ML23156A130

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PRM-032-004 - 58FR53670 - Petition of MB-Microtec (USA) Concerning Timepieces with Gaseous Tritium Light Sources (Gtls)
ML23156A130
Person / Time
Issue date: 10/18/1993
From:
NRC/SECY
To:
References
PRM-032-004, 58FR53670
Download: ML23156A130 (1)
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Text

ADAMS Template: SECY-067

DOCUMENT DATE: 10/18/1993

TITLE: PRM-032-004 - 58FR53670 - PETITION OF MB-MICROTEC (USA) CONCERNING TIMEPIECES WITH GASEOUS TRITIUM LIGHT SOURCES (GTLS)

CASE

REFERENCE:

PRM-032-004

58FR53670

KEYWORD: RULEMAKING COMMENTS

Document Sensitivity: Non-sensitive - SUNSI Review Complete STATUS OF RULEMAKING

PROPOSED RULE: PRM-032-004 OPEN ITEM (Y/N) N

RULE NAME: PETITION OF MB-MICROTEC (USA) CONCERNING TIMEPIECES WITH GASEOUS TRITIUM LIGHT SOURCES (GTLS)

PROPOSED RULE FED REG CITE: 58FR53670

PROPOSED RULE PUBLICATION DATE: 10/18/93 NUMBER OF COMMENTS: 0

ORIGINAL DATE FOR COMMENTS: 01/03/94 EXTENSION DATE: I I

FINAL RULE FED. REG. CITE: 63FR32969 FINAL RULE PUBLICATION DATE: 06/17/98

NOTES ON: PETITION RE AMENDMENT OF NRC REGS. TO PLACE TIMEPIECES WITH GASEOU STATUS S TRITIUM LIGHT SOURCES ON THE SAME REGULATORY BASIS AS THOSE WITH OF RULE LUMINOUS TRITIUM PAINT. (SEE PR-32, 62FR49173, PUB. 9/19/97)

HISTORY OF THE RULE

PART AFFECTED: PRM-032-004

RULE TITLE: PETITION OF MB-MICROTEC (USA) CONCERNING TIMEPIECES WITH GASEOUS TRITIUM LIGHT SOURCES (GTLS)

PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: 10/08/93

FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: 98-060 SRM DATE: 05/13/98 SIGNED BY SECRETARY: 06/09/98

STAFF CONTACTS ON THE RULE

CONTACT!: MICHAEL T. LESAR MAIL STOP: P-223 PHONE: 492-7758

CONTACT2: MAIL STOP: PHONE:

DOCKET NO. PRM-032-004 (58FR53670)

In the Matter of TIMEPIECES WITH GASEOUS TRITIUM LIGHT SOURCES PETITION OF MB-MICROTEC (USA) CONCERNING (GTLS)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

108/09/93 07/30/93 PETITION FOR RULEMAKING SUBMITTED BY LARRY KEATING, VICE PRESIDENT OF MB-MICROTEC (USA), INC.

ON BEHALF OF THE COMPANY 08/17 /93 07/12/93 LETTER FROM LARRY KEATING OF MB-MICROTEC ENCLOSING LAST PAGE OF PETITION

10/21/93 10/08/93 FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING 12/05/95 06/21/95 LTR FM LAWRENCE KEATING, PRESIDENT, MB-MICROTEC, RE DELAY IN RESOLUTION OF THEIR PETITION AND PROVIDING INFORMATION ON NEW DEVELOPMENTS 12/05/95 11/08/95 LTR FM LAWRENCE KEATING, PRESIDENT, MB-MICROTEC, REQUESTING MODIFICATION TO PETITION

8/02/96 07/25/96 LETTER FROM LARRY KEATING, PRESIDENT, MB-MICROTEC TO FRANK CONSTANZI, RES ENCLOSING RESPONSE TO ARTICLE IN HEALTH PHYSICS JOURNAL ON WATCHES.

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DOCK ET NL' ~,18E R PETITION RULE PRM JJ.:,'-/

Dr. Frank Constanzi July 25,1996 :;, 3 670) L5 r-F(lr USNRC Office of Research Washington, DC 20555

Dear Dr. Costanzi,

Health Physics Journal on watches. The response was prepared by I have enclosed a response to an article in the Oscar W. Thuler the president of mb microtec ag. Please pass it on to your investigators, if we can be of further assistance let me know.

Sincere /{+'

Larry Keating /

President mbrn Inc.

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TRITIUM INTAKE BY EXPOSURE TO PLASTIC CASE WATCHES

Dear Editors,

Both our company and its predecessor have supplied radioluminous materials and sources to the watch industry since 1918. We therefore take the liberty of commenting on the paper "Tritium Intake by exposure to plastic: case watches", Health Physics, Vol.

70, No. 4 in order to put the problem In a more general perspective.

The radiolumlnous watch is the oldest and moat widespread consumer product containing radioactive material. The associated risks have been continuously assessed -

the paper In question is an example, not the exception. "Oegasaing, as the release of tritium from tritium paint by radiolysls Is called, was investigated in the laboratories of the Swiss watch Industry In the sixties. Despite degassing, the replacement of radium 228 by tritium in radioluminous watches has reduced the effective dose to the watch wearer by a factor of 10 to 100 while at the same time permitting 10 times higher brightness and better dark reading. The reduced dose Is considered negligible as comprehensive investigations In the US 1) and the UK 1 ) have shown, being of the order of a few µSv/yr.

The authors of the paper in question show that wearers of plastic case watches with tritium paint may be exposed to higher doses estlmated at 20 µSv/yr effective dose and 180 mSv/yr skin dose over a very small area. They state, rightly, that the effective dose Is negligible. It is indeed I This i1 the consensus of the health physics community as presented In the "1990 Recommendations of the ICRP". An effective dose limit of 1 mSv/yr In public exposures is recommended by the Commission for the total of such "practices". This "Judgment is based on the vartatlona in the existing level of dose from natural sources", whleh, it says, "can hardly be called unacceptable~. It further believes, that exempting practices wm, public exposure below this limit *Is an important component of the regulatory function".

The International Atomic Energy Agency (IAEA) issues further advice on this subject to its member states ") by reeommending a llmlt of 10 1JSv/yr of expected effective dose due to any one "practice or source within a practice" as one criterion for an exemption from the Standards.

In the European Union (EU), a *aasic Safety Standard Directive* will be publlshed shortly. The same ideas and detailed criteria for exemption* as in the 1990 ICRP Report and the IAEA Basic Safely Standards are part of this directive. EU-Directives are usually approved by the member countries and become law within a period varying between months and years after Issue.

