which consisted of conducting an l investigation, removing the radiographer from work involving further radiation exposures, developing administrative actions when an employee's annual dose exceeds certain predetermined values, revising proce+res for issuing and receiving film badges, and requiring closer observations of employee dose reports to better control annual exposures.

United States Environmental Protection Agency, National Air and Radiation Environmental Laboratory, Montgomery, Alabama, Supplement VI, EA 98-545 A Notice of Violation for a Severity Level Ill violation was issued January 15,1999. The action was based on two examples of failure to secure licensed materials from unauthorized removal or access, including the loss of the Pu-239 source, and failure to implement adequate controls of licensed material in controlled or unrestricted areas. A civil penalty was not proposed because the licensee had not been the subject of escalated enforcement in the past two years and the licensee took corrective actions i which included the realignment ohe Radiation Protection Office (RPO) within the NUREG-0940. PART 3 8

program, the RPO's full time assignment and commitment to the radiation safety program, the rekeying of the lock on the radioactive waste storage building, the granting of keycard access only to authorized licensee personnel, the repairing of the main entry access release button to control visitor access, and the conduct of various meetings with laboratory personnel to discuss corrective measures implemented.

United States Enrichment Corporation, Bethesda, Maryland Supplement lil, EA 99-016 A Notice of Violation for a Severity Level Ill violation was issued March 5,1999. The action involved the failure to maintain control of classified matter at the Paducah Kentucky facility. Because the facility had been the subject of escalated enforcement action, the NRC considered whether credit for identification and corrective actions were warranted. Credit for identification was given because the violation was identified by USEC personnel. Credit for corrective actions was also warranted since the actions were considered prompt and comprehensive. The actions included (1) the classified document was immediately secured by the plant staff and a security sweep was pedormed, (2) an assessment of other areas outside the controlled access area was initiated by plant personnel, (3) a global self-assessment of the security process and recent security events at the facility was performed, (4) a job aid was published in the plant newsletter to provide procedures for handling classified matters, (5) a revised training module was developed, and (6) the involved individual was reminded of his responsibility to follow procedures and properly protect classified matter.

XRI Testing, Troy, Michigan Supplement VI, EA 98-507 A Notice of Violation for a Severity Level 11 problem was issued February 25,1999. The '

action was based on (1) the deliberate failure of an employee to wear an alarming ratemeter during radiographic operations, and (2) the failure to have two qualified individuals present during radiographic operations. Because the problem involved willfulness, the NRC considered whether credit was warranted for identification and corrective action. Credit was warranted for identification because the licensee identified l the violations. Credit was also warranted for corrective actions based on the l promptness and comprehensiveness of the actions taken. The corrective actions included (1) the radiographer was immediately suspended following the incident and subsequently terminated, (2) all radiography personnel were informed of the incident, (3) all radiography personnel were re-instructed in the requirements and use of all personnel monitoring equipment, (4) the licensee revised its "two-man rule" for jobsite activities, and (5) the licensee made a decision to no longer perform work at temporary jobsites outside of the confines of its facilities.

NUREG-0940. PART 3 9

I l

1 I

4 l

A. CIVIL PENALTIES AND ORDERS l

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1 1

NUREG-0940. PART 3

p tro

& UNITED STATES

[ g NUCLEAR REGULATORY COMMISSION 5 j REGloN I g 475 ALLENDALE ROAD KING oF PRUSSIA, PENNSYLVANIA 19406 1415 0%

• e . . + ,e June 2,1999 EA 99-060 David P. Beck Ph.D.

President Coriell institute for Medical Research 401 Haddon Avenue Camden, New Jersey 08103

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -

$4,400 (U.S. Department of Labor Case No. 97-ERA-46)

Dear Dr. Beck:

This letter refers to an investigation conducted by the NRC Office of Investigations, as well as a decision by the U.S. Department of Labor (DOL), regarding a complaint filed on April 18,1997, by a former employee of Coriell Institute for Medical Research (Corie!1) in Camden, New Jersey. The former employee alleged that he was terminated for raising safety concems. A DOL Administrative Law Judge (ALJ) issued a Recommended Decision and Order on December 3,1997, finding that Coriell discriminated against the employee because he engaged in protected activities, in violation of Section 211 of the Energy Reorganization Act of 1974, as amended. The Recommended Decision was adopted by the DOL Administrative Review Board (ARB) on February 26,1999. As a result of this apparent violation, on May 3,1999, a transcribed predecisional enforcement conference was held with Mr. Mintzner, and other members of your staff, to discuss the apparent violation, its causes, and your corrective actions. A copy of the enforcement conference report was forward to you on May 18,1999.

After considering the DOL finding, the evidence developed by the Office of Investigations (01), and the information that you provided during the conference, the NRC has concluded that a violation of the Commission's regulations has occurred. The violation is cited in the enclosed Notice of Violation cnd Proposed imposition of Civil Penalty (Notice). The circumstances surrounding the violation are described in detailin the ALJ's Recommended Decision and Order dated December 3,1997. The violation concems the finding of discrimination which is a violation of 10 CFR 30.7, " Employee Protection." Specifically, a laboratory technician raised a safety concem regarding unnecessary cxposure to employees from phosphorus-32, in a Coriell laboratory on September 13,1996. The cmployment of that technician was terminated by Coriell on November 21,1996. DOL concluded that the employment termination was, at least in part, in retaliation for the employee raising this safety concem.

10 CFR 30.7 prohibits discrimination by a Commission licensee against an employee for engaging in certain protected activities. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. Protected activities are established in Section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related i

NUREG-0940, PART 3 A-1

CoriellInstitute for Medical 2 Research to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act. Protected activities include, but are not limited to, providing the Commission or his or her employerinformation about alleged violations of either the Atomic Energy Act or the Energy Reorganization Act. In this case, the discriminatory actions were initiated by the employee's supervisor, and taken by the Vice President. Therefore, this violation has been categorized at Severity Level ll In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,400 is considered for a Severity Level ll violation. Since the violation is categorized at Severity Level ll, the NRC considered whether credit was warranted forIdentification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy.

No credit is warranted for identification since you did not identify the discriminatory actions. Credit is warranted for your coir.ctive actions since your corrective actions were considered prompt and comprehensive. Your corrective actions were described at the conference, as well as in your letter dated February 20,1998, in response to a NRC " chilling effect letter" issued on February 4,1998.

The actions included: (1) preparation of a written policy statement that indicates employees are to be encouraged to identify safety concems without fear of retaliation; (2) distribution of this policy to all employees; (3) meeting with all supervisors to discuss the ALJ decision; and (4) meeting with all employees to discuss the Coriell policy for identification and reporting of safety concerns.

To emphasize the importance of continuously assuring a work environment that is free of any harassment, intimidation, or discrimination against those who raise safety concems, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Pena!ty (Notice) in the amount of $4,400, for the Severity Level ll violation set forth in the Notice.

You are required to respond to this letter and should follow the instructions specified in the enclosed  !

Notice when preparing your response. In your response, you should document the specific actions I taken and any additional actions you plan to prevent recurrence. You may reference your previous submittal, as appropriate. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.

Sincerely, H :ert J. Il r Regional Administrator NUREG-0940, PART 3 A-2 l

(.

CoriellInstitute for Medical . 3 Research Docket No. 030-02537 1 License No. 29-11811-01

Enclosure:

Notice of Violation and Proposed imposition of Civil Penalty 4 cc w/enci:

State of New Jersey I

I NUREG-0940, PART 3 A-3

ENCLOSURE i

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVll PENALTY Coriell institute for Medical Research Docket No. 030-02537 Camden, New Jersey License No. 29-11811-01 EA 99-060

)

Based on a decision by the U.S. Department of Labor (DOL) Administrative Review Board (ARB), I dated February 26,1999, and the evidence developed during an investigation conducted by the NRC Office of Investigations, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act),42 U.S.C. 2282, and 10 CFR 2.205. The particular violation and associated civil penalty are set forth below:

10 CFR 30.7(a) prohibits, in part, discrimination by a Commission licensee against an employee for engaging in certain protected activities. Discrimination includes discharge and  ;

other actions that relate to compensation, terms, conditions, or privileges of employment. l The protected activities are established in Section 211 of the Energy Reorganization Act of L 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act. 10 CFR 30.7(a)(1)(i) provides that protected activities include, but are not limited to, providing the Commission or his or her employer information about alleged violations of either the Atomic Energy Act or the Energy Reorganization Act named in 10 CFR 30.7(a) or possible violations of requ*3ments imposed under either of those statutes.

Contrary to the above, on November 21,1996, Coriell Institute for Medical Research discriminated against an employee for engaging in protected activities when Coriell terminated the employment of the employee as a result of raising safety concems regarding unnecessary exposure to employees from the use of phosphorus-32 in a laboratory.

(01012)

This is a Severity Level ll violation (Supplement Vil).

Civil Penalty - $4,400.

Pursuant to the provisions of 10 CFR 2.201, Coriell institute for Medical Research (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed imposition of Civil Penalty (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received witnin the time specified in this Notice, an order or a Demand for NUREG-0940, PART 3 A-4

L l

l Enclosure 2 Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254, by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" and may: (1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circum':tances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or l mitigation of the penalty. j in requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanaFon in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act,42 U.S.C. 2282c. l The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, ,

and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.

Your response will be placed in the NRC Public Document Room (PDR); therefore, to the extent possible, it should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

NUREG-0940, PART 3 A-5

Enclosure 3

. In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 2*' day of June 1999 NUREG-0940, PART 3 A-6

pa "f o UNITED STATES ug'o NUCLEAR REGULATORY COMMISSION g

[ n REGION til 5 y 801 WARRENVILLE ROAD

• USLE, ILLINOIS 60532-4351

.g February 24, 1999 l

l EA 97-189 Mr. Dennis Clemenson, President l and Radiation Safety Officer DMS imaging, Inc.

P.O. Box 1010 Bemidji, MN 56601

SUBJECT:

NOTICE OF VlOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -

$2,500 (NRC Inspection Report 03010809/96001(DMNS!, NRC Office of Inspector General (OlG) Investigation Report 97-79G, ar.d NRC Office of Investigations (01) Reports 3-96-045 & 3-96-45S)

Dear Mr. Clemenson:

This refers to the August 23,1996, NRC inspection and the Ol and OlG investigations conducted between November 13,1996, and November 4,1998. The purpose of the inspection was to review DMS Imaging, Inc. (DMS), licensed activities. The investigations were conducted to follow up on statements made by your staff during the inspection and the May 13,1997, predecisional enforcement conference (conference) held in the NRC Region til office. The inspection and investigations findings were sent to you by letters dated April 29,1997, and November 20,1998. Because of the new information DMS was offered the opportunity to attend a second predecisional enforcement conference, which you declined.

Based on the information developed during the inspection, the 01 and OlG investigations, the information provided during the 1997 conference, and the information provided in your letter dated December 2,1998, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed imposition of Civil Penalty, and the circumstances surrounding them are described in detailin the subject inspection report.

During the May 13,1997, conference, violations involving the failure of staff to wear lab coats and proper dosimetry when handling radioactive materials were discussed. DMS provided its corrective actions during the conference and those actions appeared appropriate. A i subsaquent inspection was conducted on December 15 and 16,1997, and confirmed the adequacy of the corrective actions implemented. However, based on the findings of the OlG report, the NRC staff concludes that the violation involving failure to wear dosimetry occurred because a DMS supervisor deliberately allowed the technologist to perform routine nuclear medicine duties, knowing that the technologist had not yet obtained the required dosimetry. J A second violation identified during the investigations involves the failure of DMS employees, on October 1,1996, to provide complete and accurate information to an NRC investigator about i performing licensed activities without wearing dosimetry. This violation is of significant concern to the NRC. DMS employees claimed that a newly-hired technologist did not handle radioactive NUREG-0940, PART 3 A-7

D. Clemenson material prior to receiving dosimetry when, in fact, the technologist had eluted a generator, '

prepared doses and injected patients prior to receiving dosimetry. Based on the findings of the OlG report, the NRC staff concludes that the same DMS supervisor deliberately instructed the DMS employees to provide the inaccurate information to the NRC investigator.

The explanation given by the DMS supervisor is that he was concerned about the consistency of the answers that the DMS employees would provide to the NRC investigator, i.e., that they should be the same as those given to the NRC inspector by the employees during the August 23,1996, inspection. However, the standard is not consistency, but rather accuracy and truthfulness. The importance of promptly identifying and correcting inaccurate or incomplete information provided to the NRC is emphasized in Section IX of the NRC's " General Statement of Policy and Procedures for NRC Enforcement Actions"(Enforcement Policy),

NUREG-1600, Rev 1. Moreover, the DMS employees were, in fact, truthful with the NRC inspector during the August 23,1996, inspection. Thus, a concern for consistency would dictate that they be truthful with the NRC investigator as well.

It is essential that the NRC be able to maintain the highest trust that individuals supervising or working with radioactive materials will comply with regulatory requirements. The NRC's l

regulatory programs are based on licensees and their employees acting with integrity and J conducting their programs in an open and honest manner, and DMS, as an entity licensed to possess and use radioactive material, is responsible for the acts of its employees. Therefore, because of the willful nature of these violations, they have been categorized as a Severity Level 111 problem in accordance with the Enforcement Policy.

The NRC is corresponding directly with the DMS supervisor and the nuclear medicine technologists concerning these issues. You will receive a copies of that correspondence under separate cover.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level ill violation. Because the violations involve willfulness, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. NRC staff identified the violations; consequently, credit for identification is not warranted. Credit for corrective action is warranted based on the following actions taken by DMS: (1) adding a written notice to the new hire orientation which informs nuclear medicine personnel that it is imperative that they abide by all DMS policies and procedures, and that they ensure that all NRC policies are carried out to maintain strict compliance with NRC licensing; (2) establishing that failure to abide by all policies snd procedures will result in immediate employment termination; and (3) requiring all new hires and existing nuclear medicine technologists to acknowledge by signature that they have received and understand the notice. The initial issue of providing dosimetry and lab coats was discussed during the May 13,1997, conference. DMS instituted a policy that, prior to beginning the orientation, a new hire technologist will be issued lab coats and other protective clothing and proper personnel monitoring devices.

l l

i l

NUREG-0940, PART 3 A-8 .

l

D. Clemenson Therefore, to emphasize the importance of providing accurate and complete information to the NRC, procedural compliance, and prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2,500 for the i Severity Level ill problem, in addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

I You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. Your response should include your basis for concluding that the DMS supervisor will not, in the future, commit willful violations of NRC  ;

requirements and that he is committed to assuring that all NRC requirements are followed and that information provided to the NRC is complete and accurate in all material respects. The NRC will use your response, in part, to determine whether further enforcement action is 1 necessary to ensure compliance with regulatory requirements.

All final NRC documents, including the final OlG investigation report, are official agency records and may be made available to the public under the Freedom of Information Act (FOIA), subject to redaction of information in accordance with the FOIA.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room.

i Sincerely, l l

l Olbtl6V James E. Dyer Regional Administrator

' Docket No. 030-10809 License No. 22-16328-01

Enclosures:

1. Notice of Violation and Proposed imposition of Civil Perialty

2. NUREG/BR-0254 Payment Methods NUREG-0940, PART 3 A-9

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY DMS Imaging, Inc. Docket No. 030-10809 Bemidji, MN License No. 22-16328-01 EA 97-189 During an NRC inspection and investigations conducted between August 23,1996, and November 4,1998, violations of NRC requirements were identified. In accordance with the

" General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act),42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

1. Condition 16 of License No. 22-16328-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated June 27,1991, which includes implementation of Appendix l to Regulatory Guide 10.8, Revision 2., item 7 of Appendix 1, "Model Rules for Safe Use of Radiopharmaceuticals," requires individuals to wear personnel monitoring devices at all times while in areas where radioactive materials are used or stored. Item 8 of Appendix I requires individuals to wear a finger exposure monitor during the elution of generators; during the preparation, assay and injection of radiopharmaceuticals; and ,

when holding patients during procedures. )

(

Contrary to the above, on August 21 and 23,1996, a newly-hired technologist eluted a generator, injected patients, and performed patient scans without the appropriate personal monitoring devices.

II. 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee, or information required by the Commission's regulations to be maintained by the licensee, shall be complete and accurate in all material respects.

Contrary to the above, on October 1,1996, information provided by licensee employees to an NRC investigator was inaccurate. Specifically, two of the licensee's nuclear medicine technologists, in response to questions regarding the use of licensed material, told the NRC investigator that one of them, a newly-hired technologist, did not elute generators or inject patients during the period of August 19 through 23,1996. These j statements were inaccurate in that on August 21 and 23,1996, the newly-hired 1 technologist eluted a generator, injected patients, and performed patient scans without the appropriate personal monitoring devices. This information is material because it could have influenced the NRC as to whether a violation existed, and if so, the scope of {

that violation. j l

These violations represent a Severity Level lli problem (Supplements VI and Vil), l Civil Penalty - $2,500 NUREG-0940, PART 3 A-10

Notice of Violation and - Imposition of Civil Penalty Pursuant to the provisions of 10 CFR 2.201, DMS Imaging, Inc. (Licensee), is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be -

achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken.

Consideration may be given to extending the response time for good cause shown.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the c;vil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in 4 whole or in part, such answer may request remission or mitigation of the penalty. I In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act,42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, NUREG-0940, PART 3 A-11

Notice of Violation and Imposition of Civil Penalty 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region lil, 801 Warrenville Road, Lisle, IL 60532-4351.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personai privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g "xplain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 24* day of February 1999 4

4 NUREG-0940, PART 3 A-12

/ $" UNITED STATES

,8 NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. sosspoot

( * *=**. January 27, 1999 EA 98 529 Mr. James Egan President March Metalfab, Inc.

2250 Davis Ct.

Hayward, CA 94545-1190

SUBJECT:

CONFIRMATORY ORDER PROHIBITING INVOLVEMENT IN NRC-LICENSED ACTIVITIES (EFFECTIVE IMMEDIATELY)

Dear Mr. Egan:

This letter refers to our letter of January 6,1999 concerning consent to the provisions of a Confirmatory Order and your reply consenting to the terms proposed.

The enclosed Order is being issued as a result of the NRC's determination that as a result of the provision of inaccurate and incomplete information by two March Metalfab, Inc. managers, public health and safety require that commitments be confirmed by a Confirmatory Order Prohibiting involvement in NRC-Licensed Activities (Effective immedictely).

Pursuant to section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be subject to criminal prosecution as set forth in that section. Violation of this order may also subject the person to civil monetary penalty.

Questions concerning this order should be addressed to Mr. Geoffrey Cant,301/415-3283.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room.

Sincerely, M

ames Lieberman, Director Office of Enforcement Docket No: 72-1007

Enclosure:

As stated NUREG-0940, PART 3 A-13

UNITED STATES l NUCLEAR REGULATORY COMMISSION in the Matter of )

) Docket No. 72-1007 March Metalfab, Inc. )

Hayward, California ) EA 98-529 CONFIRMATORY ORDER PROHIBITING INVOLVEMENT IN NRC-LICENSED ACTIVITIES (EFFECTIVE IMMEDIATELY) l March Metalfab, Inc. (MMI) is a subcontractor of Sierra Nuclear Corporation (SNC), which holds NRC Certificate of Compliance 72-1007 for the VSC 24 cask, used by general licensees, Palisades Nuclear Plant (PNP) and Arkansas Nuclear One (ANO). The general license (10 CFR 72.210) relied on by PNP and ANO la for the storage of spent nuclear fuel under 10 CFR Part 72.

Il i

in March 1995, PNP loaded spent fuel into a multi-assembly sealed basket (MSB) spent fuel cask that had been supplied by SNC and fabricated by MMI. When the cask was pressurized with helium, two leaks were identified in the wall of the MSB adjacent to the closure weld.

Subsequent analysis by PNP metallurgical personnel determined that the defects were caused by underbead or hydrogen cracking, resulting from a base metal weld repair to the MSB shell inner wall that was performed during MSB manufacturing. The NRC staff learned of the problem experienced by PNP as a result of inspection activities following a similar closure weld failure at ANO. The staff became concerned that undetected cracks in other MSBs, produced by SNC that were already loaded with i, pent fuel, could propagate while the casks were in storage, affecting the integrity of the cask confinement boundary. As a result, during the week of March 17-21,1997, a special inspection was conducted at SNC and MMI.

NUREG-0940, PART 3 A-14

l i

2 During the special inspection, five MMI employees who were considered most likely to have been aware of the fabrication activities during the manufacture of the MSBs that failed were interviewod. They included two managers, the Project Manager and the Quality Assurance (QA) Manager. All of the individuals interviewed denied having any knowledge of any undocumented or unauthorized welds or weld repairs during the manufacture of the MSBs.

In July 1997, the NRC conducted a further inspection of MMI and SNC. During that inspection, i

employees of both companies acknowledged that undocumented welds had been made on casks sold to ANO and PNP. In the course of this inspection, both the Project Manager and the GA Manager for MMI admitted that they were aware that repair welding had been performed on the inside of the MSBs during fr.brication and that they had not informed the NRC inspectors of those welds during the March 1997 inspection interviews. The NRC continued to investigate the matter and the Office of Investigations issued its report on October 16,1998.

The NRC has concluded that because the two managers were knowledgeable about the fabrication process and were aware that welding had been done on the insides of the MSBs, they deliberately made statements in March 1997 to SNC and to the NRC that were inaccurate conceming the internal welding. The information involved was material to the NRC'a understanding as to the quality of the MSBs and delayed the NRC's action to ensure integrity of f

i MSBs. As a result, the NRC has further concluded that in providing the information, MMI violated 10 CFR 72.11, " Completeness and Accuracy of Information" and 10 CFR 72.12,

" Deliberate Misconduct." The NRC believes that the circumstances of this matter raise questions as to MMI's willingness to comply with Commission requirements. MMI has not admitted that a violation occurred.

NUREG-0940, PART 3 A-15

3 Ill in a telephone call on December 7,1998, MMI agreed to issuance of a Confirmatory Order prohibiting MMI from engaging in NRC-licensed activities for a period of five years from the date that the Order is issued. The staff believes that such a prohibition will adequately protect the public heath and safety and, therefore, finds this acceptable. MMI requested that if the Order is issued, it be allowed to complete work on one small existing contract to supply 10 plug assemblies for a NUHOMS cask. This provision is acceptable, as the assemblies have a limited safety function that can be verified by measurement at the time of use. On January 6,1999, the . staff forwarded to MMI a copy of the factual basis of the proposed order and the implementation paragraph. On January 10,1999, MMI consented to the issuance of the order with those provisions and waived its rights to a hearing on this action.

I find that MMI's commitments as set forth in Section IV are acceptable and necessary and conclude that with these commitments the public health and safety are reasonably assured. In view of the foregoing, I have determined that the public health and safety require thet MMI's commitments be confirmed by this Order. Based on the above and MMI's consent to this i

action, this Order is immediately effective upon issuance.

IV Accordingly, pursuant to sections 53,161b,1611,161o,182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202,10 CFR Part 72, and i 10 CFR 72.12, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, AS FOLLOWS:

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A. l Except as noted in paragraph B, MMI is prohibited for five years from the date of this Oider from any involvement in NRC-licensed activities. For purposes of this Order, 1 NUREG-0940, PART 3 A-16 ,

4 licensed actMiles include providing or supplying, whether directly to NRC licensees or Certificate of Compliance holders, or as a contractor or subcontractor to a licensee or Certificate of Compliance holder, structures, systems, or components, subject to a procurement contract specifying compliance with 10 CFR Chapter 1.

B. Provided that MMI notifies Transnuclear West, the Certificate of Compliance holder for the NUHOMS cask, of the existence of this Order, MMI may complete work on the contract that was entered into prior to the date of this order to fabricate a total of 10 plug assemblies for a NUHOMS cask.

The Director, Office of Enforcement, may relax or rescind, in writing, any of the above conditions upon a showing by the Licensee of good cause.

V Any person adversely affected by this Confirmatory Order, other than MMI, may request a hearing within 20 days of its issuance. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time must be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and include a statement of good cause for the extension. Any request for a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN:

Rulemakings and Adjudications Staff, Washington, DC 20555. Copies also shall be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555,

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to the Deputy Assistant General Counsel for Enforcement, and to the Director, Office of Nuclear Materials Safety and Safeguards, at the same address, and to Sierra Nuclear Corporation. If

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such a person requests a hearing, that person shall set forth with particularity the manner in f

NUREG-0940, PART 3 A-17 i

5 which his or her interest is adversely affected by this Order and shall address the criteria set j

l forth in 10 CFR 2.714(d). i If a hearing is requested by a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Confirmatory Order should be sustained. I in the absence of any request for hearing, or written approval of an extension of time in which to request a hearing, the provisions specified in Section IV above shall be final 20 days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section IV shall be final when the extension expires if a hearing request has not been received.

FOR THE NUCLEAR REGULATORY COMMISSION Jm 65 man, Director ffi 'e of Enforcement Dated this _27thday of January 1999 NUREG-0940, PART 3 A-18

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[nn ne49\

UNITED STATES NUCLEAR REGULATORY COMMISSION 8

• REGION il U ATLANTA FEDERAL CENTER 61 FoRSYTH STREET. sW. SulTE 23T85 ATLANTA. GEORGIA 30303-3415

• • • • • January 29,1999 EAs97-444 & 98-313 Marshall Miller & Associates ATTN: Mr. Scott Keim Senior Vice-President P. O. Box 848 Bluefield, VA 24605 0848

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTIES - $8,800 (NRC INSPECTION REPORT NOS. 52-1719541/97-01 AND OFF!CE OF INVESTIGATIONS REPORT NO. 2-97-023)

Dear Mr. Keim:

This refers to the Nuclear Regulatory Commission (NRC) inspection conducted on September 2-3,1997, at your facility in Bluefield, Virginia, and an NRC Office of Investigations (01) investigation completed on August 11,1998. The purpose of the inspection was to follow up on the events surrounding the unplanned radiation exposures to individuals as a result of handling and transporting an unshielded welllogging source in August 1997. The report documenting the inspection was issued on September 29,1997. The purpose of the 01 investigation was to determine whether Marshall Miller & Associates (MMA) employees willfully failed to conduct radiation surveys, failed to provide adequate radiation safety training, and falsified training and radiation survey records. The synopsis to the Ol report and a discussion of each apparent violation were transmitted to you by letter dated October 8,1998. At your request, additional information regarding the apparent violations was provided to you by letter dated October 21,1998. Based on the results of the inspection and investigation, a closed, transcribed, predecisional enforcement conference was conducted at the NRC Region 11 office in Atlanta, Georgia, on November 6,1998, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. Enclosure 2 provides a listing of attendees at the predecisional enforcement conference. Enclosures 3 and 4 contain copies of the materials presented by MMA (redacted) and the NRC, respectively.

Based on the information developed during the inspection and the Of investigation, and the information you provided during the conference, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed imposition of Civil Penalties (Notice), and the circumstances surrounding them are described in detail in the subject inspection report and in our letters dated October 8 and 21,1998.

The violations in Part I.A of the Notice involve multiple instances in which regulatory and license requirements were violated, and include: (1) the failure of the Radiation Safety Officer (RSO) to perform the minimum duties as required by License Condition 26; (2) the conduct of logging activities by eight individuals who had not received training in the amount or manner required by 10 CFR 39.61(b) and/or License Condition 26; (3) the failure to conduct radiation surveys associated with well logging activities as required by 10 CFR 39.67(a) and (b) (this issue also NUREG-0940, PART 3 A-19

Marshall Miller & Associates 2 involves failure to conduct vehicle surveys at temporary job sites prior to transporting licensed material,'which is repetitive of a violation issued in Inspection Report No. 45-17195-01/96-01);

(4) the failure to keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at a temperaryjob site in order to conduct the radiation surveys as required by 10 CFR 39.33(a); (5) the failure of a well logger to visually check a source holder, logging tool, and source handling tool for defects before each use to ensure that the equipment was in good working condition and labeling was present, as required by 10 CFR 39.43(a); and (6) the failure to lock, and physically secure to prevent tampering or removal by unauthorized persons, a cesium 137 source located in a tool box when it was transported to and from temporary job sites, as required by 10 CFR 39.31(b)(1).

