EA-97-040 - Cerac, Inc.
Mr. Daniel Verzal
P.O. Box 1178
Milwaukee, WI 53201
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 040-0885/96001(DNMS))
Dear Mr. Verzal:
This refers to the inspection conducted on December 18 and 20, 1996,
at CERAC, Inc., in Milwaukee, Wisconsin. The purpose of the inspection
was to determine that the activities authorized under this license were
conducted safely and in accordance with NRC requirements. Our inspection
findings were discussed with Dr. M. Colton by telephone on January 23,
1997, and the inspection report was sent to you by letter dated February
11, 1997. A predecisional enforcement conference was held on February
26, 1997, in the NRC Region III office with you, Dr. Colton, and other
members of your staff to discuss the violations, their causes, and proposed
Based on the information developed during the inspection and the information
that you provided during the conference, 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 are
described in detail in the subject inspection report.
Collectively, the violations demonstrate a lack of attention toward licensed
activities. The fundamental theme of the violations is failure to conduct
adequate and timely evaluations to ensure that effluents released into
the environment as a result of CERAC's production process are controlled
in accordance with the license and regulatory requirements. The fact that
these violations were identified by NRC further confirms the apparent
deficiencies in the control of the program. The deficiencies include the
staff's overall lack of knowledge about license requirements, failure
to take action on issues requiring correction, and inadequate management
oversight of the program.
The number and nature of the violations identified in the Notice is of
regulatory and safety concern. Incumbent upon each NRC licensee is the
responsibility to protect the health and safety of its workers and the
public by ensuring that all requirements of the NRC license are met and
any potential violations of NRC requirements are identified and corrected
expeditiously. In this case, adequate attention was not provided to that
portion of your radiation safety program which required assessment and
evaluation to ensure the safety of all persons who may be directly or
indirectly affected by effluents released by your facility. Therefore,
these 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 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 not been the subject of escalated enforcement actions
within the last two years, or last two inspections, the NRC considered
whether credit was warranted for
with the civil penalty assessment process in Section VI.B.2 of the Enforcement
Policy. Corrective actions discussed during the February 26, 1997, predecisional
enforcement conference included, but were not limited to: (1) creation
of a management team to audit all program areas of CERAC; (2) comprehensive
review of the license and all license documents by management staff and
the radiation safety officer; (3) implementation of a master calendar
to ensure that tests and procedures will be conducted at the required
intervals; (4) organizational change to incorporate the radiation safety
program into the plant Safety Department to ensure systematic oversight;
and (5) significantly increased management oversight. Credit was warranted
for your comprehensive corrective actions. Therefore, to encourage prompt
identification 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, significant violations
in the future could result in a civil penalty. In addition, issuance of
this Severity Level III problem constitutes escalated enforcement action
that may subject you to increased inspection effort.
In addition to the violations, two concerns detailed in the inspection
report were discussed during the predecisional enforcement conference.
The concern regarding the increased concentration of radioactive effluent
releases from the Dry Torit stack following filter changes has been resolved
and does not require further NRC review. However, the concern regarding
the licensee's audits of internal dose assessment and use of respiratory
protection factors requires further review. Please include in your response
to the violations, the actions you have taken or plan to take to perform
dose assessments in accordance with license conditions and NRC regulations.
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, A. Bill Beach Regional Administrator
Docket No. 040-08805
License No. SMB-1402
Enclosure: Notice of Violation
CERAC, Inc. Docket No. 040-08805 Milwaukee, WI License No. SMB-1402 EA 97-040
During an NRC inspection conducted on December 18 and 20, 1996, with continuing NRC review through January 23, 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:
1. 10 CFR 20.2003(a)(1) states, in part, that a licensee may discharge licensed material into sanitary sewerage if the material is readily soluble (or is readily dispersible biological material) in water.
Contrary to the above, between October 1994 and December 1996, the licensee discharged into the sanitary sewerage licensed material that was not readily soluble (or readily dispersible biological material) in water. (01013)
2. 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.a. Contrary to the above, from October 1994 through December 18, 1996, the licensee did not make surveys to assure compliance with 10 CFR 20.2003(a), which limits the disposal of licensed material by release into a sanitary sewerage system. Specifically, the licensee failed to determine if licensed material discharged into the sanitary sewerage was readily soluble (or readily dispersible biological material) in water. (01023)
b. Contrary to the above, from October 1994 through December 18, 1996, the licensee did not make surveys to assure compliance with 10 CFR 20.1201(a), which limits radiation doses to occupational workers. Specifically, the licensee failed to evaluate doses received by occupational workers who had access to the licensee's roof where radioactive material effluents are released. (01033)
3. 10 CFR 20.1202(a) requires, in part, that if the licensee is required to monitor under both 10 CFR 20.1502(a) and (b), the licensee shall demonstrate compliance with the 10 CFR 20.1502 dose limits by summing external and internal doses of occupational workers.
Contrary to the above, as of December 18, 1996, the licensee was required to monitor under both 10 CFR 20.1502(a) and (b) but had not summed the external and internal doses for occupational workers. (01043)
4. 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 that the licensee control and maintain constant surveillance of licensed material that is in an 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, on December 18, 1996, the licensee did not secure from unauthorized removal or limit access to the Radioactive Material Room (a thorium-232 airborne radioactivity area) or a storage room containing thorium-232 nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, an exterior door to the licensee's facility was found to be unlocked and unsecured during the onsite inspection. (01053)
5. Condition 15 of License No. SMB-1402 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in a letter dated April 28, 1995.
Item 6 of the letter dated April 28, 1995, states, in part, that for individuals whom the licensee anticipates may be exposed to greater than 10% of the ALI or, equivalently, 200 DAC-hours, the licensee will perform baseline and quarterly urinalysis.
Contrary to the above, as of December 18, 1996, the licensee did not perform baseline or quarterly urinalysis on all individuals who the licensee anticipated may be exposed to greater than 10% of the ALI or, equivalently, 200 DAC-hours. (01063)
6. Condition 15 of License No. SMB-1402 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in a letter dated March 15, 1994.
Item 5 of the letter dated March 15, 1994 states, in part, that the scintillation alpha counter will be calibrated and a CHI-squared calculation will be performed on a semi-annual basis.
Contrary to the above, between March 1995 and December 1996, calibrations on the scintillation alpha counter and the CHI-square calculations were not performed at the required intervals. Specifically, the counter was calibrated twice during the above period while the CHI-squared calculation was not performed at all. (01073)
These violations represent a Severity Level III problem (Supplements
IV and VI).
Pursuant to the provisions of 10 CFR 2.201, CERAC, Inc., 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 III, 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 violation, or,
if contested, the basis for disputing the violation, (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
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 Lisle, Illinois, this 4th day of April 1997