To put the 10 µSv/yr effective dose per practice to members of the public In the proper perspective: the average dose due to the total natural background radiation is some 2000 µSv/yr. It is often double and may be ten times that. Doses due to cosmic rays alone Increase by 10 µSv/yr for every 200 ft Increment In altitude above sea level.

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Clearly, the affect of the paper runs counter to the aim of the regulators, which l!I *~ pivi::-i~.. _

wastage of limited resources on trivia, in order to focus them on real issues in radiation protection. It will not only be read by the specialist capable of seeing the results in context, but will also be quoted and requoted in the watch Industry media and thu, reach the consumer. The wordage evokes emotions and will lead the nonnal consumer to perceive the wearing of all radioluminous watches as dangerous. Indeed, anticipating this reaction, the cited "leading manufacturer of the nndy plastic watches" has already ceased using tritium paint in response to an earffer artide on the same topic by the same Institute 4). This perception may rule out radloluminous watches altogether - at a loss to the consumer. He or she recognizes night reading as a benefit, the demand for this feature over decades Is proof.

We also hold the author's estimate of the skin dose III daring speculation. Thay offer no evidence of the tritium fraction excreted In organically bound form (OBT). The cited formula to calculate the skin dose is derived from experiments 'Nhic:h may be far off dupllcating the conditions encountered in wearing a plastic watch. Inhalation and immersion in HTO diffused through the plastic case material can well account for the tritium observed In the body water. It strikes as unlikely, that an effective dose of 20 µSv is connected with a skin dose of 180 mSv.

To make matters worse, this paper appears at a time when a new technology is avallable in the form of gaseous tritium light sources (GTLS). These re sealed, hollow bodies of borosilicate glass internally coated with a luminophor and filled with tritium gas.

Compared with tritium paints the conversion efficiency to light is superior, the achievable brightness 100-fold, more stable, and the tritium better contained by

  • factor of at leaat 1000. These light sources ere small and light enough to mark dial positions and the hands, providing excellent dark reading under an ambient illumination. Property designed, such watches meet the requirements of the lntemational Standard ISO 2919

Sealed radioactive Sources" for their respective environment. In norm,1 use, a GTLS watch With an activity of 1 GBq T will exPO&e the wearer to an effective dose In the range of one tenth of 1 µSv/yr. The most exposed member of the population In the worst scenario would be subjected to 100 µSv/yr in the diaposal of the watches. The worst, and highly unlikely accident with a GTLS wetcn can expose the wearer to no more than 100

µSv/yr. Rationally seen, this detriment is negligible and well worth the benefit of a watch readable safely under all ambient lighting conditions - It has often proven to be a valuable safety feature.

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- 3 -

1. "Estimates Aug. 1978, Rapport NUREG/CR-0215, ORNL of Potential Radiation Doses from Wristwatches Containing Tritium Gas",
2. "Board Statement on Approval of Consumer Goods Containing Radioactive Substances'., 1992, National Radiological Protection Board
3. "lntemational Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources", Safety Series No. 115, International Atomic Energy Agency, Vienna 1996
4. "Tritium exposure from plastic case watches", lancet, Vol. 343, p. 116, Jan. 1994

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Dr.Frank Constanzi USNRC Office of Research Washington,DC 20555 mb-microtec (USA) mb-microtec P.O. Box 1174 North Tonawan <tfb ~Kf:' T ~ ~ 14120-917 4 USN RC to/16) 694-2695

  • 95 DE C -5 P 1 :51

OFF ICE OF StCRETARY DOC KETING & SERV ICE BRANCH November 8, 1995

Mr. Steven Baggett DOCKET NUMBER US NRC PETITION RULE PRM>3a - +/-

Washington, DC 20555 ( 5-=c. FR.S"oCc 7 OJ

Re: PRM-32-4

Dear Mr. Baggett:

We have reviewed our petition for rule making dated July 29, 1993.

There is an error on page one (iii) it should read, "Attachment of the hub ends of the hands and pointers to a clamp on a vibrating fixture and vibration rate of not less than 26 cycles per second and a vibration acceleration of not less than 2G for a period of not less than one hour".

We have suggested this test since it has been accepted by IAEA Safety Series No. 23 when bending of the hands is not practicable.

We request that our petition be modified to include the change.

Sincerely,

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Lawrence Keating _J___

President LK:db

Enclosure:

IAEA abstract U.S. NUCLE AR R~C. tiLi,TORY COMMISSIOt-.

DOCKETING & OfFICE OF THE SECRETARY SERVICE SECTION OF THE COMMISSION

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03/11/1995 15:32 0041319811105 s. 01

SAFETY SERIES No.23

  • RADIATION PROTECTION STANDARDS FOR RADIOLUMINOUS TIMEPIECES

RECOMMENDATIONS DRAWN UP BY A JOINT GROUP OF EXPERTS OF THE EUROPEAN NUCLEAR ENERGY AGENCY AND THE

- INTERNATIONAL ATOMIC ENERGY AGENCY

INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 1987

. 03/11/1995 15: 32 004131981'..H!5 l'IB-MICRJTEC.C.G 02

2. 2. 2. Adhesion, release ot* activity ar.d solubility

(a) Adhesion: The dial shall be attached to a vibratini fixture and undergo vibration at a rate of between 20* and 30 Hz, and a vibration acceleration of not less than 2 i for a period of not less than one hour (& ia the acceleration due to the earth's gravity).

The hands shall be bent over a* cylinder of 2. 5 cm diameter.

If the length of the hand exceeds 1.5 crn, a larger bending radius up to the length of the hand teated shall be permitted. If, for reason of special design, bending tests are not practioable, they should be replaced by a vibration test similar to that for dials.

After this, appropriate tests should be made to check the firm adhe'Jion of the paints on the dials and hands, i.e. by means of ultra-violet lamps and/or measurement of the activity ot the painted components in order to enaure that no significant loss of activity has occurred.

(b) Release of activity and solubility for tritium-activated paints: Hands and dials containing tritium-activated paints that have been subject to vibration or bending tests shall be totally immersed in distilled water at 20 +/- 2°c for' 24 h. The water must stand at least 3 mro abov~.the painted area. The tritium I I content of the water shall not exceed s,o ot the original activity of the tested components. I ' I I

I,II!

