[ RadSafe ] Re: SSDR's and Licensing

[Clayton J Bradt]

Bill:

The first thing to understand about SS&D registrations is that they are in
and of themselves UNENFORCIBLE. It is the license issued by the regulating
agency that authorizes the manufacture and distribution of radioactive
devices/sources. The SS&D is written solely for information purposes, to be
used by other regulators to assist them in determining whether a
device/source is suitable for possession/use by a licensee, what level of
expertise in radiation protection is required, what conditions should be
placed upon the license, etc.

Furthermore an SS&D registration is OPTIONAL. 10CFR32.210 (a) states: "Any
manufacturer or initial distributor of a sealed source or device containing
a sealed source whose product is intended for use under a specific license
MAY submit a request to NRC for evaluation of radiation safety information
about its product and for its registration."  In the law MAY includes MAY
NOT.
In addition, neither 10CFR31.5 (general license for self-luminous exit
signs) nor 10CFR32.51 (specific license to manufacture and distribute
self-luminous exit signs) contain any requirements for an SS&D review at
all.

As a practical matter, most regulating agencies (NRC or Agreement States)
will probably insist that you get an SS&D sheet written before they will
authorize manufacture and distribution under a license. Even though they
have no legal authority to impose this requirement, it is probably not
worth the cost and hassle of bringing them to court over it.

If you currently hold a license authorizing you to manufacture and
distribute these devices, it is immaterial who requested the SS&D review.


Clayton J. Bradt
Principal Radiophysicist
NYS Dept. of Health

------------------------------

Original Message:


Message: 7
Date: Wed, 9 Dec 2009 12:36:15 -0500
From: "Bill Rowan" <browan at self-powered.com>
Subject: [ RadSafe ] SSDR's and Licensing
To: <radsafe at radlab.nl>
Message-ID: <00b901ca78f6$1babc3d0$53034b70$@com>
Content-Type: text/plain;            charset="us-ascii"

We've run into a hurdle in the USA with SSDR's and Licensing.  I'm trying
to
perform additional due-diligence.



Does anybody have knowledge of the following instance where:



"Company A" holds a device registration (for exempt distribution devices )

"Company B" holds the possession and distribution licenses for the product
that is registered by "Company A".



We "Company B" have a relationship with a "CompanyA" that has designed a
product which contains nuclear material.



We have proposed to be the "contract manufacturer" that would produce and
distribute Company-A's  product.  Company-A would like to hold the SSDR;
Company-B would like to add this (once registered) product to its
possession
and distribution licenses.  The thought is that if the relationship ever
soured, CompanyA could identify other companies who could produce and/or
distribute these items in accordance with the SSDR, companyA & B could
separate and go their respective ways, with no harm to either company.



NRC is telling us that either CompanyA or CompanyB must hold all 3 items:
SSDR, Possession license & Distribution license.



If we were to hold the SSDR, the original design firm would have lost
control of their product.  Obviously they are not happy with this
situation.
Nor are they familiar with the operation of a nuclear facility.



Does anybody have any thoughts on how to protect both companies or have
knowledge where one company holds the SSDR and another holds the licenses
to
manufacture and distribute?



Thank you.



Bill Rowan

Vice-President & General Manager

browan at self-powered.com



Self-Powered Lighting

31 Waterloo Ave

Berwyn, PA  19312

USA



484-595-9130 T

484-595-9135 F





------------------------------







IMPORTANT NOTICE:  This e-mail and any attachments may contain confidential or sensitive information which is, or may be, legally privileged or otherwise protected by law from further disclosure.  It is intended only for the addressee.  If you received this in error or from someone who was not authorized to send it to you, please do not distribute, copy or use it or any attachments.  Please notify the sender immediately by reply e-mail and delete this from your system. Thank you for your cooperation.