NRC Supplementary Information for General Licensees - TSI Aerosol Neutralizers (Models 3012/3012A, 3054/3054A, 3077/3077A)

Sep 27, 2026

Uploaded by acoobca

NRC supplementary information explains regulatory responsibilities for general licensees who receive TSI aerosol neutralizers containing Krypton-85 gas. It clarifies how licensing is governed by the U.S. NRC or state Agreement States, and emphasizes compliance with enclosed NRC regulations. The notice lists mandatory actions for maintaining device labels, appointing a responsible individual, preventing unauthorized transfer, keeping receipt and disposal records for at least three years, and providing timely notification for transfers, changes, leaks, damage, loss, or theft. It also includes return and material compatibility guidance and a receipt/disposal record section.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages24

Reading Time1 h 0 min

AccessFree to download

NRC Supplementary Information for General Licensees

Licensed receipt and regulatory authority

General licensee requirements

Receipt and disposal record

Records retention (10 CFR 30.51)

NRC Supplementary Information for General Licensees of TSI® Aerosol Neutralizers Models 3012, 3012A Aerosol Neutralizers Models 3054, 3054A Aerosol Neutralizers Models 3077, 3077A Aerosol Neutralizers NRC Supplementary Information for General Licensees of TSI Neutralizers Models 3012, 3012A Aerosol Neutralizers Models 3054, 3054A Aerosol Neutralizers Models 3077, 3077A Aerosol Neutralizers | IMPORTANT | | --- | | An above-listed Model Aerosol Neutralizer has been supplied to you under MN Department of Health License Number 1154 issued to TSI® Incorporated. Your receipt of the neutralizer automatically makes you a “General Licensee” under the license. Your purchase of the Aerosol Neutralizer has been reported to the NRC as required by the license. You are required to read and comply with the applicable requirements in the enclosed NRC regulations. | The aerosol neutralizers listed above contain radioactive material in the form of Krypton-85 gas. In the United States the possession and use of radioactive materials falls under the regulatory authority of the U.S. Nuclear Regulatory Commission (NRC) at the federal level, or of a regulatory agency in your state. This depends on whether your state has entered into an agreement with the NRC for the purpose of controlling the use of radioactive material within the state. The states that appear on the list enclosed have their own control programs and are therefore called Agreement States. If your state is not on the list, your possession and use of the aerosol neutralizer is regulated by the NRC. The NRC divides itself into four regions across the United States (see Part 20, Appendix D enclosed) . You must be licensed to have the device in your possession. As stated above, receipt of the neutralizer automatically makes you a general licensee under NRC – Agreement State terminology. CFR regulations and Agreement States Points of Contact are available at web site [http://www.nrc.gov/](http://www.nrc.gov/) . As a new general licensee you must adhere to the following requirements: 1. YOU MUST BE SUPPLIED WITH A COPY OF 10 CFR 30.51, 31.2, 31.5, 20.2201, AND 20.2202. SEE ENCLOSED. CURRENT REGULATIONS MAY BE ACCESSED AT [http://www.nrc.gov/](http://www.nrc.gov/) . 2. YOU ARE REQUIRED TO APPOINT A RESPONSIBLE INDIVIDUAL WHO WILL KNOW ABOUT THE REQUIREMENTS AND HAVE THE AUTHORITY TO CARRY OUT THE NECESSARY DUTIES TO COMPLY WITH THE REGULATORY REQUIREMENTS. 3. YOU MUST MAINTAIN THE DEVICE LABEL IN LEGIBLE CONDITION, SECURELY ATTACHED TO THE DEVICE AT ALL TIMES. 4. THE DEVICE SHALL NOT BE TRANSFERRED TO ANOTHER LOCATION, PERSON OR COMPANY. 5. YOU MUST RETAIN ACCURATE RECORDS OF THE RECEIPT AND DISPOSAL OF EACH DEVICE IN YOUR POSSESSION FOR A MINIMUM PERIOD OF THREE YEARS AFTER THE DEVICE IS RETURNED OR DISPOSED. 6. THE DEVICE SHOULD NOT BE ABANDONED OR DISPOSED OF EXCEPT BY RETURN TO: RADIOACTIVE NEUTRALIZER RETURN TSI INCORPORATED 500 CARDIGAN ROAD SHOREVIEW, MN 55126-3996 FOR RETURN INFORMATION CALL TSI® INCORPORATED AT: TEL\# 651-490-2860 FAX\# 651-490-3824. 7. YOU MUST NOTIFY THE NRC OR AN AGREEMENT STATE WITHIN 30 DAYS OF TRANSFER OR DISPOSAL OF THE DEVICE OR A CHANGE OF COMPANY NAME OR ADDRESS. SEE 10 CFR 31.5 (C)(8),(C)(9) AND (C)(14) AND/OR THE APPLICABLE STATE REGULATIONS. 8. IT IS THE POLICY OF THE NRC TO ISSUE HIGH CIVIL PENALTIES FOR LOSS, ABANDONMENT OR IMPROPER DISPOSAL. 9. IN THE EVENT THAT A DEVICE BECOMES DAMAGED, LOST, OR STOLEN, NOTIFY TSI® INCORPORATED AT 651-490-2811 IMMEDIATELY. YOU WILL BE ADVISED AS TO REPORTING REQUIREMENTS, IF NECESSARY. 10. CORROSIVE MATERIALS CAN DEGRADE THE INTEGRITY OF THE UNIT. DO NOT USE CHEMICALS THAT CORRODE 303, 304, OR 316 STAINLESS STEEL, COPPER, SILVER BRAZE, OR EPOXY. 11. IN THE EVENT OF A LEAK, THE AREA CONTAINING THE DEVICE SHOULD BE IMMEDIATELY VENTILATED. BECAUSE KRYPTON-85 IS A GAS THERE IS NO CONTAMINATION THREAT ASSOCIATED WITH KRYPTON-85. 12. SOME AGREEMENT STATES REQ

FAQs

What makes a recipient a “General Licensee” under the NRC license?

Receipt of the listed aerosol neutralizer automatically makes the recipient a “General Licensee” under the license. The purchase is reported to the NRC as required.

What requirements must general licensees follow?

General licensees must use the enclosed NRC regulations, appoint a responsible individual, keep the device label legible, prevent transfer to other locations or persons, and retain accurate receipt and disposal records for at least three years after return or disposal.

How should leaks, damage, loss, or theft be handled?

If a leak occurs, the area containing the device should be immediately ventilated. If a device is damaged, lost, or stolen, TSI Incorporated must be notified immediately so reporting requirements can be provided.

Sep 27, 2026

Uploaded by acoobca