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EA-03-036 - Testwell Laboratories, Inc.

May 14, 2003

EA 03-036

Reddy Kancharla, Ph.D.
Testwell Laboratories, Inc.
47 Hudson Street
Ossining, NY 10562

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $6,000
(NRC Inspection Report No. 15000031/2002001 and NRC Office of Investigations Report No. 1-2002-037)

Dear Dr. Kancharla:

The enclosed Notice of Violation (Notice) and Proposed Imposition of Civil Penalty is being issued to Testwell Laboratories, Inc. (TLI) based, in part, on a deliberate violation of NRC requirements. Specifically, your Radiation Safety Officer (RSO)/Director of Radiography performed and/or allowed radiography to be performed on at least three occasions without the supervision of a certified radiographer, even though he knew that the supervision of a certified radiographer was required. This violation was identified during an NRC inspection conducted between September 18, 2002, and November 21, 2002, and during a subsequent investigation by the NRC Region I Office of Investigation (OI). Although your company is located in an Agreement State with a license issued by the State of New York, the violation occurred while your staff was performing activities in the State of New Jersey, a non-Agreement State. Therefore, these activities were subject to NRC jurisdiction.

During the inspection, several other violations were also identified. The most significant of these violations involved the failure (non-willful) to file for reciprocity with the NRC for storage and use of licensed sources in a location outside an Agreement State. The 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 inspection report and factual summary of the OI investigation were forwarded to you on March 24, 2003, and the findings were discussed with you during a predecisional enforcement conference held with you on April 10, 2003. The discussion included the violations, their causes, and your corrective action. At the conference, you acknowledged that the violations had occurred, but you denied that any of the violations were the result of deliberate actions by your employees. A summary of the conference is enclosed.

Notwithstanding your denial, the NRC has concluded that one of the violations, involving performance of radiography on at least three occasions without the supervision of a certified radiographer, was deliberate. In reaching this conclusion, the NRC considered the facts that: (1) the individual who performed the radiography admitted to OI, during an interview on November 21, 2002, that he thought that his performing the source changes without the supervision of a certified radiographer would only be a minor violation (indicating that he understood the requirements at the time the violations occurred), and that he was cavalier about complying with the NRC regulations; and (2) the individual clearly should have known the requirements since he had, (a) previously been certified as a radiographer until his certification expired in November 1997, (b) spent more than thirty years in radiography activities, and (c) was the Director of Radiography and the RSO for your company. Given the individual's admission to the OI investigator and level of experience, the NRC concluded that the violation was deliberate.

Deliberate violations are a very serious concern because the NRC's regulatory program relies, in part, on the honesty and integrity of licensees and their employees. As such, deliberate violations cannot be tolerated. Therefore, based on the level of management involvement with violation I.A. in the enclosed Notice, it is classified at a 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 current version of the Enforcement Policy, a base civil penalty in the amount of $6,000 is considered for a Severity Level III violation or problem. Because the violation was deliberate in nature, 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 for identification is not warranted because the violation was identified by the NRC during an inspection of your facility and your staff had prior opportunities to identify the problem to the NRC. Credit for corrective actions is warranted because your corrective actions at the time of the enforcement conference, were considered comprehensive. These actions included, but were not limited to: (1) providing instructions to all radiographers and assistant radiographers regarding the proper performance of radiography; (2) requiring that the RSO have certification to perform radiography; (3) providing training to management personnel regarding radiography requirements and procedures; and (4) plans to provide more management oversight of the RSO and radiography activities in the form of audits and involvement in the scheduling of radiography.

Therefore, to emphasize the significance of deliberate violations of NRC requirements, 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 base amount of $6,000 for this Severity Level III violation. By crediting your corrective actions, the civil penalty remained at the base amount. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

Another violation is also classified at a Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. That violation (violation II.A in the Notice) involved the failure to file for reciprocity with the NRC for storage and use of licensed sources in New Jersey, a location outside New York (an Agreement State). This failure negatively impacts the NRC's ability to inspect and regulate licensed activities outside the Agreement State. Because your facility has not been the subject of escalated enforcement actions within the last two inspections and the violation was not willful in nature, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions at the time of the enforcement conference, were considered comprehensive. These actions included, but were not limited to: (1) providing training to management personnel regarding radiography requirements and procedures; and (2) providing more management oversight of the RSO and radiography activities, including annual audits by management personnel.