I I, The transparent cover must have a thickness equivalent to not I,*1 1 less than 50 mg/ cm2 at any point. I Ii\\

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2. 3. QuaUty control I

Quality control procedures ahall be used to ensure that the quality of the timepiece or components compares adequately with the quality of those timepieces or ~omponents employed in the proto*

type tests. As a minimum. quality control shall consist of 1000/o visual inspection to detect cracking or flaking of paint, imperfections in the transparent cover. inadequate markinge, etc.

Spec:ial control procedures may be set out by the appropriate national authority, which shall take any measures necessary to en su:re compliance with the standards. The manufacturer should make any additional teats nec:eaaary to fulfil the standards.

13 mb -microtec (USA) mb-microtec North Ton~. 1'.Jew York 14120-917 OO0CKKEETE En P.O. Box 1174 4

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OFF ICE Of s:cR ET RY oocK ET 1N\\ x SE,' 1c BR ANCH

June 21, 1995 DOCKET NUMBER PETITION RULE PRM >'3 - 4 Ms. Catherine Mattsen ( 51lr"R.5a<o, o)

U. S. Nuclear Regu latory Commission Washington, D.C. 20555

Re: WATCHES WITH GASEOUS TRITIUM LIGHT SOURCES (GTLS)

PRM-32-4

Dear Ms. Mattsen:

On July 29, 1993, we submitted a "Petition for Rulemak ing per 1 0CFR 2.802." Its goal was to put watches with GT LS for dark reading from the regu latory point of view on the same basis as those with tritium paint. Almost two years have passed and we still have no resolution. We fail to understand this situation considering the widespread agreement, that GTLS watches per proposal cause a negligible exposure to the consumer and the public, which is shown to be smaller than the one by tritium paint watches. Our efforts to introduce the GTLS for watch illumination are seriously hampered by this regulatory disadvantage. We pay a heavy price for delays in regulatory actions and a distinct benefit to the consumer is withheld.

Since submitting the proposal, important developments in two ways have taken place. One, more data on the expected effective doses due to GTLS-watches have become available. Two, new standards by the most prominent international bodies on radioprotection have been worked out, which also specify criteria for exempting practices, sources and substances from the Standards. It should be noted, that the commission of the European Communities has adopted the same exemption criteria in 1993 and made them part of their "European Directive" on radioprotection. In the enclosure, we have summarized the results of our survey.

A review of the data presented can only lead to one conclusion : GTLS-watches as we have proposed them qualify automatically for exemption from the standards without further notification, registration or licensing. This refers in particular to the most recent, most comprehensive and most authoritative standard by the IAEA, co-

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Md'\\ Spec\\al Copies ~.£\\Reproduced ~ ---see-n,::::fPB.::B> 16 sponsored by the FAQ, ILO, WHO, OECD(NEA), and PAHO. Contributors to drafting and reviewing were prominent US experts, e.g. Mr. Cunninham of the US NRC, Mr. James of the DOE, and Mr. Richardson, of the EPA.

We would appreciate your help in getting this information to the people reviewing our proposal for a rule change. Indeed, we hope they conclude that an exemption in line with the cited standards is a window of opportunity to initiate a welcome de-regulation and a uniform "practice" worldwide.

We wait for a decision and are glad to provide any further information.

Sincerely yours,

~ I & q!w.-1.

awrence Keating President

LK:kjw Enclosures ( 14 pages)

cc: Steven Baggett ii t ) q1*crr'[1-1 c :tl

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WATCHES WITH GASEOUS TRITIUM LIGHT SOURCES (GTLS):

STANDARDS AND REGULATIONS GOVERNING THEIR DISTRIBUTION

1. Introduction

Gaseous tritium light sources (GTLS) contain radioactive tritium in a sealed envelope of mineral glass. Its betarays (electrons) excite light in luminescent materials on the inside walls much like the electrons in a television tube produce light in the screen. No electrons can penetrate the glass.

GTLSs can be used to mark the hands and hour positions of a watch for dark reading and provide much higher brightness than the presently used tritium paints. In addition, the tritium in a GTLS is much better contained than in paint.

The use of GTLS in watches reduces potential irradiation to an absolutely negligible level. Despite these established facts, GTLS-watches suffer from more severe regulatory constraints. This needs to be corrected!

GTLS-watches are subject to regulations even though the watch is free of any radiation. These regulations concern mainly their distribution. They are derived from standards which are developed by the world's experts in international institutions like the,,International Commission on Radiological Protection" (ICRP) or the,,International Atomic Energy Agency " (IAEA). The IAEA is particularly active in developing standards for radioprotection and has published in 1994 its most comprehensive guide,,,Safety Series No. 115-1", cosponsered by such other international organizations as FAQ, ILO, WHO, OECD (NEA), and PAHO. Also the Commission of the European Communities has adopted the same exemption criteria in 1993 and made them part of their,,European Directive" on radioprotection.

These latest standards are of particular importance to the status of the GTLS watch. They exhibit criteria for practices, sources and substances, which shall be exempted from the regular standards. The GTLS-watch with well defined design and testing criteria ( see 3. below) can be distributed to the consumer without regulatory limitations according to these criteria.

It is the purpose of this paper to inform on the exemption criteria in the cited standards and to demonstrate compliance to these for the GTLS-watch with the proposed design and testing characteristics.

2. Exemptions from Regulations

The following recent standards treat radiation protection in general and the criteria for exemptions from all or certain requirements from these standards :

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1. 1990 Recommendations of the International Commission on Radiological Protection.

2. Principles for the Exemption of Radiation Sources and Practices from Regulatory Control, 1988, Sponsored by the IAEA and OECD/NEA.

3. International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources, 1994, Safety Series No. 115-1.
4. Principles and Methods for Establishing Concentrations and Quantities (Exemption values) Below which Reporting is not Required in the European Directive, Doc. XI - 28/93 by the Commission of the EU.

The last two are comprehensive and very specific as regards criteria for exempting,,practices and sources within practices" from the requirements of the Standard. The pages under,,Schedule I, Exemptions" are enclosed in the annex.

Besides the general principles it gives two quantitative sets of criteria:

1. A practice or a source within a practice may be exempted without further consideration provided that the following criteria are met in all feasible situations:

a) the effective dose expected to be incurred by any member of the public due to the exempted practice or source is of the order of 10 µSv or less in a year, and b) either the collective effective dose committed by one year of performance of the practice is no more than about 1 man.Sv or an assessment for the optimi zation of protection shows that exemption is the optimum option.

