ML20138C982
| ML20138C982 | |
| Person / Time | |
|---|---|
| Issue date: | 04/22/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Hyland J MAINE, STATE OF |
| Shared Package | |
| ML20138C985 | List: |
| References | |
| NUDOCS 9704300266 | |
| Download: ML20138C982 (5) | |
Text
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t APR 2_21997 l Mr. Jay Hhland, Environmental Specialist i
- Radiological Health Program . !
Division of Health Engineering 'i State House, Station 10 ;
Augusta,' ME 04333 :
j
Dear Mr. Hyland:
-l This is in response to your January-10,1997 e-mail message on the handling of exempt !
quantities. 'l First, you are correct in that Maine has the authority to license the' manufacture and distribution of devices containing byproduct material to persons covered under the general license equivalent to 10 CFR 31.5. However, for distribution to persons exempt from l'
-licensing, an NRC license authorizing such distribution is required.
Second,'the Atomic Energy Act does not address the regulation of Naturally Occurring and Accelerator Produced Material (NARM). Therefore, since NRC does nc,t license the i distribution of devices or sources containing only NARM, regulatory control is a matter subject to State jurisdiction. We suggest that you consult with your State's legal staff for an interpretation of the Maine regulations in this area.
-I apologize for my delay in responding to your request.
Sincerely, OriginalSigned Br.
PAULH.LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs
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[ %,t UNITED STATES s# j NUCLEAR REGULATORY COMMISSION WASHiNGYoN, D.C. 61 April 22, 1997
%***** l Mr. Jay Hyland, Environmental Specialist Radiological Health Program Division of Health Engineering State House, Station 10 ,
Augusta, ME 04333 i
Dear Mr. Hyland:
This is in response to your January 10,1997 e-mail message on the handling of exempt quantitles.
First,.you are correct in that the State of Maine has the authority to license the manufacture and distribution of devices containing byproduct material to persons covered under the general license equivalent to 10 CFR 31.5. However, for distribution to persons exempt from licensing, an NRC license authorizing such distribution is required.
Second, the Atomic Energy Act does not address the regulation of Naturally Occurring and Accelerator Produced Material (NARM). Therefore, since NRC does not license the distiibution of devices or sources containing NARM, regulatory control is a matter subject :
to State jurisdiction. We suggest that you consult with your State's legal staff for an !
interpretation of the Maine regulations in this area. !
i 4 apologize for my delay in responding to your request. I in rely
( ) /[8' Paul H. bohaus, eputy Director Office of State Programs l
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I Mr. Jay Hyland, Environmental Specialist Radiological Health Program Division of Health Engineering f 10 State House Station ;
Augusta, ME 04333
Dear Mr. Hyland:
This is in response to your January 10,1997 e-mail message on the handling of exempt quantities.
First, you are correct in assuming that your program ppil license firms in Maine to ;
manufacture and distribute devices containing byproduct materialin quantities less than those listed in Maine's equivalent to 10 CFR 30.71/ Schedule B, and intended for persons covered under the general license equivalent to }O CFR 31.5. However, if distribution is intended to persons exempt from licensing, an,NRC license authorizing such distribution would be required.
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Second, the Atomic Energy Act does not, address the regulation of Naturally Occurring and Accelerator Produced Material (NARM)./Therefore, NRC does not license the distribution of devices or sources containing only NARM. Regulatory control is a matter subject to State jurisdiction. We suggest that you c,onsult with your State's legal staff for an interpretation of the Maine regulations in this area.
I apologize for my delaynding in respo/
to your request.
Sincerely,
/
/
/
/ Paul H. Lohaus, Deputy Director
/ Office of State Programs l
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Mr.-Jay Hyland, Environmental Specialist Radiological Health Program ,
Division of Health Engineering 10 State House Station Augusta, ME 04333
Dear Mr. Hyland:
This is in response to your January 10,1997 e-mail message on the handling of exempt quantities.
First, you are correct in that Maine has the authority to license the manufacture and distribution of devices containing byproduct material to persons covered under the general license equivalent to 10 CFR 31.5. However, for distribution to persons exempt from licensing, an NRC license authorizing such distribution is required, t
Second, the Atomic Energy Act does not address the regulation of Naturally Occurring and Accelerator Produced Material (NARM). Therefore, since NRC does not license the distribution of devices or sources containing only NARM, regulatory control is a matter subject to State jurisdiction. We suggest that you consult with your State's legal staff for an interpretation of the Maine regulations in this area. e I apologize for my delay in responding to your request.
