ML20138J809

Informs Commission That EDO Intends to Approve Rulemaking Plan to Amend 10CFR32.14(d)(1) Re Prototype Testing Requirements for Hands,Dials & Pointers Containing Tritium (Used Primarily in Timepieces)

ML20138J809
Person / Time
Issue date:	02/04/1997
From:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-97-028, SECY-97-028-R, SECY-97-28, SECY-97-28-R, NUDOCS 9702110070
Download: ML20138J809 (21)

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RULEMAKING ISSUE (NEGATIVE CONSENT)

February 4, 1997 SECY-97-028 EQB: The Commissioners FROM: Hugh L. Thompson, Jr., Acting Executive Director for Operations

SUBJECT:

RULEMAKING PLAN FOR REVISION OF PROTOTYPE TESTING REQUIREMENTS FOR HANDS, DIALS, AND POINTERS USING TRITIUM: RESPONSE TO PRM-32-4 TO PUT TIMEPIECES WITH GASEOUS TRITlUM LIGHT SOURCES ON THE SAME REGULATORY BASIS AS TIMEPIECES WITH LUMINOUS TRITIUM PAINT PURPOSE:

To inform the Commission that the EDO intends to approve a rulemaking plan to amend 10 CFR 32.14(d)(1) relating to the prototype testing requirements for hands, dials, and pointers containing tritium (used primarily in timepieces). The rulemaking would grant mb-microtec's petition to allow distribution of a new technology in self-illuminated timepieces.

CATEGORY:

This paper covers a minor policy question requiring Commission consideration.

BACKGROUND:

A petition from mb-microtec was received and noticed for public comment (58 FR 52670; October 29,1993). The petitioner requested that timepieces with gaseous tritium light sources (GTLS) be placed on the same regulatory basis as timepieces with luminous tritium paint. A GTLS consists of a sealed glass tube internally coated with a phosphor and may contain up to 200 mci gaseous tritium. The petitioner stated that design improvements have enabled the use of less tritium.

Timepieces using up to 25 mci of tritium for illumination have been distributed for use by the general public since the 1961 amendment to Part 30 which allows the possession, CONTACT: NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN THE Mary L Thomas,ilES FINAL SRM IS MADE AVAILABLE 415 6230 h

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The Commissioner: 2 use, and transfer of such timepieces without a li::ense. Prototype testing requirements applicable to the licensee distributor of timepieces and other devices containing tritium were established in 10 CFR 32.14(d)(1). The prototype tests were developed to ensure that under normal use tritium paint would remain bound to the dials and hands of timepieces, thermostat dials and pointers.

Timepieces containing greater than 25 mci of tritium in the form of GTLSs have more recently been distributed for use under a different exemption from licensing contained in 10 CFR 30.19, Self-luminous products. Licensing for distribution of self illuminated products under 10 CFR 30.19 is approved on a case-by-case basis, and is therefore more burdensome on licensees and NRC. Becsuse of improvements in the design of GTLSs, timepieces using GTLSs can now be produced using quantities specified in 10 CFR 30.15(a)(1), i.e., less than 25 mci. Howaver, the requirements for distribution under this section specify a prototype bending test."This is an appropriate test for hands and pointers painted with tritium paint, but not for the inflexible glass tubes that are the GTLSs. Because another licensing path is available to licensees, the staff has been reluctant to approve any individual exemptions from this specified test (authority to grant exemptions provided in 10 CFR 30.11). Therefore, no timepieces using GTLSs have been distributed for use under 10 CFR 30.15(a)(1).

i DISCUSSION: l Because of the requirements to distribute products for use under 10 CFR 30.19, the licensing process is more burdensome to the potential distributor of timepieces than is the case with an application to distribute timepieces for use under 10 CFR 30.15(a)(1). A simple change to the prototype testing requirements in 10 CFR 32.14(d)(1) would simplify the licensing process for distributors of timepieces containing GTLSs by allowing them to apply to distribute these timepieces for use under 10 CFR 30.15(a)(1). Thus, timepieces using GTLSs would be distributed and used under the same sections of the regulations as l timepieces using tritium paint. l Rather than revise the specific testing requirements in the regulations as proposed by the  !

petitioner to accommodate both tritium paint and GTLSs, the staff plans to take a more l

- performance-based approach and remove the existing specific testing proceduies from the i

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regulations and provide guidance on the appropriate procedures in a regulatory guide. The existing general performance standard that the tritium must be properly contained in the '

product would not be changed. The planned action will not change the level of radiation ,

protection provided to users of tritium illuminated timepieces.