2. Under the criteria in paras 1-1 to 1-3, the following sources within practices are automatically exempted without further consideration from the requirements of the Standards, including those for notification, registration or licensing:

a) radioactive substances for which either the total activity of a given nuclide present on the premises at any one time or the activity concentration used in the practice does not exceed the exemption levels given in Table 1-1 of Sche dule I.

Schedule I gives the limit of activity for tritium at 1 GBq or about 27 mCi.

As outlined earlier, the Commission of the European Communities has adopted the same exemption criteria.

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3. GTLS-Watches Proposed for Exempt Distribution

With present regulations in the US, Canada, the UK and Switzerland, GTLS watches have been distributed exempt from certain regulatory requirements.

Based on this experience our company has proposed design and testing require

  • ments which are in several ways considerably more restrictive than the regulations in the above countries provide. They are the following:

- Tritium activity per watch max_ 25 mCi

- Tritium release per watch max. 5 nCd/d

- Prototype testing: meeting or exceeding all requirements of,,American National Standard N540" for temperature, temperature shock, pressure (reduced), impact, vibration and immersion

- Quality Control testing: 100% testing of GTLS to a tritium release rate of max. 5 nCd/d for all sources of one watch

- Final testing: random sample test for tritium release on finished watches

- Quality control and final testing results to be recorded and available for docu-mentation

In particular, this proposal is more stringent than the GTLS-watches investigated in the two studies summarized in the next section regarding

- Max. T-activity per watch : 1 GBq or 27 mCi instead of 200 mCi

- Max. T-release per watch and day : 5 nCi or 200 Bq instead of 50 nCi or 2000 Bq

- 100% testing of GTLS to the requirement for T-release.

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Page4

4. Expected Radiation Exposure Due to GTLS-Watches

Here the summarized results of two comprehensive exposure studies for the GTLS-watch over its lifecycle.

A. Estimates of Potential Radiation Doses from Wristwatches Containing Tritium Gas, Oak Ridge National Laboratory, 1978

Estimates are based on the following assumptions:

  • Activity per watch 200 mCi T
  • Activity release per watch (HTO) 50 nCi T/d
  • Annual distribution 1 Mio. watches
  • Average I ife 10 years i -
  • Average watch population 10 Mio. watches
  • Disposal p.a. 1 Mio. watches

of which storing in home for 5 years before disposal 50%

Burial 25%

Incineration 25%

SUMMARY

OF EXPOSURES

-7 -1 Distribution 8 X 10 to 3 X 10 mrem/a

-2 Wearer & Bystander 0 to 2 X 10 mrem/a

Disposal -3 -2

- storing in home 2 X 10 to 3 X 10 mrem/a

- HTO release at incineration 0 to 17 mrem/a

One-time exposure in accident with one watch 0,5 to 50 mrem

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From these exposures the ones for the GTLS-watch per our proposal (see 3.) can be calculated. Account is taken of the eight times smaller activity (25 mCi T instead of 200 mCi T), and the ten times smaller tritium release rate, as applicable. Only the maxima of the given ranges are recalculated. Also population e doses per report are recalculated and listed. All values are restated in SI-units.

Derived exposures for GTLS-watch per Section 3

Effective indi Population vidual dose dose

Distribution max. 0.3 µSv/a 0.015 man Sv/a Use max. 0.02 µSv/a 0.3 man Sv/a Disposal max. 25 µSv/a 1) 0.35 man Sv/a 2) average 0.035 µSv/a Accident with one watch max. 70 µSv 3) N.A.

1) Potential max. dose of most exposed individual, i.e. remaining continuously in 100 m distance from the stack of an incinerator in which 500'000 watches are disposed of annually.
2) Population dose, when incinerator under 1 is operated in the midst of an area populated by 8.4 Mio. inhabitants.
3) This accident is extremely rare and the estimate is based on very conservative assumption.

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Page6

B. Board Statement on Approval of Consumer Goods Containing Radioactive Substances, National Radiological Protection Board, 1992

Calculations are based on the following assumptions:

  • Activity per watch 7,4 GBq T
  • Activity release per watch (HTO) 2000 Bq T/d
  • Annual distribution 10'000 watches
  • Average life 5 years
  • Average watch population 50'000 watches
  • Disposal p.a. 10'000 watches of which in 500 landfills 8'000 watches and in 200 incinerators 2'000 watches

SUMMARY

OF EXPOSURES

  • Watch wearer in normal use (inhalation, immersion) max. 0,9 µSv/a
  • Disposal

- Landfill (inhalation, immersion, ingestion) max. 1, 1 µSv/a

- Incineration (inhalation, immersion) max. 8 µSv/a

  • Accident and misuse

- Fire, one watch max. 300 µSv

- Breakage of all GTLS of one watch max. 100 µSv

From these exposures, the ones for the GTLS-watch per our proposal is now calculated. Account is taken if the seven times smaller activity ( 1 Gbq T instead of 7,4 Gbq T), and the ten times smaller tritium release rate (200 Bq T/d instead of 2000 Bq T/d).

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Page 7

Derived exposures for the GTLS-watch per Section 3

Effective indivi dual dose

  • Watch wearer in normal use max. 0,09 µSv/a
  • Disposal

- Landfill max. 0, 15 µSv/a

- Incinerator max. 1,2 µSv/a

  • Accidents and Misuse

- Fire, one watch max. 42 µSv

- Breakage of all GTLS of one watch max. 15 µSv

5. Does the GTLS-Watch Qualify for Exemption from the Standards?

Reviewing the data presented under 3. and 4., one must conclude that the GTLS watch as proposed meets all criteria for exemption from the requirements of the relevant standards. The following table permits a comparison justifying the above conclusion. It should be noted, that the max. activity of the watch does not exceed the limit per,,source on the premises" specified at 1 GBq T.

It may put the irradiation due to watches in the proper perspective by a compari son with the ever present natural radiation background. Rays of cosmic origin as well as radiation from radioactive materials around and within our bodies bombard us continuously and inescapably. Moreover, the effective radiation attributable to the natural background easily reaches intensities up to 5 times above the average, depending on altitude above sea level, geographical latitude and terrestrial characteristics such as geological formations and thickness of soil cover. The average dose rate due to this natural background amounts to some 2000 µSv/a and often reaches 10000 µSv/a!

mb-m1crotec ag CH-3172 Niederwangen tBern Fre1burgstrasse 624 Telefon 031 98111 25 Telex 912 757 mebe ch Telefax 031 98111 05

Page 8

Even though compliance with the cited exemption criteria is established, a number of questions remain open. They revolve around the procedures. Just exactly what is formally required when a practice meets the criteria and is,,automatically exempted without further considerations from the requirements of the Standards, including those for notification, registration or licensing" as stated in the 1994 IAEA Standard and in the 1993 European Directive? Clearly, the legislators are asked to translate the standards into laws and plain, practicable regulations. They are years behind the standards! It is also clearly indicated that in doing so they respect the spirit and the letter of the standards. They have evolved over years by efforts of the world's experts and represent delicately balanced judgements.

