[ RadSafe ] Transfer exempt quantity byproduct sealed sources without a license? Revisited from this time last year. Now with references.

[Geo>K0FF]

 At first glimpse, NRC section 30.14 seems to say that it is OK to "transfer" exempt  
quantity byproduct sources without a license (see below for full context). 
30.14 says: "any person is exempt from the requirements for a license.......... to the extent 
that such person receives, possesses, uses, transfers, owns or acquires products or materials 
containing byproduct material in concentrations not in excess of those listed in § 30.70."
Well it sure says "transfer" is OK, however that word has multiple meanings, one of 
which "is to carry about, to move from one place to another".
Whatever the legal types had in mind, there has been a lot of controversy, confusion and 
problems caused by that statement.


Again the following verbiage is very confusing and seemingly contradictory. 32.18 says in part: "When the transfer of 
byproduct material in individual quantities not exceeding the limits set in §30.71, Schedule B, 
occurs for commercial benefit, then §§30.18(c) and (d) apply and the manufacture, transfer, or 
distribution to persons exempt from licensing requirements must be specifically licensed. "

OK that appears to say that an unlicensed person who possesses a sealed source cannot sell it, but it is 
OK to give it away. After all, no money changes hands so it can't be a "commercial benefit".

Notwithstanding the apparent pass given above, 
clearly the NRC does not intend that an ordinary person can buy a radiation source from a properly 
licensed vendor, then turn around and sell or give it away to the next unlicensed person.This is made 
abundantly clear in  
"Guidance About Exempt Distribution Licenses (NUREG-1556, Volume 8) 9.5 10 CFR 32.18" where they 
clarify the phrase "commercial benefit":

"The commercial transfer of a product refers to the introduction of a material into the marketplace, whether 
or not a charge is assessed for that distribution. Commercial benefit does not necessarily include a 
monetary exchange.

One company who manufactured X-Ray equipment was caught buying the needed sources 
then giving them away to their customers, seemingly avoiding the "commercial benefit" trap. To their 
chagrin they were cited and fined, further being ridiculed when the NRC said their position was "laughable". 

Personally I don't think it was laughable at all, rather someone really did their homework and thought 
they understood what the rules say and mean. Indeed I have run across more than one NRC Field Agent 
this year alone who took the same interpretation of the word "transfer" in section 30.14!!





Below are the actual full text NRC documents which at once caused the controversy 
then later explains in plain language what the deal really is.

§ 30.14 Exempt concentrations.
(a) Except as provided in paragraphs (c) and (d) of this section, any person is exempt from the 
requirements for a license set forth in section 81 of the Act and from the regulations in this part 
and parts 31 through 36 and 39 of this chapter to the extent that such person receives, possesses, 
uses, transfers, owns or acquires products or materials containing byproduct material in concentrations 
not in excess of those listed in § 30.70.


§ 30.18 Exempt quantities.
(a) Except as provided in paragraphs (c) through (e) of this section, any person is 
exempt from the requirements for a license set forth in section 81 of the Act and 
from the regulations in parts 30 through 34, 36, and 39 of this chapter to the extent 
that such person receives, possesses, uses, transfers, owns, or acquires byproduct 
material in individual quantities, each of which does not exceed the applicable quantity 
set forth in § 30.71, Schedule B.
(b) Any person, who possesses byproduct material received or acquired before 
September 25, 1971, under the general license then provided in § 31.4 of this chapter 
or similar general license of a State, is exempt from the requirements for a license set 
forth in section 81 of the Act and from the regulations in parts 30 through 34, 36 and 39 
of this chapter to the extent that this person possesses, uses, transfers, or owns byproduct material.
(c) This section does not authorize for purposes of commercial distribution the production, 
packaging, repackaging, or transfer of byproduct material or the incorporation of byproduct 
material into products intended for commercial distribution.
(d) No person may, for purposes of commercial distribution, transfer byproduct material 
in the individual quantities set forth in § 30.71 Schedule B, knowing or having reason to 
believe that such quantities of byproduct material will be transferred to persons exempt 
under this section or equivalent regulations of an Agreement State, except in accordance 
with a license issued under § 32.18 of this chapter, which license states that the byproduct 
material may be transferred by the licensee to persons exempt under this section or the 
equivalent regulations of an Agreement State.
(e) No person may, for purposes of producing an increased radiation level, combine 
quantities of byproduct material covered by this exemption so that the aggregate 
quantity exceeds the limits set forth in § 30.71, Schedule B, except for byproduct 
material combined within a device placed in use before May 3, 1999, or as otherwise 
permitted by the regulations in this part.
Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 
Exempt Distribution Licenses (NUREG-1556, Volume 8) 9.5 10 CFR 32.18: Exempt Quantities
Section 32.18(a), 10 CFR Part 32, "Manufacture, distribution and transfer of exempt 

quantities of byproduct material: Requirements for license," authorizes an exemption 

to persons who receive, possess, use, transfer, own, or acquire byproduct material in 

individual quantities not exceeding limits set in §30.71, Schedule B. This exemption 

allows persons to receive, possess, use, own, or acquire small quantities of 

byproduct material and to transfer items such as tissue samples and counting 

standards to other unlicensed persons on an occasional basis, not for commercial 

benefit, without a distribution license.

Figure 9.3 Example of Exempt Quantities: Labeling

When the transfer of byproduct material in individual quantities not exceeding the 

limits set in §30.71, Schedule B, occurs for commercial benefit, then §§30.18(c) and 

(d) apply and the manufacture, transfer, or distribution to persons exempt from licensing 

requirements must be specifically licensed. Therefore, each person engaging in the 

commercial transfer or distribution of exempt distribution products must have a 

license authorizing distribution under §32.18. The commercial transfer of a product 

refers to the introduction of a material into the marketplace, whether or not a charge 

is assessed for that distribution. Commercial benefit does not necessarily include a monetary exchange.



and from :

http://www.nrc.gov/materials/miau/consumer-pdts.html#exempt

Generally, distribution of byproduct material to persons exempt from regulatory authority (the general public) can only be made by persons who have a specific license from the Commission authorizing the distribution of their products to persons exempt from the requirements for an NRC license. Manufacturers and distributors of these products must be licensed in order to initially transfer or distribute them to persons exempt from licensing. The licensed distributor is required to satisfy the Commission that all products are manufactured, tested, and distributed in accordance with the regulations and specifications provided in its license application. These specific licenses are issued by the Commission and are referred to as "exempt distribution" or "E" licenses. 



References

Definition of Byproduct Material:

http://www.nrc.gov/materials/byproduct-mat.html



George Dowell

New London Nucleonics Lab