EA-97-509 - South Dakota, University of

December 22, 1997

EA 97-509

James W. Abbott, President
University of South Dakota
School of Medicine
414 East Clark Street
Vermillion, South Dakota 57069-2390

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-15186/97-01)

Dear Mr. Abbott:

This refers to the predecisional enforcement conference conducted on December 15, 1997, in the NRC's Arlington, Texas office. The conference was conducted to discuss several apparent violations of NRC requirements identified during an NRC inspection completed November 7, 1997. An inspection report describing the apparent violations was issued on November 24, 1997.

Based on the information developed during the inspection, our consideration of information your representatives provided during the conference, as well as our consideration of your response to the inspection report provided in a December 10, 1997 letter, 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 were described in detail in the inspection report. Please note that the violations being cited differ from the apparent violations in the following respect: We are not citing the apparent violation of 10 CFR 20.1101(d), involving the need to estimate exposures to members of the public from airborne emissions. This apparent violation is not being cited based on the non-volatile type and form of radioactive materials that were used in vented hoods.

The remaining violations include failures to: 1) secure radioactive materials against unauthorized removal; 2) conduct quarterly radiation safety program reviews with the university president; 3) assure, through the appointed radiation safety officer (RSO), that activities were being conducted in accordance with all requirements; 4) hold radioactive waste for 10 half-lives prior to disposal; 5) use only radiation survey instruments calibrated at six-month intervals; 6) conduct physical inventories of radioactive sources at six-month intervals; 7) assure that all purchases of radioactive materials were approved in advance by the RSO; 8) provide annual radiation exposure reports to workers; and 9) provide radiation safety training to housekeeping and security personnel.

While none of these violations appears to have resulted in actual radiation safety consequences, they are indicative of a breakdown in the radiation safety program which, if not corrected, has the potential to cause radiation safety incidents. For example, the failure to conduct inventories of radioactive sources has in other cases resulted in sources being lost or disposed of improperly. Therefore, these violations have been categorized collectively at Severity Level III 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 civil penalty with a base value of $2,750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last two NRC inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. In your December 10, 1997, letter and at the conference, corrective actions were described which addressed not only the individual violations, but the university's efforts to assure continued compliance with NRC requirements through a renewed commitment to the radiation safety program. While the NRC finds the actions you have taken to date adequate, and therefore deserving of corrective action credit, we recommend that you revisit your commitment of resources during your quarterly meetings with the RSO to assure that it is sufficient to maintain compliance.

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, similar violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III problem constitutes escalated enforcement action which 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. In addition to describing actions to correct the individual violations, you should document those actions that you are taking to assure continued oversight of the radiation safety program and to avoid further neglect as was evidenced by our inspection findings. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

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

Sincerely,

Ellis W. Merschoff Regional Administrator

Docket No. 030-15186
License No. 40-02331-19

Enclosure: Notice of Violation

cc w/Enclosure: State of South Dakota

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NOTICE OF VIOLATION

University of South Dakota Vermillion, South Dakota

Docket No. 030-15186 License No. 40-02331-19 EA 97-509

During an NRC inspection completed November 7, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A. 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the 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 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 October 9, 1997, the licensee failed to secure from unauthorized removal, or limit access to, millicurie quantities of radioactive material located in the Lee Medicine Building, Room 61, and biochemistry department research laboratories in Rooms Nos. 58 and 139, which are controlled areas, nor did the licensee control and maintain constant surveillance of licensed material in these controlled areas. (01013)

B. License Condition 24 requires, in part, that the licensee conduct its program in accordance with statements, representations,, and procedures contained in the license application dated March 30, 1990, and letter dated June 1, 1993. Item 7, Management Control and Responsibilities, of the letter dated June 1, 1993, specifies that the RSO will meet quarterly with the president to review the audit of the procurement, use, and disposal of byproduct radioactive materials, the training programs of users, and the radiation safety program in place.

