Sealed Source Device Registration Services

The Radiation Safety Academy has successfully prepared applications for companies wishing to distribute devices containing radioactive material sources within the United States. We are ready to guide you through the licensing process for securing the required approvals to import and sell these products to consumers. We have prepared sealed source device registration (SSDR) applications and possession license applications for several clients for submittal to the U.S. Nuclear Regulatory Commission (NRC) or NRC approved Agreement State agencies which regulate this business.

Our services include preparing the application packages and follow NRC guidance contained in NUREG-1556, Vol. 3 (“Consolidated Guidance About Materials Licenses, Applications for Sealed Source and Device Evaluation and Registration”), Vol. 8 (“Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Exempt Distribution Licenses”), Vol. 16 (“Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees”), and Vol. 12 (“Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution”), as necessary.

Companies wishing to import products manufactured overseas which contain radioactive material are required to “register” the products with the NRC or Agreement State agency. The registration certificate designates the U.S. representative as the distributor of the product and designates the foreign vendor as the manufacturer. The U.S. distributor’s responsibilities include the implementation of a quality assurance program to assure that the imported products are in accordance with the statements made in support of the registration certificates. In addition, NRC inspects the distributor of the product and may periodically audit foreign vendors to determine if the products distributed in the United States are in accordance with the statements made in support of the registration certificates.

The Academy has prepared successful Nuclear Regulatory Commission (NRC) and Agreement State license applications for several clients. The application will include a discussion of the appropriate radiation safety elements necessary to support license activities. By closely adhering to guidance provided by NRC, Academy license applications are constructed with a goal of providing the regulators all of the information they require to issue a materials license.

Our services include assuring that all elements of the license applications will be provided to the NRC or Agreement State. These elements include, but are not limited to:

• Description of product and intended use,
• Type and quantity of radioactive material per unit,
• Chemical and physical form of radioactive material and changes that may occur during the useful life of the product,
• Details and design as related to containment and shielding and other safety features under normal and severe conditions of handling, storage, use, and disposal,
• Total quantity of radioactive material expected to be distributed annually,
• Proposed method of labeling or marking, and
• Quality Control procedures followed in fabrication of production lots of product and Quality Control standards the product must meet.

Recent Client History

The Academy professional staff have successfully prepared many sealed source device registration (SSDR) applications. Services for the following companies may have also include possession and/or distribution license applications.

ASP, Inc. - 2004

Sean Austin

Bahia 21 Corp - 2001-2002

Sean Austin, Alan Fellman

Competition Wireline Services, Inc. - 2006

Alan Fellman

DuPont Consumer Safety & Protection - 2005

Sean Austin

GNS TruView - 2003-2004

Alan Fellman

Hotwell US - 2008

Alan Fellman

Paper Making Controls - 2004

Alan Fellman

Superior Energy Services - 2003

Alan Fellman

Voith Paper Automation - 2004

Alan Fellman

The Radiation Safety Academy's team of experts are available to help you with your sealed source device registration needs. Call us at 800-871-7930 now.