Therefore, to emphasize the importance of compliance with the regulations and of prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty for this Severity Level III violation.

Other violations identified during the inspection are also described in Section II of the enclosed Notice. Those other violations are classified at Severity Level IV.

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 may reference any previous correspondence that is applicable to this case to avoid repetitive submissions. 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 made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room). The NRC also includes significant enforcement actions on its Web site at www.nrc.gov; select What We Do, Enforcement, then Significant Enforcement Actions.

Questions concerning this Notice may be addressed to John Kinneman of my staff. Mr. Kinneman can be reached at telephone number (610) 337-5252.

		Sincerely,
		*/RA/ James T. Wiggins Acting For*
		Hubert J. Miller Regional Administrator

Docket No. 150-00031
License No. 2930-4164 (NY)

Enclosure:Notice of Violation and Proposed

cc w/encl:
State of New York
State of New Jersey
American Society for Nondestructive Testing Inc.

ENCLOSURE

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Testwell Laboratories, Inc.
Ossining, NY

License No. 2930-4164 (NY)
Docket No. 150-00031
EA 03-036

During an NRC inspection conducted at Testwell Laboratories, Inc. (TLI) between September 18, 2002, and November 21, 2002, and a subsequent investigation by the NRC Office of Investigations (OI), the report of which was issued on January 31, 2003, 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 (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
	10 CFR 34.41(a) requires, in part, that whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or radiographer's assistant. 10 CFR 34.43(a)(1) requires, in part, the licensee may not permit any individual to act as a radiographer until the individual is certified through a radiographer certification program. 10 CFR 34.46 requires that whenever a radiographer's assistant uses radiographic exposure devices, uses sealed sources or related source handling tools, or conducts radiation surveys required by 10 CFR 34.49(b) to determine that the sealed source has returned to the shielded position after an exposure, he shall be under the personal supervision of a radiographer. 10 CFR 34.42 requires that the RSO ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's program. Contrary to the above, on at least two occasions in 2002 and on November 11, 2001, the licensee performed radiographic operations at 6 Woodbridge Avenue, Woodbridge, New Jersey, a location other than a permanent radiographic installation, without the supervision of a certified radiographer. Specifically, the Radiation Safety Officer, who was a radiographer's assistant, but was not a certified radiographer, deliberately conducted and/or supervised the following radiographic operations without a certified radiographer being physically present:
	a.	performed source changes on two occasions in 2002; and
	b.	performed and/or supervised radiographic operations as part of a training course for radiographer's assistants on November 11, 2001.
	This is a Severity Level III violation (Supplement VI). Civil Penalty - $6,000
II.	VIOLATIONS NOT ASSESSED A CIVIL PENALTY
	A.	10 CFR 30.3 requires in relevant part, that no person shall possess or use byproduct material except as authorized by a specific or general license issued by the NRC. 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 subject to the provisions of 10 CFR 150.20(b). 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 4 copies of NRC Form-241, "Report of Proposed Activities in Non-Agreement States", with the Regional Administrator of the appropriate NRC regional office. 10 CFR 150.20(b)(4) requires, in part, that any person engaging in activities in non-Agreement States shall, not possess or use radioactive materials for more than 180 days in any calendar year. Contrary to the above,
		1.	between March 4, 2002 and September 28, 2002, Testwell Laboratories, Inc., a licensee of New York (Agreement State), used and/or stored cobalt-60 and iridium-192 at 6 Woodbridge Avenue, Woodbridge, New Jersey, a non-Agreement State, for a period exceeding 180 days, without a specific license issued by the NRC and without filing Form-241 with the Regional Administrator of the NRC Region I office.
		2.	on November 11, 2001, and May 13, 2002, Testwell Laboratories, Inc. used cobalt-60 and/or iridium-192 at 6 Woodbridge Avenue, Woodbridge, New Jersey, a non-Agreement State, without filing Form-241 with the Regional Administrator of the NRC Region I office.
		3.	on September 24, 2002, Testwell Laboratories, Inc. used cobalt-60 at a temporary job site in Hoboken, New Jersey, a non-Agreement State, without filing Form-241 with the Regional Administrator of the NRC Region I office. Although the licensee filed for reciprocity to use the source in Hoboken on September 18 and 19, 2002, the licensee did not perform the work on those dates. Instead, the licensee used the source on September 24, 2002, and did not revise the Form 241.