June 15, 1995 OWT/yr EXPOSURE BY GTLS-WATCHES AS PROPOSED BY MB-MICROTEC AND LIMITS FOR EXEMPTION

Study A Study B Limit for Exemption

Normal use of watch max. 0,02 µSv/a max. 0,09 µSv/a max. 10 µSv/a

Disposal max. 25 µSv/a max. 1,2 µSv/a max. 1 mSv/a a)

Misuse/Accident (1 Watch) max. 70 µSv max. 42 µSv max. 1 mSv/a a)

Population Dose 0,8 manSv not assessed max. 1 manSv

-2 a) To be assessed together with probability of occurrence. A probability of 10 would lead to 1 mSv as limit for dose or

annual dose rate (max. admissible for member of the general population). The actual probability of occurrence in the

-2 case of GTLS watches is much less than 1 0.

SAFETY SERIES No. 115-I

INTERNATIONAL BASIC SAFETY STANDARDS FOR PROTECTION AGAINST IONIZING RJ\\DIA TION AND FOR THE SAFETY OF RADIATION SOURCES

INTERIM EDITION

Jointly sponsored by:

Food and Agriculture Organization of the United ~ations International Atomic Energy Agency International Labour Organisation Nuclear Energy Agency of the Organisation for Economic Co-operation and Development Pan American Health Organization World Health Organization

INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA. 1994 Schedule I

EXE1\\1PTIONS

EXEMPTION CRITERIA

I-1. Practices and sources within practices may be exempted from the requirements of the Standards, including those for notification. registration or licensing, if the Regulatory Authority is satisfied that the sources meet the exemption criteria or the exemption levels specified in this Schedule or other exemption levels specified by the Regulatory Authority on the basis of these exemption criteria. Exemption should

  • not be granted to permit practices that would otherwise not be justified.

I-2. The general principles for exemption 35 are that:

(a) the radiation risks to individuals caused by the exempted practice or source be sufficiently low as to be of no regulatory concern; (b) the collective radiological impact of the exempted practice or source be suffi ciently low as not to warrant regulatory control under the prevailing circum stances: and (c) the exempted practices and sources be inherently safe, with no appreciable likelihood of scenarios that could lead to a failure to meet the criteria in (a) and (b).

1-3. A practice or a source within a practice may be exempted without further consideration provided that the following criteria are met in all feasible situations:

(a) the effective dose expected to be incurred by any member of the public due to the exempted practice or source is of the order of 10 µSv or less in a year, and (b) either the collective effective dose committed by one year of performance of the practice is no more than about 1 man.Sv or an assessment for the optimiza tion of protection shows that exemption is the optimum option.

33 See INTERNATIONAL ATOMIC ENERGY AGENCY, Principles for the Exemption of Radiation Sources and Practices from Regulatory Control, Safety Series No. 89, IAEA, Vienna (1988).

81

~

EXEMPTED SOURCES AND EXEMPTION LEVELS

1-4. Under the criteria in paras 1-1 to 1-3, the following sources within practices are automatically exempted without further consideration from the requirements of the Standards, including those for notification, registration or licensing:

(a) radioactive substances for which either the total activity of a given nuclide present on the premises at any one time or the activity concentration used in the practice does not exceed the exemption levels given in Table 1-1 of Schedule 136 ; and (b) radiation generators, of a type approved by the Regulatory Authority, and any electronic tube, such as a cathode ray tube for the display of visual images,

  • provided that:

(i) they do not cause in normal operating conditions an ambient dose equiva lent rate or a directional dose equivalent rate, as appropriate, exceeding 1 µ.Sv*h-1 at a distance of 0.1 m from any accessible surface of the apparatus; or (ii) the maximum energy of the radiation produced is no greater than 5 kc V.

36 The guidance exemption levels set forth in Table 1-1 of Schedule I are subject to the following considerations: (a) They have been derived using a conservative model based on (i) the criteria of para. (1-3) and (ii) a series of limiting (bounding) use and disposal scenarios.

The values of activity concentration and total activity represent the lowest values calculated in any scenario for a moderate quantity of material. (See COMMISSION OF THE EUROPEAN COMMUNITIES, Principles and Methods for Establishing Concentrations and Quantities (Exemption Values) below Which Reporting Is Not Required in the European Directive, Radiation Protection 65, Doc. XI-028/93, CEC, Brussels (1993). (b) The applica tion of exemption to natural radionuclides, where these arc not excluded, is limited to the incorporation of naturally occurring radionuclides into consumer products or their use as a radioactive source (e.g. Ra-226, Po-210) or for their elemental properties (e.g. thorium, uranium). (c) In the case of more than one radionuclide, the appropriate sum of the ratios of the activity or activity concentration of each radionuclide and the corresponding exempt activity or activity concentration shall be taken into account. (d) Unless excluded, exemption for bulk amounts of materials with activity concentrations lower than the guidance exemption levels of Table 1-1 may nevertheless require further consideration by the Regulatory Authority.

82 I-5. Conditional exemptions may be granted subject to conditions specified by the Regulatory Authority, such as conditions relating to the physical or chemical form and to the use or disposal of the radioactive materials. In particular, such an exemp tion may be granted for an apparatus containing radioactive substances not otherwise exempted under para. I-4 (a) provided that:

(a) it is of a type approved by the Regulatory Authority; (b) the radioactive substances are in the* form of sealed sources that effectively prevent any contact with radioactive substances or their leakage except that this should not prevent exemption of small quantities of unsealed sources such as those used for radioimmunoassay; (c) in normal operating conditions it docs not cause an ambient dose equivalent rate or a directional dose equivalent rate,. as appropriate, exceeding I ~v

  • h-1 at a distance of 0.1 m from any accessible surface of the apparatus; and (d) necessary conditions for disposal have been specified by the Regulatory Authority.