Sincerely, 1
Paul H. Lohaus, Deputy Director l Office of State Programs l
l Distribution:
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Mr. Jay Hyland, Environmental Specialist l
Radiological Health Program )
Division of Health Engineering !
'10 State House Station Augusta, ME 04333 l Dear Mr. Hyland-1 This is in response to your January 10,1997 e-mail message on the handling of exempt quantities.
F:rst, you are correct in assuming that your program garg license firms in Maine to manufacture and distribute devices containing byproduct materialin quantities less than those listed in Maine's equivalent to 10 CFR 30.71, Schedule B, and intended for persons 1 covered under the general license equivalent to 10 CFR 31.5. However, if distribution is )
intended to persons exempt from licensing, an NRC license authorizing such distribution i would be required. ,
l Second, the Atomic Energy Act does not address the regulation of Naturally Occurring and i Accelerator Produced Material (NARM). Therefore, NRC does not license the distribution of devices or sources containing only NARM. Regulatory control is a matter subject to State l jurisdiction. We suggest that you consult with your State's legal staff for an interpretation of the Maine regulations in this area. ,
I apologize for my delay in responding to your request.
1 Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs !
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DATE 03/$/97 03/7ty97 03/ /97 03/Q/97 03/ /97 l
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NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 30006 4 001
,, December 26, 1996 Mr. Jay Hyland, Environmental Specialist ,
Radiation Control Program Department of Human Services !
State House, Station 10 Augusta, ME 04333
Dear Mr. Hyland:
This is in response to your October 4,1996 letter on the handling of exempt quantities.
Section 274c of the Atomic Ener Act (AEA) reserves to the Nuclear Regulatory Commission (NRC) the authority to require that the manufacturer, processor, or producer of any equipment, device, commodity, other product containing source, byproduct, or special nuclear material shall ncit transfer possession er control of such product except pursuant to a license issued by the Commission. In other words, the Commission has exclusive authority, even in Agreement States, over the manufacture and distribution of products intended for use by tha public on an exempt basis. The primary purpose of this provision is to ensure that the controls with respect to the distribution of devices (e.g.,
gauges) are uniform throughout the United States.
NRC's regulations are consistent with the statutory provision in Section 274c of the AEA.
Pursuant to 10 CFR 150.15(a)(6), persons in Agreement States are not exempt from the Commission's licensing and regulatory requirements with respect to:
... the transfer of possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from licensing and regulatory requirements of the Commission under Parts 30 and 40 of this chapter.
Enclosed are specific responses to your questions on exempt quantities and smoke detectors. Also enclosed, is a May 13,1996 letter to Mr. William J. Sinclair, Director of the Division of Radiation Controlin Utah, addressing concerns similar to the ones you raised.
We hoped that your concerns in this area have been adequately addressed.
Sincerely,
/ /i1 tht d) 3 Paul H. Lohaus, Deputy Dire tor Office of State Programs v
Enclosures:
As stated
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, Questions On Exammt Quantities I i !
- 1. Why can't 10 CFR 30.18 products be redistributed by their recipients who are .
j persons exempt from licensing?
l Answer - Commercial distribution which includes redistribution is prohibited except in
- accordance with a license issued pursuant to 532.18. It should also be noted that j ll30.18(a) and (b) allows for the infrequent transfer of exempt quantities such as tissue
- _ samples for norwommercial purposes.
i 2.- 10 CFR 32.19 limits the number of exempt quantities (listed in 530.71, Schedule 8) j sold or transferred in any single transaction to 10 items. At wiwt point do these
- sources become "non-exempt"?
Answer - it should be noted that the sources are not exempt; the exemption applies to the persons receiving the sources. You should also note that 532.19(a) contains a " unity rule" which indicates that no more than 10 exempt quantities may be transferred in any single j transaction. Each individual quantity may be composed of fractional parts (e.g. specific
- items) of one or more of the exempt quantities authorized in 530.71, Schedule 8, as long
! as the total of the fractions does not exceed unity. In the example of 10 exempt items, you can also ship 20 exempt items if the total activity is equal to the 10 exempt
! quantities.
- 3. Can 100 orders, each order containing 10 exempt quantities, be sent to a person exempt from licensing under 10 CFR 30.18?