This action involves no resource adjustments to the NRC Five-Year Plan.

The Commissioners 3 COORDINATION:

The Office of the General Counsel has no legal objection to this paper. The staff does not intend to coordinate this rule plan with the Agreement States because the licensing of manufacturers and initial distributors of watches and other products for use under exemption is reserved to NRC by 10 CFR 150.15.

RECOMMENDATION:

Note that it is my intention to implement the Rulemaking Plan within 10 days from the date of this paper unless otherwise directed by the Commission.

H h L. T omps ,

A 'g i Executiv D' ect r f Operations

Enclosures:

1. PRM-32-4

2. Plan for Rulemaking

3. Regulatory Agenda Entry SECY NOTE: In the abasnce of instructions to the contrary, SECY will notify the staff on Friday, February 21, 1997 that the Commission, by negative consent, assents to the action proposed in this paper.

DISTRIBUTION:

Commissioners OGC OCAA OIG OPA OCA EDO CIO CFO SECY

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l ENCLOSURE 1 J

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l 0 ~.0 microteC (USA) am P.O. Box 1174 l [ . . ,

North Tonowanco.New York 14120-9174 (716)694-2695 i

Julv 30.1993 l

.I He Secretary US NRC Atta: Chief. Docketing and i Service Branch

, Washington, DC 20555

Dear Sir:

l Attached you will find my Petition for Rulemakmg. I was adsised that my letter of April 28, I

1993 to Stew Baggett requesting an amendment would not accomplish the change requested.

Stew has held up work in that direction, I have sent a check for the amendment process. If there ,

is an additional fee required, please let me know.

Sincerely, Larry K Vice President i mb-microtec (US A) Inc.

cc: Steven Baggett 1 Medical, Academic and Commercial Use Branch, NMSS US NRC Washington, DC 20555 .

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i mb-microtec mb-microtec (USA)

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July 29.1993 t -

The Secretarv l US Nuclear Regulatory Comnussion Ref. License a 31-23712-ole

Attn

Chief. Docketir.g and Service Branch j Washington. DC 20555 1

Dear Sir:

l PETITION FOR RULEMAKING i In accordance with 10 CFR 2.802. we petition the Comnussion to amend its regulat;on. The purpose of the requested amendment is to put watches with gaseous tritium light sources (GTLS) i on the same regulatory basis as watches with lununous tritium paint regarding the requirements for i their distribution exempt from the requirements of 10 CFR 30.19.

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l' At present, watches with GTLS's can be distributed with an activity up to 200 mci T, but only, -

when each watch model is individually approved by the Comnussion for its exempt distribution, a

requirement in contrast to those for watches with tritium paint. 'Ihe Commission exerts a further

control over GTLS watches as it requires a disclosure on the pertment properties of GTLS's used in watches. An approval of satisfactory disclosure may be in the form of a registration of the I

GTLS in general as is e.g. the case of the products by our company (NR-446-S-102-S).

. It is our experience that watch marmb% do not want to become involved with the present

' licensing procedures conceming GTLS watches. In that sense, the present regulations are indeed counterproductive, withholding a better and safer watch illununation from the consumer.

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Further, persent regulations do not take account of the progress GTLS technology has rhieved over the past 15 years. Today, an anMog watch can be wellillumied with 14 GTLS of a total activity of 25 mci T, the same activity pMy admitted for tritium paint watches. Moreover, l today's production techniques permit GTLS manufacture of small, efficient sources with perfect seals. Only the minute amounts of tritium diffusing through the glass walls can escape.

i In support of the petrtion, we submit additional ishormation.