I-6. Radioactive substances from an authorized practice or source whose release to the environment has been authorized, are exempted from any new requirements of notification, registration or licensing unless otherwise specified by the Regulatory Authority.

83 r 1 *

  • TABLE I-I. EXEMPTION LEVELS: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (ROUNDED) (see footnote 36)

Activity Activity Activity Activity Nuclide concentration Nuclide concentration (Bq/g) (Bq) (Bq/g) (Bq)

H-3 X 106 X 109 Fe-52 1 X 10 1 1 X 106 Be-7 X 10 3 1 X 107 Fe-55 1 X 104 1 X 106 C-14 1 X 10* X 10 7 Fe-59 1 X 101 1 X 106

  • 0-15 1 X 10 2 1 X 109 Co-55 X 10 1 X 10 6 F-18 1 X 10 1 X 10 6 Co-56 X 10 1 1 X 10 5 Na-22 X 10 1 X 106 Co-57 1 X 102 1 X 106 Na-24 1 X 10 1 X 105 Co-58 1 X 101 1 X 106 Si-31 1 X 10 3 1 X 106 Co-58m 1 X 104 1 X 107 P-32 1 X 10 3 1 X 105 Co-60 1 X 10 1 1 X 105 P-33 1 X 10' 1 X 10' Co-60m 1 X 103 1 X 106 S-35 1 X 10 5 X 10 8 Co-61 X 102 l X 106 Cl-36 X 10 4 X 106 Co-62m 1 X 101 1 X 105 Cl-38 X 10 1 X 10 5 Ni-59 1 X 10* 1 X 10 8 Ar-37 X 10 6 1 X 108 Ni-63 1 X 105 1 X 10 8 Ar-41 1 X 102 X 10 9 Ni-65 1 X 101 1 X 10 6 K-40 1 X 102 X 106 Cu-64 X 10 2 1 X 106 K-42 1 X 102 X 10 6 Zn-65 X 10 1 1 X 106

- K-43 1 X 101 X 10 6 Zn-69 X 10 4 X 10 6

Ca-45 1 X 10 4 X 10 7 Zn-69m X 10 2 1 X 10 6 Ca-47 1 X 101 X 106 Ga-72 X 10 1 1 X 10 5 Sc-46 1 X 101 1 X 10 6 Gc-71 1 X 104 X 10 8 Sc-47 1 X 10 2 X 106 As-73 1 X 10 3 X 10 7 Sc-48 X 10 1 1 X 10 5 As-74 X 10 1 X 10 6 V-48 1 X 101 X 10 5 As-76 X 10 2 1 X 10s Cr-51 1 X 103 1 X 10 7 As-77 X 10 3 1 X 106 Mn-51 X 10 1 1 X 10 5 Se-75 X 10 2 X 10 6 Mn-52 X 10 1 X 105 Br-82 1 X 10 1 1 X 106 Mn-52m 1 X 10 1 1 X 10 5 Kr-74 1 X 10 2 1 X 10 9 Mn-53 1 X 10* 1 X 109 Kr-76 1 X 10 2 1 X 10 9 Mn-54 1 X 10 1 1 X 10 6 Kr-77 1 X 102 1 X 109 Mn-56 1 X 101 1 X 10s Kr-79 1 X 103 X 10 5

84 Note to: Docketing and Service Branch From: Catherine R. Mattsen/1~.e.s

Subject:

Additional Submittals concerning PRM-32-4

Please add these two documents to the docket for PRM-32-4. They are supplementary information submitted by the petitioner, mb-microtec.

NUCLEAR REGULATORY COMMISSION *93 OCT 21 p 7 :J6

10 CFR Part 32

(Docket No. PRM-32-4]

mb-microtec (USA); Receipt of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

- ACTION: Petition for rulemaking; Notice of receipt.

SUMMARY

The Nuclear Regulatory Commission (NRC) is publishing

for public comment a notice of receipt of a petition for

rulemaking, dated July 30, 1993, which was filed with the

Commission by mb-microtec (USA). The petition was docketed by

the NRC on August 9, 1993, and has been assigned Docket No. PRM-

32-4. The petitioner requests that the NRC amend its regulations

to place timepieces with gaseous tritium light sources (GTLSs) on

  • the same regulatory basis as timepieces with luminous tritium

paint. Specifically, the petitioner requests that the

regulations be amended to include timepieces with GTLSs and

subsequently allow their distribution under the same requirements

applicable to the distribution of timepieces with luminous

tritium paint.

1 DATE: Submit comments by (75 days after publication in the 1/3Jq~

Federal Register). Comments received after this date will be considered if it is practical to do so but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES: Submit written comments to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Hand deliver

  • comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m. and 4:15 p.m. Federal workdays.

For a copy of the petition, write the Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

The petition and copies of comments received may be

  • inspected and copied for a fee at the NRC Public Document Room,

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules Review Section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: 301-492-7758 or Toll Free: 800-368-5642.

2 SUPPLEMENTARY INFORMATION:

Background

The NRC has established regulations governing the domestic licensing of byproduct material in 10 CFR Part 30 and the domestic licenses to manufacture or transfer certain items containing byproduct material in 10 CFR Part 32. The regulations in these parts govern the individuals or firms who apply byproduct material to or incorporate byproduct material into a product. These regulations also apply to firms or individuals

  • who initially transfer a product containing small amounts of byproduct material for sale or distribution. These regulations govern the manufacture and transfer for sale or distribution of self-luminous products such as timepieces that contain small amounts of tritium.

Discussion The petitioner believes that the regulations that govern the

. manufacture and distribution for sale of timepieces that contain

  • small amounts of tritium are outdated. According to the petitioner, the NRC's regulations permit the exempt distribution of timepieces that use small amounts of tritium paint for luminescence but do not consider timepieces with GTLSs.

3 The Petition The petitioner states that current regulations allow watches with GTLSs that have a level of activity up to 200 mci T to be distributed only after each watch model is individually approved by the Commission for exempt distribution. The petitioner states that this requirement is in contrast to requirements applicable to timepieces that use tritium paint. The petitioner believes that the Commission exerts further control over GTLS timepieces by requiring a disclosure on the pertinent properties of GTLSs used in watches.

  • The petitioner believes that current regulations do not take

into account the progress that GTLS technology has achieved over the past 15 years. According to the petitioner, an analog watch can be well illuminated with 14 GTLSs that have a total level activity of 25 mci T, the same level of activity that is presently permitted in tritium paint timepieces.

