EA-96-256 - GCME, Inc.

October 4, 1996

EA 96-256 and EA 96-377

Wayne Weinfurter
President
GCME, Inc.
3471 Packerland Drive
DePere, WI 54115

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $5,000 AND DEMAND FOR INFORMATION (NRC Inspection Report No. 030-31195/96001(DNMS))

Dear Mr. Weinfurter:

This refers to the routine safety inspection conducted at GCME, Inc., from June 27 to July 22, 1996, during which several violations of NRC requirements were identified. A copy of the inspection report was sent to GCME, Inc., on August 12, 1996, and a predecisional enforcement conference was held in the NRC Region III office, Lisle, Illinois, on August 29, 1996.

Based on the information developed during the inspection and the information provided at the conference by you and the GCME Radiation Protection Officer (RPO), the NRC has determined that significant violations of NRC requirements have occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding the violations are described in detail in the inspection report. Additional examples of the failure to monitor the user of a nuclear gauge with a film badge and the failure to secure or maintain surveillance of NRC-licensed material in an unrestricted area were identified during the predecisional enforcement conference. Specifically, the RPO stated that he permitted a new employee to operate a nuclear gauge without the employee having a film badge during training sessions while under the RPO's direct supervision in June 1996. During other discussions with the RPO at the conference, he stated that he routinely left a nuclear gauge unsecured or unattended while working at construction sites. These issues are included in the enclosed Notice as additional examples of the violations previously described in the inspection report.

The NRC is particularly concerned about your repetitive failure to ensure that your employees are wearing film badges while using NRC-licensed material. Specifically, during an inspection of GCME, Inc., on October 10, 1989, the NRC identified that an employee had not worn a film badge while using NRC-licensed material on August 15, 1989. This violation of NRC requirements was cited at Severity Level IV on November 6, 1989. GCME, Inc., responded to that violation in a letter dated November 6, 1989, and stated that ". . . film badges have been received and are worn every time (sic) machine is used . . . ." The next NRC inspection was conducted on January 10, 1995, with a subsequent investigation by the NRC Office of Investigations (OI). That investigation and inspection found that GCME, Inc., had not provided film badges to any of the authorized users of NRC-licensed materials from October 1990 through the summer of 1991 and from the end of 1992 to July 3, 1993. The 1990 to 1993 violations were considered to represent careless disregard of NRC requirements and were categorized at Severity Level III. By letter, dated October 5, 1995, GCME, Inc., described its corrective action to ensure that film badges were distributed to employees. Since the current inspection and conference found more examples of the same violation, it is apparent that GCME, Inc., has not taken effective corrective action to prevent the recurrence of this violation. Furthermore, the failure by employees of GCME, Inc., to properly secure or maintain surveillance of NRC-licensed material in an unrestricted area is also of concern because inadequate controls could lead to the inadvertent release of radioactive material to the public domain.

In the aggregate, the violations are of significant regulatory concern because they are indicative of a breakdown in the control of NRC-licensed activities that collectively represent a potentially significant lack of attention or carelessness toward licensed responsibilities. Incumbent upon each company licensed by the NRC to use byproduct material in a commercial enterprise is the responsibility to protect public health and safety, including its employees, by ensuring that the rules, regulations and license conditions are followed at all times. That has not been the case at GCME, Inc. Therefore, the violations are collectively categorized 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 $2,500 is considered for a Severity Level III problem. Because your facility has been the subject of an escalated enforcement action within the last two inspections,<1> 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. Credit was not given for the Identification factor because the NRC identified the violations. Credit was not warranted for the Corrective Action factor because GCME, Inc., had not determined the root cause of the problem or developed corrective actions prior to the August 29, 1996 conference even though GCME, Inc., was informed of the potential violations during the inspection exit meeting on June 27, 1996, and during several follow-up telephone conversations from July 3 to July 24, 1996. Additionally, a copy of NRC Information Notice 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," was provided to GCME, Inc., on August 12, 1996. Furthermore, it was not until the August 29, 1996 predecisional enforcement conference that GCME, Inc., with NRC prompting, proposed corrective actions.

