EA-02-255 - American Radiolabeled Chemicals

April 17, 2003

EA-02-255

Surendra Gupta, Ph.D., President
American Radiolabeled Chemicals
101 ARC Drive
St. Louis, MO 63146

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $12,000 (NRC INSPECTION REPORT NOS. 030-20567/2002001(DNMS); 030-20567/2002003(DNMS) AND OFFICE OF INVESTIGATIONS REPORT NOS. 3-2002-009; AND 3-2002-016

Dear Dr. Gupta:

This refers to the inspections conducted on March 19 and 20, 2002, and April 17 through 19, 2002, at the American Radiolabeled Chemicals (ARC) facility, St. Louis, Missouri, with continuing in-office review through May 23, 2002. This also refers to the investigation, Report No. 3-2002-009, completed by the Office of Investigations on October 31, 2002. The purpose of the inspections was to determine whether activities authorized by the license were conducted safely an in accordance with NRC requirements. The inspection reports were transmitted to you on June 26, 2002, and documented five violations of NRC requirements and four unresolved issues. The purpose of the investigation was to review potentially deliberate actions by members of your staff involving the conduct of removable contamination surveys and the documentation of fume hood flow measurements. Based on the results of the investigation, three apparent deliberate violations were identified.

On March 6, 2003, a closed (transcribed) predecisional enforcement conference was conducted in the Region III office with you and members of your staff to discuss the apparent violations, their significance, their root causes, and your corrective actions.

Based on the information developed during the inspections and investigation, and the information that you provided during the conference, and in your March 6 and 18, 2003 letters, the NRC has determined that three deliberate 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 reports.

The violations in Section I of the Notice involve the deliberate failure to: (1) make surveys to comply with 10 CFR 20.1301, which limits the dose to members of the public; (2) perform required weekly removable contamination surveys in the restricted and unrestricted areas of Building 200; and (3) accurately record the results of required weekly fume hood face velocity measurements.

The violations discussed above would normally be characterized as Severity Level IV violations due to their low safety significance, since there is no indication that radioactive materials migrated offsite or that individuals received an internal dose due to the potentially malfunctioning fume hoods. However, because the violations were deliberate and had potential safety consequences, the NRC considers these violations a significant regulatory concern. It is essential that the NRC be able to maintain the highest trust and confidence that licensees and their employees will act with integrity and abide by requirements to protect the health and safety of workers and members of the public. Therefore, based on deliberateness, the NRC has categorized these violations collectively in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $6,000 is considered for a Severity Level III problem. Because the violations are considered willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit is not warranted for Identification since the violations were NRC identified. Credit is warranted for Corrective Action that included: (1) removing the involved individual from radiation safety duties; (2) increasing radiation protection oversight by hiring an onsite radiation safety officer; (3) discussing with employees and management their responsibilities in implementing the radiation safety program; (4) assigning lab managers to Buildings 100 and 300 to work with the radiation safety officer to ensure that the radiation safety program is being properly implemented; and (5) revising procedures and forms to include documenting building 200 weekly wipe results and the "as found" velocity flow measurements of fume hoods.

While the NRC recognizes that application of the civil penalty assessment process in the Enforcement Policy would result in a base civil penalty, we are exercising discretion in accordance with Section VII.A.1(c) of the Enforcement Policy to increase the penalty due to your particularly poor performance surrounding the violations. This poor performance involves the inadequate oversight by management and the radiation safety officer (RSO) of the radiation protection program to ensure radiological safety and compliance with NRC regulations. The lack of oversight is a function of the RSO rarely being onsite due to the remoteness of his residency and the fact that there is little or no compensating oversight of the radiation protection program by onsite management. This lack of effective oversight contributed to the actions of your staff that resulted in the four violations cited in the enclosed Notice and the five violations cited in the Notice transmitted to you in our June 26, 2002, letter. Of particular concern, the lack of oversight of the radiation protection technician's activities and the lack of in-depth reviews of the technician's reports to look for trends, patterns, or other deficiencies, appears to be one of the root causes for the deliberate violations cited in the enclosed Notice. The lack of oversight also resulted in the violations continuing for almost seven months until identified by the NRC.

Therefore, to emphasize the significance of willful violations, the importance of compliance with regulatory requirements, and the need for continuing and appropriate oversight of the radiation protection program, 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 $12,000, which is twice the base amount. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

The violation in Section II of the Notice involves the failure of the radiation safety officer to conduct the Radiation Protection Program in a manner to maintain compliance with established standards and procedures. In accordance with the Enforcement Policy, this violation is categorized at Severity Level IV.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in your letters, dated March 6 and 18, 2003. Therefore, you are not required to respond to the provisions of 10 CFR 2.201 unless the description in your letters 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.