'Ihe enclosure 1, details the proposed amendment in the regulation to achieve the stated goal. Two j furtherenclosures review the existing regulations conceming timepieces with tritium, and assess the i

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US Suclear Regulatorv Commission. Washington Page 2 expected dose cammitment under the proposed amendment. In our opinion. the submined information suffices to satisfy all the requirements of the petition under 10 CFR 2.802.

Any desired additional information is of course gladly prosided.

- Sincerely yours Larry Kea '

Vice President l mb-microtec (US A) Inc. '

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Enclosures:

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1. Petition for Rulemaking per 10 CFR 2.802

2. Surwy of Existing Regulations Concernmg Tirnepieces with GTLS

3. Dose Commitment for Timepieces with Tritium Paint and GTLS Illumination _

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1. Petition for Rulemaking r>er 10 CFR 2.802 I It is the goal of the proposed amendment to put timepieces with gaseous tritium light sources (GTLS) on the same regulatory basis as those with tritium paint in regard to their distnbution

exempt from the requirements of 10 CFR 32.14 starting with (d). Other changes are not necessary 1

to keep the regulation consistent with the amendment.

(d) The Commission determines that:

) (1) 'Ehe method of contamment or binding of the byproduct materialin the product is j such that the radioactrve material will not be released or be removed from the product  ;

i under the most severe conditions which are likely to be encountered in normal use anii

! handling.

j Tritium in luminous paint will be considered to be properly bound to dials. hands. pointers and bezels if there is no visible flakmg or chippmg and the totalloss of tntium does not j exceed 5 percent of the total tritium when prototype dials. hands, pointers. and bezels are subjected to the tests (i), (ii), and (iiii) below in the order specified.

j l Tritium is also considered to be properly bound ifit is contained in gaseous form in a

! scaled vial of mineral glass if the vials do not get damaged or become dislodged and the loss of tritium does not e.xceed 5 nCi when prototype dials, hands. pointers and bezels are

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subjected to the test (i), (iii), and (iiii) below in the order specified.

i (i) Attachment of dials and bezels to a vibrating fixture at a rate of not less than 26 cycles .

I per second and a vibration acceleration of not less than 2G for a period of not less than one i hour.

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l (ii) Attachment of the hub ends of the hands or pointers to a clamp and bending of hands l or pointers over a 1-inch diameter cylinder, or i l I (iii) Attachment of the hub ends of the hands and pointers to a clamp on a sibratir:g fixture and vibration at a rate of not less than 16 cycles per secono ano a sibration acceleration of not less than 2G for a period of not less than one hour,

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(iiii) Totalimmenion of the dials, hands, pointers and bezels used in the tests described in

subdivision (i), (ii), or (iii) of this subperasteisi in 100 rtulliliten of water at room _

temperature for a period of 24 consecutiw houn and analysis of the test water for its i

radioactiw materials content by liquid scintillatinn counting or other equally sensitive i method.

(2) The product has been subjected to and nNets the requirements of the prototype tests.

Prototype tests for automobile lock illummators are prescribed by S 32.40. Schedule A.

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Survev of Esistina Regulations Concerning Timer,ieces with GTLS

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Present regulations conceming the use of tritium in paint for the dark reading of timepieces are outdated and do not consider gaseous tritium light sources (GTLS). There are a few exceptions to this mle. notably the US A. UK and Switzerland. 'these countries pemut a tritium actisity (a quantity of tritium) up to 200 mci: they recognize that GTLS are a superior form of self-activated light with a much better " containment" of tritium than paint.

Existing regulations for the use of tritium on timepieces are all based on recommendations by the "Intemati2nal Atomic Energy Agency"(IAEA). published in 1%7: " Radiation Protection Standards for Radioluminous Timepieces". It limits the tritium activity to be used per watch to 25 mci T and specifies further requirements, e.g. conceming adhermcc of paint and the water solubility of tritium. They are all casily met. These recommendations were adopted in a number of countries as binding regulations goveming manufacture and import of timepieces. 4 also ISO-Norm 3157 of the " International Standardizing Orgamzation" was issued along the lines of the IAE-recommendations, they are followed worldwide. Some of the regulations differentiate between watches wom on the body (wrist. pocket) and stationarv ones (alarm. wali), some also between " ordinary" and "special" watches. " Ordinary" watches have a lower max admissible tritium actisity (5 - 10 mci T) than the "special" ones. Others don't. and apply a general 25 mci T limit. e.g. the US.