Contrary to the above, in calendar years 1994 through 1996, and up to October 9, 1997, the radiation safety officer had not met quarterly with the University of South Dakota's president to review the radiation safety program. (01023)

C. 10 CFR 33.14(b) requires that the licensee, through the RSO, ensure that radiation safety activities are being performed in accordance with Commission regulations, license conditions, and the licensee's radiation safety procedures.

Contrary to the above, as of October 9, 1997, the licensee did not ensure, through the RSO, that radiation safety activities were being performed in accordance with Commission regulations, license conditions, and the licensee's radiation safety procedures. The inspection identified several violations of NRC requirements, including a repeat violation from a previous inspection involving calibration of survey instruments. (01033)

D. License Condition 19 specifies, in part, that the licensee is authorized to hold radioactive material with a physical half-life of less than 65 days for decay-in storage before disposal in ordinary trash provided: (1) radioactive waste to be disposed of in this manner is held for decay a minimum of 10 half-lives; and (2) before disposal as ordinary trash, byproduct material is surveyed at the container surface with the appropriate meter set on its most sensitive scale and with no interposed shielding to determine that any radioactivity present cannot be distinguished from background.

Contrary to the above, as of October 9, 1997, the licensee had routinely disposed of radioactive material in ordinary trash without holding this material for decay for a minimum of 10 half-lives. (01043)

E. License Condition 24 requires, in part, that licensed material be used in accordance with statements, representations, and procedures contained in the application dated March 30, 1990, and letter dated June 1, 1993. Item B of the letter dated June 1, 1993, specifies that the licensee will have available for use survey instruments calibrated within a 6-month period.

Contrary to the above, on October 9, 1997, during a tour of the research laboratories in the Lee Medicine Building , the inspector observed three survey instruments in three different laboratories which were being used to conduct daily radiation area surveys and personnel contamination checks, and the survey instruments being used had not been calibrated within the past 6 months. (01053)

F. License Condition 16 requires that the licensee conduct a physical inventory each 6 months to account for all sources and/devices received and possessed under the license.

Contrary to the above, in calendar years 1994 through 1996 and up to October 9, 1997, the licensee had not conducted a physical inventory of two sealed sources each 6 months. Specifically, the licensee had not conducted physical inventories of a 900-microcurie cobalt-60 sealed source (Serial No. 1273), and two 16 gram plutonium-239 sealed sources (Serial Nos. 160A33 and 160A48). (01063)

G. License Condition 24 requires, in part, that licensed material be used in accordance with statements, representation, and procedures contained in the application dated March 30, 1990, and letter dated June 1, 1993. Item 10 of the application specifies that all orders for licensed material must be authorized by the RSO, and phone orders by authorized users without the RSO's authorization is prohibited.

Contrary to the above, as of October 9, 1997, phone orders for licensed material had been routinely made by authorized users prior to receiving the RSO's authorization and signature on a requisition. (01073)

H. 10 CFR 19.13 (b) requires that each licensee advise each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to 20.2106 of Part 20.

Contrary to the above, for calendar years 1994 through 1996, the licensee had not advised each worker annually of their radiation dose as shown in records maintained by the licensee pursuant to 20.2106 of Part 20. (01083)

I. License Condition 24 requires, in part, that licensed material be used in accordance with statements, representation, and procedures contained in the application dated March 30, 1990, and letter dated June 1, 1993. Item 10, "Radiation Safety," Section 10.2.5 "Other Procedures," Subsection (a) "Training and Supervision of Laboratory Personnel," of the application specifies that all housekeeping and security personnel are to be trained in radiation safety.

Contrary to the above, as of October 9, 1997, the licensee had not provided radiation safety training for housekeeping and security personnel. (01093)

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

Pursuant to the provisions of 10 CFR 2.201, the University of South Dakota 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 violations, or, if contested, the basis for disputing the violations, (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.

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 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 Arlington, Texas
this 22nd day of December 1997