		This is a Severity Level III violation (Supplement VI).
	B.	10 CFR 34.43(c)(1) requires that the licensee not permit any individual to act as a radiographer's assistant until that individual has received copies of and instruction in the licensee's operating and emergency procedures. Contrary to the above, between May 3, 2001 and September 18, 2002, the licensee permitted an individual to act as a radiographer's assistant before the individual had received copies of the licensee's operating and emergency procedures. This is a Severity Level IV violation (Supplement VI).
	C.	10 CFR 34.43(c)(2) and (3) requires, in part, that the licensee not permit an individual to act as a radiographer's assistant until this individual has developed competence to use, under the personal supervision of the radiographer, the radiographic exposure devices and sealed sources that the assistant will use, and has successfully completed a practical exam on the use of such hardware. Contrary to the above, between May 3, 2001 and September 26, 2002, the licensee permitted individuals to act as radiographer's assistants, and use a cobalt-60 radiographic sealed source and exposure device, before the individuals had demonstrated competence in the use of the radiographic equipment by successful completion of a practical exam on the cobalt-60 equipment. This is a Severity Level IV violation (Supplement VI).
	D.	10 CFR 34.27(c)(1) requires, in part, that each sealed source be tested for leakage at intervals not to exceed six months. Contrary to the above, from June 29, 2001 to May 17, 2002, an interval greater than six months, the licensee did not leak test a sealed source containing 84 curies of cobalt-60. This is a Severity Level IV violation (Supplement VI).
	E.	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.
		1.	49 CFR 172.202(a) and (b) require in part, with exceptions not applicable here, that the shipping description of a hazardous material on the shipping paper include, in the following sequence: (1) the proper shipping name prescribed for the material in 172.101; (2) the hazard class prescribed for the material as shown in Column 3 of the 172.101 Table; and (3) the identification number prescribed for the material as shown in Column 4 of the 172.101 Table. Pursuant to 49 CFR 172.101, radioactive material is classified as hazardous material. Contrary to the above, on September 18, 2002, the licensee transported hazardous material (namely, a radiography device containing 84 curies of cobalt-60) from 6 Woodbridge Avenue, Woodbridge, New Jersey, to 320 Frank Sinatra Drive, Hoboken, New Jersey, and the shipping description on the shipping paper that accompanied the shipment did not include the proper shipping name. Specifically, radiographic equipment containing the cobalt-60 source was labeled as hazard class UN2974, but the shipping paper listed the equipment as hazard class UN2874.
		2.	49 CFR 172.602(c) requires, with exceptions not applicable here, that the emergency response information specified in 49 CFR 172.602(a) must be maintained by each carrier who transports hazardous material in the same manner as prescribed for shipping papers. 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 an accident or inspection. Specifically, (i) 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 driver's compartment or in a holder which is mounted to the inside of the door on the driver's side of the vehicle; and (ii) 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 driver's side of the vehicle; or (b) on the driver's seat in the vehicle. Pursuant to 49 CFR 172.101, radioactive material is classified as a hazardous material. Contrary to the above, on September 18, 2002, the licensee transported hazardous (radioactive) material, namely a radiography device containing 84 curies of cobalt-60, and the emergency response information was not readily available to, and recognizable by, authorities in the event of an accident or inspection. Specifically, the information was in a briefcase in the passenger's seat of the vehicle.
		These two examples represent a Severity Level IV violation (Supplement V).

Pursuant to the provisions of 10 CFR 2.201, Testwell Laboratories, 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 clearly marked as a "Reply to a Notice of Violation, EA 03-036" 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. 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 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.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, 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 30 days of the date of this Notice, 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, EA 03-036" 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 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: F. 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 I.

Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Reading Room). 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).

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

Dated this 14th day of May 2003