Therefore, to emphasize the need to immediately identify violations, to assure that the root cause of each violation is fully identified and understood, to ensure that corrective actions are prompt and comprehensive to avoid repetition of a violation, and in recognition of the previous escalated enforcement action involving GCME, Inc., I am issuing the enclosed Notice in the amount of $5,000 for the Severity Level III problem. You should be aware that the issuance of this Notice constitutes an escalated enforcement action that may subject GCME, Inc., to increased inspection effort.

Since this problem demonstrates a lack of regard for, and adherence to, procedures and a lack of management control and supervision over licensed activities, it raises a question as to whether GCME, Inc., will in the future be able to effectively manage the NRC-licensed radiation safety program. Therefore, a Demand for Information is also enclosed. The Demand for Information seeks further information to determine: (1) whether the NRC can have reasonable assurance that in the future GCME, Inc., will conduct its activities in accordance with the Commission's requirements; and (2) whether your license should be modified, suspended or revoked, or other enforcement action taken to ensure compliance with NRC regulatory requirements. Failure to comply with the provisions of this Demand for Information may result in additional enforcement action.

Questions concerning the Demand for Information should be addressed to Mr. James Lieberman, Director, Office of Enforcement, who can be reached at telephone number (301) 415-2741.

You are required to respond to this letter and should follow the instructions specified in the enclosures when preparing your responses.

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

Sincerely,

James Lieberman, Director Office of Enforcement

Docket No. 030-31195
License No. 48-23409-01

Enclosures:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. Demand for Information

---

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

GCME, Inc. DePere, Wisconsin

Docket No. 030-31195 License No. 48-23409-01 EA 96-256

During an NRC inspection conducted from June 27 to July 22, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions,"

NUREG-1600 (60 FR 34381; June 30, 1995), the Nuclear Regulatory Commission 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:

A. Condition 18 of NRC Materials License No. 48-23409-01, requires that licensed material be possessed and used in accordance with the statements, representations and procedures contained in an application dated August 7, 1995, and the enclosure to the application.

Item 10.1 of the enclosure to the application, "Radiation Safety Program: Personnel Monitoring Program," requires, in part, that all gauge users be monitored with a film badge.

Contrary to the above, on June 27, 1996, a gauge user was not monitored with a film badge while using a moisture/density gauge containing NRC-licensed material (nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 50 millicuries (1.9 GBq) of americium-241). (01013)

(This is a repeat violation.)

B. 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in unrestricted areas. 10 CFR 20.1802 requires 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, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, the licensee did not secure from unauthorized removal or limit access to moisture/density gauges containing NRC-licensed material (nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 40-50 millicuries (1.9 GBq) of americium-241) located in unrestricted areas and that were not in storage, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically,

1. On June 27, 1996, a gauge technician returned to the licensee's facility, parked the truck in the licensee's front parking lot, an unrestricted area, and entered the licensee's office. A gauge containing NRC-licensed material was in the rear of the truck, the gauge was not secured within the truck, the rear hatch of the pickup truck was missing, and the technician did not maintain constant surveillance of the gauge containing licensed material.

2. As of the August 29, 1996 predecisional enforcement conference, the licensee's Radiation Protection Officer stated that he routinely left gauges unattended or uncontrolled at various temporary job sites. As a regular practice, he would walk away from a gauge that was not secured, often with his back to the device, in order to perform other tasks; therefore, the gauge containing NRC-licensed material was not controlled or under constant surveillance. (01023)

C. Condition 11.A. of NRC Materials License No. 48-23409-01 requires, in part, that licensed material shall be used by, or under the supervision and in the physical presence of, individuals who have successfully completed the device manufacturer's training program for gauge users, and have been designated by the licensee's Radiation Protection Officer.

Contrary to the above, on June 27, 1996, a Campbell Pacific Nuclear moisture/density gauge containing NRC-licensed material (nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 50 millicuries (1.9 GBq) of americium-241) was used by an individual who had not successfully completed the device manufacturer's training program for gauge users and who had not been under the supervision and in the physical presence of an individual who had successfully completed the device manufacturer's training program. Furthermore, the individual had not been designated by the licensee's Radiation Protection Officer to use licensed material. (01033)

D. 10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the confines of its plant or other place of use, 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 177.842 requires, in part, that packages of radioactive materials be so blocked and braced that they cannot change position during conditions normally incident to transportation.