All existing regulations for GTLS timepieces stipulate an approval for every specific model. in contrast to timepieces with tritium paint. His has proved to be a major hurdle for the GTLS timepiece.

Some countries refuse to accept GTLS timepieces altogether, notably Germany and some Scandinasian countries, even if the aethity limits for tritium paint are respected.

A large majority of countries, the less industrialized ones, do not question the confomtity to certain regulations, but accept imports if compliance with US. UK or Swiss regulations can be established.

3. Dose Commitment for Timepieces witn Tritium Paint and GTLS Illumination The dose-commitments due to timepieces with tritium paint and 200 mci of GTLS's are derived from the following papers:

Ref.1: " Radiation Dose Estimates from Timepieces containmg Tritium or Promethium 147 in Radic'uminous Paints", Oak Ridge Nationallaboratory, Report NUREG/CR 0216,1978. l l

Ref. 2: " Estimates of Potential Radiation Doses from Wrist watches Containing Tritium Gas".

Oak Ridge National Laboratory, Report NUREG/CR 0215,1978.

l He results for tritium paint per Ref. I are compiled in column 1 of the table. They refer to I timeptooes with an activity of 1.5 mci T as paint per analysis of timepieces actually distribu the US. To permit comparisons with the following data, the dose estimates are restated for an 2

n annual distiibution of 1 Slio. timepieces with an average 10 year life resulting in a timepiece

- population of 10 .\ tio.

The dose estimates for timepieces with 200 mci T refer directly to Ref. 2. which are based on the

' same annual distribution. average life and timepiece population and are presented in column 2 of the table.

Column 3 gives the dose estimates for timepieco ..ith 25 mci T in the form of GTLS according to the proposed reguistion for such timepieces. It is directiv derived from Column 2. but takes account of the 8-fold reduction of the activity (25 mci T w 200 mci T) and the 10-fold reduction in the tritium release rate (5 nCi T/24 hours w 50 nCi T/24 hours).

Ref. I and Ref. 2 also show that dose commitments following accidents are negligible when their low probabilities are considered.

j j - An accident with a single timepiece of 2 mci T-paint can entail a dose of only a fraction of 1 mrem (a tire releasing all the tritium as HTO). ,

. If paint is ingested and 2 mci T are incorporated. the dose may reach 60 mrem. )

i - If all GTLS of a timepiece break and release their tritium in oxidized form. 200 mci T might

entail a dose of 50 mrem. and 25 mci T a dose of 6 mrem l

- In a warehouse fire releasing all the tritium of 60 timepieces in oxidized form, the individual dose could reach 120 mrem for 200 mci timepieces and 15 mrem for 25 mci timepieces. _

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Clearly, the doses estimated for distribution, use, repair service and disposal per table and for accidents is very low and negligible for practical purposes for all considered tritium contauung l'

timepieces. It is extremely low for timepieces with 25 mci T as GTLS, in particular also low in comparison with the presently distributed tritium paint watches.

j It it in'erestmg to relate the dose estimates to accepted norms. e.g. to "A Guide for Controlling l Consumer Products Contauung Radioactive Substances",1985, by the " Nuclear Energy Agency".

' OECD. It recommends as max acceptable an "effectiw dose equrvalent" of 5 mrem /yr (0,05 mSviyr) for safety-related products, 0,5 mrenvyr (0,005 mSv/yr) for other products. Even if any

< safety function to a welllegible timepiece is denied, and even if the dose to 30 Mio. non-users is included. the dose estimate for timepieces per proposed regulation is some two ordets of j magnitude smaller than is admitted in the abow OECD document.