As enumerated above, MMA failed to adhere to multiple safety and regulatory barriers, which resulted in the failure to promptly identify on August 18-20,1997, that a 125-millicurie cesium 137 well logging source had become detached from its housing. The consequences of the lack of control a' nd proper handling of the unshielded source were unplanned radiation exposures to MMA employees. Although the occupational exposure limits of 10 CFR Part 20 were not exceeded, this lack of control of radioactive material could have resulted in more substantial exposures to MMA employees and to members of the public. In addition to the unplanned exposures, the extent of noncompliance which existed at MMA and the lack of proper oversight of the licensed activities by the RSO underscores the significance of these issues. Although the violations are principally indicative of performance deficiencies of the RSO and the welllogging staff, senior MMA management was unaware of the pervasiveness of these issues, and provided little or no oversight of the RSO with respect to his regulatory duties and responsibilities. MMA management did not establish a standard of regulatory compliance and ensure adherence fo this standard. Therefore, the NRC concluded that these issues collectively represented a breakdown in the radiation safety program at MMA.

The violations in Part I.B of the Notice are associated with the completeness and accuracy of training records provided to the NRC for seven well loggers as required by 10 CFR 30.9(a), and the failure to maintain complete and accurate radiation survey and utilization records as required by 10 CFR 30.9(a),10 CFR 39.39(b), and 10 CFR 39.67(f). Violation (1) of Part I.B of the Notice occurred, in part, because the RSO did not understand that the training requirements prescribed by the license did not provide for equivalency determinations in lieu of the conduct of training, nor did he have a complete understanding of the need for literal compliance in this regard. The RSO erroneously believed that an individual's prior education and experience could be used to satisfy training requirements. in addition, the RSO documented only estimates of the training provided to individuals, which were an inaccurate reflection of the actual number of hours of training provided by the RSO and this information was provided to the NRC. The RSO also provided to the NRC " certifications" that individuals had received the required training, when in fact all required training had not been completed. Violation (2) of i Part I.B of the Notice occurred when a well logger documented the conduct of radiation surveys during the period of July and August 1997, when in fact no surveys had been performed. In addition, although not the subject of the enclosed Notice, interviews with other MMA well loggers indicated that this practice was not an isolated event.

The NRC concluded that certain of the violations described in Part I.A. and I.B. of the Notice (i.e., the failures to conduct radiation surveys and maintain complete and accurate survey and utilization logs) were willful, in this case careless disregard. Willful violations of regulatory requirements are of significant concern to the NRC because our regulatory program is based NUREG-0940, PART 3 A-20

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Marshall Miller & Associates 3 on licensees and their employees acting with integrity and communicating with candor. The completeness and accuracy of records required by NRC regulations and the license are essential elements to providing NRC with assurance that personnel are adequately trained and that activities are being conducted safely and in accordance with regulatory requirements. In addition, MMA's failure in its oversight responsibilities to provide the RSO with adequate guidance, to provide sufficient resources to the RSO to perform his duties, and to provide {

oversight of the RSO with respect to his RSO activities demonstrates careless disregard of l NRC requirements. In accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enfcrcement Policy), NUREG-1600, the violations described in Part I.A and in Part I.B of the Notice have been categorized separately as two Severity Level ll problems.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,400 is considered for each Severity Level 11 problem. The NRC considered whether credit was warranted for /denti/ication and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Although MMA identified and reported the uncontrolled logging source event, the violations described in Parts 1.A and I.B of  ;

the Notice were generally identified by the NRC as t. msult of the inspection and investigation.  !

Therefore, credit for the factor of Identi/ication was determined not to be warranted. MMA's {

corrective actions for the violations %cluded promptly hiring a consu! tant knowledgeable in well logging activities and the regulatory requirements relating to these activities; substantial retraining of well loggers by the consultant; appointment of a new RSO; establishment of a Radiation Safety Committee to review and oversee radiation safety program issues and program implementation; daily review of radiation survey and utilization records by senior MMA management; periodic inspection of logging units and activities by the RSO or an assistant RSO, including unannounced inspections; establishment of disciplinary action for individuals who fail to properly conduct and document surveys; and other actions discussed and documented by MMA management at the predecisional enforcement conference. Based on theso facts, the NRC determined that corrective actions for the violations were prompt and comprehensive, and that credit was warranted for the factor of Corrective Action, resulting in a base civil penalty of $4400 for each Severity Level 11 problem.

Therefore, to emphasize the need for effective management oversight of licensed activities and in recognition of the seriousness of violations involving careless disregard, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed

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Notice in the total amount of $8,800 for the two Severity Level ll problems. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort. ,

I The remaining violations being cited are described in Section ll of the enclosed Notice and are classified separately at Severity Level IV. These violations involve the failure to maintain survey documents and records at the Bluefield, Virginia, field station for well logging truck #10 for the periods November 14,23, and 26,1996, and May 1-14,1997, as required by 10 CFR 39.73(j), and the failure on September 2,1997, to store licensed material with a proper label as required by 10 CFR 39.31(a)(2).

The NRC's letter of October 8,1998, and Inspection Report No. 45-17195-01/97-01 also identified an apparent violation associated with the failure to maintain utilization documents and records at the Bluefield, Virginia, field station for well logging truck #10 for the period NUREG-0940, PART 3 A-21

Marshall Miller & Associates 4 March 17-23,1997 (apparent violation No.11 in our October 8 letter, eel 4517195-01/97-01-10 in the inspection report). Based on the additionalinformation MMA provided at the predecisional enforcement conference, the NRC has concluded that a violation did not occur. We will adjust our records accordingly.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your respon' s e. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the Public Document Room (POR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

if you have any questions regarding this letter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at (404) 562-4700.

Sincerely, T7M 12-4 uis A. eyes Regional Administrator Docket No. 030-12341 License No. 45-17195-01

Enclosures:

1. Notice of Violation and Proposed imposition of Civil Penalties

2. Conference Attendees

3. Material Presented by MMA

4. Material Presented by NRC

5. NUREG/BR 0254 cc w/encis:

Commonwealth of Virginia NUREG-0940, PART 3 A-22

p NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTIES Marshall Miller and Associates . Docket No.030-12341 Bluefield, Virginia License No.45-17195-01 EAs97-444 & 98-313 During an NRC inspection conducted on September 2 3,1997, and an NRC Office of Investigations investigation completed on August 11,1998, violations of NRC requirements were identified.. In accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions,' NUREG 1600, the NRC proposes to impose civil penalties pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act),42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalties are set forth below:

1. Violations Assessed a Civil Penalty A. (1) Co,1dition 26.8 of License No. 45-17195-01, Amendment No.19, requires, in Pit, that the licensee conduct its program in accordance with the statements, representations and procedures contained in a letter dated February 8,1993.

Licensee letter dated February 8,1993, states, in part, that the minimum duties of the Radiation Safety Officer (RSO) are to establish and conduct the training program for logging supervisors, examine and determine the competence of logging personnel, ensure that licensed materials are used only by those individuals who have satisfactorily completed appropriate training programs or who are authorized by the license, review and ensure maintenance of utilization logs, and establish and maintain proper transportation labels.

Contrary to the above, as of September 2,1997, the minimum duties of the RSO were not being conducted, as required by License Condition 26.0, in that the RSO failed to adequately train logging l supervisors (as described in Violation I.A.(2)), to adequately examine and determine the competence of logging personnel (as described in Violation I.A.(2)), to ensure that licensed materials were used only by i those individuals who had satisfactorily completed appropriate training programs (as described in Violation I.A.(2)), to adequately review and ensure maintenance of utilization logs (as described in Violation 1.B.(2)),

and to establish and maintain proper transportation labels. (01012)

(2) 10 CFR 39.61(b) requires that the licensee may not permit an individual to act as a logging assistant until that person: (1) has received instruction in applicable sections of 10 CFR Parts 19 and 20; (2) has received copies of, and instruction in, the licensee's operating and emergency procedures required by 10 CFR 39.63; (3) has demonstrated understanding of the materials listed in paragraphs (b)(1) and (2) of this section by successfully completing a written or oral test; and (4) has received instruction in the use of licensed materials, remote handling NUREG-0940, PART 3 A-23

l NOV 2 tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities.

License ccndition 268 requires, in part, that the licensee conduct its program in accordance with the statements, representations and prm.edures contained in a letter dated February 8,1993.

Exhibit "N" to the February 8,1993, letter, Trainina Manual. states in part, that (1) all logging supervisors will have at least 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom instruction in the applicable sections of 10 CFR Parts 19,20 and 39, in the terms and conditions of the NRC license and in operating and emergency procedures required by section 39.63, approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom instruction in the topics in paragraph 39.61(e) of 10 CFR Part 39, and a minimum of one month field operations for small sources and three months for the larger sources; (2) all training is performed by the RSO or his assistant; and (3) written and field examinations are given to each logging supervisor before they are allowed to independently use equipment containing radioactive material and any incorrect answers are gone over and explained in as much detail as needed.

Contrary to the above, the licensee failed to conduct training in accordance with 10 CFR 39.61(b) and/or Exhibit "N" of the Trainina f

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Manual as evidenced by the following examples:

a. On numerous occasions from August 11-27,1997, the licensee 1 i

permitted an individual to act as a logging assistant and to l

conduct welllogging activities using millicurie quantities of cesium 137 and americium 241 at temporary job sites without receiving all training, as required by 10 CFR 39.61(b).

b. During the period July 1996 through August 1997, seven well logging supervisors had conducted licensed activities without receiving the required number of hours of training by the RSO or his assistant. Specifically, although Training Progress Reports for the seven welllogging supervisors documented a range of from 8 to 32 hours3.703704e-4 days <br />0.00889 hours <br />5.291005e-5 weeks <br />1.2176e-5 months <br /> of training, movement records and electronic logging sheets reflected that the RSO and the welllogging supervisors were not in the same locations during the hours that the training was purportedly given. In fact, the RSO relied on his estimate of trainee self-study time in recording the documented hours rather than performing actual training.

c. As of September 3,1997, all training of wellloggers was not performed by either the RSO or his assistant, as required by Exhibit "N", Trainina Manual. Specifically two wellloggers had been given training by two senior well loggers and two other well loggers. In addition, another welllogger had been trained by the NUREG-0940, PART 3 A-24 ,

NOV 3 Assistant Manager of Geophysical Logging, an individual who was not named as either the RSO or RSO assistant.

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d. I On or about June 17,1997, the licensee gave a logging '

supervisor a written examination, and the incorrect answers had not been reviewed with that individual as of September 3,1997, i and the individual had been permitted to independently use equipment that contained radioactive material between June 17 L and September 3,1997. (01022) I (3) 10 CFR 39.67(a) requires, in part, that the licensee make radiation surveys of each area where licensed materials are used and stored.10 CFR 39.67(b) requires that before transporting licensed materials, the licensee shall make a radiation survey of the position occupied by each i individualin the vehicle and of the exterior of each vehicle used to I transport the licensed materials.-

Contrary to the above, from June 17 - August 25, and on August 27, 1997, the licensee did not conduct surveys of each area where licensed materials were used and stored, nor did the licensee conduct radiation surveys of the position occupied by each individualin the vehicle and the exterior of the vehicles used to transport licensed material from temporary job sites, before transporting the licensed material. (01032)

(4) 10 CFR 39.33(a) requires, in part, that the licensee keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at temporary jobsites to make the radiation surveys required by 10 CFR Parts 20 and 39.

Contrary to the above, on August 27,1997, the licensee did not keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at a temporary job site in Brandy, Virginia, in order to conduct the radiation surveys specified in by 10 CFR Parts 20 l and 39. (01042)

(5) 10 CFR 39.43(a) requires, in part, that the licensee visually check source holders, logging tools, and source handling tools, for de'ects before each use to ensure that equipment is in good working condition and required labeling is present.

Contrary to the above, on August 19,20, and 25,1997, a licensee well logger did not visually check a source holder, logging tool, and, source handling tool for defects before each use of a 125-millicurie cesium 137 source to ensure that the equipment was in good working condition and labeling was present. As a result, the licensee failed to identify that a well logging source had become separated from its source holder. (01052)

NUREG-0940, PART 3 A 25

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NOV 4 (6) 10 CFR 39.31(b)(1) requires, in part, that the licensee store each source containing licensed material in a storage container or transportation package. The container or package must be locked and physically secured to prevent tampering or removal of licensed material from storage by unauthorized personnel.

Contrary to the above, from August 20-27,1997, the licensee failed to lock and physically secure to prevent tampering or removal by unauthorized persons a 125 millicurie cesium-137 source located in a tool box when it was transported to and from temporary job sites. (01062)

These violations represent a Severity Level 11 problem. (Supplement VI).

Civil Penalty - $4,400.

B. (1) 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the licensee shall be complete and accurate in all material respects.

Contrary to the above, on September 2 3,1997, the licensee provided  ;

information to a representative of the Commission which was incomplete 3 and inaccurate. Specifically, the licenser provided to an NRC inspector Training Progress Reports for seven we'llogging supervisors that documented only estimates of the training provided to the individuals, and these estimates were an inaccurate reflection of the actual number of '

hours of training provided by the RSO. In addition, the licensee provided to the inspector training certifications for seven well logging supervisors that indicated that the welllogging supervisors had completed the required training when in fact all required training had not been completed. The Training Progress Reports and certification records were material to the NRC as this information is relied upon to determine whether individuals who use licensed material are adequately trained in the use of licensed materials and the license ar.d regulatory requirements governing its use. (02012)

(2) 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the licensee shall be complete and accurate in all material respects.

10 CFR 39.39(a) requires, in part, that the licensee maintain records for each use of licensed material showing the make, model number and a serial number or a description of each sealed source used; the identity of the logging supervisor who is responsible for the licensed material and the identity of logging assistants present; and the location and date of use of the licensed material, t

NUREG-0940, PART 3 A-26 l

I

l NOV 5 10 CFR 39.67(f) requires that results of radiation surveys required under paragraphs 10 CFR 39.67(a) and 10 CFR 39.67(b) must be recorded and must include the date of the survey, the name of the individual making the survey, the identification of the survey, instrument used, and the location of the survey.

Contrary to the above, from June 17 to August 26,1997, the licensee failed to maintain complete and accurate radiation survey and utilization records. Rather, the licensee created and provided to the NRC on September 2 and 3,1997, inaccurate radiation survey and utilization records for the period of June 17 to August 26,1997, in that the records contained information conceming radiation surveys when in fact no surveys had been conducted. The records were material to the NRC as this information is relied upon to determine compliance with regulatory requirements and to ensure that adequate measures were taken to ensure public health and safety. (02022)

These violations represent a Severity Level ll problem. (Supplement Vil).

Civil Penalty - $4,400.

fl. Violations Not Assessed a Civil Penaltv A. 10 CFR 39.73(j) requires, in part, that each licensee maintain documents and records at the field station to include survey records required by 10 CFR 39.67.

Contrary to the above, the licensee did not maintain survey documents and records required by 10 CFR 34.67 at the Bluefield, Virginia, field station for well logging truck #10 for the periods November 14,23, and 26,1996, and May 1-14,1997. (03014)

This is a Severity Level IV violation (Supplement VI).

B. 10 CFR 39.31(a)(2) requires, in part, that the licensee may not use a container to store licensed material unless the container has securely attached to it a durable, legible, and clearly visible label. The label must contain the radiation symbol specified in 10 CFR 20.1901(a) and the wording " Caution (or Danger),

Radioa'etive Material, Notify Civil Authorities (or Name of Company)."

Contrary to the above, on September 2,1997, the licensee used a container to store licensed material that did not have attached to it a durable, legible, and clearly visible label, as required by 10 CFR 39.31(a)(2). Specifically, a container in which millicurie quantities of cesium 137 were stored in a welllogging truck did not have the required label attached. (03024)

This is a Severity Level IV violation (Supplement VI).

NUREG-0940, PART 3 A-27 j l

NOV 6 Pursuant to the provisions of 10 CFR 2.201, Marshall f 4 iller and Associates (Ucensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the dete of this Notice of Violation and Proposed imposition of Civil Penalties (Notice). This reply should be clearly i

marked as a " Reply to a Notice of Violation" and should include for each alleged violation: '

(1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date '

when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Ucensee may pay the civil penalties proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submittiig to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalties in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission.

Should the Ucensee fail to answer within the time specified, an order imposing the civil 1 penalties will be issued. Should the Ucensee elect to file an answer in accordance with j 10 CFR 2.205 protesting the civil penalties, in whole or in part, such answer should be clearly {

marked as an " Answer te a Notice of Violation" and may: (1) deny the violation (s) listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.

In requesting mitigation of the proposed penalties, the factors addressed in Section VI.B.2 of  ;

the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Ucensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalties.

Upon failure to pay any civil penalties due which subsequently have been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attomey General, and the penalties, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act,42 U.S.C. 2282c.

l The response noted above (Reply to Notice of Violation, letter with payment of civil penalties, and Answer to a Notice of Violation) should be addressed to: Mr. James Ueberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555'Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region 11. Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal I NUREG-0940, PART 3 A-28 i

c NOV 7 privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information, if

)

you request withholding of such material, you gull specifically identify the portions of your t response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion )

1 of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information), if safeguards information is ,

necessary to provide an acceptable response, please provide the level of protection described In to CFR 73.21.  !

i i

J In accordance with 10 CFR 19,11, you may be required to post this Notice within two working j days after receipt.

Dated at Atlanta, Georgia this 29th day of January 1999 NUPEG-0940, PART 3 A 29

r

@ Mecq\ UNITED STATES

[- p, NUCLEAR REGULATORY COMMISSION 5 8.

REGION I P,, 175 ALLENDALE ROAD g*.*** KING oF PRUSSIA, PENNSYLVANIA 19406-1415 June 17,1999 EA 99-037 Mr. Kevin M. Cosgrove, President Materials Testing Laboratory, Inc.

1529 Jericho Turnpike New Hyde Park, New York 11040

SUBJECT:

NOTICE OF VIOL.ATION AND PROPOSED IMPOSITION OF civil PENALTY - $2,750 (NRC Investigation Report No.1-98-034)

Dear Mr. Cosgrove:

This refers to an investigation conducted by the NRC Office of investigations (01) which was initiated in July 1998. Based on the 01 investigation, the NRC found that a former Vice President of your company, on at least one occasion, deliberately allowed a field inspector technician to operate a nuclear gauge without proper training certification, and without the dosimetry required by the license. A copy of the synopsis of the Ol investigation was forwarded to you on April 9,1999, in that letter, the NRC informed you of the apparent violations identified as a result of the investigation, and also informed you that it might not be necessary to conduct a predecisional enforcement conference in orderto enable the NRC to make an enforcement decision. Rather, the NRC provided you an opportunity to either (1) respond to the apparent violations in writing, or (2) request a predecisional enforcement conference. You provided a response in a letter dated May 20,1999.

Based on the information developed during the investigation, and the information provided in your response, two violations of NRC requirements are being cited. The violations, which are described in the enclosed Notice of Violation and Proposed imposition of Civil Penalty (Notice), involve at least one individual operating a nuclear gauge at a field site without (1) being properly certified, and (2) without appropriate dosimetry, in your May 20,1999 letter, you admit the violations, and you indicate that the violations were caused by the former Vice President not following proper procedures. However, you also indicated, based on your review, that while the former Vice President exercised poorjudgement in hi tactions, you contend that he was not malicious nor was there a pattem of circumvention of the wnditions of the license.

Notwithstanding your contention, the NRC maintains that the violations were deliberate in that the former Vice President was aware of the regulatory requirements, as he admitted in an interview with O1, and he allowed the regulatory requirements to be violated. Therefore, given their willful nature, the violations have been classified as a Severity Level lil problem in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600, Revision 1.

NUREG-0940, PART 3 A-30

Materials Testing Laboratory, Inc. 2 in accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level lli violation or problem. Because these violations were willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy.

Credit for identification is not warranted since the violations were identified by the NRC. Credit for

corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions, which were described in your May 20,1999, letter to the l NRC included, but were not limited to

(1) demotion of the Vice President, as well as removal of him from any involvement in overseeing the radioactive materials program; (2) review by the Radiation Safety Officer (RSO) of the certifications for all technicians; and (3) reviews of all dosimetry reports.

Therefore, I have decided, after consultation with the Director, Office of Enforcement, to issue a Notice of Violation and Proposed imposition of a Civil Penalty in the amount of $2,750. If not for your corrective actions, the civil penalty amount would have been higher.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence is already adequately addressed in your letter dated May 20,1999. Therefore, you are not required to submit a written statement or explanation to the questions contained in 10 CFR 2.201 unless the description in your l letter does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice of Violation and Proposed imposition of Civil Penalty. i

in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its l enclosure and your response, if any, will be placed in the NRC Public Document Room (PDR).

Sincerely, I/

Vi Hubert J. Miller l Regional Administrator l

l Docket No. 030-17801

License No. 31-19502-01

Enclosure:

Notice of Violation and Proposed imposition of Civil Penalty cc w/ encl:

State of New York State of Connecticut NUREG-0940, PART 3 A-31

i NOTICE OF VIOLATION AND I PROPOSED IMPOSITION OF civil PENALTY Materials Testing Laboratory, Inc. License No. 31-19502-01 New Hyde Park, New York Docket No. 030-17801 EA 99-037 During an NRC investigation conducted by the NRC Office of investigations at Materials Testing Laboratory, Inc., violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions,"(Enforcement Policy), NUREG-1600, the NRC proposes a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act),42 U.S.C. 2282 and 10 CFR 2.205. The violations and associated civil penalty are set forth below:

A. Condition 11.A. of License No. 31-19502-01 requires that licensed material be used by, or under the supervision of and in the presence of, the corporate RSO or individuals who had successfully completed the manufacturer's training program for gauge users and who had been designated by the Radiation Safety Officer.

Contrary to the above, in or about June 1996, licensed material (nuclear gauge) was used at temporary job sites in Connecticut by at least one individual who was not under the

)

supervision of nor in the presence of the corporate RSO or an individual who had successfully completed the manufacturer's training program, and the individual had not completed the manufacturer's training program for gauge users. (01013) ,

B. Condition 18 of License No. 31-19502-01 requires, in part, that the licensee shall conduct its program in accordance with statements, representations, and procedures contained in the letter dated February 26,1991. Item 4 of the February 26,1991 letter, Handling Procedures, requires that film badges or other dosimetry devices be wom when transporting or using the instrument.

Contrary to the above, in or about June 1996, licensed material was used at temporary job sites in Connecticut by at least one individual who did not wear a film badge or other dosimetry. (01023)

These violations, given their deliberate nature, represent a Severity Level ill problem (Supplement VI).

Civil Penalty - $2,750.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in your letter dated May 20,1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a NUREG-0940, PART 3 A-32

Materials Testing Laboratory, Inc. 2 Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

Within 30 days of the date of this Notice, you may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money

- order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockvi!!e, MD 20852-2738.

Should you fail to answerwithin the time specified, an order imposing the civil penalty will be issued.

Should you elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not J be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Your attention is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attomey General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act,42 U.S.C. 2282c.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR).

Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a )

bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you mutt speedically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of wi+hholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the infom1ation  !

required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financialinformation).

Dated this 1P' day of June 1999 NUREG-0940, PART 3 A-33

purig

'g k

• UNITED STATES

r

• NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30666 0001

• • • • • January 15, 1999 EA 99-014 NDT Services, Inc.

c/o Crossland Boilers Sales and Service, Inc.

ATTN: Mr. Thomas B. Crossland, Owner Rio Ca6as Industrial Park, Suite 370 Road No.175, Km. 0.02, Comer Road No.1 Caguas, Puerto Rico 00726-4952

SUBJECT:

ORDER MODIFYING LICENSE (EFFECTIVE IMMEDIATELY)

Dear Mr. Crossland:

The enclosed Order Modifying License (Effective immediately) (Order) is being issued based on the findings of Nuclear Regulatory Commission (NRC) inspections conducted on January 11 and 14,1999, at your Caguas, Puerto Rico facility. The inspection was conducted to determine NDT Services, Inc.'s (NDTS) compliance with the March 27,1998, Order Suspending License (Effective immediately). Based on the conditions observed by the NRC, it was concluded that NDTS had failed to maintain adequate security of licensed material.

Specifically, seven radiographic exposure devices, containing Iridium 192 and/or Cobalt 60, which were stored at Crossland Boilers Sales and Service, Inc's. facility at Rio Canas industrial Park, were not under the control of NDTS or its Radiation Safety Officer and were not secured from access by unauthorized individuals and members of the public. The specific observed conditions are addressed in the enclosed Order.

Based on the public health and safety implications of the failure to adequately secure the licensed material and the NRC's lack of confidence in NDTS long-term ability to maintain adequate security, the Order requires, among oth6: things, that (1) within seven days of receipt of this Order the licensee temporarily transfer its licensad material to a secure location which is under the control of NDTS and has been approved by the NRC; and (2) within thirty days of receipt of this Order the licensee permanently transfer its licensed material to an authorized recipient.

Pursuant to Section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be subject to criminal prosecution as set forth in that section. Violation of this Order may also subject the person to civil monetary penalty.

Questions concerni.,g this Order should be addressed to R. W. Borchardt, Deputy Director, Office of Enforcement, who may be reached at (301) 415-2741.

NUREG-0940 PART 3 A-34

NDT Services, Inc. 2 in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy o.f this letter and its ,

enclosure will be placed in the NRC Public Document Room. l l

Sincerely, Malcolm R. Knapp 7

Deputy Executive Director  ;

For Regulatory Effectiveness Docket No. 030-17711 License No. 52-19438-01

Enclosure:

Order Modifying Licence cc w/ encl:

Commonwealth of Puerto Rico Mr. Thomas B. Crossland Crossland Boilers Sales and Service, Inc.

c/o Mr. Thomas B. Crossland, Sr.

11839 FM 2478 Celina, TX 75009 NDT Services, Inc.

ATTN: Mr. Clarence David Vaughn Radiation Safety Officer HC3 Box 7129 Humacao, PR 00791 First Bank ATTN: Mr. David Gadrou, Attorney Latimer, Biaggi, Rachid, and Gadrou P. O. Box 9146 Santurce, Puerto Rico 00908-0146 First Bank ATTN: Mr. Fernando Iglacious Senior Vice President Workout and REO P. O. Box 9146 Santurce, Puerto Rico 00908-0146 NUREG 0940, PART 3 A-35

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of 9 NDT SERVICES, INC.

) Docket No. 030-17711

- Caugus, Puerto Rico

) License No. 52-19438-01

) EA 99-014

)

ORDER MODIFYING LICENSE (EFFECTIVE IMMEDIATELY) i 3

NDT Services, Inc. (Licensee or NDTS) is the holder of Material License No. 52-19438-01 (License) issued by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 30. The License authorizes possession and use of up to 100 curies of Iridium 192 in sealed radiography sources and up to 20 curies of Cobalt 60 in sealed sources for performing radiography. The license was originally issued on August 21,1980, was most recently amended on December 12,1995, and is due to expire on January 31,2002.

ll On March 27,1998, the NRC issued an Order Suspending License (Effective immediately) to NDTS based on the seriousness of issues identified during inspections conducted on August 6 and October 4,1997, and February 6,1998, and the initial evidence gathered during an investigation conducted by the NRC Office of Investigations (01). The Order of March 27,1998, required, among other things, that NDTS immediately suspend all radiographic operations authorized by its license and ensure that the licensed material was placed in locked, safe storage.

in response to the Order of March 27,1998, NDTS immediately suspended all radiographic operations and secured all licensed material in locked, safe storage at the location specified in NUREG-0940, PART 3 A-36

2 Condition 10 of the 1: cense. This facility in owned by Crossland Boilers Sales and Service, Inc.

(Crossland Boilers).

