ML20212K105

Responds to 990707 Ltr Re Regulation & Management of Ionizing Chamber Smoke Detectors

ML20212K105
Person / Time
Issue date:	09/17/1999
From:	Sturz F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Martinez P SPAIN, GOVT. OF
References
NUDOCS 9910060131
Download: ML20212K105 (6)

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September 17,1999 Empresa Nacional de Residuos Radiactivos, S.A.

ATTN: Pedro Carboneras Martinez, Head of Safety and Licensing Dpt.

Emilio Vargas,7 - 28043 MADRID

Dear Mr. Martinez:

This refers to your inquiry of July 7,1999, concerning the regulation and management of lonizing Chamber Smoke Detectors (ICSD's). Some background information follows on the process for obtaining a U. S. Nuclear Regulatory Commission (NRC) license pursuant to Section 32.26,10 CFR Part 32, authorizing the distribution of smoke detectors.

In order to possess and use byproduct material, you must first satisfy tile general requirements of 10 CFR 30.33. Therefore, you must apply for and obtain a specific license authorizing the possession and use of byproduct material. As a foreign entity you would have to establish an office in the United States for licensing and inspection purposes. Based on the state (s) from which a device will be manufactured and/or distributed, you would either submit an application to the appropriate NRC regional office or since the NRC has no regulatory jurisdiction in an Agreement State, contact the appropriate Agreement State office (s) for application information.

An applicant wishing to distribute or irsitially transfer products containing byproduct material, such as smoke detectors, to persons exempt from licensing, must also obtain an exempt distribution license from NRC. Prior to licensing smoko detectors for distribution, it is necessary for our Sealed Source Safety Staff to perform a device review pursuant to the issuance of a device registration sheet. The product information to be submitted for a distribution license and a device registration is outlined in 10 CFR Part 32, specifically in Sections 32.26,32.27, and 32.29(c), and in Regulatory Guide 6.9 (RG 6.9) " Establishing Quality Assurance Programs For The Manufacturing And Distribution Of Sealed Sources And Devices Containing Byproduct Material," and NUREG-1556, Vol. 3, " Consolidated Guidance About Material Licenses, Applic::tions for Sealed Source and Device Evaluation and Registration."and NUREG-1556, Vol. 8, " Consolidated Guidance About Materials Licenses, Program-specific Guidance About Exempt Distribution Licenses." An applicant should submit detailed drawings of the device and an example of the point-of-sale package.

For your use in understanding the process for applying for a distribution license and device O review, I have enclosed reference copies of:

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- 10 CFR Parts 30 and 32 (Enclosure 1); l Regulatory Guide 6.9 (Enclosure 2);  !

NUREG's-1556,Vol. 3(Enclosure 3);g p gyg gpp

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S P. Martinez l NUREG-1556, Vol. 8 (Enclosure 4);

l NRC's Consumer Policy Statement (Enclosure 5); and l

NUREG/CR-1775 (Enclosure 6)

In answer to your specific questions, I will restate the question and follow with our answer.

1. The manufacture, import, distribution and repair services of ICSD's, is it regulated?

As you can see by my introductory remarks the manufacture, import, and distribution of ICSD's are regulated and require authorization from NRC to initially distribute and also authorization from NRC or an " agreement" state to possess prior to initial distribution.

After initial distribution, no further regulatory requirements are imposed. Repair services separate from licensed distributors are not subject to regulation unless some health and safety hazard is identified.

2. Are special tests and formal certification (NEA or similar) required for ICSD's to be distributed to end users?

We require that smoke detectors undergo a sealed source and device engineering / safety review and are then registered with the NRC prior to initial distribution by a licensed distributor.

Both the source and the source and device combination must meet certain criteria and be registered with an agreement state and the NRC. Both the source and the source and device combination must meet certain requirements such as, solubility, l construction, radiation levels, etc. Greater detail on the specific requirements can be found in the enclosed 10 CFR Part 32 regulations and in NUREG's 1556, Volumes 3 and 8. j

3. Are special conditions for the management of those ICSD's at the end of their useful lifetime, imposed as part of the " licenses" to manufacture, import or distribute them?