The NRC Office of Investigations completed a second investigation, Report No. 3-2002-016, on December 22, 2002. The purpose of this investigation was to review whether a health physics technician was discriminated against for raising safety concerns to the NRC. Based upon the results of the investigation, the NRC did not substantiate that the health physics technician was discriminated against. A copy of the investigation report synopsis is enclosed.

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 made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. The NRC also includes Issued Significant Enforcement Actions on its Web site.

		Sincerely,
		/RA/James L. Caldwell for
		J. E. Dyer Regional Administrator

Docket No. 030-20567
License No. 24-21362-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

American Radiolabled Chemicals St. Louis, Missouri

Docket No. 030-20567 License No. 24-21362-01 EA-02-255

During NRC inspections conducted on March 19 and 20, 2002, and April 17 through 19, 2002, with continuing in-office review through May 23, 2002, and the investigation completed on October 31, 2002, four 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 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 present. Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. Contrary to the above, as of March 19, 2002, the licensee did not make surveys to comply with 10 CFR 20.1101(b), which requires that doses to members of the public are as low as is reasonably achievable. Specifically, the licensee's routine surveys for removable contamination in unrestricted areas were performed after the areas had been cleaned, and therefore were not reasonable under the circumstances to evaluate the extent of the radiological hazards that could be present due to contamination, potentially resulting in unnecessary exposure to workers and members of the public.
	B.	Condition 20.A of License No. 24-21362-01 requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the October 1, 1992 application, and other referenced documents. Licensee Standard Operating Procedure (SOP) -16, "Radioactive Contamination Control Program," referenced in the application, requires, in part, that removable contamination surveys in restricted and unrestricted areas be performed weekly. Contrary to the above, from December 4, 2001, to March 22, 2002, the licensee did not perform removable contamination surveys in the restricted and unrestricted areas of Building 200.
	C.	10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee or required by regulations, orders or license conditions to be maintained, be complete and accurate in all material respects. Condition 20.A of License No. 24-21362-01 requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the October 1, 1992 application, and other referenced documents. Licensee Standard Operating Procedure (SOP) -09, "Hood Face Velocity Maintenance Program," referenced in the application, requires, in part, that the licensee measure the linear feet per minute velocity at the center of the hood face opening and record the values. The action level is 100 feet/minute. Contrary to the above, the licensee did not provide information to the Commission that was complete and accurate in all material respects. Specifically, during the March 19 and 20, 2002, inspection, the licensee provided records of weekly hood face velocity measurements, required to be measured and recorded by licensee SOP-9, that did not accurately reflect the face velocity measurements for hoods designated by the licensee as "100DR," the hood located in the Building 100 darkroom; "200LW4," a solvent evaporation hood in Building 200; and "300C3," a production hood in building 300. On numerous occasions between August 6, 2001, and March 12, 2002, the licensee measured hood face velocities as much as 50 percent less than the licensee's action level of 100 linear feet per minute, and the licensee recorded the velocities as "100" linear feet per minute. The information was material because the licensee was required by license condition to record it and the NRC uses the records to determine whether the fume hoods were operated within acceptable limits.
	This is a Severity Level III problem (Supplements IV and VI). Civil Penalty - $12,000
II.	Violation Not Assessed a Civil Penalty
	D.	Condition 20.A of License No. 24-21362-01 requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the October 1, 1992 application, and other referenced documents. Section 3.3.3 of the licensee's Radiation Protection Program, referenced in the application, requires, in part, that the radiation safety officer conduct the Radiation Protection Program to assure compliance with established standards and procedures. Contrary to the above, as of April 19, 2002, the licensee's radiation safety officer did not conduct the Radiation Protection Program in a manner to maintain compliance with established standards and procedures. Specifically, the radiation safety officer did not implement or require to be implemented licensee SOP-16, "Radioactive Contamination Control Program," which requires weekly removable contamination surveys in restricted and unrestricted areas.
	This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in letters from the licensee, dated March 6 and March 18, 2003. However, American Radiolabeled Chemicals is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description in your letters 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; EA-02-255" and send it to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of the letter transmitting this Notice of Violation (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, 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 penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.C.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 234(c) 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: Frank Congel, 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, 801 Warrenville Road, Suite 255, Lisle, IL 60532-4351.

Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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.

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

Dated this 17^th day of April 2003.