Answer - The regulations requ!re that no more than 10 exempt quantities may be transferred per single transaction by the distributor. There are, however, no restrictions on the number of exempt quantity sources distributed pursuant to 532.18 that can be possessed by a person exempt from the requirements for a license under 530.18. ;
i- 4. Are there any other Maine companies that appear on the list of recipients of exempt quantities reported by "E-distribution" (10 CFR 32.18) licensees to the NRC7 How i is this information reviewed?
Answer - The reporting requirements of 10 CFR 32.20 only require that the licensee (distributor) file a summary report stating the total quantity of each isotope transferred and does not require that the person to whom shipments are made be identified.
- 5. How else do you propose we regulate this community?
- Answer - The Maine equivalent of the 10 CFR 30.18 exemption permits users in Maine to obtain these products from firms licensed by NRC to distribute to persons exempt from licensing. If the terms of this exemption are violated, the user loses their exemption and will need to obtain a specific Maine possession license.
1 ENCLOSURE 1 1
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- 8. Can Maine issue a specific license that only authorizes redistribution of licensed exempt sources? Or is this a NRC *E" license?
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Answer - No, the authority to issue specific licenses for the commercial distribution of products to persons exempt from licensing is reserved to the NRC (see 5 532.18 and 32.19). !
- 7. Is it the original manufacturers responsibility to make sure that an exempt source is only purchased by exempt people for exempt purposes? Stated another way, is the fact that the source is exempt not enough?
Arnwer - Yes. The original msr.decturer or distributor may transfer byproduct material to
, persons exempt from licensing or to another specific licensee authorized to distribute the 4 material to persons exempt from licensing. The exemption only applies to the person and
. the activities permitted by ll30.18 and 32.18 and not to the source, it should also be ,
, noted that 530.18(d) states that "No person may, for purposes of commercial distribution, i transfer byproduct material... knowing or having reason to believe that such quantities of byproduct material will be transferred to persons exempt" except in accordance with a specific license issued pursuant to 532.18. See also 530.41(b)(2).
- 8. Once a source is distributed as exempt does it remain exempt?
1 l Answer - As noted earlier, the exemption applies only to the person and activity and not I the source. Except for material distributed commercially pursuant to 532.18, once the material has been initially transferred to a person exempt from licensing, the exempt status applies to all persons thereafter. It should be noted, however, that the regulations are not
- clear as to whether the exempt status applies to the distributor if the material is returned
! to the distributor or whether the specifically licensed distributor must treat the source as licensed radioactive material and as such include it under its possession and use license.
- 9. If someone wanted to recycle smoke detectors as a disposal option and redistribute
! the sources, would this still be exempt? Why are smoke detectors more exempt than other exempt sources?
l Answer - This type of activity is not permitted by NRC or equivalent Maine regulations.
The reason why this activity is not allowed is not predicated by the fact that these gas and aerosol detectors are designed to protect life or property or because smoke detectors are more exempt than other exempt sources. As stated in the enclosed letter to Mr. William J. Sinclair, Director of the Division of Radiation Control in Utah, the exemption provided iri 530.20 allows for the possession of byproduct material when used in gas and aerosol detectors manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 532.26. The products are authorized for exempt distribution based on a sealed source and device review of the product. The exemption from licensing only applies to the byproduct materialin the assembled detector for which it
- was licensed. The person exempt from licensing may use the detector in whatever fashion
- - they choose; however, if the byproduct materialis removed from the detector and used for another purpose, then the exemption no longer applies and the person would need to obtain a specific license. You should also note that the environmental assessment performed to examine the likely consequences of the manufacture, distribution, use and
, disposal of smoke detection devices did not analyze such conditions.
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/- UNffED STATES
/- [ NUCLEAR REGULATORY COMMISSION j't 8 ' i wasumerom, s.c. senee I
,,,,, May 13.' 1996 i i' t
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Nr. William J. Sinclair Director !
! Division of Radiation Control ;
i Department of Environmental Quality '
168 North 1950 West p.0. Box 144850 Salt Lake City, Utah 84114-4850 :
! Dea'r Mr. Sinclair:
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This is in response to your February 15, 1996, letter requesting technical assistance on several issues related P.o smoke detectors. For e arity, we will i
restate each,,of your questions before responding, j
- 1. *When in the manufacturina nrocers does a smoke ilatector became a device l accontable for distribution to norsons exasmt from ' iconsina." !