Pertinent to this issue is the current corporate status of NDTS and Crossland Boilers. Although no corporate relationship exists between NDTS and Crossland Boilers, they have a common owner, Mr. Thomas B. Crossland. On July 24,1998, the NRC Region ll Office received information that Crossland Boilers had filed for Chapter 11 Bankruptcy on May 22,1998. First Bank of Puerto Rico, a secured lender of Crossland Boilers, provided security to protect some of the assets of Crossland Boilers, which are subject to liquidatico in favor of the Bank. The licensed material is in the same building as these assets.

The security of the sources and continued compliance with the Order of March 27,1998, was verified during NRC inspections conducted on March 30, June 3, July 16, and August 19,1998.

These inspections confirmed that the licensed material was being maintained inside a fenced building. The fence contained a gate to allow access, and access to the building interior was controlled by a door with a lock. The building contained a vault located on the second floor which has a metal cabinet with three cubicles. Each cubicle possessed a separate lock, and contained two radiographic exposure devices containing Iridium 192 per cubicle (six radiographic exposure devices in total). An additional radiographic exposure device containing a Cobalt 60 source was also located inside the vault (not inside a cubicle). Each radiographic exposure device also contained its own locking device to control licensed material removal and exposure.

NRC inspections confirmed that the licensed material and locking devices, including all keys,  !

i were under the control of Clarence David Vaughn, President and Radiation Safety Officer (RSO) of NDTS. The inspection of August 19,1998, confirmed that representatives of First Bank had NUREG-0940, PART 3 A-37

3 arranged for a contractor to provide for 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> security at the facility. The RSO indicated '

during the June 3,1998, inspection his understanding and willingness to contact the NRC should the RSO determine that he can no longer maintain adequate control of the licensed material.

On January 11,1999, an NRC inspector, accompanied by the RSO, attempted to determine the security of the sources and continued compliance with the Order of March 27,1998. The RSO informed the inspector at that time that on September 24,1998, in response to Hurricane Georges, he had conducted an inspection of the facility and confirmed the security and safe storage of the licensed material. During the January 11,1999 inspection, the NRC and the RSO were unable to gain access to the building as the lock which secured access to the building had been changed. The NRC leamed shortly thereafter that a representative of First Bank maintained the key to this lock. After subsequent contact with a First Bank representative, on January 14,1999, the NRC, the RSO, and Mr. Sergio Olivero, Assistant Vice President for First Bank, gained access to the building. The NRC determined the status and security of the licensed material on January 14,1999 to be as follows:

The building perimeter was accessible via the building yard gate. A building truck bay door, used to load and unload equipment / materials, was observed to be significantly

. damaged such that access to the building interior could easily be accomplished through the bay door. After entry through the building access door, the NRC noted that someone had entered the building previously and had vandalized and ransacked the building interior. The security lock to the vault that housed the licensed material was sheared. A new lock had been placed on the vault; however, the key to the new lock was in close proximity, was visible, and accessible to anyone desiring to gain entry. The NRC, RSO, l NUREG-0940, PART 3 A-36

I 4

and the First Bank representative accessed the vault with the key, and found that the locks for the three cubicles which housed the six radiographic devices containing the Iridium 192 licensed material were also sheared. The radiographic device containing the Cobalt 60 licensed material was found to be inside the vault, where the RSO had last verified this device to be (during his September 24,1998 inspection in the aftermath of j Hurricane Georges). The NRG confirmed that all seven radiographic devices remained I

intact and verified the position of the radiation sources inside the devices by taking local >

I radiation readings. The NRC recommended that the RSO obtain a new lock for the vault i and a new lock for the building yard gate. The First Bank representative obtained two new locks. As of January 15,1999, the NRC has confirmed that these locks were in place. The RSO only has control of the vault lock key, while the RSO and a First Bank representative have control of the building yard gate lock key.

The NRC also observed during the January 14,1999, inspection that a security guard, who was onsite to monitor the facility, was inattentive to duties and appeared to be i 1

sleeping. The NRC subsequently learned that 24-hour security for the building was not maintained, but rather security was provided by First Bank on Mondays through Saturdays, from 7:00 a.m. to 3:00 p.m.

The NRC also learned that the RSO did not have knowledge or accountability of the new vault lock, was unaware that the vault cubicle locks had been sheared, was unaware that the building interior could be easily accessed, and was unaware that the building interior had been vandalized since his inspection of September 24,1998.

NUREG 0940, PART 3 A-39

5 Discussions with the RSO during the NRC Inspections of January 11 and 14,1999, and during previous NRC inspections as discussed above, identified the following pertinent information:

The RSO is not currently and has not been financially compensated by Mr. Crossland for his efforts in controlling the security and access to the licensed material, although he has made a good faith effort to do so.

The RSO does not have access to NDTS corporate monies to initiate transfer of the sources to an authorized recipient.

The RSO is not authorized by Mr. Crossland to transfer and/or dispose of the sources.

The RSO has indicated that he may not remain in the Commonwealth of Puerto Rico much longer.

The RSO, though aware of his inability to access the facility, failed to notify the NRC of his inability to verify the status of the licensed materials.

NDTS is not currently performing any income generating work.

Actions initiated following the January 14,1999, inspection to ensure the security of the licensed material were at the initiative of the NRC, not the RSO.

Mr. Crossland currently is not present in the Commonwealth of Puerto Rico. As of the date of this Order, attempts to contact Mr. Crossland to discuss the status and security of licensed material have been unsuccessful.

lll The observed lack of security of licensed material presents a hazard to public health and safety l and is in violation of Section V.A of the March 27,1998, Order Suspending License (Effectively '

immediately) and 10 CFR 20.1801, which requires that the licensee secure from unauthorized l

NUREG-0940, PART 3 A-40

6 removal or access licensed materials that are stored in controlled or unrestricted areas. In addition, the corporate and financial status of the licensee, and the uncertainties associated with the ability of the RSO to continue to maintain adequate control over the licensed material, call into question the ability of the licensee to maintain adequate long-term security controls of the licensed material.

c Consequently, I lack the requisite reasonable assurance that the Licensee's current operations can be conducted under License No. 52-19438-01 in compliance with the Commission's requirements and that the health and safety of the public will be protected. Therefore, the public, health, safety and interest require that License No. 52-19438-01 be modified immediately to require both the relocation of the licensed material to a location where acceptable security can be maintained, and subsequent transfer of the licensed material to an authorized recipient.

Furthermore, pursuant to 10 CFR 2.202, I find that the significance of the conditions described above is such that the public health, safety and interest require that this Order be immediately effective.

IV Accordingly, pursuant to sections 81,161b,1611,161o,182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202,10 CFR 30.3, 10 CFR Parts 30 and 34, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT LICENSE NO. 52-19438-01 IS MODIFIED AS FOLLOWS:

NUREG-0940, PART 3 A-41

l 7

A. Within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receipt of this Order, the Licensee shall, (1) take immediate measures to maintain and ensure adequate security of licensed material stored at your facility located at Rio Cahas industrial Park, Lots 1 and 2, Caugus, Puerto Rico; and (2) identify an interim safe storage location within NDTS control to which the licensed 1

material will be transferred. Within the same 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall contact Mr.

Douglas Collins, Director, Division of Nuclear Materials Safety, NRC Region ll, at telephone number (404) 562-4700 or through the NRC Operations Center (24 -hours a day) at 301-816-5100, to inform him of the actions which have been taken in response to item (1) above and the proposed interim storage location idantified in response to item (2), items (1) and (2) are subject to NRC approval. A written response documenting this information shall be submitted under oath or affirmation to the Regional Administrator, NRC Region ll, Atlanta Federal Center,61 Forsyth Street, SW, Suite 23T85, Atlanta, Georgia within 10 days of this Order. ,

B.- Within seven days of receiving NRC approval of the proposed storage location, the Licensee shall: (1) complete leak tests pursuant to 10 CF.R Part 34.27(c), to confirm the absence of leakage rf radioactive materials and to establish the levels of residual radioactive contamination; (2) submit the results of the leak tests in writing to the NRC Region ll office; and (3) transfer the licensed material to the approved storage location.

Mr. Douglas Collins, or his designee, shall be notified immediately following the transfer.

C. Within 30 days of the date of this Order, the Licensee shall cause alllicensed materialin its possession to be transferred to an authorized recipient in accordance with NUREG-0940, PART 3 A-42

L 8

10 CFR 30.41 and submit for NRC approval a completed Form NRC 314. This information should be submitted to the Regional Administrator, NRC Region 11, at the address given in Paragraph A above.

D. At least two working days prior to the date of the transfer of the licensed material, the License shall notify Mr. Douglas M. Collins, NRC Region 11, at one of the telephone numbers given in Paragraph A above, so that the NRC may observe the transfer of the material to the authorized recipient.

The Regional Administrator, Region ll, may, in writing, relax or rescind any of the above conditions upon demonstration by the Licensee of good cause.

V in accordance with 10 CFR 2.202, the Licensee must, and any person adversely affected by this Order may, submit an answer to this Order, and may request a hearing on this Order, within 20 days of the date of this Order. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time must be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission Washington, D.C. '

20555, and include a statement of good cause for the extension. The answer may consent to this Order. Unless the answer consents to this Order, the answer shali, in writing and under  !

I oath or affirmation, specifically admit or deny each allegation or charge made in this Order and set forth the matters of fact and law on which the Licensee or any persons adversely affect relies and the reason as to why the Order should not have been issued. Any answer or request for a NUREG-0940, PART 3 A-43

9 hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief, Rulemakings and Adjudicat!cns Staff, Washington, D.C. 20555. Copies also shall be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, to the Deputy Assistant General Counsel for Enforcement at the same address, and to the Regional Administrator, NRC Region 11, Atlanta Federal Center,61 Forsyth Street, S.W., Suite 23T85, Atlanta, Georgia 30303-3415 and to the Licensee if the answer or hearing request is by a person other than the Licensee. If a person other than the Licensee requests a hearing, that person shall set forth with particularity the manner in which his interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.714(d).

If a hearing is requested by the Licensee or a person whose interest is adversely affected, the Commission willissue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.

4 Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee, may, in addition to demanding a hearing, at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the Order on the ground that the Order, including the need for immediate effectiveness, is not based on adequate evidence but on mere suspicion, unfounded allegations, or error.

In the absence of any request for hearing, or written approval of an extension of time in which to request a hearirr, the provisions specified Section IV above shall be final 20 days from the date of this Order without further order or proceedings. If an extension of time for requesting a i

NUREG-0940, PART 3 A-44 i

l 10 hearing has been approved, the provisions specified in Section IV shall be final when the extension expires if a hearing request has not been received. AN ANSWER OR A REQUEST FOR HEARING SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER.

FOR THE NUCLEAR REGULATORY COMMISSION i

f k-Malcolm R. Knapp i Deputy Executive Director for Regulatory Effectiveness Datedit Rockville, Maryland this#cTay of January 1999 NUREG-0940, PART 3 A-45

pug

.p 4 UNITED STATES g

o j

NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 3068H001 l

+.,4..,*/ February 18, 1997 EA 95-025 Mr. Paul Chambers, President Power Inspection, Inc.

c/o PEC Contracting Engineers 4420 Lorigan Street Pittsburgh, PA 15224

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES -

'$40,000 (NRC Inspection Report No. 030-20644/93-002 and Investigation Report No. 1-93-069R)

Dear Mr. Chambers:

This refers to the NRC inspection conducted on December 2-3, 1993, at the Power Inspection, Inc., (PI) facility in Wexford, Pennsylvania, as well as the findings of a subsequent investigation by the NRC Office of Investigations (01). The inspection report and OI Synopsis were sent to the former President of PI on August 9, 1996. On October 18, 1996, a Predecisional Enforcement Conference was conducted with the former President of PI to discuss the violations, their causes, and corrective actions. Given that you are the current owner of PI and had owned 49% of the company assets when the violations occurred, this letter is being sent to you for your attention and action.

Based on the information developed during the inspection, subsequent investigation, and conference, the NRC has determined that numerous violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice) and the circumstances surrounding them are described in detail in the subject inspection and investigation reports. The violations involved activities conducted by PI as both a vendor providing nuclear-related services to the nuclear industry, such as eddy current testing (ET), and an NRC materials licensee.

The violation cited in Section I of the Notice (i.e., the vendor-related activities) involves four examples of deliberate failure to provide to the Cleveland Electric Illuminating Company and Nebraska Public Power District, both licensees of the NRC, accurate information in accordance with the requirements of 10 CFR 50.5(a)(2) and 10 CFR 73.56(b)(2)(1). Specifically, at the direction of PI's former President, PI deliberately submitted inaccurate information to the two licensees regarding the reliability or trustworthiness of individuals who used illegal substances, and regarding the certifications of individuals who performed eddy current testing.

Deliberately directing employees to fabricate false records, and deliberately providing false information to licensees of the NRC, are of very significant regulatory concern because the conduct of licensed activities in accordance NUREG-0940, PART 3 A-46

L l PEC Contracting Engineers 2 with the Commission's requirements depends in large part on the integrity of individuals conducting licensed activities. These actions are particularly egregious given the prior conviction of PI and its former President in 1988, for falsifying ET equipment calibration certification involving work performed i at the Beaver Valley Nuclear Plant in Shippingport, Pennsylvania. Despite the I prior actions taken against PI and its former President, your company and its representatives continued to engage in wrongdoing. Because the inaccurate information was provided by the former PI president, the violation is classified at Severity Level I in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy),

NUREG-1600.

The violations cited in Section II of the Notice (i.e., the materials-related radiography activities) include an example of deliberate failure to provide to the NRC complete and accurate information in accordance with the requirements of 10 CFR 30.9(a), and an example of deliberate failure to maintain information required by 10 CFR 34.27. Specifically, PI's former Vice President / Radiation Safety Officer deliberately submitted inaccurate information to the NRC in response to a prior Notice of Violation, and PI's former President directed PI employees to fabricate source utilization records. In addition, seven other violations are cited including failure to:

(1) observe the performance of a radiographer at intervals not to exceed three months; (2) maintain utilization logs at the licensee's facility located in Wexford, Pennsylvania, for certain radiographic operations; (3) administer the required training to radiography personnel; (4) perform scheduled routine maintenance and inspection of a radiographic camera; (5) promptly return a film badge to a vendor for processing; (6) request a license amendment before '

appointing an individual to assume the duties of the RS0; and (7) test two radiography sealed sources for leakage within an interval of six months.

The violations in Section II of the Notice are of very significant regulatory concern because the inaccurate information submitted to the NRC by PI's former Vice President / Radiation Safety Officer influenced the NRC as to whether corrective actions had been taken in response to prior violations. In addition, the former PI President's direction to fabricate source utilization records is also of very significant regulatory concern. These actions are particularly serious because the President and the Radiation Safety Officer are charged with ensuring that PI staff adhere to NRC requirements and perform activities in a safe manner. Therefore, the violations have been classified, in accordance with the Enforcement Policy, in the aggregate as a Severity Level I problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $10,000 is considered for a Severity Level I violation / problem. It is recognized that you no longer plan to maintain a materials license (and the license is being terminated by separate correspondence, based on a request for termination by the former President of PI, sent to the NRC in a letter dated December 30,1993), and are not now providing services to the nuclear industry. However, given the egregiousness of the violations, the extensive record falsification, and the fact that management was directly involved in the deliberate misconduct, I have been authorized, after consultation with the NUREG-0940, PART 3 A-47

l PEC Contracting Engineers 3

)

Commission, to exercise enforcement discretion pursuant to Sections '

VII.A.I.(a) and (c) of the Enforcement Policy to issue the enclosed Notice in the amount of $40,000 for the Severity Level I violation and problem in the enclosed Notice (i.e., $20,000 for the Severity Level I violation in Section I and $20,000 for the Severity Level I problem in Section II). This civil penalty is being issued to emphasize the unacceptability of such actions, should Power Inspection engage in licensed activities in the future.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room.

Sincerely, l

l dwar L.

??  % _

ordan Deputy Ege utive Director for i Regul ory Effectiveness, Program Oversight, Investigations and Enforcement )

i Docket No. 030-20644 License No. 37-21428-01

Enclosure:

Notice of Violation and Proposed Imposition of Civil Penalties

\

cc w/encis:

Commonwealth of Pennsylvania State of Florida State of Ohio State of Nebraska Nebraska Public Power District Cleveland Electric Illuminating Company j I

J NUREG-0940, PART 3 A-48

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES Power Inspection, Inc. Docket No. 030-20644 Wexford, Pennsylvania License No. 37-21428-01 EA 95-025 During an NRC inspection conducted on December 2-3, 1993, and subsequent investigation by the NRC Office of Investigations (01), violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission proposes to impose these civil penalties pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C.

2282, and 10 CFR 2.205. The particular violations and associated civil penalties are set forth below: l I. Violation Associated with Vendor-Related Activities 10 CFR 50.5(a)(2) requires, in part, that any contractor of any licensee may not deliberately submit to a licensee information that the person submitting the information knows to be incomplete or inaccurate in some I respect material to the NRC.

Contrary to the above, Power Inspection, Inc. (PI), acting as a contractor to the Cleveland Electric Illuminating Company (CEIC) and Nebraska Public Power District (NPPD), both licensees of the NRC, deliberately submitted to the licensees information which was inaccurate in some respect material to the NRC. Specifically:

1. on March 5, 1993, PI deliberately submitted to the NPPD three

' inaccurate letters statinq that the trustworthiness and reliability of two individuals had been established by an investigation, when PI knew that the individuals had used illegal substances. This information was material because, given the individuals' use of illegal substances, the reliability of the ,

individuals was in question and the lack of information deprived 4 the NPPD of an opportunity to investigate the matter, pursuant to 10 CFR Part 73.

2. on October 6, 1993, PI deliberately submitted to the CEIC three inaccurate letters stating th u the trustworthiness and )

reliability of three individuals had been established by an investigation, when PI knew that the individuals had used illegal substances. This information was material because, given the individuals' use of illegal substances, the reliability of the individuals was in question and the lack of information deprived the CEIC of an opportunity to investigate the matter, pursuant to 10 CFR Part 73.

3. in approximately March 1993, PI deliberately submitted to the NPPD, Cooper facility, three inaccurate eddy current qualification certifications for three individuals stating that the individuals had passed a Level-2 examination. The information was NUREG-0940, PART 3 A-49

i 1

Notice of Violation 2 deliberately inaccurate in that PI knew that the individuals never obtained the' required training in order to be qualified and, in addition, the individuals were given the correct answers while taking the certification examination. This information was material because it provided false verification to NRC licensees that the individuals were knowledgeable and capable of 'performing eddy current testing which provides information regarding the quality of equipment.

i 4 .- in approximately October 1993, PI deliberately submitted to the CEIC's Perry Nuclear Station two eddy current qualification i certifications for two individuals stating that the individuals had passed a Level-2 examination. The information was

. deliberately inaccurate in that PI knew that the individuals never obtained the required training in order to be qualified and, in i addition, the individuals were given the answers while taking the certification examination. This information was material because it provided false verification to NRC licensees that the l individuals were knowledgeable and capable of performing eddy

~

current testing which provides information regarding the quality of equipment. (01011)

This is a Severity Level I Violation (Supplement VII)

Civil Penalty $20,000 II.- Violations Associated with Material License Activities A. 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee be complete and accurate in all material respects.

Contrary to the above, in a July 14, 1993 letter to the NRC, the licensee provided the Commission.information which was not accurate in all material respects. Specifically, in response to violations listed in the NRC Notice of Violation dated June 16, 1993, the licensee stated that:

1. observations of the licensee's radiographers had been made when, in fact, the observations had not been made;

2. a ratemeter had been sent for calibration when, in fact, the ratemeter had not been sent;

3. pocket dosimeters had been calibrated when, in fact, the dosimeters had not been calibrated;

4. source utilization logs had been maintained when, in fact, the legs had not been maintained; and

5. persont;e1 monitoring reports were available when, in fact, the reports had not been available.

NUREG-0940, PART 3 A-50

Notice of Violation 3 ,

This information was material because it had the capability to j influence the NRC evaluation of the licensee's corrective actions  !

in response to the June 16, 1993, Notice of Violation. (02011) 1 B. 10 CFR 30.9(a) states, in part, that information required by the Commission's regulations to be maintained by the licensee shall be complete and accurate in all material respects.

10 CFR 34.27 requires, in part, that each licensee shall maintain current utilization logs, which shall be kept available for three years from the date of the recorded events, for inspection by the Commission, at the address specified in the license, showing for each sealed source: the make and model number of the radiographic

. exposure device or storage container in which the sealed source is located; the identity of the radiographer to whom assigned; and the plant or site where used and dates of use.

Contrary to the above, as of December 2, 1993, information required by the Commission's regulations to be maintained by the licensee was not accurate in all material respects. Specifically, the licensee's utilization logs maintained at the licensee's Wexford, Pennsylvania, facility for the period of November 1992 through April 1993, were inaccurate because they were fabricated by the licensee. Specifically, the logs were not created on the date of source use, but were created afterwards by PI staff in order to address questions asked by the NRC during a previous NRC inspection. This information was material because it had the capability to influence an NRC enforcement decision. (02021)

C. 10 CFR 34.ll(d)(1) requires, in part, that an applicant have an inspection program that requires the observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed three months.

License Condition 17 incorporates the inspection program containing the requirements stated in 10 CFR 34.11(d)(1) as submitted in the licensee's application dated March 7, 1988, into NRC License No. 37-21428-01.

Contrary to the above, as of December 2, 1993, the licensee had not observed the performance of a radiographer involved in radiographic operations since April of 1993, an interval in excess of three months. (02031)

D. 10 CFR 34.27 requires, in part, that each licensee maintain current utilization logs, which shall be kept available for three years from the cate of the recorded events, for inspection by the Commission, at the address specified in the license, showing for

.each sealed source; the make and model number of the radiographic exposure device or storage container in which the sealed source is NUREG-0940, PART 3 A-51 l

Notice of Violation 4 located; the identity of the radiographer to whom assigned; and the plant or site where used and dates of use.

i Contrary to the above, as of December 2, 1993, the licensee failed '

to maintain utilization logs at its facility located in Wexford, Pennsylvania, for radiographic operations conducted in May and June of 1993 utilizing a cobalt-60 source, as well as operations conducted from July through November 1993 with an iridium-192 source at various locations in Pennsylvania and Ohio. (02041)

E. Condition No.17 of NRC License No. 37-21428-01 requires that the licensee conduct its program in accordance with statements, representations, and procedures contained in the Power Inspection, Inc. Radiation Safety Manual Administrative Procedures and Operating Procedures submitted as part of the licensee's application dated March 7, 1988.

1. Section 4.B.(1) of the Manual, entitled " Film Badge Procedures," states that new film badges are issued monthly to radiographic personnel and that badges worn during the previous period are returned promptly for processing by the vendor.

Contrary to the above, film badges issued to radiographers were not promptly returned by the licensee to the vendor for processing. Specifically, a film badge issued to a radiographer in April 1993 was not received for processing by the Landauer Company until September 17, 1993. Also, a film badge issued to another radiographer in February 1993  !

was not received for processing by Landauer until l l

September 10, 1993. (02051) '

2. Section 8.D of the Manual, entitled " Periodic Updating Training," requires that periodic training be given to radiographic personnel every 12 months.

Contrary to the above, the required periodic training had not been given to radiography personnel every 12 months.

Specifically, training had not been given in either 1992 or 1993, a period greater than 12 months. (02061)

F.

10 CFR 34.28(b) requires that the licensee conduct a program for inspection and maintenance of radiographic exposure devices at intervals not to exceed three months or prior to the first use thereafter, to ensure the proper functioning of components important to safety.

Contrary to the above, as of December 3, 1993, the scheduled routine maintenance and inspection had not been performed on an Amersham Model 660B iridium-192 exposure device (Serial #8624).

Specifically, the last inspection had been performed in June 1993,

{

NUREG-0940, PART 3 A-52 '

]

1 l

l Notice of Violation 5 and although scheduled to be performed in September 1993, the routine maintenance had not been performed as of December 3, 1993, an interval in excess of three months. (02071)

G. Condition No. 12 of NRC License No. 37-21428-01 names a specific individual as radiation safety officer.

Contrary to the above, in August 1093, the licensee appointed an individual to assume the duties of radiation safety officer, and that individual was not named in License Condition No.12.

(02081)

H. 10 CFR 34.25(b) requires that each sealed source be tested for leakage at intervals not to exceed six months.

Contrary to the above, as of December 2,1993, a leak test had not ,

been performed on a 79-curie cobalt-60 source since December 2, l 1992, and a leak test had not been performed on a 54-curie l iridium-92 source since October 20, 1992, time intervals greater l than six months. (02091) ]

These violations represent a Severity Level I problem (Supplements VI I and VII).

Civil Penalty - $20,000. )

Pursuant to the provisions of 10 CFR 2.201, Power Inspection, Inc. (Licensee) l 1s hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalties (Notice). This reply should be clearly marked as a " Reply to j a Notice of Violation" and should include for each alleged violation: )

(1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective  !

steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under

, 10 CFR 2.201, the Licensee may pay the civil penalties by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalties proposed above, or  !

the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalties in whole or in part, by a written answer addressed to the Director, Office of Enforcement, NUREG-0940, PART 3 A-53

Notice of Violation 6 I

U.S. Nuclear Regulatory Commission.

Should the Licensee fail to answer within the time specified, an Order imposing the civil penalties will be issued.

Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in wL.,le or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.

In requesting mitigation of the proposed penalties, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g.,

citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing civil penalties.

Upon failure to pay any civil penalties due which subsequently has seen determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalties, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalties, and Answer to a Notice of Violation) should be addressed to:

Mr. James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region 1, 475 Allendale Road, King of Prussia, PA 19406-1415.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to '

provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you gLu11 u specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

Dated at Rockville, Maryland this , , h day of February 1997 NUREG-0940, PART 3 A-54

a nau p Sk UNITED STATES g j NUCLEAR REGULATORY COMMISSION o 4" WASHINGTON, D.C. 20666-0001

% . . . . . p$

February 3, 1998 EA 95-025 Mr. Krishna Kumar, President Power Inspection, Inc.

c/o William F. Manifesto, Esq.

1550 Koppers Building 436 Svventh Avenue Pittsburgh, PA 15219 Mr. Paul Chambers Power inspection, Inc.

c/o PEC Contracting Engineers P.O. Box 7872 Pittsburgh, PA 15215

SUBJECT:

ORDER IMPOSING CIVIL MONETARY PENALTIES - $40,000 (NRC Inspection Report No. 030-20644/93-002 and Investigation Report No.1-93-069R)

This refers to Mr. Chambers' letter dated May 13,1997, in response to the Notice of Violation and Proposed imposition of Civil Penalty (Notice) sent to Mr. Chambers by our letter dated February 18,1997. This also refers to Mr. Kumar's letters dated October 28,1997 and January 6,1998 (submitted by his counsel, Mr. Manifesto), in response to the Notice sent by our letter dated October 22,1997. Our Notice described nine violations identified during an NRC inspection and a subsequent investigation.