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1 RULEMAKING PLAN FOR MINOR REVISION OF 10 CFR 32.14, TRITIUM LIGHT SOURCES (PRM-32-4)

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Lead Office: Office of Nuclear Regulatory Research Staff

Contact:

Charleen Raddatz, RPHEB l

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Concurrences: --

D. Morrison, RES Date C. Paperiello, NMSS Date J. Lieberman, OE Date R. L. Bangart, OSP Date W. J. Olmstead, OGC Date -

Approval:

J. M. Taylor, EDO Date

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RULEMAKING PLAN FOR MINOR REVISION OF 10 CFR 32.14 TRITIUM LIGHT SOURCES (PRM-32-4)

Lead Office: Office of Nuclear Regulatory Research Staff

Contact:

Mary Thomas, RPHEB/DRA LLq Concurrences: September 4. 1996 (see attached)

[D.Morrison,RES Date f .19 -9 7-October 4. 1996 (see attached)

C. Paperiello, NMSS Date January 8. 19,91 (see attached)

, J. Lieberman, OE Date October 9. 1996 (see attached)

R. L. Bangart, OSP Date October 15. 1996 (ireby - see attached)

W. J. Olmstead, OGC Date Approval: -

At 2/4/97 H. L. Thomps ,J. -

Date Acting Exec iv ctor for Operations

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PLAN FOR RULEMAKING 1

f A. THE ISSUE TO BE ADDRESSED BY THE RULEMAKING I 1 A petition from mb-microtec was received and noticed for public comment (58 FR l

j 52670; October 29,1993). The petitioner requested that timepieces with gaseous tritium i light sources (GTLS) be placed on the same regulatory basis as timepieces with luminous i tritium paint. A GTLS consists of a sealed glass tube internally coated with a phosphor and may contain up to 200 mci gaseous tritium. Beta particles emitted by the tritium i interact with the phosphor which subsequently emits visible light. The petitioner stated i that, over time, improvements in the design of these tubes have increased the efficiency j so that less tritium is required for a given luminosity, and as a result, an effective self-

luminous timepiece using GTLS, rath3r than paint, can be manufactured using 25 mci of

, tritium. The petitioner stated that the current requirements for GTLSs are more stringent t than requirements for watches with the same millicurie amounts of tritium paint. The petitioner further stated with new technology greater illumination could be achieved with

less radioactivity than needed for a painted watch but that the additional requirements to j get a GTLS watch approved for distribution results in manufacturers not using this i technology. No public comments were received on the notice published conceming the' i l petition. I I

I B. RELEVANT REGULATORY FRAMEWORK

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l Section 30.15(a)(1) states that if a timepiece containing byproduct materialis to be i distributed to persons exempt from the Commission's licensing requirements, it may not l contain more than 5 millicuries per hand, not more than 15 millicuries in the dial, and not i more than 25 millicuries of tritium total. Section 32.14(d)(1) contains an overall i performance requirement for the binding of tritium to watch hands, pointers, and dials, as i 4

well as specific prototype testing requirements for tritium painted watch hands, pointers, and dials. Although 10 CFR 30.15(a)(1) does not specify a form for tritium in timepieces,

the prototype testing requirements in 10 CFR 32.14(d)(1) - the relevant section of the Commission's regulations under which a specific license to distribute watches exempt j under 10 CFR 30.15(a)(1) is granted - are only applicable to timepieces employing tritium paint.

Watches containing greater than 25 millicuries tritium in GTLSs may be distributed as

exempt by meeting the requirements of 10 CFR 30.19, "Self-luminous products," which,

,- unlike 10 CFR 30.15(a)(1), specifies neither a limit on the amount of tritium that may be I incorporated into self-luminous products, nor the end use of the product. However, to distribute a self-luminous watch containing tritium under 10 CFR 30.19 a specific license must be obtained under 10 CFR 32.22. The requirements to manufacture, process, produce, or initially transfer self-luminous products containing unrestricted amounts of i tritium under 10 CFR 32.22(a)(2) require the licensee to submit detailed information and j analyses concerning the particular product in order to obtain approval for distribution. The

information required by 10 CFR 32.22 must be sufficient to demonstrate that the product 4 1 i

i meets a number of specific safety criteria, including dose criteria for use and disposa!. It must include proposed prototype testing procedures, which in turn must be approved by the Commission. Further, the evaluations conducted both by the licensee and the staff, as well as the prototype testing proposed, apply to the entire product rather than ,

