ML20204J489

Enforcement Actions: Significant Actions Resolved Material Licensees.Semiannual Progress Report,July-December 1998

ML20204J489
Person / Time
Issue date:	03/31/1999
From:	NRC OFFICE OF ENFORCEMENT (OE)
To:
References
NUREG-0940, NUREG-0940-PT03, NUREG-0940-V17-N2-P3, NUREG-940, NUREG-940-PT3, NUREG-940-V17-N2-P3, NUDOCS 9903300102
Download: ML20204J489 (200)

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NUREG-0940 Vol.17, No. 2, Part 3 Material Licensees Enforcement Actions:

1 Significant Actions Resolved Material Licensees Semiannual Progress Report July - December 1998 1

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l AVAILABILITY NOTICE )

Ava!! ability of Reference Materials Cited in NRC Publications NRC publications in the NUREG series, NRC regu- NRC Public Document Room lations, and T*/e 10, Energy, of the Code o/ 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.n rc. g ov/N R C/PD R/pd r1. htm >

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2.

previous paragraph) or through: J The National Technical Information Service Springfield, VA 22161 -0002 <http://www.nrc. gov /NRC/NUREGS/

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

703 -487- 4650 Publicly released documents include, to name a 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 resulting and correspondence; NRC corresponder>ce and from international agreements (NUREG/lA-XXXX), internal memoranda; bulletins and information no-(4) technical and administrative reports and books tices; inspection and investigation reports; licens-

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

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

NUREG-0940 Vol.17, No. 2, Part 3 Material Licensees Enforcement Actions:

Significant Actions Resolved Material Licensees l

Semiannual Progress Report July - December 1998 Manuscript Completed: March 1999 Date Published: March 1999 l l

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. ABSTRACT i

This compilation summarizes significant enforcement actions that have been resolved during the period (July - December 1998) and includes copies of letters, Notices, and Orders sent by L 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 i managers and employees engaged in activities licensed by the NRC, so that actions can be l taken to improve safety by avoiding future violations similar to those described in this publication.

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l CONTENTS EA92 AB STR ACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iil

> l NTRODU CTI ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 S U M MA R I E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 l 4

MATERIAL LICENSEES A. CIVIL PENALTIES AND ORDERS Alaron Corporation, Wampum, Pennsylvania EA 98- 1 4 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 Baxter Healthcare Corporation of Puerto Rico, Aibonito, Puerto Rico I EA 9 7- 51 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6 Breitling USA, Inc., Stamford, Connecticut 1 EA 98- 1 6 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25 l 1

Jose M. Colon-Vaquer, Manati, Puerto Rico i EA 98- 1 84 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-32 I 1

Conam Inspection, Inc., Itasca, Illinois E A 97-207 : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-44 Jose N. De Leon, M.D., Isla Verde, Puerto Rico EA 9 7-627 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 6  :

l Mattingly Testing Services, Inc., Great Falls, Montana i E A 97- 1 80 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-85 l NDT Services, Inc., Caguas, Puerto EA 98-108 . ........................................................... A-92 i

Overhoff Technology Corporation, Milford, Ohio EA 96-2 4 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 05 The Terracon Companies, Lenexa, Kansas i EA 98- 1 2 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 1 5 l U.S. Enrichment Corporation, Bethesda, Maryland EA 98 - 1 56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 2 9 United States Enrichment Corporation, Bethesda, Maryland EA 98-249,98-250, 98-251 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-139

NUREG-0940.' PART III v

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SEVERITY LEVEL 1. II. AND lli VIOLATIONS. NO civil PENALTY -

t Brucker Engineering, Inc., St. Louis, Missouri E A 98-326 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 1 Cardinal Surveys Company, Odessa, Texas EA 98-347 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B -6

• Conam inspection, Inc., Glendale Heights, Illinois .

EA 98-404 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 1 1 1 Engineering Surveys and Services, Inc., Columbia, Missouri EA 98-386 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 1 5 l Geotechnical Consultants, Inc., Westerville, Ohio EA 98-385 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 1 8 .

KTl Construction Services, Inc., Merriam, Kansas .

EA 9 '8-3 77 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-23 Materials Testing Lab, Inc., Nev. Hyde Park, New York EA 98-4 37 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-28 ,

. Met-Chem Testing Laboratories of Utah, Inc., Salt Lake City, Utah EA 98-362 . . . . . . . . . .................................................... B-36 ,

c Nuclear Pharmacy of Idaho, Inc., Boise, Idaho l EA 98-36 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-41 Sinal Hospital, Detroit, Michigan EA 98-52 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 7  ;

Southern Processing Enterprises, Beaver, West Virginia ,

EA 98-4 9 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B 52 State of Hawaii, DOT, Honolulu, Hawaii .

EA 98-2 3 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-57 l University of Medicine and Dentistry of New Jersey, Newark, New Jersey EA 98-5 36 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-61 j

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, 4 NUREG-0940. PART III vi l

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c ENFORCEMENT ACTIONS: SIGNIFICANT ACTIONS RESOLVED MATERIAL LICENSEES July - December 1998 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 second half of 1998. 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 for the DEDS in the 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, 11, and lll (where violations are 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 'JRC makes this NUREG available to all materials licensees in the interest of avoiding sirr" s significant noncompliance issues. Therefore, it is anticipated that the information i.. this publication will be widely disseminated to managers and employees engaged in activities licensed by NRC. l A brief summary of each significant enforcement action that has been resolved in the second half of 1998 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 i supplement number refers to the activity area in which the violations are classified in accordance with the Enforcement Policy.

Supplement I - Reactor Operations Supplement ll - Facility Construction Supplement 111 - Safeguards Supplement IV - Health Physics Supplement V - Transportation Supplement VI - Fuel Cycle and Materials Operations Supplement Vil - Miscellaneous Matters Supplement Vill - Emergency Preparedness Section A of this report consists of copies of completed civil penalty or Order actions involving materials licensees, arranged alphabetically. Section B includes copies of Notices of Violation that were issued to materials licensees for a Severity Level I, ll, or lil 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.

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= SUMMARIES A. CIVIL PENALTIES AND ORDERS'  ;

Alaron Corporation, Wampum, Pennsylvania .

Supplement VI, EA 98-144 A Notice of Violation and Pioposed Imposition of Civil Penalty in the amount'of $5,500 was issued on June 3,1998. ' The action was based on a Severity Level lil violation involving a willful failure to dispor.e of waste at the licensee's facility that had been in storage for more than 2 years. A base civil penalty was proposed for this violation '

because: (1) this was a willful violation, (2) credit was not warranted for identification,-

and (3) credit was warranted for corrective action. The licensee responded and paid the civil penalty on June 30,1998.

Baxter Healthcare Corporation of Puerto Rico, Aibonito, Puerto Rico Supplement VI, EA 97-518 A Notice of Violation and Proposed imposition of Civil Penalties the amount of $10,500 l was issued May 14,1998. The action was based on two Geverity Level 111 violations for:

(1) willfully performing an unauthorized alteration to the licensee's irradiator by disabling the lower roof plug safety interlock switch and bypassing its associated circuitry; and (2) willfully perforrning multiple unauthorized repairs of the irradiator's control console and safety systems. The licensee responded in lettem dated July 8 and 15,1998. Another inspection was conducted on August 19,1998 following a fatality on July 31,1998. An Amended Notice of Violation and Proposed Imposition of Civil Penalties was issued October 9,1998. The licensee responded and paid the civil penalties on November 17, 1998.

Breitling USA Watch Company, Stamford, Connecticut Supplement VI, EA 98-163 A Notice of Violation and Proposed imposition of Civil Penalties in the amount of

$26,400 and a Demand for information was issued July 10,1998. The action was based on two Severity Level ll violations involving the possession and use, as well as distribution, of NRC licensed material without possessing NRC licenses. After considering the regulatory significance of the violations, which included the inability of the NRC to conduct inspections of the company's activities, the duration of the violations, the costs of maintaining NRC licenses which the licensee avoided during the period of noncompliance, and the company's failure to promptly contact the NRC once it had indications that the need for a license was likely. The NRC determined, in accordance with Section Vll.A.1(a) of the Enforcement Policy, that it was appropriate to ,

exercise enforcement discretion in this case and issue separate civil penalties for the two violations. The company responded and paid the civil penalties on August 7,1998.

Jose M. Colon-Vaquer, M.D., Manati, Puerto Rico j Supplement VI, EA 98-184 ,

A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $4,400 was issued on May 22,1998. The action was based on a Severity Level ll problem that irrvolved two misadministrations. A base civil penalty was proposed for the Severity NUREG-0940. PART III' ~3

Level ll problem because: (1) it was a Severity Level 11 issue, (2) credit was not warranted for identification, and (3) credit was warranted for corrective action. A Notice of Violation was also issued f ar a Severity Levei Ill that involved use of licensed material when the license was expired, and a Severity Level lli problem that involved seven violations that co:lectively demonstrated the licensee's inability or unwillingness to develop and maintain the required oversight of the use of licensed material. The licensee responded on June 21,1998 requesting if the licensee transferred the licensed material a reduction of half the civil penalty which the NRC had indicated in the Notice.

The licensee paid the civil penalty in the amount of $2,200 on July 28,1998.

Conam inspection, Inc., Itaska, Illinois Supplements IV and VI, EA 97-207 A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $16,000 was issued on June 9,1997. The action was based on three violations, each consisting of multiple examples, aggregated into a Severity Level 11 problem. The violations were grouped into a number of categories which included: numerous longstanding deficiencies in engineering programs and practices some of which led to significant safety equipment being inoperable or degraded for extended periods; numerous operational deficiencies, which led to an event in which nitrogen gas was allowed to intrude into the reactor coolant system; and an inadequate implementation of emergency preparedness program during the August 1996 exercise. The licensee responded to the Notice in July 1997 admitting some of the violations and denying others. The licensee also requested remission or full mitigation of the civil penalty. An Order imposing the civil penalty was issued November 5,1997. On December 1,1997, the licensee requested a hearing. A hearing was held the week of September 16,1998.

On December 14,1998, the NRC staff and the licensee filed a joint settlement agr. 3 ment which reduced the civil penalty by $1,000, it was approved and dismissed on December 17,1998. The licensee paid the civil penalty in the amount of $15,000 on December 30,1998.

Jose N. DeLeon, M.D., Isla Verde, Puerto Rico Supplement VI, EA 97-627 A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $5,000 was issued April 28,1998. The violation involved the failure to establish and maintain a written quality management program to provide high confidence that the strontium-90 eye applicator would be administered as directed by an authorized user, that resulted in nine misadministrations. The NRC exercised enforcement discretion in accordance with Section Vll.A of the Enforcement Policy and proposed twice the civil penalty. The licensee responded on May 20,1998, and again on June 22,1998. In the June 22, 1998, letter the licensee informed the NRC that the licensed material had been transferred to another NRC licensee and requested that the license be terminated. The civil penalty was subsequently withdrawn on July 30,1998.

Mattingly Testing Services, Inc., Great Falls, Montana Supplement Vll, EA 97180 l

A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $10,000 was issued October 31,1997. The action was based on a violation of 10 CFR 30.7(a),

which prohibits discrimination by a Commission licensee against an employee for NUREG-0940, PART III 4 I

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I engaging in certain protected activity. Specifically, the employee was terminated from his position because he identified violations of NRC requirements to the NRC. A double base civil penalty was proposed because: (1) this violation was not the first escalated enforcement action within the last two years, (2) credit was rot warranted for identification and, (3) credit was not warranted for corrective action. The action was subsequently withdrawn on September 15,1998, based on the underlying facts of the case, the licensee's response to the proposed action, and the differing 01 reports and  ;

DOL decisions.

NDT Services, Inc., Caguas, Puerto Rico Supplement VI, EA 98-108 l An Order Suspending License was issued March 27,1998. The action was based on numerous violations identified during an inspection and investigation which indicated that the licensee was either unwilling or unable to comply with NRC requirements for the safe conduct of industrial radiography.

t Overhoff Technology Corporation, Milford, Ohio Supplement VI, EA 96-242 A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $2,500 .

! wasissued April 16,1998. The action was based on a Severity Level lli problem that l involved a shipment of devices containing tritium in excess of the exempt quantity,in violation of the licensee's distribution license. A base civil penalty was proposed because: (1) this violation involved careless disregard, (2) credit was not warranted for identification, and (3) credit was warranted for corrective action. However, on August 19,1998, after reconsideration of the types and quantities for material involved in the violations, together with the fact that the licensee constitutes a small entity for purposes of the Small Business Regulatory Enforcement Fairness Act, the NRC exercised enforcement discretion in accordance with Section Vll.B.6 of the Enforcement Policy and withdrew the civil penalty.

"i ne Terracon Companies, Lenexa, Kansas Supplement IV, EA 98-124 A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2,750 was issued on May 15,1998. The action was based on a Severity Level lli violation involving the failure to mainte.in adequate control of a portable moisture / density gauge, resulting in its theft. A bm civil penalty was proposed because: (1) this was not the first escalated untorcement in the past two years, (2) credit was not warranted for identification, and (3) credit was warranted for corrective action. The licensee responded to the Notice on June 9,1998 and after consideration of the response, an Order Imposing the Civil Penalty was issued October 19,1998. The licensee paid the civil penalty on October 21,1998.

U.S. Enrichment Corporation, Bethesda, Maryland Supplement VI, EA 98-156 i

A Confirmatory Order Modifying Certificate was issued for the Paducah Gaseous Diffusion Plant on April 22,1998. The Order was issued to confirm commitments on the part of the Certificate holder to install seismic modifications required to bring the facility NUREG-0940. PART III 5

back into compliance with the Safety Analysis Report.

United States Enrichment Corporation, Bethesda, Maryland Supplement VI, EA 98-249,98-250,98-251 A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $55,000 was issued July 14,1998. The action was based on a Severity Level til problem invciving a programmatic deficiency in the maintenance and surveillance program for air-operated, safety-related air-to-close autoclave containment valves at the Portsmouth plant. A base civil penalty was proposed because: (1) the Portsmouth facility had been the subject of escalated enforcement actions within the last two inspections, (2) credit for identification was not warranted, and (3) cre . corrective action was warranted.

The licensee responded and paid the civil penalty on August 10,1998. '

B. SEVERITY LEVEL 1. II. AND lil VIOLATIONS. NO CIVIL PENALTY Brucker Engineering, Ltd., St. Louis, Missouri Supplement VI. EA 98-326 l

l A Notice of Violation for a Severity Level 111 violation was issued July 20,1998. The action was based on the licensee's failure to control licensed material in an unrestricted area. Specifically, a moisture / density gauge containing 11 millicuries of cesium-137 and i 44 millicuries of americium-241 was unaccounted for between May 29 and June 3, 1 1998, because the operator could not find his vehicle. The civil penalty was fully mitigated because: (1) this was the first escalated issue in 2 years, and (2) credit was warranted for corrective action.

Cardinal Surveys Company, Odessa, Texas  !

Supplement VI, EA 99-347 A Notice of Violation for a Severity Level ill violation was issued on July 22,1998, for a failure to file an NRC Form 241 for proposed activities in non-Agreement states in accordance with 10 CFR 15.20. The civil penalty was fully mitigated because: (1) this was the first escalated issue in 2 years, and (2) credit was warranted for corrective action.

Conam inspection, Inc., Kapolei, Hawaii 4 Supplements IV and VI, EA 98-404 A Notice of Violation for a Severity Level lil violation was issued on September 14,1998.

The action was based on the failure to secure from unauthorized removal, access, or tampering and maintain constant surveillance of licensed material (a radiography camera containing a nominal 55 curie iridium-192 sealed source) in accordance with 10 CFR 20.1801,10 CFR 20.1802 and 10 CFR 34.35. The civil penalty was fully mitigated because: (1) this was the first escalated issue in 2 years, and (2) credit was warranted for corrective action.

NUREG-0940. PART III 6

W Engineering Surveys and Services, Inc., Columbia, Maryland I Supplement IV, EA 98-386  ;

A Notice of Violation was issued on July 24,1998, for a Severity Level lil violation involving the failure to secure or maintain constant surveillance of licensed material at a temporary jobsite. This failure contributed to a gauge, containing 8 millicuries of cesium-137 and 40 millicuries of americium-241, being run over and severely damaged by a construction vehicle. The civil penalty was fully mitigated because: (1) this was the first escalated issue in 2 years, and (2) credit was warranted for corrective action.

Geotechnical Consultants, Inc., Westerville, Ohio Supplement IV, EA 98-385 A Notice of Violation was issued on August 27,1998, for a Severity Level ll1 violation involving the failure to controllicensed material in an unrestricted area. The civil penalty

. was fully mitigated because: (1) this was the first escalated issue in 2 inspections, and (2) credit was warranted for corrective action.

KTl Construction Services, Inc., Merriam, Kansas Supplements IV and VI, EA 98-377 I

., A Notice of Violation for a Severity Level lli problem was issued on July 20,1998. The l action was based on violations that involved: (1) failure to maintain control of licensed material, (2) licensed material used by an unauthorized person, (3) failure to wear a film )

badge, and (4) failure to follow emergency procedures as required. The civil penalty )

was fully mitigated because: (1) this was the first escalated issue in the last two 1 inspections or 2 years, and (2) credit was warranted for corrective action.

> Materials Testing Lab, Inc., New Hyde Park, New York 4

- Supplements IV, V, and VI, EA 98-437 A Notice of Violation for a Severity Level 111 problem was issued November 3,1998. The action was based cn violations involving: (1) failure to secure licensed material from unauthorized access or removal from a controlled or unrestricted area which resulted in a loss of a gauge from the Newington, Connecticut facility, (2) failure to review the radiation safety program content and implementation at least annually, (3) failure to perform surveys that are reasonable under the circumstances to evaluate the potential radiological hazards that could be present, (4 and 5) failure to mark and Ighal packages containing hazardous material transported on public highways, (6) failure to train hazmat employees, (7) failure to maintain possession limits for materials under NRC ~ 'Hiction below 750 millicuries of americium-241, and (8) failure to maintain records to uirea Sy the license at the New York office. The civil penalty was fu!!y mitigated becau. '*

'e facility had not been the subject of an escalated enforcemerst action in the last rv inspections, and (2) credit was warranted for corrective actions.

Met-Chem Testing Laboratories of Utah, Salt Lake City, Utah Supplement VI, EA 98-362 A Notice of Violation was issued on July 31,1998, for a Severity Level 111 violation o involving a f ailure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. The civil penalty

, NUREG-0940. PART'III 7

I l

was fully mitigated because: (1) this was the first escalated issue in two inspections, and (2) credit was warranted for corrective action.

Nuclear Pharmacy of Idaho, Inc., Boise, Idaho ,

Supplements IV and VI, EA 98-363 A Notice of Violation was issued October 19,1998, for a Severity Level lli involving violations associated with an event at the licensee's facility on November 13,1997. The violations included failures to: (1) perform an evaluation to determine the dose to the skin of the right forearm of the individual involved in the contamination event, (2) limit to 50 rems the annual shallow-dose equivalent to the skin of the individual involved, and (3) submit a written report within 30 days rollowing the contamination event. The civil .

penalty was fully mitigated because: (1) the facility had not been the subject of I escalated enforcement within the last two inspections, and (2) credit was warranted for

~

corrective action.-

Sinal Hospital, Detroit, Michigan Supplement VI, EA 98-523 ,

A Notice of Violation was issued December 18,1998, for a Severity Level ill violation involving the licensee's quality management program. The violations involved: (1) i failure to assure that the treatment was in accordance with the written directive by  !

checking dose calculations within three working days of initiation of treatment, (2) failure of the treating therapists to compare the written directive with the calculations each day of treatment, and (3) failure of the staff to perform weekly chart checks to verify treatment parameters were in accordance with the written directive. The civil penalty l was fully mitigated becauset (1) the licensee's staff identified the violations and exercised considerable effort to determine the root cause, and (2) credit was warranted i for the cerrective actions taken or planned.

1 Southem Processing Enterprises, Beaver, West Virginia Supplement VI, EA 98-495  ;

A Notice of Violation was issued October 30,1998, for a Severity Level lil violation involving: (1) the unauthorized removal of two generally licensed fixed gauges containing 250 millicuries of cesium-137, and (2) the failure to properly transfer the gauges. The gauges were inadvertently transferred in May 1998, to facilities in Kentucky and Tennessee which were not licensed to possess byproduct material. The civil penalty was fully mitigated because: (1) the facility had not been the subject of escalated enforcement actions within the last two years, and (2) credit was warranted for corrective actions. <

State of Hawaii, Department of Transportation, Honolulu, Hawaii Supplement IV, EA 98-237 A Notice of Violation for a Severity Level 111 violation was issued July 21,1998. The action was based on two instances of failures to adequately secure gauges containing licensed material from unauthorized removal or access. The civil penalty was fully mitigated because: (1) this was the iPt escalated issue in two inspections, and (2) credit was warranted for corrective actions.

NUREG-0940 PART III 8

i University of Medicine and Dentistry of New Jersey Supplement IV, EA 98-536 A Notice of Violation for a Severity Level Ill violation was issued December 29,1998. j The action was based on three examples of failure to secure licensed materials in an j unrestricted area. The civil penalty was fully mitigated because: (1) this was the first i escalated enforcement action within the past two years, and (2) credit was warranted for corrective actions, i i

l NUREG-0940. PART III 9

1 l

l l l l l t  !

l I

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A. CIVll PENALTlES AND ORDERS 1

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l I

NUREG-0940 PART III

j p ut k UNITED STATES NUCLEAR RESULATORY COMMISSION

[ g G REGloN I 475 ALLENDALE ROAD o,% KING oF PRUSSIA, PENNSYLVANIA 19406-1415

) . *****

l June 3,1998 j

EA 98-144

! ~ Mr. Michael Rollor, President Alaron Corporation Point industrial Park Route #18, New Beaver Boro.

! RD 2 Box 2140A l Wampum, Pennsylvania 16157  ;

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTY I

- $5,500 AND DEMAND FOR INFORMATION (NRC Inspection Report No. 030-30666/98-001) i

Dear Mr. Rollor:

i

This refers to the NRC inspection conducted on February 26,1998, at the above address in l

Wampum, Pennsylvania, the findings of which were discussed with your Operations Manager

and Radiation Safety Officer during an exit meeting on that date. During the inspection, one j

violation of NRC requirements was identified, as described in the NRC inspection report  !

i transmitted with our letter dated March 31,1998. On April 15,1998, a Predecisional Enforcement Conference (conference) was held with you and your Operations Manager to

discuss the violation, *ts causes, and your corrective actions. A copy of the enforcement conference report was sent to you on April 23,1998.

Based on the information developed during the inspection and the conference, the NRC has i determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed imposition of Civil Penalty (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The j violation involves your willful failure to dispose of waste at your facility that had been in storage for more than two years. Although the NRC issued you a Notice of Violation (NOV) on April 11,1997 for a violation involving at least 15 waste packages being in storage at your i facility for more than two years, the NRC found, during the February 1998 inspection, that not I

only had you not removed two of those packages from the site, but the number of packages i that had been in storage for more than two years had increased to 83.

As a result of this finding, the NRC issued you a Confirmatory Action Letter (CAL) (No.1 004) which confirmed your commitment to (1) provide the NRC, by March 12,1998, your

, final decision to either dispose of the waste with available funds, dispose of the waste with funds provided by the generator of the waste, or to remove this waste from your facility and retum it to the generator's facility; and (2) remove from your facirsty, by April 12,1998, all the licensed radioactive waste held greater than two years. In a letter dated March 12,1998,

.i you informed the NRC that you would dispose of the waste with funds provided by the generator of the waste. Also, in a letter dated April 10,1998, you requested an extension i

NUREG-0940. PART III A-1

i l

Alaron Corporation 2 l

until April 30,1998, to remove from your facility all licensed radioactive waste which had been held greater than two years. The NRC granted the requested extension in a revision to

the CAL dated April 13,1998.

The NRC is concerned that although you were aware that it was a violation of your license 4

requirements to store radioactive waste at your facility for a period of more than two years, ,

as you admitted at the predecisloral enforcement conference, you failed to dispose of all of the waste that was the subject of that previous NOV and failed to prevent recurrence of the violation. At the conference, you explained that between April 1997 and the February 1998 inspection, you had seiectively disposed of waste packages regardless of how long they had been held, so that you could maximize the amount of waste that could be disposed given your limited resources. Using this approach resulted in your failure to dispose of certain material held greater than two years. Although you also contended that this met the intent of the license requirement and would ultimately prevent recurrence of the violation, the recent violation is, nonetheless, classified at Severity Level 111 in accordance with the " General

Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy),

NUREG-1600, given the significance the NRC places on willful violations of requirements.

Willful violations are of concern because the NRC's regulatory programs are based on licensees and their employees acting with integrity.

In accordance with the Enfcrcement Policy, a base civil penalty in the amount of $5,500is considered for a Severity Level 111 violation. Because the violation is considered willful, the NRC considered whether credit was warranted for /dend// cat /on and Correct /ve Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for identification is not warranted because the NRC identified the repetitive failure to dispose of the waste within two years. Credit for corrective actions is warranted because once this violation was identified by the NRC in Fabruary 1998, your corrective i actions were considered prompt and comprehensive. These actions, which were described l

at the conference, included, but were not limited to: (1) plans to dispose, by June 30,1998, i of all waste that would have been in storage for two years on December 31, 1998; (2) development of a tracking system, reports, and an administrative limit to ensure that all waste is disposed of within 18 months of when it was generated or received; (3) obtainiry, a coni,T&v,ent from your parent corporation to provide funding for waste disposal if operating funds are not available; and (4) training of your employees on the importance of waste  !

disporalin a timely manner.

Therefore, to emphasize the importance of compliance with license conditions and of prompt identification of violations, and in recognition of the willful nature of the violation, 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 in the base amount of $5,500 for the Severity Level ill violation. In addition, issuance of this Notice constitutes escalated enforcement action, and may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when prepering your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

NUREG-0940. PART III A-2

Alaron Corporation 3 ,

in addition to the Notice, the NRC is issuing to you this Demand for Information (DFi) because, as discussed above, you willfully failed to dispose of all of the waste that was the subject of a previous NOV to prevent recurrence of the violation, or to contact the NRC once you determined that you lacked adequate resources to comply with the conditions of your license.  ;

Therefore, in addition to the response required above, the Commission requires further information concerning Alaron Corporation's ability to comply with NRC regulatory requirements. Accordingly, pursuant to sections 161c,161o,182, and 186 of the Atomic Energy Act of 1954, as amended, and tha Commission's regulations in 10 CFR 2.204 and 10 CFR 30.32(b), in order for the Commission to determine whether your license should be modified, suspended or revoked, or other enforcement action taken to ensure compliance with NRC regulatory requirements, you are required, pursuant to this DFl, to submit to the Director, Office of Enforcement, U.S. Nuclear Regulatory Cornmission, Washington D.C. 20555, within 30 days of the date of this DFI, a response to the following questions, in writing and under oath or affirmation:

A. Why should the Commission have confidence that you will have adequate resources )

available in the future to comply with NRC regulatory requirements? l l

B. Why should the Commission have confidence that you will not knowingly allow violations to go unc.>rrected or unreported in the future in the event adequate resources are not available?

C. Why, in light of the willful nature of your violation, should the Commission have l confidence that you will comply with NRC regulatory requirements in the future?

You may provide any other information that you want the Commission to consider.

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, l

Hubert J. Miller y Regional Administrator Docket No. 030-30666 License No. 37-20826-02

Enclosure:

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

Commonwealth of Pennsylvania NUREG-0940. PART III A-3

I i

ENCLOSURE i NOTICE OF VIOLATION  ;

AND PROPOSED IMPOSITION OF CIVIL PENALTY Alaron Corporation Docket No. 030-30666 Wampum, PA License No. 37-20826-02 EA 98-144 During an NRC inspection conducted on February 26,1998, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the 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 violation and associated civil penalty are set forth below:

Condition 13 of License No. 37-20826-02 requires, in part, that the licensee not store l hcensed material contained in waste for more than two years from the date the waste is put into storage.

Contrary to the above, as of February 26,1998, the licensee stored licensed material  ;

contained in waste for more than the two years from the date the waste was placed  ;

into storage. Specifically, the licensee possessed a minimum of 83 waste packages  !

containing licensed radioactive waste (7155-gallon drums,1 C-48 container, 8 30-  ;

gallon drums, and 3 B-25 containers) which had been in storage at their Wampum, '

Pennsylvania facility for more than two years. (01013)

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

Civil Penalty - $5,500.

Pursuant to the provisions of 10 CFR 2.201, Alaron Corporation (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 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 j 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 i Order or a Demand for information may be issued as to why the license should not be mod!fied, 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.

NUREG-0940. PART III A-4

4 4

i

. Enclosure 2 Within the same time as provided for the response required above under 10 CFR 2.201, the

! Ucensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, i 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 amouht 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 l 3 Commission. Should the Ucensee fall to answer within the time specified, an order imposing l

the civil penalty will be issued, Should the Ucensee elect to file an answer in accordance with i 10 CFR.2.205 protesting the civil penalty, in whole or in part, such answer should be clearly j 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 l- ' the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR j 2.205 should be set forth sepaately 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 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.

The responce 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 Ueberman, Directo ,

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 Cr mmission, Region 1.

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 Hmal 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 cf protection described in 10 CFR 73.21.

NUREG-0940, PART III A-5

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i

1. g aab q, UNITED STATES

{

NUCLEAR REGULATORY COMMISSION  !

ATLANTA E A CENTER' I "

(

,*****/ 7TETA.GEO May 14, 1998 5

EA 97 518 Baxter Healthcare Corporation of Puerto Rico l ATTN: Mr. Edwin A. Betancourt General Manager l

.P. O. Box 1389 i

Aibonito. Puerto Rico 00705 -l

SUBJECT:

NOTICE OF VIOLATION ~AND PROPOSED IMPOSITION OF CIVIL PENALTIES  !

$10.500 (NRC INSPECTION REPORT NOS. 52 21175 01/96 01 AND 52-21175 01/97 01 AND OFFICE OF INVESTIGATIONS REPORT l N0. 2 96 040) l

Dear Mr. Betancourt:

l This refers to the Nuclear Regulatory Commission (NRC) inspections conducted on October 29, 1996, and April 2, 1997, at your facility in Aibonito, Puerto Rico, and an NRC Office of Investigations (0I) investigation completed on November 19, 1997. The reports documenting the inspections were issued on November 27,19%, and June 3,1997. respectively. As a result of the j

initial inspection findings, the NRC issued a Confirmatory Action Letter (CAL) on October 31, 1996. Summaries of the apparent violations identified and the  :

01 findings were formally transmitted to you by letter dated December 30, l 1997, which also confirmed arrangements for a predecisional enforcement 1 conference. A closed. transcribed predecisional enforcement conference was conducted at your offices in Aibonito, Puerto Rico, on January 12, 1998, to discuss the apparent violations, the root causes, and your corrective actions to. preclude recurrence. A summary of the conference was transmitted to you by letter dated January 27, 1998. After the conference. Baxter Healthcare Corporation of Puerto Rico (Baxter) requested that NRC alco consider the ,

results of an investigation of the event by its corporatc office. By letter dated March 5,1998. Mr. Raymond T. Murphy of Ross & Hardies, attorney for the Baxter corporate office, submitted the results of the corporate investigation to the NRC. A su to the NRC by Mr.pplemental response to the March 5, 1998 letter was submitted Murphy on March 17, 1998. On May 11.1998. Mr Murphy informed the IRC that the Radiation Safety Officer (RS0) involved in this event had voluntarily resigned.

Based on the information developed during the inspections and the OI investigation, and the information you provided during the conference and by letters dated March 5 and March 17, 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 Penalties  !

.(Notice), and the circumstances surrounding them are described in detail in the subject inspection reports and our letter dated December 30, 1997.

Violation I.A involves willful actions, approximately in June 1996 that caused Baxter to be in violation of NRC requirements. Specifically. the roof l plug interlock switch, a safety system which affected the irradiator "on/off" -

L L NUREG-0940,, PART III A-6

Baxter Healthcare Corporation 2 of Puerto Rico mechanism, was altered (i.e., bypassed) in violation of License Condition 14 and the RS0 was aware that the switch had been altered, but authorized restart of.the irradiator knowing that the switch was in an altered condition.

Notwithstanding your view to the contrary in your March 5,1998 response, the NRC concludes that the RSO's authorization to keep the roof interlock switch-in an altered condition (after trouble shooting of the system had been completed) was made with careless disregard. The conclusion is based on transcribed statements made by Baxter employees to an investigator from the NRC's Office of Investigations, which indicates that the RSO was initially aware of the bypassed switch and was reminded by the senior electrician of the inoperative switch one to two weeks later.

The NRC normally would issue a Severity Level IV violation for Violation I.A.

because the actual and potential safety consequences of bypassing the roof plug interlock were low given the existence of a second interlock. However, the primary regulatory issue is the willful unauthorized alteration of a safety system. This issue is further exacerbated by the duration of the bypassed condition (i.e., the condition was not corrected until it was identified by the NRC on October 29,1996), and the fact that the RSO was reminded of the' inoperable inside roof plug interlock switch and failed to I take action to correct the altered safety system. As noted in Section IV.C of i the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy). NUREG 1600, the PRC attaches high regulatory significance to willful violations because the NRC must be able to rely on the integrity of licensee employees to implement and follow regulatory requirements. The willful, unauthorized bypassing of any safety system interlock is unacceptable and is of significant regulatory concern.

Therefore, in accordance with the Enforcement Policy, the severity level of Violation I.A has been increased to Severity Level III. l Violation I.B involves three additional examples of a violation of License  !

Condition 14 whereby Baxter conducted subsequent, unauthorized re) airs to equipment affecting the irradiator control console's "on off" meclanism.

Notwithstanding your explanation in your March 5,1998 letter that you believed your RSO and Assistant RSO were "specifically licensed" to )erform these repairs, the NRC has concluded that Baxter should have known t11s was not the case, and that these examples constitute a willful violation of NRC requirements. This conclusion is based on Baxter's performance of these repairs after being advised by NRC inspectors, during the October 29, 1996 inspection, in a CAL dated October 31, 1996 in NRC Inspection Report No. 52-21175 01/96 02 dated November 27, 1996, and in the NRC's December 4, 19% acknowledgment of your response to the CAL that repairs could only be conducted by the irradiator manufacturer or other persons specifically licensed by the Commission or an Agreement State to perform these services unless otherwise specified in writing by the Commission. Further, in a February 17, 1997 investigation memorandum to the o>erations manager. your facility's superintendent stated: "Until we have tie approved License Amendment we will consult with MS Nordion for any repair to the irradiator and request written authorization and instructions. We will also inform the NRC of these repairs and the instructions provided by 2S Nordion."

Notwithstanding the above, you performed repairs to the irradiator on March 10 and 14, 1997. without obtaining NRC authorization. Consequently, NUREG-0940. PART III A-7

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Baxter Healthcare Corporation ~ .3

-of Puerto Rico Violation I.B is also of significant regulatory concern due to its willful nature and, thus, has been categorized. in accordance with the Enforcement

. Policy, at Severity Level III.

In accordance with the Enforcement Policy, for a Severity Level III violation occurring before November 12, 1996 a base civil penalty of $2,500 is considered. For a Severity Level-III violation occurring after November 12, '

4 1996, a base civil penalty in the amount of $2.750 is considered. Because the violations described in the enclosed Notice are willful violations of NRC requirements, 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 NRC identified Violation I.A. thus, credit for the factor of Identification was not warranted. Your corrective actions for Violation I.A included repair of the roof plug interlock, a performance check on irradiator safety systems, a review by a representative of the irradiator's manufacturer of the actual as built configuration of.the irradiator safety systems and functional inspections of safety system response, and re training of irradiator operators and support personnel including training on specific License limitations on repairs and alterations and additional controls on  ;

maintenance of safety systems. However, Baxter's corrective action was not comprehensive in that it did not )reclude' recurrence of the violation, as i evidenced by the subsequent unaut1orized repairs described in Violation I.B.

As a result, the NRC determined that credit was not warranted for the factor of Corrective Action and, therefore, twice the base civil penalty is proposed for Violation I.A ($5,000).

With regard to Violation I.B. credit for the Identification factor is not warranted because the'NRC identified the violation. Your corrective actions included obtaining written approval of all repairs from the irradiator manufacturer and the NRC, and submission of a license amendment to clarify the requirements of License Condition 14. Based on these facts and in light of l the training you have provided on specific license limitations on repairs and alterations, the NRC determined that credit was warranted for the factor of  ;

Corrective Action. Therefore, a base civil penalty would normally be 1 proposed. However, in this case, additional violations similar to Violation l I.A occurred between October 29, 1996 and April 2, 1997, due to Baxter's failure to comply with License Condition 14. In addition, the NRC considers '

Violation I.B to be particularly egregious due to the verbal and written notice of the requirements of License Condition 14 that were given to Baxter by the NRC. Therefore, the NRC is exercising discretion in accordance with Section VII.A.1 of the Enforcement Policy and proposing a civil penalty at twice the base amount ($5.500).

Therefore, to emphasize the seriousness of willful violations and the need for prompt identification and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Regulatory Effectiveness to issue the enclosed Notice in the total' amount of $10,500 for the two Severity Level III violations. 'In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

NUREG-0940. PART III~ A-8 ,

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Baxter Healthcare Corporation 4 of Puerto Rico The other apparent violations described in the NRC's letter of December 30, 1997, with regard to inadequate radiation safety training and electrical 1 interlock of-the source hoist mechanism (identified as issue numbers 4 and 5 )

in your March 5, 1998 letter), are being withdrawn, based on review of Baxter's corporate office response dated March 5,1998. However, the four remaining violations, which are described in Part II of the Notice and have each been categorized at Severity Level IV based on their low safety significance, are being cited for the following reasons:

• Violation II.A: In the March 5,1998 letter, Baxter disagreed with this violation stating that all operators are and have been given an annual written examination covering irradiator operations, safety, and l emergency procedures as required by 10 CFR 36.51(e). A copy of the exam was provided as an attachment to the March 5,1998 letter.

10 CFR 36.51(e) requires, in part, that the licensee evaluate the safety performance of each irradiator operator at least annually to ensure that  !

regulations, license conditions, and operating and emergency procedures  !

are followed. The purpose of this requirement is to ensure that the operator's performance is observed while the operator is operating the l irradiator to determine if the operator complies with the regulations, l license conditions, and operating and emergency procedures when he actually performs his job. The regulations distinguish between the safety review described in 10 CFR 36.51(d), which includes a written test, and the evaluation of safety performance required by 10 CFR i 36.51(e). 10 CFR 36.51(d) contains requirements to ensure that, on an annual basis, the operator is knowledaeable of changes effecting the operation of the irradiator, recent events, and results of the performance review required in 10 CFR 36.51(e). During the April 2, 1997 inspection, the inspectors asked the RSO if the licensee conducted performance evaluations of each irradiator operator at least annually and the RSO responded that the licensee did not do an annual performance evaluation of each irradiator operator.

• Violation II.B: In the March 5,1998 letter, Baxter disagreed with this violation stating that the Nordion irradiator plans did not provide for removal of the conductivity meters and, thus, there was no way to calibrate them. Further,Baxterarguedthatgrabsamplesweret@nof the pool water using a bench model conductivity meter. /,

10 CFR 36.63(b) requires that the pool water conductivity be measured .

with a conductivity meter that has been calibrated annually. This measurement is required to be obtained weekly. During the April 2, 1997 inspection, the inspectors determined that the licensee monitored the pool water conductivity on a weekly basis with a conductivity meter system that was installed next to the water recirculation system and which had its detection probe mounted inside one of the recirculation 4 system pipes. The inspectors asked the licensee if this meter was calibrated annually and the licensee responded that it was not. The inspector reviewed the records of these grab samples taken by the licensee and determined that these samples were obtained and monitored not weekly, but about once every two months.

NUREG-0940, PART III A-9

1 Baxter Healthcare Corporation 5 of Puerto Rico Violation II.C: In the March 5, 1998 letter Baxter stated that they disagreed with the violation and maintained that the cited regulation ,

did not require recording of all repairs and maintenance but rather only major malfunctions, significant defects, operating difficulties or irregularities and major operating problems.

An irradiator condition resulting from the malfunction of a safety system that causes the source rack to automatically return to the pool and/or prevent the continued operation of the irradiator is an operating difficulty or irregularity that is recordable pursuant to 10 CFR 36.81(j), and if not properly corrected, is a major operating problem.

In this case. the licensee did not maintain a record of the operating l difficulty associated with the malfunction of the inside roof plug interlock switch which apparently occurred on June 21, 1996, that, if 4

not properly corrected, is clearly a major operating problem. Had such 4

a record been maintained, difficulties associated with determining the date the malfunction occurred would have been avoided, and a record may have served as a reminder to the licensee's staff that the switch had not been replaced.

Violation II.D: In the March 5. 1998 letter Baxter disagreed with this violation stating that neither License Condition 17 nor Baxter's letter of September 12,' 1994 require wiring inspections every six months.

In a response dated A 12, 1994, to a previously cited violation in Inspection Report No.pril 52-21175 01/94 01, dated March 15, 1994 Baxter stated in Item F that procedures were in olace for electrical wiring i inspection.for radiation damage. The electrical wiring inspection I procedure, submitted to the NRC in a separate April IP.,1994 letter, states that this inspect.on will be performed by an authorized i irradiator operator every six months and requires that the irradiator I o>erator perform specific activities and inspect specific elements of t1e irradiator wiring system. As documented in NRC Inspection Report No. 52 21175 01/96 02, this specific procedure was shown to the RSO and the alternate RSO who is also the Maintenance Engineer during the October 29, 1996, inspection. The RSO and the alternate RSO (ARS0) both responded that they were not familiar with this procedure and that the activities required by the procedure had not been performed. At no time I during the inspection, subsequent to the inspection, or in the March 5 or March 17, 1998 letters, has the licensee provided any evidence that this procedure was implemented as described in its March 17, 1998 letter. In evaluating Baxter's response to the enclosed Notice, the NRC )

will consider an affirmative evidence such as affidavits from the individuals that you believe im)1emented the procedure. In any such response please describe why tie RSO and ARS0 were not familiar with this procedure.

Our letter dated December 30, 1997, also identified an apparent violation for providing inaccurate information to the NRC. After review of the available.

information, the NRC has decided not to take enforcement action for this matter. However, we remain concerned that information provided to the NRC at the time of the inspections, during interviews with OI, during the NUREG-0940, PART III A-10

Baxter Healthcare Corporation 6 of Puerto Rico predecisional enforcement conference, and in letters dated March 5 and March 17, 1998, contained inconsistencies which raise questions with regard to the quality of the information provided by Baxter to the NRC and Baxter's overall ability to ensure that information provided to the NRC is complete and :

accurate. Notwithstanding our decision, you should note that licensees are I required to ensure that such information provided to the NRC is in accordance with 10 CFR 30.9. The NRC must be able to rely on complete and accurate information, both written and verbal, to ensure that regulatory requirements are met. Failure to provide complete and accurate information in the future may result in escalated enforcement action.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice and described above 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 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 any response will be placed in the PDR. To the extent possible, your response should not include any personal privacy, pro)rietary, or safeguards information so that it can be placed in the PDR wit 1out 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.

Luis A. Rey Regional mi strator Docket Nos: 030 19882 License Nos: 52 21175 01

Enclosure:

Notice of Violation and Proposed Imposition of Civil Penalties cc w/ encl:

Commonwealth of Puerto Rico Mr. Raymond T. Murphy Ross & Hardies 150 North Michigan Avenue Chicago. Illinois 60601-7567 NUREG-0940. PART III A-11

i NOTICE OF VIOLATION '

AND PROPOSED IMPOSITION OF CIVIL PENALTIES i

Baxter Healthcare Corporation Docket No.030 19882 of Puerto Rico License No.52 21175 01 '

Aibonito Puerto Rico- EA 97 518 During NRC inspections conducted on October 29, 1996 and April 2,1997, ard 4n investigation completed on November 19, 1997, violations of NRC requirements 1 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 amelded (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalties are set forth below:  ;

I. Violations Assessed a Civil Penalty A. Condition 14 to License No. 52 21175 01, Amendment No. 10, reluires, ir part, that the licensee not perform repairs and/or alterations on the irradiator, its control console and safety systems, its shielding or any other mechanism that might affect the irradiator "on off" mechanism. Unless otherwise specified in writing by the Commission. these services shall be performed only by the irradiator manufacturer or other persons specifically l licensed by the Commission to perform these services. i Contrary to the above, in approximately June 1996, the licensee performed an unauthorized alteration to its irradiator consisting i of disabling the lower roof plug safety interlock switch and l bypassing its associated circuitry, which affected the irradiator  !

"on off" mechanism, and such alteration had been neither performed l by persons specifically licensed by the Commission to >erform  ;

these services nor otherwise specified in writing by tie .

Commission. (01013) ,

This is a Severity Level III violation (Supplement VI). l Civil Penalty - 15,000 .

t B. Condition 14 to License No. 52 21175 01, Amendment No. 10, 7aquires, in part, that the licensee not perform repairs and/or '

alterations on the irradiator, its control console and safety i systems, its shielding or any other mechanism that might affect i the irradiator "on off" mechanism. Unless otherwise specified in '

wrPing by the Commission, these services shall be performed only 1 by t.;e irradiator canufacturer or other persons specifically  !

licensed by the Commission to perform these services. l Enclosure NUREG-0940 -PART 1.. A-12 l

! Notice of Violation and Proposed 2

( Imposition of Civil Penalties Contrary to the above, the licensee performed repairs and/or alterations on the irradiator, its control console and safety systems, which affected the irradiator "on off" mechanism, and such alteration had been neither performed by persons specifically licensed by the Commission to perform these services nor otherwise specified in writing by the Commission. Specifically,

1. On November 19 and 25, 1996, the licensee replaced the

control console start switch, which might have affected the "on off" mechanism.

2. On March 10. 1997. the licensee replaced wiring from the DL-2 #5 radiation monitor, a safety system, to the control console, which operates the irradiator "on off" mechanism.

3. On March 14, 1997, the licensee replaced a floor mat (safety system) located in the product entrance area, which operated the irradiator "on off" mechanism. (02013)

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

Civil Penalty - $5,500 II. Violations Not Assessed a Civil Penalty A. 10 CFR 36.51(e) requires, in part, that the licensee evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed.

Contrary to the above, during the year 1996, the licensee failed to evaluate the safety performance of any irradiator operator, to ensure that regulations, license conditions, and operating and emergency procedures were followed. (03014)

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

B. 10 CFR 36.63(b) requires, in part, that conductivity meters (used to neeasure pool water conductivity) be calibrated at least annually.

Contrary to the above, from July 1,1993, until April 2,1997, the licensee failed to calibrate the conductivity meter used to measure the pool water conductivity. (04014)

This is a Severit" Level IV violation (Supplement VI).

C. 10 CFR 36.81(j) requires that the licensee maintain records of

major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed.

l l

NUREG-0940. PART III A-13

Notice of Violation and Proposed 3 l Imposition of, Civil Penalties i Contrary to the above, as of October 29, 1996, the licensee failed to maintain records of major malfunctions significant defects, operating difficulties or irregularities, and major operating problems thatinvolve required radiation safety equipment for three years after repairs are completed. Specifically, the licensee failed to maintain records of a roof plug switch failure .

which occurred in approximately June 1996. (05014) i This is a Severity Level IV violation (Supplement VI). l D. Condition 17 to License No. 52 21175 01. Amendment No. 10, requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated July 22. 1993, and in letters dated September 12. 1994, and February 5. 1995. ,

Item 4.7 in Addendum 7 to the letter dated September 12. 1994, describes the electrical wiring inspection procedure which will be i performed by an authorized operator every six months. j l

Contrary to the above, between February 23. 1995 and March 2. l 1997, the licensee failed to perform the electrical wiring inspection procedure. (06014)

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

Pursuant to the provisions of 10 CFR 2.201 Baxter Healthcare Corporation of Puerto Rico (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 Prowsed Imposition of Civil Penalties (Notice). This reply should be clearly mar (ed 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 i reasons for the violation if admitted, and if denied, the reasons why. (3) the i corrective steps that have been taken and the results achieved. (4) the i 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 i 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 t taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Att. 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 i 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 penalties in whole or in part, by a written answer addressed to the Director. Office of Enforcement.  ;

NUREG-0940. PART III A-14

I Notice of Violation and Proposed 4 Imposition of Civil Penalties U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within l 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 l clearly marked as an " Answer to a Notice of Violation" 7d 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 Licensee 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 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.

4 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, 2 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region II.

Because your res)onse will be placed in the EC Public Document Room (PDR), to the extent possi)le, it should not include any personal privacy, )roprietary, or safeguards information so that it can be placed in the PDR wit 1out 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 muLt s)ecifically identify the portions of your response that you seek to have with1 eld 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 Atlanta, Georgia this /# day of May 1998 NUREG-0940. PART III A-15 w, , ,,n

-~ -_~ - . - ~ _ . _ -___ -~.-._ , .

0 UNITED STATES

1. g"80 9'o NUCLEAR REGULATORY COMMISSION g

$ ATLANTA ER CENTER

\ 'u' j/ "!"ti"NTA.GE R October 9. 1998 b

EA 97-518 Baxter Healthcare Corporation of Puerto Rico ATTN: Mr. Edwin A. Betancourt General Manager P. O. Box 1389 Aibonito..Puerte Rico 00705

SUBJECT:

AMENDED NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES - $10.500. AND DEMAND FOR INFORMATION (NRC INSPECTION REPORT NOS. 52-21175-01/96-01. 52 21175-01/97-01. 52-21175-01/98-

02. AND OFFICE OF INVESTIGATIONS REPORT N0. 2-96-040)

Dear Mr. Betancourt:

This refers to a Nuclear Regulatory Commission (NRC) inspection conducted on August 19. 1998, at your facility in Aibonito. Puerto Rico. The purposes of the inspection were to determine whether activities were conducted safely and in accordance with regulatory requirements and to followup on a July 31, 1998.

operational event at the facility involving a fatality. The results of the inspection were discussed with you on September 16. 1998. The enclosed report presents the results of the inspection.

Based on the results of this inspection, the NRC identified that a violation of regulatory requirements occurred. The violation involved a failure to adhere to the requirements of 10 CFR 36.31(a), which requires that the lock for the source control of a panoramic irradiator be designed so that the key '

may not be removed if the sources are in an unshielded position. The NRC inspection identified that between November 19 ano 25. 1996. Baxter operated the irradiator with a lock for the source cc:d/01 that allowed the key to be removed with the sources in an unshielded position.

The inspection revealed that individuals at Baxter were apparently aware that the design of the replacement source control switch permitted the key to be removed while the sources were in the unshielded position. In addition. based on discussions with the inspector. these same individuals knew, or should have known, that NRC regulations at 10 CFR 36.31 s)ecifically prohibit this condition because the individuals contacted tie irradiator manufacturer and took measures to compensate for the lack of a properly functioning switch.

Notwithstanding this knowledge. these individuals allowed the irradiator to be operated in noncompliance with 10 CFR 36.31. During this time. Baxter did institute compensatory measures recormiended by the irradiator manufacturer:

however, thuse measures were not a substitute for compliance with NRC requirements.

The NRC is citing the above violation and amending and reissuing the Notice of Violation and Proposed Imposition of Civil Penalties (Notice) originally issued to Baxter on May 14. 1998. As discussed in the enclosed inspection report, this violation is directly related to Violation I.B. of the NUREG-0940. PART III A-16

M Baxter Healthcare Corporation- '

of Puerto Rico May 14. 1998 Notice, which was associated with the unauthorized replacement of

.the lock for the irradiator source control on November 19 and 25, 1996. At the time that the original Notice was issued.'the NRC was unaware that the replacement lock was a different design, and that this design allowed the key to be removed with the sources in an unshielded position resulting in a viciation of 10 CFR 36.31(a). This new violation is included in Section 1.B.

of the amended Notice as Violation I.B.(2). The civil penalty assessed for the violations cited in Section I.B. of the amended Notice remains the same as in the original Notice. $5.500.

In its letters dated July 8 and 15,1998. Baxter provided responses to the

May 14, 1998 Notice. Baxter is hereby required to respond to Violation I.B.(2) of the enclosed amended Notice. You may also supplement or amend any ,

portion of your previous responses in order to take into account this new violation, or for any other reason. You should follow the instructions

- specified in the enclosed amended Notice when preparing your response. In your response, you should document the specific actions taken and any

-additional actions you plan to prevent recurrence of Violation I.B.(2).

In addition to the enclosed amended Notice of Violation and Proposed

! Imposition of Civil Penalties, the NRC is issuin a Demand for Information j

(Demand) because.-as discussed above. Baxter emp oyees were apparently aware  !

l that the' design of the replacement source contro switch permitted the key to be removed while the sources were in the unshielded position: and they apparently also knew, or should have known. that 10 CFR 36.31 specifically prohibits this condition. Therefore, in addition to the response required above. further information is needed to determine whether the Comission can have reasonable assurance that Baxter will, in the future, conduct NRC-licensed activities in compliance with NRC requirements.

Accordingly, pursuant to sections 81. 161c 1610. 182 and 186 of the Atomic Energy Act of 1954. as amended.. and the Commission's regulations in 10 CFR 2.204 and 10 CFR 30.32(b). in order to determine whether your license should be modified. suspended or revoked or other enforcement action taken to ensure compliance with NRC requirements. Baxter is hereby required to submit to the i J Director. Office of Enforcement. 'U.S. Nuclear Regulatory Comission. One White Flint North. 11555 Rockville Pike Rockville Maryland 20852 2738, within 30 days of the date of this Demand, with a copy to the Regional Administrator.

U.S. Nuclear Regulatory Comission. Region II, the following information in writing and under oath or affirmation:

1. An explanation as to why the NRC should not conclude that

- Violation I.B.(2) of the Amended Notice of Violation and Proposed Imposition of Civil Penalties is a willful violation as defined in Section IV.C of the NRC Enforcement Policyl . If your employees were not aware of the relevant NRC requirements, you should address the reasons i

1 General Statement of Policy and Procedures for Mtc Enforcement Actions.* MUREG 1600.

NUREG-0940. PART III A-17

1 saxter Healthcare Corporation of Puerto Rico for the lack of awareness and why the Commission should have reasonable i assurance that Baxter employees will. In the future, have sufficient I knowledge and understanding of NRC requirements.  !

2. An explanation as to why the NRC should have confidence that, in the  ;

future. Baxter employees will conduct NRC-licensed activities in i accordance with NRC requirements. In developing your response, you )

should address whether Baxter has considered acquiring the services of J an outside contractor familiar with NRC regulatory requirements to serve l as a consultant and to train and audit your staff to ensure that they l understand and comply with NRC requirements. '

You may provide any other information you deem appropriate, including an i assessment of whether the facts related to this issue as cocumented in Inspection Report 52-21175-01/98-02 are correct.

The NRC's evaluation of your responses of July 8 and 15.1998. is ongoing. l After we review the responses required by the enclosed amended Notice and the 1 Demand, the NRC will inform you of our decision as to whether additional Agency action will be taken with regard to these violations.

In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice." a co)y of this letter. its enclosures, and any response will be placed in the Pu)lic 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 POR 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.

Luis A. Reye" Regional Adm trator Docket Nos: 030 19882 License Nos: 52-21175-01

Enclosures:

1. Amended Notice of Violation and Proposed Imposition of Civil Penalties

2. Inspection Report 52-21175 01/98 02 cc w/encls: (see page 4)

NUREG-0940. PART III A-18

Baxter Healthcare Corporation  !

of Puerto Rico I

cc w/ encis:

Comonwealth of Puerto Rico Mr. Raymond T. Murphy 4 Ross & Hardies 150 North Michigan Avenue l Chicago, Illinois 60601-7567 ,

l I

l

. I l

l f

I NUREG-0940. PART III A-19

AMENDE0 NOTICE OF VIOLATION l AND l PROPOSED IMPOSITION OF CIVll PENALTIES  !

I Baxter Healthcare Corporation Docket No.030-19882 l of Puerto Rico License No.52-21175-01 L Aibonito. Puerto Rico EA 97-518

)

During NRC inspections conducted on October 29.1996. April 2. '1997, and I August 19. 1998, and an investigation completed on November 19. 1997.

violations of NRC requirements were identified. In accordance with the .

l

" General Statement of Policy and Procedures for NRC Enforcement Actions. J NUREG-1600, the NRC proposes to impose civil penalties pursuant to Section 234 I 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: '

I. Violations Assessed a-Civil Penalty l A. Condition 14 to License No. 52-21175-01. Amendment No. 10.

requires, in part, that the licensee not perform repairs and/or 1 alterations on the irradiator, its control console and safety

, systems. Its shielding or any other mechanism that might affect l the irradiator "on off" mechanism. Unless otherwise specified in l l writing by the Commission, these services shall be performed only l by the irradiator manufacturer or other persons specifically l licensed by the Commission to perform these services.

Contrary to the above. in approximately June 1996, the licensee performed an unauthorized alteration to its irradiator consisting of disabling the lower roof plug safety interlock switch and bypassing its associated circuitry, which affected the irradiator l "on-off" mechanism, and such alteration had been neither performed

by persons specifically licensed by the Conmission to perform these services rar otherwise specified in writing by the l Comission. (0* 43) l This is a Severity Level III violation (Supplement VI).

Civil Penalty - s5.000 -

B. (1) Condition 14 to License No. 52-21175 01. Amendment No. 10.

recuires. in part that the licensee not perform repairs l l

anc/or alterations on the irradiator. Its control console l and safety systems. Its shielding or any other mechanism that might affect the irradiator "on off" mechanism. Unless otherwise specified in writing by the Commission, these services shall be Erformed only by the irradiator manufacturer or otler persons specifically licensed by the

, Commission to perform these services.

L

Contrary to the above the licensee performed repairs and/or alterations on the irradiator. its control console and safety systems. which affected the irradiator "on-off"

[

Enclosure 1 NUREG-0940. PART III A-20 l

l Notice of Violation and Proposed Imposition of Civil Penalties mechanism, and such alteration had been neither perfonned by persons specifically licensed by the Comission to perform these services nor otherwise'specified in writing by the j Comission. i Specifically:.

1. On November 19 and 25. 1996.. the licensee replaced the

-control console start switch, which might have affected the "on off" mechanism.

2. On March 10. 1997, the licensee replaced wiring from the DL-2 #5 radiation monitor, a safety system, to the control console, which operates the irradiator "on-off" mechanism.

3. On March 14. 1997, the licensee replaced a floor mat (safety-system) located in the product entrance area.

which operated the irradiator "on-off" mechanism.

(02013)

B. (2) 10 CFR 36.31(a) requires that the lock for the source-control of a panoramic irradiator be designed so that the  :

key may not be removed if the sources are in an unshielded l

. position. J Contrary to the above, between November 19 and 25, 1996, the licensee operated the irradiator with a lock for the source control having a design that allowed the key to be removed with the sources in an unshielded position. (02023)

These violations represent a Severity 1.evel III problem (Supplement VI).

Civil Penalty-- 55.500 II. Violations Not Assessed a Civil Penalty A. 10 CFR 36.51(e) requires. in part that the licensee evaluate the safety performance of each irradiator operator at least annually-

-to ensure that regulations, license conditions, and operating and emergency procedures are followed.

Contrary to the above, during the year 1996, the licensee failed to evaluate the safety performance of any irradiator operator, to  ;

ensure that-regulations, license conditions, and operating and

-emergency procedures were followed. (03014) l This is a_ Severity L.evel'IV violation (Supplement VI).

B. 10 CFR 36.63(b) requires. in part, that conductivity meters (used to measure pool water conductivity) be calibrated at least annually.

NUREG-0940. PART III. A-21

Notice of Violation and Proposed Imposition of Civil Penalties Contrary to the above, from July 1.1993 until April 2.1997, the licensee failed to calibrate the. conductivity meter used to measure the pool water conductivity, (04014) l This is a Severity Level IV violation (Supplement VI).

C. 10 CFR 36.81(j) requires that the licensee maintain records of major malfunctions significant defects, operating difficulties or irregularities, and major operating problems that involve required i radiation safety equipment for three years after repairs are  ;

completed. '

1 Contrary to the above, as of October 29. 1996. the licensee failed I to maintain records of major malfunctions, significant defects. ,

operating difficulties or irregularities, and major operating l problems that involve required radiation safety equipment for l three years after repairs are completed. Specifically, the  !

licensee failed to maintain records of a roof plug switch failure l which occurred in approximately June 1996. (05014) l This is a Severity Level IV violation (Supplement VI).

D. Condition 17 to License No. 52 21175-01. Amendment No. 10.

requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the license application dated July 22. 1993. and in letters dated September 12. 1994, and February 5. 1993.

Item 4.7 in Addendum 7 to the letter dated September 12, 1994.

describes the electrical wiring inspection procedure which will be performed by an authorized operator every six months.

Contrary to the above, between February 23, 1995 and March 2.1997, the licensee failed to perform the electrical wiring inspection procedure. (06014)

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

Pursuant to the provisions of 10 CFR 2.201 Baxter Healthcare Corporation of Puerto Rico (Licensee) is hereby required to submit a written statement or explanation to the Director. Office of Enforcement. U.S. Nuclear Regulatory Cmmission within 30 days of the date of this Amended Notice of Violation and Proposed Imposition of Civil Penalties (Notice) for Violation I.B.(2) only.

The Licensee has already resx)nded to the remaining violations in its letters dated July 8 and 15,1998. iowever, the Licensee may amend its responses or provide any additional information at this time, and may address the aggregation of Violations I.B (1) and I.B.(2) if it chooses to do so. This reply should be clearly marked as a " Reply to a Notice of Violation" and should include, for Violation I.B.(2): (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 NUREG-0940. PART III A-22

Notice of Violation and Proposed Imposition of Civil Penalties 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, sus) ended, or revoked or why such other action as may be proper l should not be tacen. Consideration may be given to extending the response  ;

time for good cause shown. Under the authority of Section 182 of the Act. l 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Although the licensee's responses of July 8 and 15.1993, protested the civil penalties proposed in the NRC's May 14, 1998 Notice, the Licensee may pay the civil penalties at this time if it chooses to do so: or the Licensee may await NRC's determination concerning this matter, including the Licensee's response to Violation I.B.(2) and any other information that the Licensee chooses to  ;

submit. If the Licensee chooses to pay the civil penalties at this time, l payment should be made within 30 days 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. The Licensee may if it chooses, submit a further response protesting the 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 Comission. Should the Licensee fail to answer within the time specified, the NRC will proceed with its review on the basis of the information available to l date. 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 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 l 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 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 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 responses noted above (Reply to Notice of Violation, letter with payment of civil penalties, and Answer to a Notice of Violation) should be an.?essed to: Mr. James Lieberman. Director. Office of Enforcement. U.S. NuclcJr NUREG-0940. PART III A-23

Notice of Violation and Proposed Imposition of. Civil Penalties Regulatory Comnission. One White Flint North.11555 Rockville Pike. Rockville.

MD 20852-2738. with a copy to the Regional Administrator. U.S. Nuclear Regulatory Commission. Region II.

Because your resmnse will be placed in the NRC Public Document Room (PDR). to the extent.possi)le it should not include any personal privacy. 3roprietary, or safeguards information so that it can be placed in the PDR wit 1out redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then piease 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 muit sacifically identify the portions of your response that you seek to have withield and provide in detail the bases for your claim of withholding (e.g..

will create an unwarranted invasion o. fexplain why personal the disclosure privacy or provide of the information information required by 10 CFR 2.790(b) to support a request for withholding confidential.connercial 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 Atlanta. Georgia this 9th day of October 1998 l

l l NUREG-0940. PART III A-24 1 l - -

\

_ . . _ . _. ~_..__...,___.-.___..______.-___~.__.m._ m utog j kg UNITED STATES NUCLEAR REGULATORY COMMISSION 4

-[

ti f REoloN I QL 475 ALLENoALE RoAo KING oF PRusstA, FONSYLVANIA 1940s 1416 j  %*****

i July 10,1998 l - EA No.98-163 1

i Ms. Marie Bodman, President Breitling USA, Inc.

2 Stamford Landing j Stamford, Connecticut 06902

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES j - $26,400 AND DEMAND FOR INFORMATION 3 (NRC inspection Report No. 999-90001/98-002) i

Dear Ms. Bodman:

I j This letter refers to the Nuclear Regulatory Commission (NRC) inspection conducted at your

facility in Stamford, Connecticut, on March 10,1998, during which the NRC found that you l had possessed, used (repaired) and distributed from your facility, between 1989 and 1998, j more than 70,000 timepieces (watches) (containing up to 3.1 millicuries of tritium per l

timepiece) without an NRC license authorizing such activities. The inspection was conducted

after the NRC contacted you in February 1998 following notification from tM State of

{ Connecticut that such activities may have been occurring at your facility. Previously, on i March 6,1998, the NRC issued a Confirmatory Action Letter (CAL), which confirmed your i commitment to cease such distribution until the NRC issued a license authorizing such use. )

j You submitted en application for an exempt distribution license with the NRC Office of Nuclear Material Safety and Safeguards (NMSS) on March 14,1998, and NMSS issued a license on 3

March 27,1998. In addition, you submitted an application for a possession license with the i NRC Region I office on March 15,1998, and a license was issued on March 20,1998.

j in a letter dated April 6,1998, the NRC forwarded to you the related inspection report. In that j letter, the NRC informed you that you could either respond in writing to the results of the

inspection, or request a predecisional enforcement conference. On April 16,1998, Mr. Keith 1

Brown of your staff contacted the NRC and requested a predecisional enforcement conference to discuss the apparent violations, their causes, and your corrective actions. The predecisional enforcement conference was held with him on May 7,1998. A copy of the

! predecisional enforcement conference report was forwarded to you by separate j correspondence on May 14,1998.

j Based on the inspection findings and the information you provided at the predecisional j enforcement conference, the NRC has determined that two violations of NRC requirements f occurred. The violations are described in the enclosed Notice of Violation and Proposed j Imposition of Civil Penalty (Notice), and the circumstances surrounding the violations are described in detailin the subject inspection report. The violations involve the possession and

• - use, as well as distribution, of NRC licensed material without possessing NRC licenses j authorizing these activities. Furthermore, since you received the timepieces (watches) from j your parent company in Switzerland and distributed them to Jewelry shops in the United i

j. NUREG-0940. PART III A-25

-- - -- - . . - -- .. ._ - . .~. --.----

1 4

i

Breitling USA, Inc. 2 {

l

! States, you did not qualify for the exemption set forth in 10 CFR 30.15(a) regarding such activities. The NRC is principally concerned that for an extended duration you operated your ,

i business outside the regulatory framework established to assure that the possession, use, and l

distribution of radioactive materials does not adversely affect puolic health and safety.

,' Because you operated outside the regulatory framework, the NRC was unable to conduct inspections of your facility to determine whether the methods and controls you established <

1 for possessing, using, and distributing radioactive materials were in accordance with regulatory )

, requirements established to protect public health and safety. In fact, during the inspection,

, the NRC identified contamination at your facility, although the amount of contamination was j low and was subsequently cleaned.

j' The NRC is also concerned that your company had strong indications, beginning in early 1997, that you needed an NRC license, as Mr. Brown indicated at the predecisional enforcement j conference. Mr. Brown also stated that in November 1997, your parent company in j Switzerland, raised questions regarding regulation of tritium in the United States, and you .

i sought advice from your staff, your in-house attorney, and an independent contractor as to I

! whether you needed an NRC license. Although Mr. Brown admitted that he was informed by 3 those parties that you probably needed an NRC license, he also stated that Breitling decided, i j given the holiday season, not to contact the NRC at that time, for fear that it could shutdown i

] your business. Instead, another consultant was retained to confirm that an NRC license was

! needed. Furthermore, despite all of the indications that an NRC license was required, action '

i was not taken to obtain a license until after the NRC inspection on March 10,1998. The  !

i failure to act sooner to either obtain an NRC license, or contact the NRC to determine if a j t

license was needed, constitutes, at a minimum, careless disregard of NRC requirements, which  !

i is considered willful within the context of the NRC Enforcement Policy. In the NRC's view, l

your company either made a conscious decision to remain in violation of NRC regulatory I j requirements to obtain economic benefit, or chose to carelessly disregard NRC regulatory j I requirements and not contact the NRC to determine whether NRC licenses were required. 1 Given the importance of assuring that possession and use, as well as distribution of I radioactive material, is properly controlled, and given the willful nature of the violations by i

senior individuals in your organization, the violations are classified at Severity Level ll in accordance with the " General Statement of Policy and Procedure for NRC Enforcement 3 Actions" (Enforcement Policy), NUREG-1600.

4 J

1

Civil penalties are assessed according to the Civil Penalty Assessment Factors in Section VI.B.2 of the NRC Enforcement Policy, which allows for consideration of discretion to ensure ,

that the proposed civil pe+ eflects the significance of the circumstances and conveys the appropriate regulatory' After considering the regulatory significance of the violations,

which included the ir u of the NRC to conduct inspections of your activities, the duration j of the violations, the costs of maintaining NRC licenses which you avoided during the period of noncompliance, and your failure to promptly contact the NRC once you had indications that the need for a license was likMy, the NRC has determined, in accordance with Section -

Vll.A.1.(a) of the Enforcement Pdicy, that it is appropriate to exercise enforcement discretion ,

in this case and issue separate civil penalties in the amount of $13,200 for each of the two '

violations, resulting in a cumulative civil penalty of $26,400. The NRC arrived at the $13,200 amount for each civil penalty by tripling the base civil penalty amount of $4,400 for a Severity Level ll violation listed in Tables 1 A and 18, Base Civil Penalties, of the Enforcement Policy.

}-

NUREG-0940. PART III A-26

.. . _ _ _ ___ _ _ _ _ _ .. _ ..~.__. - - _. _ _ _ .. _ _ _ _ _ _

i Breitling USA, Inc. 3 l l In determining the amount of the civil penalty, recognition was given for corrective action. i The NRC recognizes that you eventually initiated comprehensive corrective action, described at the conference, which included: (1) applying for an NRC license; (2) ceasing distribution of the materials; and (3) maintaining your operations in a shutdown condition until your license was issued.- Consideration was also given to the length of time during which the NRC was unable to carry out its statutory responsibility. Between 1989 and 1998, Breitling USA, Inc. I distributed approximately 70,000 timepieces containing byproduct material without a license in violation of NRC regulations. However, since the statute of limitations period for assessing civil penalties is only five years (28 U.S.C. 2462), the NRC only considered the period between August 1993 and March 1998 for purposes of determining the amount of the civil "

penalty.

Therefore, to emphasize (1) the importance of conducting NRC activities only after receiving an NRC license, and adhering to the terms and conditions of that license, and (2) the significance of willful violations, I have been authorized, after consultation with the Commission to issue the enclosed Notice of Violation and Proposed imposition of Civil Penalty (Notice)in the amount of $26,400 for the violations described in the enclosed Notice. I also note that due to a recent revision to the Enforcement Policy issued on May 13,1998, the NRC would have considered a much larger civil penalty had the violations continued past May of I 1998 (see Table 1 A-Base Civil Penalties,- item c, of the Enforcement Policy).' in addition, I issuance of this Notice constitutes escalated enforcement action that may subject you to l increased inspection effort. i l

You are required to respond to this letter and enclosed Notice, and you 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 1 compliance with regulatory requirements, l

in addition to the civil penalty, given the willful nature of your failure to contact the NRC once you had indications that a license was probably needed, the NRC is also issuing a Demand for  ;

Information to you, pursuant to sections 161c,1610,182 and 186 of the Atomic Energy Act i of '1954, as amended, and the Commission's regulations in 10 CFR 2.204 and 10 CFR l 30.32(b), in order for the Commission ts determine whether your license should be modified, l suspended or revoked, or other enforcement action taken to ensure compliance with NRC regulatory requirements. In response to this Demand, you are required to submit to James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 0001, within 30 days of the date of this Demand for Information, in writing and under oath or affirmation:

(1) The reasons why Breitling's licenses should not be revoked; (2) The reasons why the NRC should have confidence that Breitling will comply

'with regulatory requirements in the future and not engage in willful violations of those requirements, i

' Effective May 13,1998, the base civil penalty for a Seventy Level I violation was i changed from $5,500 to $11,000 for large material users l

NUREG-0940. PART III A-27

. . . . - . - .. -~ . - .. - - - - . - - . . - _- - _. - -__- . - -_ .

1 Breitling USA, Inc. 4 After reviewing your response, the NRC will determine whether further action is necessary to ensure compliance with regulatory requirements. 1

, 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. If personal privacy or J proprietary informatica 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 muti 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). ,

i Sincerely, l

Hubert J. Mille &

Regional Administrator ,

Docket No. 999-90001 License No. N/A

Enclosure:

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

State of Connecticut i

NUREG-0940. PART III A-28 l

, _U

u-. - - - - . - . - - - - - . - . _ . - - - - - . - . - . - - . - - - - - . . . . - . _ . .

ENCLOSURE NOTICE OF VIOLATION AND i

PROPOSED IMPOSITION OF civil PENALTIES Breitling USA, Inc. Docket No. 999-90001  ;

Stamford, Connecticut License No. N/A EA 98-163 During an NRC inspection on March 10,1998, 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 civil penalties pursuant to i 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 penalties are set forth below:

A. 10 CFR 30.3 requires, in part, that except for persons exempt, no person shall receive, acquire, own, possess or use byproduct material except as authorized in a specific or general license issued pursuant to Title 10, Chapter 1, Code of Federal Regulations.

10 CFR 30.15(a) provides, in part, that persons who initially transfer for sale or distribution timepieces containing byproduct material are not exempt from the requirements for a license.

Contrary to the above, between 1989 and March 1998, Breitling USA, Inc., received and possessed approximately 70,000 timepieces (watches), containing up to 3.1 millicuries of tritium per timepiece, without a valid NRC possession license, and was not exempt from the requirements for a license, since it received the timepieces from its parent company in Switzerland and distributed them to Jewelry shops in the United States. (01012)

This is a Severity Level ll Violation (Supplement VI).

Civil Penalty - $13,200 B. 10 CFR 30.3 requires, in part, that except for persons exempt, no person shall transfer byproduct material except as authorized in a specific or general license issued pursuant to Title 10, Chapter 1, Code of Federal Regulations.

10 CFR 30.15(a) provides, in part, that persons who initially transfer for sale or distribution timepieces containing byproduct material are not exempt from the requirements for a license.

Contrary to the above, between 1989 and March 1998, Breitling USA, Inc.,

transferred (distributed) approximately 70,000 timepieces (watches), containing up  !

to 3.1 millicuries of tritium per timepiece, without a valid NRC distribution license, and !

was not exempt from the requirements for a license, since it received the timepieces from its parent company in Switzerland and distributed them to jewelry shops in the i United States. (01022)

This is a Severity Level ll Violation (Supplement VI).

Civil Penalty - $13,200 NUREG-0940. PART III A-29

Enclosure 2 Pursuant to the provisions of 10 CFR 2.201, Breitling USA, 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. 20555-0001, with a copy to the Regional Administrator, Region I, within 30 days of the date of ths letter transmitting this Notice of  ;

Violation and Proposed imposition of Civil Penalties (No: ice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each alleged 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 previous docketed correspondence, if the ,

correspondence adequately addresses the required response. If an adequate reply is not j 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 James Lieberman, 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.

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 ad+essed 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 penalties 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 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 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 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 l 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 penalties.

l Upon failure to pay any civil penalties due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the j 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.

NUREG-0940. PART III A-30

Enclosure 3 The response noted above (Reph to Notice of Violation, letter with payment of civil penalties, 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 l l

Rockville Pike, Rockville, MD 20852 2738,with a copy to the Regional Administrator, U.S.

Nuclear Regulatory Commission, Region 1.

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 mM11 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.

i Dated at King of Prussia, Pennsylvania this 10th day of July 1998 L

l i

I NUREG-0940. PART III A-31

_ - . _ _. __ ____s -- _____.m . _ _ . - - - _ _ _ _ _ _

1. g 40 0g UNITED STATES NUCLEAR REGULATORY COMMISSION 8' e,'h REGION il

$ ATLANTA FEDERAL CENTER k .j 61 FORSYTH STREET. SW. SUITE 23T85 ATLANTA. GEORGIA 30303-3415

"*** May 22. 1998 EA 98-184 Jos6 M. Col 6n Vaquer M.D.

P.O. Box 76 Manati. Puerto Rico 00674

SUBJECT:

NOTICEOFVIOLATIdNANDPROPOSEDIMPOSITIONOFCIVILPENALTY-

$4.400 (NRC INSPECTION REPORT NO. 52-25113-02/98-01)

Dear Dr'. Col 6n:

This refers to the special inspection conducted on March 2 and 5. 1998 at your Manati. Puerto Rico facility. The pur)ose of the special inspection was to determine whether activities authorized )y the license were conducted safely and in accordance with regulatory requirements. The results of the inspection were discussed with you on March 5. 1998, and were formally transmitted to you by letter dated April 4. 1998. Based on the preliminary inspection results, you submitted a March 6. 1998, letter stating that you would suspend use of your Strontium-90 (Sr-90) eye applicator and place it in locked safe storage. On April 16. 1998. you agreed with the commitments i described in the NRC's letter of April 15. 1998. regarding a Confirmatory i Order Modifying License (Order) associated with discontinuance of use of your Sr-90 eye applicator. The NRC confirmed your commitment to do so with the  !

issuance of the Order, effective immediately, on April 21. 1998. A closed and j transcribed predecisional enforcement conference was conducted in the Region II office on May 4.1998, to discuss the apparent violations. the root i causes, and your corrective actions to preclude recurrence. A list of l conference attendees, a copy of the Nuclear Regulatory Commission's (NRC) presentation material, and a copy of the information you provided at the j conference are enclosed.

Based on the information developed during the inspection and the information you provided during the conference, the NRC has determined that ten violations  !

of regulatory requirements occurred. The violations are cited in the enclosed Notice of Violation and Pro 30 sed Imposition of Civil Penalty (Notice), and the circumstances surrounding t1em are described in detail in the subject inspection report.

The violations, as enumerated in the enclosed Notice. involve: the failure to use written directives on multiple occasions as required by 10 CFR '

35.32(a)(1): the failure to have a written procedure to ensure that final treatment plans and related calculations (exposure time) were in accordance with written directives as required by 10 CFR 35.32(a)(3): the failure to limit activities involving byproduct material to those related to decommissioning following the expiration of license No. 52-25113-01 as l required by 10 CFR 30.36(c): the failure to secure from unauthorized removal l

or access to licensed material as required by 10 CFR 20.1801: the failure to perform annual reviews of the radiation protection program as required by 10 CFR 20.1101(c):'the failure to test a brachytherapy source for leakage as l

NUREG-0940. PART III A-32

J Jos6 M. Col 6n Vaquer. M.D. 2 required by 10 CFR 35.59(b)(2) (this is a repeat violation): the failure to perform brachytherapy surveys qutrterly as required by 10 CFR 35.59(h): the i

failure to issue personnel dosimetry monitoring as required by condition 17 of license No. 52-25113-02: the failure to record brachytherapy source inventories as required by 10 CFR 35.59(g): and the failure to post copies of i the current license and NRC regulations as required by 10 CFR 19.11(a) and I (b). In addition, our inspection of March 2 and 5.1998, identified that you did not take actions to correct an earlier violation identified during an 1 inspection conducted on August 10. 1995, regarding the performance of an )

annual review of the Quality Management Program (OMP) as required by 10 CFR 35.32(b)(1). Thus, you continued to be in violation of this requirement from the time of identification on August 10. 1995. until the expiration of license No. 52-25113-01. on November 30, 1995. It should also be noted that you have not conducted a review of your OMP since issuance of License No. 52-25113-02 on March 28. 1997. l At the conference, you agreed that the violations occurred as documented in NRC Inspection Report No. 52-25113-02/98-01, and stated that the cause of the violations involved several factors including personal hardship, the loss of key personnel at your office, and increased demands on your office associated with new health services reforms. Because of these factors, you did not apply the appropriate attention to ensure compliance with regulatory requirements.

Violations I. A and I.B of the enclosed Notice describe two misadminstrations.

Although the misadministrations were not substantial and were within the normal treatment ranges the violations represent a substantial programmatic failure in the implementation of your OMP that resulted in at least these two misadminastrations. As a result, one individual was misadministered aaproximately 1500 centigrays instead of the intended dose of 1000 centigrays, w1ile another individual was misadministered approximately 1000 centigrays i instead of the intended dose of 1500 centigrays. In addition to the misadministrations, as a license holder, you are required to establish and maintain a written OMP to provide high confidence that byproduct material or .

radiation from byproduct material will be administered as directed by you, the l authorized' user. In this case, you routinely failed to prepare written

~

directives to ensure proper administration of radiation dose and failed to '

provide for the verification of the calculations for exposure times. )

Therefore. Violations I.A and I.B are considered to be of very significant  ;

regulatory concern and have been classified in the aggregate in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy). NUREG-1600, as a Severity Level II problem.

l In accordance with the Enforcement Policy, a base civil penalty in the amount of $4400 is normally considered for a Severity Level 11 problem. The NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil Senalty assessment process in Section VI.B.2 of the Enforcement Policy. T1ese issues were identified as a result of an NRC inspection. Although you identified Violations I.A and I.B at the beginning of the inspection, you did so only after our announcement of an  !

inspection at your facility which prompted you to review your OMP. The NRC has concluded that absent the announcement of our intent to conduct an inspection, these issues would not have been identified by you. As such. no NUREG-0940. PART Ib A-33  ;

Joss M. Col 6n Vaquer. M.D. 3 credit is warranted for Identification. Your corrective actions, as indicated at the predecisional enforcement conference, included immediately suspending the use of your Sr-90 eye applicator source, and immediate placement of the l Sr-90 source in locked safe storage. As stated earlier, you confirmed your commitment to take these actions by agreement to a Confirmatory Order Modifying License, effective immediately, issued by the NRC on April 21. 1998.

You stated that you have reviewed the misadministrations and have concluded l that no adverse consequences will result, as the total applied doses in both  !

cases were below the maximum recommended dosage. You also have notified one I of the patients involved and have attempted to notify the other one and have  ;

offered medical followu). In addition, you stated at the conference that you I are actively pursuing tie transfer or disposal of your Sr-90 source. Thus, based on these facts. the NRC determined that credit is warranted for Corrective Action. I Violations I.A and I.B represent a substantial programmatic failure in your 0MP which resulted in the misadministration of dose to two individuals.

Therefore, to emphasize the importance of compliance with OMPs associated with the administration of brachytherapy doses to the eye, and after consultation i with the Director. Office of Enforcement. I have been authorized to propose the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $4.400. Issuance of this Notice constitutes escalated enforcement action. that may subject you to increased inspection effort. In addition, you should be aware that future similar violations may result in a prohibition against conducting licensed activities in NRC jurisdiction.

Violation A in Part II of the Notice occurred as a result of your use of the Sr-90 eye applicator during a period when your license was expired, contrary to regulatory requirements and verbal instructions by the NRC. You stated at the conference that you unsuccessfully attempted to file a new application for an NRC license after expiration of your first license on December 1.1995, and solicited the help of other individuals to assist in the preparation of the required application document. However, due to difficulties you encountered in acquiring assistance in completing and filing the new application, and the 3ersonal hardships you were experiencing at that time, you failed to do so.

ionetheless. your failure in assuring regulatory processes were adequately completed. which resulted in the unauthorized use of licensed radioactive material, represents a significant regulatory concern. Therefore, this violation is classified at Severity Level III in accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy). NUREG-1600.

Violations B through H of Part II of th. Notice indicate a significant breakdown and lack of attention toward licensed responsibilities. The large number of non-compliances with regulatory requirements demonstrate your inability or unwillingness to develop and maintain the required oversight of the use of licensed radioactive material. Accordingly, these violations have been classified in the aggregate in accordance with the " General Statement of l Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy).

NUREG-1600, as a Severity Level III problem.

1 NUREG-0940. PART III A-34

Jos6 M. Col 6n Vaquer. h.D. 4 Regarding Violations A through H in Part II of the Notice, in accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for each Severity Level III problem or violation. Because you have not been the subject of escalated enforcement action within the last two years l or two inspections. the NRC considered whether credit was warranted for  !

Corrective Actiqn in accordance with the civil penalty assessment process described in Section VI.B.2 of the Enforcement Policy. As discussed above for I the Violations in Part I of the Notice, credit is warranted for Corrective Action.

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 for Violations A through H of Part II of the Notice. However, significant violations in the future could 1 result in a civil penalty. j Since you have indicated your intent to transfer or dispose of your Sr-90 eye applicator in the future. the NRC will consider reducing the proposed civil penalty to $2200 if you properly dispose of or transfer the Sr-90 eye applicator in accordance with existing regulations within 90 days of the date of this enforcement action. If you decide to do so, you should specify your intentions in your response to the enclosed Notice. In addition, you should provide written confirmation to the NRC when you have properly disposed of or transferred the Sr-90 eye applicator.

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 any response will be placed in the NRC Public Document Room (PDR). 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.

Luis A. R Regional A i nistrator Docket No. 030-34060 License No. 52-25113-02 NUREG-0940. PART III A-35

Jose M. Col 6n Vaquer. H.D. 5

Enclosures:

1. Notice of Violation and Imposition of Civil Penalty

2. List of Attendees

3. NRC Slides

4. License Material J cc w/encls:

Commonwealth of Puerto Rico l

l l

I l

l NUREG-0940. PART III A-36 l

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NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Jos6 H. Co16n Vaquer. M.D. Docket No. 030-34060 Manati. PJerto Rico License Nos. 52-25113-01 (expired) and 52-25113-02 EA 98-184 During ar NRC inspection conducted on March 2 and 5. 1998 violations of NRC requirerrants were identified. In accordance with the " General Statement of Policy .snd Procedures for NRC Enforcement Actions." NUREG-1600, the NRC 3roposas 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:

I. Violations Assessed a Civil Penalty A. 10 CFR 35.32(d) requires. for each administration of a radiopharmaceutical or radiation for which a written directive is required under 10 CFR 35.32(a)(1), that the licensee retain, for three years after the date of the administration. M .iritten directive and a record of the radiation dose or radiopharmaceutical dosage administered.

10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing certain specified information.

10 CFR 35.32(a)(1)(iii) requires. with exemptions not aaplicable I here. that a written directive be prepared for 6ny braclytherapy radiation dose.

Contrary to the above, between June 24. 1994, and March 5. 1998, the licensee used a 91 millicurie (mC1) Strontium-90 eye applicator for the administration of brachytherapy radiation doses on approximately 131 occasions, and did not prepare written directives for the administrations. Consequently. no written directives or radiation dose records were retained for the required retention period. (01012)

B. 10 CFR 35.32(a) requires, in part, that the licensee establish and l maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

Pursuant to 10 CFR 35.32(a)(3). the quality management program l must include written policies and procedures to meet the specific objective that final plans of treatment and related calculations for brachytherapy, teletherapy. and gamma stereotactic Enclosure 1 l- NUREG-0940. PART III A-37 l

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NOV 2 l radiosurgery are in accordance with a written directive, which is defined in 10 CFR 35.2.

10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing, for brachytherapy. (1) prior to implantation: the radioisotope, number of sources, and source strengths: and (2) after implantation but prior to completion of the procedure:

the radioisotope. treatment site, and total source strength and exposure time (or, equivalently, the total dose).

Contrary to the above, as of March 5.1998, the licensee's quality management program did not include a dosimetry calculation / verification procedure to ensure that final treatment plans and related calculations for brachythecapy were in accordance with written directives. As a result two misadministrations occurred on August 23. and September 27. 1994 respectively. (01022)

This is a Severity Level II Problem (Supplement VI).

Civil Penalty - $4.400.

II. Violations Not Assessed a Civil Penalty A. 10 CFR 30.36(c) states that each specific license continues in effect, beyond the expiration date if ne:essary, with respect to possession of byproduct material until t1e Commission notifies the iicensee in writing that the license is terminated. During this time, the licensee shall limit its actions involving byproduct material to those related to decommissioniig.

Contrary to the above, on November 30. 1995, the licensee's byproduct material license No. 52-25113-01 expired, and between December 1. 1995 and March 27. 1997, the licens3e failed to limit actions involving byproduct material to those related to decommissioning. Specifically. the licensee used byproduct material (91 mci of Strontium-90) for medical purposes on approximately 52 occasions after expiration of the license.

(02013)

This is a Severity Level III Violation (Supplement VI).

B. 10 CFR 20.1801 requires that the licensee shall secure from i unauthorized removal or access licensed materials that are stored 1 in controlled or unrestricted areas. As defined in 10 CFR 20.1003, controlled area means an area, outside of a I restricted area but inside the site boundary, access to which can  !

be limited by the 11cer.see for any reason; and unrestricted area l means an area, access to which is neither limited nor controlled by the licensee.

NUREG-0940. PART III A-38

NOV 3 Contrary to the above, on March 5. 1998, the licensee did not secure from unauthorized removal or limit access to an e e applicator brachytherapy source containing approximatel 91 mci of Sr-90. Specifically the Sr-90 source was in an unlock d file cabinet, and the licensee did not control and maintain constant surveillance of the area. (03013)

C. 10 CFR 20.1101(c) requires, in part. that licensees review periodically (at least annually) the radiation protection program content and implementation.

Contrary to the above, as of March 5.1998, the licensee failed to I review periodically (at least annually) the radiation protection I program content and implementation for the years 1995 and 1997.

(03023)

D. 10 CFR 35.59(b)(2) recuires. in part, that a licensee in possession of a sealec source test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State.

Contrary to the above, between March 28. 1997, and March 5. 1998, an interval in excess of six months. the licensee did not test a sealed source contaiaing approximately 91 mci of Sr-90 for leakage. No other interval was approved by the Commission or an Agreement State. (03033)  ;

1 E. 10 CFR 35.59(h) requires in ) art, that a licensee in possession of a sealed source or brachytlerapy source measure the ambient dose rates quarterly in all areas where such sources are stored.

Contrary to the above, from March 28, 1997, until March 5. 1998, a period in excess of a calendar quarter, the licensee did not measure the ambient dose rates in exam room 1. the area where the brachytherapy source was stored. (03043)

F. Condition 17 of NRC License No. 52-25113 02, requires, in aart.

that the licensee conduct its program in accordance with tie statements, representations, and procedures contained in the documents listed therein, including any of their enclosures.

Included therein are the application dated January 31, 1996, and a letter dated May 16, 1996.

Item C of the application, states in part, that the licensee "will establish and implement the model )ersonnel external radiation exposure monitoring program pu)lished in Appendix D -

Regulatory Guide 10.8 Revision 2. August 1987."

The model personnel external radiation exposure monitoring program published in Appendix 0 to Regulatory Guide 10.8. Revision 2.

August 1987. states that "all individuals who, on a regular basis, handle radioactive materials that emit ionizing photons will be NUREG-0940. PART III A-39

4 NOV 4 issued a film or TLD finger monitor that will be processed by a contract service on a monthly basis."

Contrary to the above, from September 1995 until March 5.1998, the licensee did not issue a film or TLD finger monitor to an authorized user who, on a regular basis, handled radioactive materials that emit ionizing photons. Specifically. the ,

licensee's personnel dosimetry contract service was canceled by  ;

the supplier in September 1995 and the licensee did not obtain the '

serv 1ces of another provider. (03053)

G. 10 CFR 35.59(g) requires. In part. that a licensee retain for five years records of quarterly physical inventories of sealed sources '

and brachytherapy sources in its possession, and that the records contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and f its nominal activity. the location of each source. and the I signature of the Radiation Safety Officer.

Contrary to the above, as of March 5. 1998, the licensee did not -

retain records of quarterly physical inventories of the brachytherapy sources in its possession between March 28. 1997 and March 5, 1998. Specifically the licensee did not create  !

physical inventory records. Consequently no records were retained for the required retention period. (03063)

H. 10 CFR 19.11(a) and (b) require, in part. that the licensee post current copies of Part 19. Part 20. the license license conditions, documents incorporated into the license, license amendments and operating procedures: or that the licensee post a notice describing these documents and where they may be examined.

10 CFR 19.11(c) requires that a licensee post Form NRC-3 " Notice to Employees."

Contrary to the above, as of March 5.1998, the licensee had not posted current copies of Part 19. Part 20. Form NRC-3, the license, license conditions, documents incorporated into the ,

license. license amendments and operating procedures: nor had the licensee posted a notice describing these documents and where they '

may be examined. (03073) t This is a Severity Level III Problem (Supplement VI).

Pursuant-to the provisions of 10 CFR 2.201. Jos6 M. Col 6n Vaquer. M.D.

(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 NUREG-0940. PART III A-40 l

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NOV 5 J that will be taken to avoid further violations, and (5) the date when full l 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 i why such other action as may be proper should not be taken. Consideration may be given to extending the res)onse time for good cause shown. Under the authority of Section 182 of t1e 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 impositior, of the civil penalty in whole or in part. i by a written answer addressed to the Director. Office of Enforcement. U.S. i Nuclear Regulatory Commission. Should the Licensee fail to answer within the  !

time specifiea, 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 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 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 provisions of 10 CFR 2.205. regarding the procedure for imposing a civil penalty.

l 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. letter with payment u.

civil penalty. and Answer to a Notice of Violation) should be addressed to.

James Lieberman. Director. Office of Enforcement. U.S. Nuclear Regulatory l i

Commission. One White Flint North. 11555 Rockville Pike. Rockville. MD 20852-2735. with a copy to the Regional Administrator. U.S. Nuclear Regulatory Comnossion. Region II.

Because your res3onse will be placed in the NRC Public Document Room (PDR), to ,

the extent possi)le, it should not include any personal privacy. proprietary..

NUREG-0940. PART III A-41

NOV 6 or safeguards information.so that it can be placed in the PDR without i 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 mult specifically identify the portions of your response.that you seek to have witt eld 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. t Dated at Atlanta. Georgia this 22nd day of May 1998 l

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NUREG-0940 PART III A-42

pm aueuq p k UNITE] STATES g ) NUCLEAR REOULATORY COMMISSION WASHINGTON. D.C. 30086 4 001

• • • • • August 1, 1998 I

EA 98-184

! Jos6 M. Col 6n Vaquer M.D. l P.O. Box 76  !

Manati. Puerto Rico 00674

SUBJECT:

NOTICE OF VIOLATION AND CIVIL PENALTY (NRC INSPECTION REPORT N0. 52-25113-02/98-01)

Dear Dr. Col 6n:

l Thank you for your responses of June 21. 1998, to our Notice of Vio% tion and Proposed Imposition of Civil Penalty (Notice), issued on May 22, 1998. We have evaluated your responses and found that they meet the requirements of 10 CFR 2.201 and 10 CFR 2.205. The NRC notes that although your responses were dated June 21, 1998, the correspondence was post-marked July 22, 1998.

Our Notice of May 22. 1998, indicated that the NRC would consider reducing the proposed civil penalty of $4.400 to $2.200 if you properly disposed of or transferred the Strontium-90 (Sr-90) eye applicator in accordance with existing regulations within 90 days of the date of the enforcement action. In your June 21, 1998. letters, you indicated your intent to properly transfer the Sr-90 eye applicator, and enclosed a check in the amount of $2.200.

However, you requested an additional 30 days to complete the proper transfer ,

of the source, which would extend the date to September 22, 1998. '

Based on our review of your letters, the NRC is granting your request for an additional 30 days to properly transfer the Sr-90 eye app.icator. If you are unable to pro >erly transfer the source and provide written confirmation to the NRC by Septem)er 22. 1998, an additional $2.200, which represents the remaining balance of the proposed civil penalty, will be due at that time.

Any balance due that remains unpaid after that date may be imposed by Order.

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

Sincerely, Q

e~ h James Lieberman. Director Office of Enforcement l Docket No. 030-34060 License No. 52-25113-Oc l

cc w/encls:

l Commonwealth of Puerto Rico NUREG-0940. PART III A-43

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t UNITED STATES p * "8%g%

, NUCLEAR REGULATORY COMMISSION

, S REGION 111 E E 801 WARRENVILLE ROAD 8 USLE. ILLINOIS 60632-4351 l June 9, 1997 i

EA 97-207 Mr. Michael B. Creech President Conam Inspection 1245 W. Norwood i Itasca. IL 60143  :

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SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -

$16,000 (NRC Inspection Report No. 030-31373 (DNMS) and l Investigation Report No. 3-96-014)

Dear Mr. Creech:

P This refers to matters discussed with you and other Conam Inspection (Conam) representatives at a transcribed predecisional enforcement conference conducted on December 13, 1996. The conference was held to discuss several violations of Nuclear Regulatory Commission (NRC) requirements addressed in the NRC inspec+(an report issued on November 18, 1996. As a result of the conference, a Lwand ror Information (DFI) was issued March 10, 1997, to obtain additional information and to clarify some unresolved issues.

-Based on the information developed during the inspection, the investigation, the information that you provided during the conference, and the information that you provided in your April 9,1997 response to the DFI, the NRC has determined that violations of NRC requirements occurred. These violations are i cited in the enclosed Notice of Violation and Proposed Impodtion of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. In particular, the violations involve: (1) a failure to secure the sealed source assembly in the shielded after position (Violation exposure each radiographic I.A): (2)afailuretopertermanadequatesurve{eannual (Violation I.B): (3) a failure to limit ti.

occupational dose to an adult radiographer to 5 rems (Violation I.C): (4) a failure to submit a 30-day written report concerning a dose in excess of the occupational dose limits (Violation II.A): and (5) a failure to wear a film badge and a pocket dosimeter at all times when working with ionizing radiation (Violation II.8).

As described in the inspection report and discussed during the predecisional enforcement conference. the NRC determined that a Conam radiographer violated several license requirements while performing radiography on vacuum pump welds for a customer facility located in Indianapolis. Indiana. Specifically, on February 27, 1996, after completing a radiographic exposure, the radiographer ,

cranked in the source. However, in violation of certairi Conam Operating and Emergency Procedures. the radiographer failed to rotate the selector ring to NUREG-0940. PART III A-44 i

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M, Creech I secure the sealed source assembly in the shieldet nosition because he depended solely on the automatic locking mechanism to sectce the source. Further the same individual failed to conduct a proper surve' of the camera following each  !

exposure to assure that the source was in a shirided position. As a result of these failures, the radiographer received a whrse body exposure in excess of NRC requirements.

Based on a dose assessment perfcrmed by the .RC, the NRC concludes that the radiographer's exposure is in the range of 6 to 20 rems, total effective dose equivalent. Based on a dose assessment performed by Integrated Environmental Management Inc., a Conam consultant, the radiographer's exposure was calculated to be 9.369 rems, total effective dose equivalent. The NRC acknowledges that film badge exposures are normally used as the basis for I assigning occupational doses to workers, However, given that the film badge j was not olaced in the region of the whole body receiving the highest exposure -

(i.e.. the right thigh), the NRC concludes that, consistent with 10 CFR 20.1201(c), a specific dose assessment is warranted to reflect the correct dose received by the radiographer. Ir this regard, we note that: (1) NRC l requirements in 10 CFR 20 do not permit Conam to compartmentalize the external -

dose to the radiographer, as was performed by your consultant: and (2) the radiographer's ex)osure of 9.369 rems based on your consultant's assessment is j in the range of t1e NRC dose assessment.

1 Locking of the sealed source in the shielded position following a radiographic 1 exposure and conducting an adequate survey of the radiographic exposure device are each intended to serve as safety barriers designed to protect workers and members of the public from inadvertent and potentially significant radiation  !

exposures. In this case, the failure to comply with these requirements circumvented these separate barriers resulting in an exposure to the radiographer in excess of NRC requirements. Further, based on the Office of Investigations (01) findings, the NRC concludes that the radiographer's failure to lock the radiographic exposure device is willful in that his )

actions demonstrated careless disregard for NRC requirements.

Violation I.A is of concern not only because of its willful nature, but also because the OI investigation determined that other radiographers typically rely on the automatic locking mechanism rather than locking the camera in the required manner. It is essential that the NRC be able to maintain the highest trust in individuals working with licensed material, given the nature and quantity of radioactive material ~used by your employees. Licensees should a)propriately manage their programs to ensure that personnel fully understand t1e importance of complying with regulatory requirements. As an entity licensed to possess and use radioactive material Conam is responsible for the acts of its employees.

Individually, each violation in Section I of the Notice is of significant

, regulatory concern. However, in consideration of the willfulness involved.

l the relationship of these violations to a single incident, and the fact that I two safety barriers were breached, the violations are of very significant l regulatory concern. ' Therefore the violations are classified in the aggregate i

NUREG-0940. PART III A 45

M. Creech in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy). NUREG-1600, as a Severity Level 11 problem.

Ir: accordance with the Enforcement Policy, a base civil of $8000 is considered for a Severity Level II problem. Thepenalty NRC considered in the amount 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. No credit is warranted for Identification given the circumstances of the case. In particular, that the violations were essentially revealed through an event that did not occur as a result of a Conam self-monitoring effort, and, as noted below. Conam did not demonstrate an adequate initiative in identifying the problem requiring corrective action.

At the predecisional enforcement conference. Conam indicated that a memorandum dated February 29, 1996, had been sent to all radiation safety supervisory personnel to advise all radiography staff to complete a full and accurate survey of the exposure device, collimator, guide tube, and connector after each exposure and to secure the source assembly in accordance with Conam's operating procedures. We acknowledge your prompt action in issuing the memorandum: however, at the time of the conference, your actions did not appear to be comprehensive. Specifically Conam could not confirm that each radiographer had received the instructions set forth in the memorandum nor had Conam instituted any monitoring / auditing program to evaluate the effectiveness of the memorandum. Given the potential for radiation exposure when violations such as I.A and 1.8 occur, and given the practice of Conam radiographers in not locking cameras, your corrective actions were not comprehensive.

Accordingly, credit for Corrective Action is not warranted.

Therefore, to emphasize the importance of compliance with NRC requirements, and the need for prompt identification and comprehensive correction of violations. I have been authorized, after :.onsultation with the Director.

Office of Enforcement, to issue the enclosed Notice in twice the base amount (i.e. $16,000) for the Severity Level II problem in Section I of the Notice.

In addition. issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

The violations in Section II of the Notice, which involve failure to meet the 30-day reporting requirement and use of licensed material Nithout prooer personnel monitoring devices, are each categorized as Severity level IV violations in accordance with the Enforcement Policy. You are reminded that this notice does not relieve you of the reporting requirements contained in 10 CFR 20.2203 and 20.2205 and that you must still comply with the reporting requirements contained in 10 CFR 20.

Finally, we note that during the predecisional enforcement conference there appeared to be some confusion concerning what constitutes a survey. In order to maintain the NRC's confidence in Conan's ability to manage its program, it is imperative that the Conam radiation safety officer and radiography staff understand that an adequate survey includes, in addition to the physical act, correctly reading, evaluating the results provided, and acting on those results in accordance with good health physics practices.

NUREG-0940, PART III A-46

M. Creech You are required to respond to this letter and should follow the instructions 1 specified in the enclosed Notice when preparing your response. The NRC will (

use your response, in part, to determine whether further enforcement action is I 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.

Sincerely.

1 A. Bill Beach Regional Administrator Docket No. 030-31373 License No. 12-16559-01 ,

Enclosure:

Notice of Violation and Proposed Imposition of Civil Penalty l

NUREG-0940. PART III A-47

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NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY I Conam Inspection Docket No.030-31373 Itasca. Illinois License No. 12-16559-01 EA 97-207 During an NRC inspection conducted March 28 through April 11, 1996, with -

continuing NRC review through November 12, 1996, and an investigation I conducted by the Office of Investigations from April 8,1996, through October 16, 1996, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC j Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty

)ursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 J.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

1. Violations Assessed a Civil Penalty

' A. 10 CFR 34.22(a) requires, in part that during radiographic operations, the sealed source assembly be secured in the shielded position each time the source is returned to that position.

Condition 26 of License No. 12-16559-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated March 29, 1993. .

The licensee's application dated March 29, 1993, included the Operating and Emergency Procedure Manual (0 EPM) that is required to be followed by the licensee's radiography personnel.

Item 10.3.3(c) of the OEPM, entitled, " Technical Operations Model 533, 660, Capacity 100 Curies", describes the operating 3rocedures for the Amersham Model 660B exposure device. Steps 12 t1 rough 15 of the procedure describe the requirements to secure the radiography source in the exposure device by: 1) retracting the source to engage the automatic locking mechanism. 2) rotating the selector ring from operate to lock, and 3) depressing the key ,

lock.

Contrary to the above, on February 27, 1996, at Eli Lilly, Indianapolis, IN, a licensee radiographer did not secure the sealed source assembly in the shielded position after returning the source to the shielded position at the termination of a radiographic exposure. Specifically, the radiographer did not retract the source to engage the automatic locking mechanism, rotate the selector ring from operate to lock, and depress the key lock as required.

B. 10 CFR 34.43(b) requires, in part, the licensee to ensure that a survey with a calibrated and operable radiation survey instrument is made after each radiographic exposure to determine that the sealed source has been returned to its shielded position. The >

l NUREG-0940. PART III A-48

Notice of Violation and Proposed Imposition of Civil Penalty survey must include the entire circumference of the radiographic exposure device and any source guide tube.

Contrary to the above, on February 27, 1996, at Eli Lilly. l Indianapolis. IN, a licensee radiographer did not perform an adequate survey after each radiographic exposure to determine that the sealed source had been returned to its shielded position, in that the survey did not include the entire circumference of the radiographic exposure device and the source guide tube. ,

1 C. 10 CFR 20.1201(a)(1)(i) requires, with exceptions not applicable i here. that the licensee control the occupational dose to individual adults to an annual dose limit of 5 rems total  !

effective dose equivalent. 1 Contrary to the above, the licensee did not limit the annual i occupational dose to an adult radiographer to 5 rems, total i effective dose equivalent. Specifically, the individual received a radiation dose of a minimum of 6 rems, total effective dose l equivalent, during an event on February 27. 1996. '

These violations represent a Severity Level 11 problem (Supplement IV ' ,

VI). l Civil Penalty - $16.000 Violations Not Accessed a Civil Penalty II.

)

A. 10 CFR 20.2203(a)(2)(i) requires, in part, that the licensee shall submit a written report within 30 days after learning of a dose in excess of the occupational dose limits for adults as defined in 10 CFR 20.1201 I 1

Contrary to the above, on April 11, 1996, the licensee learned of an event that caused an adult radiographer to receive a total effective dose equivalent of more than 5 rems total effective dose equivalent and did not submit a written report within 30 days as required. .

This is a Severity Level IV violation (Supplement IV)

B. Condition 26 of License No. 12-16559-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated March 29, 1993.

NUREG-0940. PART III A-49

Notice of Violation and Proposed Imposition of Civil Penalty 1

l The licensee's application dated March 29. 1993, included the i Operating and Emergency Procedure Manual (OEPM). Item 5.1 of the OEPM. entitled. " Personnel Monitoring Equipment", requires, in i part, that radiographers and radiographers' assistants and trainees shall wear a film badge and a pocket dosimeter at all times when working with ionizing radiation.

Contrary to the above. on March 14. 1996, a trainee at the licensee's Gary. Indiana, location calibrated portable radiation survey instruments with a device containing cesium-137 and did not wear a film badge or pocket dosimeter. )

This is a Severity Level IV violation (Supplement VI). l Pursuant to the provisions of 10 CFR 2.201. Conam Inspection (Licensee) is hereby required to submit a written statement or explanation to the Director.

4 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 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 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 rr.are than one civil penalty is

)roposed, or may protest imposition of the civil penalty in whole or in part.

)y 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 (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 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.  !

NUREG-0940. PART'III A-50 1

__ _ __ __ .. _ .__.__ _ __ _ . . _ . . ~ _ . _. m l Notice of Violation and Proposed l Imposition of Civil Penalty i l 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 re)1y pursuant to 10 CFR 2.201. but may incorporate parts of the 10 CFl 2.201 reply by specific reference (e.g.,

i 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 l 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 referr.ed to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant l to Section 234c of the Act. 42 U.S.C. 2282c.  !

The response noted above (Reply to Notice of Violation, letter with payment of '

l civil 3enalty, and Answer to a Notice of Violation) should be addressed to:

l James _ieberman. Director. Office of Enforcement. U.S. Nuclear Regulatory l 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 III.

l Because your res>onse will be placed in the NRC Public Document Room (PDR) to

! the extent possi)le, it should not taclude any personal privacy. 3roprietary.

l or safeguards information so that it can be placed in the PDR wit 1out

redaction. If personal privacy or proprietary information is necessary to l provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a l

redacted copy of your response that deletes such information. If you request i

, withholding of such material, you muit s)ecifically identify the portions of l your response that you seek to have withield 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 l confidential commercial or financial information). If safeguards information l 1s necessary to provide an acceptable response, please provide the level of I

protection described in 10 CFR 73.21.

Dated at Lisle. Illinois this 9th day of June 1997 i

4 NUREG-0940. PART III A-51 L

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a ux

• t UNITED STATES fg j e

NUCLEAR REGULATORY COMMISSION WASHINGTON, D.c. 206eH001 l

+*****/ November 5, 1997 )

i EA 97-207 Mr. Michael B. Creech President l Conam inspection, Inc.

l 1245 W. Norwood Itasca, Illinois 60143 l

SUBJECT:

ORDER IMPOSING CIVIL MONETARY PENALTY - $16,000 I

Dear Mr. Creech:

1 This refers to the letter dated July 7,1997 from Clifton A. Lake, attomey for Conam inspection,

{

inc., in response to the NRC Notice c,f Violation and Proposed Imposition of Civil Penalty 1 (Notice) sent to you on June 9,1997 Our letter and Notice described three violations (Violations 1.A, l.8, and I.C) which were classified in the aggregate as a Severity Level ll problem.

A civil penalty of $16,000 was proposed for the violations to emphasize the importance of compliance with NRC requirements, and the need for prompt identification and comprehensive correction of violatior s. In addi';on, two other violations (Violations ll.A and ll.B) were classified at Severity Level IV for which nc civil penalty was assessed. l l

In its response to the Notice, Conam admitted Violations 1.A and ll.B; denied Violations I.B. l.C.

and ll.A; and requested remission or full mitigation of the civil penalty.

l After consideration of Cenam's response, we have concluded, for the reasons given in the Appendices attached to the enclosed Order imposing Civil Monetary Penalty, the following:

(a) Violation ll.A is hereby withdrawn; and (b) Conam did not provide an adequate basis for withdrawing Violations I.B and I.C, for mitigating the severity level of Violations 1.A, l.B, and I.C .

in the aggregate, or for mitigating the civil penalty associated with Violations 1.A,1.8, and I.C. l Accordingly, we hereby serve the enclosed Order on Conam inspection, Inc., imposing a civil l monetary penalty in the amount of $16,000. As provided 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 James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738. We will review the effectiveness of your corrective actions during a subsequent inspection.

NUREG-0940, PART III A-52

. . .. . .- . - . . . _ = . . = . - -.. .- - . - - . .- - . . .

Conam inspection, Inc. i i

'In 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's Public Document Room.

Sincerely, 1

\

h James Lieberman, Director Mice of Enforcement Docket No. 030-31373 License No. 12-16559-01

Enclosures:

As stated (2)

)

l l

I I

l l

NUREG-0940. PART III A-53

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of )

) Docket No. 030-31373 CONAM INSPECTION, INC. ) License No. 12-16559-01 Itasca,IL ) EA 97-207

)

ORDER IMPOSING civil MONETARY PENALTY l

Conam inspection, Inc. (Conam or Licensee) is the holder of Byproduct Materials License No.12-16559-01 issued by the Nuclear Regulatory Commission (NRC or Commission) on January 2,1990. The license authorizes the Licensee to possess and use certain byproduct materials in accordance with the conditions specified therein at the Licensee's facilities in Columbus, Ohio; Gary, Indiana; Reading, Pennsylvania; Gallipolis, Ohio; and at temporary job sites anywhere in the United States where the NRC maintains jurisdiction for regulating the use of licensed material.

l 11 1

l l

An inspection and investigation of the Licensee's activities were conducted between March 28, 1996 and November 12,1996. The results of the inspection and investigation indicated that the Licensee had not conducted its activities in full compliance with NRC requirements. A written Notice of Violation and Proposed imposition of Civil Penalty (Notice) was served upon the Licensee by letter dated June 9,1997. The Notice states the nature of the violations, the provisions of the NRC's requirements that the Licensee had violated, and the amount of the civil penalty proposed for three of the violations in the aggregate (Violations 1.A, l.B. and I.C).

NUREG-0940. PART III A-54

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I

)

The Licensee responded to the Notice in a letter dated July 7,1997. In its response, the Licensee denied Violations I.B and I.C. and requested re mission or full mitigation of the civil penalty.

l l l .

l Ill )

1 i

l After consideration of the Licensee's response and arguments for mitigation contained therein, the NRC staff has determined, as set forth in the Appendix to this Order, that the Licensee did not provide an adequate basis for withdrawing Violations I.B and 1.C, or mitigating the severity 1 level of Violations 1.A, l.B, and I.C in the aggregate, or mitigating the civil penalty associated with Violations 1.A. l.B, and I.C. Therefore, a civil penalty in the amount of 516.000 should be imposed I i .

l iv i

s 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

l

! The Licensee pay a civil penalty in the amount of $16,000 within 30 days of the date of this Order, by check, draft, money order, or electronic transfer, payable t(. ..ie Treasurer of the United States and mailed to James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738.

J NUREG-0940. PART III A-55 i

l 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 shculd 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 i

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 l

Regional Administrator, NRC Region ill, 801 Warrenville Road, Lisle, IL 60532.

j i

4 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 referred to the Attomey General for collection.

in the event the Licensee requests a hearing as provided above, the issues to be considered at such hearing shall be:

NUREG-0940, PART III A-56

4 l

(a) whether the Licensee was in violation of the Commission's requirements as set forth in Violations I.B and I.C of the Notice referenced in Section il above, and 1

(b). whether, on the basis of such violations and the additional violations set forth in the Notice of Violation that the Licensee admitted, this Order should be sustained.

FOR THE NUCLEAR REGULATORY COMMISSION ames Lieberman, Director Office of Enforcement Dated at Rockville, Maryland this5th day of November 1997 i

I l

i 9

i NUREG-0940. PART III A-57 l 1

( -

l APPENDIX A EVALUATIONS AND CONCLUSION I 1

On June 9,1997, the NRC issued to Conam Inspection, Inc., (Licensee or Conam) a Notice of Violation and Proposed imposition of Civil Penalty (Notice) in the amount of $16,000 for violations identified during an NRC inspection and investigation conducted from March 28 ,

through November 12,1996. The Licensee responded to the Notice by letter dated July 7,1997. With regard to the violations assessed a civil penalty, the Licensee admitted Violation I.A; denied Violations I.B and I.C; and requested remission or full mitigation of the civil ,

penalty. The NRC's evaluations and conclusion regarding the Licensee's requests are as follows:

Restatement of Violation I.B l.B 10 CFR 34.43(b) requires, in part, a licensee to ensure that a survey with a calibrated I and operable radiation survey instrument is made after each radiographic exposure to determine that the sealed source has been retumed to its shielded position. The survey ,

must include the entire circumference of the radiographic exposure device and any source guide tube.

Contrary to the above, on February 27,1996, at Eli Lilly, Indianapolis, IN, a Licensee -

radiographer did not perform an adequate survey after each radiographic exposure to determine that the sealed source had been retumed to its shielded position, in that the survey did not include the entire circumference of the radiographic exposure device and the source guide tube.

Summarv of Licensee's Resoonse to Violation I.B The Licensee, in its response, denies Violation I.B and states that on February 28,1996, the day following the incident, the radiographer expressly stated to the Licensee's Radiation Safety Officer (RSO) that he had performed a full 360-degree circumferential survey of the radiographic exposure device.

NRC Evaluation of Licensee's Resoonse to Violation I.B 1

The specific issue addressed in Violation I.B is whether the radiographer performed the required survey to determine that the source had completely been withdrawn into the -

radiographic exposure device. This requires, among other things, that the radiographer be aware of the results of the survey, especially the dose rate measured at the exit port (front) of the radiographic exposure device. As noted on page 7 of the Licensee's reply to the Notice, the Licensee states (regarding the radiographer's survey) that: 'He then failed to properly read his survey meter when he performed a radiation survey in a 360-degree motion around the camera." The fact that the radiographer improperly read the survey meter means that he failed to properly determine: (1) whether the source had been completely withdrawn into the radiographic exposure device; and (2) the radiological conditions and potential hazards incident to use of radioactive material.

NUREG-0940 PART III A-58

Appendix A In addition, durbg the investigation conducted by the NRC's Office of Investigations, the radiographer stated that he surveyed the radiographic exposure device, but only on the sides.

He also stated to the investigator that because of the position of the radiographic exposure device, he did not survey the front part. This conflicts with the information provided by the radiographer to the Licensee's RSO, but appears to be more in line with the facts of the case given the elevated exposure result to the radiographer's film badge.

In either case, whether the radiographer improperly read the survey meter or whether the radiographer failed to survey the froM part, the NRC concludes that Violation I.B occurred as

' stated in the Notice.

Restatement of Violation I.C l.C 10 CFR 20.1201(a)(1)(i) requires, with exceptions not applicable here, that a 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 radiographer to 5 rems, total effective dose equivalent. Specifically, the individual received a radiation dose of a minimum of 6 rems, total effective dose equivalent, during an event on February 27,1996.

Summarv of Licensee's Resoonse to Violation I.C The Licensee, in its response, denies Violation I.C, states that the NRC's methodology in determining tne total effective dose equivalent is flawed, and does not agree with the intent of the regulations. The Licensee contends that using conventional dose assessmerit models, consensus industry standards, and the NRC's own definitions, the maximum likely Total Effective Dose Equivalent (TEDE) incurred by the radiographer during the event was 2.9 rems, based upon the radiographer's desenption of time and motion.

As a basis for its argument, the Licensee asserts that while the Licensee's consultant calculated a dose to the right thigh of 9.369 rems, this dose does not constitute the TEDE. The Licensee states that the dose limits are based on the 1976 [1977] recommendations of the International Commission on Radiological Protection (ICRP), which states that there is a predictable relationship between irradiation of the whole body and biological effects. The Licensee argues that the dose to the radiographer's thigh is not an appropriate predictor of biological effects, and thus should not be compared to the primary dose limit in 10 CFR 20.1201.

The Licensee asserts that the ICRP recommendations should take precedence in determining how the TEDE is computed. As such, in calculating the TEDE, the Licer'we uses weighting factors for each tissue area which are derived from ICRP Publication 26. The Licensee believes this is an acceptable approach because the Statements of Consideration for the issuance of the revised 10 CFR Part 20 included, as reasons for the revision, the need to incorporate updated scientific information, to reflect changes in the basic philosophy of radiation protection, and to put into practice recommendations from ICRP 26 and subsequent ICRP publications. The Licensee asserts that sections 10 CFR 20.1003, which defines the TEDE.

NUREG-0940. PART III A-59

Appendix A and 10 CFR 20.1201(a), which specifies exposure limits, conform with ICRP 26 recommendations.

The Licensee maintains that the NRC's guidance on interpretation of 10 CFR 20.1201(c) pemlits use of external dose weighting factors. However, the Licensee argues that the language in 10 CFR 20.1201(c): (1) conflicts with the definition of deep-dose equivalent provided in 10 CFR 20.1003; (2) is inconsistent with the ICRP recommendations; and (3) deviates from the fundamental principles underlying the dose limits in 10 CFR Part 20.

The Licensee does note that the specific use of weighting factors other than 1.0 for all organs was not approved by 10 CFR Part 20; rather,10 CFR 20.1003 states that "[f]or the purpose of j weighting the extemal whole-body dose (for adding it to the intemal dose), a single weighting I factor, Wt = 1.0, has been specified. The use of other weighting factors for extemal exposures I will be approved on a case-by-case basis until such time as specific guidance is issued." The f

Licensee notes that the NRC has not yet issued specific guidance in interpreting this issue; l however, since the American National Standards institute (ANSI) has issued N13.41, ' Criteria 1 for Performing Multiple Dosimetry," the Licensee believes that it should be able to use this methodology in computing its TEDE value. This guidance was utilized and the resulting TEDE was 2.9 rems.

I The Licensee asserts that in light of the conflicting regulatory language in 10 CFR Part 20 l regarding non-uniform exposure of the whole body, and the fact that 10 CFR 20.1003 allows weighting factors to be considered, the dose determined for the raciographer using ANSI .

N13.41 protocol was appropriate and consistent with the rationale underlying the occupational dose limits. j NRC Evaluation of Licensee's Resoonstt.lo Violation I.C The specific issue addressed in Violation I.C is whether the radiographer's total effective dose equivalent as defined in the reaulations exceeded the regulatory limits. The Licensee's use of ICRP 26 and ANSI N13.41 (i.e., uso of a compartmentalization methodology to sum the effective dose equivalents for various areas of the whole body) was neither approved by the NRC nor in accordance with NRC requirements, for the reasons described below.

1. NRC Basis for Violation I.C: As noted in the Notice,10 CFR 20.1201(a)(1)(i) requires, in part, that a licensee control the occupational dose to individual adults to an annual dose limit of 5 rems total effective dose, equivalent. In addition,10 CFR 20.1201(c) requires, in part, that the assigned deep-dose equivalent must be for the part of the body receiving the highest exposure and that the deep-dose equivalent may be assessed from surveys or other radiation measurements for the purpcse of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure. As defined in 10 CFR 20.1003, Whole body means: "for purposes of extemal exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee.  ;

1 i

The NRC's definition is based. in part. on the fact that these portions of the whole body contain blood-forming organs.

I NUREG-0940. PART III A-60 l

l I

Appendix A Based on the findings in the NRC inspection report dated November 18,1996, the NRC concluded, as described in the Notice, that the radiographer received a TEDE of 6 rems. The conclusion was based on: (1) measurements of time and distances as re-enacted by the radiographer and the Licensee's film badge dose; and (2) the dose to the part of the body receiving the highest exposure (i.e., upper left thigh), given that the j individual monitoring device was not in the region of highest potential exposure, the I dose field from the radiographic exposure device was non-uniform, and the position of the radiographer and his film badge in relationship to the radiographic exposure device.

2. The Licensee's Use of ICRP 26 and ANSI N13.41: The NRC agrees that the dose limits in 10 CFR Part 20 are based on the ICRP 26 recommendations and acknowledges that i the radiographer's thigh may not be an appropriate predictor of biological effects.  !

However, the Licensee's use of ICRP 26 and the draft ANSI N13.41 for calculating the radiographer's whole-body dose is inappropriate in this case.

While the ICRP 26 recommendations in principle permit the use of extemal weighting j factors, no specific recommendations were included concoming the use of weighting j factors for extemal dose because there are practical problems with such use. The application of weighting factors also entails calculation of organ doses instead of whole body doses from extemal radiation.~ One component of this calculation is the estimation of radiation attenuation as a function of the depth in the body. Therefore, as noted in the NRC's Statement of Consideration for 10 CFR Part 20 (56 FR 23369), the Commission decided that ' application of weighting factors for extemal exposures will be evaluated on a case-by-case basis until more guidance and additional weighting factors (such as for the head and the extremities) are recommended ... The use of other weighting factors for extemal exposure may be anoroved on a case-bv-case basis uoon reauest to the NRQ." (emphasis added). This means that, if a limnsee proposes to use other weighting factors for extemal use, the licensee needs to develop the basis and technical justification for its request, submit the request to the NRC, and await approval of its request before usina any modified weighting factors. To date, the Licensee has not submitted to the Commission such a request for an exemption of 10 CFR 20.1201.

With regard to ANSI N13.41, this is a draft standard that has been neither approved by ANSI, nor reviewed and approved by the Commission for use by NRC licensees.

Moreover, ANSI N13.41 is not applicable because this case falls outside of the scope of that standard. This is evident from the standard itself, which states, under Scope, page 9, that "this standard contains criteria applicable to routine occuoational activities (emphasis added) for when and how to use multiple dosimeters to monitor the body and extremity of individuals exposed to sources of ionizing radiation." The next paragraph under this section goes on to state, " Sudden or unexpected changes in the radiation environment as miaht occur durina accidents ar.3)gvond the scone of this standard" (emphasis added).

The dose calculated by the consultant to the radiographer's right thigh was 9.369 rems.

As noted in the Licensee's response, the footnote attached to 10 CFR 20.1003 specifies that a single weighting factor, Wt=1.0, be used for extemal exposures. However, rather NUREG-0940 PART III A-61

Appendix A than using this weighting factor, the Licensee applied the factors provided in ANSI N13.41 (which are less than 1.0) to calculate exposures of portions of the whole body to arrive at the overall dose determination. The Licensee's use of weighting factors (on the l basis that the NRC has not issued new weighting factors) without prior NRC approval is contrary to NRC requirements. Given the above, the Licensee's method for calculating the radiographers exposure is incorrect.

3. Arauments Concomina Deso-Dose Eauivalent: 10 CFR 20.1201(c) requires, in part, that the assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.10 CFR 20.1003 defines deep-dose equivalent as the dose i equivalent at a tissue depth of 1 cm (1000 mg/cm') [regardless of the part of the whole i i

body that is exposed). Given that ICRP 26 did not include specific recommendations j conceming the use of weighting factors for extemal dose, and the fact that there are l practical problems in using weighting factors to assess extemal exposure as noted '

above, the NRC disagrees with the Licensee's argument that 10 CFR 20.1201(c) is i inconsistent with the ICRP recommendations and that 10 CFR 20.1201(c) deviates from j the fundamental principles underlying the dose limits in 10 CFR Part 20. l l

4. Use of the Consultant Results and Part 20 Weiahtina Factors: The NRC bases its j enforcement actions on its regulations as codified in Title 10, Code of Federal '

Regulations. In this case,10 CFR 20.1003 defines the weighting factor for the whole body as 1.0. As noted in the Licensee's response, the NRC has not approved the use l' of other weighting factors for extemal exposures nor has the NRC issued specific-guidance on the use of other weighting factors. The regulations do allow for the use of a different methodology, but only after review and prior approval by the NRC. In this case, such approval was not obtained by the Licensee. Because the thigh (right or left) is an area of the body meeting the definition for whole body, the appropriate weighting factor per the regulations is 1.0. Therefore, if the Licensee chooses to use the consultant's results in conjunction with the Part 20 weighting factors, the radiographers TEDE for the event would be:

Dose to right thigh (9.369 rems) x weighting factor (1.0) = 9.369 rems The Licensee correctly notes that the limit for whole-body exposure in 10 CFR 20.1201(a)(1)(i) is a TEDE of 5 rems.10 CFR 20.1003 defines the TEDE as the sum of the deep-dose equivalent (extemal exposure) and committed effective dose equivalent )

(intemal exposure). In this case, the TEDE can be considered to be equal to the deep-dose equivalent, because there was no intemal exposure involved.

The circumstances surrounding the exposure, as described in the inspection report and by the radiographer during the conduct of the NRC's investigation, demonstrated that the radiographers body was between the radiographic exposure device and the radiographefs film badge. As noted in the radiographers and RSO's description of the I Licensee's time-motion study, no props were used - the event was discussed at a table with the radiographer describing to the RSO what occurred. During this time-motion discussion, it was not clear that the radiographers film badge was at the point nearest the source. It was clear that the beam from the exit port of the radiographic exposure NUREG-0940. PART III A-62

Appendix A device would be very directional and non-uniform. Later, on April 11,1996, a re-enactment of the event by the radiographer in the presence of the Licensee's RSO and NRC personnel was performed and appropriate props were used. The radiographer ,

was asked to demonstrate his activities at the time the exposure occurred. This re-enactment provided information that the Licensee had not obtained during its verbal time-motion discussion, namely, that the radiographer's leg was significantly closer to the source than was his film badge. For the sake of argument, the NRC has chosen to utilize the Licensee's dose calculation based on its vert >al characterization, and the resulting dose obtained to the right thigh. If the Licensee chooses to use the consultant's results (which utilized variables from the NRC's re-enactment) in conjunction with the Part 20 weighting factors, the radiographer's TEDE for the event would be:

Dose to left thigh (42.075 rems) x weighting factor (1.0) = 42.075 rems 10 CFR 20.1201(c) states that "the assigned deep dose equivalent and shallow-dose equivalent must be for the part of the body receiving the highest exposure. The deep-dose equivalent, eye dose equivalent and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring j device was not in the region of highest potential exposure, or the results of individual l monitoring are unavailable." in this case, the individual monitoring device was not in the region of highest potential exposure, given the non-uniform nature of the dose field from the radiographic exposure device and the position of the radiographer and his film badge in relationship to the radiographic exposure device. Therefore, per this requirement, the assigned deep-dose equivalent must be for the right thigh (using the Licensee's computation), as it is part of the whole body. This results in an assigned deep-dose equivalent of g.36g rems. As noted above, the TEDE consists of the sum of the deep-dose equivalent and committed effective dose equivalent. In this case, it is

, equal to the deep-dose equivalent, g.36g rems, a value that is in excess of the limit specified in 10 CFR 20.1201(a)(1)(i).

Given the above, the NRC concludes that: (a) the Licensee has not provided a basis to substantiate that the radiographer's TEDE was below 5 rems; and (b) Violation I.C occurred as stated in the Notice.

Summarv of Licensee's Reauest for Raml== ion or Ms'=1;en and Recon =idaration of Severity LSEtl The Licensee offered several arguments in support of its request for remission or mitigation of the proposed penalty. Below is a summary listing of the Licensee's arguments that are related to its request for remission or mitigation, some of which have been consolidated. The NRC's svaluation follows each argument.

1 NUREG-0940. PART III A-63

4 Appendix A 1. Licensee's Araument The Licensee asserts that violations cited in Section I of the Notice should not be l considered willful, for the following reasons: l l

Based on the Licensee's discussion of the event on February 28,1996, between l the RSO and the radiographer, the Licensee concluded that the radiographer ]

was negligent in failing to rotate the selector ring from the " operate" to the ' lock" l position and failing to depress the plunger mechanism of the radiographic l exposure device. j This act was not the result of deficiencies in the Licensee's Radiation Safety Program, nor did it follow other incidents of a similar nature. As evidence for its argument, the Licensee notes that seven prior unannounced NRC inspections had not identified any violations of applicable regulations.

• The Licensee disputes the fact that it was a

• typical" practice of Conam l radiographers to rely upon the automatic locking mechanism of their radiographic exposure devices rather than locking them in the manner required by the Licensee's radiation safety procedures.

The Licensee believes that "[b]ecause the NRC's conclusion that a ' willful' violation has occurred is influenced by its erroneous conclusion that a violation of 1 the occupational exposure limit occurred, its characterization of the violation as willful' is flawed."

NRC Evaluation in its Notice, the NRC did not conclude that the violations in Section I were willful; rather, the NRC concluded that only Violation I.A was willful. In this regard,Section IV.C of the NRC Enforcement Policy defines willful violations to encompass not merely deliberate acts but acts of careless disregard as well. As part of the NRC's evaluation of this event, an investigation was conducted by the NRC's Office of Investigations (01). That investigation concluded that the Licensee's radiographer willfully failed to follow the Licensee's procedures while operating the radiographic exposure device. The radiographer, who was knowledgeable of the requirement but failed to perform it due to being " lax," demonstrated careless disregard for NRC requirements, a condition that clearly meets the NRC's definition of a willful violation.

Given the results of the 01 investigation, the problem with failing to follow procedures was not isolated. As noted both in the November 18,1990 inspection report and during the subsequent Predecisional Enforcement Conference, the Licensee's policy for performing field audits did not encompass multiple exposures or other situations where the potential existed for a radiographer to fail to properly rotate the selector ring and depress the plenger. A single radiographic shot was often used, where this act would be performed prior to moving the radiographic exposure device. As such, the Licensee was unaware of the problem until it manifested itself in the exposure event that occurred NUREG-0940 PART III A-64  ;

I

Appendix A l on February 27,1996, although a better field auditing technique may have allowed the

Licensee to identify the problem prior to the February event. Therefore, the Licensee's d

arguments (i.e., lack of deficiencies in its radiation safety program and the lack of NRC findings during prior unannounced NRC inspections) do not alter the NRC's conclusion i

concoming the willful act of the radiographer.

1

} When questioned by the 01 investigator, approximately 25% of the Licensee's

! radiographers at the Gary, Indiana facility, including the radiographer associated with

! the event, admitted that on or prior to February 28,1996, they failed on occasion to l rotate the selector ring from the " operate" to the " lock" position and failed to depress the

plunger mechanism as required by the Licensee's operating procedures. They stated to

the investigator that they had been " lax," but that they were knowledgeable of the i requirement. They also stated that after the memo was issued by the RSO discussing 2

the event and the need to follow procedures, they no longer violated this requirement.

In determining whether the radiographer willfully failed to lock the radiographic exposure

device, the NRC based its conclusion on interviews with the radiographer as noted above. The Licensee's belief that the NRC's conclusion concerning willfulness was j influenced by whether a violation of the occupational exposure limit occurred is simply i incorrect.

I

! 2. Licensee's Araument i

j The Licensee asserts that the NRC improperly denied identification and corrective action

, credit under the terms of the NRC Enforcement Policy,Section VI.B.2.b and c, by

ignoring essential facts. The Licensee asserts that while the incident was identified i

through an event, this fact does not preclude identification credit where the problem arose from a single incident of negligence by a radiographer in violation of

! well-publicized Conam safety procedures, whsre the Licensee's quarterly radiation l safety compliance audit program was demonstrably adequate, and where there were no j prior deficient occurrences to identify the problem.

d l In addition, the Licensee argues that its corrective actions were also prompt and

comprehensive and should result in credit. The Licensee believes that the incident was

! promptly and comprehensively addressed and corrected by the Licensee's RSO through j his analysis of the film badge, his issuance of a February 29,1996, memorandum

! reminding all Conam radiographic personnel of the proper procedure for operating j radiographic exposure devices, his withdrawal of the radiographer from further

radiographic duties, and the suspension of the radiographer without pay for one week.

i

The Licensee disagrees with the NRC's position, as described in the Notice, that credit

should not be given because the Licensee did not confirm that each radiographer had j received the February 29,1996, memorandum from the RSO, nor had the Licensee

] instituted any monitoring / auditing program to evaluate the effectiveness of the j memorandum. The Licensee states that there is no evidence that the radiographers did i not receive the memorandum, and that there has been no repetition of the problem since the February event's occurrence. The Licensee believes that the NRC's dismissal 1

1 NUREG-0940. PART III A-65 1

Appendix A of credit for identification and corrective action ignores the fact that the February event was the only one of its kind against a record of no violations whatsoever during seven prior NRC inspections, and no that subsequent violations since the event have been identified by NRC inspections.

NRC Evaluation I

The NRC Enforcement Policy,Section VI.B.2.b, discusses the criteria to be considered when deciding if a licensee should be given credit for actions related to identification.

l These circumstances include: (i) whether the problem requiring corrective action was NRC-identified, licensee-identified, or revealed through an event; and (ii) for a problem revealed through an event, the ease of discovery, the licensee's self monitoring effort, the degree of licensee initiative in identifying the problem requiring corrective action, and whether prior opportunities existed to identify the problem (Section VI.B.2.b(2)(ii) of the Enforcement Policy).

The NRC and the Licensee both agree that the problem requiring corrective action was revealed through an event. Therefore, the criteria in Section VI.B.2.b(2)(ii) of the Enforcement Policy are applicable in this case. Regarding the ease of discovery, as well as the Licensee's self-monitoring effort, the radiographer involved in the incident reported the problem to the Licensee's RSO; and the problem was not identified through any self-monitoring action of the Licensee's RSO or management, such as an audit.

Regarding the degree of licensee initiative in identifying the probicm requiring corrective action, the Licensee's initiative does not deserve credit, as described below. Regarding the existence of prior opportunitics to identify the problem, as stated earlier, the Ol investigation revealed that approximately 25% of the Licensee's radiographers and i assistant radiographers at the Gary, Indiana facility admitted that on or prior to l February 28,1996, they on occasion failed to rotate the' selector ring from the " operate"  :

to the " lock" position and failed to depress the plunger mechanism as required by the  ;

, Licensee's operating procedures. Thus, the problem with failing to follow procedures was not isolated. The Licensee performs quarterly field audits of its radiographers. As noted in the inspection report and during the Predecisional Enforcement Conference, the Licensee's policy for performing field audits did not encompass multiple exposures or other situations where the potential existed for a radiograpner to fail to properly rotate the selector ring and depress the plunger. Therefore, numerous prior opportunities existed to identify the problem, yet the problem was not identified prior to the February 27,1996 inci& t. Thus, credit for identification is not warranted.

The NRC Enforcement Policy,Section VI.B.2.c, discusses the criteria to be considered when deciding if a licensee should be given credit for prompt and comprehensive corrective actions. These criteria include: (i) the timeliness of the corrective action, (ii) the adequacy of the licensee's root cause analysis for the violation, and (iii) the comprehensiveness of the corrective action. As stated in the inspection report, the NRC acknowledges the Licensee's prompt action in issuing a memorandum to all radiation safety supervisory personnel advising all radiography staff to complete a full and accurate survey of the radiographic exposure device, collimator, guide tube, and l

connector after each exposure and to secure the source assembly in accordance with i l

NUREG-0940. PART III A-66 _.

Appendix A the Licensee's procedures. However, although the issuance of the memorandum was timely, it does not constitute a comprehensive corrective action.

Specifically, after the Licensee received the vendor's report indicating the radiographer's dose, the Licensee did not perform an exact time-motion study at the scene of the event to determine the locations of the whole body, film badge and radiographic exposure device exit port. - Photographs of the scene that were obtained later did not include the position of the radiographer, in addition, the Licensee could not confirm that each radiographer had received the memorandum, nor had the Licensee instituted any monitoring / auditing program to evaluate the effectiveness of the memorandum. The Licensee's argument that there is no ev!dence that the radiographers did nD1 receive the r9emorandum is not persuasive; a comprehensive corrective action would ensure that each radiographer had received, reviewed, and understood the memorandum, and would monitor the radiographers' understanding of and compliance with the memorandum. Such comprehensive corrective actions were not implemented by the Licensee.

Finally, the fact that no violations had been identified during seven NRC inspections prior to the February 27,1996 event, although commendable, is not relevant as far as credit for corrective action is concemed. Further, in accordance with Section VI.B.2.c of the NRC Enforcement Policy, the adequacy of a licensee's corrective actions is judged at the time of the enforcement conference, not on the basis of whether subsequent violations following the event have been identified by the NRC Given the above, the NRC concludes that while the Licensee took some timely actions, on balance, such actions did not address the root cause of the violations and were not comprehensive.

Thus, credit for prompt and comprehensive corrective actions is not warranted. 1 l

3. Licensee's Araument The Licensee asserts that the NRC Enforcement Policy should find, at worst, that the February 27,1996 incident involved two non-willful Severity Level lil violations which, with appropriate identification and corrective action credit, do not justify any civil penalty.

The Licensee asserts that to aggregate the violations cited in Section I of the Notice and assign a Severity Level ll ' problem" to this collection is not consistent with the NRC's Enforcement Policy published in 60 FR 34381 (June 30,1995). The Licensee believes that the NRC's Notice compounds that error by determining that the Severity Level ll problem was willful, and on that basis justifying a 100% escalation of the $8,000 Severity Level ll base penalty.

NRC Evaluation As described above, the NRC has determined that Violation I.A was willful, that Violations 1.A, l.B and I.C occurred as described in the inspection report, and that credit for identification and corrective action is not warranted. The NRC Enforcement Policy,Section IV.A, states, in part, that the purpose of aggregating violations is to focus the licensee's attention on the fundamental underlying e ases for which enforcement action appears warranted and to reflect the fact that sev6 J violations with a common cause NUREG-0940, PART III A-67

Appendix A may be more significant collectively than individually and may, therefore, warrant a more substantial enforcement action. As noted in the Notice, in consideration of the willfulness involved, the relationship of these violations to a single incident, and the fact i I

that two safety barriers were breached, the violations are of very significant regulatory ccncem. Therefore, consistent with Section IV.A of the Enforcement Policy, the violations in Section I of the Notice were combined to reflect that. collectively, they are more signrficant than individually and, therefore, warrant a more substantial enforcement action.

As to the Licensee's argument concerning escalation of the $8,000 base penalty, the ,

NRC did not escalate the civil penalty on the basis of a willful violation. The base l amount for a Severity Level ll problem is $8,000, Credit was not warranted for the l

identification and corrective action factors. Therefore, in accordance with the civil  ;

penalty assessment process described in Section VI.b.2, the civil penalty for the  :

I Severity Level 11 problem is twice the base amount (i.e., $16,000).

NRC Conclusion The NRC concludes that the Licensee did not provide an adequate basis for withdrawing Violations I.B and I.C, for mitigs ting the severity level of Violations 1.A, l.B, and I.C in the ,

aggregate, or for mitigating the civil penalty associated with Violations 1.A, l.B, and I.C. I Therefore, the p:sposed civil penalty in the amount of $16,000 should be imposed by order.

I s

NUREG-0940, PART III A-68

APPENDIX B EVALUATION OF VIOL.ATIONS NOT ASSEGSED A civil PENALTY Of the violations not assessed a civil penalty, the Licenses admitted violation ll.B and denied Violation ll.A.

Restatement of Violation ll.A l II.A 10 CFR 20.2203(a)(2)(i) requires, in part, that a licensee submit a written report within 30 days after leaming of a dose in excess of the occupational dose limits for adults as defined in 10 CFR 20.1201.

Contrary to the above, on April 11,1996, the Licensee leamed of an event that caused an adult radiographer to receive a total effectivo dose equivalent of more than 5 rems total effective dose equivalent and did not submit a written report within 30 days as required.

Summarv of Licensee's Response to Violation II.A The Licensee, in its response, denies Violation ll.A and states that, because the radiographer wIs not exposed to a dose in excess of 5 roms, total effective dose equivalent, no reporting obligation arose under applicable regulations.

NRC Evaluation of Licensee's Resoonse to Violation ll.A The specific issue raised by Violation ll.A was whether the Licensee was required to submit a report to the NRC after leaming of a dose in excess of the occupational dose limits for adults as '

l defined in 10 CFR 20.1201. In this case, the Licensee's evaluation of the circumstances did not cppear to be adequate in that the Licensee did not complete an exact time / motion study at the scene of the event to determine the locations of the whole body, film badge, and radiography Exposure device. As a result, the Licensee did not conclude that an exposure in excess of the dose limits occurred.8 By letter dated June 23,1997, the Licensee did submit the report required by 10 CFR 20.2203(a)(2)(i), but solely en the basis that the NRC's letter transmitting the Notice of Violation cnd Proposed Imposition of Civil Penalty specifically stated that the Licensee was required to m:ke such a report. As noted above, the Licensee still contends that an exposure in excess of regulatory limits did not cccur based on the Licensee's unapproved methodology it used to compute the TEDE.

Given that the Licensee did not learn that the radiographer's exposure was in excess of regulatory limits, and that, after being informed by the NRC of the radiographer's exposure, the Licensee submitted a report per the requirements of 10 CFR 20.2203(a)(2)(i), the NRC concludes that Violation ll.A should be withdrawn.

8 For dotads conceming the Licensee's evaluation. see Summary of the Licensee's Response to Violation I.C and the NRC's Evaluation of the Licensee's Response to Violation I.C.

NUREG-0940, PART III A-69

Appendix B NRC Condusion The NRC staff concludes that the Licensee provided an adequate basis for withdrawirnj Violation ll.A. Therefore, Violation ll.A should be withdrawn.

I i

NUREG-0940. PART III A-70

i l

l DOCVEfEC LBP-98-31U3N '

UNITED STATES OF AMERICA .

NUCLEAR REG ** aTORY COMMISSION 38 DEC 16 P3 :59  !

l ATOMIC SAFETY AND LICENSING BOARD OF-fL ,

Before Administrative Judges: ADO.s. _ ,; ;

i Charles Bechhoefer, Chairman Dr. Richard F. Cole gg g ) 7 g Dr. Charles N. Kelber In the Matter of Docket No. 30-31373-CivP ,

i Conam Inspection, Inc. ASLBP No. 98-735-01-CivP i Itasca, Illinois  !

(License No. 12-16559-01) EA 97-207 Order Imposing Civil Monetary December 16, 1998 Penalty MEMORANDUM AND ORDER (Acoroval of Settlement Acreement and Dismissal of Proceedina) i On' December 14, 1998, both parties to this civil  !

penalty proceeding--Conam Inspection, Inc. and the NRC Staff--filed a joint motion for this Atomic Safety and Licensing Board to approve a settlement agreement (a copy of which is attached to this Order) and dismiss the proceeding.

The NRC Staff initially sought a civil penalty of

$16,000.00. The proposed settlement that we have before us would require Conam to pay $15 000.00 but would also have the Order of November 5, 1997 imposing a civil monetary penalty rescinded.

The Licensing Board has, of course, already conducted a five-day evidentiary hearing on the Order. Pursuant to 10 C.F.R. S 2.203, we are authorized at any time following NUREG-0940. PART III A-71

issuance'of a notice of hearing, and without regard as to whether a hearing has already been held, to entertain a compromise and to approve a settlement, according "due weight" to the position of the Staff. By its December 14, 1998 motion for us to approve the set sment agreement, the .

Staff has indicated its approval of ti.at agreement.

According due weight to the position of the Staff, we hereby acorove the attached settlement agreement and dismiss the proceeding.

IT IS SO ORDERED.

The Atomic Safety and Licensing Board

' YoY, u /Y. > :. bu Charle6 ~Bech'hoef er, Cp' air nan  :

ADMINISTRATIVE JUDGE  !

R c4_,  :

Dr. RTchard F. Cole ADMINISTRATIVE JUDGE J' .on j / s Y u l

/Dr . Charles N. Kelber ADMINISTRATIVE JUDGE

Attachment:

Settlement Agreement Rockville, Maryland December 16, 1998

'NUREG-0940 PART III A-72

p UNITED STATES NUCLEAR REGULATORY COMMISSION l

In the Matter of )

) Docket No. 30-31373-CivP j CONAM INSPECTION, INC. )

l Itasca, Illinois ) ASLB No. 98 735-01-CivP l )

SETTLEMENT AGREEMENT The United States Nuclear Regulatory Commission ("NRC") and Conam l

Ir,spection, Inc. ("Conam"), through their respective counsel, each of whom is '

authorized to execute this document,in consideration of the promises and representations contained in this document, hereby agree as follows:

1. On November 5,1997, the NRC issued an " Order imposing Civil Monetary Penalty" (the " Order') in Enforcemer:t Action 97-207 ("EA 97-207) with respect to certain alleged violations by Conam. The Order asserted that (a) a Conam radiographer had willfully failed to secure a sealed source assembly in the shielded position; (b) the Conam radiographer failed to conduct a survey of the entire circumference of the radiographic exposure device; and (c) the Conam radiographer received a radiation dose that brought his annual dose in excess of 5 roms total  ;

effective dose equivalent. The Order sought to aggregate these alleged violations to a I

Severity Level 11 problem.

2. On December 1,1997, Conam requested an enforcement hearing in response to the Order entered in EA 97-207 in order to present to an Atomic Safety and Licensing Board (the fBoard") testimony and evidence to contest the alleged violations and the Order as not justified under the evidence and applicable regulations.

In connection therewith, Conam (a) admitted that the radiographer had failed to secure the sealed source assembly in the shielded position, but denied that this failure was l

l willful; (b) denied that the radiographer failed to perform a survey as required in the l

regulations; and (c) denied that the radiographer's annual dose exceeded 5 rems total r

NUREG-0940._PART III A-73

effective dose equivalent. Conam denied that there was any basis for aggregating the alleged violations to a Severity Level ll problem.

3. After the depositions, admission of documents in evidence, the filing of a number of briefs, and one week of oral testimony during the hearing in this matter, Conam and the NRC have concluded it is in their respective interests, as well as the public interest, to settle the disputes at issue in and related to EA 97-207. Therefore, '

the NRC and Conam agree as follows:

A. The NRC (through NRC Staff) and Conam willjointly move the Board to approve this Settlement Agreement and to terminate this proceeding. l B. Upon approval of this Settlement Agreement by the Board,

1. the Order dated November 5,1997, regarding the Notice of Violation and Proposed imposition of Civil Penalty dated June 9,1997, is and shall be rescinded and the ongoing litigation in EA 97-207 is and shall be terminated by agreement of the parties; and

2. within five (5) business days of such approval, Conam will pay

$15,000, to be paid to the Treasurer of the United States.

C. This Settlement Agreement constitutes final disposition of the matters giving rise to EA 97-207 and to this litigation. In consideration of the terms of this Agreem ,nt, the NRC Staff will assert no further enforcement claims, in any form or forum, related to the matters addressed in EA 97-207 and the underlying inspection and investigation reports; and CONAM will not pursue any further hearings on, orjudicial review of, this matter.

4. The parties continue in maintain their respective positions in regard to the November 5,1997 Order imposing Civil Monetary Penalty. The parties agree that there remain differences of opinion on many of the issues raised by EA-97-207, the resolution of which involve factual and legalissues which have not yet been resolved.

2 NUREG-0940 PART III A-74

i i

!' Accordingly, the parties understand and acknowledge that this Settiement Agreement is the result of compromise and shall not for any purpose be construed as an admission of the regulatory violations that Conam denies or as a concession by the NRC that no l such violations occurred. Instead, this Settlement Agreement has been entered into in l

i order to tem 11nate further litigation without resolving the alleged violations and severity 1

levd disputed by Conam. Each party shall bear its own fees and costs.

IN WITNESS WHEREOF Conam and the NRC have caused this Settlement Agreement to be executed by their duly authorized representatives.

United States Nuclear Regulatory Commission By: #dd / * ~M ff Charles A. Barth Office of the General Counsel )!

I Conam inspection, Inc.

By; / $ '

!)

• W Malcolm H. Brooks ,

McBride Baker & Coles 1 Chicago, Illinois i

3 NUREG-0940. PART III A-75

. ,._. _ _ . _ _ . . . . - - _ _ ~ ~ _ _ ._ _ _ . . _ _ _. . _ . _ _ .

UNITED STATES

1. gush 4 NUCLEAR REGULATORY COMMISSION ATLANTA F ERA CENTER t 61 FORSYTH STREET. SW. SUITE 23T85 ATLANTA. GEORGIA 30303 3415 k"******0[ April 28, 1998 EA 97-627 .

Dr. Jos6 N. De Le6n. M. D.

Ccndominio Castillo Del Mar  :

Suite #1427 Isla Verde. PR 00979

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -

$5.000_AND EXERCISE OF DISCRETION (NRC SPECIAL INSPECTION REPORT NO. 52-19206-01/97-01)

Dear Dr. ue Le6n:

This refers to the ins)ection conducted on December 11. 1997, at your facility in Isla Verde. Puerto Rico, and a medical consultant's review completed on February 20. 1998. The purpose of the inspection was to determine whether activities authorized by the license. specifically the use of a Strontium-90 (Sr-90) eye applicator, were conducted safely and in accordance with regulatory requirements. The results of the inspection were discussed with .

you at exit meetings on December 11 and 15. 1997, and formally transmitted to you by letter dated January 30. 1998. The results of the review by our medical consultant were transmitted to you on February 24. 1998. You responded to the conclusions of the medical report on April 9.1998.

An open and transcribed predecisional enforcement conference was conducted in Isla Verde. Puerto Rico on March 2. 1998, with you to discuss the apparent violation, root causes, and corrective actions to preclude recurrence. A list of conference attendees and copies of the Nuclear Regulatory Commission's (NRC's) slides are enclosed. The apparent violation involved the failure to establish and maintain Quality Management Program (OMP) procedures for the use of strontium-90 in ophthalmic brachytherapy.

Based on the information developed during the inspection. the information you provided during the conference, and your letter of April 9. 1998, the NRC has determined that two examples of a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding it are described in detail in the subject inspection report. The first example of the violation is associated with the failure to include in your OMP a written procedure to meet the objective of 10 CFR 35.32(a)(3) that final plans of treatment and related calculations for brachytherapy were in accordance with written directives. Specifically, between June 1.1994 and July 3,1996. your written OMP failed to include a procedure to verify the Sr-90 eye applicator surface dose rate, a key factor in calculations for brachytherapy. to account i for radioactive material decay. On April 27. 1995. you submitted to the NRC  !

an amended OMP which contained a revised treatment time necessary to achieve a 2.000 centigray dose based on calculations performed by a Health Physics Consultant. These calculations contained a significant decay factor error that was used to determine the proper treatment time: however, you failed to NUREG-0940. PART III A-76

L u

I. ,

j Dr. J. De Le6n 2

. identify this error As a result, misadministrations of radiation dose to nine patients occurred, where each received approximately 4.000 centigrays instead of the intended dose of approximately 2.000 centigrays. -The second example of the violation.also involves the failure to include in your OMP a written procedure to meet the objective that any unintended deviation from the ,

written directive is identified and evaluated, and appropriate action is i taken.

Based on the NRC's medical consultant's evaluation of the significance of the

.nine misadministrations that occurred at your office, the violation is of significant regulatory concern because of the potential safety consevences to the patients, in that the probability of adverse consequences (i.e. cataract formation) to these patients has somewhat increased. The violation also is of particular regulatory concern due to the programmatic nature of the issues and the lack of oversight of Sr-90 treatments. Therefore.-this violation has been categorized at Severity Level III in accordance with the " General Statement of l Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy).

NUREG-1600.

In accordance with the Enforcement Policy, for a Severity Level III violation

occJrring before November 12, 1996, a base civil penalty of $2.500 is l

considered. However, in this case, the NRC determined the violation to be l particularly egregious because you were directly responsible for nine l

misadministrations at your facility. You should have realized the significant change in treatment time calculated for you by a Health Physics Consultant when you amended your QMP by letter to the NRC dated April 27, 1995. and taken further action to verify the accuracy of the calculations prior to treatment of patients. Had you done this, all the misadministrations could have been prevented. Thus, the NRC is exercising discretion in accordance with Section VII.A.1 of the Enforcement Policy and proposing a civil penalty that is twice the base civil penalty.

! Therefore, to emphasize the importance of conducting safe and compliant brachytherapy programs. I have been authorized after consultation with the

- Director. Office of Enforcement to issue the enclosed Notice for twice the base amount (i.e.. $5,000) for the Severity Level III violation. Issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort. In addition, you should be aware that future similar violations may result in a prohibition against conducting licensed

! activities in NRC jurisdiction.

Since you have indicated your intent to discontinue use of your Sr-90 eye applicator in the future, the NRC will consider withdrawing the proposed civil penalty if you properly dispose of or transfer.the Sr-90 eye applicator in accordance with existing regulations If you decide to do so, you should specify in your response to the enclosed Notice the date on which this action will be completed, and provide written confirmation to the NRC when you have properly disposed of or transferred the Sr-90 eye applicator.

In addition to the misadministration of radiation doses to nine patients at your facility.'you were directly responsible for 14 additional misadministrations at Ryder Memorial Hospital. Enclosure 2 documents the

.NUREG-0940. PART III A-77

'Dr. J. De Le6n 3 circumstances surrounding these misadministrations. The NRC also considers  !

these misadministrations to be significant because: (1) they highlight your carelessness or lack of regard for your responsibilities " a user of byproduct material at Ryder Memorial Hospital, after being informed by the j hospital that you could not use the Sr-90 source under their license; and l (2) the hospital was not specifically listed as a location of use on your '

license.

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

Luis A. Rey Regional mi strator '

Docket No. 030-17134 License No. 52-19206-01

Enclosures:

1. Notice of Violation and Proposed Imposition of Civil Penalty

2. Misadministrations at Ryder Memorial Hospital

3. NRC Presentation Material

4. List of Attendees cc w/ encls:

Commonwealth of Puerto Rico NUREG-0940. PART III A-78

i i NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Jos6 N. De Le6n, M. D. Docket No. 030-17134 Isla Verde. Puerto Rico License No. 52-19206-01 EA 97-627 During an NRC inspection conducted on December 11. 1997, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the NRC l 3roposes 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: l i

10 CFR 35.32(a) requires, in part. that the licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

Pursuant to 10 CFR 35.32(a)(3). the quality management program (OMP) must include written policies and procedures to meet the specific objective that final plans of treatment and related calculations for brachytherapy are in accordance with a written directive, which is defined in 10 CFR 35.2.

10 CFR 35.2 defines a written directive for brachytherapy as an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of radiation, containing (1) prior to implantation: the radioisotope, number of sources, and source strengths; and (2) after implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

Pursuant to 10 CFR 35.32(a)(5), the quality management program must include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is identified and evaluated.-and appropriate action is taken.

Contrary to the above.

A. Between June 1. 1994 and July 3, 1996, the licensee's quality management 3rogram did not include a written procedure to meet the objective tlat final plans of treatment and related calculations for.brachythera)y were in accordance with written directives.

Specifically, t1e licensee's written OMP failed to include a procedure to correct the eye applicator surface dose rate, a key factor for related calculations for brachytherapy, to account for radioactive material decay. As a result, nine misadministrations occurred.

B. Between June 1, 1994 and July 3, 1996, the licensee's OMP did not include a written procedure to meet the objective that any l Enclosure 1 NUREG-0940. PART III A-79

Notice of Violation 2 l

l l

unintended deviation from the written directive is identified and evaluated and appropriate action is taken. (01013) l This is a Severity Level III violation (Supplement VI).

Civil Per.lty - $5,000.

Pursuant to the provisions of 10 CFR 2.201. Dr. Jos6 N. De Le6n (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 rep y should be clearly marked as a " Reply to-a Notice of Violation" and shou d 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 bken to avoid further violations, and (5) the date when full compliance will be cchieved. If an adequate reply is not received within the time specified  !

m 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 thould not be taken. Consideration may be given to extending the response t1:ne.for good cause shown. Under the authority of l

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

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

)roposed, or may protest imposition of the civil penalty in whole or in part.

)y 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 L (e.g., citing page and paragraph numbers) to avoid repetition. The attention i of the Licensee is directed to the other provisions of 10 CFR 2.205. regarding the procedure for imposing a civil penalty.

r NUREG-0940. P F III A-80

- . - . - . _ - _ , ~

e

Notice of Violation 3 j 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 j 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 Jenalty and Answer to a Notice of Violation) should be addressed to: 1 James _ieberman. Dirc: tor. Office of Enforcement. U.S. Nuclear Regulatory I Commission. One White Flint North. 11555 Rockville Pike Rockville. MD l 20852-2738. with a copy to the Regional Administrator. U.S. Nuclear Regulatory .

Commission. Region II, l

! Because your res)onse will be placed in the NRC Public Document Room (PDR), to the extent possi)le. it should not include any personal privacy 3roprietary.

! or safeguards information so that it can be placed in the PDR witlout 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 l withholding of such material, you must s)ecifically identify the portions of l your response that you seek to have with1 eld 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 l information required by 10 CFR 2.790(b) to support a request for withholding i

' 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 Atlanta. Georgia this 28th day of April 1998 I

l S

NUREG-0940.-PART III A-81

MISADMINISTRATIONS AT RYDER MEMORIAL HOSPITAL BY JOSC N. DE LE6N. M.D.

On July 1, 1994, the NRC initiated enforcement of compliance with the requirements specified in 10 CFR 35.32. Quality Management Program. for Strontium-90 eye a)plicator users. As a result. Jos6 N. De Le6n.

M.D. (licensee) su)mitted a Quality Management Program (OMP) to the NRC for activities conducted under NRC License No. 52-19206-01 (Amendment No. 5). At this time Dr. De Le6n was also named as en authorized user of Sr-90 on Ryder Memorial Hospital's (RHH) NRC License No. 52-21026-01. On June 28, 1994 RMH's Executive Director notified the NRC and Dr. De Le6n in writing that his authorization to conduct operations under RMH's NRC materials license was canceled. Although he was notified by RMH about the cancellation of his privileges to use the Sr-90 source under their license. Dr. De Le6n continued to use the Sr-90 eye ap)licator without RMH's knowledge. During the use of the device at RMH. Dr. Je Le6n established and im31emented OMP procedures as described in the OMP used under his personal NRC icense No. 52-19206-01.

Dr. De Le6n used the Sr-90 eye applicator at RMH between July 1. 1994 and February 21. 1996. but the OMP did not include a written procedure to meet the objective that final plans of treatment and related calculations for i brachytherapy were in accordance with written directives. Specifically.  !

Dr. De Le6n's written OMP failed to include a procedure to verify the eye  :

applicator surface dose rate, a key factor in calculations for brachytherapy. '

to account for radioactive material decay, contrary to 10 CFR 35.32(a)(3).

Because of an error by Dr. De Le6n's Health Physics Consultant, an incorrect decay factor was determined resulting in an incorrect surface dose rate and treatment time calculation. This error resulted in fourteen overdose misadministrations which were each approximately two times the intended dose (2000 centigra Dr. De Le6n was directly responsible for the error.ys Also, vs. 4000 as ofcentigrays).

July 1. 1994. Dr. De Le6n's OMP used at Ryder Memorial Hospital failed to include a written procedure to meet the objective that any unintended deviations from written directives were identified and ,

evaluated, and appropriate action taken contrary to 10 CFR 35.32(a)(5).

l l

l l

l l Enclosure 2 1

NUREG-0940. PART III A-82 i

UNffED STATES jpatogo

• NUCLEAR RECULATORY COMMISSION g

61 FO SYTH S R TE 23T85

%, ATLANTA. GEORGIA 30303 3415

• • • • • July 30,1998

-EA 97-627  ;

Jos6 N. De Le6n. M.D. I Condominio Castillo del Mar Suite 1427 l Isla Verde. PR 00979

SUBJECT:

NRC INSPECTION REPORT N0. 52-19206-01/97-01 AND TERMINATION OF LICENSE NO. 52-19206-01 (

REFERENCE:

CONTROL N0. 257984: DOCKET NO. 030-17134) l

Dear Dr. De Le6n:

Thank you for your response of May 20. 1998, to our Notice of Violation, issued on April 28. 1998, concerning activities conducted under NRC License No. 52-19206-01. We have evaluated your response and found that it meets the requirements of 10 CFR 2.201.

Our letter dated April 28. 1998, stated that the NRC would consider I withdrawing the proposed civil penalty if you properly disposed of or transferred the strontium 90 eye applicator in accordance with existing regulations. In your letter dated June 22. 1998. you informed the NRC that you had transferred the source to a physician in the Dominican Republic and requested that your NRC license be terminated. Consequently, since you properly transferred the strontium 90 eye applicator to an authorized recipient, we are withdrawing the proposed civil penalty.  ;

In response to your request of June 22. 1998. enclosed you will find Amendment No. 7 to NRC License No. 52-19206-01 which terminates your NRC materials license.

We appreciate your cooperation in this matter.

Sincerely.

% R. W Luis A. Reyes K' Regional Administrator Docket No. 030-17134 License No. 52-19206-01

Enclosure:

NRC Materials License Termination cc w/ encl:

Commonwealth of Puerto Rico NUREG-0940. PART III A-83

NRC FORM 374A U.S. NUCLEAR REIULATORY COMMISSION PAGE 1 of 1 PAGES Ucense No.

52-19206-01 MATERIALS LICENSE oocket or Reference No.

SUPPLEMENTARY SHEET 030-17134 Arnendrnent No. 7 Joss N. De Le6n, M.D.

Condominio Castillo del Mar, Suite 1427 Isi; Verde, Carolina 00979 in cccordance with Certification of Disposition of Materials dated June 21,1998, License No. 5219206-01, is hereby terminated, g

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FOR THE U.S. NUCLEAR REGULATORY COMMISSION Michael L. Fuller

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DJ.te July 30,1998 By

' Region 11, Divi'sion of Nuclear Materials Safety 61 Forsyth Street, SW, Suite 23T85 Atlanta, GA 30303 N:\TEMPLATEWATUC\5219206.T07 LillD M_00A9 DA_DT III A_AA

i UNITE D ST ATES

! gam A NUCLEAR REGULATORY COMMISSION l

, REGION IV

." 611 RYAN PLAZA ORIVE. SUITE 400

%, , /, ARLINGTON. TEXAS 760114064 i October 31, 1997 EA 97-180 Mattingly Testing Services, Inc.

ATTN: Mark Mattingly, President Post Office Box 3126 Great Falls, Montana 59403

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -

$10,000 1 (U.S. DOL Case 95-ERA-40 and O1 Report No. 4-95-019S)

Dear Mr. Mattingly:

This refers to the investigation of Mattingly Testing Services, Inc. (MTSI), completed on April 16,1997 (Office of Investigation (01) Report Nos. 4-95-019 and 4-95-019S) at MTSl's Billings, Montana facility and the March 11,1997 Department of Labor (DOL) Administrative Law Judge's (ALJ) Recommended Decision and Order (RDO). The ALJ found that Mattingly Testing Services, Inc. (MTSI), discriminated against a former MTSI employee for engaging in protected activities in violation of Section 211 of the Energy Reorganization Act (ERA).

Specifically, the ALJ found that MTSI discriminated against the former employee when it terminated him April 17,1995, for having raised nuclear safety concerns to the NRC (DOL case No. 95-ERA-40). On April 18,1997, the DOL Administrative Review Board dismissed the case based upon a settlement between MTSI and its former employee without issuing a decision on the merits. The NRC's 01 investigation also concluded that MTSI had discriminated against the former employee by terminating his employment for raising safety concerns to the NRC.'

By letter dated June 11,1997, you were informed that, based upon its review of the ALJ's recomrnended decision and transcripts from the DOL proceedings, the NRC had determined that the action taken against the former employee may have been in violation of 10 CFR 30.7, and that a transcribed telephonic predecisional enforcement conference had been scheduled to discuss this apparent violation. The transcribed conference was held on August 13,1997.

Based on a thorough review of all the available information related to the ca.se, including information which you provided during the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice).

' In an earlier Recommended Decision Denying Complaint, the ALJ had found that MTSI did not discriminate against the former employee. However, the case was remanded based upon a determination that the ALJ erred in limiting testimony and refusing to admit certain evidence, as well as new evidence which was admitted in the second DOL proceeding. Ol had also conducted an earlier investigation in which discrimination against the former employee was not substantiated.

NUREG-0940, PART III A-85 l

Mattingly Testing Services, Inc.

During the August 13,1997 conference with the NRC, as well as during the DOL proceedings, you maintained that the former employee was fired because he had performed a poor l inspection and had missed a significant number of welding defects on girders intended for use  ;

on a bridge project. You stated that your former employee was not fired for his protected I activities. Notwithstanding this argument, the NRC has determined that MTSI has not shown l that it would have terminated the former employee solely for having conducted a poor l inspection, absent his having brought safety concerns to the NRC. The NRC has concluded l

that MTSI discriminated against its former employee in violation of 10 CFR 30.7. In reviewing the significance of the violation, we considered the fact that the former employee brought I significant and legitimate issues to the attention of the NRC, for which the NRC ultimately took significant enforcement action.2 Therefore, we have concluded that this violation should be categorized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), NUREG-1600, at Severity Level 111.

In accordance with the Enforcement Policy in effect at the time of the adverse action, a civil penalty with a base value of $5,000 is considered for a Severity Level lli violation. Because your company has been the subject of escalated enforcement action 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. In this case, the violation was identified through the DOL adjudicatory process, and therefore, credit for identification is not warranted.

With regard to corrective actions for discrimination violations, the NRC considers the promptness and comprehensiveness of licensee actions taken to address the broader i

environment for raising concerns in the workplace, and to provide a remedy to the individual l

who was the subject of the discrimination at issue. MTSI stated at the conference that it encourages employees to identify problems to MTSI senior management and that its employees fully understand their right to raise safety issues directly to the NRC. However, MTSI has not provided any information regarding specific actions it took between April 1995, when MTSI fired the former employee, and April 1997, when a settlement was reached in the DOL proceeding, to insure that his termination did not have a chilling effect upon other employees raising safety concerns directly to the NRC. Therefore, no credit is warranted for corrective action.

Therefore, to emphasize the importance of this violation as well as to emphasize the importance of identification and comprehensive correction 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 amount of $10,000 for this Severity Level ill violation. i

'A Severity Level 11 Notice of Violation assessing a $15,000 civil penalty was issued to MTSI on May 5,1995 (EA 95-035) for multiple violations of radiography requirements. In addition, Notices of Violation were issued to the individuals who committed the deliberate violations mentioned above. An Order was also issued.

NUREG-0940. PART III A-86

Mattingly Testing Services, Inc.

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. 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). i Sincerely, 1

Ellis W. Mersch j Regional Admi strator 1

Docket No. 030-20836 )

License No. 25-21479-01 j

Enclosure:

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

State of Montana Mr. Michael Timmons NUREG-0940, PART III A-87

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Mattingly Testing Services, Inc. Docket No. 030-20836 Great Falls, Montana License No. 25-21479-01 {

EA 97-180 i

Based on the results of an NRC investigation completed on April 16,1997, and the NRC's l

review of a U.S. Department of Labor Administrative Law Judge's Recommended Decision and l Order dated March 11,1997 (ERA 95-ERA-40), and the information received at the predecisional enforcement conference on August 13,1997, a violation of NRC requirements I was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the N?.C 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 violation and its associated civil penalty are set forth below:

10 CFR 30.7(a) prohibits discrimination by a Commission licensee against an employee for engaging in certain protected activities. Discrimination includes diccharge or other actions relating to the compensation, terms, conditions, and privileges of employment.

Under 10 CFR 30.7(a)(1)(l), the activities which are protected include, but are not limited to, the reporting by an employee to his employer or to the NRC information about alleged regulatory violations.

Contrary to the above, on April 17,1995, the licensee discriminated against Mr. Michael Timmons for engaging in protected activity. Specifically, Mr. Timmons was terminated from his position because he provided safety concerns to the NRC.

3 This is a Severity Level lli violation (Supplement Vil).

Civil Penalty - $10,000.

Pursuant to the provisions of 10 CFR 2.201, Mattingly Testing Services, 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 j 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 i

achieved, (4) the corrective steps that will be taken to avoid further violationt., and (5) the date j

when full compliance will N acnieved. 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 i 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 I 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, NUREG-0940, PART III A-88

l I-Notice of Violation )

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 l 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) demonstr.  ;

ate 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, l 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 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 deterrnined 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. i l

I 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 IV,611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent i 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 must j 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 Arlington, Texas, this 31st day of October 1997 l

l I

NUREG-0940, PART III A-89

py..,k* UNITED STATES g NUCLEAR REGULATORY COMMISSION o, WASHINGTON, D.C. asseH001 k***** September 15, 1998 l EA 97180 Mattingly Testing Services, Inc.

ATTN: Mark Mattingly, President Post Office Box 3126 Great Falls, Montana 59403 l

SUBJECT:

WITHDRAWAL OF NOTICE OF VIOLATION AND PROPOSED IMPOSITION l OF civil PENALTY-$10,000 l (U.S. DOL Case 95-ERA-40 and Ol Report No. 4-95-019S) l

Dear Mr. Mattingly:

By letter dated October 31,1997, and the attached Notice of Violation and Proposed imposition of Civil Penalty (Notice), you were informed that based on the results of the NRC investigation completed on April 16,1997, and the NRC's review of the U.S. Department of Labor Administrative Law Judge's Recommended Decision and Order dated March 11,1997 (95-ERA-40), and the information received at the predecisional enforcement conference on August >

13,1997, Mattingly Testing Services, Inc. (MTSI) was in violation of 10 CFR 30.7(a) for discrimination against one of your employees for that employee engaging in protected activity.  ;

On January 30,1998, you submitted your Reply to the Notice in which you denied that discrimination had occurred.

Upon further review of the facts underlying this case, your response including your Policy for the Cooperative Maintenance of a Safety Conscious Work Environment, submitted by letter dated August 28,1998, and the differing 01 reports and Department of Labor decisions, the NRC is terminating this matter without reaching a final decision on the merits. Accordingly, the i NRC is withdrawing the October 31,1997 Notice. The staff intends to reflect this withdrawal action in a future Information Notice. However, I must emphasize to you the importance of ,

conducting your business in compliance with 3H NRC regulations, including the employee l protection requirements contained in 10 CFR 30.7. We urge you follow your new guidance on the Safety Conscious Work Environment at MTSI and to remind your staff that they are free to raise safety concerns to you or to the NRC without fear of retaliation by MTSI for raising such safety concems. A violation of 10 CFR 30.7 (a) in the future could lead to formal NRC enforcement action. Depending on the facts and circumstances, such action could be issued against MTSI, or to you as an Individual, and prohibit MTSI, or you, from engaging in licensed activities.

You are not required to respond to this letter. However, if you choose to provide a response, please provide it to me within 30 days at the U.S. Nuclear Regulatory Commission, Office of Enforcement,11555 Rockville Pike, Rockville, Md. 20852.

1 In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, records or documents compiled for enforcement purposes are placed in the NRC Public Document Room (PDR). A copy of this letter, and your response, if you choose to submit one, will be placed in the PDR.

NUREG-0940. PART III A-90 i

. .. . . _ . _ - _ - .- -... ~. . . . . . . . . . _ . . - . - . - . _ . . - .

-2 If you have any questions or comments about this correspondence, or questions related to your compliance with NRC regulatory requirements, including compliance with 10 CFR 30.7, please do not hesitate to call Mr. Ross Scarano, NRC Region IV at (817) 860-8106.

Sincerely, W

James Lieberman, Director Office of Enforcement 4

NUREG-0940. PART III A-91

a nay 6  % UNITED STATEC

!" ]'

NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30086 4001

• • • • • • March 27, 1998 EA 98-108 NDT Services, Inc. I c/o Crossland Boiler Sales and Service, Inc.

ATTN: Mr. Thomas Crossland, Owner Rio Canas Industrial Park, Suite 370  :

Road No.175, Km. 0.02, Comer Road No.1  !

Caguas, Puerto Rico 00726 4952

SUBJECT:

ORDER SUSPENDING LICENSE (EFFECTIVE IMMEDIATELY) l

Dear Mr. Crossland:

The enclosed Order Suspending License (Effective immediately) (Order) is being issued based on the findings of NRC inspections at temporary job sites at the Puerto Rico Electric Power Authority's San Juan and Costa Sur Power Stations and an ongoing investigation being conducted by the NRC Office of Investigations. Our findings to date have raised serious concerns regarding NDT Services, Inc.'s (NDTS) ability and/or willingness to comply with the Commission's reqr.irements and its ability to conduct licensed activities in a manner that adequately protects health and safety of workers and the public.

i The Order requires that: (1) NDTS immediately suspend all radiographic operations authorized by its license; (2) within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> following the date of this Order, NDTS contact NRC Region 11 and advise the NRC of the current location, physical status, and storage arrangements of licensed material; (3) if NDTS removes licensed material from locked storage, NDTS notify NRC Region il 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> before removal of the licensed material; (4) NDTS not receive any NRC-  ;

licensed materials while this Order is in effect; and (5) NDTS maintain all records related to '

licensed activities in their current form and not remove or alter the records in any way.

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 you )

to civil sanctions.  ;

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

NUREG-0940,-PART III A-92

- ..- ~ .... . . _ _ - - - . . - .. . . . . -- ._. .-.-... . . - - - -_.

f l

{ NDT Services, Inc.  !

In accordance with 10 CFR 2.700 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, i b~

As ok'C.TIia~dani Acting Deputy Executive Director for Regulatory Effectiveness Docket No MO-17711 License N- 2-19438-01 l

Enclosure:

Order Suspending License (Immediately Effective) l cc w/ encl:

Commonwealth of Puerto Rico l

NUREG-0940, PART 111 A-93

UNITED STATES NUCLEAR REGUI.ATORY COMMISSION in the Matter of NDT SERVICES, INC. )

Caguas, Puerto Rico ) Docket No: 030-17711 '

) License No: 52-19438-01

) EA 98-108 ORDER SUSPENDING LICENSE (EFFECTIVE IMMEDIATELY)

NDT Services, Inc. (Licensee or NDTS) is the holder of Material License Nl i

(License) issued by the Nuclear Regulatory Commission (NRC or Commis 10 CFR Part 30. The License authorizes possession and use of up to 10 in each sealed radiography source and up to 20 curies of Cobalt 6 source for performing industrial radiography. The License was originally i 1980, was most recently amended on December 12,1995, and is due to expire January 31,2002.

It On August 6 and October 4,1997, the NRC Region ll staff oerformed inspect Licensee's facility and a temporary job site at the Puerto Rico Electric P Juan Power Station. The inspections determined that the Licensee had not activities in accordance with NRC recairements. On November 7,1997, the NR inspection Report No. 52-19438-01'97-01 and Notice of Violation (Notic five violations identified during the incpections. Briefly summarized, the Licensee's: (1) use of a set of Operating and Emergency Procedures th approved by the NRC; (2) certification of individuals as radiographers who had no required training; (3) failure to conduct surveys or continuous monitoring wher being exposed; (4) failure of an assistant radiographer to recharge his poc

{

beginning of his shift; based upon the inspector's observation and the ass i NUREG-0940, PART III A-94 1

4 I I

statement to the inspector that he usually recharged his dosimeter when it reached a reading of about 50 millirem and that he was unaware of the requirement to recharge the dosimeter at the beginning of each shift; and (5) failure to provide hazardous materials transportation training to its employees. In an unsigned and undated written response, which was sent by facsimile to the NRC on December 5,1997, the Licensee responded to the Notice. As a result of NRC

! questions conceming the Licensee's response, the Licensee submitted a second signed but undated response to the NRC, which was received by the NRC on March 17,19'>8. In its second response, the Licensee did not contest four of the violations; however, with regard to the l

l l hazardous materials training violation, the Licensee disputed the violation.

l On August 26,1997, the NRC Office of Investigations (01) initiated an investigation to detemVae l whether the Licensee and any of its employees had willfully violated NRC requirements. )n addition, on February 6,1998, the NRC inspected the Licensee's activities at a temporary job l

site, Puerto Rico Power Authority's Costa Sur Power Station. The 01 investigation of these matters is still ongoing. Nonetheless, based on the February 6,1998 inspection and the 01

evidence to date, the following violations, in addition to the violations described in the >

November 7,1997 Notice, have been identified to date:

A. On February 6,1998, the Licensee failed during two separate source exposures at the Costa Sur Power Station to conduct operations so that the dose in any unrestricted area did not exceed 2 millirem in any one hour, as required by 10 CFR 20.1301(a)(2).

Specifically, during the first exposure the Licensee performed radiography operations in a manner that created a dose in an unrestricted area of 22 millirems in an hour based on a radiation field of 73 millirems per hour (mR/hr) during an 18-minute exposure.

Following identification of this example by the NRC inspector, the NRC inspector reminded the Licensee radiographer of the NRC requirements to survey and monitor areas surrounding the radiography area to ensure that radiation areas in unrestricted l

NUREG-0940, PART III A-95

areas were not inadvertently created or that mambers of the public were not being unnececsarily exposed to radiation. However, approximately 30 minutes after the inspector's reminder, the Licensee radiographer again performed radiography such that a dose was created in another unrestricted area of 6 millirems in an hour based on a radiation field of 19 mR/hr during an 18-minute exposure. The 19 mR/hr radiatior level was confirmed by the Licensee radiographer using two survey meters.

i l

B. O'n February 6,1998, the Licensee failed during two separate source exposures (described in Paragraph ll.A of this Order) to perform adequate survey = and continuous monitoring, as required by License Condition No. 21 (which requires the Licensee to comply with Section 6.3.1 of its appl: cation dated October 25,1991). Specifically, during these source exposures, no surveys or continuous monitoring were cor, icted on levels above or below the level where radiography was being conducted to ensure that radia: ion levels were within permissible limits and that no one was being inadvertently exposed to radiation. The failure to perform adequate surveys and continuous monitoring is a repeat of a violation identified ouring the August and October 1997 inspections.

C. On February 6,1998, the Licensee failed during two separate source exposures to post radiation areas, as required by 10 CFR 20.1902(a). Specifically, during these source exposures, the Licensee radiographer failed to post the radiation areas described in Paragraphs ll.A and ll.B of this Order, in addition, notwithstanding the inspector's reminder of the need to post radiation areas, during the second source exposure, the radiographer did not comply with 10 CFR 20.1002(a) in that the radiographer continued to perform radiography activities (i.e., the second source exposure) without posting the radiation area.

l l

A-96 NUREG-0940. PART III I

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3 4

l D. On February 6,1998, the Licensee failed to control the restricted areas that are 1

described in Paragraphs ll.A and ll.B of this Order, as required by License Condition 21 (which requires the Licensee to comply with Sections 6.1.1 and 6.4 of its application of October 25,1991). Specifically, during the inspection, a non-licensee employee of the

- Costa Sur Power Station, a member of the public, indicated he had observed the radiographic operations while standing within the radiation areas that should have been posted.

E. Transcribed swom statements by one or more individuals indicate that, on multiple occasions between 1994 and 1997, the Licensee allowed multiple individuals to work as radiographers when the individuals failed to meet the training requirements, as required by License Condition 12 ( which requires that licensed material be used by or under the supervision and in the physical presence of trained individuals).

i F. Transcribed swom statements by one or more individuals indicate that, on multiple occasions in 1994 and 1995, the Licensee permitted assistant radiographers to conduct radiographic operations without wearing dosimetry, as required by 10 CFR 34.33 (the requirement in effect at the time of occurrence), and that, in 1995, Licensee employees I

who retrieved a disconnected source at the Phillips Chemical Company facility in Guayama, Puerto Rico, intentionally removed their dosimetry and thereby failed to comply with 10 CFR 34.33.

G. Transcribed swom statements by one or more individuals indicate that, in 1995, the Licensee failed to report the source disconnect event that occurred at the Phillips facility, referenced in Paragraph II.F of this Order, as required by 10 CFR 34.30 (the requirement

, in effect at the time of occurrence).

i NUREG-0940. PART III A-97 w ,- - - .

, . .- .- .. _ - = . _ . . - ,-. . - - . - . - -.- . --

H. The Licensee failed to maintain, or provide to the NRC, complete and accurate information, contrary to 10 CFR 30.9. Specifically:

1. A daily pocket dosimeter reading log, required to be maintained by l 10 CFR 34.83(a) (the requirement in effect at time of occurrence), reflected that, prior to the beginning of the shift on October 4,1997, a pocket dosimeter had been rechowed when, in fact, it had not.

2. The Licensee's undated responses to the November 7,1997 Notice, which are  !

described above, were inaccurate. Specifically, in response to the violation involving the failure of the assistant radiographer to recharge his pocket dosimeter at the beginning of his shift, the Licensee stated in both responses that the [ assistant] radiographer "did not remember making the statement that he recharged his dosimeter when it reached about 50 mR or that he was unaware of the requirement to recharge the dosimeter at the beginning of each shift." This asserwn was not correct in that the employee was directed to sign an intamal document indicating that he did not recall making such statement, when he had made the statement.

3. Training records required by 10 CFR 34.31(c) (the requirement in effect at time of occurrence) and License Condition 21 (which requires the Licensee to conduct classroom training in accordance with Sectior. . Of its application dated October 25,1991), documented that two individuals had received 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of radiation safety training on August 31,1994, and January 10,1995, respectively.

However, the Licensee only gave the individuals NUREG BR-0024, ' Working Safely in Gamma Radiography," and asked them to read it.

NUREG-0940. PART III A-98

4. Radiation exposure records for calendar year 1995, required to be maintained by 10 CFR 20.2106(a), did not reflect actual doses received by Licensee employees who retrieved a disconnected source in 1995 described in Paragraph II.F of this Order because the involved employees removed their dosimetry.

l

1. Transcribed swom statements by one or more individuals indicate that, on multiple occasions between 1994 and 1997, and with the knowledge of the Licensee's l President / Radiation Safety Officer and the Assistant Radiation Sa .% Officer, Licensee i radiographers GIlowed radiographers' assistants to conduct radiogrepnic operations l while unsupervised, in violation of 10 CFR 34.44 (the requirement in effect at the time of 1

j occurrence).

i J. Transcribed swom statements by one or more individuals indicate that, on multiple j occasions between 1994 and 1997, Licensee radiographers failed to stop work when Licensee employees' pocket dosimeters went off-scale, in violation of License f Condition 21 (which requires the Licensee to meet Section 2.5.2 of its application dated October 25,1991).

i i

lli in addition to the above, the Licensee's previous enforcement history is pertinent to this Order in that on July 16,1996, the NRC issued to the Licensee a Notice of Violation and Proposed Imposition of Civil Ponalty (Notice) for numerous and significant violations (EA 94-029). This Notice included violations that directly resulted from the misconduct of the Licensee's former l i

President and former Radiation Safety Officer (RSO), who willfully disregarded regulatory l 1

requirements, falsified documents, and provided inaccurate and incomplete information to the NRC in violation of 10 CFR 30.9. The Notice cited the Licensee for, among other things, failure 1

l NUREG-0946. PART III A-99 ,

1 1

}

7 to utilize personnel who were trained and qualified as radiograohers in accordance with the l requirements of 10 CFR 34.31(a), providing false information to the NRC regarding the 4

qualifications of two radiographers, and failure of two radiographers to wear alarming ratemeters during radiographic and source disconnect activities. In addit;on, on July 16,1996, the NRC

, issued two individual Orders against the Licensee's former President and former RSO as a result of their deliberate misconduct. The Orders prohibited the former Paesident and former RSO from engaging in any licensed activities for a period of five years. By letter dated August 15,1996, the Licensee responded to the July 16,1996 Notice. In its response, the Licensee i

admitted all of the violations. Among other things, it acknowledged that "NDTS Company l

officials ignored NRC and company regulations and procedures," and outlined its corrective

' l actions. '

] Notwithstanding the Licensee's response to the July 16,1996 Notice of Violation, the Licensee j has again been either unwilling or unable to comply with numerous NRC requirements l 2

l established to protect public health and safety. As described above, the Licensee has violated a l number of NRC requirements which are extremely important to protecting public health and I'

safety, including that of Licensee employees. Specifically, the Licensee allowed the conduct of radiographic operations by unsupervised, inadequately-trained radiographer's assistants, i

conducted operations such that the dose limits in controlled areas accessible to the public j exceeded those specified in 10 CFR 20.1301, failed to post or control radiation areas, failed to monitor or conduct surveys in areas where a source was being exposed, failed to report a I

source disconnect event as required by NRC regulations, and failed to maintain complete and accurate numerous required records. These violations have potential serious adverse consequences for public health and safety because they could directly cause unnecessary exposures and overexposures to the public and Licensee employees. Therefore, the violations are of very significant regulatory concem, irrespective cl dether they resulted from willful misconduct on the part of the Licensee, particularly in viea cr the potential safety consequences NUREG-0940. PART III A-100

inherent in not controlling radiographic work sites and failing to properly train or supervise radiographers. In addition, the fact that many of the violations which have been identified to date are either repetitive or appear to be the result of willful misconduct on the part of Licensee employees is of further significant concem to the NRC. In addition, the Commission must be able to rely on its licensees to provide complete and accurate information to the Commission to ensure protection of public health and safety.

l IV Consequently, in light of the above, I lack the requisite reasonable assurance that the Licensee's I current operations can be conducted under License No. 52-19438-01 in compliance with the Commission's requirements and that public health and safety, including the health and safety of Licensee employees, will be protected. Therefore, public health, safety, and interest require that License No. 52-19438-01 be suspended pending further order by the NRC and that licensed material be placed in locked, safe storage. Furthermore, pursuant to 10 CFR 2.202, I find that the significance of the violations and conduct described above is such that public health, safety, and interest require that this Order be immediately effective.

V Accordingly, pursuant to Sections 81,161b,1611,182 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. The authority to perform radiographic operations under License No. 52-19438-01 is hereby suspended pending further Order by the NRC. The Licensee shall cease all radiographic operations and retum all byproduct tr.aterial possessed under this license to NUREG-0940, PART III A-101

9 locked, safe storage at the Licensee's facilities. All other requirements of the License and applicable Commission requirements, including those in 10 CFR Part 20, remain in effect. i B. Within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> following issuance of this Order, the Licensee shall contact Mr. Douglas M. Collins, Director, Division of Nuclear Materials Safety, NRC Region 11, or 4 l

his designee, through the NRC Operations Center at telephone number (301) 816-5100, l and advise him of the current location, physical status, and storage arrangements of l licensed material. A written response documenting this information shall be submitted, under oath or affirmation, to the Regional Administrator, NRC Region 11, Atlanta Federal l

Center,61 Forsyth Street, SW, Suite 23T85, Atlanta, Georgia 30303-3415 within seven days of receipt of this Order.

C. If the Licensee removes licensed material from locked storage, the Licensee shall notify NRC Region ll 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> before removal of the licensed material. The notice shall be provided to Mr. Douglas M. Collins, Director, Division of Nuclear Materials Safety, NRC Region ll, or his designee, at telephone number (404) 562-4700.

D. The Licensee shall not receive any NRC-licensed material while this Order is in effect.

j l

l E. All records related to licensed activities shall be maintained in their current form and  !

must not be altered in any way.

The Regional Administrator, Region 11, may, in writing, relax or rescind this order upon demonstration by the Licensee of good cause.

NUREG-0940. PART III A-102

VI 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 t% date of this Order. Where good cause is shown, consideration will be j given to extending the time to request a hearing. A request for extension of time must be made l in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatry Commission, Washington, D.C. 20555, and include a statement of good cause for the extension. The answer l 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 relies 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 Rulemakings 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 et the same address, and to the Regional Administrator, NRC Region 11, Atlanta Federal Center,61 Forsyth Street, SW, Suite 23T85, Atlar,ta, Georgia 30303 and to the Licensee if the 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, 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.

NUREG-0940. PART III .A-103

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Pursuant to 10 CFR 2.202(c)(2)(1), 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 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

/ kDy-As k C'.ihadani Acting Deputy Executive Director for Regulatory Effectiveness Dated at Rockville, Maryland thiaWay of March 1998 NUREG-0940. PART III A-104

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4 UNITE 3 STATES j+g 884k NUCLEAR RE2U1.ATORY COMMISSION REGION m 4 - ,, S i .U 801 WARRENVILLE ROAD

) k USLE. ILUNOIS 60632-4361

• • • • • April 16, 1998 4

A EA 96-242

)

Mario W. Overhoff Ph.D.,' President Overhoff Technology Corporation P.O. Box 182 Milford, OH 45150

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -

$2500 (Inspection Report 030-33731/96001(DNMS) and Ol Investigation Report 3-96-028)

Dear Dr. Overhoff:

This refers to the inspection conducted on May 16,1996 through July 3,1996, and the investigation initiated on May 21,1996, by the NRC Office of Investigations (01) and completed on February 17,1998, at Overhoff Technology Corporation (OTC) in Milford, Ohio. The subject inspection report was sent to you by letter dated July 9,1996. A transcribed predecisional -  ;

I enforcement conference was held in the NRC Region lit office with you on July 30,1996, to discuss the apparent violations. their causes, and proposed corrective actions. As a result of the issues raised during the conference an Ol investigation was conducted. A copy of the synopsis l of the 01 investigation report is enclosed with this action. j I

Based on the information developed during the inspection, the 01 investigation, and the information that was provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and  ;

Proposed imposition of Civil Penalty (Notice) and the circumstances surrounding them are ,

described in detail in the subject inspection report.

The NRC has concluded that the violations cited in Section I of the Notice, the failure to ensure I that the quantity of tritium contained in gas calibrator devices did not exceed the 10 CFR 30.71 limits, and the failure to ensure that no more than 10 exempt quantities were transferred in any a single transaction, are willful. Based upon statements made during the transcribed predecisional enforcement conference and during the 01 investigation, the reason given for these violations is that there was confusion of the requirements between OTC's "G" license and the "E"licente.

However, these very same issues regarding exempt quantities and shipping practices were discussed at length between you and the NRC reviewer during the licensing process for the "E"

. license. It is the NRC's view that OTC staff was aware of the "E" license requirements, and demonstrated careless disregard by failing to meet those "E" license requirements. Willful violations are of concem because the NRC's regulatory programs are based on licensees and their employees acting with integrity. This is particularly true in this case because you have the

authority to ship radioactive materials to persons who are exempt from the regulations. A consideration in permitting the distribution of radioactive material to persons exempt from an NRC license is the limitation imposed on the quantity that may be distributed in order to minimize the potential for harm.

t NUREG-0940. PART III A-105

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M. Overhoff 4 it is essential that the NRC be able to maintain the highest trust in individuals working with  ;

licensed material and that licensees appropriately manage their programs to ensure that all  !

Individuals fully understand the importance of complying with regulatory requirements. Because  ;

of the willfui nature of the violations and your involvement, as an OTC official, the violations in  !

Section i of the Notice are classified in the aggregate in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy), WUREG-1600, as a Severity Level 111 problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level lli problem. . Because the violations were deemed as willful, the NRC considered whether credit was warranted for /denti# cation and Corrective Action in '

accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement )

Policy. Credit for identification was not warranted because the violations were identified by the NRC during a routine inspection. A Confirmatory Action Letter (CAL) dated August 19,1996, discussed the actions OTC agreed to take in response to the violations. The actions included, but were not limited to: (1) a review of the NRC license including all referenced documents and pertinent NRC rules by all ste '. (2) development of written procedures to ensure that all calibrator bottles contained the appropriate quantity of tritium; and (3) training of all staff regarding written procedures for filling gas cylinders and shipping material to customers, t Subsequent to the CAL, a re-inspection of OTC's license activities confirmed that the corrective actions had been implemented; therefore, credit for Corrective Action is warranted.

Therefore, to emphasize that willful violations of NRC requirements w;ll not be tolerated and to ensure 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 in the amount of $2,500 for the Severity Level ill problem in Section I of the Notice. -

The violation in Section 11 of the Notice involves the failure to label tritium gas calibrators in accordance with the license documents is categorized as a Severity Level IV violation in accordance with the Enforcement Policy.

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 addition, issuance of this Notice constitutes escalatad enforcement action that may subject you to increased inspection effort.

1 l l

NUREG-0940. PART III A-106

l i

M. Overhoff i in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its ;

j enclosures, and your response will be placed in the NRC Public Document Room.

Sincerely, w eA 1 A. Bill Beach I Regional Administrator l Docket No. 030-33731 License No. 34-18214-03E

Enclosures:

1. Notice of Violation and Proposed imposition of Civil Penalty

2. 01 synopsis 4

i 1

1 I

3 l

NUREG-0940. PART III A-107 i

l

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Overhoff Technology Corporation Docket No. 030-33731 Milford, Ohio Ucense No. 34-18214-03E i EA 96-242 i During the NRC inspection conducted from May 16 through July 3,1996, and the Ol investigation conducted between May 21,1996 and February 17,1998, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure 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 penalty are set forth below: '

l. Violaflons Assessed a Civil Penalty i A. Ucense No. 34-18214-03E authorizes the licensee to distribute check sources containing byproduct materiallisted in 10 CFR 30.71, Schedule B and tritium gas calibrators in accordance with the license application dated October 3,1994, and letters dated September 8,1995, September 13,1995, and September 30,1995.

Section 6.2 of the license application dated October 3,1994, states, in part, that in gas form, quantitles of each byproduct material will not exceed 10 CFR 30.71, Schedule B. The Schedule B limit for tritium (hydrogen-3) is one millicurie.

Contrary to the above, in March 1996, devices were distributed that contained quantities of byproduct materialin excess of the limits listed in 10 CFR 30.71, Schedule B. Specifically, two calibrators were distributed to Kirtland Air Force base and Argonne National Laboratories, each containing approximately 9.0 millicuries (333 MBq) of tritium gas. (01013)

8. 10 CFR 32.19(a) requires that no more than 10 exempt quantities set forth in Schedule B of 10 CFR 30.71 shall be sold or transferred in any single transaction.

Contrary to the above, between March 18 and 22,1996, seven transactions were made involving 687 krypton-85 calibration sources. These transactions were made in six transfers in lots of 100 exempt quantities at a time and one transfer of 87 exempt quantities. (01023)

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

Civil Penalty- $2,500 1

1 1

L NUREG-0940. PART III A-108

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1 l

l Notice of Violation and Proposed  ; imposition of Civil Penalty d

i ll. Violation Not Assessed a Civil Penalty Ucense No. 34-18214-03E authorizes the distribution of check sources containing

byproduct material listed in 10 CFR 30.71, Schedule B and tritium gas calibrators in  !

accordance with the license application dated October 3,1994, and letters dated j t September 8,1995, September 13,1995, and September 30,1995. l 1 Item 2 of the letter dated September 30,1995, references drawing N090695-1 with

- related drawings NO32895-4 and NO32895-6, which describe the dimensions of the

lecture bottle radioactive calibration standard as well as type, quantities, and locations of the labeling to be applied on the tritium calibrators.

Contrary to the above, tritium calibrators distributed in March 1996, specifically, Serial Nos.1939 and 1919, were not labeled in accordance with the representation in drawings I i

N090695-1 and NO32895-6. (R2014)

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

Pursuant to the provisions of 10 CFR 2.201, Ovedioff Technology Corporation (Ucensee) is I hereby required to submit a written statement or explanation to the Director, Office of  ;

i Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of l Violation and Proposed imposition of Civil Penalties (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, j (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 j

~

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

. or affirmation.

i Within the ser e time as provided for the response required above under 10 CFR 2.201, the

' Ucensee ma) Say the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear '.egulatory Commission, with a check, draft, money order, or electronic transfer s payable to the Treasurer of the United States in the amount of the civil penalty proposed above, 2

or the cumulative amount of the civil penalty if more than one civil penalty is proposed, or may 4 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 Ucensee fail 4

to answer within the time specified, an order imposing the civil penalty will be issued. Should the Ucensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in wnole 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 NUREG-0940. PART III A-109

Notice of Violation and Proposed Imposition of Civil Penalty 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 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 I 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 c' he 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 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 111,801 Warrenville Road, Usic, Illinois 60532-4351.

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 POR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please prov!de 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 MM11 specifically identify the portions of your response that you seek to have withheld and provide in I 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 necesscry to provide an acceptable response, please l provnb the level of protection described in 10 CFR 73.21.

]

Dated at IAle, Illinois this 16th day of April 1998 l l

NUREG-0940 PART III A-110

, SYN 0PSIS This investigation was initiated by the U. S. Nuclear Regulatory Commission, Office of Investigations, Region III, on May 21, 1996, to determine if personnel of.0verhoff Technology Corporation (0TC) deliberately shipped more than 10 exempt krypton 85 calibration sources in a single transaction, and to determine if OTC personnel distributed tritium gas calibrators that contained

quantities of byproduct material in excess of the authorized limit.

Based on evidence developed during this investigation, the allegations that OTC personnel shipped more than 10 exempt sources in a single transaction, and

-that OTC personnel distributed tritium gas calibrators containing excess byproduct material were substantiated. However, these acts although willful, were not deliberate.

A 4

4 NUREG-0940. PART III 1A-111

p neg g k UNITED STATES g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30006 4001 l

l

• • • • • August 19, 1998 EA 96-242 Mario W. Overhoff, Ph.D., President Overhoff Technology Corporation P.O. Box 182 Milford, OH 45150 -

SUBJECT:

WITHDRAWAL OF PROPOSED civil MONETARY PENALTY j EXERCISE OF ENFORCEMENT DISCRETlON i

Dear Dr. Overhoff:

l This refers to your letter dated May 12,1998, in response to the Notice of Violation and Proposed Imposition of Civil Penalty (Notice) sent to you by our letter dated April 16,1998. Our letter and the Notice described two violations which were classified in the aggregate as a Severity Level lli problem. A civil penalty of $2,500 was proposed for the violations to emphasize that willful violations of NRC requirements will not be tolerated and to ensure prompt identification of violations. In addition, one other violation classified at Severity Level IV was not assessed a civil penalty, in the response to the Notice, you admitted the violations; however, you denied that they were willful, argued that they were without safety consequence, and requested full mitigation of the civil penalty.

The term " willfulness" Q _ a ussed in the NRC Enforcement Policy, embraces a spectrum of violations ranging from deliberate intent to violate or falsify to and including careless disregard for requirements. After considering your response to the Notice, the NRC staff concludes that the violations do represent careless disregard for requirements, as determined by the circumstances associated with Overhoff's application for its exempt distribution license, as well as statements made by you and your staff during the inspection, the NRC investigation by the Office of Investigations, and the transcribed predecisional enforcement conference.

Your response to the Notice indicates the cause for Violation I.A was oversight due to work pressures and the desire to provide good customer service, and that you believe you met the spirit of the regulations. In addition, the response stated the shipments were of negligible quantities and had no safety consequences. The NRC agrees that the amounts of material shipped were relatively small; however, they exceeded the regulatory limits for the amount of radioactive material which may be distributed to persons exempt from a license. These regulatory limits are based upon minimizing the potential for harm. It is apparent that Overhoff was aware of these limits because the license application dated October 3,1994, stated that quantities of tritium gas in any single lecture bottle would not exceed the limits listed in 10 CFR 30.71, Schedule B (1 millicurie). The application also specified that each lecture bottle would not exceed 1 millicurie. However, you stated to the Ol investigator that, during March 1996, two tritium gas calibrators were filled in excess of allowable limits because you did not do any calculations prior to filling the calibrators. You stated that you "made a judgement on the fly" because you thought the gas being used to fill the calibrators was " pretty weak" and thus did not NUREG-0940. PART III A-112

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4

, 2 ,

i  ;

perform the calculations prior to filling the calibrators. You were aware that you did not know the  ;

specific activity, you were aware of the requirement, and you made a conscious decision to i proceed without checking. Under these circumstances, exceeding regulatory limits in March i 1996 by distributing two calibrators, each containing several times the permitted level of

] radioactive gas (tritium), demonstrates careless disregard for regulatory requirements.

5 l Your response to Violation I.B indicates the violation was caused by confusion between the '

3 requirements of Overhoff's licenses for manufacturing, general distribution, and exempt l distribution. However, during the licensing process for the exempt distribution license, the shipping requirements for exempt distribution were discussed at length between yourself and the  ;

NRC licensing reviewer. Additionally, in Overhoff's initial application for its exempt distribution j

license, you quoted the regulations for shipping exempt sources word-for-word and made a 1 i request for an exemption to them. Specifically, you requested that Overhoff be allowed to ship

! 50 exempt sources per package rather than the required 10 sources per package. This request l 1

was not granted. At the time of licensing, the requirement was clear. Therefore, the NRC does i not accept your argument regarding confusion. During the May 16 through July 3,1996 l q inspection, NRC found that Overhoff shipped 100 sources per package in six shipments and 87 sources per package in one shipment.

You state in your response that the Navy, which was a recipient of greater than ten exempt 4

quantities, holds an NRC license; and that the Navy did the actual distribution to persons i exempt. However, Overhoff shipped these sources to the Navy labeled for exempt distribution.

Therefore, while the Navy may hold an NRC license, it was under no obligation to treat these sources as licensed material, and their receipt and use by the Navy was not in any way i;

controlled by the Navy's NRC license. Overhoff, not the Navy, holds the license that permits

) distribution to persons exempt. Under these circumstances, it is Overhoff, not the Navy, that 3 l must control the exempt distribution and assure that it is in accordance with 10 CFR 32.19. i i

For these reasons, the NRC staff has determined that the violations occurred as stated and that

! you did not provide an adequate basis for your contention that the violations were not willful.

j However, upon reconsideration of the types and quantities of materialinvolved in the violations, i together with the fact that Overhoff constitutes a small entity for purposes of the Small Business j Regulatory Enforcement Fairness Act (SBREFA), I have been authorized, after consultation with i the Deputy Executive Director for Regulatory Effectiveness, to exercise enforcement discretion

, and withdraw the civil penalty assessed for the two violations constituting a Severity Level lli j problem. The withdrawal of this civil penalty should not be considered a lessening of the

! seriousness with which the NRC views willful violations, and similar treatment should not be l cxpected for any future violations. You should now be aware of the importance of maintaining

{ full compliance with NRC requirements. You are on notice that work pressures and the desire to j provide good customer service do not excuse violations of regulatory requirements. Therefore, i willful noncompliance in the future may result in a significant civil penalty, as well as modification, j suspension, or revocation of your license (s).

Based upon the actions that Overhoff agreed to take in response to the violations, as j documented in the Confirmatory Action Letter (CAL) dated August 19,1996, as well as the results of a follow-up inspection conducted on October 28,1997, the NRC staff has concluded that a further response to the Notice of Violation is not necessary. In accordance with 10 CFR i

i NUREG-0940. PART III A-113 i

i' __ . , _ _ . _ _ . _ . - - . _ . _ _ _ _ , . _ , _ _ ,

3 2.790 of the NRC's ' Rules of Practice," a copy of this letter and the enclosures will be placed in the NRC's Public Document Room.

Sincerely,

.by ,

I R. W. Borchardt, Acting Director Office of Enforcement Docket No. 030-33731 License No. 34-18214-03E i

l NUREG-0940. PART III A-114

--- - .-- -.~,..-~-._.n.-_-_ ~.~..=~,,--,.w_., - . . - - - - . . ,

["4, 8 UNITE D sT ATES

NUCLEAR REGULATORY COMMISSION R EGION IV kN

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e G11 HYAN PLAZA DRIVE. SUITE 400 AR LING TON, T E x AS 76011 8064

• • • • • May 15, 1998 EA 98-124 M.. Larry K Davidson President and CEO 1 The Terracon Companies, Inc.

16000 College Boulevard Lenexa, Kansas 66219 1

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTY -

$2,750 (NRC Inspection Report No. 030-32176/98-01) .

I

Dear Mr. Davidson:

)

l This is in response to your letter dated April 6,1998, in which Mr. Gary Bradley of your staff I submitted a " Response to an Apparent Violation" on behalf of The Terracon Companies, Inc.

(Terracon). The NRC's inspection was completed on February 26,1998. The apparent violation was described in the NRC's March 24,1998 inspection report and involved a failure to maintain adequate control of a portable moisture / density gauge, resulting in its theft. The NRC's letter transmitting the inspection report indicated that the NRC was considering escalated enforcement action for this apparent violation. Terracon was given a choice of responding in writing or requesting a predecisional enforcement conference, and you chose to submit a written response.

In its April 6,1998 response, Terracon stated that the gauge was stolen from a truck parked at a restaurant on January 23,1998. Terracon stated that it was stolen from its shipping container because a Terracon technician did not secure a padlock which had been placed in the hasp of the gauge case, Terracon stated that the technician's negligence occurred despite recent retraining ir, gauge transport and security procedures.' Terracon also indicated that disciplinary action had been taken against the involved technician for his negligence, and an electronic memorandum regarding the theft and failed security measures was sent to all Terracon office managers / radiation safety officers. Finally, Terracon indicated that it will instruct local radiation safety officers to enhance periodic policing of gauge security efforts at temporary project sites. I Based on the information developed during the NRC's inspection, and our consideration of the information provided in Terracon's April 6 letter, the NRC has determined that a violation of NRC requirements occurred. This violation is cited in the enclosed Notice of Violation and Proposed imposition of Civil Penalty. The violation involves the failure to maintain adequate control and surveillance of licensed material in accordance with the requirements of 10 CFR 20.1802.

'The NRC's Enforcement Policy states in Section VI.A that generally, licensees are held responsible for the acts of their employees and that the policy should not be construed to excuse personnel errors.

NUREG-0940. PART III A-115

The Terracon Companies, Inc. Although the stolen gauge was recovered by the Tulsa Police Department and was intact.

Terracon's failure to assure proper security of this gauge resulted in the theft of licensed radioactive material and the potential for its misuse and unnecessary radiation exposures to members of the public. Therefore, this violation has been classified at Severity Levelill in  ;

accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions"  ;

(Enforcement Policy) NUREG-1600.

j in accordance with the Enforcement Policy, a civil penalty with a base value of $2,750 is I considered for a Severity Level 111 violation. Because Terracon has been the subject of escalated enforcement action within the last 2 years,r the NRC considered whether credit was warranted for /dentification and Corrective Action in accordance with the civil penalty j assessment process in Section VI.B.2 of the Enforcement Policy. The NRC has determined that l credit for identification is not warranted because the violation was self-disclosing, i.e., it was apparent as a result of the theft of the gauge. The NRC has determined that credit for corrective action is warranted because your actions, which are described above, were prompt and sufficiently comprehensive to minimize the potential for a similar event. This results in the assessment of a penalty at the base value.

Therefore, to emphasize the importance of compliance with requirements that are designed to assure that licensed material remains in the control of licensees, the need to prevent similar events from occurring, and in recognition of the previous escalated enforcement action against Terracon, I have been authorized to issue the enclosed Notice of Violation and Proposed imposition of Civil Penalty (Notice) in the base amount of $2,750 for the Severity Level ill violation described above.

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. You may reference previously docketed correspondence in providing the required information. In addition, although we find your described corrective actions sufficient, we request that you provide additional details on your statement that you intend to enhance loce radiation safety officer policing of gauge security at temporary job sites. The NRC will _ se your response, in part, to determine whether further enforcement action is necessary to ;nsure 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 plar.ed in the NRC Public Document Room (PDR). I I

Sincerely fff.#

Ellis W. Merse Regional Ad.T istrator 2On November 17,1997, the NRC issued a $5,000 civil penalty to Terracon for a willful failure to provide gauge operators a manufacturer's training course (EA 97-425).

NUREG-0940, PART III A-116

. _ _ . _ . _ . _ _ . - . . . - _ _ _ . _ _ , _ _ . . _ . - . . . . . _ . _ _ _ . _ _ _ _ _ _ . . . . _ _ . . _ _ ..__.._1 d

1

- The Terracon Companies, Inc. -3 Docket No. 030-32176 - .

License No.'15-27070-01

Enclosure:

Notice of Violation and

' Proposed imposition of Civil Penalty cc w/

Enclosure:

State of Kansas '

4 4

l 4

i 1

4 NUREG-0940, PART III- A-117

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY The Terracon Companies, Inc. Docket No. 030-32176 Lenexa, Kansas License No. 15-27070-01 EA 98-124 During an NRC inspection completed February 26,1998, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the 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 20.1802 states, in part, that the licensee shall control and maintain constant surveillance of licensed material that is an unrestricted area and that is not in storage.

As defined in 10 CFR 20.1003, unrestricted area means an area to which access is neither limited nor controlled by the licensee.

Contrary to the above, on January 23,1998, the licensee did not control and maintain constant surveillance of licensed materialin an unrestricted area. Specifically, the licensee did not maintain adequate control or constant surveillance of a CPN Model MC1-DR portable nuclear moisture / density gauge containing a nominal 8-millicurie cesium-137 sealed source and a nominal 40-millicurie americium-241 sealed source.

The licensee failed to secure a padlock on the gauge container, resulting in the theft of the gauge from a vehicle parked at a restaurant. (01013)

This is a Severity Level ll1 violation (Supplement IV).

Civil Penalty - $2,750 Pursuant to the provisions of 10 CFR 2.201, The Terracon Companies, Inc., 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 c!early marked as a " Reply in 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, NUREG-0940. PART III A-118

2-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 (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 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 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, letter with payment of civil penalty, and l Answer to a Notice of Violation) should be addressed to: Mr. James Lieberman, Director, Office i of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738, with copies to the Regional Administrator, Region IV,611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, and the Walnut Creek Field Office,1450 Maria Lane, Suite 300, Walnut Creek, California 94596.

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 must l 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 l 10 CFR 2.790(b) to support a requsst for withholding confidential commercial or financial l 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 Arlington, Texas this 15th day of May 1998 NUREG-0940. PART III A-119

OM*h p  % UNITED STATES g

j NUCLEAR REOULATORY COMMISSION WA8HINGTON, D.C. 20066 4 001

\*****/ October 19, 1998 EA 98124 Mr. Larry K. Davidson President and CEO The Terracon Companies, Inc.

16000 College Boulevard Lenexa, Kansas 66219

SUBJECT:

ORDER IMPOSING civil MONETARY PENALTY $2,750

Dear Mr. Davidson:

This is in reference to the June 9,1998 Answer to Notice of Violation and a Reply to Notice of Violation signed by Mr. Gary Bradley, Corporate Radiation Safety Officer for The Terracon Companies, Inc. (Terracon), in response to the NRC's May 15,1998 Notice of Violation and Proposed imposition of Civil Penalty --$2,750 (Notice). The Notice described a failure to maintain constant surveillance of an NRC-licensed nuclear moisture / density gauge, resulting in the gauge's theft from a Terracon vehicle on January 23,1998.'

To emphasize the importance of compliance with requirement , that are designed to assure that ,

licensed material remains in the control of licensees, the need to prevent similar events from occurring, and in recognition of previous escalated enforcement action against Terracon, a civil penalty of $2,750 was proposed.

Terracon's Answer to Notice of VicL an and Reply to Notice of Violation admit that a Terracon technician failed to secure a padlock on a gauge container, resulting in the theft of the gauge from the vehicle in which the gauge was being transported. Terracon states that the actions of the technician constituted " careless disregard of security protocols by a properly trained individual who knowingly violated Terracon policies and NRC regulations," that Terracon had done all that was required by its license, and that the NRC's enforcement action should have been focused on the technician, not Terracon. Terracon also challenges the rationale for the proposed penalty as contradictory,in that the NRC staff gave Terracon credit for its corrective actions but cited the need to prevent similar events from occurring, After consideration of Terracon's responses, we have concluded, for the reasons given in the Appendix to the enclosed Order, that Terracon is responsible for the violation committed by its technician and that the civil penalty was assessed in accordance with the Enforcement Policy.

Accordingly, we hereby serve the enclosed Order on Terrecon imposing a civil monetary penalty in the amount of $2,750. As provided 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 James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Terracon reported the theft to the NRC on the date of its occurrence.

NUREG-0940, PART III A-120

. _ . _ = __. _- . _ _ __ ._ . . _ . .

The Terracun Companies, Inc. i l

Flint North,11555 Rockville Pike, Rockville, MD 20852-2738. We will review the effectiveness of your corrective actions during subsequent inspections.

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

Sincerely, i James Lieberman, Director  !

Office of Enforcement Docket No. 030-32176 License No. 15-27070-01

Enclosure:

As Stated i

I NUREG-0940. PART III A-121 1

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of )

)

The Terracon Companies, Inc. ) Docket No. 030 32176 Lenexa, Kansas ) License No. 15 27070-01

) EA 98-124 I

ORDER IMPOSING CIVIL MONETARY PENALTY l l

l l The Terracon Companies, Inc. (Terracon or the Licensee), is the holder of Materials License No.15-27070-01, Amendment 7, Issued by the Nuclear Regulatory Commission (NRC or

- Commission) on April 21,1997. The license authorizes the Licensee to possess and utilize moisture / density' gauges containing sealed sources in accordance with the conditions specified therein.

ll An inspection of the Licensee's activities was completed on February 26,1998. The results of this inspection indicated that the Licensee had not conducted its activities in full compliance with NRC requirements. A written Notice of Violation and Proposed imposition of Civil Penalty (Notice) was served upon the Licensee by letter dated May 15,1998. The Notice stated the nature of the violation, the provisions of the NRC's requirements that the Licensee had violated, ,

and the amount of the civil penalty proposed for the violation.

The Licensee responded to the Notice in an Answer to Notice of Violation and a Reply to Notice of Violation, both dated June 9,1998. The Licensee states that the actions of the technician who caused the violation constituted " careless disregard of security protocols by a properly I

I NUREG-0940. PART III A-122

trained individual who knowingly violated Terracon policies and NRC regulations," that Terracon had done all that wLs required by its license, and that the NRC's enforcement action should have been focused on the technician, not Terracon. Terracon also challenges the rationale for the proposed cMI penalty as contradictory, in that the NRC ga/e Terracon credit for its corrective actions in assessing the civil penalty, but cited the need to prevent similar events from occurring.

t lli After consideration of the Licensee's response and the statements of fact, explanation, and crgument for mitigation contained therein, the NRC staff has determined, as set forth in the Appendix to this Order, that the violation occurred as stated and that the penalty proposed for the violation designated in the Notice should be imposed by Order.

j in view of the '?q.ing 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 Uconsee pay a civil penalty in the amount of $2,750 within 30 days of the date of tNs Order, by check, draft money order, or electronic transfer, payable to the Treasurer of the United States and mailed to James Ueberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, MD 20852-2738.

1 NUREG-0940. PART III A-123

3-v l 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 j

request for extension of time must be made in writing to the Director, Office of Enforcement, I 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 Secretary, U.S. Nuclear Regulatory ,

Commission, ATTN: Rulemakings 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, and to the Regional Administrator, NRC Region IV,611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.

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 1

. granted), the provisions of this Order shall be effective without further procsedings. If payment has not been made by that time, the matter may be referred to the Attorney General for 1

collection. '

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

l ,

NUREG-0940, PART III A-124

i

.4 Whether, on the basis of the violation admitted by the Licensee, this Order should be sustained.

FOR THE NUCLEAR REGULATORY COMMISSION h

James Lieberman, Director Office of Enforcement Dated al this /f/gockville, Maryland day of October 1998 Attachment - Appendix l

NUREG-0940. PART III A-125

. -. . _- - - - - - - - - . - - - _ . - ~ - - - - - - . - . -

APPENCslX EVALUATION AND CONCLUSION On May 15,1998, a Notice of Violation and Proposed imposition of Civil Pe nity (Notice) was issued for a violation identified during an NRC inspection. The Terracon Con panies, Inc.

(Terracon or the Licensee) responded to the Notice by an Answer to Notice of Violation and a reply to Notice of Violation, both dated June 9,1998. In its responses, the Licensee admitted i the violation, but protested the proposed civil penalty. The NRC's evaluation and conclusion regarding the Licensee's response are as follows:

Restatement of Vip' s tg1 10 CFR 20.1802 states, in part, that the licensee shall cor' trol and maintain constant surveillance of licensed material that is in an unrestricted area and that is not in storage.

As defined in 10 CFR 20.1003, unrestricted area means an area to which access is neither limited nor controlled by the licensee.  ;

Contrary to the above, on January 23,1998, the licensee did not control and maintain constant surveillance of licensed materialin an unrestricted area. Specifically, the licensee did not maintain adequate control or constant surveillance of a CPN Model MC1-DR portable nuclear moisture / density gauge containing a nominal 8-rnillicurie cesium-137 sealed source and a nominal 40-millicurie americium 241 sealed source.

The licensee failed to secure a padlock on the gauge container, resulting in the theft of the gauge from a vehicle parked at a restaurant. (01013)

Summarv of Licensee's Reauest for Mitiaation Terracon states that the actions of the technician who enused the violation constituted " careless disregard of security protocols by a properly trained individual who knowingly violated Terracon ,

policies and NRC regulations," that Terracon had done all that was required by its license, and that NRC's enforcement action should have been focused on the technician, not Terracon.

Terracon also challenges the rationale for the proposed penalty as contradictory, in that the NRC gave Terracon credit for its corrective actions in assessing the civil penalty, but cited the need to prevent similar events from occurring as one of the reasons for the penalty.

NAC Evaluatir.c of Licensee's Reouest for Mitlaation First, the tecnnician informed the NRC inspector during the inspection that he had placed a nuclear moisture / density gauge in its case, had chained and locked the gauge case to the bed of the truck, and had placed a padlock in the hasp of the gauge case, but inadvertently had failed to secure the padlock. The inspection's findings are reflected in the NRC's May 15,1998 Notice. The NRC did not conduct an investigation to determine whether the technician willfully violated NRC requirements. Had the NRC conducted an investigation and concluded that the '

technician willfully failed to secure the moisture / density gauge from unauthorized removal, the enforcement sanction against Terracon could have been more significant. Regardless of the cause of the technician's action (i.e., inadvertent error or willful act), a failure to secure NRC-licensed materialin a public area is of significant concern to the NRC beccuse of the potential  ;

for radiation exposures to members of the public. j NUREG-0940. PART II.I A-126-

2-Second, as Terracon notes, the " General Statement of Policy and Procedure for NRC Enforcement Action", NUREG 1600 (Enforcement Policy), provides at Section Vill that enforcement actions may be taken against individuals when their conduct is willful and when they fail to take required actions which have actual or potential safety significance. However, the Enforcement Policy also provides that "[M]ost transgressions of individuals at the level of Severity Level lli or IV violations will be handled by citing only the facility licensee. More serious violations, including those involving the integrity of an individual (e.g., lying to the NRC) conceming matters within the scope of the individual's responsibilities, will be considered for enforcement action against the individual as well as against the facility licensee." Terracon's suggestion that the technician, and not Terracon, should not be held responsible for the Severity Level ill violatic. esp 3cially when the integrity of the technician was not involved, is contrary to the Enforcemec.t Niicy.

Third, notwithstanding the issue of willfulness, the Licensee is responsible for violations caused by its employees, whether arising from inadvertent error or willful acts. The Commission has formally resolved the issue of a licensee's responsibility for violations caused by licensee employees. In At/t.ntic Research. Corporation, CLI-80-7,11 NRC 413 (March 14,1980), the Commission held that "a division of responsibility between a licensee and its employees has no place in the NRC regulatory regime which is designed to implement our obligation to provide adequate protection to the health and safety of the public in the commercial nuclear field" and that the licensee is " accountable for all violations committed by its employees in the conduct of licensed activities." /d. at 418. The licensee uses, and is responsible for the possession of, licensed material. The licensee hires, trains, and supervises its employees. All licensed activities are carried out by employees of the licensee and, therefore, all violations are caused by employees of the licensee. A licensee enjoys the benefits of good employee performance and suffers the consequences of poor employee performance. To not hold the licensee responsible for the actions of its employees, whether such actions result from incompetence, negligence, or willfulness, is tantamount to not holding the licensee responsible for its use and possession of licensed material. If the NRC were to adopt such a regime, there would be no incentive for licensees to assure compliance with NRC requirements.

Finally, the NRC finds no contradiction between giving Terracon credit for its corrective acouns and citing the need to prevent recurrence of the violation as a reason to propose a civil penalty.

In the civil penalty assessment process, the NRC routinely considers whether the licensee should be given credit for identification of the violation" and for corrective actions, in determining whether a civil penalty should be assessed and, if so, the size of the penalty. See Enforcement Policy,Section VI.B.2. Because the violation in this case was self-disclosing, (e.g., the violation was apparent as a result of the theft of the gauge), credit for identification was not warranted. /d. at Section VI.B.2.b. The Licensee was, however, given credit for its corrective actions. Consideration of the identification and corrective action factors yielded a civil penalty of 100% of the base penalty for this Severity Level lli violation. The NRC staff found no reason to exercise its discretion to either mitigate or escalate the civil penalty yielded 8 The identification factor is considered if a licensee has been the subject of enforcement action for Severity Level lll violations within in the past two years or previous two inspections. See Enforcement Policy,Section VI.R.2. Since Terracon had previously been the subject of enforcement action in 1997 for a Severity Level 111 violation (EA 97-425), the identification factor was considered in this case.

NUREG-0940. PART III A-127

3-by standard application of the identification and corrective action factors. Nor has the Licensee presented any reason to mitigate the penalty. Once it had been determined that a civil penalty was warranted, there was nothing contradictory about noting that a civil penalty would serve the purpose of preventing similar incidents from occurring. The Enforcement Policy specifies that one of the purposes of civil penalties is to deter future violations. /d. at Section V.B. In short, the NRC followed the assessment process of the Enforcement Policy in determining the civil penalty proposed in the Notice.

l l NRC Conclusion l The NRC concludes that Terracon is responsible for the violation caused by its technician, and that the proposed civil penalty was properly assessed in accordance with the NRC's Enforcement Policy. The Licensee has not presented a basis for withdrawal of the violation nor for mitigation of the civil penalty. Consequently, the proposed civil penalty in the amount of

$2,750 should be imposed by Order.

l l

l NUREG-0940. PART III A-128

., _.. . _ . . ___ ._..___.m . - - .. _ _ -. ____ _ __ _ _ _ . - -- ____ _ .- . . . . . _ _ _

s% MC j p  % UNITED STATES i g p

j 2

NUCLEAR REQULATORY COMMISSION WASHINGTON, D.C. N h ,,,,, # April 22, 1998 EA 98-156 Mr. James H. Miller Vice President, Production U. S. Enrichment Corporation 2 Democracy Center 6903 Rockledge Drive Bethesda, MD 20817

SUBJECT:

CONFIRMATORY ORDER MODIFYING CERTIFICATE FOR THE PADUCAH GASEOUS DIFFUSION PLANT i

Dear Mr. Miller:

Based on the Nuclear Regulatory Commission's (NRC) review of a certificate amendment request dated October 31,1997, submitted by the Corporation, the NRC has concluded that a

, violation of NRC requirements occurred. The violation involved a failure to perform an analysis

of potential accidents (10 CFR 76.85) and a failure to comply with the conditions of certification (10 CFR 76.51).

The enclosed Order is being issued to confirm your commitments to install seismic modifications in the C-310/310A and C-315 Buildings at the Paducah Gaseous Diffusion Plant (Paducah) by no later than September 30,1998. That action is required to bring those facilities back into compliance with the Paducah Safety Analysis Report. The modifications willincrease the seismic capacity of the equipment in the facilities to withstand an earthquake producing a peak ground acceleration of 0.165 g. Until the modifications are completed, operations in the C-310/310A and C-315 Buildings will have restrictions imposed by Condition 13 of the  !

Paducah Certificate of Compliance as modified by the enclosed Order. Your letter dated  ;

April 1,1998, provided your signed agreement to incorporating these commitments into a Confirmatory Order Modifying Certificate, to be effective upon issuance.

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 a civil monetary penalty.

Issuance of this Order does not preclude the NRC from issuing additional enforcement action.

NUREG-0940, PART III A-129

U. S. Enrichment Corporation Questions conceming this Order should be addressed to me and I can be reached at (301) 415-2741. In accordance with 10 CFR 2.700 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, p

I ames Lieberman, Director Office of Enforcement Docket No. 70-7001 Certificate No. GDP-1 l

Enclosure:

As stated l NUREG-0940 PART III A-130

l-l i

UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of )

) Docket No. 70-7001 UNITED STATES ENRICHMENT ) Certificate No. GDP-1 CORPORATION ) EA 98-156 Bethesda, Maryland )

CONFIRMATORY ORDER MODIFYING CERTIFICATE (EFFECTIVE IMMEDIATELY) i United States Enrichment Corporation (Corporation) is the holder of Certificate No. GDP-1 issued by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 76. The certificate authorizes the Corporation to operate the Paducah Gaseous Diffusion Plant (Paducah) for the purpose of enriching uranium up to 2.75 percent assU by weight. The certificate, originally issued on November 26,1996, is due to expire on December 31,1998 Il Since transition to NRC regulatory oversight on March 3,1997, the Corporation has been Operating its withdrawal facilities (Buildings C-310/310A and C-315) with liquid uranium hexafluoride (UF.) inventories in process piping, condensers, and accumulators. The certificate conditions placed no restrictions on those inventories, thereby allowing the accumulators to contain any emount up to their full capacity. A certificate amendment request dated October 31, 1997, submitted by the Corporation, requested an update to the Safety Analysis Report (SAR) to include a new Chapter 4, " Accident Analysis." An NRC request for additional information (RAI) dated February 5,1998, identified questions about the conseNative nature of assumptions for the seismic accident scenario in Chapter 4. In response to the RAI, the Corporation reviewed l Paducah's liquid UF, withdrawal facilities' records and determined that the seismic accident NUREG-0940. PART III A-131

2 analysis assumption of no liquid UF. in both facilities' accumulators underestimated the potential source term from the withdrawal facilities for the seismic accident scenario. In telephone discussions with the NRC on February 18,1998, the NRC made it clear to the Corporation that a notification pursuant to 10 CFR 76.9(b) was warranted. Thereafter, the Corporation provided verbal notification to NRC Region lli on February 19,1908, and a follow-up written report on February 20,1998, identifying the potential nonconservative assumption in the SAR updated accident analysis. Then, on February 24,1998, in telephone discussions with NRC, the Corporation also provided information that the withdrawal facilities' current operations were outside the Certification SAR because the Chapter 4 seismic accident analysis assumed no 1

liquid UF. In Building C-315 withdrawal facility's process piping, condensers, and accumulators.

In addition, the source term from Building C-310/310A was probably too low.

1 Based on the NRC's review of the certificate amendment request dated October 31,1997, submitted by the Corporation and the current Certification SAR, the NRC has concluded that violations of NRC requirements occurred. The violations involve an inadequate accident analysis and a failure to comply with the conditions of certification. The Commission's regulations in 10 CFR 76.85 require the Corporation, as the certificate holder, to perform an analysis of potential accidents and consequences to establish the basis for limiting conditions for operations and to provide assurance that plant operation will be conducted in a manner ta prevent or to mitigate the consequences from a reasonable spectrum of postulated accidents, including natural phenomena. Further,10 CFR 76.85 requires that the assessment consider the full range of operations, including operations at the maximum capacity contemplated. The Commission's regulations in 10 CFR 76.51 require the Corporation, as the certificate holder, to comply with the conditions set forth in the Cert ficate of Compliance. Condition 8 of the NUREG-0940. PART III A-132

Certificate of Compliance (GDP-1) for the Paducah Gaseous Diffusion Plant requires the Corporation to conduct its operations in accordance with the statements and representations contained in the certification application and subsequent amendments. The certification application includes Safety Analysis Report (SAR) Chapter 4, " Accident Analysis," Section 4.6 l

l " Natural Phenomena," describing assumptions made on facility operations to determine the l

l consequences of postulated seismically-induced failures. The Chapter 4 seismic accident 1

analysis is based on an inappropriately low assumption of the amount of liquid UF in Buildings C-310/310A and C-315 withdrawal facilities' process piping, condensers, and accumulators in calculating the possible releases. Current facility configuration and operations are such that significantly higher volumes (on the order of several thousand pounds (Ibs)) of liquid UF. may be present. Therefore the accident analysis in the Certification SAR is not in compliance with 10 CFR 76.85 and operation of that facility is not in compliance with Condition 8. Furthermore, operation with the larger amount of liquid UF. in the withdrawal facilities is safety significant because failure could result in potential on-site fatalities / injuries and off site injuries. During a seismic event of 0.05 g peak ground acceleration, failure of equipment in both withdrawal facilities would likely occur with releases of liquid UF.. If the 0.05 g seismic event occurred with substantial amounts oi liquid UF. in those facilities, the on-site and off-site consequences would exceed any analyzed accident and be unacceptable.

lll By letter dated February 25,1998, the Corporation committed to implement the administrative control as stated below; i

I l

NUREG-0940 PART III A-133

_ . . _ _ _ _ . _ _ _ _ - _ _ . _ _ . _ _ _ . _ _ _ _ _ _ _ . .__.m ._ . _ _ _

1.

Access to Buildings C-310/310A and C-315 will be limited to only those individuals essential to operations, inspections, or those personnel performing any modifications to fix the identified seismic failures.

By letter dated March 5,1998, the Corporation committed to implement the following additional administrative controls in order to mitigate the consequences of a seismic event:

2. When flow of liquid UF. has been diverted to the on-line accumulator in C-310A or C-315 for greater than one hour (nominal 2,000 and 5,000 lbs liquid UF., respectively, at one hour), the Corporation will take the following immediate actions:

a. Notify the Plant Shift Superintendent (PSS) of accumulator usage.

b. Begin tracking of quantities by using calculated withdrawal rates.  !

c. The PSS willinitiate high priority actions for timely resolution of unscheduled outages.

J ThnCascade Coordinator will take actions to reduce tails downflow and/or product or tails withdrawal rates to minimize accumulator use as appropriate.

l i

e. Notify the NRC,

3. If the calculated accumulator inventory reaches 4,000 lbs liquid UF. in C-310A or 10,000 lbs liquid UF, in C-315, flow of liquid UF. to the affected accumulator will be stopped immediately.

By letter dated March 11,1998, the Corporation proposed to install seismic modifications to the equipment in Buildings C-310/310A and C-315 by September 30,1908. Those seismic NUREG-0940. PART III A-134

l modifications willincrease the seismic capacity of the equipment to withstand an earthquake producing a peak ground acceleration of 0.165 g.

I find that the Corporation's commitments to install the seismic modification within the proposed l

l time frame and these administrative controls 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 Corporation's I commitments be confirmed by this Order. By letter dated, April 1,1998, the Corporation consented to the issuance of this Order confirming its commitments, as described in Section IV below. The Corporation further agreed in that letter that this Order is to be effective upon l

issuance. Implementation of these commitments will minimize the available liquid UF.

inventories that could be released in a seismic event and reduce the on-site and off site i

consequences. Based upon the above and the Corporation's consent, this Order is immediately effective upon issuance.

IV l

l Accordingly, pursuant to sections 161b,1611,1610, and 1701 of the Atomic Energy Act of 1954, l as amended, and the Commisslan's regulations in 10 CFR Part 76, including specifically 10 CFR 76.70, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT CERTIFICATE NO.

l l GDP-1 IS MODIFIED AS FOLLOWS:

I l

NUREG-0940. PART III A-135

6-Condition 13 is added to the Certificate of Compliance GDP-1 to require that:

1. The Corporation will by no later than September 30,1998, complete seismic modifications to the equipment containing liquid UF In Buildings C-310/310A and C-315.

Those seismic modifications will increase the seismic capacity of the equiprnent to i

withstand an earthquake producing a peak ground acceleration of 0.165 g. i

2. Until such time as the above seismic modifications are completed, the following additional administrative controls shall be followed:

a. When flow of liquid UF. has been diverted to the on-line accumulatoi % C-310A i or C-315 for greater than one hour (nominal 2,000 and 5,000 pounds (Ibs) liquid UF. respectively at one hour), the Corporation will immediately:

1. Notify the Plant Shift Superintendent (PSS) of accumulator usage.

ii. Begin tracking of quantities by using calculated withdrawal rates.

iii. Ensure that the PSS willinitiate high priority actions for timely resolution of unscheduled outages.

iv. Ensure that the Cascade Coordinator will take actions to reduce tails downflow and/or product or tails withdrawal rates to minimize accumulator use as approp<iate.

v. Notify the NRC.

b. If the calculated accumulator inventory reaches 4,000 lbs liquid UF, in C-310A or 10.000 lbs liquid UF. in C-315, flow of liquid UF. to the affected accumulator will be stopped immediately.

NUREG-0940. PART III A-136 l

1

l i

l c. Access to Buildings C-310/310A and C-315 will be limited to only those 1 individaals essential to operations, inspections, or those personnel performing any modifications to fix the identified seismic failures.

The Director, Office of Enforcement, may, in writing, relax or rescind this Order upon demonstration by the Corporation of good cause.

V Any person adversely affected by this Confirmatory Order, other than the Corporation, may submit a written response within 20 days of its issuance. Where good cause is shown, consideration will be given to extending the time to respond. A request for extension of time must be made in writing to the Director, Office of Nuclear Material Safety and Safeguards, U.S.

Nuclear Regulatory Commission, Washington, D.C. 20555, and include a statement of good cause for the extension. Any response shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief, Rulemaking and Adjudications Staff, Washington, D.C.

20555. Copies of the response shall also 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 lil, 801 Warrenville Road, Lisle, Illinois 60532-4351, and to the Corporation.

In the absence of any response, or written approval of an extension of time in which to respond, 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 submitting a response has been NUREG-0940. PART III A-137

approved, the provisions specified in Section IV shall be final when the extension expires if a response is not received. If a written response is received, the Commission may make a final decision or may adopt by order further procedures for consideration of the issues before making a final enforcement decision. WRITTEN RESPONSES SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER.

FOR THE NUCLEAR REGULATORY COMMISSION W-ames Lieberman, Director Office of Enforcement Dated at Rockville, Maryland thidf day of April 1998 I

NUREG-0940. PART III A-138

_ __m _ _ _ -.____...m__ .

i

_- a UNITED STATES n52%q% NUCLEAR REGULATORY COMMISSION

[ o REGION til g j 801 WARRENVILLE ROAD

1. LISLE. ILLINolS 60532-4351

%g! July 14, 1998 1-

EAs98-249; 98-253;98-251 Mr. J. H. Miller Vice President- Production United States Enrichment Corporation Two Democracy Center

, 6903 Rockledge Drive Bethesda, MD 20817

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF civil PENALTY-

$55,000 (NRC Inspection Report 70-7002/98005(DNMS))

Dear Mr. Miller:

This refers to the inspection conducted March 9,1998 through May 8,1998, at the United  ;

States Enrichment Corporation (USEC) Portsmouth Gaseous Diffusion Plant in Piketon, Ohio. l The purpose of the inspection was to review the activities authorized by NRC Certificate Number GDP-2. The inspection report detailing our findings was issued on May 18,1998. A predecisional enforcement conference was held with you and members of your staff on 7 June 5,1998, to discuss the apparent violations, the root causes, and the corrective actions. A l summary report of the conference will be sent to you by separate correspondence.

Based on the information developed during the inspection and the information 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 Penalty (Notice) and the circumstances surrounding the violations are described in detall in the subject inspection report.

The most significant violation, which is described in Section I of the Notice, involves a programmatic deficiency in the maintenance and surveillance program for air-operated, safety-related valves at the Portsmouth plant. Specifically, during the inspection, NRC staff raised concems about the ability of air-operated autoclave containment isolation valves to perform their intended safety function with a degraded plant air system. The air.-operated isolation valves normally operate with nonsafety-related plant air, and have safety-related backup air reservoirs. At the time of the inspection, routine functional tests of the air-operated valves were not performed; however, a scheduled leak rate test was performed on each cutoclave for the " pigtail" isolation valve. As a result of the NRC's concems, you initiated testing of air-op6 rated autoclave isolation valves, which identified that as of June 5,1998, numerous valves were not capable of meeting the test acceptance criteria (24 failures out of 55 valves tested).

' During the conference, your staff stated that the root cause for the violation in Section I was the failure to develop.a testing program to demonstrate that autoclave air-to-close valves perform their design function after a loss of normal supply air. In addition, your staff stated that this NUREG-0940. PART III A-139

J. Miller ,

violation should be categorized at Severity Level lV based on your assessment that there was no impact on safety. The NRC has considered all of the information surrounding this violation and concluded that while there were no actual safety consequences in this case, the violation is a significant safety concem because: (1) there was an increased potential for a significant release if a loss of plant air and a catastrophic rupture of a uranium hexafluoride cylinder had occurred concurrently; and (2) the root cause indicates a lack of fundamental understanding of the importance of demonstrating that safety system components will perform their intended safety functions over the full range of operating conditions. Further, this violation is of particular concem given the duration and number of test failures identified. Therefore, the violation has been categorized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Act8ons (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 considered for a Severity Level lli violation. Because Portsmouth has been the subject of escalated enforcement actions within the last two years, the NRC considered whether credit i 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 because NRC staff identified the valve issue and brought it to USEC's attention'.

However, credit for corrective action is warranted because you took prompt and comprehensive action to define the magnitude of the problem and to implement corrective actions. Specifically, the corrective actions described during the conference included: (1) declaring affected  ;

autoclaves inoperable; (2) declaring all safety-related systems with air-to-close valves either inoperable or performing an Operability Evaluation; (3) establishing criteria by which to test and repair the valves; (4) issuing by June 17,1998, formal testing criteria to be used for surveillance testing of the backup air reservoir tanks; and (5) developing by July 10,1998, an action plan to verify that design bases systems credited for backup are being properly tested, t

Therefore, to emphasize the importance of 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 in the base amount of $55,000 for the Severity Level ill violation.

The violations in Section ll of the Notice involving improper installation of a containment valve ,

actuator, failure to maintain a fluorinating environment for a uranium deposit greater than

• safe-mass, failure to repori laboratory sample results, failure to implement maintenance procedures, and failure to perform adequate post-maintenance testing, are each categorized as Severity Level IV violatic 's in accordance with the Enforcement Policy. At the conference, you provided information regarding one of the examples (Cell 29-3-6) of an apparent vioiation regarding the failure to maintain a fluorinating environment for which you believed a violation did 3 not occur. After reviewing the information presented at the conference, the NRC concluded that no violation of Technical Safety Requirements occurred for Cell 29-3-6.

! During the conference, one apparent violation regarding exceeding your possession limit for enriched uranium was discussed. In your presentation, you stated that a possession limit violation had not occurred, based en a December 20,1993 Joint Statement of Understanding 1

NUREG-0940. PART III A-140 l

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I i J. Miller 3-i between the NRC and the Department of Energy Further, you stated that Compliance Plan issue A4 did not clearty describe severalissues regarding possession of uranium enriched to greater than ten percent U-235. Upon further review, the NRC concluded that the enriched uranium possession limits of Portsmouth Safety Analysis Report, Section 1.5 were violated.

However, this non-repetitive, licensee-identified and corrected violation is being treated as a Non Cited Violation in accordance with Section Vll.B.1 of the NRC Enforcement Policy.

i You are required to respond to this letter and should follow the instructions specifHxf 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.

4 Sincerely, V

Cari J. Paperiello Acting Regional Administrator ,

1 I

Docket No. 70-7002 Certificate No. GDP-2 1

Enclosure:

Notice of Violation and Proposed imposition of Civil Penalty 4

NUREG-0940. PART III A-141

NOTICE OF VIOLATION AND PROPOSED IMPOSIT!ON OF civil PENALTY United States Enrichment Corporation Docket No. 70-7002 Portsmouth Gaseous Diffusion Plant Certificate No. GDP-2 Piketon, Ohio EAs98-249; 250; 251 During an NRC inspection conducted March 9,1998 through May 8,1998, 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 to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (.*CT),42 U.S.C. 2282, and 10 CFR 2.205. The violations and associated civil penalty are brth below:

1

1. Violation Assessed a Civil Penaltv 1 Technical Safety Requirement Section 2.1.3.5 titled, " Autoclave Shell High Pressure Containment Shutdown," requims that the autoclave shell high pressure containment l system shall be operable. l l

Technical Safety Requirement Section 1.2.13, requires, in part, that a safety system  !

component shall be operable or have operability when it is capable of performing its specified function (s), and when other auxiliary equipment that are required for the safety system component to perform its specified function (s) are also capable of performing their related support function (s).

Contrary to the cbove, prior to April 9,1998, Autoclave Numbers 1,2,3,4, and 5 in i Building X-343 were operated with an autociave shell high pressure containment safety system component incapable of performing a specified safety function. Specifically, as-found testing conducted April 10 through April 21,1998, of the air-to-close autoclave containment valves for Autoclavas 1,2,3,4, and 5 in Building X-343, demonstrated that l 7 of 25 of the air-to-close containment valves failed the test acceptance criteria and I were not capable of performing the related support function. (01013) l l

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

Civil Penalty $55,000  !

II. Violations Not Assessed a Civil Penaltv l A. Technical Safety Requirement Section 2.1.3.5 titled, " Autoclave Shell High Pressure Containment Shutdown," requires that the autoclave shell high pressure containment system shall be operable.

Technical Safety Requirement Section 1.2.13, requires, in part, that a safety system component shall be operable or have operability when it is capable of performing its specified function (s), and when other auxiliary equipment that are required for the safety system component to perform its specified function (s) are I also capable of performing their related support function (s).

NUREG-0940. PART III A-142

i Notice of Violation and Proposed 2 Imposition of Civil Penalty Contrary to the above, from March 25 through March 27,1998, Autoclave Number 4 in Building X-343 was operated with an autoclave shell high pressure containment safety system component incapable of performing a specified safety I

function. Specifically, on March 24,1998, a containment valve actuator was incorrectly installed, causing the FV 416X containment valve to work

" backwards' while the autoclave was operated for two heating and feeding cycles. (02014)

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

B. Technical Safety Requirement 2.2.3.15, " Moderation Control," limiting condition for operation requires, in part, for cascade operational modes I, ll, Ill, IV, V and VI, that moderation control shall be maintained when the UO2 F (uranyl fluoride) mass is greater than safe mass.

Action B.1 of Technical Safety Requirement 2.2.3.15, requires, in part, that-equipment containing UO2F, deposits greater than safe mass not in a fluorinating environment ar.d in Mode VI, to be pressurized with plant air or N2 (nitrogen) to greater than or equal to 14 psia within eight hours after a UF, (uranium hexafluoride) negative was obtained in the system.

Contrary to the above, from March 31,1998 through April 8,1998, Cell 29-5-2 contained a UO,F, deposit with an errichment of 5.5 percent of approximately 6238 grams (+/- 3119 grams) of uranium-235, a deposit greater than safe mass, was not in a fluorinating environment and in Mode VI, and was not pressurized with plant air or N2to greater than or equal to 14 psia within eight hours as required. (03014) .

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

C. Technical Safety Requirement Section 3.9.1, requires, in part, that written procedures shall be implemented for the activities described in Safety Analysis Report (SAR) Section 6.11.4.1 and listed in Appendix A to SAR Section 6.11.

Appendix A to SAR Section 6.11 requires communication activities to be covered by written procedures.

Section 6.4 of written Procedure XP2-TS-TS1032 Revision 0, dated September 11,1996, titled " Communications with Cascade Operations,"

requires, in part, that process services staff shall report sample results (requested by the Cascade Controller) to the Cascade Controller as the sample results become available.

NUREG-0940. PART III A-143

Notice of Violation and Proposed 3 Imposition of Civil Penalty Contrary to the above, process services staff failed to report sample results (requested by the Cascade Controller) to the Cascade Controller as the sample results became available for Cell 29-5-2 on March 31,1998. (02034)

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

D. Technical Safety Requirement Section 3.9.1, requires, in part, that written procedures shall be implemented for activities described in Safety Analysis Report (SAR), Section 6.11.4.1, and listed in Appendix A to SAR Section 6.11.

Appendix A to SAR Section 6.11 requires maintenance activities to be covered by written procedures.

Section 8.2.12 of written Procedure XP4-TE-MM4104, Revision 0, Cuange C, dated January 15,1997, titled, " Valve Actuator Removal, Replacement and installation," requires, in part, that the maintenance staff performing the work activity ensure that each of the following has a "V" stamped on it: valve end of the torque shaft; valve side of the actuator housing; and, valve end of the coupling between the torque shaft and the valve stem. In addition, Section 8.2.24 directs the maintenance staff performing the work activity to i request Operations personnel to perform an operational check. I Contrary to the above, on March 24,1998, maintenance staff performing an actuator replacement on autoclave containment valve FV-416X did not ensure that a "V" was stamped on the valve end of the torque shaft, the valve side of the actuator housing, and the valve end of the coupling between the torque shaft and the valve stem. Further, maintenance staff did not request that an operational check be performed on the repaired actuator. (04014)

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

1 E. 10 CFR 76.93, " Quality Assurance," requires, in part, that the Corporation shall l establish, maintain, and execute a quality assurance program satisfying each of 1 the applicable requirements of ASME NQA-1-1989," Quality Assurance Program Requirements for Nuclear Facilities." l Section 2.11 of the Quality Assurance Program titled, " Test Control," requires, in part, that the test control system for "Q" items, is planned and executed to assure that testing is performed to demonstrate that safety system components will perform satisfactorily in service.

i NUREG-0940. PART III A-144

i Notice of Violation and Proposed 4 Imposition of Civil Penalty Contrary to the above, on March 24,1998, the post-maintenance test planned and executed for Work Order Number R98116?6-01, failed to demonstrate that the "Q" safety system component, autoclave containment valve FV-4166X, would perform satisfactorily in service by closing upon a containment signal.

(05014)

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

Pursuant to the provisions of 10 CFR 76.70, the United States Enrichment Corporation (Certificatee) is hereby required to submit a written statement or explanation to the Director, 4

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 Certificate of Compliance 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 76.70, the Cedificatee 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 Certificatee fali to answer within the time specified, an order imposing the civil penalty will be issued.

Should the Certificatee 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 pad, (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 i 10 CFR 76.70, but may incorporate parts of the 10 CFR 76.70 reply by specific reference 4

I NUREG-0940. PART III A-145

l

, Notice of Violation and Proposed 5 Imposition of CMI Penalty (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Certificatee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penaity.

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.

l 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 Ill,801 Warrenville Road, Lisle, Illinois 60532 and a copy to the NRC Resident inspector at the facility that is the subject of this Notice.

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 mual 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 i 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial i information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21. I Dated at Lisle, Illinois this 14th day of July 1998 )

I NUREG-0940. PART III A-146

i l

1 l

l I

B. SEVERITY LEVEL 1,11,111 VIOLATIONS l NO civil PENALTY l

l l

NUREG-0940. PART III l

- ... .. ~ ._ -, . . .-. - - --.. - ..~ - -- - - _.- - - -

1. gta49 UNITED STATES 8 %o NUCLEAR REGULATORY COMMISSION REGloN lit

{o $

e 801 WARRENVILLE ROAD LISLE,ILLINolS 60532-4351

%gg* - July 20, 1998 EA 98-326 Mr. Leo Turek .

Vice President-Engineering Brucker Engineering, Ltd.

7565 Ravensridge Drive St. Louis, MO 63119

SUBJECT:

NOTICE OF VIOLATION r (NRC Inspection Report 030-34708/98001(DNMS)

Dear Mr. Turek:

This refers to the inspection conducted on June 2 and 3,1998, at Brucker Engineering, Ltd.

(Brucker)in St. Louis, Missouri. The purpose of the inspection was to review an event involving the reported loss of a moisture / density gauge containing licensed material. During the  :

inspection an apparent violation of NRC requirements was identified. A predecisional enforcement conference was held on July 1,1998, at the Brucker office to discuss the apparent violation, its cause and corrective actions. A summary of this conference will be sent to you by separate correspondence.

Based on the information developed during the inspection and the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the i enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in l detail in the subject inspection report.

The violation involved the failure to control licensed material in an unrestricted area.

Specifically, a moisture / density gauge containing 11 millicuries of cesium-137 and 44 millicuries of americium-241 was unaccounted for between May 29 and June 3,1998, because the operator could not find his vehicle.- The device was subsequently found locked in the trunk of the gauge operator's vehicle. ' The root cause of this event was the operator's failure to retum the device to its designated storage location at the end of the work shift as required.

incumbent upon each licensee is the responsibility to exercise the necessary controls over ,

licensed material, especially material that is routinely used in the public domain, such as  !'

portable gauging devices. Such controlis necessary to ensure that only trained, knowledgeable, and responsible personnel have access to the devices. We are concemed that adequate control was not exercised. Our concem is exacerbated by the fact that Brucker had been licensed for only six weeks prior to the May 29,1998, incident and all Brucker workers should have just received instruction and training on the handling of portable gauges. ,

Therefore, the violation is classified in accordance with the " General Statement of Policy and l Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a Severity j Level 111 violation.

t NUREG-0940 PART III B-1

i L. Turek In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level til violation. Because your facility has not been the subject of escalated enforcement actions, 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. We have determined that the actions following the event were both prompt and comprehensive and, therefore, credit for corrective action is warranted. These actions included: (a) the temporary suspension of the operator involved and he has been prohibited from using the device for at least one year; (b) all gauge operators were informed of the event; (c) all staff were reinstructed in the security and control requirements; (d) implementation of a disciplinary procedure as of July 6,1998; and (e) the conduct of monthly audits of operators field performance.

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.

During the predecisional conference, an example of failure of an operator to maintain constant surveillance of a gauge at a jobsite identified in Section 3.0 of the NRC inspection report was discussed. Your staff contended that the example was not valid because: (a) visual surveillance was maintained at all times, (b) the device was in a physically safe location, (c) the distance was at least 10 feet closer than discussed during the inspection, (d) and only authorized workers were at the Olivette location and there was no public access. After further review of this matter, we have decided not to include the example described in Section 3.0 of the inspection report in the Notice of Violation.

The NRC has concluded that information regarding the reason for the violation and the corrective actions taken and/or planned to correct the violation and prevent recurrence have been adequately addressed in the inspection Report 030-34708/98001(DNMS) and during the July 1,1998, predecisional enforcement conference. 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 III B-2

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

Sincerely, Carl J. Paperiello Acting Regional Administrator Docket No. 030-34708 i License No. 24-32076-01 I

Enclosure:

Notice of Violation l 1

l i

i NUREG-0940. PART III B-3

NOTICE OF VIOLATION Brucker Engineering, Ltd. Docket No. 030-34708 St. Louis, Missouri License No. 24-32076-01 EA 98-326 During an NRC inspection conducted on June 2 and 3,1998, 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 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in unrestricted areas.10 CFR 20.1802 requires 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 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Condition 21.A. of License No. 24-32076-01 requires that the licensee conduct its program in accordance with statements, representations and procedures contained in an application dated March 28,1998.

Item 10 of the referenced application, titled " Radiation Safety Program - Operating &

Emergency Procedures," requires the licensee to implement t ad maintain operating and emergency procedures in accordance with Appendix H of NUREG-1556, Vol.1, dated May 1997. Appendix H requires gauges to be retumed to their proper storage location at the licensee's St. Louis, Missouri, office at the end of the work shift.

Contrary to the above, on May 29,1998, the licensee did not secure from unauthorized removal or limit access to a Humboldt Scientific, Inc., Model 5001 portable gauge containing 11 millicuries of cesium-137 and 44 millicuries of americium-241, as sealed sources, located in the trunk of a licensee employee's vehicle, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. The operator did not retum the gauge to the proper storage location at the end of the work shift on May 29,1998, and the gauge was subsequently unaccounted for until June 3,1998.

This is a Severity Level lil 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 will be achieved was adequately addressed in inspection Report 030-34708/98001(DNMS) and during the July 1,1998, predecisional enforcement conference.

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, D.C. 20555 with a copy to the Regional Administrator, Region ill,801 Warrenville Road, Lisle, Illinois 60532, within 30 days of the date of the letter transmitting this Notice. ,'

NUREG-0940, PART III B-4

. l l

Notice of Violation l If you contest this enforcement action, you should also provide a copy of your response to the f Director, Office of Entreement, United St:tes Nuclear Regulatory Commission,  !

Washington, D.C. 20555-0001.  !

l if you choose to respond your response will be placed in the NRC Public Document  :

Room (PDR). Therefore, 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. 1 Under the authority of Section 182 of Act 42 U.S.C. 2232, any recponse shall be submitted under oath or affirmation.

Dated at Lisle, Illinois this 20th day of July 1998 i

WUREG-0940 PART III B-5

ew

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g'.,<\'g UNITED STATES 3* NUCLEAR REGULATORY COMMISSION 0, f g REGION IV

% 6 611 RYAN PLAZA DRIVE SulTE 400 ARLINGTON TEXAS 76011 8064 July 22, 1998 1

' EA 98-347 - )

l James S. McLaughlin, President Cardinal Surveys Company P.O. Box 729 Odessa, Texas 79760-0729

SUBJECT:

NRC INSPECTION REPORT NO. 150-00042/98 09 AND NOTICE OF VIOLATION

Dear Mr. McLaughlin:

This refers to the inspection conducted on June 11-12,1998, at your office in Odessa, Texas.

The enclosed report presents the results of this inspection. A preliminary exit briefing was conducted with your staff at the conclusion of the inspection. A telephonic exit briefing was later conducted with you on June 26,1998.

Based on the information developed during the inspection, 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 The significance of the violation and the need forlasting and effective corrective action were discussed with members of your staff at the conclusion of the inspection and during the telephonic exit briefing with you on June 26,1998. The violation involved the failure to file an NRC Form 241 for proposed activities in non-Agreement states in accordance with 10 CFR 150.20. Licensed material was used in a non-Agreement state on April 17,1998, without prior authorization from NRC's Region IV office in Arlington, Texas. The NRC acknowledges that the licensee identified their failure to file an NRC Form 241, at which time Cardinal immediately contacted the NRC Region IV office anci submitted a properly completed NRC Form 241.

The NRC considers the violation to be significant, in part, because this failure denied the NRC t'n opportunity to inspect to ase,ure the safety of Cardinal's activities. Therefore, this violation ius been categorized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level ill.

Based on our review of the inspection findings and your discussion of proposed corrective actions during the inspection conducted on June 12,1998, the NRC has concluded that we have sufficient information to make an enforcement decision without the need for a predecisional enforcement conference. -

NUREG-0940. PART Ill B-6

i d

Cardinal Surveys Company l

.' i

, 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 j credit was warranted for Corrective Action in accordance with the civil penalty assessment

process in Section VI.B.2 of the Enforcement Policy. Based on the corrective actions that you i have previously described, it appears that credit is warranted for prompt and comprehensive j corrective actions. As noted below, the decision on providing credit for corrective action will be j subject to your confirming on the license docket that the actions previously described to the staff 1 j have been or are being taken.

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

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.

(

i You are required to respond to this letter and should follow the instructions specified in the i enclosed Notice when preparing your response. The NRC will use your response, in part, to I determine whether further enforcement action is necessary to ensure compliance with regulatory

]. requirements.

As provided for in the enclosed Notice, you are required to include a description of the reasons ,

i for the violation, if admitted, and your corrective action. This description should address the '

l i actions taken following identification and the long term comprehensive actions taken or that will be taken to prevent recurrence. Your response should be submitted under oath or affirmation and may reference or include previous docketed correspondence if the correspondence

, adequately addresses the required response, if the NRC is satisfied with your response, you j will be notified that this enforcement action is comp lated. However, if your documented j corrective action is not sufficiently prompt and comprehensivo such that a civil penalty may be j warranted, we may telephone you or schedule a produisionil enforcement conference with 4 you. In addition, if you dispute the enclosed violation or its se, verity level, you should describe l the basis for the dispute in your response. Further, you may request that an enforcement 1 conference be held,in which case, please advise D. Blair Spitzberg, Ph.D. within 7 days of the i date of this letter. In the absence of such a request but where matters are disputed, we may i also elect to hold an enforcement conference. In the event that a conference is to be held, it will i be scheduled at least 2 weeks after receiving the written response to the Notice. Following i review of any disputes and the record of the conference, if held, a decision will be made to j modify, withdraw, or affirm the Notice and, if warranted, issue a civil penalty.

NUREG-0940. PART III B-7

1 l

Cardinal Surveys Company In accordanca 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 (PDR).

Sincerely,

/

Ellis W. Mers Regional Admi strator Docket No.: 150-00042 License No.: Texas LOOO65

Enclosures:

1. NRC Inspection Report 150-00042/98-09

2. Notice of Violation cc w/ enclosures:

Texas Radiation Control Program Director NUREG-0940. PART III 8-8

NOTICE OF VIOLATION I l Cardinal Surveys Company Docket No. 150-00042

, Odessa, Texas License No. Texas L00065 EA 98-347 During an NRC inspection conducted on June 11-12,1998, 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: '

10 CFR 150.20(a) provides, in part, that any person who holds a specific license from an Agreement State is granted an NRC general license to conduct the same activity in Non-Agreement States, provided that the provisions of 10 CFR 150.20(b) have been met.

10 CFR 150.20(b)(1) requires, in part, that any person engaging in activities in Non-Agreement States, shall, at least 3 days before engaging in each such activity, file four copies of NRC Form 241, " Report of Proposed Activities in Non-Agreement States, with the Regional Administrator of the appropriate NRC regional office. j l

Contrary to the above, on April 17,1998, Cardinal Surveys Company, a licensee of )

Texas used licensed materials in Oklahoma, a Non-Agreement State, without filing )

Form 241 with the NRC. i This is a Severity Level 111 violation (Supplement VI). (01013)

Pursuant to the provisions of 10 CFR 2.201, Cardinal Surveys Company, 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 IV, 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 fuil 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 hformation 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, 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.

4 NUREG-0940, PART III B-S

2 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, yoq must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholoing (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 respcase, please provide the level of protection described in 10 CFR 73.21.

l Dated at Arlington, Texas this 22nd of July 1998 NUREG-0940. PART III B-10

ta4 UNITED STATES 9'o NUCLEAR REGULATORY COMMISSION g

8 o REGloN ';i U

y 801 WARnENVILLE ROAD 2 LISLE, ILLINOIS 60532-4351

• %ooo**/ September 14, 1998 EA 98-404 Mr. Michael B. Creech President /CEO Conam inspection, Inc.

192-4 Intemational Blvd.

Glendale Heights,IL 60139

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-31373/98003(DNMS))

Dear Mr. Creech:

This refers to the inspection conducted on July 20,1998, with continuing NRC review through July 31,1998, at the Conam Inspection, Inc. (Conam), field office in Kapolei, Hawaii. The purpose of the inspection was to review the circumstances surrounding a June 26,1998, incident involving the loss of control of licensed material. One apparent violation of NRC requirements was identified and documented in the inspection report sent to you on August 21, 1998. As stated in our letter, the apparent violation was being considered for an escalated action at Severity Level 111 without a civil penalty. You were given an opportunity to request an enforcement conference and/or respond to the inspection report findings. You did not request a conference or provide a written response.

Based on the information developed during the inspection, 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 oubject inspection report. The violation involved a failure to secure from unauthorized removal, access, or tampering and maintain constant surveillance of licensed material in accordance with 10 CFR 20.1801,10 CFR 20.1802 and 10 CFR 34.35. On June 26,1998, two radiographers filled to stow a radiography camera containing a nominal 55 curie iridium-192 sealed source into their vehicle following completion of radiographic activities at the Tesoro Refinery in Kapolei, Hawaii. The drive cables and guide tubes had been removed and the camera was locked with the source in a fully shielded position ready for transport. The radiographers Stumed to the Conam office, completed their paperwork, drove to their hotel, and went to sleep withcut realizing they had left the camera at the jobsite. As a result the camera was left unattended in an unrestricted area for approximately four hours. The NRC considers the failure to control and secure a radiographic exposure device to be of significant safety concem because of the potential for members of the public to receive unintended radiation exposures.

Therefore, 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 Level 111.

NUREG-0940. PART III B-11 1

M. Creech In accordance with the Enforcement Policy, a base civil penalty in the amount of $5,500 is considered for a Severity Level lli violation. Because your facility has not been the subject of escalated enforcement actions 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. In this case, NRC determined that credit was warranted based on the following corrective actions taken or planned: (1) the radiographers involved in this event were suspended without pay for five days and removed from radiographic operations for a period of one year; (2) prior to commencement of future radiographic activities the radiographers must be retrained and recertified; (3) a notice was distributed to all radiographic personnel informing them of the incident; and (4) the Vice President and/or the Corporate Radiation Safety Officer will visit each divisional office to further discuss this matter with all radiographic personnel.  !

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 l propose a civil penalty at this time. However, significant violations in the future could result in a  ;

civil penalty. In addition, issuance of this Severity Level ill violation constitutes escalated i enforcement action that may .?ubject you to increased inspection effort.

The NRC has concluded that the reasons for the violation, and the corrective act6ns taken and/or planned to correct the violation and prevent recurrence have been adequately addressed. Therefore, you are not required to respond to this letter unless the description herein does not accurately reflect your corrective actions or your position. In that case, 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 provide one, will be placed in the NRC Public Document Room.

Sincerely, l

l mes L. Caldwell )

Acting Regional Administrator l Docket No. 030-31373 License No. 12-16559-01

Enclosure:

Notice of Violation cc w/ encl: Robert.J. Slack, Corporate Radiation Safety Officer l NUREG-0940. PART III B-12 l

, ..- .-.- -. - . - - . - - - . - - - . ~ - _ - - . . -

l NOTICE OF VIOLATION l

l- Conam inspection, Inc. Docket No. 030-31373 f Kapolel, Hawaii License No.12-16559-01 i

EA 98-404 During an NRC inspection conducted on July 20,1998, with continuing NRC review through July 31,1998, a violation of NRC requirements was identified. In accordance with the " General i_ Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in unrestricted areas.10 CFR 20.1802 requires that l . 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 20.1003, unrestricted

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

10 CFR 34.35(c) requires, in part, that locked radiographic exposure devices must be physically secured to prevent tampering or removal by unauthorized personnel.

Contrary to the above, on June 26,1998, the licensee did not secure from unauthorized removal or limit access to a locked INC IR-100 gamma camera containing a 55 curie iridium-192 source that was located near Heater H-402 at the Tesoro refinery in Kapolei, Hawaii, an unrestricted area. Nor did the licensee control and maintain constant surveillance of this licensed material to prevent tampering or removal by -

unauthorized personnel.

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

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 Edequately addressed. However, you are required to respond to the provisions of 10 CFR 2.201 if the description herein does not accurately reflect your corrective actions or your position. In that case, or if you choose to re', pond, 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 Ill,801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.

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

Under the authcrity of Section 182 of Act 42 U.S.C. 2232, any response shall be submitted

l. under oath or affirmation.

i NUREG-0940. PART III B-13

Notice of Violation If you choose to respond your response will be placed in the NRC Public Document Room

' (PDR). Therefore, 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.

Dated at Lisle, Illinois this 14th day of September 1998 l

l l

\

l 1

l NUREG-0940. PART III B-14

_- -- - - -- ~- - .. ~- _- _ -- .

/#"%g UNITED STATES NUCLEAR REGULATOFlY COMMISSION 8 4'o REGloN ill E 801 WARRENvlLLE ROAD

• lisle, ILLINolS 60532-4351

\ew/ July 24, 1998 EA 98-386 Larry Hendren, President Engineering Surveys and Services, Inc.

1113 Fay Street Columbia, MO 65401

SUBJECT:

NOTICE OF VIOLATION AND NRC INSPECTION REPORT 030-17948/98001(DNMS)

Dear Mr. Hendren:

l This refers to the inspection of activities at Engineering Surveys and Services, Inc. (ESSI),

I conducted on July 7,1998. The inspection was conducted at your facilities in Columbia and Jefferson City, Missouri. The purpose of the inspection was to review an event involving damage to a moisture / density gauge at a construction site in Fulton, Missouri, and to assess l

the routine radiation safety program. The inspection findings are described in the enclosed report.

Based on the information developed during the inspection, 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.

i The violation involves failure to secure or maintain constant surveillance of licensed material at I a temporary jobsite. This failure contributed to a gauge, containing 8 millicuries of cesium-137 and 40 millicuries of americium-241, being run over and severely damaged by a wnstruction i vehicle. The circumstances of the incident indicete that the operator failed to ensure that the i

moisture density gauge was appropriately safeguarded and not left in the path of heavy l construction equipment. Incumbent upon each NRC licensee and its employees is the l responsibility to protect public health and safety by ensuring that all NRC requirements are met, l 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. The NRC recognizes that the operator subsequently acted properly in securing the area around the damaged gauge and contacting the Radiation Safety Officer. Nonetheless, leaving licensed material unsecured and uncontrolled in an unrestricted area is of significant concem to the NRC. Therefore, the violation is categorized at Severity Level lli la accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG 1600, Rev.1.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Se terity Level ill 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 accordarece with the civil penalty assessment NUREG-0940. PART III B-15 l

l l

_ ~ _ . _ . - _ .. _ _ . ._..._ _ . . . _ _ _ _ . _ _ . . . _ _ . . _ . _ _. _

L. Hendren process in Section VI.B.2 of the Enforcement Policy. Based upon the prompt and comprehensive actions taken following the inspection, credit for Corrective Action was warranted. The corrective actions planned or taken to address the root cause included discussion meetings with engineering technicians at both ESSI offices to review safety practices on construction sites and emergency response procedures. These meetings were completed on July 14,1998. In addition, the Radiation Safety Officer is currently modifying the training procedures to further highlight opc.ator responsibility for personal safety, equipment safety, and constant evaluation of jobsite operations and conditions that could affect personal safety and equipment safety.

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 the Severity Level ill violation constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that the reasons for the violation, and the corrective actions taken and/or planned to correct the violation and prevent recurrence have been adequately addressed. Therefore, you are not required to respond to this letter unless the description herein does not accurately reflect your corrective actions or your position. In that case, if you '

choose to provide additional information, you should follow the instructions specified in the enclosed Nodce.

The NRC . as determined that we have sufficient information to make an informed enforcement decision without the need for a predecisional enforcement conference. However, in accordance with the NRC Enforcement Policy, NUREG 1600, Rev.1, you may request an enforcement conference to discuss the violations and/or any disputes regarding them. If this is your choice, please contact Geoffrey Wright at (630) 829-9602 within seven days of the date of this letter. ,

in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of thh letter, the enclosed Notice, and your response, if you choose to respond, will be placed in the NRC Public Document Room.

Sincerely, Cari J. Paperiello Acting Regional Administrator Docket No. 030-17948 License No. 24-20089-01

Enclosures:

1. Notice of Violation

2. Inspection Report 030-17948/98001(DNMS)

NUREG-0940 PART III B-16

NOTICE OF VIOLATION Engineering Surveys and Services, Inc. Docket No. 030-17948 Columbia, Missouri License No. 24-20089-01 EA 98-386 During an NRC inspection conducted on July 7,1998, 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 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in unrestricted areas.10 CFR 20.1802 requires 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 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on June 25,1998, the licensee did not secure from unauthorized removal or limit access to a portable moisture / density gauge containing 8 millicuries (0.3 GBq) of cesium-137 and 40 millicuries (1.48 GBq) of americium-241 located at a construction site in Fulton, Missouri, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material.

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

i 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. However, you are required to respond to the provisions of 10 CFR 2.201 if the description herein does not accurately reflect your corrective actions or your position. In that cae, 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, D.C. 20555, with a copy to the Regional Administrator, Region lil,801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.

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

Under the authority of Section 182 of 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, it should not include any personal, privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Dated at Lisle. Illinois this 24th day of July 1998 NUREG-0940. PART III B-17

- - . _ . - .- . .- .~ - -- _ . .

UNITED STATES

" %'o,, NUCLEAR REGULATORY COMMISSION 8 o REGloN 111 U E

• 801 WARRENVILLE ROAD

$ LISLE, ILLINotS 60532-4351 o

,,g August 27, 1998 EA 98-385 Mr. Daniel Longo, President /CEO Geotechnical Consultants, Inc.

720 Greencrest Drive Westerville, OH 43081-1657

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-31021/98001(DNMS))

Dear Mr. Longo:

This refers to the inspection conducted on July 8 and 9,1998, at Geotechnical Consultants, Inc. (GCl), in Westerville, Ohio. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. During the inspection five apparent violations of NRC requirements were identified, one of which was considered for escalated enforcement. The apparent violations and the areas examined during the inspection were sent to you by letter dated July 22,1998.

You were given the option of requesting a predecisional enforcement conference or submitting a written response to the apparent violations. You chose to submit a response in a letter dated August 5,1998.

Based on the information developed during the inspection, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detailin the subject inspection report.

The violation in Section I of the Notice involves the failure to controllicensed materialin an unrestricted area. On July 8,1998, an NRC inspector approached the rear of GCl's facility from its publicly accessible parking le' and observed that a gauge user's vehicle was unlocked with the key in the ignition. Inside tne , assenger compartment of the vehicle was a moisture density gauge with an unsecured source rod handle containing 10 millicuries (370 MBq) of ceslum-137 and 50 millicuries (1850 MBq) of americium-241. The inspector had unfettered access to the nuclear gauge for approximately 5 minutes before being noticed by an authorized user. While the NRC recognizes that no event occurred in this case, the situation represented a significant l failure to take basic precautions to prevent loss of licensed material and reduce potential radiation risks to members of the public. Incumbent upon each NRC licensee is the responsibility to protect public health and safety by ensuring that radioactive materials are controlled at all times. Therefore, the violation in Section I of the Notice is classified 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 $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 warranted for Correct /ve Action in accordance with the civil penalty assessment NUREG-0940 PART III B-18

l I

D. Longo process in Section VI.B.2 of the Enforcement Policy. We have determined that credit for corrective action is warranted based on the following corrective actions: (1) institution of an audit program to be conducted on a random unannounced basis at least twice during a 1 12 month period for permanent gauge users; (2) instruction has been provided for all gauge i users concerning program safety issues and the audit process; (3) the gauge operator involved was sent to the manufacturer's training course for re-instruction prior to reuse of the gauge; (4) radiation safety guidelines have been developed to be used as a handy referenc( guide for gauge operators; and (5) the NRC inspection report was circulated as required readint to all gauge users.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition o' 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 tnat may subject you to increased inspection effort.

The violations in Section 11 of the Notice have been classified as Severity Level IV violations in accordance with the Enforcement Policy. The violations address failures to: (1) lock the gauge when unattended; (2) ensure each package closure device is free of defects and that packaging requirements are met; (3) block and brace; and (4) carry shipping papers in the appropriate location in the vehicle.

The NRC has concluded that information regarding the reason for the violations and the corrective actions taken and/or planned to correct the violations and prevent recurrence is already adequately addressed in your letter dated August 5,1998. Therefore, you are not required to respond to this letter unless the description herein 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 enclosures, and your response, if you choose to send one, will be placer v NRC Public Document Room.

Sincerely, ames L. Caldwell Acting Regional Administrator Docket No. 030-31021 l License No. 34-26022 41 i

Enclosure:

Notice of Violation NUREG-0940, PART III B-19

NOTICE OF VIOLATION Geotechnical Consultants, Inc. Docket No. 030-31021 Westerville, Ohio License No. 34-26022-01 EA 98-385 During an NRC inspection conducted on July 8 and 9,1998, violations 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:

1. Violation Associated with Security of Licensed Material 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 licensee 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 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 July 8,1998, the licensee did not secure from unauthorized removal or limit access to a nuclear gauge containing nominal activities of 10 millicuries (370 MBq) of cesium-137 and 50 millicuries (1850 MBq) of americium-241 while located in an unlocked vehicle in an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. (01013)

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

II. Violations Associated with Transportation of Licensed Materials 10 CFR 71.5(a) requires that a licensee who transports licensed material 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 Transportation (DOT)in 49 CFR Parts 170 through 189.

A. 49 CFR 177.842 requires, in part, that packages of radioactive materials be so blocked and braced that they cannot change position during conditions normally incident to transportation.

Contrary to the above, on July 8,1998, the licensee transported a package containing licensed material, outside the site of usage, as specified on the NRC license, or on a public highway, and the package was not blocked and braced such that d could not change position during conditions normally incident to transportation. Specifically, a nuclear gauge was placed on the floor of the passenger compartment of a vehicle without a means of preventing it from chsnging position incident to normal transportation. (02014)

NUREG-0940. PART III B-20 1

i Notice of Violation l 3

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

B. 49 CFR 173.475 requires, in part, that before each shipment of any Class 7 l (radioactive) materials package, the offeror must insure by examination or

appropriate tests, that the packaging is proper for the contents to be shipped and that the packaging is in unimpaired physical condition, except for superficial marks. 49 CFR 173.415 lists the packages that are authorized for shipment to

contain quantities of Class 7 (radioactive) material not exceeding the A, or A2 value,' as appropriate.

J Contrary to the above, on July 8,1998, the licensee transported on a public highway 10 millicuries of cesium-137 and 50 rr!Ilicuries of americium-241, a quantity not exceeding the A, value, in a pacs 1ge which was not authorized for that material pursuant to 49 CFR 173.415. Specifically, a Campbell Pacific Nuclear Model MC-1DR nuclear gauge containing licensed material was transported without its transport Type A package. Additionally, on other occasions from approximately May 1998 to July 7,1998, a nuclear gauge was transported in an authorized package pursuant to 49 CFR 173.415, but the licensee failed to ensure that each closure device of the packaging was free of defects. For example, the package used to transport a nuclear gauge had a damaged, inoperable latch. (03014)

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

C. 49 CFR 177.817(e) requires, in part, that the driver of a motor vehicle containing hazardous material ensure that the shipping paper is readily available to, and recognizable by, authorities in the event of accident or inspection. Specifically, (1) When the driver is at the vehicle's controls, the shipping paper shall be:

(a) within his immediate reach while he is restrained by the lap belt; and (b) either readily visible to a person entering the drivers compartment or in a holder which is mounted to the inside of the door on the drivers side of the vehicle; (2) When the driver is not at the vehicle's controls, the shipping paper shall be:

(a) in a holder which is mounted to the side of the door on the drivers side of the vehicle; or (b) on the drivers seat in the vehicle.

NUREG-0940. PART III B-21

Notice of Violar 1 Pursuant to 49 CFR 172.101, radioactive materialis classified as a hazardous material.

Contrary to the above, on July 8,1998, the licensee transported a moisture / density gauge containing cesium-137 and americium-241 outside the site of usage as specified on the NRC license, or on a public highway, and the

&iver of the vehicle did not ensure that the shipping paper was readily available in the drivers's compartment as required. Specifically, the shipping paper was on the floor of the rear passenger compartment. (04014)

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

D. Condition 18 of License No. 34-26022-01 requires, in part, that a nuclear gauge or its container be locked when in transport.

Contrary to the above, on July 8,1998, a nuclear gauge was transported and neither the nuclear gauge or its container was locked. (05014)

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

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 date when full comp!!ance will be achieved is already adequately addressed in a letter from Geotechnical Consultants, Inc. dated August 5,1998. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description herein 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, D.C. 20555 with a copy to the Regional Administrator, Region lil,801 Warrenville Road, Lisle, Illinois 60532, within 30 days of the date of the letter transmitting this Notice.

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

Under the authority of Section 182 of 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, it should not include any personal, privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Dated at Lisle, Illinois this 27th day of August 1998 NUREG-0940, PART III B-22

g "49 UNITED STATES J  %, NUCl. EAR REGULATORY COMMISSION 8 g REGION ill

{

• g 801 WARRENVILLE ROAD LISLE, ILLINOIS 60532-4351 og ,o July 20, 1998 EA 98-377 Otto J. Kruger Vice President KTl Construction Services, Inc.

9003 West 51st Street Merriam, KS 66203

SUBJECT:

NOTICE OF VIOLATION AND NRC INSPECTION REPORT ,

030-30164/98001(DNMS) l

Dear Mr. Kruger:

This refers to the inspection conducted on June 22 and 23,1998, with continuing NRC review through July 7,1998, at KTl Construction Senrices, Inc., (KTl) in Merriam, Kansas, and Knob Noster, Missouri. The purpose of the inspection included review of the reported incident i involving damage to a moisture / density gauge. The inspection findings and areas examined I during the inspection are described in the enclosed report. l Based on the ir, formation developed during the inspection, 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. The violations include: (1) failure to maintain control of licensed material; (2) licensed material used by an unauthorized person; (3) failure to wear a film badge; and (4) failure to follow emergency procedures as required.

Collectively, the violations demonstrate a programmatic breakdown in the control of your licensed activities. The root cause of this breakdown stems from inadequate lines of communication among the Radiation Safety Officer (RSO), the Construction Services Supervisor, and Field Engineers. The workers misunderstood the Operating and Emergency procedures and the authorization process for gauge users. The RSO delegated radiation safety responsibilities to the Supervisor and did not audit or otherwise follow-up to ensure that the i radiation safety program was being implemented safely. The violations are of significant concem to the NRC because they represent the major requirements of the KTl's radiation safety program and failure to follow them increases the risk to workers and members of the public of unsafe use of radioactive materials. Incumbent upon each NRC licensee is the responsibility to ensure that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and corrected expeditiously. 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 Swerity Levellli problem.

NUREG-0940. PART III B-23

O. Kruger In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level ill 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. Based upon the prompt and comprehensive actions taken following the inspection, credit for Corrective Action was warranted, in addition to addressing each of the individual violations, the corrective actions planned or taken to address the root cause included: (1) updating and re-issuing to the operators written Operating and Emergency procedures; (2) revising, posting, and distributing to all workers the list of authorized users with emphasis that only those on the list may have access to the gauges; (3) sending four operators to the manufacturers training course; and (4) training two field engineers to provide program oversight at each of the licensee's offices.

These individuals will report directly to the Radiation Safety Officer.

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. 'n addition, issuance of the Severity Level lli problem constitutes escalated enforcemer< tion that may subject you to increased inspection effort.

The NRC b < concluded that the reasons for the violations, and the corrective actions taken and/or planr. .d to correct the violations and prevent recurrence have been adequately addressed. 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, if you choose to provide additional information, you should follow the instructions specifux! In the enclosed Notice.

The NRC has determined that we have sufficient information to make an informed enforcement decision without the need for a predec.sional enforcement conference. However, in accordance with the NRC Enforcement Policy, NUREG 1600, Rev.1, you may request an enforcement conference to discuss the violations and/or any disputes regarding them. If this is your choice, please contact Geoffrey Wright at (630) 829-9602 within seven days of the date of this letter.

f NUREG-0940. PART III B-24

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

Sincerely, Carl J. Paperielo Acting Regional Administrator Docket No. 030-30164 License No. 24-25827-01 l

Enclosures:

1. Notice of Violation l 2. Inspection Report 030-30164/98001(DNMS) l l

NUREG-0940, PART III B-25 I

_ _ _ . _ _ _ . . . _ .. ..~.. _ _ _ _ . _ . _ . _ . _ _ _ . _ _ . _ . _ _ _ _

l l

t i NOTICE OF VIOLATION I

KTl Construction Services, Inc. Docket No. 030-30164 Knob Noster, Missouri License No. 24-25827-01 EA 98-377 During an NRC inspection conducted on June 22 and 23,1998, with continuing NRC review through July 7,1998, 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:

l l A. 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access l_ licensed materials that are stored in unrestricted areas.10 CFR 20.1802 requires 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 20.1003, unestricted area means an area, access to which is neither limited nor controlled by the licensee.

, Contrary to the above, on April 11,1998, the licensee did not secure from unauthorized removal or limit access to a portable moisture / density gauge containing 8 millicuries of cesium-137 and 40 millicuries of americium-241 located at a temporary jobsite, an

• unrestricted area, nor did the licensee control and maintain constant surveillance of this

. licensed material.

B Condition 12 of License No. 24-25827-01, requires, in part, that licensed materials shall j l only be used by, or under the supervision and in the physical presence of Pamela J. Kruger, or individuals who have successfully completed the manufacturer's

training program for gauge users, have been instructed in the licensee's routine and emergency operating procedures, and who have been designated by the Radiation '

Safety Officer.

Contrary to the above, on April 11,1998, licensed materials were used by an individual l who was not in the physical presence of Pamela J. Kruger or individuals who had i successfully completed the manufacturer's training program for gauge users, nor was i the individual designated (as an authorized user) by the Radiation Safety Officer.

C. Condition 20 of License No. 24-25827-01 requires that licensed materia' be possessed l and used in accordance with the licensee's application dated September 29,1992.

l

1. Item 10.1 of the referenced application entitled " Personnel Monitoring Equipment," states, in part, that all personnel will wear a film badge. Item 10.6 of i the referenced application entitled " Operating and Emergency Procedures," ,

topic 'i, indicates that all personnel who use the device should wear their

• personal dosimeters when they are working with the device.

Contrary to the above, on April 11,1998, the licensee's employee operated a moisture density gauge containing 8 millicuries of cesium-137 and 40 millicuries of americium-241 and did not wear a film badge or other personal monitoring dosimeter.

l i

NUREG-0940. PART III B-26 i

.- - = - . - _

Notice of Violation 4

. 2. Item 10.6 of the referenced application entitled " Operating and Emergency l Procedures," states, in part, that all personnel are provided with operating and emergency procedures. The Emergency Procedures provided to personnel

. . requires that in the event of physical damage to a gauge: (1) an area of 15 feet in radius from the gauge must be sealed or cordoned off to prevent entry by

unauthorized persons, and (2) as soon as possible, after the situation has be stabilized and is under control, you must contact the Radiation Safety Officer , ,.

3 describe the present existing conditions and follow the instructions of the Radiation Safety Officer.

]

l Contrary to the above, on April 11,1998, after physical damage of a gauge, the 1 worker did not seal or cordon off an area of 15 feet in radius to prevent entry by

unauthorized persons, nor did the worker and or the supervisor contact the Radiation Safety Officer and describe the existing conditions and follow the instructions of the Radiation Safety Officer. Specifically, the worker transported the damaged gauge from the construction site, and the supervisor left a telephone message at the Radiation Safety Officer's residence.

l These violations represent a Severity Level lli problem (Supplements IV & VI).

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the virbtion and prevent recurrence is already i' adequately addressed. 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 l 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, D.C. 20555, with a copy to the Regional Administrator, j Region lil,801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.

4 If you contest this enforcement action, you should also provide a copy of your response, with the basis for denial, to the Director, Office of Enforcement, United States Nuclear Regulatory

, Commission, Washington, DC 20555-0001.

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

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

Dated at Lisle, Illinois

, this 20th day of July 1998 i

i NUREG-0940, PART-III B-27

M it kg UNITED STATES NUCLEAR REGULATORY COMMISSION

[

5 j REGloN I o 475 ALLENDALE ROAD KING oF PRuSstA, PENNSYLVANIA 19406-1415

• * * * * /a November 3, 1998 EA 98-437 Mr. Kevin M. Cosgrove Pres l dent Materials Testing Lab, Inc.

1529 Jericho Turnpike New Hyde Park, New York 11040

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-08728/98-001) i

Dear Mr. Cosgrove:

i This refers to the NRC inspection conducted on July 13,14,29, and 30,1998, at your facility ,

located at 101 A Liberty Street, Newington, Connecticut, and a temporary job site in Hartford, l Connecticut, to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. As described in the NRC inspection report sent to you on September 16,1998, nine apparent violations of NRC requirements were identified during the inspection. In that letter, you were offered the opportunity to respond to the apparent violations in writing or request a predecisional enforcement conference. You requested a conference. On October 23,1998, a preducisional enforcement conference was conducted with you to discuss the apparent violations, their causes, and your corrective actions. A copy of the enforcement conference report is enclosed.

Based on the information developed during the inspection, and the information provided during the conference, eight 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 violations being cited include:

(1) failure to secure licensed material from unauthorized access or removal from a controlled or unrestricted area which resulted in a loss of a gauge from the Newington, Connecticut facility; (2) failure to review the radiation safety program content and implementation at least annually; (3) failure to perform surveys that are reasonable under the circumstances to evaluate the potential radiological hazards that could be present; (4) and (5) failure to mAEE and lghal packages containing hazardous material transported on public highways; (6) failure to train hazmat employees; (7) failure to maintain possession limits for materials under NRC jurisdiction below 750 millicuries of americium-241; and (8) failure to maintain records reauired by the license at the New York office as stated in the correspondence dated November 29,1996.

NUREG-0940. PART III B-28

. . -- . ~ . .. - - . - - - - - - - - . - - - . - -- . .-

i Materials Testing Lab, Inc. 2 The violations collectively demonstrate that a significant breakdown in the control of licensed activities existed at your facility. For example, a lack of attention to detail in program oversight resulted in inadequate control of keys for the storage of gauges, contributing to the loss of the gauge. in addition, the Radiation Safety Officer (RSO) was not aware of basic regulatory requirements, such as the requirement to perform an annual review of the program, demonstrating that the RSO did not spend the time required in reviewing changes in the regulations to ensure prompt implementation. The NRC entrusts responsibility for radiation safety to management and the RSO. Therefore, the NRC expects effective oversight of its licensed programs. Incumbent upon each NRC licensee is the responsibility for management in general, and the RSO in particular, to protect the public health and safety by ensuring that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and corrected expeditiously. Given the lack of management attention towards licensed ...pcssibilities, these violations are classified in the aggregate as a Severity Level lli protv.am in accord &ce with the " General Statemant of Policy and Procedure for NRC E..rorcement Actions," (Enforcement Policy) NUREG-1600, Rev.1.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750is considered for a Severity Level til violation or problem. Because your facility has not been the subject of an escalated enforcement action within the last two inspections in February 1993 and March 1998, the NRC considered whether credit was warranted for Correct /ve Act/on in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement

. Policy. Those actions, which were described at the enforcement conference, included:

l (1) performance of audits of the program by the RSO with plans to increase the frequencies of these audits; (2) initiation of a stricter key control policy in addition to requiring that utilization logs be completed when gauges are used; (3) changing the locks and security code l at the Connecticut facility; (4) review of the training certificates of all employees, and i suspension of the use of gauges for the employee whose hazmat certificate expired until such l time that it is renewed; (5) filing separate applications for licenses for your Connecticut, New l Jersey, and Delaware facilities; and (6) plans to provide the necessary resources to ensure that the program has the appropriate oversight to ensure that these violations do not recur.

Credit for corrective actions is warranted because your corrective a'ctions were both prompt and comprehensive.

Therefore, to encourage prompt and comprehensive corrective actions, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could l result in further escalated enforcement action.

The apparent violation described in the inspection report, associated with the failure to store licensed material at the New York facility, is being classified as a minor violation, and is not being cited.

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.

i l

i NUREG-0940. PART III B-29

Materials Testing Lab, Inc. 3 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, f

I Hubert J. Miller A Regional Administrator Docket No. 030-17801 License No. 31-19502-01

Enclosures:

1. Notice of Violation

2. Enforcement Conference Report I

1 l

l l

9 NUREG-0940. PART III B-30

_ . _ _ _ _ . . . - _ . - . _ _ _ _ . . - . . . _ _ _ . . .__ _ ._ _.._ _ -.____ .~._

i' Materials Testing Lab, Inc. 4 4

cc w/encis:

Fred Hauck, Radiation Safety Officer State of New York State of Connecticut State of New Jersey State of Delaware 1

4 i

NUREG-0940. PART III B-31

f ENCLOSURE 1 NOTICE OF VIOLATION Materials Testing Lab, Inc. License No. 31-19502-01 New Hyde Park, NY Docket No. 030-17801 EA 98-437 During an NRC inspection conducted on July 13,14,29, and 30,1998, eight violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, Rev.1, the violations are listed below:

A. 10 CFR 20.1801 requires that licensees secure licensed material from unauthorized access or removal from a controlled or unrestricted area.

Contrary to the above, on or about May 29,1998, the licensee did not secure licensed material from unauthorized access or removal from a controlled or unrestricted area.

Specifically, on or about May 29,1998, the licensee left a portable gauge (containing sealed sources of nominal 8 millicuries (mCl) of cesium-137 and nominal 44 mci of americium-241) unsecured and unattended at its facility located in Newington, Connecticut. The storage area was left unlocked, and there was easy access by unauthorized personnel to the key for the storage area. The gauge was subsequently lost and has not been recovered. Also, licensee personnel recounted instances where unattended portable gauges containing licensed material were left in an unsecured condition for periods of time on the dock at the Connecticut facility (01013)

8. 10 CFR 20.1101(c) requires that each licensee perform a review of the content and implementation of the radiation safety program at least annually.

Contrary to the above, as of July 30,1998,the licensee did not perform a review of the content and implementation of the radiation safety program at least annually.

Specifically, since the regulation went into effect in January of 1994, the licensee had not performed a review. (01023)

C. 10 CFR 20.1501 requires, in part, that licensees make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in 10 CFR Part 20 and are reasonable under the circumstances to evaluate the potential radiological -

hazards that could be present.

10 CFR 20.1201 requires, in part, that licensees control the occupational dose to individual adults, except for planned special exposures under 10 CFR 20.1206,to an annual limit, which is the more limiting of the total effective dose equivalent being equal to 5 rem (0.05 Sieverts); or the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eyo being equal to 50 rem (0.5 Sieverts).

NUREG-0940. PART III B-32

4 Enclosure 1 2 Contrary to the above, as of July 29,1998, the licensee did not make or cause to be made surveys that were necessary for the licensee to show compliance with 10 CFR 20.1201, and were reasonabie under the circumstances to evaluate the radiological hazards that could have been present. Specifically, the licensee failed to have the necessary surveys (TLDs) when individuals either lost their personnel monitors or turned their personnel monitors in late, nor did the licensee perform an assessment to determine whether the individuals were within the regulatory limits. (01033)

D. 10 CFR 715 requires that each licensee who transports licensed material outside of the site of usage, as specified on the NRC license, or whera transport is on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the DOT regulations in 49 CFR Parts 170 through 189 appropriate to the mode of transport.

1. 49 CFR 172.324(b) requires that the letters "RQ" be marked on packages in association with the proper shipping name.

Contrary to the above, as of July 29,1998, the letters "RQ" were not marked on packages ln association with the proper shipping name. Specifically, some transportation cases were used to transport hazardous materials (containing up to 44 mci of americium-241) on public highways from the Newington, Connecticut facility to temporary job sites in Connecticut, and at the time, the cazes wara not marked with the letters "RQ". (01043)

2. 49 CFR 172.403(f)requines, in part, that each package required to be labeled with a RADIOACTIVE label must hne two of these labels affixed to opposite sides of the package.

Contrary to the above, as of July 29,1998, packages required to be labeled with a RADIOACTIVE label did not have two of these labels affixed to opposite sides of the package. Specifically, the packages used to transport hazardous materials on the public highway only had one RADIOACTIVE label. (01063)

3. 49 CFR 172.702(a) requires that a hazmat employer ensure that each of its hazmat employees !s trained in accordance with the requirements prescribed in

, 49 CFR 172.704.

Contrary to the above, as of July 13,1998, the licensee, a hazmat employer, did not ensure that each of its hazmat empirryees was trained in accordance with the requirements prescribed in 49 CFR 177.704. Specifically, one hazmat employee's training certificate had previously exp! red, and that individual transported hazardous materials on public highways while the certificate was expired, in addition, another hazmat employee, who did not have a valid trrining certificate, and was not trained upon obtaining his employment at the

!icensee's facility, also trarisoorted hazardous material on the public highways.

(01063) l l

NUREG-0940. PART IIT B-33

__ _ . . ~ _ _ . _ . _ _ _. _ _ _ _ . _ - _ . _ . ~ _ _ _ _ _ _ _ _ _

Enclosure 1 3 E. Condition 8.B of Ucense No. 31-19502-01 requires that the licensae not p. ess more than 750 mci of americium-241 under NRC jurisdiction.

Contrary to the above, for a period between June 1997 and December 1997, the licensee possessed more than 750 mci of americium-241 under NRC jurisdiction.

Specifically, the licensee possessed a total of 21 devices under NRC Jurisdiction which contained approximately 800 mci of americium-241. (01073)

F. Condition 18 of License No. 31-19502-01 requires, in part, that the licensee conduct i its program in accordance with the statements, representations and procedures contained in the letter dated November 29,1996.

1 The letter dated November 29,1996 requirer that records pertaining to the licensed program be kept at 1539 Jericho Turnpike, New Hyde Park, New York.

Contrary to the above, as of July 30,1998, the licensee kept certain records p' taining to the licensed program at locations other than at 1539 Mho Turnpike, New Hyde Park, New York. Specifically, training records, as well as other recore pertaining to the licensed program, were maintained at the facilities in Newington, Connecticut; Edison, New Jersey; and Dover, Delaware. (01083)

These violations represent a Severity Level ill problem (Supplements IV, V, and VI).

Pursuant to the provisions of 10 CFR 2.201, Muerlab Testing Lab, Inc. is required to submit a written stetement or explanation to the Doctor, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Impsition 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 I

wW. (3) the corrective steps that have been taken and the results achieved, (4) the corrective i.4. that will be taken to avoid further violations, and (5) the date when full compilance 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 bection 182 of the Act, 42 U.S.C. 2232, this 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, 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 informat!on. If you request withholding of such NUREG-0940. PART III B-34 l

Enclosure 1 4 material, you mugl 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 16 CFR 73.21.

Dated at King of Prussia, Pennsylvania this 3rd ony of November 1998 l

I l

l l

f 1

NUREG-0940. PART III B-35

a a ""'c g UNITED STATES f

E y ^h NUCLEAR REGULATORY COMMISSION REGloN iv

/[

9. gA hI

%, O 611 RYAN PLAZA DRIVE SUITE 400

• • • • • ARUNGToN TEXAS 76011 806.1 July 31, 1998 EA 98-362 Douglas R. Johnston, President /CEO Met-Chrm Testing Laboratories of Utah, Inc.

389 West Gregson Avenue Salt Lake City, Utah 84115-3440

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT 030-32304/98-01)

Dear Mr. Johnston:

On June 23-26,1998, the NRC conducted an inspection at your Salt Lake City, Utah, facility.

The enclosed report presents the results of this inspection. Additionally, a telephonic exit briefing was subserp ently conducted with you on July 9,1998.

Based on the information developed during the inspection, 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. The significance of the violation and the need for lasting and effective corrective action were discussed with members of your staff at the close of the on-site inspection on June 26, 1998. The violation involved a failure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. Specifically, on October 29,1997, two qualified radiographers inadvertently failed to load a radiography camera (containing approximately 47 curies of Iridium-192) into their vehicle prior to leaving a temporary job site at the Tooele Army Depot. The temporary job site was located in an area in which Tooele Army Depot maintained restricted access and required security escorts at all times. After completing radiographic operations at the job site, the source had been locked in the fully shielded position within the camera, and the drive cables and guide tubes were removed from the camera in preparation for transport. However, when the radiographers returned to the office, they discovered that th.ey had left the camera behind. One of the radiographers immediately returned to the job site to retrieve the camera. Upon arrival at the job site, the radiographer determined that the camera had not been disturbed and that the source had remained in the fully shielded position. The radiographers estimated that the camera was left unattended for approximately 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />. This violation is of concern because of the potential adverse impact on the health and safety of the public.

The day following the incident, October 30,1997, the radiation safety officer (RSO) issued verbal reprimands to both of the radiographers involved in the incident and required that both radiographers document the circumstances which led to the camera being inadvertent'y left unattended at mtemporary job site. Since both of the radiographers had over 5 years of experience as qualified radiographers and had not been involved in any similar incidents, the RSO determined that no further corrective actions were required regarding this isolated event.

NUREG-0940, PART III 8-36

l

l l

I Met-Chem Testing l Laboratories of Utah, Inc.

2 I

In this case the actual risk to members of the public was limited in that: 1) the source was secured . ..hin the radiography camera,2) the device'was located in an area not readily accessible to the public, and 3) individuals working at your client's facility had previously been informed of the potential hazards associated with radiographic operations. However, the NRC considers the loss of control of byproduct material to be of significant concern because of the potential for members of the public to receive unintended and possibly significant radiation exposures. Therefore, 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 Level 111.

Based on our review of the inspection findings and your corrective actions described during an inspection on June 23-26,1998, the NRC has concluded that we have su+'icient information to make an enforcement decision without the need for a predecisional enforcement conference.

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 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. Based on the corrective actions that you have previously described, it appears that credit is warranted for prompt and comprehensive corrective actions. As noted below, the decision on providing credit for corrective action will be subject to your confirming on the license docket that the actions previously described to the staff have been or are being taken. )

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 at this time. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity LevelllI violation constitutes escalated enforcement action that may subject you to increased inspection effort.

You a4e required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your resporise. For your consideration and convenience, NRC Information Notice 96 28, " SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION,"is enclosed. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

As provided for in the enclosed Notice, you era required to include a description of the reasons for the violation, if admitteo, and your corrective action. This description should address the actions taken following identification and the long term comprehensive actions taken or that will be taken to prevent recurrence. Your response should be submitted under oath or affirmation and may reference or include previous docketed correspondence if the correspondence adequately addresses the required response, if the NRC is satisfied with your response, you will be notified that this enforcement action is completed. However, if your documented corrective action is not sufficiently prompt and comprehensive such that a civil penalty may be NUREG-0940 PART III B-37

Met-Chem Testing Laboratories of Utah, Inc.

warranted, we may telephone you or schedule a predecisional enforcement conference with you. In addition, if you dispute any of the enclosed violations or their severity levels, you should describe the basis for the dispute in your response. Further, you may request that an enforcement conference be held, in which case, please contact D. Blair Spitzberg, Ph.D., at (817) 860-8191 with:n 7 days of the date of this letter. In the absence of such a request but where matters are disputed, we may also elect to hold an enforcement conference. In the event that a conference is to be held, it will be scheduled at least 2 weeks after receiving the written response to the Notice. Following review of any disputes and the record of the conference, if held, a decision will be made to modify, withdraw, or affirm the Notice and, if warranted, issue a civil penalty.

in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its

{

enclosures, and your response (if you choose to provide one) will be placed in the NRC Public 1 Document Room (PDR). 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 witilout redaction.

l Should you have t ; questions concerning this inspection, please contact Mr. Jeffrey Cruz at ,

(817) 860-8164 or Jr. Spitzberg at the number identified above. +

Sincerely, r?

% 8V h Ellis W. Merschoff Regional Administrator Docket No.: 030-32304 License No.: 43 27362-01

Enclosures:

1. Notice of Violation l

2. NRC Inspection Report 030-32304/98-01

3. NRC Enforcement Policy, NUREG-1600 l

4. NRC Information Notice 96-28 i

cc w/ Enclosures 1 & 2:

Utah Radiation Control Prograr.1 Director ,

1 1

NUREG-0940. PART III B-38

1 ENCLOSURE 1 NOTICE OF VIOLATION Met-Chem Testing Laboratories of Utah,Inc. Docket No.: 030-32304 Salt Lake City, Utah License No.: 43-27362-01 EA 98-362 During an NRC inspection completed on July 9,1998, 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 20.1801 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 licensee 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, for approximately 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> on October 29,1997, the licensee did not secure from unauthorized removal or limit access to 47 curies of iridium-192 contained within a radiography camera at a temporary job site, which was an unrestricted area, nor did the licensee control and maimain constant surveillance of this licensed material. (01013)

This is a Severity Level 111 violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Met-Chem Testing Laboratories of Utah, 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 l Regional Administrator, Region IV, 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 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, this 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, proprietary, or l

WREG-0940 PART III B-39 l

safeguards information so that it can be placed in the PDR without redaction. If personal privacy or propriatary 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 mus! 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 com-mercial 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 Arlington, Texas this 31st day of July 1998 l

i 9

NUREG-0940. PART III B-40

pf"%s

/ 7g U:.ITED STATES y / p, f4UCLEAR REGULATORY COMMISSIOf4 L -j 0 j ltE GION IV SN g 611 IMAN PL AZA DRIVE. SUITE 400 96 ARUNGTON TEXAS 70011-8064

• • • • • October 19, 1998 EA 98-363 Sebastian Ned Gregorio President and Radiation Safety Officer Nuclear Pharmacy of Idaho, Inc.

622S Overland Road Boise, Idaho 83709

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-32223/98-01)

Dear Mr. Gregorio:

This refers to the predecisional enforcement conference conducted on August 11,1998,in NRC's Region IV office in Arlington, Texas. The conference was conducted to review several apparent violations which had been identified during an inspection at 'Juclear Pharmacy of Idaho's (NPI's) f acility in Boise, Idaho, and during subsequent in-office reviews. The findings of our inspection wem discussed with you during a telephonic exit briefing on July 14,1998.

Based on the information developed during the inspection and the information that 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 (Notice) and the circumstances surrounding them are described in detailin the subject inspection report. The most significant violations were asso:iated with an event at your facility on November 13,1997, involving a spill of iodine-131 (1-131) which contaminated the laboratory and the skin of the authorized nuclear pharmacist. These violations include failures to: (1) perform an evaluation to determine the dose to the skin of the right forearm of the individualinvolved in the contamination event; (2) limit to 50 rems the ai:nual shallow-dose equivalent to the skin of the individual involved in the contamination event (the individual received an estimated sha"ow dose equivalent of 115 rems to the skin); and (3) submit a written report within 30 days foliowing the contamination event.

The f act that an individual received a dose to the skin of 115 rems is significant. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, violations associated with a dose to the skin in excess of 100 rems would normally be considered for enforcement at Severity Level 11. However, in recognition of the conservatism contained in the calculated result of 115 rems, these violations are instead classified in the aggregate as a Severity Level ill problem.

In accordance with the Enforcement Policy, a civil penalty in the base amount of $ 2 750 is considered for a Severity Levet lli 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 Act;on in accoroonce with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. NPI's comprehensive corrective actions included closing the retail pharmacy during July 1998, thereby giving the RSO more time to NUREG-0940. PART III B-41

2 7

manage and oversee the radiation safety program. In addition, the RSO committed to:

(1) attend a 5-day radiation safety course to become more familiar with NRC regulations, (2) hire an independent auditor to observe and review NPI activities to ensure compliance with the license and regulations, and (3) request changes to NPI's license to include use of an additional fume hood and improve its air monitoring program. As a result, the NRC has ,

determined that NPI is deserving of Corrective Action credit.

In addition, the NRC normally considers exercising discretion to escalate a civil penalty in cases involving overexposures. However, in this case, the NRC has decided not to exercise discretion based on the nature of the incident and the good corrective actions taken.

Therefore, to encourage prompt 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 Seventy Level lli violation constitutes escalated .

enforcement action, that may subject you to increased inspection effort.

In addition to the above cited violations, other violations were identified. These include failures to: (1) use a fume hood authorized by the license for compounding radioiodine; (2) check a dose calibrator for constancy at the beginning of each day of use; (3) store vials of xenon-133 inside a fume hood as specified in procedures referenced in the license; and (4) wear shoulder ,

length gloves while compounding millicurie quantities of iodine-131. These violaSons were each classified at Severity Level IV in accordance with the Enforcement Policy.

Regarding two other apparent violation described in our inspection report, the NRC has concluded that no violation of regulatory requirements occurred. Section 1 of the inspection report described Apparent Violation 030-32223/9801-01 involving unauthorized use of a nuclear pharmacist. During the conference, you presented information indicating that this individual worked under the supervision of an authorized nuclear pharmacist, not as an authorized nuclear pharmacist himself. Section 3 of the inspection report described Apparent Violation 030-32223/9801-03 involving the failure to perform bioassays at the required intervals. During and af ter the conference, you presented additional information documenting that the bioassays had been performed.

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 to Violation B, please include the steps you have taken to correct your radiation dose of record. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

. e NUREG-0940, PART III B-42 ,

/

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,

//9 Ellis W. Mersch Regional Admi rator Docket No. 030-32223 License No. 11-27398-01 MD

Enclosure:

Notice of Violation cc (w/ enclosure):

Idaho Radiation Control Program Director NUREG-0940. PART III B-43

NOTICE OF VIOLATION Nuclear Pharmacy of Idaho Docket No. 030-32223 Boise, Idaho . License No. 11-27398-01 MD l EA 98-363 During an NRC inspection conducted on April 21 through July 14,1998, violations of NRC l requirements were identified. In accordance with the " General Statement of Policy and e Procadure for NRC Enforcement Actions," NUREG-1600_ the violations are listed below:

A. 10 CFR 20.1501 requires that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be p;esent.

Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions ,

and potential hazards incident to the product;on, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

Contrary to the above, as of April 21,1998, tho licensee had failed to perform an adequate survey to assure compliance with iO CFR 20.1201, which limits radiation exposure to 50 rems shallow dose equivalent to the skin of the whole body. Specifically, the licensee failed to perform an evaluation to deterrrine the quantity of iodine-131 contamination and the radiological hazards to the skin of the right forearm for an authorized nuclear pharmacist involved in an iodine-131 contamination event which occurred on November 13,1997. (01013)

8. 10 CFR 20.1201(a)(2)(ii) requires that the licensee control the annual occupational dose to individual adults, except for planned special exposures under 10 CFR 20.1206, to a shallow-dose equivalent of 50 rems to the skin or to any extremity.

Contrary to the above, the licensee failed to limit the annual shallow-dose equivalent to .

the skin of an adult authorized nuclear pharmacist (ANP) to 50 rems during 1997.

Specifically, the ANP received an estimated dose of approximately 115 rems shallow-dose equivalent to the skin of his right forearm following a contamination event which occurred on November 13,1997. (01023)

C. 10 CFR 30.50(c)(2) requires, in part, each licensee who makes a report required by . ?'

10 CFR 30.50(b) to submit a written follow-up report within 30 days of the initial report.

Contrary to the above, the licensee failed to submit a written report within 30 days of an initial report made on November 17,1997, of a contamination event which occurred on November 13,1997, an event requiring notification by 10 CFR 30.50(b)(2). The written '

report was submitted on June 4,1998. (01033)

These violations represent a Severity Level ill problem (Supplement IV).

NUREG-0940 PART III B-44 -

1

' D. 10 CFR 32.72 requires, in part, that a licensee possess and use instrumentation to measure the radioactivity of radioactive drugs and to check each instrument (dose calibrator) for constancy at the beginning of each day of use.

Contrary to the above, between July 1997 and April 21,1998, the licensee failed to check its dose calibrator for constancy at the beainnina of each day of use. Specifically, the licensee routinefy performed dose calibrator constancy checks each day of use af ter the morning radiopharmaceuticals had been prepared and delivered to customer sites for patient administrations. (02014)

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

E. License Condition 25 requires, in part, that except as specifically provided otherwise in the license, the licensee shall conduct its program in accordance with statemt nts,

, representations, and procedures contained in the license application dated July 3,1991.

1. Section 10.10.3.1 of the application, entitled Special Eauipment and Procedures Heauired For Handlina Radioactive lodine-131, requires the use of shoulder length gloves.

Contrary to the above, while compounding millicurio quantities of iodine-131 on November 13,1997, the licensee's authorized nuclear pharmacist failed to wear shoulder length gloves.

2. Section 9.3 of the application, entitled Adeauacy of Facility for Handlina Xenon-133, specifies, in part, that vials of xenon-133 will be stored in a fume hood which will operate on a continual basis with an air flow velocity not to be less than 100 foot per minute at its exhaust opening.

Contrary to the above, on numerous occasions between February 27,1997 and April 21,1998, vials of xenon-133 were stored in an area located outside the fume hood. (03014)

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

F. License Condition 25 requires, in part, that except as specifically provided otherwise in the license, the licensee shall conduct its program in accordance with statements, representations, and procedures contained in the licensee's letters dated August 15 and 25,1994.

The licensee's' letter dated August 15,1994, informing NRC of the licensee's relocation to its r.aw facility, specifies that radiciodine will be stored in the licensee's f ume hood and that iodine will be transferred to the licensee's approved glove box for compounding ano dispensing. The licensea's letter dated August 25,1994, informing NRC that the licensee had completed its move and was now housed at 6225 Overland Road, specifies that the licensee's approved charcoal filtered fume hood and glove box were in place at the licensee's facility.

NUREG-0940, PART Ili B-45 i '"

3-Contrary to the above, from about February 1998 until April 28,1998, the licensee used a fume-free hood for compounding millicurie quantities of iodine 131 and this fume free hood was not authorized by the license. (04014)

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

Pursuant to the provisions of 10 CFR 2.201, Nuclear Pharmacy of Idaho (Licensee) 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 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). 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 f,'otice, 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, United States Nuclear Regulatory Commission Washington, DC 20555-0001, Under the authority of Section 182 of the Act,42 U.S.C. 2232, tl.is 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, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necassary 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 withho' ding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information requirod by 10 CFR 2.790(b) to support a request for withholding confidential cornmercial or financial information).

Dated at Arlington, Texas this lffd day of October 1998 NUREG-0940, PART III B-46

UNITED STATES an n'%q'o NUCLEAR REGULATORY COMMISS ON ,

g E o REGION 111

• l E I 801 WARRENVILLE ROAD lisle, ILLINOIS 60532-4351

%*****/ December 18, 1998 ,

EA 98-523 ,

Ann Regling Senior Vice President Administration Sinai Hospital 6767 West Outer Drive s Detroit, MI 48236

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-00252/98001(DNMS))

Dear Ms. Regling:

This refers to the inspection conducted on October 28 through November 9,1998, at Sinai Hospital (Sinai) in Detroit, Michigan. The inspection was conducted to review the circumstances surrounding a reported cobalt-60 teletherapy misadministration. Three apparent /

violations of your quality management program (QMP) were identified and considered for escalated enforcemst action. These apparent violations are described in the inspection report -,

sent to you by letter dated November 27,1998. A predecisional enforcement conference was held on December 16,1998, in the NRC Region lli office to discuss the apparent violations, the root causes, and the corrective actions planned or taken.

Based on the information developed during the insoection, the information provided in Sinai's letters dated October 30 and November 16,1998, and the information provided during the conference, 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 detailin the subject inspection report. The violctions involve:

(1) failure to assure that the treatment was in accordance with the written directive by checking dose calculations within three working days of initiation of treatment, (2) failure of the treating therapists to compare the written directive with the calculations each day of treatment, and ~

(3) failure of the staff to perform weekly chart checks to verify treatment parameters were in ~

accordance with the written directive.

~

The misadministration occurred when a patient received in one week a dose that was twice the prescribed weekly dose. An error occurred when incorrect dose information was used in the dose calculation. If Sinai's staff had fully implemented Sinai's QMP, the incorrect dose per fraction would not have continued through the seventh day of treatment and the misadministration likely would not have occurred. The fact that a number of staff were involved with this treatment over a period of several days and no one noticed the error until the eighth

/

day, indicates a significant programmatic weakness in the implementation of the QMP.

Although we recognize that the misadministration did not cause any adverse effects to the e patient and all required notifications were made, the violations are of concern to NRC because, if allowed to continue, more serious consequences could potentially arise with future patient treatments. ,

1 NUREG-0940. PART III B-47 '

___._ _a__.___._____-___-__m_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

A. Regling 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 lli problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is normally considered for a Severity Level 111 problem. Because your facility has been the subject of escalated enforcement actions within the last two inspections,' 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. Since your staffidentified the violations and exercised considerable effort to determine the root cause, credit for identification is warranted. The NRC has also determined that credit is warranted for the corrective actions taken and/or planned. The actions include: (1) dosimetry calculations will be logged in a separate binder by the person performing the task; (2) the therapists will verify the physician's written directive with that information entered in the treatment verification system; (3) chart checks will be scheduled to be completed before Friday of each week and the site specialist will insure that they are completed before the end of the work week; (4) the therapy staff will be reminded of the department's procedure for documenting calculation checks in the chart and of the policy that treatments are not to be given beyond the specified number of fractions without a documented check and this point will be included in the annual QMP in-service training sessions; (5) the supervisory staff will conduct random quality assurance audits to ensure compliance; and (6) all therapy staff have been informed of the incident and everyone who works with the cobalt-60 teletherapy unit has received refresher training on the contents and implementation of the QM9 Therefore, to encourage prompt identification and comprehensive correction of violations, I tave been authorized not to propose a ",ivil penalty in this case. However, significant violations in the future could result in a civil per .y. In addition, issuance of this Severity Level 111 problem constitutes escalated enforcement action that may subject you to increased inspection effort.

During the conference your staff provided a written statement addressing apparent inaccuracies in the subject inspection report. We have reviewed the noted inaccuracies and concluded that no revision to the attached Notice was warranted. We will address these statements in the conference summary report to be provided to you by separate correspondence.

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 will be (was) achieved is already adequately addressed on the docket in inspection Report 030-00252/98001(DNMS). Therefore, you are not required to respond to thit letter unless the description therein does not accurately reflect your corrective actions or your position. In tha: case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

' A Severity Level 111 violation wasJssued on September 21,1994 (EA 94-138) for a violation of a QMP procedural requirement.

NUREG-0940. PART III B-48

s A. Regling 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 provide one, will be placed in the NRC Pub!ic Document Room.

incerely, James L. Caldwell Acting Regional Administrator Docket No. 030-00252 License No. 21-00299-06

Enclosure:

Notice of Violation

\

NUREG-0940. PART III B-49

NOTICE OF VIOLATION Sinal Hospital Docket No.030-00252 Detroit, Michigan License No.21-00299-06 EA 98-523 During an NRC inspection conducted on October 28 through November 9,1998, 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:

10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program (QMP) to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

A The licensee's written QMP revised September 9,1994, in the paragraph titled

" Treatment Plan / Calculation (s) Check," requires that dose calculations be checked within three working days after the administration of the first teletherapy dose.

Contrary to the above, on October 8 and 9,1998, dose calculations were made by the physicist and the dosimetrist, respectively, and neither calculation was checked within three working days after administration of the first teletherapy dose. (01013)

B. The licensee's written QMP, revised September 9,1994, in the paragraph titled

" Execution of the Written Directive," requires that before administering each teletherapy dose, the specific details of the administration be verified. For example, the dose per fraction shall be confirmed by the person administering the teletherapy treatment to verify agreement wit'h the latest written directive and plan of treatment.

Contrary to the above, on October 12,13,14,15 and 16,1998, the persons administering the teletherapy treatments did not verify agreement with the latest written directive and plan of treatment. Specifically, the dose per fraction wa! not verified before administering each teletherapy dose. (01023)

C. The licensee's QMP, revised September 9,1994, in the paragraph titled " Weekly Chart Checks," requires that the treatment charts of all patients undergoing treatment in Radiation Oncology be checked by a qualified person on a weekly basis to detect mistakes that may have occurred in the daily and cumulative teletherapy dose administrations from all treatment fields, or in connection with any changes in the written directive or plan of treatment.

Contrary to the above, during the week of October 12,1998, and on several occasions during the months of August, September and October 1998, all treatment charts of patients undergoing treatment in Radiation Oncology were not checked by a qualified person on a weekly basis. (01033)

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

NUREG-0940. PART III B-50

Notice of Violation 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 will be achieved is already adequately a+1ressed on the docket in Inspection Report 030-00252/98001(DNMS). However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description herein 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 ill, 801 Warrenville Road, Lisle, Illinois 60137, within 30 days of the date of the 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 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, 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 18* day of December 1998 4

e a

NUREG-0940 PART III B-51

UNITED STATES

1. g na%g% NUCLEAR REGULATORY COMMISSION 8' $ REGloN tl j ' '

S E ATLANTA FEDERAL CENTER

• 61 FoRsYTH STREET, sW. sulTE 23T85 k, ArLANTA, GEORGIA 30303-3415 October 30,1998 EA 98-495 Southem Processing Enterprises ATTN: Mr. Joe Childress President Box 719 Deaver, West Virginia 25813 .

SUBJECT:

NOTICE OF VIOLATION (NRG INSPECTION REPORT NO. 999 90002/98-02)

Dear Mr. Childress:

This refers to the special, announced onsite inspection of Southem Processing Enterprises (SPE), conducted on July 2 and October 9,1998, at a temporary job site near KnoxviHe, Tennessee and at your facility in Beckley, West Virginia, respectively. The enclosed report presents the results of this inspection.

Based on the information developed during the inspection, the Nuclear Regulatory Commission (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 detailin the subject inspection report. Violation A involves the unauthorized removal, in late 1997, of two generally licensed fixed gauges containing 250 millicuries (mci) of ,

cesium-137 (Cs-137). The gauges were removed by an individual who was neither trained nor ,.

licensed to perform such activities. The individual removed the gauges, from their fixed position, by cutting around the pipe where the gauges were attached. The gauges were placed in storage pending their transfer.

Violation B involves the failure to properly transfer these gauges. Specifically, the generally licensed gauges were inadvertently transferred in May 1998, to facilities in Kentucky and Tennessee. These facilities did not hold specific licenses to possess byproduct material, and SPE did not meet the requirement of 10 CFR 31.5 to transfer the byproduct material to a generallicensee. SPE identified the unauthorized transfer and notified both the vendor of these generally licensed gauges and the Commonwealth of Kentucky, who in turn notified the State c.f Tennessee and the NRC Region ll office.

The removal and unauthorized transfer of the generally licensed gauges resulted in minimal safety consequences to the public. Although subsequent investigation determined that one of the gauges was transferred with the shutter in the open position, the radioactive source was effectively shielded by surrounding piping, which resulted in minimal dose rates and little potential exposure to individuals handling the gauge. During the in.spection, you acknowledged your awareness of the requirements for transferring the devices; however, you failed , , .

NUREG-0940 PART III B-52 m m_ , _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

1 Southern Processing Enterprises 2 l to ensure that the transfers of the gauges were performed correctly. Both Violations A and B ,

could have been avoided had you employed the services of a trained and licensed Individual to perform the gauge removal. Because these activities were conducted by a technically unqualified individual and, under different circumstances could have placed you and others at risk for radiological exposure, these violations are classified in the aggregate in accordance with the "Gerieral Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement ',

Policy), NUREG-1600 as a Severity Level lli problem. p Based on our review of the inspection findings and your corrective actions described during our inspection on July 2 and October 9,1998, the NRC has concluded that we have sufficient information to make an enforcement decision without the need for a predecisional enforcement conference.

, Because your facility has not been the subject of escalated enforcement actions within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.B.2 of the Enforcement Policy. Your corrective actions included: (1) immediate notification of the vendor and the Commonwealth of Kentucky; (2) prompt follow-up on the status of the gauges at the recipient locations; and (3) permanent discontinuation of all generally licensed gauge activities.

As noted below, the decision to assess credit for corrective action will be subject to your written confirmation that the actions previously described to the staff have been or are being taken.

l Therefore, to encourage prompt identification and comprehensive correction of violations, and in recognition of the absence of previous escalated onforcement action, I have been authorized not to propose a civil penalty at this time. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level lli problem constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the . -

enclosed Notice when preparing your response. For your consideration and convenience, NRC Information Notice 96 28. " SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION,"is enclosed. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

As provided for in the enclosed Notice, you are required to include a description of the reasons -

for the violation, if admitted, and your corrective action. This description should address the actions taken following identification and the long term comprehensive actions taken or that will ,

be taken to prevent recurrence. Your response should be submitted under oath or affirmation and may reference or include previously docketed correspondence if the correspondence adequately addresses the required response. If the NRC is satisfied with your response, you will be notified that this enforcement action is completed. However,if your documented corrective action is not sufficiently prompt and comprehensive such that a civil penalty may be warranted, we may telephone you or schedule a predecisional enforcement conference with you. In addition, if you dispute any of the enclosed violations or their severity levels, you should describe the basis for the dispute in your response. Further, you may request that an -

enforcement conference be held, in which case, please advise Mr. Mark Lesser at (404) 562-4731, within seven days of the date of this letter. In the absence of such a request but where matters are disputed, we may also elect to hold an enforcement conference. In the NUREG-0940. PART III B-53

(

Southem Processing Enterprises 3 event that a conference is to be held, it will be scheduled at least two weeks after our receipt of your written response to the Notice. Following reviaw of any disputed information and the record of the conference, if held, a decision will be made to modify, withdraw, or affirm the l Notice and, if warranted, issue a civil penalty.

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 (PDR).

Sincerely,

k. W Luis A. Heyes Regional Administrator 7

Docket No. 999-90002

('

License No. General Licensee

Enclosures:

1. Notice of Violation

2. Inspection Report No. 999-90002/98-02

3. NRC Information Notice 96-28 cc w/o enci 3:

State of West Virginia Commonwealth of Kentucky State of Tennessee b

9 NUREG-0940. PART III B-54

NOTICE OF VIOLATION Southern Processing Enterprises Docket No. 999-90002 Beckley, West Virginia License No. General License EA 98-495 During an NRC special inspection conducted on July 2 and October 9,1998, 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:

s A. 10 CFR 31.5(c)(3)(ii) requires, in part, that any person who possesses, uses or transfers byproduct material in a device pursuant to the general license in 10 CFR 31.5(a) assure that installation, servicing and removal from installation involving the radioactive material, its shielding or container are performed by a person holding a specific license pursuant to 10 CFR 30 and 32 or from an Agreement State to perform such activities.

Contrary to the above, in late 1997, Southern Processing Enterprises (SPE), an entity who possessed byproduct materialin a device pursuant to 10 CFR 31.5(a), failed to assure that removal from installation of radioactive material and its shielding contained in generally licensed devices (fixed nuclear gauges) was performed by a person specifically licensed to perform such activity, under either 10 CFR 30 and 32 or an Agreement State. Specifically, an SPE employee personally removed, from installation, two fixed gauges, each containing 250 mci of Cs 137 and neither the employee nor SPE were specifically licensed to perform such activity. (030101)

B 10 CFR 31.5(c)(8) requires, in part, that any person who transfers byproduct material in a device pursuant to the general license in 10 CFR 31.5(a), transfer the device only to persons holding a specific license pursuant to 10 CFR 30 and 32 or from an Agreement State to receive the device.

Contrary to the above, in or about May 1998, SPE transferred two generally licensed devices, each containing 250 mci of Cs-137, one to a facility in Kentucky and another to a facility in Tennessee, and neither facility held a specific license, pursuant to 10 CFR 30 and 32 or from an Agreement State, authorizina their receipt. (030102)

This is a Severity Level lli problem (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Southern Processing Enterprises 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 each 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.

Enclosure 1 NUREG-0940, ' ART III B-55

Notice of Violation 2 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 enforcernent 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 Director, Enforcement and investigations Coordination Staff, 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.

Because your response will be placed in the NRC Pubhc 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 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at Atlanta, Georgia this 30th day of October,1998 NUREG-0940 PART III B-56

.,# '*c o .

1 UfDTED STATES

~ '

' . '4UCL Er.P REGUL ATOr'Y CO*.WISSION

% .;E -

July 21, 1998 EA 98-237 Mr. Pericles Manthos, Administrator State of Hawaii Department of Transportation, Highvfays Division Materials Testing and Research Branch 869 Punchbowl Street Honolulu, Hawaii 96813 SbBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-13127/98-01)

Dear Mr. Manthos:

This refers to subject inspection report which identified an apparent violation that was being considered for escalated enforcement action. The apparent violation involved the failure to secure from unauthorized removal or limit access to portable gauges containing licensed material. The findings of the inspection were discussed with members of your staff on April 24, 1998, and were documented in the subject report dated April 28,1998. Our letter informed you that it may not be necessary to conduct a predecisional enforcement conference in order to enable the NRC to make an enforcement decision and we provided you with either the opportunity to respond to the apparent violation in writing or the opportunity to request a predecisional enforcement conference. You did not request a conference, and instead provided a written response by letter dated June 4,1998. Your June 4 letter also responded to other nonescalated violations which were issued with the inspection report.

Based on the.information developed during the inspection and the information that you provided in your June 4 letter, the NRC has determined tirat 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. The violation involves two instances of failures to adequately secure gauges containing licensed material from unauthorized removal or access. In the first instance, our inspector found a gauge stored inside an unlocked vehicle inside the State of Hawaii's baseyard in Kapa'a, Hawaii. In the second instance, the inspector observed a gauge stored inside an unlocked room in the baseyard. Also, the room was partially walled off in that the walls did not go all the way to the ceiling. As such, the gauges could not be secured in their normal storage area because individuals were not prevented from climbing over the wall and to have access to the gauge. In fact, at one point late in the inspection, the user did climb over the wall because he did not have the key to the door.

There viere no safety consequences associated with this violation. Nonetheless, these two instances of failures to secure gauges to prevent unauthorized access to licensed material are considered significant because of the potential for improperly secured gauges to be lost or stolen. Therefore, this violation has been categorized in accordance with the " General NUREG-0940. PART III B-57

I 2-Statement of Policy and Procedure for NRC Enforcement Actions"(Enforcement Policy),

NUREG-1600 at Severity Level .'11.

In accordance with the Enforcement Policy, a civil penalty in the base amount of $2,750 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. Your corrective actions included emphasizing procedures and requirements for proper gauge storage and security, better control of the keys to the locked storage area, enclosing the opening between the top of the wall and the ceiling, reprimanding the individual involved, and implementing additional controls for gauge users and their supervisors. Our evaluation of your corrective actions indicates that Corrective Action credit 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 lil 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 c.;hieved is already adequately addressed on the docket in the subject inspection report and your June 4,1998, 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 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, its enclosure, and your June 4 letter will be placed in the NRC Public Document Room (PDR).

Sincerely,

/#

Ellis W. Mersch Regional Admin strator Docket No. 030-13127 l

License No. 53-17656-01

Enclosure:

Notice of Violation cc (w/ encl):

Hawaii Radiation Control Program Director NUREG-0940. PART III B-58

NOTICE OF VIOLATION State of Hawaii Docket No. 030-13127 Department of Transportation, Highways Division License No. 53-17656-01 Materials Testing and Research Branch EA 98-237 Honolulu, Hawaii During an NRC inspection conducted on March 23,1998, 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 20.1801 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 licensee 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 March 23,1998, the licensee did not secure from unauthorized removal or limit access to a portable gauge containing 10 millicuries of cesium-137 and 50 millicuries of americium-241 located in an unlocked veh;cle and to a portable gauge containing 8 millicuries of cesium-137 and 40 millicuries of americium-241 located in an unlocked storage area both located in the licensee's baseyard in Kapa'a, Hawaii, which is a controlled area, nor did the licensee control and maintain constant surveillance of the licensed material. (01013)

This is a Severity Level hl 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. 030-113127/98-01 and the Licensee's June 4,1998, 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 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 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.

l l NUREG-0940. PART III B-59

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_q1gst 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 recuired by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

Dated at Arlington, Texas this 21th day of July 1998 NUREG-0940, PART III B-60

~ . - - - _

f Ketug M k UNITED STATES 8 p, NUCLEAR REGULATORY COMMISSION E

G REGloN I g 475 ALLENDALE ROAD g*****,d,[ KING oF PRUSSIA, PENNSYLVANIA 19406-1415

, December 29, 1998 EA 98-536 Mr. Louis C. Goetting Executive Director for Materials Management University of Medicine and Dentistry of New Jersey 65 Bergen Street University Heights Newark, New Jersey 07107-3001

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-09926/98-001) l

Dear Mr. Goetting:

This refers to the NRC inspection canducted on November 17-19,1998, at the above location, to determine whether activities authorized by your NRC license were conducted safely and in accordance with NRC sequirements. At the conclusion of the inspection, the findings were discussed with those members of your staff identified in the inspection report. During the inspection, two apparent violations of NRC requirements were identified involving the failure to ap;,ropriately accure licensed radioactive material at your facility. The apparent vidations were described in the NRC inspection report transmitted with our letter, dated December 15, 1998. On December 23,1998, a preoecisional enforcement conference was held with you and members of your staff to discuss each of the apparent violations, the causes, and your corrective actions. A copy of the enforcement conference report is enclosed. At the conference, you also provided the NRC a letter, dated December 23,1993, summarizing your corrective actions. l Based on fucher review of the information developed during the inspection and the information you provided during the conference, the NRC has determined that _one violation of NRC requirement; occurred. That violation involved three examples of failure to secure licensed materials In an unrestricted area. One example of the violation is c;ted in the enclosed Notice of Violation (Notice) and the circumstances surroun d ing it are described in detail in the subject inspection report. The remaining two examples of the violation were not cited as discussed below.

Thc cited violatien involved the failure to secure approximatel/136 microcuries (uCi) of polonium-210 (Po-210)in one of your research laboratories. Specifically, the NRC inspector discovered that a research laboratory in the Medical School Building at your facility was unsecured and unattended. In this case, the laboratory was shared by individuals wL use licensed materiai, as well as individuals who did not use licensed materials. Since the amount of Po-210 in the laborakry wa= greater than 1000 times the levels set forth in 10 CFR Part 20, Appendix C (approximately 36 times the Annual Limit on intake), and since the material existed in a liquid form (polonium chloride), failure to maintain security of the laboratory constitutes a significant safety concern in that, it could have resulted in the material being lost, stolen, or misused by an individual. Ingestion of such material would have resulted in a NUREG-0940. PART III B-61

University of Medicine end Dentistry 2 of New Jersey significant exposure. Therefore, the violation is classified at Severity Level lli 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 $2,750is considemd for a Severity Levellil violation. Because your fa lty has not been the subject of an escalawd 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, at the time of the enforcement conference, were considered prompt and comprehensive; These actions, which were described at the eniorcement conference, included, but not limited to, (1) review of all 125 laboratories located in the four buildirra containing radioactive material to ensure availability of locking refrigerators, storage, or 1c J storage within locking refrigsrators; (2) placement of a locking device on the only laboratory which is being utilized by both individuals who use licensed material, as well as individuals who do not use material; (3) issuance of a notice to all users of licensed material emphasizing the importance of security of material, and informing them that a mandatory six month probation period would be imposed for any violation of security requirements; (4) enhanced training of all individuals who do not use licensed material but work in laboratories where licensed material is used; and (5) increasing the frewency of inspections of the laboratories by your radiation safety staff from monthly to twice monthly. j Therefore, to encourage prompt and comprehensive correction of violations, I have t,een authorized not to propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.

The second example of the violation involved the failure to secure approximately 50 uCi of carbon 14 (C-14) in a research laboratory. Your corrective actions for this problem were appropriato also. This occurrence was of minor safety significance and is not subject to formal enforcement action.

The thirri example of the violation of security requirements occurred in December 1997 and resulted in the loss of con:rol of a package containing 5 millicur!as of tritiem. Although this violation was Montified as a result of an event, namely, the loss of the material, the NRC has determined that this example of the violation was caused by an isolated human error with minimal opportunity for prevention, and you exerted noteworthy effort in ferreting out the root cause of the loss of the material and taking corrective actions. Therefore, this example of the violation is being treated as a noncited violation consistent with Section Vll.B.1 of the  ;

Enforcement Policy. ~

The NRC has conctoded that information regarding the reason for the violation, the corrective actions taken and planned to correct ! ~ tiolation and prevent recurrence, and the date when fell compliance was achieved is already adequately addressed on the docket in your December 23, 1998 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 soecified in the enclosed Notice.

r NUREG-0940. PART III B-62

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University of Medicine and Dentistry 3 of New Jersey 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, I I M

Hu ert J. Miller /

Regi nel Adminis ahar l

\  !

! Docket No. 030-09926 License No. 79-02957-13

Enclosures:

1. Notice of Violation  !

2. Predecisional En'orcement Conference Summary Report cc w/encis:

State of New Jersey J I

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NUREG-0940. PART III B-63

ENCLOSURE NOTICE OF VIOLATION University of Medicine and Dentistry Docket No. 030-09926 of New Jersey License No. 29-02957-13 Newark, New Jersey EA No.98-526 During an NRC inspection conducted on November 17-19, 1998, 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 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 licensee control and maintain constant surveillance of licensed materimi that is in a ct"1 trolled or unrestricted area and that is not in storage. As defined n 10 CFR 20.1L3, contro//edarse 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 November 18,1998, the licensee did not secure from unauthorized removal or limit access to licensed material stored in controlled or unrestricted areas. Specifically, licensee personnel left two vials of polonium-210 (containing a total of 136 microcuries liquid polonium chloride) unattended and unsecured in Room F451 of the Medical Science Building. (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 the licensee's December 23,1998 letter to the NRC. However, the licensee is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect its corrective actions or its positan. In that case, or if the licensee chooses to respond, the licensee shall clearly mark its response as a " Reply to a Notice of Viols an,"

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 1, 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 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.

NUREG-0940, PART III B-64

. . _ . ._ _ _.._ .~. -_ -_

l l Enclosure 2 1

l If the licensee chooses to respond, its response will be placed in the NRC Public Document j Room (PDR). Therefore, to the extent possible, the response should not include any personal i 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.

i Dated a King of Prussia, Pennsylvania this day of December 1998 l

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3 NUREG-0940, PART III B-65

N C FocM 335 U.S. NUCLEAR RECULATORY COMMISSloN 1. Rf PORT NUMBER NC 11 % and Num f un um CIBLIOGRAPHIC DATA SHEET l

tse,i,urruce,or on en,,,,,r ,j NUREG-0940, PART III '

2. TITLE AND SUCTITLE VOL. 17, No. 2 i

Enforcement Actions: Significant Actim. "molved l Material Licensees 3. DATE REPORT Pl'BLISHED Semiannual Progress Report uoNta j veAa July - December 1998 March 1999

4. FIN oR GR ANT NUMBE R

5. AUTHoMS) 6 TYPE oF REPORT Office of Enforcement Technical .

1. PE RioD CoV E R E D isnetuswr onres)

8. PEnFoRMiNG oRGANtZ AT ton - N AM E AND ADDR ESS tor Nnc. orovnar onw.sen. ortsee or needen. U.S Nuclear Repuserary Commauen and mettons ocuress, or contracwr. provnne none end maams addrent Office of Enforcement U. S. Nuclear Regulatory Commission Washington, DC 20555-0001

9. SPoN50 RING oRG ANIZATloN - N AME AND ADDR ESS for Nnc. ryou %me a encer". itcentractor, provant Nnc owenson. Otrace or noston. US Nucerer neousatory commnamn.

and merome edeens Same as above

10. SUPPLEMENTARY NOTES

11. ABSTR ACT (200 words or arms This compilation summarizes significant enforcement actions that have been resolved during this period (July - December 1998) 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 taken to improve safety by avoiding future violations similar to those described in this publication. j i

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12. KE Y WoRDS/DESCR:PT 03 S ttas woras orparens raer ur on s,,,nmeaer, m sacerm, rae resorr.s n avAstAseu n siATEmtN1 Diagnostic Radiopharmaceut icals, Teletherapy, Brachytherapy, Unlimited Radiation Safety Program, Safety Evaluation, Quality Management """'"'""*"'""*

Program, HDR Unclassified

$The Rep.or) ,

Unclassified l Ib. NUMBER of PAGES 16 PRICE NRC FOMM 3M (2491

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UMTED STATES SPECIAL STANDARD Mall NUCLEAR REGut.ATORY COMM!OSiON POSTAGE AND FEES PAID WASHINGTON, DC 20555-0001 "RC PE N9 g OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300 120555154486 1 1ANICJ1CYlXP1 US NRC-0CIO DIV-INFORMATION MANAGEMENT TPS-PDR-NU'tEG 2WFN-6E7 WASHINGTON DC 20555 I .

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