Contrary to the above, on June 27, 1996, the licensee transported a package containing nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 50 millicuries (1.9 GBq) of americium-241 outside the confines of its plant, and the package was not blocked and braced such that it could not change position during conditions normally incident to transportation. Specifically, a gauge user did not use the equipment provided by the licensee to block and brace the moisture/density gauge during transport. (01043)

2. 49 CFR 173.475(a) requires, in part, that before each shipment of any radioactive materials package, the shipper shall ensure by examination or appropriate tests, that the packaging is proper for the contents to be shipped.

Contrary to the above, on June 27, 1996, the licensee offered for transportation nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 40 millicuries (1.5 GBq) of americium-241 (special form) and the licensee did not ensure by examination or appropriate tests, that the packaging was proper for the contents to be shipped. Specifically, a gauge user did not transport the moisture/density gauge in a Type A transport container in that the gauge was not transported in its transport container. (01053)

This is a Severity Level III problem (Supplements IV, V, and VI).
Civil Penalty - $5,000

Pursuant to the provisions of 10 CFR 2.201, GCME Inc. (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 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 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.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: Mr. 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, 801 Warrenville Road, Lisle, IL 60532-4351.

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 Rockville, Maryland
this 4th day of October 1996

---

UNITED STATES
NUCLEAR REGULATORY COMMISSION

In the Matter of GCME, Inc. DePere, Wisconsin

) ) ) ) )

Docket No. 030-31195 License No. 48-23409-01 EA 96-377

DEMAND FOR INFORMATION

I

GCME, Inc. (Licensee) holds Byproduct Materials License No. 48-23409-01, issued by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 30. The license was initially issued on July 27, 1989, was renewed in its entirety on November 2, 1995, and will expire on November 30, 2000. The license authorizes the Licensee to use sealed sources of cesium-137 and americium-241 in moisture/density gauges of several manufacturers at 3741 Packerland Drive, DePere, Wisconsin, and at temporary job sites anywhere in the United States that the U. S. Nuclear Regulatory Commission maintains jurisdiction for regulating the use of licensed material.

II

A routine safety inspection was conducted at the Licensee's facility on June 27, 1996, during which significant violations of NRC requirements were identified. The inspection continued through July 22, 1996. On August 29, 1996, a predecisional enforcement conference was held with the Licensee. The Licensee was represented at the conference by the president of GCME, Inc., and its Radiation Protection Officer (RPO). The inspection and information provided by the Licensee's representatives at the conference established the violations cited in the Notice of Violation and Proposed Imposition of Civil Penalty issued on October 4th, 1996. Specifically:

A. On June 27, 1996, the Licensee permitted an individual to use a moisture/density gauge containing NRC-licensed material (nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 40-50 millicuries (1.9 GBq) of americium-241) and the individual was not provided with a film badge as required by License Condition No. 18.

B. On June 27, 1996, and on several other occasions the Licensee failed to secure NRC-licensed materials from unauthorized removal or access when licensed materials (nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 40-50 millicuries (1.9 GBq) of americium-241) were in unrestricted areas<1> as required by 10 CFR 20.1801 and 20.1802.

C. On June 27, 1996, a Campbell Pacific Nuclear moisture/density gauge containing NRC-licensed material (nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 50 millicuries (1.9 GBq) of americium-241) was used by an individual who had not successfully completed the device manufacturer's training program for gauge users and had not been authorized by the RPO to use a gauge as required by License Condition 11.A.

D. On June 27, 1996, the Licensee transported a package containing nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 50 millicuries (1.9 GBq) of americium-241 and the package was not blocked and braced such that it could not change position during conditions normally incident to transportation as required by 10 CFR 71.5(a) and 49 CFR 177.842.

E. On June 27, 1996, the Licensee offered for transportation nominally 10 millicuries (0.37 GBq) of cesium-137 and nominally 40 millicuries (1.5 GBq) of americium-241 (special form) which was not blocked or braced as required by 10 CFR 71.5(a) and 49 CFR 177.842, and was not properly packaged as required by 10 CFR 71.5(a) and 49 CFR 173.475(a).