1 components. Conversely, approval for distribution of timepieces containing less than 25

, millicuries tritium under 10 CFR 30.15(a)(1) only requires satisfaction of the prototype 4

testing requirements contained in 10 CFR 32.14(d), along with some general requirements applicable to all specific byproduct material licensees. Consequently, it is less burdensome upon a licensee to distribute watches employing tritium illumination under 10 CFR 32.14 than 10 CFR 32.22.

C. ALTERNATIVES FOR RESOLUTION

1. No Action. Excent to Denv the Petition: Not changing the regulations would maintain the current situation, which is: since the bending test requirement of 10 CFR 32.14(d)(1)(ii) is not appropriate for GTLS, commercial distributors must apply for and obtain a license amendment in accordance with 10 CFR 32.22 for watches using GTLS, I with the attendant cost in time and expense of performing detailed safety analyses not l considered necessary for watches employing the same quantities of tritium but in the form of paint. The cost for distributors to initially obtain a distribution license under 532.22 rather than under 10 CFR 32.14 is an unnecessary administrative expense without commensurate health and safety benefit.

2. Amendment of Reaulations: Revision of the testing requirements of 10 CFR 32.14(d) to accommodate GTLS containing no more than 25 mci of tritium would permit simplification of the licensing process for watches containing GTLS. For vendors who want to continue marketing self-luminous watches containing GTLS with greater than 25 millicuries tritium, the provisions of 10 CFR 32.22 will remain.

As noted above, watches using GTLS can be produced without exceeding the quantities of tritium specified in 10 CFR 30.15(a)(1). Further, an appropriate test can be devised, and has been proposed by the petitioner,' that would demonstrate that a watch employing GTLS illumination would meet the requirement in 10 CFR 32.14(d)(1) that "...

the method of containment or binding is such that it is unlikely that the radioactive The petitioner has proposed substituting a vibratory test, similar to that specified for painted dials, in place of the bending test for hands and pointers in the case of timepieces using GTLS, to ensure the unit integrity of the GTLS, pointers, and hands. As pointed out by the petitioner, this would be consistent with the comparable but somewhat more flexible prototype testing requirements described in IAEA Safety Series 23, " Radiation Protection Standards for Radio Luminous Timepieces." Attaching only the hub end of the hands and pointers to a fixture and subjecting them to vibration as proposed by the petitioner would involve smaller forces than the bending test but would still exceed the forces these elements would encounter under the most severe conditions expected in normal use. The NRC staff has reviewed the petitioner's proposed test, and agrees that the suggested testing would be adequate and acceptable.

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material will be released or be removed from the product under the most severe conditions

[ which are likely to be encountered in normal use and handling..,"

. Within the alternative of rulemaking to accommodate GTLS, a variant to the specific

, proposal of the petitioner has been considered. Thus, the alternatives considered are:

) (a) revise the regulations to incorporate the prototype test specified by the petitioner to accommodate GTLS:

i (b) remove specific prototype testing requirements from the regulations and place both

! the test proposed by the petitioner and the current prototype test for painted hands, dials, j etc., in a regulatory guide, but maintain in the regulations the overall performance criterion:

i that the Commission determine that the method of containment or binding is such that the j radioactive material will not be released or be removed from the product under the most i severe conditions which are likely to be encountered in normal use and handling.

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While either approach will grant the intent of the petitioner's request, the second is a i more performance-based approach that would bettor accommodate future developments in j luminous technology. Specifically, even though the prototype test procedure proposed by i the petitioner is considered acceptable and reasonable for GTLS on watches, other methods or applications may arise where it may not be optimal or appropriate. Hence, with this variant the staff can approve new or different applications and methods without need for either an amendment to or exception from existing regulations, and yet continue

' to assure that "...the method of containment or binding of the byproduct materialin the l product is such that the radioactive material will not be released or be removed from the i product under the most severe conditions which are likely to be encountered in normal use and handling."