The petitioner believes that watch manufacturers do not want

  • to become involved with the present licensing procedures that apply to the manufacture and distribution of GTLS watches.

Therefore, the petitioner believes that the present regulations are counterproductive because they withhold a better and safer means of watch illumination from the consumer.

4 The Suggested Amendments In order to put timepieces that use GTLSs on the same regulatory basis as those that use tritium paint, the petitioner suggests that 10 CFR 32.14(d) (1) be amended by adding the words "and bezels" to the first sentence of the introductory text, and by adding a third paragraph to read: "Tritium is also considered to be properly bound if it is contained in gaseous form in a sealed vial of mineral glass if the vials do not get damaged or become dislodged and the loss of tritium does not exceed 5 nci

  • when prototype dials, hands, pointers, and bezels are subjected

to the tests as specified in §32.14(d)(l) (i), (ii), and (iii)."

Section 32.14(d) (1) (iii) would be redesignated as

§ 32.14(d) (1) (iv) and a new§ 32.14(d) (1) (iii) would be added to read: "Attachment of the hub ends of the hands and pointers to a clamp on a vibrating fixture and vibration at a rate of not less than 16 cycles per second and a vibration acceleration of not

.. less than 2G for a period of not less than one hour."

  • As revised, § 32.14, paragraph d(l) would read as follows:

§ 32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.

(d) * *

  • 5 (1) The method of containment or binding of the byproduct material in the product is such that the radioactive material will not be released or be removed from the product under the most severe conditions that are likely to be encountered in normal use and handling. Tritium in luminous paint will be considered to be properly bound to dials, hands, pointers, and bezels if there is no visible flaking or chipping and the total loss of tritium does not exceed 5 percent of the total
  • tritium when prototype dials, hands, pointers, and

bezels are subjected to the tests as specified in

§32.14(d) (1) (i), (ii), and (iii). Tritium is also considered to be properly bound if it is contained in gaseous form in a sealed vial of mineral glass if the vials do not get damaged or become dislodged and the loss of tritium does not exceed 5 nci when prototype dials, hands, pointers, and

  • bezels are subjected to the tests as specified in

§ 3 2. 14 ( d) ( 1) ( i), ( ii), and (iii) *

(i) Attachment of dials and bezels to a vibrating fixture at a rate of not less than 26 cycles per second and a vibration acceleration of not less than 2G for a period of not less than one hour.

6

' (ii) Attachment of the hub ends of the hands or l..,

pointers to a clamp and bending of hands or pointers over a 1-inch diameter cylinder, or (iii) Attachment of the hub ends of the hands and pointers to a clamp on a vibrating fixture and vibration at a rate of not less than 16 cycles per second and a vibration acceleration of not less than 2G for a period of not less than one hour.

(iv) Total immersion of the dials, hands, pointers, and

  • bezels used in the tests described in

§32.14(d) {l) (i), (ii), or (iii) in 100 milliliters of water at room temperature for a period of 24 consecutive hours and analysis of the test water for its radioactive materials content by liquid scintillation counting or other equally sensitive method.

  • * * *rf.
  • Dated at Rockville, Maryland, this g - day of October 1993.
  • Regulatory Commission.

hi~~

f the Commission.

7 DOCKET NU.,1BER,. ' ) ':i FD IT!OJ J RULE PR~..f ~ mb-microtec CUSA) mb -m1crotec ( SS'-F R § 3670) P.O. Boxll74 * ' NorthTonawanda,NewYork 14120-9174 (716) 694-2695

  • 93 AUG 17 Pl2 :QQ

July 12, 1993

The Secretary USNRC Attn: Chief, Docketing and RE: Rule Change Petition Service Branch dated 7-29-93

\\Vashington, DC 20555

Dear Sir:

I forgot to attach the last page of the petition (pg. 5). I am enclosing it and request that you

add it to my submission.

Sincerely,

~~,~j Larry Keating, Vice President mb-microtec, Inc. (USA)

cc: Steven Baggett

!\\1edicai Academic and Commercial Use Branch, NMSS USNRC Washington, DC 20555 EXP ECTED POP ULATION D OSE ESTIMATES DUE TO TIMEPIECES WITH TRITITJM PAINT AND WITH GTLS

Annual distribution: 1 :rvfio. Time pieces

Average Life: 10 years Average Timepiece Population: 10 :rvfio.

Column 1 Column 2 Column 3 Results per Results per Derived from Ref 1 restated Ref 2 Co. 2 TGLQ 200 mCiT / TGLQ 25 mCiT /

T-paint, 1.5 mCiT / timepiece timep iece timepiece 50 nCd T/day 5 nCd T/day leakage leakage Distrib u tion 6,5 man-rem 9 man-rem 1 m an-re m Use*) 253 " 226 " 23 "

Repair Service 1 " 1 " 1 "

Disposal 10 " 250 " max30 "

271 man-rem 486 man-rem 36 man-rem TOTAL (2, 71 man-Sv) ( 4,86 man-Sv) (0,36 man-Sv)

  • ) It is assumed, that 3 persons in the environment of the timepiece are addition ally exp osed to radiation.

5 DOCKET NUMBER... ---~ *~j RUL E PRM

  • mb-microtec (USA) m -micro ec (5"8"~R53~li-fb
  • t r -= TtTIOt\\l onawd~ftfewYo~-~4~~g:

lJSNRt (716) 694-2695

July 30, 1993

The Secretary USNRC Attn: Chief, Docketing and Service Branch Washington, DC 20555

Dear Sir:

Attached you will find my Petition for Rulemaking. I was advised that my letter of April 28,

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

Steve 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,

~A~~ -~

~ ny~ e~ ;J Vice President mb-microtec (USA) Inc.

cc: Steven Baggett Medical, Academic and Commercial Use Branch, NMSS USNRC Washington, DC 20555

~ECEIVf.0 1993 omcel>1 the -secretary mb -microtec (USA) mb-microtec P.O. Box 1174 North Tonawanda. New York 141 20-9174 (716) 694-2695

July 29, 1993

The Secretary US Nuclear Regulatory Commission Ref. License # 31-23712-0lE Attn: Chief, Docketing and Service Branch Washington, DC 20555

Dear Sir:

PETITION FOR RULEMAKING

In accordance with 10 CFR 2.802, we petition the Commission to amend its regulation. The purpose of the requested amendment is to put watches with gaseous tritium light sources (G1LS) on the same regulatory basis as watches with luminous tritium paint regarding the requirements for their distribution exempt from the requirements of 10 CFR 30.19.