- A brief explanation of the NRC's exempt distribution licensing process may help to better understand this answer. There is no ' point" in the j
manufacturing process when a smoke detector becomes a device acceptable for distribution to persons exempt from licensing. The smoke detector becomes
- ' acceptable" for distribution only after a safety evaluation and registration of the detector has been performed and a license has been issued authorizing j the product for exempt distribution.
i To possess and use byproduct material, as in the manufacture of smoke i detectors, a specific license authorizing possession and use of byproduct ;
material must be obtained from NRC or, in this case, from the State of Utah.
This specific license covers manufacturing, processing, producing and i
distribution of products containing byproduct materia , provided the products are distributed to persons who have a specific license that authorizes them to possess such byproduct material.
In accordance with $150.15(a)(6), NRC retains jurisdiction for the transfer of j
byproduct material to persons exempt from licensing. Thus, licants who j wish to distribute er initially' transfer products containing reduct anterial, s9ch as smoke detectors, to persons who are exempt licensing, i
must also obtain a separate exempt distribution Itcense from the NRC pursuant
. to $32.26 (Enclosure 1). Before licensing smoke detectors for distribution, NRC would also perform a device safety review resulting in the issuance of a i
device registration certificate. 0nly after the device review is completed and the exempt distribution license is issued is the smoke detector authorized
[, for distribution to persons exempt from licensing.
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L ENCLOSURE 2
, William J. Sinclair I 4
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It is also important to understand that smoke detectors are not considered j exempt to the manufacturer / initial distributor. The exemption only applies to
! those persons who receive the products from persons who are authorized to distribute under an exempt distribution license.
- 2. 'As a serson ar-t Frem the mulations in IParts 20 and 30-16 and 39 of i
Title 10. is Mr. Jones ' n violation of any reau' ations when he uses the foil j source from a sina' a detector for another oursose."
l' byproduct satorial when use)d ja gas and aerosol detectors manufactured, processed, produced, or initially transferred in accordance with a specific
! license issued pursuant to 10 CFR $32.26. If the material remains in an j assembled gas er aerosol detector, the exemption in Section 30.20 applies.
4 Nowever, if the material is removed from the detector and used for another purpose, the exemption in $30.20 no lonper applies. Therefore, onder the provisions of $30.20, or equivalent Utas regulations, Mr. Jones is exempt from 1 licensin However,g requirements once the byproduct as to his possession material or fell sources and use areofremoved the smoke from detectors.
the
- detector and used for another purpose, the exemption in $30.20, or equivalent l
. Utah regulations, no longer applies.
) Incorporation of the foil sources into check sources requires a specific
- license from the State of Utah for the possession and use of the material.
i Questions as to violations concerning the possession of byproduct material
- without the preper authorization wou d have to be addressed by the State; however, the distribution or transfer of check sources to persons exempt from licensing without an NRC license would be considered and treated by NRC as a l violation of the provisions of $30.18. (See further discussion below).
l 3. 'If the detectors are not exemot. what licensina actions will be reautred j of Mr. Jones by NRC and/or the State."
l The use of the material for a purpose other than as a source in gas and i
aerosol detectors requires a specific license from NRC or, in this case, from i Utah. In addition, we agree that Mr. Jones requires a specific license in 1
this case for possession and storage of the unassembled detectors and sources.
A specific Itcense to manufacture or initially transfer calibration or reference sources containing Americium 241, for distribution to persons
- generally licensed, must be obtained pursuant to section 32.57 or Utah's equivalent regulation. We note that, ponerally, the provisions in Section
- 32.18 require a specific license for the commercial distribution of those exempt quantities covered under Section 30.18 and identified in Section 30.71, i
Schedule B. However, Section 32.18 does not apply in this context because i Section 30.71, Schedule B does not include a listing for Americium-241.
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, , _ . - . . . _ . . . _ _ _ .-._,m , . , . . . . . _ . . ._
g William.J. Sinclair -
3 N I3 E f you have any questions regarding this correspondence, please contact me or the individual named below: .
1
. . POINT OF CONTACT: Jim Iqyers - -
- TELEPHONE
- 415-2328 '.
- N: 415 3502
! INTERNET: NRC.G0V L .
Richard L. Bangart. Director
> Office of State Programs
Enclosures:
. As stated
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