To emphasize the unacceptability of deliberate misconduct and the need to provide the NRC  ;

complete and accurate information, a civil penalty of $40,000 was proposed.

In response, Mr. Chambers protested the proposed civil penalties arguing that he is reither the owner nor President of Power Inspection (PI), that his involvement with Pl was strictly as an investor, and that Mr. Kumar, President and major stockholder of Pl, is fully responsible for the violations. Mr. Kumar's response argued that Mr. Chambers was the secretary / treasurer of PI during the relevant time period, that Mr. Chambers had total control of the bank account of the '

corporation, that Mr. Chambers served as an officer and on the Board of Directors of Pl, and that Mr. Chambers maintained all of the assets of Pi (including bank accounts and equipment) after Mr. Kumar severed his relation with Pi in August 1994.

After careful consideration of your responses, we havs concluded, for the reasons given in the Appendix attached to the Order imposing Civil Monetary Penalty (Order), that: (1) neither Mr. Chambers nor Mr. Kumar provided a basis for mitigation of the proposed civil penalty; and (2) both Mr. Kumar and Mr. Chambers, as current or former officers and owners of Pl during the  ;

period of time that the violations occurred, are responsible for ensuring that PI pays the civil  !

penalties concerning its violations of NRC requirements. Accordingly, we hereby serve the NUREG-0940, PART 3 A-55  !

Mr. Krishna Kumar Mr. Paul Chambers enclosed Order on Pi imposing civil monetary penalties in the amount of $40,000. As provided I in Section IV of the enclosed Order, payment should be made within 30 days of the date of this Order, by check, draft, money order, or electronic transfer, payable to the Treasurer of the United States and mailed to Mr. James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738. As noted in the enclosed Order, if Pl fails to request a hearing, or if payment has not been made, within 30 days of the date of this Order, the provisions of this Order shall be effective without further proceedings and the matter may be referred to the Attorney General for collection.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and the enclosure will be placed in the NRC's Public Document Room.

Sincerely, y h

< r m Asho C. Thadani Acting Deputy Executive Director for Regulatory Effectiveness Docket No. 030-20644 License No. 37-21428-01

Enclosure:

As Stated cc: Commonwealth of Pennsylvania State of Florida NUREG-0940, PART 3 A-56

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of )

)

POWER INSPECTION, INC. ) Docket No. 030-20644 Wexford, Pennsylvania ) License No. 37-21428-01 ,

) EA 95-025 i ORDER IMPOSING CIVIL MONETARY PENALTY l

Power Inspection, Inc., (Pl or Licensee) is the holder of NRC Materials License No. 37-21428-01 issued by the Nuclear Regulatory Commission (NRC or Commission). The license authorizes the Licensee to possess sealed radioactive sources and to utilize those sources to conduct industrial radiography in accordance with the conditions specified therein. The license expired on January 31,1994.

11 An NRC inspection of the Licensee's activities was conducted on December 2-3,1993, and a subsequent NRC investigation was conducted from March 9 through December 22,1994. The results of the inspection and investigation indicated that the Licensee had not conducted its activities in compliance with NRC requirements. A written Notice of Violation and Proposed imposition of Civil Penalty (Notice) was served upon the Licensee by letter dated February 18, 1997. The Notice states the nature of the violations, the provisions of NRC requirements that the Licensee had violated, and the amount of the civil penalties proposed for the violations.

Two officers of the Licensee responded to the Notice in letters dated May 13,1997, October 28, 1997, and January 6,1998. The officers' responses did not deny the violations and proposed NUREG-0940, PART 3 A-57

I no reason for mitigating the civil penalties; rather, each officer maintained that he was not responsible for the violations and each officer proposed that the other officer should be held responsible for the violations and associated civil penalties.

111 After consideration of the Licensee's responses and the statements of fact, explanation, and arguments for liability of the civil penalties contained therein, the NRC staff has determined, as set forth in the Appendix to this Order, that the violations occurred as stated and that the penalties proposed for the violations designated in the Notice should be imposed.

IV in view of the foregoing and pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act),42 U.S.C. 2282, and 10 CFR 2.205, IT IS HEREBY ORDERED THAT:

The Licensee pay a civil penalty in the amount of $40,000 within 30 days of the date of this Order, by check, draft, money order, or electronic transfer, payable to the Treasurer of the United States and mailed to Mr. James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738.

NUREG-0940, PART 3 A-58

i V

The Licensee may request a hearing within 30 days of the date of this Order. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time must be made in writing to the Director, Office of Enforcement, U.S.

Nuclear Regulatory Commission, Washington, D.C. 20555, and include a statement of good cause for the extension. A request for a hearing should be clearly marked as a " Request for an Enforcement Hearing" and shall be addressed to the Director, Office of Enforcement, U.S.

Nuclear Regulatory Commission, Washington, D.C. 20555, with a copy to the Commission's Document Control Desk, Washington, D.C. 20555. Copies also shall be sent to the Assistant General Counsel for Hearings and Enforcement at the same address and to the Regional {

l Administrator, NRC Region I,475 Allendale Road, King of Prussia, PA 19406-1415. .

If a hearing is requested, the Commission will issue an Order designating the time and place of the hearing. If the Licensee fails to request a hearing within 30 days of the date of this Order (or  ;

if written approval of an extension of time in which to request a hearing has not been granted),

the provisions of this Order shall be effective without further proceedings. If payment has not been made by that time, the matter may be refarred to the Attomey General for collection.

1 In the event the Licensee requests a hearing as provided above, the issue to be considered at such hearing shall be:

(a) Whether the Licensee was in violation of the Commission's requirements as set forth in the '

Notice referenced in Section ll mbove; and NUREG-0940, PART 3 A-50

(b) Whether, on the basis of the violations described in the NRC's Notice, this Order should be sustained.

FOR THE NUCLEAR REGULATORY COMMISSION

/

O ,

Ashok C. Thadani Acting Deputy Executive Director for Regulatory Effectiveness Dated t Rockville, Maryland this y of February 1998 i

f NUREG-0940, PART 3 A-60

APPENDIX EVALUATION AND CONCLUSIONS On February 18,1997, a Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $40,000 was issued to Power inspection, Inc., (Pl or Licensee) for violations identified during an NRC inspection conducted on December 2-3,1993, and a subsequent investigation was conducted from March 9 through December 22,1994. Two officers of the Licensee responded to the Notice in letters dated May 13,1997, October 28,1997, and January 6,1998. The officers' responses did not deny the violations and proposed no reason for mitigating the civil penalties; rather, each officer maintained that he was not responsible for the violations and each officer proposed that the other officer should be held responsible for the violations and associated civil penalties.

Summarv of the Licensee's Rannonses Concomina i inhility and Rannansibi!ity for the Violations

1. Pl's Resoonse Dated May 13.1997 (Submitted bv Mr. Chambers. PI's Secretarv/ Treasurer):

Mr. Chambers protested the proposed civil penalties arguing that he is neither the owner nor President of Pi, and that his involvement with PI was strictly as an investor, in addition, Mr. Chambers maintained that he did not take part in the day-to-day operations of Pl and that Mr. Kumar, President and major stockholder of Pl, is fully responsible for the violations. Mr. Chambers subsequently provided the NRC a copy of " Stock f Restriction and Purchase Agreement" among Pl, Mr. Chambers, and Mr. Kumar as evidence that his involvement was strictly as an investor.

2. PI's Resoonses Dated October 28.1997. and Januarv 6.1998 (Submitted bv Mr. Kuma;,

Pl's President):

Mr. Kumar's responses submitted by Mr. Manifesto, Mr. Kumar's counsel, argued that Mr. Chambers was the secretary / treasurer of Pi during the relevant time period and that PI was owned jointly by Mr. Kumar and Mr. Chambers. Mr. Kumar further argued that Mr. Chambers had total control of the bank account of the corporation, and had equal financial control over all financial matters, as evidenced by the fact that no payment in excess of $1,000.00 could be made without Mr. Chambers' signature. In addition, Mr.

Kumar maintained that: (1) Mr. Chambers served not only as an officer, but also on the Board of Directors of Pl; and (2) after Mr. Kumar severed his relation with Pi in August 1994, Mr. Chambers maintained all of the assets of Pl, including bank accounts and equipment.

NRC Evaluation of the Licensee's Resoonses: 1 i

The Licensee's arguments, as set forth above, do not provide a basis under the NRC's  !

Enforcement Policy for mitigation or remission of the civil penalties. As to the question of 3

responsibility, PI must pay the civil penalty in accordance with this Order. The Licensee's '

arguments do not relieve Mr. Chambers or Mr. Kumar of their responsibilities for ensuring that PI pays the civil penalty. Both Mr. Chambers and Mr. Kumar were part-owners and corporate officers of Pi during the time period when the violations of NRC requirements occurred.

NUREG-0940, PART 3 A-61

Appendix Therefore, after careful consideration of the responses, the NRC has determined that neither .

Mr. Chambers nor Mr. Kumar provided an adequate basis for the NRC to conclude that they should not be responsible for ensuring payment of the civil penalties by Pl concerning its  ;

violations of NRC requirements. The NRC's determination is based on the fact that: '

Mr. Chambers served as an officer, and on the Board of Directors, of Pl during the relevant time period; Mr. Chambers had control of all personnel matters during the relevant time period; Mr. Chambers had total financial control of Pl; and Mr. Chambers maintained all of PI's assets, including bank accounts and equipment after PI became defunct.

Mr. Kumar was the President of PI during the relevant time period; Mr. Kumar is the last known President of Power inspection as noted in a July 16,1996 " Stock Restriction and Purchase Agreement"; Mr. Kumar is currently listed as the Chief Executive Officer of PI on the Pennsylvania Department of State Corporate / Limited Partnership records; and Mr.

Kumar is currently listed as the Chief Executive Officer / President of Pl on the Dunn & Bradstreet listing.

NRC

Conclusion:

The NRC has considered all of the arguments the Licensee made and concluded that the Licensee has not provided an adequate basis for mitigation of the proposed civil penalties. In addition, the NRC has concluded that Mr. Chambers and Mr. Kumar are responsible for ensuring payment of the civil penalties by Pl concerning its violations of NRC requirements.

Consequently, the civil penalties in the amount of $40,000 should be imposed by order.

NUREG-0940, PART 3 A-62

pwou ,

p & UNITED STATES s

]

e NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30666 4001 d

• • • • • December 23, 1998 EA 98-521 Mr. Richard Speciale, President SpecialTesting Laboratories,Inc.

Post Office Box 200 Bethel, Connecticut 06801-0200

SUBJECT:

ORDER SUSPENDING LICENSE (EFFECTIVE IMMEDIATELY)

Dear Mr. Speciale:

The enclosed Order Suspending License (Order) is being issued because of violations of the Commission's regulations. The Order requires that: (1) you suspend all activities under your license, other than storage of licensed materials; (2) all NRC-licensed material in your -

possession shall be placed in locked storage at 21 Henry Street, Bethel, Connecticut and shall not be used; (3) you shall not receive any NRC-licensed material while this order is in effect; q (4) all records related to licensed activities shall be maintained in their original form and shall l

not be removed or altered in any way; (5) within 2 days of the date of the Order, all employees '

shall be informed of this Order; (6) within 7 days of the date of the Order, the NRC shall be provided a list of all clients for whom you have performed licensed activities in the past 12 months; and (7) within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, a copy of this Order shall be posted at the facility, pursuant to 10 CFR 19.11(a)(4).

Pursuant to Section 223 of the Atomic Energy Act of 1954, as amended, any person who l willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be l subject to criminal prosecution as set forth in that section. Violation of this Order may also '

subject you to civil sanctions.

Ouestions conceming this Order should be addressed to Mr. James Lieberman, Director, Office of Enforcement, who may be reached at (301) 415 2741.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and the enclosure will be placed in the NRC's Public Document Room.

Sincerely, Dr. Malcolm R. Knapp Deputy Executive r;irector for Regulatory Effectiveness Docket No. 030-34318 License No. 06-30361-01 NUREG-0940, PART 3 A-63

Enclosure:

As Stated cc w/ encl:

State of Connecticut i

l i

I NUREG-0940, PART 3 A-64

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of )

) Docket No. 030-34318 Special Testing Laboratories, Inc. ) License No. 06-30361-01 P.O. Box 200 ) EA 98-521 Bethel, Connecticut 06801-0200 )

ORDER SUSPENDING LICENSE (EFFECTIVE IMMEDIATELY) 1 Special Testing Laboratories, Inc. (Special Testing or Licensee) is the holder of Byproduct Nuclear Material License No. 06-30361-01 issued by the Nuclear Regulatory Commission (NRC j

1 or Commission) pursuant to 10 CFR Part 30. The license authorizes possession and use of Troxler Electronics Laboratories, Campbell Pacific Nuclear, Humbolt Scientific, Seamen l Nuclear, or Soittest nuclear gauges. Mr. Richard Speciale (Mr. Speciale) is the President and Radiation Safety Officer oi Special Testing Laboratories. The license was issued on August 6, 1997, and is due to expire on August 31,2007.

License No. 0619720-01 authorizing possession and use of portable nuclear density gauges was previously issued to Testwell Craig Laboratories of Connecticut, Inc. (Testwell Craig), but was suspended on July 1,1996, due to non-payment of fees. Mr. Speciale was also the President of Testwell Craig.

11 On October 14,15, and 16,1998, and November 9-10,1998, an NRC Region I inspector, accompanied by an investigator from the NRC Office of Investigations, conducted an inspection at the Licensee's facility in Bethel, Connecticut. During the inspection, the NRC determined NUREG-0940, PART 3 A-65

2 that:

(1) portable gauges containing NRC-licensed material were routinely used by some Licensee employees who had not received the required training; (2)'some Ucensee employe were using the gauges without being provided the required personnel dosimeters; and (3) leak i

tests of the gauges were not being performed at the required frequency.

l During the October inspection, Mr. Speciale was interviewed by the inspector and investigat In that interview, Mr. Speciale, when questioned conceming the scope of the Licensee's program, informed the NRC that the Licensee possessed four Troxler portable gauges that were used by three or four authorized users, including himself. He also stated that he did not believe any of his field technicians were operating gauges without training.

The NRC inspector and investigator returned to the facility on November 9-10,1998, to complete the investigation, at which time the NRC was provided records indicating that nine individuals had received manufacturer's training on October 29,1998, which was subsequent t the NRC's October 1998 visit. Mr. Speciale was questioned as to why nine individuals had received such training when he had previously stated that gauges were used by ihree or four users. Although Mr. Speciale initially maintained that only three individuals were using four gauges, he subsequently stated, and available records showed, that Speciale Testing possessed 13 gauges, and these gauges were used by as many as 14 Individuals. Also, during the November inspection, seven gauge users stated that they used portable gauges without formal training for periods ranging from several weeks to four years prior to October 29,1998.

In addition, the NRC learned, based on discussions with Mr. Speciale, that there were perio when gauge users were not provided personnel dosimeters. Further, five gauge users stated that they operated portable gauges without wearing " film badges" for periods ranging from one to several months prior to October 1998. When questioned as to why individuals were using NUREG-0940, PART 3 A-66

3 gauges without training or personnel dosimeters, Mr. Speciale indicated that the required training and dosimeters were not previously provided due to financial considerations, even though he continued to direct the individuals to use the gauges.

Based on this November review by the NRC, Mr. Speciale, during the October 1998 communications with the NRC regarding the review of gauges being used, the number of users, and the training of those users, provided information to the NRC that he knew at the time was not complete and accurate in all material respects.

I Furthermore, during a subsequent interview with the 01 investigator on November 19,1998, Mr. Speciale also admitted that he "never stopped using nuclear gauges" after the Testwell Craig license was suspended for non-payment of fees and before the Special Testing license was issued. He stated that he failed to do so because Testwell Craig had " job commitments to finish."

til The NRC investigation is continuing. However, in light of the facts set forth in Section ll, the NRC finds that the Licensee has deliberately violated NRC requirements by: (1) directing untrained individuals to use gauges, contrary to License Condition ll.A; (2) not providing these individuals with the necessary dosimetry while they were using the gauges, contrary to License Condition 19; (3) making false statements to the NRC, contrary to 10 CFR 30.9. Furthermore, the facts show that Mr. Speciale used gauges between July 1,1996 and August 6,1997, even NUREG-0940, PART 3 A-67

4 though Testwell Craig's license had been suspended for nonpayment of fees and Testing's license had not yet been issued, contrary to 10 CFR 30.3 and the O License issued to Testwell Craig.

Deliberately violating NRC requirements is significant because the NRC mus the integrity of Licensee employees to comply with NRC requirements. Moreo false information to the NRC is of significant regulatory concern because the Com be able to rely on its licensees to provide complete and accurate information. Dire untrained individuals to conduct NRC-licensed activities and not providing dosimetry significant regulatory concem because misuse of gauges (which contain NRC-licensed material) could result in unnecessary radiation exposures to workers or members o Given the above, it appears that the Licensee is either unwilling or unable to compl Commission's requirements.

Consequently, I lack the requisite reasonable assurance that the Licensee's curre can be conducted under License No. 06-30361-01 in compliance with the Commission's requirements, and that the health and safety of the public, including the Licensee will be protected. Therefore, the public health, safety and interest require that License No. 06-30361-01 be suspended, with the exception of certain requirements enumer Section IV below, pending completion of the NRC investigation and further Orde Furthermore, pursuant to 10 CFR 2.202, I find that the significance of the conduct de above is such that the public health, safety and interest require that this Orde effective.

NUREG-0940, PART 3 'A-68

5 IV Accordingly, pu.suant to Sections 81,161b,1611,1610,182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR Part 30, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT:

A. Except as provided below, the authority to perform NRC-licensed activities under License No. 06-3036141 is hereby suspended pending completion of the NRC Investigation and further Order by the NRC.

B. All NRC licensed material in the Licensee's possession shall be placed in locked storage at 21 Henry Street, Bethel, Connecticut and shall not be used.

C. The Licensee shall not receive any NRC licensed material while this order is in effect.

D. All records related to licensed activities shall be maintained in their original form and shall not be removed or aftered in any way.

E. Within 2 days of the date of the Order, all Licensee employees shall be informed of this Order.

F. Within 7 days of the date of the Order, the NRC shall be provided a list of all clients for whom the Licensee has performed activities that involve use of the gauges within the past 12 months.

NUREG-0940, PART 3 A-69

6 G.

Within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receipt of this Order, a copy of this Order shall be posted at the facility, pursuant to 10 CFR 19.11(a)(4).

The Regional Administrator, Region I, may, in writing, relax or rescind any of the above conditions upon demonstration by the Licensee of good cause.

V in accordance with 10 CFR 2.202, the Licensee must, and any other person adversely affected by this Order may, submit an answer to this Order, and may request a hearing on this Order, within 20 days of the date of this Order. The answer may consent to this Order. Unless the answer consents to this Order, the answer shall, in writing and under oath or affirmation, specifically admit or deny each allegation or charge made in this order and set forth the matters of fact and law on which the Licensee or other person adversely affected relles and the reasons as to why the Order should not have been issued. Any answer or request for a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief Rulemaking and Adjudications Staff, Washington, D.C. 20555. Copies also shall be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, to the Deputy Assistant General Counsel for Enforcement at the same address, to the Regional Administrator, NRC Region I,475 Allendale Road, King of Prussia, Pennsylvania,19406, and to the Licensee t if the answer or hearing request is by a person other than the Licensee. If a person other than the Licensee requests a hearing, that person shall set forth with particularity the manner in which his interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.714(d).

NUREG-0940, PART 3 A-70

l 1

l 7 l if a hearing is requested by the Ucensee or a person whose interest is adversely affected, the Commission willissue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.

Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee, or any other person adversely affected by this )

I Order, may, in addition to demanding a hearing, at the time the answer is filed or sooner, move '

the presiding officer to set aside the immediate effectiveness of the Order on the ground that the Order, including the need for immediate effectiveness, is not based on adequate evidence but on mere suspicion, unfounded allegations, or stor.

In the absence of any request for hearing, the provisions specified in Section IV above shall be final 20 days from the date of this Order without further order or proceedings. AN ANSWER OR A REQUEST FOR HEARING SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER. $

FOR THE NUCLEAR REGULATORY COMMISSION k

Dr. Malcolm R. Knapp Deputy Executive Director for Regulatory Effectiveness Dated atjockville, Maryland this) 3 oay of December 1998 NUREG-0940, PART 3 A-71

[

pcarg\ UNITED STATES s*

j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20656-0001

. . . . . ,o January 8, 1999 EA 98-521 Mr. Richard A. Speciale, Director Special Test.ng Laboratories, Inc.

Post Office Box 200 Bethel, Connecticut 06801-0200

SUBJECT:

ORDER SUSPENDING LICENSE (EFFECTIVE IMMEDIATELY)

Dear Mr. Speciale:

On December 23,1998, the NRC issued an Order Suspending License (Effective immediately)

(Order) to Special Testing Laboratories, Inc., (Licensee). By letter dated December 23,1998, you requested an enforcement hearing and moved to set aside the immediate effectiveness of the Order. Based on several telephone conversations between you and the NRC staff, it is our understanding that you desire relaxation of the Order and resumption of NRC-licensed activities under ycv license as Ms. Susan Uttalinformed you today. We are prepared to rescind the j Order and modify the conditions of License No. 06-30361-01 (License) as specified below.  !

i If you agree to these conditions, we wil! incorporate them into a Confirmatory Order Modifying  !

License following your written consent. The conditions of the Order are:

{

A. The NRC's Order Suspending License dated December 23,1998, shall be rescinded.

B. Mr. Richard C. Speciale shall replace Mr. Richard A. Speciale as the Licensee's Radiation Safety Officer. As evidence of this Licensee management change, the j Licensee shall provide the NRC with written documentation, as follows: l t

1. A delegation of authority from Mr. Richard A. Speciale to Mr. Richard C. Speciale, which states that Mr. Richard C. Speciale has the requisite authority to communicate with, and direct, Licensee employees regarding NRC regulations and license provisions and to enforce these requirements, including the ability to terminate any unsafe operation involving the use of NRC-licensed material or activities that violate the Liconse or NRC requirements.

2. A directive to all current employees that they are not to look for or take direction from Mr. Richard A. Speciale regarding NRC-licensed activities. Within 7 days of providing the directive, the Licensee shall confirm that all current employees have received the directive.

3.

A signed statement as to how Mr. Richard A. Speciale will effectively be removed from control of NRC-licensed activities.

i NUREG-0940, PART 3 A-72 I

1

, Special Testing Laboratories, Inc. i

4. A signed statement, under oath or affirmation, from Mr. Richard C. Speciale certifying that:

a. he will direct NRC-licensed operations independent from any involvement or interference by Mr. Richard A. Speciale;

b. he understands the License conditions and all NRC requirements relating to the License, including the NRC's deliberate misconduct rule;

c. he understands that the NRC expects meticulous compliance with its requirements; and

d. he intends to comply with License conditions and all NRC requirements in every respect.

5. A signed statement describing how Mr. Richard C. Speciale will inform all gauge users of NRC and License requirements and direct them to comply with such requirements. Within 7 days of providing the signed statement, the Licensee will confirm that Richard C. Speciale has so informed and directed all employees.

C. The Licensee shall notify the NRC immediately if Mr. Richard A. Speciale attempts to influence Mr. Richard C. Speciale or any other Licensee employee in the conduct of NRC licensed activities.

D. The Ucensee shall fully cooperate with the NRC with regard to inspection or investigation of NRC-licensed activities, including the provision of complete and accurate records and responding to the NRC Office of Investigations subpoena dated November 18,1998. In addition, all records related to licensed activities shall be maintained in their original form and shall not be removed or altered in any way.

E. The Licensee shall retain the services of an independent individual or organization (consultant) to perform eight quarterly audits of the Licensee's radiation safety program.

After conducting four audits, the Regional Administrator, NRC Region I, may consider, at the request of the Licensee, relief in the audit requirements based on Licensee performance. The consultant shall be independent of the Licensee's organization and is to be experienced in, or capable of, evaluating the effectiveness of management and the implementation of a radiation safety program for gauging operations. NRC has approved the use of O/C Resource as a consultant; however, if the Licensee chooses to change the consultant, the Licensee shall notify the NRC seven days in advance of a change. At a minimum, each audit shall-

1. evaluate the effectiveness of the Licensee's radiation safety program and  :

compliance with NRC requirements;

)

2. evaluate the understanding of the Licensee's Radiation Safety Officer of radiation safety and NRC requirements;  ;

NUREG-0940, PART 3 A-73

Special Testing Laboratories, Inc. 3. evaluate the adequacy of the Licensee's corrective actions for any violations or audit findings previously identified by the NRC or consultant;

4. make racommendations as necessary for improvements in management oversight of NRC-licensed activities;

5. physically observe gauging operations in the field; and i

6. evaluate whether Mr. Richard A. Speciale is or has been involved in NRC-licensed activities since the effective date of this Order.

F. Within 7 days of the date of the date of this Confirmatory Order, the Licensee shall provide a copy of this Order to the consultant, to all current, and, for the duration of these commitments, to all future Licensee employees.

G. Within 30 days of the date of this Confirmatory Order, the first audit shall be completed.

The Licensee shall ensure that the consultant submits the results of the audit, including any deficiencies identified, to NRC Region i at the same time the consultant provides the results to the Licensee.

H. Within every three months thereafter, an audit shall be completed. The Licensee shall ensure that the consultant submits the results of the audit, including any deficiencies identified, to NRC Region I at the same time the consultant provides the results to the Licensee.

l. Within 30 days of the completion each audit, the Licensee shall submit to NRC Region I its corrective actions for any identified deficiencies in the audit reports. Alternatively, if the Licensee does not believe that corrective actions should be taken, the Licensee shall provide justification for its position to the NRC.

J. For purposes of the above conditions, the Licensee shall send all documents, and provide all notifications and confirmations, required by this modification to the Director, Division of Nuclear Material Safety, NRC Region I,475 Allendale Road, King of Prussir..

PA 19406-1415.

K. If the Deputy Executive Director for Regulatory Effectiveness concludes that a substantial breach of any conditions of the Confirmatory Order has occurred, the NRC will issue an Order Suspending License.

L. The Regional Administrator, Region I, may relax the above conditions for good cause.

If you consent to issuance of a Confirmatory Order confirming the above commitments, you are agreeing to withdraw your request for a hearing on the Order Suspending License ~and waiving your right to request a hearing on all or any part of the Order. In addition, both you and Richard C. Speciale must sign the Hearing Waiver (enclosed) indicating that you agree to such commitments and are consenting to the issuance of the Confirmatory Order. You should note that issuance of the Order does not preclude the NRC from taking further enforcement action against the Licensee or you as an individual after completion of the investigation. Please return NUREG-0940, PART 3 A-74

Special Testing Laboratories, Inc. , the signed Hearing Walver within ten business days from the date of this letter to Mr. James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738. In addition, please provide a copy of your written consent to Mr. George Pangburn, Director, Division of Nuclear Materials Safety, NRC Region I,475 Allendale Road, King of Prussia, Pennsylvania 19406-1415. After receiving your written consent, the NRC will issue the aforementioned Order.

Questions concerning this letter should be addressed to Ms. Susan Uttal at (301) 415-1582.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter will be placed in the NRC Public Document Room.

Sincerely, p -

James Lieberman Director, Office of Enforcement

Enclosure:

As stated Docket No. 030-34318 License No. 06-30361-01 I

I l

NUREG-0940, PART 3 A 75 l

HEARING WAIVER Special Testing Laboratories, Inc., (Licensee) hereby agrees to comply with the commitments described in the NRC's letter dated January 8,1999, and agrees to the incorporation of these commitments into a Confirmatory Order Modifying License that will be effective upon issuance.