At present, watches with GlLS's can be distributed with an activity up to 200 mCi T, but only,

when each watch model is individually approved by the Commission for its exempt distribution, a requirement in contrast to those for watches with tritium paint. The Commission exerts a further control over GlLS watches as it requires a disclosure on the pertinent properties of G1LS's used in watches. An approval of satisfactory disclosure may be in the form of a registration of the GlLS 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 manufacturers do not want to become involved with the present licensing procedures concerning GlLS watches. In that sense, the present regulations are indeed counterproductive, withholding a better and safer watch illumination from the consumer.

Further, present regulations do not take account of the progress GlLS technology has achieved over the past 15 years. Today, an analog watch can be well illuminated with 14 GTLS of a total activity of 25 mCi T, the same activity presently admitted for tritium paint watches. Moreover, today's production techniques permit GlLS manufacture of small, efficient sources with perfect seals. Only the minute amounts of tritium diffusing through the glass walls can escape.

In support of the petition, we submit additional information.

The enclosure 1, details the proposed amendment in the regulation to achieve the stated goal. Two further enclosures review the existing regulations concerning timepieces with tritium, and assess the US Nuclear Regulatory Commission, Washington Page 2

expected dose commitment under the proposed amendment. In our opinion, the submitted information suffices to satisfy all the requirements of the petition under 10 CFR 2. 802.

Any desired additional information is of course gladly provided.

Sincerely yours

~~

Larry Kearuf J Vice President mb-microtec (USA) Inc.

Enclosures:

1. Petition for Rulemaking per 10 CFR 2. 802
2. Survey of Existing Regulations Concerning Timepieces with GTLS
3. Dose Commitment for Timepieces with Tritium Paint and GTLS illumination
1. Petition for Rulemaking per 10 CFR 2.802

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 distribution e xempt from the requirements of 10 CFR 32.14 starting with (d). Other changes are not necessary to keep the regulation consistent with the amendment.

( d) The Commission determines that:

( 1) The method of containment or binding of the byproduct material in the product is such that the radioactive material will not be released or be removed from the product under the most severe conditions which are likely to be encountered in normal use and handling.

Tritium in luminous paint will be considered to be properly bound to dials, hands, pointers and bezels if there is no visible flaking or chipping and the total loss of tritium does not 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.

Tritium is also considered to be properly bound if it is contained in gaseous form in a sealed vial of mineral glass if the vials do not get damaged or become dislodged and the loss of tritium does not exceed S nCi when prototype dials, hands, pointers and bezels are subjected to the test (i), (iii), and (iiii) below in the order specified.

(i) Attachment of dials and bezels to a vibrating fixture at a rate of not less than 26 cy cles per second and a vibration acceleration of not less than 2G for a period of not less than one hour.

(ii) Attachment of the hub ends of the hands or pointers to a clamp and bending of hands or pointers over a I -inch diameter cylinder, or

(iii) Attachment of the hub ends of the hands and pointers to a clamp on a vibrating fixture and vibration at a rate of not less than 16 cycles per second and a vibration acceleration of not less than 2G for a period of not less than one hour.

(iiii) Total immersion of the dials, hands, pointers and bezel s used in the tests described in subdivision (i), (ii), or (iii) of this subparagraph in 100 milliliters of water at room temperature for a period of 24 consecutive hours and analysis of the test water for its radioactive materials content by liquid scintillation counting or other equally sensitive method.

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

Prototype tests for automobile lock illuminators are prescribed b S 32.40, Schedule A.

1

2. Survey of Existing Regulations Concerning Timepieces with GTLS

Present regulations concerning 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 rule, notably the U SA, UK and Switzerland. These countries permit a tritium ac tivity (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 "International Atomic Energy Agency" (IAEA), published in 1967: "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. concerning adherence of paint and the water solubility of tritium. They are all easily met. These recommendations were adopted in a number of countries as binding regulations governing manufacture and import o f timepiece s. As also ISO-Norm 3157 of the "International Standardizing Organization" was issued along the lines of the IAE-recommendations, they are followed worldwide. Some of the regulations differentiate between watches worn on the body (wrist, pocket) and stationary ones (alarm, wall), some also between "ordinary" and "special" watches. "Ordinary" watches have a lower max admissible tritium activity (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 G1LS timepieces stipulate an approval fore ery specific model, in contrast to timepieces with tritium paint. This has proved to be a major hurdle for the GTLS timepiece.

Some countries refuse to accept GTLS timepieces altogether, notably German and some Scandinavian countries, even if the activity limits for tritium paint are re pected.

large majority of countrie, the less industrialized one, do not question the confonnity to certain regulations, but accept imports if compliance with US, UK or Swiss regulations can be established.

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

The dose-commitments due to timepieces with tritium paint and 200 m C i of G1LS' s are derived

.from the following papers :

Ref. 1 : "Radiation Dose Estimates from Timepieces containing Tritium or Promethium 147 in Radioluminous Paints", Oak Ridge National Laboratory, Report NUREG /CR 0216, 1978.

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

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

The results for tritium paint per Ref. 1 are compiled in column 1 of the table. They refer to timepieces with an activity of 1. 5 mCi T as paint per analysis of timepieces actually distributed in the US. To permit comparisons with the following data, the dose estimates are restated for an 2

annual distribution of I Mio. timepieces with an average IO year life, resulting in a timepiece population of IO Mio.

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 timepieces with 25 mCi Tin the form of G1LS according to the proposed regulation for such timepieces. It is directly derived from Column 2, but takes account of the 8-fold reduction of the activity (25 mCi T vs 200 mCi T) and the 10-fold reduction in the tritium release rate ( 5 nCi T /24 hours vs 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.

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

- If paint is ingested and 2 mCi T are incorporated, the dose may reach 60 mrem.

- If all G1LS 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.

- 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.

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 containing timepieces. It is extremely low for timepieces with 25 mCi T as G1LS, in particular also low in comparison with the presently distributed tritium paint watches.

It is interesting to relate the dose estimates to accepted norms, e.g. to "A Guide for Controlling Consumer Products Containing Radioactive Substances", 1985, by the "Nuclear Energy Agency",

OECD. It recommends as max acceptable an "effective dose equivalent" of 5 mrem/yr (0,05 mSv/yr) for safety-related products, 0,5 rnrem/yr (0,005 rnSv/yr) for other products. Even if any safety function to a well legible 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 orders of magnitude smaller than is admitted in the above OECD document.

3

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