ML20249A696

From kanterella
Revision as of 03:31, 1 February 2021 by StriderTol (talk | contribs) (StriderTol Bot insert)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search
Forwards Petition for Rulemaking PRM-32-4,filed W/Commission by mb-microtec (Usa),For Review.Ofc Requested to Determine Whether Petition Qualifies for Special Handling by Staff as fast-track Petition for Rulemaking as Specified
ML20249A696
Person / Time
Issue date: 08/24/1993
From: Norry P
NRC OFFICE OF ADMINISTRATION (ADM)
To: Beckjord E
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20013K439 List:
References
FRN-58FR53670, RULE-PR-32 AF76-1-004, AF76-1-4, NUDOCS 9806180114
Download: ML20249A696 (17)


Text

~

Af n- t PM

/'prec ~

'o UNITED STATES

,  !^ n NUCLEAR REGULATORY COMMISSION

{ ,E WASHINGTON, D. C. 20555

%,...../ AUG 2 41993 MEMORANDUM FOR: Eric S. Beckjord, Director Office of Nuclear Regulatory Research FROM: , Patricia G. Norry, Director Office of Administration

SUBJECT:

PETITION FOR RULEMAKING (PRM-32-4) FILED BY MB-MICROTEC (USA)

Attached for your review is a petition for rulemaking (PRM-32-4) filed with the Commission by mb-microtec (USA). We request that your office determine whether this petition qualifies for special' handling by the staff as a fast-track petition for rulemaking as specified in 10 CFR 2.802(e) of the Commission's regulations.

Also attached is section 11.7 of the NRC Regulations Handbook (NUREG/BR-0053) that contains information that will assist you in determining whether the petition is eligible for fast-track processing.

If your office determines that PRM-32-4 should not be handled as a fast-track petition, please provide your comments and concurrence on the attached draft Federal Register notice that announces receipt of and requests public comment on the petition. {

Please advise us of your response and let us know the name of the staff member you designate as task leader for action on the petition by September 10, 1993.

If you have any questions about this petition, please have a member of your staff contact Michael T. Lesar, 492-7758, or Betty K. Golden, 492-4268, of the Division of Freedom of Information and Publications Services.

Pat 1"a No , ir or Office of Administrate wn Attachments: ,.

1. PRM-32-4 l
2. Section 11.7 of the NRC Regulations Handbook .
3. Draft Federal Register l "'hotice 9906100114 990611 /

PDR PR i /

< 32 50FR53670 PDR '

l '!E~ * " MP'

o mo microtec (USA) b- I eC' " B *'

North Tonowontidi.New vork 14120-9174

'*- (716)694-2695 1

l i

l Juiy 30.1993 The Secretary US NRC Attn: Chief, Docketing and Senice Branch Washington, DC 20555

Dear Sir:

Attached you will find my Petition for Rulemaking. I was adsised 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 therc ,

is an additional fee required, please let me know.

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

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

l l

. ~rs, l

L0 AJ n nnnjJCf M M V c7l vi t i f _

i mb-microtec (USA) mb-microfec --

North Tonawanco. New York 1412Q-9174 (716) 694-2695 July 29.1993 l

l an The Secretary )

US Nuclear Regulatory Commission Ref. License n 31-23712-01E l Attn: Chief, Docketir.g and Service Branch Washington, DC 20555

Dear Sir:

l 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 (GTLS) 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 GTLS'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 GTLS watches as it requires a disclosure on the pertinent properties of GTLS*s used in watches. An approval of satisfactory disclosure may be in the form of a registration of the 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 manufacturers do not want to become involved with the present licensing procedures concermng GTLS watches. In that sense, the present regulations are indeed counterproductive, withholding a better and safer watch illununation from the consumer.

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

In support of the petition, we submit additionalinEormation.

The enclosure 1, details the proposed amendment in the regulation to achieve the stated goat Two furtherTnclosures review the existing regulations concerning timepieces with tritium, and assess the 19870s 9b /W~ EPP ,

US Nuclear Regulatorv Commission. Washington Page 2 O

expected dose commitment under the proposed amendment. In our opinion. the submitted information sutHces to satisfy all the reqturements of the petition under 10 CFR 2.802.

r Any desired additional information is of course gladly prosided. l

- Sincerely yours i

~ i d

Lany Keat' Vice Presid=

mb-microtec (US A) Inc. .

Enclosures:

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

)

i;

. wY6e

)

e

1. Petition for Rulem* king oer 10 CFR 2.802 It is the goal of the proposed amendment to put timepieces with gaseous tdtium light sources (OTLS) on the same regulatory basis as those with tritium paint in regard to their distnbution exempt'from the requirements of 10 CFR 32.14 startmg with (d). Other changes are not necessary to keep the regulation consktent with the amendment.