By signing below, the Licensee consents to the issuance of a Confirmatory Order Modifying License with the commitments described on Pages 1 through 3 of the NRC's letter dated January 8,1999, and, by doing so, pursuant to 10 CFR 2.202(d), the Licensee waives the right to request a hearing on all or any part of the Order. In addition, the Licensee agrees to withdraw its request for a hearing dated December 23,1998.

Mr. Richard C. Speciale, President Date Special Testing Laboratories, Inc.

Bethel, Connecticut Mr. Richard A.Speciale, Director Date Special Test Laboratories, Inc.

Bethel, Connecticut NUREG-0940, PART 3 A-76

I tag

1. k UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.c. 30seH001 January 22, 1999 EA 98-521 Mr. Richard Speciale, President SpecialTesting Laboratories, Inc.

Post Office Box 200 Bethel, Connecticut 06801-0200

SUBJECT:

CONFIRMATORY ORDER MODIFYING LICENSE AND RESCINDING ORDER OF DECEMBER 23,1998

Dear Mr. Speciale:

The enclosed Confirmatory Order Modifying License (Order), which is effective upon issuance, is being issued to confirm the commitments outlined in the NRC's letter dated January 8,1999. )

Our letter was issued because you verbally requested relaxation of the NRC's Order Suspending License issued on December 23,1998. Based on our review of the circumstances, including your January 11,1999 consent to the enclosed Order, the NRC is hereby rescinding the Order Suspending License and issuing the enclosed Order.

The Order requires, in part, that: (1) .Mr. Richard C. Speciale replace Mr. Richard A. Speciale as the Special Testing Laboratories' (STL) Radiation Safety Officer; (2) Mr. Richard A. Speciale refrain from any involvement or influence in the conduct of licensed activities; (3) STL notify the NRC immediately if Mr. Richard A. Speciale attempts to influence Mr. Richard C. Speciale or any other STL employee in the conduct of NRC-licensed activities; (4) STL fully cooperate with the NRC with regard to inspection or investigation of NRC-licensed activities, including the -

provision of complete and accurate records and responding to the NRC Office of Investigations subpoena; (5) STL retain the services of an independent individual or organization (consultant) l to perform eight quarterly audits of STL's radiation safety program; (6) within 7 days of the date '

of this Order, STL provide a copy of this Order to the consultant, to all current, and, for the duration of these commitments, to all future STL employees;(7) within 30 days of the date of  ;

this Order, the first audit shal; be completed; (8) within every three months thereafter, an audit '

shall be completed; and (9) within 30 days of the date each audit, STL submit to NRC Region I its corrective actions for any identified deficiencies in the audit reports.

In addition, the Order reflects your agreement to withdraw the request for hearing on the December 23,1998 Order Suspending License (Effective immediately). Finally, nothing in the Order shall be deemed to preclude the NRC from taking further enforcement action against STL or Richerd A. Speciale as an individual, upon the completion of the ongoing NRC investigation.

Pursuant to Section 223 of the Atomic Energy Act of 1954, as amended, any person who ,

willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be subject to criminal prosecution as set forth in that section. Violation of this order may also subject the person to civil monetary penalty.

NUREG 0940, PART 3 A-77

SpecialTesting Laboratories, Inc. Questions concerning this Order should be addressed to me. I can be reached at (301) 415-2741.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room.

Sincerely, i

i

%i l James Lieberman, Director Office of Enforcement i

Enclosure:

As Stated Docket No. 030-34318 License No. 06-30361-01 cc w/ encl: l State of Connecticut NUREG-0940, PART 3 A-78

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of )

) Docket No. 030-34318 Special Testing Laboratories, Inc. ) License No. 06-30361-01 P.O. Box 200 ) EA 98 521 Bethel, Connecticut 06801-0200

)

CONFlRMATORY ORDER MODIFYING LICENSE )

AND RESCINDING ORDER OF DECEMBER 23,1998 I (EFFECTIVE IMMEDIATELY) l l

I l 1

Special Testing Laboratories, Inc. (Special Testing or Licensee) is the holder of Byproduct Nuclear Material License No. 06 30361-01 (Ucense) issued by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 30. The License authorizes possession and use of Troxler Electronics Laboratories, Campbell Pacific Nuclear, Humbolt Scientific, Seamen Nuclear, or Solltest nuclear gauges. Mr. Richard A. Speciale (Mr. Speciale) is the President and Radiation Safety Officer of Specla! Testing Laboratories. The License was issued on August 6,1997, and is due to expire on August 31,2007. However, by Order Suspending License dated December 23,1998, the License was suspended by the NRC for violations of the Commission's requirements as described therein.

11 By Letter dated December 23,1998, the Licensee requested an enforcement hearing and moved to set aside the immediate effectiveness of the Order Suspending License. Further, during several telephone conversations with the NRC between December 23,1998 and January 8,1999, the Licensee requested that the Order Suspending License be relaxed. By a letter dated December 31,1998, Mr. Richard A. Speciale, the Licensee's Director and Radiation Safety Officer, voluntarily relinquished his position of Radiation Safety Officer to Mr. Richard C.

I NUREG-0940, PART 3 A 79

l 2

Speciale, the Licensee's current President, and committed not to speak to or direct Licensee employees involved in NRC-licensed activities. In a letter dated January 4,1999, Mr. Richard C. Speciale informed the NRC that he understood the Ucense requirements, that he would comply with the License requirements, and that audits would be performed by an auditor independent of the Licensee.

Based on the Licensee's commitments and the circumstances in this case, the NRC has concluded that the Order Suspending License may be rescinded provided that a series of conditions, as described in Section IV below, are agreed upon and implemented by the Licensee. By letter dated January 8,1999, the NRC sent the Licensee a list of the specific conditions and formally requested the Licensee's consent to confirming the commitments through an Order. On January 11,1999, the Licensee, by its Director, Rici,ard A. Speciale, and its President, Richard C. Speciale, signed and returned its consent to issuance of this Order agreeing that: (1) its request for a hearing on the Order Suspending License be withdrawn; (2) the conditions, as described in Section IV below, be incorporated into the License; (3) this Order be immediately effective; (4) its right to a hearing on this Order be waived; and (5) nothing in this Order shall preclude the NRC from taking further enforcement action against the Licensee and/or Richard A. Speciale as an individual, upon completion of the ongoing NRC investigation.

111 Implementation of the commitments will provide assurance that sufficient resources will be applied to the radiation safety program, and that the program will be conducted safely and in accordance with NRC requirements. I find that the Licensee's commitments as set forth in NUREG-0940, PART 3 A-80

Section IV are acceptable and necessary and conclude that with these commitments the public health and safety are reasonably assured. In view of the foregoing, I have determined that the public health and safety require that the Licensee's commitments be confirmed by this Order and that the NRC's Order Suspending License be rescinded. Based on the above and the Licensee's consent, this Order is immediately effective upon issuance.

i IV Accordingly, pursuant to Sections 81,161b,1611,161o,182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR Part 2.202, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT LICENSE NO. 06-30361-01 IS MODIFIED AS FOLLOWS:

A. The NRC's Order Suspending Ucense dated December 23,1998, shall be rescinded.

B. Mr. Richard C. Speciale shall replace Mr. Richard A. Speciale as the Licensee's Radiation Safety Officer. As evidence of this Licensee management change, the Licensee shall provide the NRC with written documentation, as follows:

1. A delegation of authority from Mr. Richard A. Speciale to Mr. Richard C. Speciale, which states that Mr. Richard C. Speciale has the requisite and unqualified authority to communicate with, and direct, Licensee employees regarding NRC regulations and License provisions and to enforce i

these requirements, including the ability to terminate any unsafe operation i

NUREG 0940, PART 3 A-81 l

1 4

involving the use of NRC-licensed material or activities that violate the License or NRC requirements.

2. A directive to all current employees that they are not to look for or take direction from Mr. Richard A. Speciale regarding NRC licensed activities, and that any and all direction is to be provided solely by Richard C. Speciale. Within 7 days of providing the directive, the Licensee shall confirm that all current employees have received the directive.

I

3. A signed statement as to how Mr. Richard A. Speciale will effectively be removed from control of NRC-licensed activities, including his agreement to refrain from any efforts to direct, control or influence in any way and to any extent, directly or indirectly, the conduct of licensed activities.

4. A signed statement, under oath or affirmation, from Mr. Richard C. Speciale certifying that:

a. he will direct NRC-licensed operations independent from any involvement or interference by Mr. Richard A. Speciale;

b. he understands the License conditions and all NRC requirements relating to the License, . Including the NRC's deliberate misconduct rule;

c. he understands that the NRC expects meticulous compliance with its requirements; and NUREG-0940, PART 3 A-82

5

d. he intends to comply with License conditions and all NRC requirements in every respect.

5. A signed statement describing how Mr. Richard C. Speciale will inform all gauge users of NRC and License requirements and direct them to comply with such requirements. Within 7 days of providing the signed statement, the Licensee will confirm that Richard C. Speciale has so informed and directed all employees.

C. The Licensee shall notify the NRC immediately if Mr. Richard A. Speciale attempts to influence Mr. Richard C. Speciale or any other Licensee employee in the conduct of NRC-licensed activities.

D. The Licensee shall fully cooperate with the NRC with regard to inspection or investigation of NRC-licensed activities, including the provision of complete and accurate records and responding to the NRC Office of Investigations subpoena dated November 18,1998. In addition, all records related to licensed activities shall be maintained in their original form and shall not be removed or altered in any way.

E. The Licensee shall retain the services of an independent individual or organization (consultant) to perform eight quarterly audits of the Licensee's radiation safety program.

After conducting four audits, the Regional Administrator, NRC Region I, may consider, at the request of the Licensee, relief of the audit requirements based on Licensee performance. The consultant shall be independent of the Licensee's organization and is to be experienced in, or capable of, evaluating the effectiveness of management and the implementation of a radiation safety program for gauging operations. NRC has NUREG-0940, PART 3 A-83

6-i approved the use of Q/C Resource as a consultant; however, if the Licensee chooses to change the consultant, the Licensee shall notify the NRC seven days in advance of a change. At a minimum, each audit shall:

1.

evaluate the effectiveness of the Licensee's radiation safety program and compliance with NRC requirements; 2.

evaluate the understanding of the Licensee's Radiation Safety Officer of radiation safety and NRC requirements; 3.

evaluate the adequacy of the Licensee's corrective actions for any violations or audit findings previously identified by the NRC or consultant; 4.

make recommendations as necessary for improvements in management oversight of NRC-licensed activities; 5.

physically observe gauging operations in the field; and 6.

evaluate whether Mr. Richard A. Speciale is or has been involved in NRC-licensed activities since the effective date of this Order.

F.

Within 7 days of the date of this Confirmatory Order, the Licensee shall provid of this Order to the consultant, to all current, and, for the duration of these commitments, to all future Licensee employees.

NUREG-0940, PART 3 A-84

7-G. Within 30 days of the date of this Confirmatory Order, the first audit shall be completed.

The Licensee shall ensure that the consultant submits the results of the audit, including any deficiencies identified, to NRC Region I at the same time the consultant provides the results to the Licensee.

H. Within every three months thereafter, an audit shall be completed. The Ucensee shall ensure that the consultant submits the results of the audit, including any deficiencies identified, to NRC Region I at tne same time the consultant provides the results to the Licensee.

1. Within 30 days of the completion of each audit, the Licensee shall submit to NRC Region I its corrective actions for any identified deficiencies in the audit reports.

Alternatively, if the Licensee does not believe that corrective actions should be taken, the Licensee shall provide justification for its position to the NRC.

J. For purposes of the above conditions, the Licensee shall send all documents, and provide notifications and confirmations, required by this modification to the Director, Division of Nuclear Material Safety, NRC Region I,475 Allendale Road, King of Prussia, PA 19406-1415.

K. The Regional Administrator, Region I, may relax the above conditions for good cause.

l I

1 NUREG-0940, PART 3 A-85

i I

V I 1

Nothing in this Order will be deemed to preclude the NRC from taking further enforcement action against the Licensee and/or Richard A. Speciale as an individual, upon the comp the ongoing NRC investigation. In addition, if the Deputy Executive Director for Regu Effectiveness concludes that a substantial breach of any conditions of the Confirmator has occurred, the NRC may issue an Order Suspending License.

VI Any person adversely affect'ed by this Confirmatory Order, other than the Licensee, m ,

i request a hearing within 20 days of its issuance. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time mus be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory C

- Washington, DC 20555, and include a statement of good cause for the extension. A

' for a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, A Rulemakings and Adjudications Staff, Washington, DC 20555. Copies also shall be sent to th Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC to the Associate General Counsel for Hearings, Enforcement, and Administrations at the same address, to the Regional Administrator, NRC Region I,475 Allendale Road, King of Pruss PA 194061415, and to the Licensee. If such a person requests a hearing, that person shal forth with particularity the manner in which his interest is adversely affected by this Order an shall address the criteria set forth in 10 CFR 2.714(d).

NUREG-0940, PART 3 A-86

l l

.g.

If a hearing is requested by a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Confirmatory Order should be sustained.

In the absence of any request for hearing, or written approval of an extension of time in which '

to request a hearing, the provisions specified in Section IV above shall be final 20 days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section IV shall be final when the extension expires if a hearing request has not been received. AN ANSWER OR A REQUEST FOR HEARING SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER.

FOR THE NUCLEAR REGULATORY COMMISSION

/"Lieberman, J$nes Director 6ffice of Enforcement Dated this 22ndday of January 1999 I

i NUREG 0940, PART 3 A-87

UNITED STATES g- NUCLEAR REGULATORY COMMISSION

% $ REGloN l g 475 ALLENDALE ROAD KING oF PRUSSIA, PENNSYLVANIA 19406-1415

• • • • • ,d March 31,1999 EA 98-555 Joyce E. Jonson, D.Sc.

Senior Vice President, Nursing and Patient Care Washington Hospital Center 110 frying Street, N.W.

Washington, DC 20010-2975

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTY - $5,500 (NRC Inspection Report Nos. 070-01500/98-001 and 030-01325/98-004)

Dear Dr. Jonson:

This refers to the NRC inspection conducted on December 2-3,1998, at your facility in Washington, D.C., to review the circumstances associated with the loss of a nuclear pacemaker, which you reported to the NRC on November 30,1998. The inspection was continued in the Region I office until December 22,1998, to review additionalinformation provided to the NRC, subsequent to the onsite inspection. As described in the NRC inspection report sent to you on January 6,1999, several apparent violations of NRC requirements were identified during the inspection. On February 8,1999, a predecisional enforcement conference was conducted with you and other members of the Washington Hospital Center (WHC) staff, including your recently appointed Acting Director of Radiation Safety, to discuss the apparent violations, their causes, and your corrective actionse A copy of the enforcement conference report was provided to you on February 25,1999.

Based on the information developed during the inspection, and the information provided during the conference, two violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation and Proposed imposition.of Civil Penalty (Notice) and the circumstances surrounding them are described in detailin the subject inspection report. The more sigt.ificant violation involved the loss of control of a nuclear pacemaker, which contained 2.8 curies (Cl) of plutonium-238 (Pu-238), when it was being prepared for shipment on September 15,1998,

- to St. Jude Medical, a non-nuclear pacemaker company in Sylmar, California. The other violation involved the failure to make a timely report (i.e., within 30 days) by telephone after your staff identified that the pacemaker was lost or missing.

During the inspection, your staff informed the NRC inspector that the pacemaker was likely shippe through the normal postal service, without a retum address on the package, and was intended to be sent to St. Jude Medical. However, that entity was not authorized, either by the NRC or an Agreement State, to receive it. At the predecisional enforcement conference, your staff presented a chronology of events similar to that presented to the inspector. Your staff also indicated that, due

~

to the uncertainty as to whether the pacemaker was actually given to the U.S. Postal Service (USPS), your staff conducted an extensive search with radiation survey instruments at your facilities in an effort to find the pacemaker. However, these efforts did not locate the pacemaker.

NUREG-0940, PART 3 A-88

Washington Hospital Center 2 The first violation is of particular concern to the NRC because: (1) the failure to control radioactive material resulted in the loss of the pacemaker; and (2) a breach of the nuclear pacemaker, within which the radioactive material is encapsulated, could result in a potentially significant intake of '

' Pu-238. On March 26,1999, you notified the NRC that the pacemaker had been located at the facilities of a NRC licensee in Minnesota. Although the pacemaker has apparently been found, the significance of the concem is not lessened because the potential still existed for a breach of the pacemaker and a significant intake of radioactive material. Therefore, Violation A has been classified as a Severity Level lil violation in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600, Revision 1.

In the past two years, three predecisional enforcement conferences were held with you for violations which occurred at your facility. The violations discussed at the prior two conferences resulted in the  ;

NRC issuance of $5,000 and $2,750 civil penalties on April 10, 1997, and April 28, 1998, '

respectively, in each of those cases, the failure to provide adequate training and instruction to staff was a contributing factor, as it was in a prior civil penalty issued to you on April 28,1994, for other  !

violations at your facility. In this case, the failure to train hazardous materials personnel in the l applicable Department of Transportation (DOT) requirements may have been a root cause of the loss of control of the pacemaker.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level lil violation or problem. Because your facility has been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for'/dentification and Conrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for identification is warranted because the violation associated with the loss of control of the nuclear pacemaker was identified by your staff after they called St. Jude Medical to confirm whether the pacemaker had been received, and leamed that it had not. Credit for corrective actions is warranted because your corrective actions, were considered prompt and comprehensive. These corrective actions include, but were not limited to: (1) placing a hold on all radioactive material shipments from your facility, except for the retum of empty radiopharmaceutical containers to radiopharmacies, until a review of the shipping protocols could be completed; (2) contracting with a consultant from the National Institute of Health to review radioactive material shipping protocols; (3) providing the necessary hazardous material training to personnel, including the necessity to verify that the recipient has the appropriate license; (4) hiring of an Acting Director of Radiation Safety to oversee the restructuring of your Radiation Safety Department and the update of your Radiation Safety Manual; (5) posting two additional health physics positions to increase radiation safety staffing at the facility; and (6) conducting radiation surveys at your facility in an effort to find the pacemaker.

Given that credit is warranted for identification and corrective actions, the NRC would not normally propose a civil penalty in this case. However, I have decided, after consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Regulatory Effectiveness, to exercise enforcement. discretion pursuant to Section Vil.A.1 of the Enforcement Policy, and issue a Notice of Violation and Proposed imposition of a Civil Pcnalty in the amount of $5,500 (twice the base I

amount for Violation A). Such discration is warranted because: (1) this case involves the loss of radioactive material, which was intended to be shipped to an entity without verifying that the entity possessed an NRC license for receipt of such material; (2) your performance in this case was poor; and (3) your prior enforcement history has been particularly poor.

NUREG-0940, PART 3 A-89

Washington Hospital Center 3 Based on the presumption that the pacemaker was shipped through the USPS, the NRC's January 6,1999 inspection report identified eight additional apparent violations involving DOT requirements.

While these apparent violations are not being cited in the Notice, they will be referred to the USPS for its review and action, as appropriate. Nevertheless, compliance with DOT requirements is intended to serve as safety barriers designed to prevent losses of radioactive material and to protect members of the public from inadvertent and potentially significant radiation exposures. DOT requirements include, but are not limited to, training, providing shipping papers, labeling of packages, and verifying (before shipping) that the transferee is authorized to receive radioactive material.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. As part of your response, you should address any actions taken, or planned to be taken, to ensure that future offsite shipments of radioactive materist meet applicable DOT requirements. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure, will be placed in the NRC Public Document Room (PDR).

Sincerely, Hu rt J. M Regional Administrator Docket Nos. 070-01500 and 030-01325 l License Nos. SNM-1446 and 08-03604-03 j

Enclosure:

Notice of Violation and Proposed imposition of Civil Penalty cc w/ encl: )

District of Columbia l

l l

i NUREG-0940, PART 3 A-90

ENCLOSURE i NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTY Washington Hospital Center (WHC) License Nos. SNM-1446 Washington, D.C. 08-03604-03 Docket Nos. 070-01500 030-01325 EA 98-555 During an NRC inspection conducted at WHC on December 2-3,1998, and continued in the Region I office until December 22,1998, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the NRC proposes a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act),42 U.S.C. 2282 and 10 CFR 2.205. The violations and l associated civil penalty are set forth below-A. 10 CFR 20.1802 states that the licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but {

inside the site boundary, access to which can be limited by the licensee for any reason; and )

unrestricted area means an area, access to which is neither limited nor controlled by the

{

licensee. I Contrary to the above, between September 15,1998, and March 25,1999, the licensee failed to control and maintain constant surveillance of licensed material, a pacemaker containing 2.8 Ci of plutonium-238 (Pu-238), that was in an unrestricted area and that was not in storage in that the licensee could not account for the pacemaker. (01013)

The is a Severity Level lil violation (Supplement IV).

Civil Penalty - $5,500.

B. 10 CFR 20.2201(a)(1)(ii) states that each licensee shall report by telephone within 30 days

. after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20 that is still missing at the time.

Contrary to the above, the licensee did not report by telephone within 30 days after the  ;

occurrence of lost, or missing licensed material became known to the licensee, all licensed i materialin a quantity greater than 10 times the quantity specified in Appendix C to Part 20 l that was still missing at that time. Specifically, the licensee knew of the missing nuclear pacemaker containing 2.8 Ci of Pu-238 on October 22,1998, when the designated recipient of the material informed the licensee that the material had not been received. However, notification was not made to NRC until November 30,1998, a period in excess of 30 days.

(02014)

The is a Severity Level IV violation (Supplement IV).

NUREG-0940, PART 3 A-91 ,

j

l

{

Washington Hospital Center 2 Pursuant to the provisions of 10 CFR 2.201, Washington Hospital Center is required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S.

Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" and may:

(1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other I provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, 4 and the penalty, unless compromiced, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act,42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.

NUREG-0940, PART 3 A 92

Washington Hospital Center 3 Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, youmust specifically identify the portions af your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at King of Prussia, Pennsylvania this 31" day of March 1999 NUREG-0940, PART 3 A-93 l

l- -

1 B. SEVERITY LEVEL I, ll, lll VIOLATIONS NO CIVIL PENALTY I

l NUREG-0940, PART 3

F UNITED STATES

[@8 8% o g NUCLEAR REGULATORY COMMISSION

[ o R EGloN 11

! j SAM NuNN ATLANTA FEoERAL CENTER

$

• 61 FoRsYTH STREET. sW. suite 23T85 p.y***

/ ATLANTA. GEORGIA 30303 8931 May 7, 1999 EA 99-074 Code Services, Inc.

ATTN: Mr. Reggie Lambert Managing Partner 26412 Old Highway 20 Madison, AL 35758

SUBJECT:

NOTICE OF VIOLATION AND EXERCISE OF DISCRETION (NRC INSPECTION REPORT NO. 150-00001/99-001)

Dear Mr. Lambert:

This refers to the inspection conducted on March 17 and 18,1999, at tN NASA Marshall Space Flight Center (MSFC), Huntsville, Alabama, an area of exclusive Feder4' jurisdiction, and your field office in Madison, Alabama. The purpose of the inspection was to ietermine whether activities authorized by a general license granted by the NRC la ecordance with 10 CFR 150.20 were conducted safely and in accordance with AC requirements. The results of the inspection including one apparent violation were discussed with members of your staff at an exit meeting on March 18,1999, and formally transmitted to you by letter dated April 18, 1999. An open, predecisional enforcement conference was conducted at the NRC Region ll office in Atlanta, Georgia, on April 22,1999, to discuss the apparent violation, the root cause, and your corrective actions. The conference afforded you the opportunity to present your assessment of the effectiveness of your corrective actions and to address similar violations occurring in 1998 and documented by the State of Alabama's Department of Public Health, Office of Radiation Control. By facsimile dated April 27,1999, you provided additional information regarding your corrective actions and documented statements of the employees interviewed by the NRC during the March 1999 inspection.

Based on the information developed during the inspection and the information that you provided during and following the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding it are described in detailin the subject inspection report. The violation involves the failure of a radiographer's assistant to wear an alarm rate meter on February 16,1999, while performing radiocjraphic operations at the NASA MSFC, an area under NRC jurisdiction, as required by 10 CFR 34.47(a). This violation was identified by the NASA Radiation Safety Officer (RSO) while observing Code Services, Inc. at MSFC. Your review of the incident with the individuals involved resulted in statements that conflicted with those of the NASA RSO; however, we believe that you adequately addressed the conflicting statements as part of your corrective actions. Based on the evidence available, we conclude that the radiographer's assistant was not wearing the alarm rate meter during the radiographic operations observed by the NASA RSO.

Although, no occupational exposure limits of 10 CFR Part 20 were exceeded during the February 16,1999 radiographic operations, the failure of personnel to use appropriate protective devices is a significant safety issue. Alarm rate meters are intended to give prompt and audible indication of high radiation levels so as to permit initiation of appropriate protective measures to avoid unnecessary or unexpected radiation exposures. Based on the safety significance of this issue, in accordance with the " General Statement of Policy and Procedures NUREG-0940, PART 3 B-1

i i

Code Services Inc. 2 for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600, the violation desenbed in i the Notice has been categorized at Severity Level 111.

In addition, the failure of Code Services, Inc. personnel to wear proper equipment during radiographic operations is a recurring problem. Code Services, Inc. was cited by the State of Alabama for a violation identified during an inspection on May 4,1998, in which a radiographer was wearing an alarm rate meter that was not turned on during radiographic operations. On October 8,1998, the State of Alabama again cited Code Services, Inc. for a violation that occurred on August 31,1998, during which a radiographer's alarm rate meter was not turned on, and the assistant did not have an alarm rate meter during radiographic operations, in accordance with the Enforcement Policy, a base civil penalty in the amount of $5500 is considered for a Severity Level 111 violation. Because you have been the subject of escalated enforcement actions involving similar violations issued by the State of Alabama within the last two years, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. The MSFC site RSO identified and reported the February 16,1999, alarm rate meter incident to you; therefore, credit for the factor of /denti// cation was determined not to be warranted. Code Services, Inc.'s corrective actions for the Severity Level lli violation included: 1) promptly conducting a mandatory safety meeting with staff on February 16,1999;

2) attending a meeting with MSFC officials on February 18,1999: 3) implementing a recovery plan with goals to achieve and maintain compliance with regulatory requirements;

4) issuing a follow-up letter to MSFC reiterating Code Services, Inc.'s commitment to safety and compliance: 5) increasing field audit frequencies of radiographers by the RSO from quarterly to monthly; 6) conducting weekly safety meetings with staff; and 7) implementing strong disciplinary action against the individual involved. Based on these actions, the NRC determined that corrective actions for the violation were prompt and comprehensive, and that credit was warranted for the factor of Corrective Action.

Based on the previously described assessment of Identification and Corrective Action, under our Enforcement Policy we would normally issue a base civil penalty of $5500 for the Severity Level lll violation. However, after review of this violation and consultation with the Director, Office of Enforcement, the NRC has concluded that while a violation did occur, enforcement discretion is warranted, and the issuance of a civil penalty is not appropriate in this ase.

Discretion is being exercised pursuant to Section Vll.B.6 of the Enforcement Policy bs on

1) the new management / ownership of the company (as of November 1998) has taken steps to improve staff compliance with safety requirements; 2) significant disciplinary action was taken demonstrating to the employees that this violation would not be tolerated; 3) initial corrective actions taken by Code Services, Inc. in response to NASA's finding were prompt; and 4) radiographic operations directly observed by the NRC inspector in March 1999 were conducted safely and in accordance with regulatory requirements. However, Code Services, Inc. is on notice that should a similar violation occur in the future, more significant enforcement may be taken.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements, In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the Public Document Room (PDR). To the NUREG-0940, PART 3 B-2

]

\

Code Services Inc. 3 extent possible, your response should not include any persorial privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

If you have any questions regarding this letter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at (404) 562-4700.