The violation for the Licensee's failure to provide a film badge to a technician using a moisture/density gauge was also cited during NRC inspections of GCME in 1989 and in 1995. The initial inspection of GCME, Inc., on October 10, 1989, found that an employee had not worn a film badge while using NRC-licensed material on August 15, 1989. This violation was cited at Severity Level IV on November 6, 1989. The second inspection of GCME, Inc., was conducted on January 10, 1995, with a subsequent investigation by the NRC Office of Investigations (OI). That investigation and inspection found that GCME, Inc., had not provided film badges to any of the authorized users of NRC-licensed materials from October 1990 through the summer of 1991 and from the end of 1992 to July 3, 1993. The violations from 1990 to 1993 were considered to be the result of careless disregard of NRC requirements and were categorized at Severity Level III. The fact that each of the three NRC inspections of the Licensee found that GCME, Inc., was in violation of the same requirement shows that the Licensee has been unable to achieve effective, comprehensive corrective action and is indicative of ineffective or insufficient management oversight of the radiation safety program at GCME, Inc.

Furthermore, as of the August 29, 1996 predecisional enforcement conference, the Licensee had not conducted a root cause analysis or proposed corrective actions for the current violations. Additionally, information provided at the conference by the Licensee representatives indicated that the Licensee placed a premium on production over compliance with NRC requirements. Also at the conference, it appeared that Licensee managers, in particular the RPO, were unfamiliar with the specific requirements of the NRC license and the rules and regulations of the Commission.

These circumstances demonstrate a lack of regard for, and adherence to, procedures and a lack of management control and supervision over licensed activities, and raise a question as to whether the Licensee will in the future be able to effectively manage the NRC-licensed radiation safety program. Therefore, further information is needed to determine whether the Commission can have reasonable assurance that in the future the Licensee will conduct its activities in accordance with the Commission's requirements.

III

Accordingly, pursuant to sections 161c, 161o, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.204 and 10 CFR 30.32(b), in order for the Commission to determine whether License No. 48-23409-01 should be modified, suspended or revoked, or other enforcement action taken to ensure compliance with NRC regulatory requirements, the Licensee is required to submit to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 30 days of the date of this Demand for Information, the following information, in writing and under oath or affirmation:

A. Provide written assurance that all nuclear gauge users, including the Radiation Protection Officer, have been, and will be in the future, trained on and fully understand the conditions of the NRC license and the rules and regulations of the Commission applicable to the NRC-licensed program at GCME, Inc. Describe your basis for reaching this conclusion.

B. Describe the steps taken to ensure that sufficient management resources are available to properly oversee the NRC-licensed program.

C. Fully describe the audit program required by the "Duties and Responsibilities of the Radiation Safety Officer" that are enclosures to the August 7, 1995 application and are incorporated into License Condition No. 18.A. The description should include the written policies, procedures, and schedules used to implement the audit program, including the type and frequency of the audits, the qualifications of the person or persons performing the audits, and whether the audits will be performed by GCME, Inc. employees or by an external source. Written audit reports shall be retained by GCME, Inc., as required by the same license condition.

D. Describe how GCME, Inc., will ensure that radiation safety considerations are given top priority despite business scheduling and other operational pressures.

E. Describe why you have confidence that your corrective actions will be long lasting.

F. In light of the inspection history, explain why the NRC: (1) should conclude that you are able to, or willing to, comply with the Commission's requirements; and (2) should not suspend and revoke GCME, Inc.'s License No. 48-23409-01 to possess and use licensed material.

Copies also shall be sent to the Assistant General Counsel for Hearings and Enforcement at the same address, and to the Regional Administrator, NRC Region III, 801 Warrenville Road, Lisle, IL 60532-4351.

After reviewing your response, the NRC will determine whether further action is necessary to ensure compliance with regulatory requirements.

FOR THE NUCLEAR REGULATORY COMMISSION James Lieberman, Director Office of Enforcement

Dated at Rockville, Maryland
this 4th day of October 1996