EA-97-207 - Conam Inspection, Inc.
Mr. Michael B. Creech
1245 W. Norwood
Itasca, IL 60143
SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $16,000 (NRC Inspection Report No. 030-31373 (DNMS) and Investigation Report No. 3-96-014)
Dear Mr. Creech:
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 inspection report issued on November 18, 1996. As a result of the conference, a Demand For 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 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. In particular, the violations involve: (1) a failure to secure the sealed source assembly in the shielded position (Violation I.A); (2) a failure to perform an adequate survey after each radiographic exposure (Violation I.B); (3) a failure to limit the annual 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.B).
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 certain Conam Operating and Emergency Procedures, the radiographer failed to rotate the selector ring to secure the sealed source assembly in the shielded position because he depended solely on the automatic locking mechanism to secure the source. Further, the same individual failed to conduct a proper survey of the camera following each exposure to assure that the source was in a shielded position. As a result of these failures, the radiographer received a whole body exposure in excess of NRC requirements.
Based on a dose assessment performed by the NRC, 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 assigning occupational doses to workers. However, given that the film badge was not placed 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. In this regard, we note that: (1) NRC 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 exposure of 9.369 rems based on your consultant's assessment is in the range of the NRC dose assessment.
Locking of the sealed source in the shielded position following a radiographic 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 (OI) 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 appropriately manage their programs to ensure that personnel fully understand the 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, the relationship of these violations to a single incident, and the fact that two safety barriers were breached, the violations are of very significant regulatory concern. Therefore, the 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 II problem.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $8000 is considered for a Severity Level II problem. 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. 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 I.B 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 consultation 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 without proper 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 Conam'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.
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 enclosure, and your response will be placed in the NRC Public Document Room.
Sincerely, Original Signed by J. Caldwell for A. Bill Beach Regional Administrator
Docket No. 030-31373
License No. 12-16559-01
Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty
PROPOSED IMPOSITION OF CIVIL PENALTY
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 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 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. 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 (OEPM) 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 procedures for the Amersham Model 660B exposure device. Steps 12 through 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 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 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.
C. 10 CFR 20.1201(a)(1)(i) requires, with exceptions not applicable here, that the licensee control the occupational dose to individual adults to an annual dose limit of 5 rems total effective dose equivalent.
Contrary to the above, the licensee did not limit the annual occupational dose to an adult 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.
These violations represent a Severity Level II problem (Supplement IV
Civil Penalty - $16,000
II. Violations Not Accessed a Civil Penalty
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.
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.
The licensee's application dated March 29, 1993, included the Operating and Emergency Procedure Manual (OEPM). Item 5.1 of the OEPM, entitled, "Personnel Monitoring Equipment", requires, in 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).
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, 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 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 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 III.
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 Lisle, Illinois
this 9th day of June 1997