Si cerel 4

Luis A. Rey Regional A y nistrator  ;

Enclosures:

1. Notice of Violation

2. Conference Attendees

3. Material Presented by Licensce (redacted)

4. Material Presented by NRC

5. Facsimile sent by Licensee dated April 27,1999 (redacted)

Docket No. 150-00009 License No. General (10 CFR 150.20) cc w/encis: ,

State of Alabama NASA RSO NUREG-0940, PART 3 B-3

NOTICE OF VIOLATION Code Services, Inc. Docket No. 150 00001 Huntsville, Alabama License No. General License EA 99-074 During an NRC inspection conducted on March 17 and 18,1999, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 150.20 provides in part that any person who holds a specific license from an Agreement State is granted an NRC generallicense to conduct the same activity in areas of exclusive Federaljurisdiction within Agreement States, provided an NRC Form-241 is properly filed. The generallicense is subject to all provisions of the Act and to all applicable rules, regulations and orders of the Commission including Subpart C of Part 34.

10 CFR 34.47(a) requires, in part, that a licensee may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operation, each individual wears, on the trunk of the body, an operating alarm rate meter, Contrary to the above, on February 16,1999, an individual, employed by Code Services, Inc., who holds a specific license from the State of Alabama and was granted an NRC generallicense pursuant to 10 CFR 150.20, acted as a radiographer's assistant at the NASA Marshall Space Flight Center, Huntsville, Alabama, an area of exclusive Federal jurisdiction, and the individual failed to wear an alarm rate meter, (01013)

This is a Severity Level til violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Code Services, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region ll, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for the violation: (1) the reason for the violation, or,if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previously docketed correspondence, if the correspondence adequately addresses the required response, if an adequate reply is not received within the time specified in this Notice, an order or a Demand for information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

If you contest this enforcement action, you should also provide a copy of your response to the Director. Office of Enforcement, U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and the Enforcement Officer, Region 11.

Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

NUREG-0940, PART 3 B-4 Enclosure 1

Notice of Violation 2 Because your response will be placed in the NRC Public Document Room (PDR), to the extent l possible, it should not include any personal privacy, proprietary, or safeguards information so  !

l that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then, please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must I I

specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

In accordance with 10 CFR 19.11, you may be required to post this Notice with two working days.

Dated at this 7th day of May,1999 i

NUREG-0940, PART 3 B-5

,(p*%,k UNITED STATES NUCLEAR REGULATORY COMMISSION E REGloN lil U f 801 WARREfMLLE ROAD USLE, ILLINols 60532-4351 March 31, 1999 EA 98-492 A. Abduishafi, Ph.D., President DAS Consult, Inc.

P.O. Box 21540 Columbus, OH 43221

SUBJECT:

NOTICE OF VIOLATION AND TERMINATION OF LICENSE (NRC Inspection Report No. 030-33414/98001(DNMS) ,

and NRC Office of Investigations (OI) Report No. 3-98-029)

Dear Dr. Abdulshafi:

Enclosed is a Notice of Violation (Notice) and Amendment No. 3 to NRC License No. 34-26551-01. License Amendment No. 3 terminates your license, as requested in your letter of August 24,1998.

Based upon the information developed during the above-referenced inspection and investigation, and the January 5,1999, predecisional enforcement conference, the NRC has determined that a willful violation of NRC requirements occurred. The violation involves the unauthorized transfer of byproduct material and is cited in the enclosed Notice. The circumstances surrounding the violation are described in detailin the subject inspection report issued on July 6,1998.

Supplement VI of the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600, which was the applicable Enforcement Policy at the time of the violation, categorizes violations involving improper transfer of byproduct material at Severity Level 111. However, because the violation was deliberate, the severity level has been increased to Severity Level 11, pursuant to Section IV.C. of the Enforcement Policy.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,400 is considered for a Severity Level 11 violation. Because DAS Consult, Inc. has suspended operation, divested itself of byproduct material, and requested termination of its license, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case A response to this letter is not required at this time. However, you may be required to respond to the violation identified in the Notice in accordance with 10 CFR 2.201 if, in the future, you wish to obtain another NRC license, if you have any questions or require clarification on any of the information stated above, you may contact Toye Simmons of my staff at (630) 810-4375.

NUREG-0940, PART 3 B-6

A. Abdulshafi l'n accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and the enclosures will be placed in the NRC Public Document Room.

Sincerely,

&w James E. Dyer Regional Administrator Docket No. 030-33414 License No. 34-26551-01

Enclosures:

1. Notice of Violation

2. Amendment No. 3 l

NUREG-0940, PART 3 B-7

NOTICE OF VIOLATION DAS Con ='t, inc. Docket No. 030-33414 Dub;in, Ohio License No. 34-26551-01 EA 98-492 During an NRC inspection conducted between June 19 and June 25,1998, and an investigation conducted by the NRC Office of investigations between June 29 and October 15,1998, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, applicable rt the time of the violation, the violation is listed below:

10 CFR 30.41(a) and (b)(5) require, in part, that no licensee may transfer byproduct material except to a person authorized to receive or possess such byproduct material under the terms of a specific or general license issued by the Commission or an Agreement State.

Contrary to the above, between January and June 1997, the licensee transferred six Troxler moisture density gauges, each containing a nominal 8 millicuries (0.296 gigabecquerels) of cesium-137 and 40 millicuries (1.5 gigabecquerels) of americium-241, to Diversified Global Enterprise Company, a person who was not authorized to receive or possess such byproduct material under the terms of a specific or general license issued by the Commission or an Agreement State.

This is a Severity Level 11 violation (Supplement VI).

Dated this 31st day of March 1999 NUREG-0940, PART 3 B-8 1

1

1. "'8

1. %g UNITED STATES 4' 1 NUCLEAR REGULATORY COMMISSION E E s I j REGloN IV l

611 RYAN PLAZA DRIVE, sulTE 400

• ARLINGTON, TEXAS 76011-8064

,,,g January 28, 1999 EA 98-471 Donald Whitener Assistant Area Director Department of interior Bureau of Indian Affairs P.O. Box 26567 Albuquerque, New Mexico 87125-6567

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-08519/98-01)

Dear Mr. Whitener:

This refers to your letter dated January 20,1999, in response to the subject inspection report dated November 23,1998. The NRC's routine inspection identified three apparent violations tnat were being considering for escalated enforcement action. These apparent violations were discussed with your radiation safety officer at the completion of the inspection, on November 2, 1998. The cover letter to the inspection report informed you that prior to making an enforcement decision, we were providing you the opportunity to either request a predecisional enforcement conference to discuss the apparent violations or respond to the apparent violations in writing. You responded to the apparent violations in writing in your January 20 letter.

Based on the information developed during the inspection and the information that you provided in your January 20,1999 letter, the NRC has determined that violations of NRC requirements occurred. These vic,lations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detailin the subject inspection report. The violations involve failures to: (1) adequately secure and restrict access to licensed materials, specifically three portable gauges; (2) store portable gauges in locked containers designed to l prevent unauthorized or accidental removal of the sealed sources from their shielded positions; and (3) perform semi-annual source inventories. These violations were identified during a routine inspection of five of your nine field sites, and information from employees indicated that some of these violations might have existed for an extended period of time, in one case for approximately one year.

These violations did not result in a safety consequence. However, collectively, the violations indicate significant failures to maintain security over, and control access to, radioactive material for radiation protection purposes as specified by NRC requirements. Therefore, these violations are classified in the aggregate in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600 as a Severity Level ill problem.

In accordance with the Enforcement Policy, a civil penalty an the base amount of $2,750 is considered for a Severity Level 111 problem. Because your f acility has not been the subject of escalated enforcernent actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment NUREG-0940, PART 3 B-9

Department of the Interior 2 process in Section VI.B.2 of the Enforcement Policy. We noted your corrective actions included ensuring all gauges were secured in locked containers, ensuring that storage facilities are locked when not in use, completing an inventory of all portable gauges, conducting training on NRC requirements, and creating a calendar of specific events to perform tasks such as physical inventories. Therefore, the NRC has concluded that credit for Corrective Actions was warranted.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty, in addition, issuance of this Severity Leve! Ill problem constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in inspection Report No. 030/08519/98-01, and your letter dated January 20,1999. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice, in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room.

Sincerely, Ellis W. Mersch Regional Admi istrator Docket No. 030-08519 License No. 30-15065-01

Enclosure:

Notice of Violation cc (w/ encl):

State of New Mexico Radiation Control Program NUREG-0340, PART 3 B-10

NOTICE OF VIOLATION Department of the Interior Docket No. 030-08519 Bureau of Indian Affairs License No. 30-15065-01 Albuquerque, New Mexico EA 98-471 During an NRC inspection conducted on June 22 through November 2,1998, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A. 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.10 CFR 20.1802 requires that the licenseo control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on June 23, and other days in 1998, the licensee did not secure from unauthorized removal or limit access to 3 portable gauging devices containing about 100 millicuries of americium-241 and 24 millicuries of cesium-137, located in an open storage facility, at the BIA Ramah Navajo Agency Branch of Roads Compound on l Highway 124, which is a controlled area, nor did the licensee maintain constant surveillance of this licensed material. (01013)

B. License Condition 14 requires that each portable nuclear gauge shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The gauge or its container must be locked when in transport, storage, or when not under the direct surveillance of an authorized user.

Contrary to the above, on June 23,1998,3 portable gauges did not have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position at the Ramah Navajo Agency storage facility. The gauges were in storage and were not under direct surveillance of an authorized user.

(01023)

C. License condition 15 requires that the licensee conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license.

Contrary to the above, the licensee did not conduct a physical inventory to account for all sources and/or devices received and possessed under the license between the period from October 1995 to June 23,1998, an interval exceeding 6 months. (01033)

These violations represent a Severity Level 111 problein. (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when NUREG-0940, PART 3 B-11

Department of the Interior 2 l futi compliance was achieved is already adequately addressed on the docket in NRC Inspection Report No. 030-08519/98-01 and in a letter from the Licensee dated January 20,1999.

However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region IV,611 Ryan Plaza Drive, Suite 400, Arlington Texas 76011, within 30 days of the date of the letter transmitting this Notice of Violation (Nob.).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information),

in accordance with 10 CFR 19.11, you may be required to post this Notice within two working days. j 1

Dated this T.8th day of January 1999 i

l 1

l l

NUREG-0940, PART 3 B-12

p* 880% UNITED STATES y NUCLEAR REGULATORY COMMISSION

$ f REGloN lv

[ 611 RYAN PLAZA drive, sulTE 400

• ARLINGTON, TEXAS 76011-8064

,, g i February 17, 1999 (

EA 98-481 Jose R. Coronado, Director Department of Veterans Affairs Audie L. Murphy Memorial Veteran's Hospital 7400 Merton Minter Boulevard San Antonio, Texas 78284

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT 030-09959/98-01)

Dear Mr. Coronado:

This refers to your letter dated January 15,1999, in response to the subject inspection report dated December 10,1998. The inspection was an examination of activities conducted under Byproduct Materials License 42-15881-01 as they relate to radiation safety and to compliance with the Commission's rules and regulations and..the conditions of the license. After the in-office review of additional documents submitted to the NRC by Audie L. Murphy Memorial Veteran's Hospital (ALMMVH), the inspection was concluded on November 10,1998, at which time the NRC informed you that it was considering escalated enforcement action for an apparent violation identified during the inspection. You elected to respond to the apparent violation in writing, by your January 15,1999 letter, in lieu of requesting a predecisional enforcement conference.

Based on the information developed during the inspection, and consideration of the information that you provided in your response to the inspection report, the NRC has deterrnined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detailin the subject inspection reporL_The. violation. involves the unauthorized use of strontium-90 scaled sources to perform intravascular brachytherapy (IVB) procedures on human subjects under a research protocol on two occasions in March 1998. In August 1998, during discussions about renewing ALMMVH's license, the radiation safety officer (RSO) identified to NRC license reviewers that the hospital had used a Novoste IVB device pn humans, under a research protocol, and that the licensee believed that 10 CFR 35.6 permitted the activity. Nevertheless,in spite of your differing interpretation of the regulatory requirements, you agreed to suspend further use of this device and take certain additional actions. Your commitments were described in a Confirmatory Action Letter (CAL 4-98-003) issued by the NRC to your facility on August 28, 1998.

There were no actual safety consequences resulting from the violation. The inspection found that appropriate radiation safety procedures were utilized by ALMMVH during use of the device.

These included conducting radiation surveys, verifying patient identification, verifying treatment sites and prescribed doses, implementing device quality control procedures, ensuring emergency equipment availability and ensuring the presence of a radiation oncologist, cardiologist, and medical physicist throughout the procedure. However, the significance of the violation rests with the fact that a device used to perform IVB procedures on human subjects had not undergone a safety (engineering) evaluation pursuant to 10 CFR 32.210 and was not NUREG-0940, PART 3 B-13

I I

Department of Veterans Affairs Audio L. Murphy Memorial Veteran's Hospital j listed on a registration certificate issued by the NRC or an Agreement State. This evaluation is especially important given that the FDA considers IVB procedures conducted under a research protocol a high risk activity and that some misadministrations have occurred while using this device as a result of failing to position the sources precisely. As such, this violation has been categorized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600 at Severity LevelIll.

In accordance with the Enforcement Policy, a civil penalty with a base value of $2,750 is considered for a Severity Level ill violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warrant" 'c r Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. ALMMVH's corrective actions included immediately suspending IVB research, retuming the sealed sources to the manufacturer, and discussing NRC regulations and the ALMMVH's license, regarding research on humans, with the ALMMVH radiation safety com'mittee. The NRC has determined that ALMMVH is deserving of corrective action credit, resulting in no civil penalty being assessed.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case.

However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level lli violation constitutes escalated enforcement action, which may subject you to increased inspection offort.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report 030-09959/98-01 and in your letter dated January 15,1099. Therefore, you are not >

required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

l In accordance with 10 CFR 2.790 of the NRp's " Rules of Practice," a copy of this letter, its l enclosure, and your response, if you choose to respond, will be placed in the NRC Public Document Room.

t S yn Ellis W. Merschof Regional Administrator Docket No. 030-09959 License No. 42-15881-01

Enclosure:

Notice of Violation NUREG-0940, PART 3 B-14

7.,___.

. Department of. Veterans Affairs - Audie L Murphy Memorial Veteran's Hospital cc (w/enct):

Texas Radiation Control Program Director Dr. Milton Gross Departmentof Veterans Affairs Nuclear Medicine Program

. 24 Frank Loyd Wright Drive -

Lobby M, P. O. Box 505 Ann Arbor, Michigan 48105 4

i NUREG-0940, PART 3 B-15

ENCLOSURE l

NOTICE OF VIOLATION l Department of Veterans Affairs Docket No. 030-09959 Audie L. Murphy Memorial Veteran's Hospital License No. 42-15881-01 San Antonio, Texas EA 98-481 During an NRC inspection completed November 10,1998, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 30.34(c) requires, in part, that each licensee confine its possession and use of byproduct materials to the locations and purposes authorized by the license.

License No. 42-15881-01, conditions 9.G. and 9.H., authorize research and development as defined in Section 30.4(q),10 CFR Part 30 (currently 10 CFR 30.4), Ln vitro studies, and tracer studies in humans as approved by the licensee's Radioactive Drug and Research Committee No. RDRC 0056.

10 CFR 30.4 states, in part, that "Research and development" as used in this part and parts 31 through 35 does not include the internal or external administration of byproduct material, or the radiation therefrom, to human beings.

Contrary to the above, on March 3 and 4,1998, the licensee did not confine its use of byproduct materials to the purposes authorized by the license. Specifically, the licensee used strontium-90 sealed sources to perform intravascular brachytherapy procedures, an internal administration of byproduct material on human subjects. (01013)

This is a Severity Level Ill violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report 030-09959/98-01 and letter from Licensee dated January 15,1999. However, you are required to submit a written statement or eglanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Docurnent Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region IV,611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, and a copy to the NRC Resident inspector at the facility that is the subject of this Notice, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

I NUREG-0940, PART 3 B-16

Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation. ,

if you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specificallyidentify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal

~

privacy or provide the information required by 10 CFR 2.790(b) to support a request for l withholding confidential commercial or financial information), if safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21. ,

f In accordance with 10 CFR 19.11, you may be required to post this Notice within two working l I

days.

Dated this 17" day of February 1999 l

I l

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1 B-17 NUREG-0940, PART 3

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a aseog*

g UNITED STATES

'[5 g 8

NUCLEAR REGULATORY COMMISSION REGION i

[ 475 ALLENDALE ROAD o,% * * . . + ,e KING OF PRUSSIA, PENNSYLVANIA 19406-1415 February 5,1999 EA 98-575 Mr. John Meehan President and CEO Hartford Hospital Post Office Box 5037 80 Seymour Street Hartford, Connecticut 06102-5037

SUBJECT:

NOTICE OF VIOLATION (NRC inspection Report No. 030-01239/98-002)

Dear Mr. Meehar; This refers to the Nn% spection conducted on December 14,1998, at your facility in Hartford, CT.,

to determine whethe a tivities authorized by your license were conducted safely and in accordance with NRC requiremen The inspection was conducted after the NRC was notified on December 10,1998, that waste am your facility containing radioactive material had been detected at the Connecticut Resource Recovery Authority (CRRA) after it had been sent there for incineration. As described in the NRC inspection report enclosed in our letter dated December 30,1998, five apparent violations of NRC requirements were identified during the inspection. On January 26,

.1999, a predecisional enforcement conference was conducted with Mr. John Fagan, and other members of your staff, to discuss the apparent violations, their causes, and your corrective actions.

A copy of the enforcement conference report is enclosed. l Based on the information developed during the inspection and the information provided during the l conference, three violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detailin the subject inspection report. The violations being cited include: (1) the failure to control :

and maintain constant surveillance of licensed material (3 to 6 millicuries of iodine-131 contaminated waste) that was in a controlled or unrestricted area (an lodine-131 therapy patient's toom) and that was not in storage; (2) the failure to make, or cause to be made, surveys which

- would have prevented the iodine-131 contaminated waste from being removed from the patient's 1

room, placed into the hospital's trash dumpster, and transported to the incinerator facility; and (3) the failure to label the bag containing iodine-131 contaminated waste which would have prevented it from being removed from the patient's room. The failure to adequately train personnel in the performance of their duties during the handling of radioactive waste contributed to these violations.

The NRC is concemed that hospital Enviror' mental Services personnel were not adequately trained to perform surveys to properly determine the extent of radiation levels and/or quantities of radioactive materials when hospital area monitors alarmed. As a result of the inadequate training, the bag was placed into the dumpster, and eventually given to a commercial waste handler who did not have authorization to receive such material. Although the bag was eventually recovered by NUREG-0940, PART 3 B-18

)

p Hartford Hospital 2 Hartford Hospital, the loss of control of radioactive material waste is a significant violation.

Therefore, the violations collectively have been classified in the aggregate as a Severity Level lil problem in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level lli violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These actions, which were described at the enforcement conference and in your January 25,1999 letter to NRC, are summarized in the enclosed Enforcement Conference Report. Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.

Two apparent violations set forth in the inspection report are not being cited for the reasons stated below. The apparent violation associated with the unauthorized disposal of licensed material, is not being cited, because the material was recovered by your Radiation Safety Officer and returned to Hartford Hospital, and because, in.our view, the problem is more accurately characterized as a  !

security and control problem. The apparent violation associated with the failure to adequately train Environmental Services personnel is not being cited because your June 21,1993 letter which is l I

incorporated into you license only requires training such personnel to recognize restricted areas and radiation labels.

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, is already adequately addressed on the docket in your January 25,1999 letter, as well as the enclosed Enforcement Conference Report. You further indicated in a telephone conversation with J. Dwyer of the NRC on February 5,1999, that all corrective actions would be completed by February 28, 1999.

Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosures, will be placed in the NRC Public Document Room (PDR).

Sincerely, I

H ubert J. Miller

)

Regional Administrator Docket No. 030-01239 License No. 06-00253-04 NUREG-0940, PART 3 B-19

Hartford Hospital 3

Enclosures:

1. Notice of Violation

2. Enforcement Conference Report with Attachment cc w/encis:

State of Connecticut 1

l I

I l

l i

. NUREG-0940, PART 3 B-20

ENCLOSURE 1 NOTICE OF VIOLATION Hartford Hospital License No. 06-00253-04 Hartford, CT. Docket No. 030-01239 EA 98-575 During an NRC inspection conducted on December 14,1998, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG -1600, the violations are listed below:

A. 10 CFR 20.1802 requires, in part, that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.

Contrary to the above, on or about December 9,1998, the licensee did not control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area. Specifically, a bag containing wash cloths, cotton socks, hospital booties, and tissue paper contaminated with 3 to 6 millicuries of iodine-131, was removed from a patient's room and was placed into a dumpster outside the facility. The material was se': aquently transported to an incinerator in Hartford, Connecticut, and was not detected until 3:45 p.m.

on December 9,1998, when area radiation monitors located at the incinerator alarmed.

(01013)

B. 10 CFR 20.1501 requires that the licensee make, or cause to be made, surveys that may be necessary for the licensee to comply with 10 CFR Past 20 and are reasortable under the circumstances to evaluate the extent of radiation levels; concentrations or quantities of radioactive material; and the potential radiological hazard that could be present.

Contrary to the above, on or about December 9,1998, the licensee did not make, or cause to be made, surveys that were necessary for the licensee to comply with 10 CFR 20.1802 and were reasonable under the circumstances to evaluate the extent of radiation levels, 1 concentrations or quantities of radioactive material, and the potential radiological hazard that could be present. Specifically, the licensee did not make, or cause to be made, surveys necessary to prevent the loss of control of 3 to 6 millicuries of iodine-131 contaminated waste which was removed from a patient's room and placed in a hospital dumpster (located  ;

outside the facility) that was reserved for ordinary trash. (01023) ]

C. 10 CFR 20.1904 requires that the licensee ensure that each container of licensed material bear a durable, clearly visible label bearing the radiation symbol and the words " CAUTION, RADIOACTIVE MATERIAL" or " DANGER, RADIOACTIVE MATERIAL."

I NUREG-0940, PART 3 B-21 I

Enclosure 1 2 i

Contrary to the above, on or about December 9,1998, the licensee did not ensure that a 4 container of licensed material bore a durable, clearly visible label bearing the radiation i symbol and the words " CAUTION, RADIOACTIVE MATERIAL" or " DANGER, RADIOACTIVE MATERIAL." Specifically, a bag containing 3 to 6 millicuries ofiodine-131 contaminated waste was removed from a patient's room and was placed into a dumpster reserved for ordinary trash without the required labeling. (01033)

These violations are categorized in the aggregate as a Severity Level 111 problem (Supplements IV and VI).

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed on the docket in the licensee's letter, dated January 25,1999. The licensee informed the NRC in a February 5,1999 telephone conversation, that all actions would be completed by February 28, 1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice),

if you choose to respond, your response will be placed in the NRC Public Document Room (PDR).

Therefore, to the extent possible, the response should not include any pemonal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Dated at King of Prussia, Pennsylvania this yM day of February 1999 NUREG-0940, PART 3 B-22

r

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UNII EU SI At 29 (p" "*

• ut,A NUCLEAR RECULATORY COMMISSION S REGloN lli E E 801 WARRENvlLLE ROAD UsLE. ILUNols 60532-4351 June 25, 1999 EA 99-107 Mr. Steven M. Elliot, P.E., President Material Testing Consultants, Inc.

693 Plymouth NE Grand Rapids, MI 49505

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-13918/99001(DNMS)

Dear Mr. Elliot:

This refers to the special inspection conducted on April 22,1999, at Materials Testing Consultants, Inc. (MTC)in Grand Rapids, Michigan. The purpose of the inspection was to review an incident involving the loss of a moisture-density gauge on April 9,1999. As a result, two apparent violations of NRC requirements were identified and considered for escalated enforcement as discussed in our letter to you dated May 13,1999. In that letter you were provided an opportunity to either discuss this case and the apparent violations at a predecisional enforcement conference or address the apparent violations in writing. You elected to provide a written response.

Based on the information developed during the inspection and the information provided in your letter dated June 10,1999, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detailin the subject inspection report.

On April 9,1999, a moisture density gauge containing a nominal 8 millicuries (0.30 GBq) cesium-137 and 40 millicuries (1.48 GBq) americium-241 sealed sources fell from a MTC truck during transport on a public highway. When the operator discovered that the device was missing, he retraced his route to look for the gauge, however, the device was gone. Neither the police nor your staff have located the lost gauge. The primary cause of the event was the failure of the operator to fully implement the MTC's operating procedures and NRC regulations by not securing the device to the vehicle and by not closing the truck tailgate. Incumbent upon each NRC licensee and its employees is the responsibility to protect public health and safety by ensuring that all NRC requirements are met, and in particular, that NRC licensed material is controlled so that it is not lost or damaged and does not constitute a hazard to the public.

Therefore, these violations are classified in the aggregate in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy),

NUREG-1600, as a Severity Levelill problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level 111 problem. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI B.2 of the Enforcement Policy. In this case, NRC determined that credit NUREG-0940, PART 3 B-23

S. Elliot was warranted based on the following prompt and comprehensive corrective actions: (1) a safety review meeting was held with all authorized gauge users to discuss the incident and to review security, control and transport procedures; (2) the operator was reprimanded and placed en probationary work status for three months; and (3) management increased its supervision of licensed activities to emphasize the importance of maintaining control of licensed material.

Therefore, to encourage prompt and comprehensive corrective actions, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty, in addition, issuance of this Severity Levelill violation constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed in your letter dated June 10,1999. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additionalinformation, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, the enclosed Notice, and your response if you choose to respond, will be placed in the NRC Public Document Room.

Sincerely,

,1 M

J E. Dyer egional Administrator Docket No. 030-13918 License No. 21-15281-02

Enclosure:

Notice of Violation NUREG-0940, PART 3 B-24 l

1 NOTICE OF VIOLATION Material Testing Consultants, Inc. Docket No. 030-13918 Grand Rapids, Michigan License No. 21-15281-02 EA 99-107 During an NRC inspection conducted on April 22,1999, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

1 10 CFR 20.1801 requires, in part, that the licensee secure from unauthorized removal or access licensed materials that are stored in unrestricted areas.10 CFR 20.1802 requires, in part, that the licensee control and maintain constant surveillance of licensed material that is in an unrestricted area and that is not in storage. As defined in 10 CFR l 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on April 9,1999, the licensee did not secure from unauthorized removal, limit access to, nor control and maintain constant surveillance of licensed materialin an unrestricted area. Specifically, during transportation a Troxler moisture j density gauge containing a nominal 8 millicuries (0.3 GBq) of cesium-137 and I 40 millicuries (1.48 GBq) of americium-241 fell from a MTC vehicle and was lost on a public highway in Grand Rapids, Michigan. (01013)

2. 10 CFR 71.5(a) requires that a licensee who transports licensed materials outside of the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transport (DOT) in 49 CFR Parts 170 through 189.

49 CFR 177.834(a) requires, in part, that packaging not permanently attached to the motor vehicle and containing radioactive material must be secured against movement within the vehicle on which it is being transported, under conditions normally incident to transportation.