No special conditions are imposed on the exempt distribution licensee to dispose of the smoke detectors at the end of their usefullifetime. However, it is a requirement of their possession license that any radioactive material possessed by them be disposed of as '

licensed material. This implies that material returned to them for disposal (voluntarily) must be disposed of as radioactive waste.

4. The use (by the final users) of the ICSD's, is regulated? (Does it need a license")?

The final users of ICSD's do not require a license. In fact, after the initial licensed distribution occurs, no person thereafter requires a license or is under any regulatory obligations. NRC has determined that the purpose of these detectors, that is to preserve life and property, far outweighs the slight regulatory concern involved with the radioactive material. Rather then placing regulatory restrictions on the use and disposal i of these items, and perhaps hindering their widespread use, NRC has authorized ICSD distribution to persons exempt from all regulatory requirements.

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! P. Martinez 10 CFR 30.20 states that."except for persons who manufacture, process, produce, or initially transfer for sale or distribution ... any person is exempt from the requirements for l a license . . . . to the extent that such person receives, possesses, uses, transfers, owns, or acquires . . . . [ smoke detectors) initially transferred in accordance with a specific license. . . ,

5. Which are the existing criteria to decide on the proper management route of ICSD's at the end of their usefullifetime?

There are no existing criteria for the management of ICSD's at the end of their useful life, but rather the criteria for management of ICSD's are incorporated in the registration / licensing process, prior to the beginning of their useful life. These criteria have been previously discussed and are found in the regulations at 10 CFR 32.26, i 32.27,32.28, and 32.29 and further clarified in NUREG-1556, Vol. 3, and NUREG-1556, Vol. 8 and RG 6.9.

' The initial registry / license review criteria do not directly depend on isotope or activity, but rather indirectly on the health effects that may be associated with the dose rates or release of material from the devices. The criteria do depend on the thoroughness of the -

source and device (apparatus) evaluation and the availability of the formal certifications.

' As already stated the review of the ICSD's prior to authorizing distribution eliminates the need to regulate disposal.

6. How is that final management being organized (or foreseen) nowadays?

As indicated in response to your question 5, disposal management of ICSD's occurs prior to distribution during the source and device registry and licensing process. As a result of successful registration and licensing, ICSD's are treated as conventional waste at the end of their useful life. As part of the perludic checks required by our policy on

" Products Intended for Use by General Public (Consumer Products)" (Enclosure 5),

published on March 16,1965, NRC contracted a 1979 study, NUREG/CR-1775, entitled " Environmental Assessment of Consumer Products Containing Radioactive Material" (Enclosure 6). The results found no significant impact from the disposal of 14 million ICSD's at landfills or by incineration.

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7. Are ICSD's being collected by (or sent to) the national agency for the management of i radioactive waste? '

ICSD's are being disposed of in the conventional waste stream without regard to their i radioactive material content.

8. What management is being made (or foreseen) for the ICSD being collected by that l agency?

As stated in answer to your question 7, ICSD's are authorized for disposal along with conventional waste. l l

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L P. Martinez ~ 9. In particular, how are those ICSD's with Am-241 sources of less than 40 KBq being -

managed?

L As stated in answer to your question 7, ICSD's are authorized for dis'posal as conventional waste, including those with americium-241 sources of less than 40 KBq (approximately 1 microcurie).

10. la recycling of the sources being applied? - >

There are no efforts being made to recycle the sources from ICSD's.

11. Which set of test and certifications are required to distribute ICSD's to final users and to allow " conventional" management. routes at the end of their useful lifetime?

As stated eartier NRC regulations found in 10 CFR 32.26,32.27, 32.28, and 32.29 as -

well as regulatory guidance found in NUREG's 1556, Volumes 3 and 8 and in RG 6.9, are used as a basis for test and certifications to allow " conventional" disposal routes for ICSD's at the end of their useful lifetime.

If I can be of further assistance, please contact me at (301) 415-6140 or e-mail askOnrc. gov.

Sincerely, Frederick C. Sturz, Chief Section A, Materials Safety and ]

Inspection Branch  :

Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosures:

1.10 CFR Parts 30 and 32 * '

2. Reg Guide 6.9

3. NUREG-1556, Vol. 3

4. NUREG-1556, Vol. 8 5.- NRC Consumer Product Policy

6. NUREG/CR-1775

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UNITED STATES

, s* NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30000-4001 September 17,1999 Empresa Nacional de Residuos Radiactivos, S.A.