. (d) The Comnussion detemunes that:

(1) ' Die method of contamment or binding of the byproduct material in the product is such that the radioactive material will not be released or be removed from ine product under the most severe conditions which are likely to be encountered in normal use anil handimg.

Tritium in luminous paint will be considered to be property bound to dials. hands, pointers and bemis if there is no visible flaking or chipping and the total loss of tntium 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 propedy 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 tr tium does not exceed $ nCi when prototype dials, hands, pointers and bemis are subjec@o 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 cycles per second and a vibration acceleration of not less than 2G for a penod 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 1-inch diameter cylinder, or (iii) Attachment of the hub ends of the hands and pointers to a clamp on a sibrating 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) Totalimmersion of the dials, hands, pointers and bezels used in the tests described in subdivision (i), (ii), or (iii) of this subparagraph in 100 mdliliters of water at room .

tm.w. hire 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) 'Ihe product has been subjected to and nNets the requirements of the prototype tests.

Prototype tests for automooile lock illummators are prescribed by S 32.40. Senedule A.

. .n.

I

L Survev of Esistine Regul tions Concerning Timepieces with GTLS Present regulations conceming the use of tritium in paint lor the dark reading of timepieces are outdated and do not consider gaseous tritium light sources (GTLS). There are a few exceptions to this mie. notably the USA. UK and Switzerland. These countries permit a tridum aethity (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 "Internstignal Atomic Energy Agency"(IAEA), pubbshed in 1%7: "Fadiation Protection Standards for Radioluminous Timepieces". It limits the tntium activity to be used per watch to 25 mci T and specifies further requirements, e.g. corsridng adherence 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 govemmg manufacture and import of timepieces. 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 wom on the body (wnst. pocket) and stationary ones (alarm. wall), some also between " ordinary" and "special" watches. " Ordinary" watches have a lower max adnussible tritium aethity (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 j

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 ahogether, notably Germany and some Scandinavian countries, even if the activity limits for tritium paint are respected.

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

3. Dose Commitment for Timenieces with Tritium Paint and GTLS Illumination The dose-commitments due to timepieces with tritium paint and 200 mci of GTLS's are derived i 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 Containing Tritium Gas",

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

The results for tritium paint per Ref. I 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 actuaDy distributed in the US. To permit comparisons with the following data, the dose estunates are restated for an 2

annual distribution of 1 Alio. timepieces with an average 10 year life. resuking in a timepiece population of 10 Alio.

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.

j l

l Column 3 ghes the dose estimates for i ..cpicces with 25 mci T in the form of GTLS according to the proposed regulation for such tirnepieces. It is directly denved from Column 2. but takes account of the 8-fold reduction of the activity (25 mci T w 200 mCiT) and the 10-fold reduction in the tritium release rate (5 nCi T/24 houn vs 50 nCi T/24 hours). ,

Ref.1 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 GTLS of a ;-. 4:e break and release their tritium in oxidized form. 200 mci T might entail m' dose of 50 mrem, and 25 mci T a dose of 6 mrem.

- In a warehouse fire releasmg 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 G. crb:s Clearly, the doses estunated for distribution, use, repair service and disposal per table and for accidents is very low and negligible for practical purposes for all cMed tritium containing 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.

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 retable an " effective dose equivalent" of 5 mrem /yr (0,05 mSv/yr) for safety-related products, 0,5 mrum/yr (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 0..epicecs per proposed regulation is some two orders of .

magnitude smaRer than is admitted in the above OECD document, i:

a n

3 l

l

ll -

i

~

[7590-01-P]

NUCLEAR REGULATORY COMMISSION-lLO CFR Part 32 (Docket No. PRM-32-4) ab-microtec,(USA); Receipt of Petition for Rulemaking

, < IAGENCY: 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 ab-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 require that timepieces with gaseous tritium light sources (GTLSs) be'put on the same' regulatory basis as timepieces with luminous tritium paint. As a result of the petitioner's suggested amendment, timepieces with GTLSs would be exempt from the requirements of NRC's regulations applicable to' distribution, s

A

., ll t oWh 1 ,

1 e

i .s

  1. 4

h,

"~

DATE: ! Submit _ comments by (60 days after publication in the 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.

a -

ADDRESSES: Submit written comments to the Secretary of the i

Commission, U.S. Nuclear Regulatory Commission, Washington, DC l 20555, Attention: Docketing and Service Branch. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between '

17:45 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, 212G L Street, NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules Review Section, Rules Review and Directives Branch, Division of

' Freedom of Informatlo and Publications Services, Office of L Administration, U.S. Nuclear Regulatory Commission, Washington, DC-20555, Telephone: 301-492-7758 cr Toll Free:- 800-368-5642.

v+s 2

_g.. ,

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.