Contrary to the above, on April 9,1999, the licensee transported a Troxler moisture density gauge containing 8 millicuries (0.3 GBq) of cesium-137 and 40 millicuries (1.48 GBq) of americium-241, on public highway and the package was not secured against movement within the vehicle. Specifically, the device was not chained and/or braced to withstand conditions normally incident to transportation. (01023)

This is a Severity Level 111 problem (Supplements IV & V).

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed in a letter from Material Testing Consultants, Inc. dated June 10,1999.

However, you are required to respond to the provisions of 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and NUREG-0940, PART 3 B-25

Notice of Violation i send it to the U. S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region Ill,

{

801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter 1 transmitting this Notice of Violation. 1 Dated at Lisle, Illinois this 25th day of June 1999

{

l NUREG-0940, PART 3 B-26 l l

p~% umaeuu m em

[ t NUCLEAR REGULATORY COMMISSION E ll j REGION IV

[ 611 RYAN PLAZA DRIVE, SUITE 400

,,,,. ARLINGTON, TEXAS 76011-8064 January 28, 1999 EA 98-527 Mr. David O. Cram, General Manager Materials Testing & Inspection, Inc.

7446 W. Lemhi Street Boise, Idaho 83709

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-33699/98-01)

Dear Mr. Cram:

This refers to the inspection conducted on October 26-30,1998, at your facility in Idaho Falls, Idaho. The purpose of the inspection was to review the circumstances surrounding two nuclear gauges owned by Materials Testing & Inspection, Inc., which were found in a residential area on September 27,1998. The results of the inspection were discussed with you by telephone on December 18,1998, and were described in NRC Inspection Report No. 030-33699/98-01 issued on January 5,1999. The NRC informed you that it was considering escalated enforcement action for an apparent violation identified during the inspection. You elected to respond to the apparent violation in writing in lieu of requesting a predecisional enforcement conference.

Based on the information developed during the inspection and the information that you provided in your response letter dated January 21,1999, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report.

This violation involved two portable gauges left unlocked and unsecured overnight in the bed of a pickup truck parked in a residential driveway, and then in a residential garage the following day and night. The root cause of the violation is considered to be a lack of appreciation of the importance of maintaining security of licensed material.

This incident represents a significant f ailure to control licensed material. Your failure to secure or maintain constant surveillance over the gauges had the potential to result in the theft of the gauges and in unnecessary radiation exposure to members of the general public. Therefore, this violation has been categorized in accordance with the " General Statement of Policy and I

Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level Ill.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level lil violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. As described in NRC Inspection Report 030-33699/98-01, your immediate corrective actions included locking the gauge cases and returning them to a storage cabinet at your facility, in your response letter, you discussed three

' additional immediate corrective actions which included: (a) having an independent consultant NUREG-0940, PART 3 B-27

Materials Testing & Inspection, Inc. I audit your portable nuclear gauge program at your Boise, Idaho office and sharing the results with your other offices, (b) disciplining the responsible individual, and (c) briefing your Idaho Falls personnel on the specit.'cs of the incident and your license and procedural requirements.

Your long-term corrective actions included: (a) refresher training on radiation safety and Department of Transportation requirements, and radiation safety officer training, (b) conducting field audits on all gauge operators, and (c) committing to make changes to your procedures as recommended by the independent consultant. Due to the thoroughness of your corrective actions, the NRC concluded that credit for corrective actions was warranted.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level lli violation constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in NRC Inspection Report 030-33699/98-01 and your letter dated January 21,1999. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this ietter, its enclosure, and your response, if you so chose, will be placed in the NRC Public Document Room.

Sincerely, Ellis W. Mersch Regional Administrator Docket No. 030-33699 License No. 11-27504-01

Enclosure:

Notice of Violation cc (w/ encl):

Idaho Radiation Control Program Director i t

I NUREG-0940, PART 3 B-28

ENCLOSURE NOTICE OF VIOLATION Materials Testing & Inspection, Inc. Docket No. 030-33699 l License No. 11-27504-01 l Boise, Idaho 83709 EA 98-527 I l

During an NRC inspection completed on December 18,1998, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC j Enforcement Actions," NUREG 1600, the violation is listed below.

1 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access )

licensed materic 's that are stored in controlled or unrestricted areas.10 CFR 20.1802 l requires that the licensee control and maintain constant surveillance of licensed material j that is in a controlled or unrestricted area and that is not in storage. As defined in i 10 CFR 20.1003, controlledarea means an area, outside of a restricted area but inside I the site boundary, access to which can be limited by the licensee for any reason; and '

unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on September 25 27,1998, the licensee did not secure from unauthorized removal or limit access to two portable moisture / density gauges containing  :

licensed material located in unrestricted areas in Idaho Falls, Idaho, nor did the licensee control and maintain constant surveillance of this licensed material. This material I consisted of 0.3 gigabecquerels (8 millicuries) of cesium-137 and 1.48 gigabecquereis (40 millicuries) of americium-241 in one gauge, and 0.37 gigabecquerels (10 millicuries) of cesium-137 and 1.85 gigabecquerels (50 millicuries) of americium-241 in the other gauge. Specifically, the gauges were stored in unlocked cases in the back of a pickup truck in the driveway of a private residence on September 25 and in an unattached garage of a private residence on September 26-27,1998. (01013)

This is a Severity Level ill violation (Supplement IV).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in NRC Inspection Report No. 030-33699/98-01, and in your letter dated January 21,1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that ,

case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of l Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region IV,611 Ryan Plazc Drive, Suite 400, Arlington, Texas 76011, within 30 days of the date of the letter ,

transmitting this Notice of Violation (Notice). l If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001. l l

NUREG-0940, PART 3 B-29 I

2-Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation, if you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, i proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you mug specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information), if safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 28* day of January 1999 l

NUREG-0940, PART 3 B-30 l l

I l

w "-wu g UNITED STATES

[ g NUCLEAR REGULATORY COMMISSION E REGION 1 G

475 ALLENDALE ROAD '

[ KING OF PRUSSIA. PENNSYLVANIA 19406-1415 y ***** ,o I dune 17, 1999 EA 99-093

' John C. Carr, R.Ph.

Facility Manager .

Medi-Physics, Inc.

d.b.a. Nycomed Amersham Imaging One Naylon Place, Suite 3 Livingston, New Jersey 07039

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-31972/99-001) 1

Dear Mr. Carr:

'This refers to the NRC inspection conducted on April 6, 8, and 22,1999, at your facility in Livingston, New Jersey, to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. The inspection was conducted after the NRC was notified by Brick Hospital, Brick, New Jersey, that it had received a package of radioactive ,

I material from your facility on April 5,1999, with removable radioactive contamination on the outside of the package, dose rates as high as 960 millirem per hour on the surface of the package, and 1 dose rates as high as approximately 19 millirem per hour at one meter from the surface. On  !

May 14,1999, the NRC sent you the inspection report which described four apparent violations.

The letter transmitting that report also indicated that it may not be necessary to conduct a predecisional enforcement conference on this matter. In the attemative, you were provided an opportunity to provide a written response which you sent to us in a letter, dated June 4,1999.

Based on the information developed during the inspection and the information provided in your letter, three violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first violation involves your failure to ensure that the package offered for shipment to Brick Hospital was proper for the contents to be shipped. The package was not properly prepared in that a gasket and absorbent pad were missing in the primary shielding container.- The individual responsible for preparing the package did not recognize that the gasket and pad were missing. As a result, when a vial (containing radioactive technetium-99m) cracked sometime after initial packaging and final survey, the contents leaked beyond the initial container. The other violations involve the failure to properly label the package, and the failure to ensure radiation and contamination levels at the package surface were within the regulatory limits.

Although subsequent follow-up indicates that there does not appear to have been any exposures to individuals as result of these violations, the violations are significant because the package, contained approximately one curie of technetium-99m in a vial and a syringe, as well as a vial of lodine-123 regulated by the State of New Jersey. The failure to properly package these radioactive materials created the potential for unnecessary exposure to any individual handling, or in close NUREG 0940, PART 3 B-31 l

l

Medi-Physics, Inc. 2 proximity to the package between the time it left your facility at 4:50 a.m. on April 5,1999, and the time it arrived at Brick Hospital, approximately two hours later. Therefore, the violations collectively represent a Severity Level lil problem in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level lli violation or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These actions, which were described in your June 4,1999, letter to the NRC, include, but are not limited to: (1) use of additional packaging to minimize the potential for damage to glass containers during transport; (2) a full inspection of the existing inventory of all such glass containers, with plans to eventually discontinue use of such containers; (3) additional training of all pharmacy staff members responsible for transportation of radioactive material; and (4) a review of this event with all staff, as well as with management of all of your other facilities.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, is already adequately addressed on the docket in your June 4,1999 letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosures, will be placed in the NRC Public Document Room (PDR).

Sincerely, ,

Hubert J. Miller Regional Administrator Docket No. 030-31972 License No. 29-28341-02MD

Enclosure:

Notice of Violation cc w/ encl:

State of Connecticut NUREG-0940, PART 3 ' B-32

ENCLOSURE NOTICE OF VIOLATION Medi-Physics, Inc., d.b.a. Nycomed Docket No. 030-31972 i Amersham Imaging License No. 29-28341-02MD Livingston, New Jersey EA 99-093 During an NRC inspection conducted on April 6,8, and 22,1999, violations of NRC requirements j were identified in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG -1600, the violations are listed below:

10 CFR 71.5 requires, in part, that each licensee who transports licensed material outside the site of usage, as specified in the NRC license, comply with the applicable requirements of the DOT regulations in 49 CFR Parts 170 through 189 appropriate to the mode of transport.

A. 49 CFR 173.475(a) requires, in part, that before each shipment of any Class 7 (radioactive) materials package, the offerer must ensure the packaging is proper for the content to be shipped.

49 CFR 173.475(c) requires, in part, that before each shipment of any Class 7 ,

(radioactive) materials package, the offerer must ensure that each closure device j of the packaging, including any required gasket, is properly installed, secured, and free of defects.

Contrary to the above, on April 5,1999, the licensee shipped a Type A package to Brick Hospital, in Brick, New Jersey, and prior to the shipment, the licensee did not ensure the packaging was proper for the content to be shipped. Specifically, the i 1

package, which contained a glass vial holding in excess of one curie of technetium-99m in solution, included neither the required gasket nor the required absorbent pad.

(01013)

B. 49 CFR 172.403(a) states, in part, that each package of radioactive material must be labeled as provided in 49 CFR 172.403(c).

-49 CFR 172.403(c) specifies radiation levels at any point on the surface of a Yellow ll labeled package must be less than or equal to 50 mrem /hr.

Contrary to the above, on April 5,1999, the licensee did not label a package of radioactive material as provided in 49 CFR 172.403(c). Specifically, the package was labeled as Yellow II, and the radiation levels at the surface of the package were as high as 960 mrem /hr upon its arrival at Brick Hospital, in Brick, New Jersey.

(01023)

C. 49 CFR 173.443 (b) states, in part, that in case of packages transported as exclusive use shipments by public highway only, the removable (non-fixed) radioactive contamination on any package at any time during transport may not exceed ten times the levels prescribed in Table 11 of 49 CFR 173.443(a).

NUREG-0940, PART 3 B 33

Enclosure 2-Contrary to the above, on April 5,1999, the licensee transported a package of radioactive material as an exclusive use shipment by public highway to Brick Hospital, Brick, New Jersey, and the removable (non-fixed) contamination on the package during the transport exceeded ten times the levels prescribed in Table 11 of 49 CFR 173.443(a). Specifically, the licensee transported a package containing i the gamma emitter technetium-99m as an exclusive use shipment and the removable contamination on the external surface of the package was 269 dpm/cm ,

f which is in excess of 220 dpm/cmr (ten times the level prescribed in Table 11).

(01033)

These violations are categorized in the aggregate as a Severity Level 111 problem (Supplements IV and VI).

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed on the docket in your letter, dated June 4,1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly maric your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR).

Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.

Dated this 17thday of June 1999 NUREG-0940, PART 3 B-34

@M%

' 9 UNITED STATES h NUCLEAR REGULATORY COMMISSION

' [ REGloN I

$ j

• 475 ALLENDALE ROAD jd,# KING oF PRUSSIA, PENNSYLVANIA 19406-1415

• • • • • May 11, 1999-EA 99-096 Mr. Frank J. Bachich Vice President Philadelphia Health and Education Corporation clo Drexel University 3141 Chestnut Street Philadelphia, Pennsylvania 19104 {

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-12998/99-001)

Dear Mr. Bachich:

This refers to the NRC inspection conducted on April 7 and 9,1999, at your facilities located at 3200 Henry Avenue; 3300 Henry Avenue; 2900 Queen Lane; and St. Christopher's Hospital for Children, Erie Avenue at Front Street, to determine whether activities authorized by your NRC license were conducted safely and in accordance with NRC requirements. The inspection consisted of observations by the inspector, interviews with personnel, and a selected examination of representative records. At the conclusien of the inspection, the findings were discussed with William Van Decker, M.D., Theodore Villafana, Ph.D., and other members of your organization.

During the inspection, the NRC reviewed the circumstances associated with an apparent violation involving the use of licensed material by an unauthorized individual in 1996. Based on our review of the inspection findings and your corrective actions described during the inspection, the NRC has concluded that we have sufficient information to make an enforcement decision without the need for a predecisional enforcement conference. During a telephone conversation on April 27,1999, Dr. Mohamed Shanbaky of my staff informed you I that the NRC was considering the apparent violation for escalated enforcement action in accordance with the " General Statement of Policy and Procedure for NRC Enforcement l l

Actions" (Enforcement Policy), NUREG-1600 and offered you an opportunity to respond to the apparent violation either in writing or at a predecisional enforcement conference. In a j

telephone conversation on April 29,1999, you informed Dr. Shanbaky that you did not believe that a written response or predecisional enforcement conference was necessary prior to the NRC making an enforcement decision.

Based on review of the information developed during the inspection, the NRC has determined that three violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice). The significance of these violations and the need for lasting and effective corrective action were discussed with members of your staff at the inspection exit 4

meeting on April 9,1999.

NUREG-0940, PART 3 B-35

i i

PhilId:lphia Hselth cnd Educstion 2 Corporation  !

The most significant of these violations involved the use of approximately 2 millicuries of iodine 125 (1-125) by an untrained, unsupervised, and unauthorized individual during a laboratory experiment on October 16,1996. Your staff identified the violation the following day and performed bioassays for the Principal Investigator (Pl), a trained researcher, and the untrained individual. The bioassays indicated no uptake of I-125. Although there were no actual safety consequences as a result of the unauthorized use of licensed material, there was a significant potential for contamination or inadvertent radiation exposure to the untrained individual or other individuals. Therefore, the violation, which is cited in Section A of the enclosed Notice, is classified at Severity Level 111 in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Levellli violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Conective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective achns were considered prompt and comprehensive. These actions included, but were not limited to: (1) immediately shutting down the laboratory and investigating the incident; (2) prohibiting the authorized user (PI and/or researcher] from conducting experiments until the investigation was completed; (3) training of the laboratory staff to emphasize their responsibilities for safe use of radioactive material; and (4) review of the operations of other laboratories for similar problem':.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Severity Level lli violation constitutes escalated enforcement action, that may subject you to increased l inspection effort.

In addition to the violation set forth in Section A of the enclosed Notice, during a December 1998 audit, your staff identified that your Pls were not providing inventory reports of licensed materials to the Radiation Safety Office in a timely manner. Although you identified this problem, your corrective actions for this deficiency were apparently not effective because the NRC identified that inventory reports for the first quarter of 1999 were not submitted for all laboratories at the time of the inspection. Therefore, this violation, which is categorized at Severity LevelIV in accordance of the Enforcement Policy, is cited in Section 8 of the enclosed

{

Notice. Additionally, the inspector identified that you failed to obtain swipe tests of storage l areas at least quarterly. This violation, which is also categorized at Severity Level IV, is also l cited in Section B of the enclosed Notice. j With respect to the violation cited in Section A of the enclosed Notice, the NRC has concluded that the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved are already l

adequately documented herein. Therefore, you are not required to respond to this violation i unless our understanding does not accurately reflect your corrective actions or your position.

In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

NUREG-0940, PART 3 B-36

Philadelphia Health and Education 3 Corporation You are required to respond to tho violations cited in Section B of the enclosed Notice and should follow the instructions specified in the enclosed Notice when preparing your response. #

The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements. ,

in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).

Sincerely, j Q iM Hubert J. Miller '

Regional Administrator Docket No. 030-12998 License No. 37-07438-15

Enclosure:

Notice of Violation oc w/ encl:

Theodore Villafana, Ph.D., Radiation Safety Officer William Van Decker, M.D., Chairman, RSC Eric Cottington, Associate VP - Research Operations Commonwealth of Pennsylvania l

l NUREG-0940, PART 3 B-37

l 1

ENCLOSURE NOTICE OF VIOLATION Philadelphia Health & Education Corporation Docket No. 030-12998 Philadelphia, PA License No. 37-07438-15 EA 99-096 During an NRC inspection conducted on April 7 and 9,1999, three violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are listed below:

A. Condition 11.A of License No. 37-07438-15 requires that licensed material be used by, or under the supervision of, individuals designated in writing by the Radiation Safety Committee. Condition 23 of License No. 37-07438-15 requires, in part, that the licensee conduct its program in accordance with the statements, representations and procedures contained in a letter dated September 23,1994. Item 1 of Supplement B of the letter dated September 23,1994, requires that a designated supervisor assure that any new worker receives orientation. Specifically, the supervisor is to introduce the new worker to radiation safety practices as well as necessary documentation procedures.

Contrary to the above, on October 16, 1996, licensed material was used by an individual who was neither designated in writing by the Radiation Safety Committee, nor under the supervision of an individual designated in writing by the Radiation Safety Committee, and the supervisor of the individual did not assure that the new worker received orientation. Specifically, an individual used about 2 millicuries of iodine-125 in a laboratory experiment without proper authorization or supervision, and the individual had not received initial radiation safety training from a licensed user or the Radiation Safety staff. (01013)

This is a Severity Level lli violation (Supplement VI).

B. Condition 23 of License No. 37-07438-15 requires, in part, that the licensee conduct its program in accordance with the statements, representations and procedures contained in the application received on August 4,1993.

1. Item IV.B. of the nadiation Safety Manual attached to the application received on August 4,1993, requires, in part, that the licensed users provide the Radiation Safety Office with monthly updates of the receipt, use and disposal of radioactive materials.

NUREG-0940, PART 3 B-38 l

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. I Contrary to the above, as of April 9,1999, licensed users did not provide the Radiation Safety Office (RS Of fice) with monthly updates of the receipt, use and disposal of radioactive materials. Specifically, as of April 9,1999, inventory reports for the months of January, February, and March 1999 had not been submitted for alllaboratories. (02014)

This is a Severity Level IV violation (Supplement VI).

2. Item B.8 of Supplement G of the Radiation Safety Manual enclosed with the application received on August 4,1993, requires, in part, that waste storage areas are to have a swipe test obtained no less than quarterly.

Contrary to the above, as of April 9,1999, the licensee had not obtained swipe tests of the storage areas no less than quarterly. Specifically, as of April 9, 1999, the swipe tests had not been obtained since July 1998, an interval greater than quarterly. (03014)

This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that information regarding the reason for Violation A, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed in the letter transmitting this NOV. Therefore, you are not required to provide a response for Violation A. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position regarding Violation A. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of  ;

Violation (Notice).

i With regard to the violations in Section B, pursuant to.the provisions of 10 CFR 2.201, Philadelphia Health and Education Corporation is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for Violations B.1 and 8.2: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence,if the correspondence adequately addresses the required response.

If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken.

Where good cause is shown, consideration will be given to extending the response time.

NUREG-0940, PART 3 B-39

Enclosure 3 l If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555 0001.

Your response will be placed in the NRC Public Document Room (PDR); therefore, to the extent possible, it should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information

. required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated at King of Prussia, PA this ll A day of May 1999 l

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May 21, 1999 EA 99-123 Joseph Backer, Ph.D.

CEO SibTech, Inc.

P.O. Box 579 Elmsford, NY 10523-0579

SUBJECT:

NOTICE OF VIOLATION (NRC Office of Investigations Report No.1-98-035)

Dear Dr. Backer:

This refers to the investigation conducted by the NRC Office of Investigations (OI) to determine if SibTech, Inc. (SibTech) knowingly engaged in the import and distribution of byproduct (radioactive) materials without a license. A copy of the Ol synopsis is enclosed. Based on its investigation, Of concluded that you, as the Chief Executive Officer (CEO) of SibTech, imported and transferred byproduct material both domestically and intemationally from 1993-1995 without a license, and distributed byproduct material to others from 1995-1998. 01 did not substantiate that you deliberately violated the NRC regulations.

While most of these activities were conducted from the New York Medical College (NYMC) located in Valhalla, New York, which is under the jurisdiction of the State of New York, a NRC Agreement State, you acknowledged, during the investigation, that you had taken byproduct material as tritiated compounds to your former home in Tenafly, New Jersey (a location under NRC Jurisdiction) during 1993-1995. Although you also indicated that you only repackaged the compounds at that location, your actions, nonetheless, violated NRC requirements since you received, possessed, and transferred NRC licensable radioactive materials in New Jersey without an NRC license. The vio!ation is described in the enclosed Notice of Violation (Notice).

The circumstances surrounding this violation, its significance, and the need for lasting corrective actions were discussed with you during a telephone conversation with Ms. Judy Joustra, NRC Region 1, on May 12,1999. During that call, you stated that you (1) admit that you violated an NRC requirement, (2) did not do so deliberately, (3) had stopped the activities that constituted the violation, and (4) had taken action to preclude the violation from happening again by applying for an NRC license on June 18,1998. During that call, you were informed that while the NRC was considering escalated enforcement action for this violation, it may not be necessary to conduct an Pradecisional Enforcement Conference since the NRC has an understanding of your corrective action. You indicated that you also did not see the need for a conference.

By possessing material in New Jersey without having an NRC license to do so, you operated outside the regulatory framework established to assure that the possession, use, and distribution NUREG-0940, PART 3 B-41

SibTech, Inc. 2 of radioactive materials do not adversely affect public health and safety. As such, the NRC was unable to conduct inspections to verify whether the methods and controls you established for possessing, using, and distributing radioactive ,naterials were in accordance with regulatory requirements established to protect public health and safety. Given the importance of proper i controls over the possession, use, and distribution of radioactive material, the violation is classified l at Severity Level ill in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600.

i in accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is  !

considered for a Severity Level til violation. Since your company has not been the subject of any )

escalated enforcement action in the past, the NRC considered whether credit was warranted for i Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the i Enforcement Policy. Credit for corrective actions is warranted because your corrective action was considered prompt and comprehensive at the time the 01 report was issued. This action consisted of filing of an application to possess and use such material in the State of Connecticut (a location under NRC jurisdiction). Therefore, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in escalated enforcement action.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should also address (1) what actions you have taken to ensure that there was no contamination at your former residence in Tenafly, New Jersey; and (2) why the NRC should have confidence that you will continue to comply with NRC requirements in the future. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements and to decide on the appropriate action on your application for an NRC license.

The 01 findings also indicate that you performed activities in New York (at NYMC and your current residence in Mount Kisco) which may be violations of New York State requirements, including the j New York State license issued to NYMC. Therefore, a copy of this letter, the attached Notice of Violation, and the Ol synopsis, will be forwarded to the State of New York for whatever action it deems appropriate.

In accordance with Section 2.790 of NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and your reply will be placed in the Public Document Room (PDR).

Your cooperation with us is appreciated.

Sincerely, i ubert J. Miller Regional Administrator i i

NUREG-0940, PART 3 B-42 l

1

P SibTech, Inc. 3

Enclosures:

1. Notice of Violation

2. 01 Synopsis cc:

State of New York State of New Jersey State of Connecticut New York Medical College NUREG-0940, PART 3 B-43

ENCLOSURE 1 NOTICE OF VIOLATION SibTech, Inc. EA 99-123

, Elmsford, NY i

During an NRC investigation conducted by the NRC Office of Investigations (01), a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions,"(Enforcement Policy), NUREG-1600, the violation is listed below:

10 CFR 30.3 requires, in part, that except for persons exempt, no person shall produce, transfer, receive, acquire, own, or possess byproduct material except as authorized in a specific or generailicense issued pursuant to Title 10, Chapter, Code of Federal Regulations.

Contrary to the above, between 1993-1995, SibTech, Inc. transferred, received, acquired, owned and possessed millicurie amounts of tritiated (H-3) compounds at the then private residence of the SibTech Chief Executive Officer in Tenafly, New Jersey, and at the time, SibTech did not possess a valid NRC license to do so, and SibTech, Inc. was not exempt from the requirements for a license.

This is a Severity Level til violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.2001, SibTech, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrater, Region 1, within 30 days ,

of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

NUREG-0940, PART 3 B-44

Enclosure 1 2 Under the authority of Section 182 of the Act,42 U.S.C. 2232, your response shall be submitted under oath or affirmation.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, youmust specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of 5 personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

Dated agKing of Prussia, PA This L day of May 1999 NUREG-0940, PART 3 B-45 l

ENCLOSURE 2 SYNOPSIS -

This investigation was initiated on August 3,1998, by the Nuclear Regulatory Commission (NRC), Office ofinvestigations (01), Region I, to determine if SibTech, Inc. (SI), an NRC licensee applicant, knowingly engaged in the importation and distribution of byproduct materials - --

without an NRC Materials License.

Based on the evidence developed during this investigation, OI concludes that the Chief Executive Officer (CEO) of SI, imported and transferred byproduct material both domestically and intemationally from 1993 to 1995, without an NRC Materials License. Further, SI distributed byproduct material from 1995-1998, with the tritiation activities being conducted at NYMC.

However, OI could not substantiate that SI or the CEO deliberately violated NRC regulations requiring the possession of an NRC materials license to import and transfer byproduct material.

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[ *g NUCLEAR REGULATORY COMMISSION b f REGloN iv 611 RYAN PLAZA DRIVE, sulTE 400

%,g ARLINGTON, TEXAS 76011-8064 February 25,1999 EA 98-475 Peter Moss, President Tulsa Gamma Ray, Inc.

1127 South Lewis Avenue Tulsa, Oklahoma 74101

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT 030-12319/98-01)

Dear Mr. Moss:

This refers to your letter dated January 28,1999, in response to an apparent violation identified in the subject inspection report dated January 5,1999. The inspection was conducted at your Tulsa, Oklahoma facility on September 4 through December 14,1998, in response to Tulsa Gamma Ray's (TGR) notification of two radiation exposures in excess of NRC limits. The first involved a 30-day written report dated August 14,1998, in accordance with 10 CFR 20.2203, regarding a radiographer who had received a total effective dose equivalent (TEDE) of 2.95 rem in June 1998, which resulted in a total TEDE of 5.64 rem for calendar year 1998. The second involved telephone notification on September 2,1998 that a radiographer's assistant film badge had received 7.56 rems for July 1998. An exit briefing was conducted by telephone on December 14,1998, and Inspection Report 030-12319/98-01 was issued on January 5, 1999.

During the exit briefing, we informed TGR of our conclusion that the 7.56 rem reported dose to the radiographer's assistant did not represent the dose received by him (we concluded he was not wearing his film badge when the badge was exposed). Also, we informed TGR that the NRC considered the 2.95 rem received by the radiographer to be a valid exposure and, as a result, we were considering escalated enforcement action for an apparent violation of 10 CFR 20.1201. Prior to making a final enforcement decision, we provided TGR with the opportunity to either request a predecisional enforcement conference or respond to the apparent violation in writing. TGR elected to respond to the apparent violation by letter dated January 28,1999 from Mr. Daniel E. Potter.