3. Use of Information Notices. Generic Letters, and Reaulatorv Guides - These I

alternatives would be inappropriate since they cannot be used to override what's required by the regulations.

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! In consideration of the above, the NRC staff intends to proceed with alternative 2(b):

! amending the regulations to accommodate watches employing GTLS by removing the

prescriptive prototype testing specification for tritium paint from the existing regulations i and placing both that specification and the prototype test proposed by the petitioner in a regulatory guide.

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! D. COST EFFECTIVENESS i

The leak rate of tritium from GTLS incorporated into timepieces is lower than that from an equivalent Curie amount of tritium paint incorporated into timepieces; thus, the I

exposures from timepieces using GTLS less than 25 mci are lower than those from timepieces using tritium paint.. In fact, ORNL recently reported that the potential skin dose from a GTLS watch containing 50 millicuries (50 millirem) is four-fold lower than a watch containing 2 millicuries tritium paint (200 millirem). Moreover, the health risk from the i release of 25 mci of gaseous tritium in the event of breakage of the glass vials is not significant.

l The proposed rule would not present a new cost burden to applicants or licensees, but could eliminate cost burdens associated with the licensed distribution of timepieces using GTLS containing 25 mci or less of tritium. '

E. BACKFIT ANALYSIS The backfit rule,10 CFR 50.109, would not apply to this proposed rule and, therefore, a backfit analysis is not required, because the amendments do not involve any provisions ,

which would impose backfits as defined in 10 CFR 50.109(a)(1). I i

F. OGC LEGAL ANALYSIS l OGC advises that, to achieve the regulatory objective of the petition, it would be necessary to amend 10 CFR 32.14 in either of the manners described under C.2(a) or 2(b)  ;

or promulgate a new rule specifically for GTLS. OGC has reviewed the rulemaking plan including the proposed approach under NEPA and the Paperwork Reduction Act. OGC believes that an Environmental Assessment will need to be prepared in support of the l proposed rule because it is not covered under any of the categorical exclusions described l under 10 CFR 51.22. There does not exist any known basis for objection to promulgation of a rule drafted in accord with C.2(b).

Since the proposed rulemaking plan would also address issues related to the petition for rulemaking, the staff will need to assure that appropriate procedural actions are taken to close the actions associated with that petition. These actions included specifically denying or granting the petition for rulemaking, either in the Federal Register notice associated with the proposed rulemaking or in a separate Federal Register notice, and informing the petitioner of the Commissions decision. The detailed procedures for responding to the rulemaking petition are contained in Part 11 of the Regulations Handbook (NUREG/BR-0053), Rev. 3).

G. IMPLEMENTATION BY THE AGREEMENT STATES The licensing of manufacturers or initial distributors of watches and other products distributed for use under exemption is reserved to NRC by 10 CFR 150.15.

H. SUPPORTING DOCUMENTS l

This rulemaking will require a simple Regulatory Analysis that will show no impact to i licensees. No backfit analysis will be needed. However, an OMB Paperwork analysis and I under alternative 2(b), a regulatory guide will need to be prepared. OGC believes that an l Environmental Assessment may be needed.

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l. RESC URCES l

The estimated resources to complete this rulemaking, alternative 2(b) would be about l 0.9 staff year. Approximately,70 percent of this effort would come from RES and about 30 percont divided among NMSS, OSP, OGC, and ADM. Although alternative 2(b) does include the preparation of a regulatory guide, preparation of the guide should require little more ef" ort than amending the regulations to incorporate the petitioner's proposed test, alternative 2(a), since the contents of the guide would be the test in the current regulation and the petitioner's test.

I No contractor support dollars will be expended. No additional resources are anticipated l to implement the rule. A slight reduction in resources might occur in that new models of '

watches containing GTLS which could be distributed under a 10 CFR 32.14 license would require less administrative effort than if approved under a 10 CFR 32.22 license.

