ML20176A221

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EA-20-082 Letter from P. Habighorst, Notice of Violation - QSA Global, Inc. Failure to Notify the U.S. Nuclear Regulatory Commission in Advance of Import Shipments
ML20176A221
Person / Time
Issue date: 07/06/2020
From: Peter Habighorst
NRC/OIP/ECNP
To: Fuller M
QSA Global
Jane Chimood, 301-287-9225
Shared Package
ML20169A747 List:
References
EA-20-082
Download: ML20176A221 (4)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 6, 2020 EA-20-082 Mr. Mike Fuller Manager, Regulatory Affairs/Quality Assurance QSA Global, Inc.

40 North Avenue Burlington, MA 01803

SUBJECT:

NOTICE OF VIOLATION - QSA GLOBAL, INC. RELATED TO FAILURE TO PROPERLY NOTIFY THE U.S. NUCLEAR REGULATORY COMMISSION IN ADVANCE OF IMPORT SHIPMENT

Dear Mr. Fuller:

This letter refers to the U.S. Nuclear Regulatory Commission (NRC) review of information concerning the import of Category 1 quantity of Iradium-192 (Ir-192) by QSA Global, Inc. (QSA),

from Russia on May 19, 2020. The results of this review were discussed with you on June 18, 2020, by a member of my staff, Jane Chimood.

Based on the results of this review, the NRC has determined that a Severity Level IV violation of NRC requirements occurred. The violation is being cited in the enclosed Notice of Violation (Notice) because the violation concerned QSAs failure to file a submittal containing the notification with the NRC at least 7 days prior to the shipment of radioactive material listed in Appendix P to 10 CFR Part 110, as required by 10 CFR 110.50(c)(4). Specifically, on May 19, 2020, the NRC received an advanced notification of shipment, submitted by QSA, for an import shipment destined for QSA, MA, containing a Category 1 quantity of Ir-192 from Russia on the same date, May 19, 2020. QSA later confirmed in its email, also dated May 19, 2020, that it failed to submit a 7-day advance notification for this shipment, NRC Agencywide Document Access and Management System (ADAMS), Accession No. ML21075A193. QSAs failure to provide timely and accurate information did not allow the NRC sufficient time to perform its review, which could have had significant implications for public health and safety or common defense and security.

The violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is available on the NRCs Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violation is cited in the enclosed Notice because all of the criteria in Section 2.3.2 on the NRC Enforcement Policy were not met in that QSA did not identify the violation.

M. Fuller You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. If you have additional information that you believe the NRC should consider, you may provide it in your response. The NRC will use your response, in part, to determine whether or not further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, a copy of this letter, its enclosures and your response will be made available electronically for public inspection in the Public Document Room or from the NRCs document system Agencywide Documents Access and Management System accessible from the NRC Website at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, 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 information, 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 2.390(b) to support a request for withholding confidential commercial or financial information).

Please contact Ms. Jane Chimood at (301) 287-9225 if you have any questions regarding this matter.

Sincerely, 7/6/2020 X Peter J. Habighorst Signed by: Peter J. Habighorst Peter J. Habighorst, Chief Export Controls and Nonproliferation Brach Office of International Programs

Enclosure:

Notice of Violation cc: Jack Priest, Director State of Massachusetts

M. Fuller

SUBJECT:

NOTICE OF VIOLATION - QSA GLOBAL, INC. RELATED TO FAILURE TO PROPERLY NOTIFY THE U.S. NUCLEAR REGULATORY COMMISSION IN ADVANCE OF IMPORT SHIPMENT DATED JULY 6, 2020 DISTRIBUTION:

OIP r/f PHabighorst, OIP J Chimood, OIP MFord, RI RFretz, OE JPeralta, OE AJones, OIP RidsOEMailCenter Resource ADAMS Accession Number: ML20169A747 (pkg) ML20176A221 (ltr) *via email OFFICE OIP OIP/ECNP* OE/EB* BC:OIP/ECNP NAME JChimood AJones RFretz PHabighorst DATE 6/24/20 6/29/20 7/06/20 7/06/20 OFFICIAL RECORD COPY

NOTICE OF VIOLATION QSA Global, Inc. EA-20-082 Burlington, MA During a U.S. Nuclear Regulatory Commission (NRC) review completed on June 2, 2020, a violation of NRC requirements was identified. In accordance with the NRC Enforcement Policy, the violation is listed below:

A. Section 110.50(c) of Title 10 of the Code of Federal Regulations (10 CFR) requires, in part, that a licensee authorized to export or import the radioactive material listed in Appendix P to 10 CFR Part 110 is responsible for notifying the NRC in advance of each shipment. Section 110.50(c)(4) also requires that import notifications be received by the NRC at least 7 days in advance of each shipment.

Contrary to the above, on May 19, 2020, QSA Global, Inc. (QSA) failed to notify the NRC in advance of an import shipment as required by NRC regulations. Specifically, on May 19, 2020, QSA notified the NRC of the intent to import 1,437 TBq of Iridium-192 from Russia. The import was shipped on May 19, 2020. The notification provided by QSA was not submitted 7 days in advance of the shipment.

This is a Severity Level IV violation (NRC Enforcement Policy, Section 6.15)

Pursuant to the provisions of 10 CFR 2.201, QSA Global, Inc., is hereby required to submit a written statement or explanation to the Director, Office of International Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 30 days of the date of this Notice of Violation. This reply should be clearly marked as a "Reply to a Notice of Violation (EA 082) and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level; (2) the corrective steps that have been taken and the results achieved; (3) any additional corrective steps that will be taken; and (4) the date when full compliance will be or was 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, the NRC may issue an Order or a Demand for Information requiring you to explain why your 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 response time.

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS) accessible from the NRC Website at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within 2 working days of receipt.

Dated this 06 day of July 2020.

Enclosure