In its January 28,1999 letter, TGR disputed the apparent violation. TGR's position was that the radiation dose received on film badge #170 was not an occupational dose (that the individual was not wearing the badge when it was exposed). The bases for the conclusion were as follows: the radiographer's dosimeter never went off scale and his alarm rate meter did not sound excessively; other radiographers that worked with him did not have excessive exposures; detection equipment was examined and functioned normally; there have been questionable film badge results with variations as much as 30%; and while noting that film badges were uncontrolled, TGR raised the possibility that someone may have overexposed the badge.

Before concluding that an individual did not receive the dose reported from his film badge, a licensee must show that the badge was exposed at a time when the individual was not wearing NUREG-0940, PART 3 B-47

Tulsa Gamma Ray, Inc. the badge or that the badge was not processed correctly by the film badge vendor. We acknowledge that TGR's initial investigation (documented in the inspection report) was reasonable and that it could not determine the cause for the high radiation dose. Further, we acknowledge that, as a result of further investigation, TGR's position is that the individual did ,

not receive an overexposure. However, after reviewing the information TGR provided, the NRC i does not find a sufficient basis to conclude that the badge was exposed when the individual was not wearing it or that the film badge vendor did not properly process the badge. Therefore, the NRC accepts the badge results of 2.95 rem as a valid indication of the exposure to the individual during the monitoring period in question. As a result, the individual's exposure for I calendar year 1998 was 5.64 rem, which constitutes a violation of 10 CFR 20.1201 in that TGR l

did not limit the individual's dose to 5 rem during calendar year 1998. This violation has been  ;

categorized in accordance with the " General Statement of Policy and Procedure for NRC l Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level lli.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $5,500 is considered for a Severity Level ll1 violation. Because your facility has not been the subject of '

escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment ,

process in Section VI.B.2 of the Enforcement Policy. TGR's corrective actions included i conducting an investigation, removing the radiographer from work involving further radiation I exposures, developing administrative actions when an employee's annual dose exceeds certain predetermined values, revising procedures for issuing and receiving film badges, and requiring closer observations of employee dose reports to better control annual exposures. As a result, the NRC has concluded that TGR is deserving of corrective action credit.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level ill violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

TGR's January 28,1999 letter stated that TGR intended to request that the film badge processer correct the dose to reflect 211 mrem, not 2950 mrem for the exposure period in question. Given the NRC's decision in this matter, modification of the individual's dose would be inappropriate. TGR should take appropriate actions to ensure that the dose records for the individual reflect the 2950 mrem dose for this monitoring period.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in the subject inspection report and in TGR's January 28,1999, letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

NUREG-0940, PART 3 B-48 l

Tulsa Gamma Ray, Inc. In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to respond, will be placed in the NRC Public Document Room.

Sincerely,

\ ORIGINAL SIGNED BY Ellis W. Merschoff\

Ellis W. Merschoff Regional Administrator Docket No. 030-12319 License No. 35-17178-01

Enclosure:

Notice of Violation cc (w/ encl):

Oklahoma Radiation Control Program Director NUREG-0940, PART 3 B-49

ENCLOSURE NOTICE OF VIOLATION Tulsa Gamma Ray, Inc. Docket No. 030-12319 Tulsa, Oklahoma License No. 35-17178-01 EA 98-475 During an NRC inspection conducted on September 4 through December 14,1998, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 20.1201(a)(1)(i) requires, with exceptions not applicable here, that the licensee control the occupational dose to individual adults to an annual dose limit of 5 rems total effective dose equivalent.

Contrary to the above, the licensee did not limit the annual occupational dose to an adult industrial radiographer to 5 rems, total effective dose equivalent. Specifically, the adult radiographer received 5.64 rems total effec *ive dose equivalent for calendar year 1998.

(01013)

This is a Severity Level lli violation (Supplement IV).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in inspection Report No. 030-12319/98-01, and the Licensee's letter dated January 28,1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region IV,611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of the Act,42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy,

- proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you musf specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding NUREG-0940, PART 3 B-50

(e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 25th day of February 1999 NUREG-0940, PART 3 B-51

1. 8 4%,# UNITED STATES

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{<, ATLAN1 A. GEORGIA 30303-3415 ens January 15, 1999 EA 98-545 United States Environmental Protection Agency ATTN: Mr. Edwin L. Sensintaffar, Acting Director National Air and Radiation Environmental Laboratory 390 South Morris Avenue Montgomery, AL 36115-2601

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 030-03576/98-01)

Dear Mr. Sensintaffer:

This refers to the inspection conducted on November 19 and 20,1998, at the United States Environmental Protection Agency's National Air and Radiation Environmental Laboratory (NAREL)in Montgomery, Alabama. The purpose of the inspection was to follow up on the loss of a 0.1 microcurie (uCi) plutonium 239 (Pu-239) source that was discovered missing on September 29,1998, by the licensee's Radiation Protection Officer (RPO) during a routine inventory of radioactive material possessed under the Nuclear Regulatory Commission (NRC) license. NAREL reported the missing licensed material to the NRC on October 29,1998. The results of the inspection were formally transmitted to you by letter dated December 10,1998.

That letter also provided you the opportunity to respond to the apparent violations or request a predecisional enforcement conference. By letter dated January 5,1999, you responded to the ,

apparent violations and addressed the root causes and your corrective actions to prevent recurrence. We have reviewed the inspection results and the additionalinformation you provided and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.

Based on the information developed during the inspection and the information that was provided in your January 5,1999, response, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.

Violation A involves two examples: failure to secure licensed materials from unauthorized removal or access, including the loss of the 0.1 Ci Pu-239 source, and failure to implement adequate controls of licensed material in controlled or unrestricted areas. The lack of adequate controls included unauthorized keycard access, master key distribution to unauthorized individuals, and the bypassing of the keycard security system by propping open doors.

Although the circumstances surrounding the unaccounted for Pu-239 source are indeterminate, the inadequate security controls may have contributed to the loss.

The 0.1 Ci of Pu-239 was 100 times the limit set forth in 10 CFR Part 20, Appendix C. Other rnaterials located in the room where the Pu-239 source was stored also contained various isotopes in quantities ranging from 10 to 2,200 times the applicable limit. Accordingly, the failure to secure, maintain constant surveillance and restrict access to licensed material constitutes a significant concern that could have caused unprotected personnel to be exposed to radioactive materials. In addition, review of your Radiation Protection Committee meeting NUREG-0940, PART 3 B-52 I

US EPA 2 minutes indicated that in March 1995, the RPO had previously identified and discussed a problem concerning licensee staff propping open doors to bypass the keycard security system.

It was determined that your corrective actions for this problem, which consisted of reminding staff not to prop open doors, were inadequate and failed to assure that the staff did not bypass building security. In addition, routine oversight activities by the RPO failed to adequately identify subsequent security deficiencies. The failure to take adequate corrective actions for

, your own previously identified security issues together with the multiple examples of failure to maintain security of controlled areas appears to be indicative of a programmatic failure to implement effective security for licensed materials. Therefore, the violation has been categorized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Action"(Enforcement Policy), NUREG-1600 st Severity Level 111.

Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.B.2 o.' the Enforcement Policy. Your corrective actions included (1) the realignment of the RPO fu the Office of the Director for NAREL; (2) the RPO's full time assignment and commitment to the NAREL radiation safety program; (3) the re-keying of the lock on the radioactive waste storage building so that the NAREL master key cannot be used to gain access to the room; (4) the granting of keycard access only to authorized licensee personnel; (5) the repairing of the main entry access release button to control visitor access; and (6) the conduct of various meetings with laboratory personnel to discuss the corrective measures implemented.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

In addition, issuance of this Severity Level lil violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

In addition, Violation B involved your failure to perform at least annual reviews of the content and implementation of the radiation protection program. Violation B has been characterized as a Severity Level IV violation. Although the NRC was unable to connect the missed audits to the security issues, it is noted that the effective audits may have provided you an opportunity to identify the previously described security deficiencies earlier.

The NRC has concluded that information regarding the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the dates when full compliance was achieved are addressed on the docket in inspection Report No. 030-03576/98-01 and your January 5,1999, letter. Therefore, you are not required to respond to this letter unless the description therein does not adequately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

NUREG-0940, PART 3 B-53

US EPA 3 In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response, if any, will be placed in the NRC Public Document Room.

Sincerely, 1M $ $W

% Luis A. Reyes Regional Administrator Docket No. 030-03576 License No. 01-07317-01

Enclosure:

Notice of Violation cc w/ encl:

State of Alabama NUREG-0940, PART 3 B-54

y,

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NOTICE OF VIOLATION US Environmental Protection Agency Docket No. 030-03576 Montgomery, Alabama License No. 01-07317-01 EA 98-545 During an NRC specialinspection conducted on November 19 and 20,1998, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A. 10 CFR 20.1801 requires that licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.10 CFR 20.1802 further requires that licensees control and maintain constant surveillance of licensed material that is in a controlled or unrestricted areas and that is not in storage.

10 CFR 20.1003, defines the term " controlled area" as used in this part as an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.10 CFR 20.1003, defines the term " restricted area" as used in this part as an area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials.10 CFR 20.1003, defines the term " unrestricted area" as used in this part as an area, access to which is neither limited nor controlled by the license.

Condition 20 of NRC License No. 01-07317-01 requires that the licensee conduct its licensed program in accordance with the statements, representations, and procedures contained in various documents including the license renewal application dated October 24,1990. Section 9.1 of the application states that access will be controlled through tha use of an electronic key card reader system to limit access to radioactive material storage areas. Section 9.2 of the application specifically limits access to Room 215, the Quality Assurance /Ouality Control (OA/OC) Laboratory of the National Air and Radiation Environmental Laboratory to the OA/OC Officer, the RPO, the Assistant RPO, the Environmental Compliance Officer and an upper management person.

Contrary to the above, the licensee failed to comply with the requirements of 10 CFR 20.1801,10 CFR 20.1802, and Condition 20 of the License as evidenced by the following examples:

(1) Prior to September 29,1998, the licensee did not secure from unauthorized removal or access licensed materials that were stored in controlled or urnestricted areas. Specifically, the licensee did not secure Room 215, the OA/QC Laboratory, a room that contained 85 sources of 36 different radioactive isotopes. Subsequently, on September 29,1998, the licensee was unable to account for an ampute containing 0.1 microcuries of plutonium 239 which had been previously stored in the OA/QC Laboratory.

(2) Prior to September 29,1998, the licensee failed to limit access to radioactive material storage areas. Specifically, the licensee did not program the keycard NUREG-0940, PART 3 B-55 Enclosure

NOV 2 system or maintain control over master keys to ensure that access to the QA/QC Laboratory and other radioactive material storage areas was limited to those persons named in the license application. (01013)

This is a Severity Level lli violation (Supplement VI).

B. 10 CFR 20.1101(a) requires that each licensee develop, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of this part.10 CFR 20.1101(c) further requires that the licensee periodically (at least annually) review the radiation protection program content and implementation.

Contrary to the above, as of November 20,1998, the licensee did not review the content or implementation of its radiation safety program at least annually in 1994,1995, or in 1997. Specifically, the required reviews were not conducted. (02014)

This is a Severity Level IV violation (Supplement IV).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and date when full compliance was achieved is already adequately addressed on the docket in inspection Report No. 030-03576/98-01 and your January 5,1999, letter. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you chose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C.

20555 with a copy to the Regional Administrator, Region ll, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

l Under the authority of Section 182 of the Act,42 U.S.C. 2232, any response shall be submitted under oath or affirmation.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be place in the PDR without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 15 day of January 1999 at Atlanta, Georgia NUREG-0940, PART 3 B-56

UNITED STATES

1. pt# H49'o,, NUCLEAR REGULATORY COMMISSION

.8 o REGION HI g a 801 WARRENVILLE ROAD

$ LISLE. ILLINOIS 60532 4351

\*****/ March 5, 1999 EA 99-016 Mr. J. N. Adkins Vice President - Production United States Enrichm'ent Corporation Two Democracy Center 6903 Rockledge Drive Bethesda, MD 20817

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 70-7001/98018(DNMS))

Dear Mr. Adkins:

This refers to the inspection conducted from December 1,1998 through January 12,1999, at the U. S. Enrichment Corporation (USEC) Paducah Gaseous Diffusion Plant in Paducah, Kentucky. The purpose of the inspection was to review the activities authorized by NRC Certificate No. GDP-1, in the inspection report sent to you by letter dated January 28,1999, an apparent violation was identified and considered for escalated enforcement. USEC declined an opportunity to attend a predecisional enforcement conference and chose to respond to the apparent violation in writing.

Based on the information developed during the inspection, and the information provided in your letter dated March 1,1999, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding the violation are described in detail in the subject inspection report.

The violation involved failure to maintain control of classified matter at the Paducah facility.

On or about December 1,1998, a USEC Paducah employee opened an envelope containing a classified document. The document had been left in the employee's desk for approximately 14 years by a retired employee. The desk is located in the materials management area in Building C-720, an area that is outside of the controlled access area (CAA) or protected area of the plant site. Although prior to December the employee had attended a number of security training sessions which covered security procedures and classified document control, the employee failed to notify management or security staff upon discovery. After attending a security briefing on recent events at Paducah on December 2,1998, the document was turned over to management when the employee recognized that it had not been properly controlled.

Because the classified document was inside an unmarked envelope, it was not identified by the individual nor facility personnel performing spot checks during the recent site-wide security sweep to identify and secure legacy classified documents. The root causes of this event are:

_ (1) improper handling of the document by the retiring employee some 14 years ago; (2) an individual not realizing that he was in possession of classified material for a number of years; NUREG-0940, PART 3 B-57

J. Adkins and (3) not following the requirements for properly securing classified matter once he identified it in his possession (personnel error).

Unsecured classified information in an uncontrolled area of the site is potentially available to those not authorized access to the information, that is, there are no controls in place to ensure the information is not compromised. Other employees in the area are generally cleared, but the facility is routinely visited by uncleared personnel. While there were no actual security consequences in this case, the NRC is concerned about USEC's deficiencies regarding the control of classified matter because of the significant potential for compromise of classified matter. The NRC expects USEC to abide by all regulations and requirements, including those requirements related to the handling of classified matter. Therefore, this violation has beca categorized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600 as a Severity Level Ill violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $55,000 is I

considered for a Severity Level lil violation. Because your facility has been the subject of escalated enforcement actions within the last two years,' the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for identification is warranted because the classified document outside of the plant CAA was identified by USEC personnel. Credit for corrective actions is also warranted since the actions were considered prompt and comprehensive. These actions, which were described during the inspection and in your March 1,1999, letter included: (1) the classified document was immediately secured by plant staff and a security sweep of the materials management area was performed. No I

additional classified documents were found; (2) an assessment of other areas outside the CAA for similar vulnerabilities was initiated by plant personnel; (3) additional corrective actions were developed including performing a global self-assessment of the security process and recent security events at Paducah; (4) a job aid was published in the plant newsletter to provide a table of activities and procedures for handling classified matter at Paducah; (5) a revised training I module was developed to cover the responsibilities of plant staff in the security arena; and (6) the involved individual was reminded of his responsibility to follow procedures and properly protect classified matter.

Therefore, to encourage prompt and comprehensive identification and correction of violations, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance will be achieved is already adequately addressed on the docket in Inspection Report 70-7001/98018(DNMS) and in your letter dated March 1,1999. Therefore, you are not required to respond to this letter unless the description herein does not accurately reflect your 1 A searity Level ill violation was issued on september 22,1997 (EA 97-267) for secunty plan violations. A seventy Level lil violation with a $55.000 civil penalty was issued December 8.1997(EA 97-431) for uncontrolled access to classified documents.

WUREG-0940, PART 3 B-58

r J. Adkins corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response if you choose to send one, will be placed in the NRC Public Document Room.

S'ncerely, I j

\

L ?tu}ut James E. Dyer L Reg onal Administrator Docket No. 070-7001 Certificate No. GDP-1

Enclosure:

Notice of Violation I

l NUREG-0940, PART 3 B-59 1

j

NOTICE OF VIOLATION United States Enrichment Corporation Docket No. 70-7001 '

Paducah Gaseous Diffusion Plant Certificate No. GDP-1 Paducah, Kentucky EA 99-016 During an NRC inspection conducted from December 1,1998 through January 12,1999, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 76.60(i) requires, in part, that the Corporation (certificatee) shall comply with the provisions of 10 CFR Part 95.

10 CFR 95.35(a) requires, in part, that no person subject to the regulations in this part may receive or may permit any individual to have access to matter revealing Confidential Restricted Data unless the individual has a "Q" or "L" access authorization.

Contrary to the above, on December 1-2,1998, the certificatee permitted individuals to have access to a document revealing Confidential Restricted Data without having a "Q" or "L" access authorization. Specifically, the classified document was left unsecured in a desk in the Building C-720 materials management area, an area outside the controlled access area for the site and accessible to individuals who did not have either a "Q" or "L" access authorization.

This is a Severity Level ill violation (Supplement Ill).

The NRC has concluded that information regarding the reason for the violation and corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance will be achieved is already adequately addressed on the docket in Inspection Report 70-7001/98018(DNMS) and in your letter dated March 1,1999. However, you are required to submit a written statement or explanation pursuant to 10 CFR 76.70 if the description herein does not accurately reflect your corrective actions or your position. In that case, orif you choose to respond, clearly mark you response as a " Reply to a Notice of l

Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region lil, and a copy to the NRC Resident inspector at the facility that is the subject of this Notice, within 30 days of the date of this letter transmitting this Notice.

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United State Nuclear Regulatory Commission, Washington, DC 20555-0001.

If you choose to provide a response, it will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 5th of March 1999 NUREG-0940, PART 3 B-60 l

1

a 0 UNITED STATES

[e' "80 9'o,, NUCLEAR REGULATORY COMMISSION

[ o REGION lit y

{ 2 801 WARnENvlLLE ROAD lisle, ILLINOIS 60532-4351

\**../ February 25, 1999 EA 98-507 Mr. Kirk Thams General Manager and Radiation Safety Officer XRI Testing Division of X-Ray industries, Inc.

1961 Thunderbird Troy, MI 48084

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-04837/98001(DNMS) and NRC Office of Investigations Report 3-1998-035)

Dear Mr. Thams:

This refers to the NRC inspection and the investigation conducted by the Office of ,

Investigations (OI) between August 24 and October 8,1998. The purpose of the inspection l was to review the circumstances surrounding a reported event at a temporary jobsite in Mishawaka, Indiana, on August 21,1998. Apparent violations were identified and discussed in the subject inspection report sent to you on September 17,1998. The 01 investigation was conducted to determine if an XRI Testing (XRI) employee deliberately failed to wear an alarming ratemeter during radiographic' operations. A copy of the 01 report synopsis was sent to you by our letter dated November 19,1998. In that letter, potential enforcement action was discussed and you were provided with an opportunity to discuss this case and the apparent violations at a predecisional enforcement conference. As XRl's representative, you elected to decline a conference.

Based on the information developed during the inspection and the Ol investigation, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. .

A violation is cited involving the failure of a radiographer to wear an alarming ratemeter at a temporary jobsite. On August 21,1998, an XRI radiographer, who was working alone at the time, forgot that the source (92 curies of iridium-192) was exposed, entered the area of operations and manipulated the collimator which resulted in a significant radiation exposure to his hand. This event could have been averted had this individual been wearing an alarming ratemeter. Calculations performed by XRI personnel and the NRC determined that his extremity (hand) exposure was approximately 20 rems shallow-dose equivalent which did not exceed the limit of 50 rems shallow dose equivalent. That notwithstanding, the violation had significant potential to result in a far more serious radiation exposure This matter is further exacerbated by the Ol investigation finding that the XRI radiographer deliberately violated an NRC requirement to wear an alarming ratemeter.

NUREG-0940, PART 3 B-61 1

K.Thams 1 l

Despite the radiographer's deliberate failure to routinely wear an alarming ratemeter, XRI has a responsibility to ensure that its employees perform radiographic operations in accordance with license requirements.

J A second violation involves the failure to have two qualified individuals present during radiographic operations. On August 21,1998, one of the two qualified radiographers at the i Mishawaka, Indiana, temporary jobsite left the facility prior to the event to look for his missing film badge while radiographic operations were in progress. Although XRI has routinely assigned two individuals to all temporaryjobsites, it failed to recognize the difference between XRI's policy and NRC's requirement that the second individual actually observe radiographic operations.

In addition, the radiographer who deliberately failed to wear his alarming ratemeter also failed to maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area and failed to conduct a radiation survey of the radiographic exposure device or the guide tube during the radiographic operation as required by NRC regulations.

Because of the willful nature of the XRI Testing radiographer's failure to wear an alarming ratemeter, as well as other violations which occurred during the radiographic operations on August 21,1998, these violations are of very significant regulatory concern and have been classified in the aggregate in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600, Rev.1, as a Severity Level 11 problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $8,800 is considered for a Severity Level ll problem. Because the problem involved willfulness, the NRC considered whether credit was warranted for /dentification and Corrective Action in accordance with the civil penalty assessment in Section VI.B.2 of the Enforcement Policy. Credit was determined to be warranted for Identification because XRI identified the issues and the root  ;

causes. In addition, credit for Corrective Action is warranted based on the promptness and comprehensiveness of the actions taken. The corrective actions taken included: (1) the radiographer in question was immediately suspended following the incident and subsequently terminated; (2) all radiography personnel were informed of the Mishawaka incident; (3) all radiography personnel were re-instructed in the requirements and use of all personnel monitoring equipment; (4) XRI Testing revised its "two-man rule" for jobsite activities; and (5)

XRI Testing had made a decision to no longer perform work at temporary jobsites outside of the confines of its facilities.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition i of the absence of previous escalated enforcement action, I have been authorized, after

{

consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. I However, issuance of this Severity Level 11 problem constitutes escalated enforcement action that may subject you to increased inspection effort. In addition, similar violations in the future could result in a civil penalty or order modifying your license.

1 NUREG-0940, PART 3 B-62 l

_a

K.Thams l The NRC has concluded that information regarding the reason for the problem, the corrective actions taken and planned to correct the problem and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in Inspection Report 030-04837/98001(DNMS) and in our letter dated November 19,1998. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to send one, will be placed in the NRC Public Document Room.

Sincerely,

$1 W James E. Dyer Regional Administrator {

Docket No. 030-04837 License No. 21-05472-01

Enclosure:

Notice of Violation i

l l

1 NUREG-0940, PART 3 B-63 1

i

1 l

l NOTICE OF VIOLATION XRI Testing Docket No. 030-04837 Troy, Michigan License No. 21-05472-01 EA 98-507 During an NRC inspection and Ol investigation conducted between August 24 and October 8,1998, violations of NRC requirements were identified. In accordance with the

" General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, Rev.1, the violations are listed below:

1. Violation Associated with Dosimetry 10 CFR 34.47(a) requires, in part, that the licensee may not permit any individual to act as a radiographer unless, at all times during radiographic operations, each individual wears an operating alarm ratemeter and either a film badge or a thermoluminescent dosimeter (TLD).

Contrary to the above, on August 21,1998, an individual permitted to act as an XRI Testing radiographer did not wear an operating alarm ratemeter during radiographic operations at temporary jobsites. In addition, on August 21,1998, another indivWual acting as an XRI Testing radiographer conducted radiographic operations without a film badge or TLD at the same temporary jobsite located in Mishawaka, Indiana.

II. Violation Associated with the Two-Man Rule 10 CFR 34.41(a) requires that whenever radiography is performed at a location other than a permanent radiographic installation, e.g., a temporary jobsite, the radiographer must be accompanied by at least one other qualified radiographer or radiographer's assistant. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

Contrary to the above, on August 21,1998, radiography was performed at a temporary jobsite located in Mishawaka, Indiana, a location other than a permanent radiographic installation, with only one qualified individual present.

Ill. Violation Associated with Surveillance 10 CFR 34.51 requires, in part, the radiographer, or other qualified individual, to maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area during each radiographic operation that is not conducted at a permanent radiographic installation where all entryways are locked and the requirements of 10 CFR 34.33 are met.

l NUREG-0940, PART 3 B-64 l 1

n r

Notice of Violation Contrary to the 'above, on August 21,1998, a licensee radiographer, during the time he was alone at the temporary jobsite, did not maintain continuous direct visual surveillance of radiographic operations.

IV. Violation Associated with Radiation Surveys 10 CFR 34.49(b) requires, in part, that the radiographer conduct a survey of the radiographic exposure device and the guide tube after each exposure when i approaching the device or the guide tube. The survey must determine that the sealed source has retumed to its shielded position.

Contrary to the above, on August 21,1998, a licensee radiographer, during the time that he was performing radiographic operations, did not conduct a survey of the device or the guide tube prior to manipulating the collimator, which resulted4n a significant radiation exposure to his hand.

These violations represent a Severity Level 11 problem (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when i full compliance was achieved is already adequate:/ addressed on the docket in inspection l Report 030-04837/98001(DNMS). However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a " Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATfN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region lil, 801 Warrenville Road, Lisle, IL 60532 within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of the Act,42 U.S.C. 2232, any response shall be submitted i under oath or affirmation.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safe 0uards information so that it can be placed in the PDR without redaction.

- in accordance with 10 CFR 19.11, you may be required to post this Notice within two working I days.

Dated this 25th day of February 1999 NUREG 0940, PART 3 B-65

NRC FORM 335 U.s. NUCLEAR REiULAToRY COMMisslON 1. REPORT NUMBER (2-89) (Assigned by NRC, Add Vol., Supp., Rev.,

"TE m BIBLIOGRAPHIC DATA SHEET '"d^"*"**"""**"*""

'8"'"'""**'""'

NUREG-0940, PART 3

2. TITLE AND SUBTITLE VOL.18, NO.1 Enforcement Actions: Significant Actions Resolved

3. DATE REPORT PUBLISHED Mittrial Licensees Srmiannual Progress Report MONTH YEAR l

Jinvary - June 1999 August 1999

4. FIN OR GRANT NUMBER

s. AUTHOR (S) 6. TYPE OF REPORT

]

Offics of Enforcement Technical

7. PERIOD CCVERED (inclus;w Dates) l

8. PEnFORMING ORGANIZATION NAME AND ADDRESS (it Nac prowde Oswse, omce or Region. u 5 Nucear Reguistory commissa and mamp acoress, # contractor, provce name and maanng address )

Office of Enforcement U.S. Nuclear Regulatory Commission Wtshington, DC 20555-0001 l

9. SPONSORING ORGANIZATION - NAME AND ADDRESS (it Nac. type 'Same es above*; # contractor. prowde NRC 0,wsm omce or Region. u S Nuewar Regudatory commisse, i l

and mMng address)

Stme as above l l

10. SUPPLEMENTARY NOTES

11. ABSTRACT (200 words ormas)

This compilation summarizes significant enforcement actions that have been reso lved during the period (January - June 1999) snd includes copies of letters, Notices, and Orders sent by the Nuclear Regulat ory Commission to material licensees with respect to these enforcement actions. It is anticipated that the information i n this publication will be widely disseminated to managers and employees engaged in activities licensed by the NRC, so that actio ns can be taken to improve safety by avoiding future violations similar to those described in this publication.

13 AVAILAB'UTY STATEMENT

12. KEY wORDS/DESCRIPTORS (bst words or phrases that wdt assist researchers a focanng ine report) unlimited Dirgnostic Radiopharmaceuticals, Teletherapy, Brachytherapy, Radiation Safety P rogram, Safety

• sEcuRiTvctAssiFicATloN Eviluation, Quality Managernent Program, HDR (The Page) unclassified (Thss Report) unclassified

15. NUMBER OF PAGES

16. PRICE NHc FORM 335 (2 89)

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