The Problem 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.

it

,ws 3-

L. .

The~ Petition-The petitioner states that. current-regulations allow watches

'l L

.w ith GTLSs that have a level of activity.up to 200 aci T to be i distributed only after each watch model is individually approved.

by the. commission'for exempt distribution. The petitioner states I 1

l that.this requirement is in contrast to requirements applicable j to timepieces that use tritium paint. The petitioner. believes that the' commission exerts further control over GTLS timepieces l 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. I the past 15 years. According to the petitioner, an analog watch' can be we1[ illuminated with 14 GTLSs that have a total level activity of 25 aci T, the same level of activity that is presently permitted i.n 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.

.ii t

b 4

..._..____.__._._._____________.____.____.__._.--__G

The Suggested Amendments In order to put timepieces that use GTLS 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 Apzels" to the first sentence of the introductory text, and byLadding a third paragraph to read, " Tritium is also considered to be properly bound if it 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 exceed 5 nci When prototype dials, hands, pointers, and bezels are subjected

'tx) the tests as specified in $32.14 (d) (1)(i), (ii) , and (iii) . "

Section 32.41(d) (1) (iii) would be redesignated as S 32.41(d) (1) (iv) and a new $ 32.41(d)(iii) would be added to read, " Attachment of the hub ends of the hands and pointers to a j 1

clamp on a vibrating fixture and vibration at a rate of not less than 16 cycles per second and a vibration acceleration.of not j less than 2G for a period of not less than one hour."

As-revised, S 32.14, paragraph d(1) would read as follows:  ;

5 32.14.

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

(d) * *

  • i;

\

l

.n.

5

l -

(1) The method of containment or binding of the l

l byproduct material in the product is such that the L

l radioactive material will not be released or be removed from the product under the most severe l

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 S32.14 (d) (1) (i) , (ii), and (iii). Tritium is also

' considered to be properly bound if it is contained )

I in gaseous form in a sealed vial of mineral glass i

if the vials do not get damaged or become dislodged and the loss of tritium does not exceed 4 1

S nci when prototype dials, hands, pointers, and )

bezels are subjected to the tests as specified in S32.14 (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 i:

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

.. + s, 6

I

- ---- __j

r E

(ii) Attachment of the hub ends of the' hands or 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

$3 2.14 (d) (1) (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 Dated at Rockville, Maryland, this day of 1993.

For the Nuclear Regulatory Commission.

Samuel J. Chilk, Secretary of the Commission.

ll

'. Wee 7

11.7 Petitions eligible for " fast-track" processing.

1 (a) Occasionally, NRC receives a petition for rulemaking that I requests an amendment to the regulations'that is obviously meritorious.

In order to expedite the rulemaking process, these petitions for ]

rulemaking may be published initially for public comment as a proposed rule. This " fast-track" procedure eliminates the usual step of publishing a notice of receipt of a petition for rulemaking and )

inviting public coment on the petition when the additional procedural step is unnecessary. " Fast-track" petitions are processed by the staff according to the procedures specified in this section and 11.9 of this handbook. The " fast-track" procedure may not be used for the expedi-tious denial of a petition for rulemaking.

(b) Following a determination that a petition for rulemaking meets the threshold requirements for a petition, RPB assigns the petition'to the appropriate staff office to determine whether the petition is eligible for " fast-track" processing. The assigned staff office assigns a contact person to handle the petition. The contact person then makes the

" fast-track" determination within 10 working days.

(c) .The NRC may consider a petition eligible for " fast-track" I

. processing if it'-- 1; (1) Proposes action granting or recognizing an exemption from requirements in 10 CFR Chapter I or granting relief from restrictions while not imposing additional burdens upon or increasing the risks to the health and safety of 'any segment of industry or the public; PETITIONS FOR RULEMAKING 231 MARCH 1991

?

(2) Proposes action involving interpretive rules, rules of agency organization, procedure, or practice, and rules for the orderly conduct of Commission business; (3) Proposes action involving an amendment to 10 CFR Chapter I that is-corrective or of a minor or nonpolicy nature and that does not substantially modify existing regulations; (4) Proposes action involving --

(1) A minor safety, safeguards, or environmental issue.,

(ii) An increase in NRC efficiency; or (iii) A reduction in the regulatory burden on licensees.

(5) Proposes action 1.nvolving a request already under consideration in an ongoing rulemaking proceeding (Note, however, that NRC consideration of a request already included in an ongoing rulemaking depends on the status of the rulemaking proceeding);

(6) Proposes other action that is clearly meritorious and will not adversely affect the rights of other licensees or persons.

(d) The NRC normally will not consider a petition eligbile for

" fast-track"' processing if the proposed action will --

(1) Require the preparation of an Environmental Impact Statement; l (2) