EA-99-300 - West Virginia University

February 4, 2000

EA 99-300

West Virginia University
ATTN: Gerald E. Lang, Ph.D.
           Provost and Vice President
           for Academic Affairs and Research
P.O. Box 6203
Morgantown, WV 26506-6203

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,750 (NRC INSPECTION REPORT NOS.: 47-23035-01/99-01 and 47-23035-02/99-01)

Dear Dr. Lang:

This refers to the inspection conducted on November 15-17, 1999, at West Virginia University (WVU) in Morgantown, West Virginia. The purpose of the inspection was to determine whether activities authorized by your license were conducted safely and in accordance with Nuclear Regulatory Commission (NRC) requirements. At the conclusion of the inspection, the findings, including the apparent violations, were discussed with you and members of your staff and formally transmitted to you by letter dated December 13, 1999. An open, predecisional enforcement conference was conducted at the NRC Region II office in Atlanta, Georgia on January 7, 2000, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. Enclosure 2 provides a listing of attendees at the predecisional enforcement conference. Enclosures 3 and 4 contain copies of the materials presented by WVU (redacted) and the NRC at the conference, respectively.

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 and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding them were described in detail in the subject inspection report. The violations include: (1) the failure to secure, limit access to, or maintain constant surveillance of licensed material stored in the Civil Engineering Building and four research laboratories; (2) the failure to prohibit eating and drinking in radionuclide work areas; (3) the failure to adequately survey for the quantity of radioactive material released into the sanitary sewer and for contamination in active laboratories; (4) the failure to label bags containing radioactive waste; and (5) the failure to post a radiation area. Please note that the violation regarding the security of materials has been recharacterized from that discussed at the predecisional enforcement conference to include the three examples identified by your staff on April 2, 1998, October 30, 1998, and June 14, 1999.

The violation in Part I of the Notice involves four examples of the failure to secure from unauthorized removal or limit access to licensed materials that are stored in controlled or unrestricted areas. The failure to adequately secure and limit access is a significant issue. Implementation of adequate security measures for licensed materials is required so as to prevent untrained and/or unauthorized individuals from gaining access to radioactive materials and from being unknowingly and unnecessarily exposed to radiation. On three separate occasions, the failure to secure the portable gauges was identified by your Radiation Safety Department (RSD). Although the findings of your RSD were discussed with the Principal Investigator (PI) involved, documented in the laboratory inspection records, and reported to the Radiation Safety Officer (RSO), actions taken following the identification of the violations were not effective in preventing a recurrence. It appears that the significance of the issues and of compliance was either unknown or unrecognized by your Radiation Safety Committee or senior university management. Although the failures did not result in the gauges becoming lost or otherwise unaccounted for, the lack of management attention and involvement in ensuring adherence to regulatory requirements led to an environment where regulatory non-compliances were not appropriately addressed by your staff following identification. Therefore, based on the potential safety significance of this issue, in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, the violation described in Part I of the Notice has been categorized at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because you have not been the subject of escalated enforcement action 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. At the conference, you stated that your corrective actions included: (1) issuing memoranda informing the staff of NRC inspection findings and WVU's expectations; (2) suspending laboratory privileges of certain involved PIs; (3) improving WVU's radiation safety program to include more aggressive training efforts; (4) strengthening WVU's enforcement policy for monitoring and enforcing compliance; and (5) increasing the frequency for radiation safety training inservices. As stated above, on three occasions prior to the recent NRC inspection, your RSD identified the failure to implement adequate security measures for the portable gauges, yet adequate corrective actions to restore compliance were not implemented until the NRC inspection conducted on November 15-17, 1999. Based on this, the NRC determined that although your corrective actions implemented at the time of the predecisional enforcement conference were comprehensive, your initial actions were not adequate to prevent recurrence. Therefore, credit was determined not to be warranted for the factor of Corrective Action, resulting in a base civil penalty of $2,750.

To emphasize the importance of prompt 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 in the base amount of $2,750 for the Severity Level III violation. In addition, the issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

The remaining violations, as described in Part II of the enclosed Notice, are classified separately at Severity Level IV. Regarding the issue associated with apparent inadequate assessment of contamination at the Health Science Center (HSC) North, laboratory 2074, you stated at the conference that the surveys were adequate to detect phosphorus-32 (P-32) and hydrogen-3 (H-3) contamination. Specifically, the liquid scintillation counter's (LSC) measured sensitivity for H-3 and P-32 was 29.0% and 29.1%, respectively, and thus it was unlikely that any contamination would have been underestimated. Accordingly, we are not citing the failure to properly assess contamination level with the LSC in HSC North, laboratory 2074, as an example of the failure to make adequate surveys. In addition, although not subject to escalated enforcement, we note that many of the violations in Part II of the Notice were repeat violations and not effectively corrected until NRC involvement.

During the predecisional enforcement conference, WVU indicated that some of the PIs who were involved in violations cited in the Notice had been previously advised that their actions were in violation of WVU and NRC regulations. WVU, as well as the research staff, should be aware that NRC regulations provide for enforcement action to be taken directly against persons who, through their deliberate misconduct, cause a licensee to be in violation of NRC requirements. Deliberate misconduct, as defined by 10 CFR 30.10, includes an intentional act or omission that the person knows constitutes a violation of a rule, regulation or order, or any term or condition of a license. Due to the significance NRC places on deliberate violations, enforcement action in such cases could include issuance of an order prohibiting an individual from engaging in NRC licensed activities for a term of years.

The NRC has concluded that information regarding the reason for the violations and the corrective actions taken and planned to correct the violations and prevent recurrence are already adequately addressed on the docket and in the information you presented at the predecisional enforcement conference. Therefore, you are not required to respond to the enclosed Notice with respect to the provisions of 10 CFR 2.201 unless the description therein does not accurately reflect your corrective action or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice. You are, however, required to remit the civil penalty or provide a response pursuant to 10 CFR 2.205 as described 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 any, will be placed in the Public Document Room.

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

		Sincerely,
		Original Signed by B. S. Mallett for
		Luis A. Reyes Regional Administrator

Docket Nos. 030-20199
License Nos. 47-23035-01

Enclosures:
1.  Notice of Violation and Proposed Imposition of Civil Penalty
2.  Conference Attendees (not to be published in NUREG-0940)
3.  Material Presented by WVU (not to be published in NUREG-0940)
4.  Material Presented by NRC (not to be published in NUREG-0940)
5.  NUREG/BR-0254 Payment Methods (Licensee only)

cc w/encls :
State of West Virginia

---

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

West Virginia University Morgantown, West Virginia

Docket No. 030-20199 License No. 47-23035-01 EA 99-300

During an NRC inspection conducted on November 15-17, 1999, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

I.	Violation Assessed a Civil Penalty
	10 CFR 20.1801 states that the licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 states that the licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. License Condition 15 requires that each portable nuclear gauge shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The gauge or its container must be locked when in transport, storage, or when not under the direct surveillance of an authorized user. Contrary to the above, the licensee failed to secure from unauthorized removal or access or control and maintain constant surveillance of licensed materials stored in controlled or unrestricted areas as evidenced by the following:
	1.	On April 2, 1998, October 30, 1998, June 14, 1999, and November 16, 1999, two portable gauges containing 10 millicuries (mCi) of cesium-137 (Cs-137) and 50 mCi of americium-241 (Am-241) were stored in an unlocked closet in the Civil Engineering Building, an unrestricted area. On November 16, 1999, neither the gauges, nor their containers were locked.
	2.	During the period of November 15-17, 1999, adjoining laboratories located in rooms 1815 and 1817, controlled areas, of the Mary Babb Randolph Cancer Center (MBRCC) containing 19.1 mCi of hydrogen-3 (H-3) were found unlocked and unattended.
	3.	During the period November 15-17, 1999, a laboratory located in room 4019 of the Health Sciences Center (HSC) North, a controlled area, containing 0.008 mCi of H-3, and 0.26 mCi of Sulfur-35 (S-35) was found unlocked and unattended.
	4.	During the period of November 15-17, 1999, a laboratory located in room G013 of the Agricultural Sciences Center, a controlled area, containing 3.0 mCi of H-3, and 62.3 microcuries (µCi) of iodine-125 (I-125) was found unlocked and unattended. (01013)
	This is a Severity Level III violation (Supplement IV). Civil Penalty - $2,750
II.	Violations Not Assessed a Civil Penalty
	A.	License Condition 27 states that except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, submitted in support of the license application, including the West Virginia University Radiation Safety Manual dated January 1, 1994. Item 3, Section 8.8.2, of the Radiation Safety Manual, "Laboratory Procedures," Page 8-16, in part, prohibits eating and drinking in radionuclide work areas. Contrary to the above, the licensee failed to prohibit eating and drinking in radionuclide work areas as evidenced by the following:
		1.	On November 17, 1999, a research assistant was observed drinking a beverage in Brooks 307, a laboratory that contained 1290 µCi of H-3, 360 µCi of Carbon-14 (C-14), 260 µCi of phosphorous-32 (P-32), and 153 µCi of S-35.
		2.	Prior to November 17, 1999, food had been eaten in HSC North 2077, a laboratory that contained 50 µCi of C-14, and 270 µCi of S-35, as indicated by a laboratory assistant.
		3.	On November 17, 1999, the NRC observed a cup of coffee and fruit in HSC North 3126 and 3127, a laboratory that contained 249 µCi of C-14, 6 µCi of P-32, and 561 µCi of S-35. (02014)
	This is a Severity Level IV violation (Supplement VI).
	B.	10 CFR 20.1501 states that each licensee shall make or cause to be made, surveys that (1) may be necessary for the licensee to comply with the regulations in Part 20; and (2) are reasonable under the circumstances to evaluate: (i) the magnitude and extent of radiation levels; and (ii) concentrations or quantities of radioactive material; and (iii) the potential radiological hazards. License Condition 27 states that except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, submitted in support of the license application including the West Virginia University Radiation Safety Manual dated January 1, 1994. Item 1, Section 8.8.4, of the Radiation Safety Manual, "Survey of Working Area," Page 8-19 states, in part, that at the end of each day in which radioactive materials have been used, the work areas are to be checked for contamination with a laboratory survey instrument and that all active labs are to be checked for contamination at least monthly. Contrary to the above:
		1.	As of November 15, 1999, the licensee failed to make surveys to assure compliance with 10 CFR 20.2003(a), which specifies the conditions under which licensed material may be released into a sanitary sewer system. Specifically, P-32 and phosphorus-33 (P-33) were disposed from a laboratory located in MBRCC 1813 to the sanitary sewer without any survey or other evaluation being made to determine compliance with the release limits specified in Appendix B to Part 20.
		2.	As of November 15, 1999, adequate surveys or evaluations to determine the levels of radioactive contamination present in HSC, laboratory 108 A, were not conducted. Specifically, the liquid scintillation counting system was incorrectly configured for assessing levels of contamination of radioactive materials used in the laboratory, resulting in the underestimation of contamination (i.e., P-32).
		3.	As of November 16, 1999, monthly surveys were not performed in the following active laboratories: HSC North 2077, a laboratory that contained 50 µCi of C-14, and 270 µCi of S-35; Brooks 307, a laboratory that contained 1290 µCi of H-3, 360 µCi of C-14, 260 µCi of P-32, and 153 µCi of S-35; HSC North 3126 and 3127, laboratories that contained 249 µCi of C-14, 6 µCi of P-32, and 561 µCi of S-35; and HSC North 2074, a laboratory that contained 9.85 µCi of H-3.
		4.	As of November 16, 1999, work area surveys at the end of each day that radioactive materials were used had not been performed in Brooks 307. (03014)
	This is a Severity Level IV violation (Supplement IV).
	C.	License Condition 27 states that except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, submitted in support of the license application including the West Virginia University Radiation Safety Manual dated January 1, 1994. Item 10, Section 12.8, of the Radiation Safety Manual, "Additional Requirements for All Radioactive Wastes", Page 12-7, states, in part, that bags containing radioactive waste are to be labeled with information specifying the radionuclide and the activity in microcuries or millicuries contained in the bag. Contrary to the above, on November 16, 1999, bags of radioactive waste in a laboratory located in Brooks 307 were not labeled with any information regarding the radionuclides and the activity contained in each of the bags. (04014)
	This is a Severity Level IV violation (Supplement VI).
	D.	10 CFR 20.1902 states that the licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA." 10 CFR 20.1003 defines "radiation area" as an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates. Contrary to the above, as of November 16, 1999, the licensee failed to post a radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA." Specifically, room 5609 in HSC South, a room used to store and operate an instrument calibrator containing 163 mCi of Cs-137, exceeded 0.005 rem per hour and was not posted. Radiation dose rates from the calibrator during operation were approximately 0.010 rem per minute. (05014)
		This is a Severity Level IV violation (Supplement IV).

The NRC has concluded that information regarding the reason for the violations and the corrective actions taken and planned to correct the violations and prevent recurrence are already adequately addressed on the docket in the letter forwarding this action and in the information you presented at the 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 action 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 II, within 30 days of the date of the letter transmitting this Notice of Violation and Proposed Imposition of Civil Penalty (Notice).

The Licensee may pay the civil penalty proposed above, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the 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 penalties.

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

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

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Mr. R. William Borchardt, 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 II.

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.

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

Dated at Atlanta, Georgia
this 4th day of February 2000

---

LIST OF ATTENDEES

Nuclear Regulatory Commission:

B. Mallett, Deputy Regional Administrator
C. Hosey, Deputy Director, Division of Nuclear Materials Safety (DNMS)
M. Lesser, Branch Chief, Materials Licensing/Inspection, Branch 2, DNMS
R. Gibson, Health Physicist, DNMS
J. Pelchat, Senior Health Physicist, DNMS
D. Collins, Health Physicist, DNMS
A. Boland, Enforcement Officer, Enforcement and Investigations Coordination Staff (EICS)
A. Jones, Enforcement Specialist, EICS
C. Evans, Regional Counsel
B. Smith, Regional Coordinator, Nuclear Materials Safety and Safeguards*
G. Cant, Enforcement Coordinator, Office of Enforcement*

West Virginia University:
G. Lang, Ph.D., Provost and Vice President for Academic Affairs and Research
K. Douglass, Ph.D., Radiation Safety Officer
F. Butcher, Ph.D. Senior Associate Vice President for Health Sciences
L. Halliburton, Ph.D., Chair, Department of Physics
       Chair, Radiological Safety Committee
N. Razmianfar, EdD, Senior Program Administrator, Radiation Safety

* Participated via telephone