Resources to complete and implement the rule are included in the current budget. A copy of the rulemaking concurrence package will be forwarded to the Office of the  ;

Controller for coordination of resource issues per EDO Memorandum of June 14,1991.

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1 J. ENHANCED PUBLIC PARTICIPATION  !

This rulemaking is a minor revi.sion which does not warrant an enhanced public participation.

K. ISSUANCE BY EDO IN ACCORDANCE WITH MD 9.17 This rule would not constitute any major policy change; rather it would update prototype testing requirements pertaining to the use of tritium on dials, hands, and  ;

pointers contained in 10 CFR 32.14. For this reason, it falls within the authority delegated i to the EDO to issue this rule in accordance with paragraph 0213 of Management Directive 9.17.

L. LEAD OFFICE STAFF AND KEY STAFF FROM OTHER OFFICES I Research - Mary L. Thomas NMSS - Steven L. Baggett OGC - Robert L. Fonner SP - Dennis M. Sollenberger M. STEERING / WORKING GROUP No steering group will be used on this rulemaking. The working group is identified above.

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N. SPECIAL MEASURES & INFORMATION There were no public comments on the notice published concerning the petition.

An expansion of this exemption could also include other uses of GTLS such as compasses, thermostats, and gun sights. However, this is both outside the scope of the petitioner's request and would require further study to either assure the appropriateness of the petitioner's proposed test, or develop appropriate prototype tests. Hence, this alternative would take more resources and time to complete. It is considered more '

responsive to the petitioner to limit this particular rulemaking to a simple change in the testing requirements of 10 CFR 32.14(d) as requested by the petitioner. Further improvements in the licensing of distribution of exempt products / materials could be considered in the future as part of the ongoing program to reevaluate the exemptions. In addition to considering rulemaking, the staff may review the licensing practices implementing Part 32 with respect to exempt distribution, such as providing for a more generic product approval for distribution under 10 CFR 30.19.

O. SCHEDULING Proposed rule 3 months after approval of the Rulemaking Plan Final rule 6 months after proposed rule published 6

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i REGULATORY AGENDA ENTRY s 1 1

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TITLE: Revision of Prototype Testing Requirements for Dials, Hands, and Pointers Containing Tritium

RIN

To be determined

CFR CITATION

10 CFR 32.14, Certain items containing byproduct material: l

. requirements for license to apply or initially transfer. l ABSTRACT:

l l Resolution of a petition received from mb-microtec to amend 10 CFR 32.14 to j include watches containing gaseous tritium light sources (GTLSs) on the same regulatory basis as luminous tritium paint. Since the application of tritium luminescent technology has changed sufficiently, a modification of the regulation is warranted. Although the exemption in 10 CFR 30.15(a)(1) puts no restriction on i

the form of tritium in timepieces, the prototype testing requirements of 10 CFR 32.14 were designed for luminous tritium paint and preclude distribution of timepieces containing gaseous tritium light sources (GTLSs) for use under this 3 exemption. Currently, timepieces containing GTLSs must be approved for distribution under 10 CFR 32.22 for use under 10 CFR 30.19, the class exemption

for self-luminous products. The licensing process in this case is more complex.

1 Exposures to the public are very low from watches using either GTLSs or luminous i tritium paint, with watches using GTLSs generally resulting in lower exposures. In this case, the more burdensome process involved in obtaining authorization to distribute this product under 10 CFR 32.22 is unnecessary. Revision of the prototype testing requirements will allow distribution on the same regulatory basis as watches containing luminous tritium paint. These prototype testing requirements also apply to thermostat dials and pointers, which may also be i affected.

1 TIMETABLE: Office concurrence 3 months after EDO approval I

Final rule published 6 months after proposed rule i published LEGAL AUTHORITY: 42 USC 2201; 42 USC 5841

EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES

None.

. AGENCY CONTACT:

i Mary L. Thomas, Office of Nuclear Regulatory Research, (301) 415-6230.

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