ATTN: Pedro Carboneras Martinez, Head of Safety and Licensing Dpt.

Emilio Vargas,7 - 20043 MADRID

Dear Mr. Martinez:

This refers to your inquiry of July 7,1999, concoming the regulation and management of lonizing Chamber Smoke Detectors (ICSD's). Some background information follows on the process for obtaining a U. S. Nuclear Regulatory Commission (NRC) license pursuant to Section 32.26,10 CFR Part 32, authorizing the distribution of smoke detectors.

In order to possess and use byproduct material, you must first satisfy the general requirements .

of 10 CFR 30.33. Therefore, you must apply for and obtain a specific license authorizing the l possession and use of byproduct material. As a foreign entity you would have to establish an office in the United States for licensing and inspection purposes. Based on the state (s) from 3 which a device will be manufactured and/or distributed, you would either submit an application i to the appropriate NRC regional office or since the NRC has no regulatory jurisdiction in an Agreement State, contact the appropriate Agreement State office (s) ior application information.

An applicant wishing to distribute or initially transfer products containing byproduct material, such as smoke detectors, to persons exempt from licensing, must also obtain an exempt

' distribution license from NRC. Prior to licensing smoke detectors for distribution, it is necessary for our Sealed Source Safety Staff to perform a device review pursuant to the issuance of a device registration sheet. The product information to be submitted for a distribution license and a device registration is outlined in 10 CFR Part 32, specifically in Sections 32.26,32.27, and  ;

32.29(c), and in Regulatory Guide 6.9 (RG 6.9) " Establishing Quality Assurance Programs For The Manufacturing And Distribution Of Sealed Sources And Devices Containing Byproduct .

Material," and NUREG 1556, Vol. 3, " Consolidated Guidance About Material Licenses, Applications for Sealed Source and Device Evaluation and Registration."and NUREG-1556, Vol. 8, " Consolidated Guidance About Materials Licenses, Program-specific Guidance About Exempt Distribution Licenses." An applicant should submit detailed drawings of the device and an example of the point-of sale package. '

For your use in understanding the process for applying for a distribution license and device review, I have enclosed reference copies of:

10 CFR Parts 30 and 32 (Enciosure 1);

Regulatory Guide 6.9 (Enclosure 2); ,

NUREG's-1556, Vol. 3 (Enclosure 3);

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P. Martinez

l. . 9. In particulir, how cr3 those ICSD's with Am-241 sourcIs of 1:ss thin 40 KBq b:ing managpd?

! As stated in answer to your question 7, ICSD's are authorized for disposal as

!' conventional waste, including those with americium-241 sources of less than 40 KBq

(approximately 1 microcurie).

10. Is recycling of the sources being' applied?

! There are no efforts being made to recycle the sources from ICSD's.

11. Which set of test and certifications are required to distribute ICSD's to final users and to allow " conventional" management routes at the end of their useful lifetime?

As stated earlier NRC regulations found in 10 CFR 32.26,32.27,32.28, and 32.29 as well as regulatory guidance found in NUREG's 1556, Volumes 3 and 8 and in RG 6.9, are used as a basis for test and certifications to allow " conventional" disposal routes for ICSD's at the end of their usefullifetime. {

l If I can be of further assistance, please contact me at (301) 415-6140 or e-mail askenrc. gov.

Sincerely,'

(orig. signed by)

Frederick C. Sturz, Chief Section A, Materials Safety and I

Inspection Branch .

Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards j

Enclosures:

1.10 CFR Parts 30 and 32

2. Reg Guide 6.9

3. NUREG 1556, Vol. 3 .

4. NUREG-1556, Vol. 8

5. NRC Consumer Product Policy

6. NUREG/CR-1775 I

DISTRIBUTION: i N IMNS Central File PDR-YES DOCUMENT NAME: H:\ EXEMPT \32.26\lNFOLTRS\ENRESA.WPD f C = COVER E m COVER & ENCLOSURE N = NO COPY OFC MSlB C Msig, C NAME - ASKirkwood:as krz  !

DATE 9/ FT /99 9/ /Q /99 OFFICIAL RECORD COPY  !

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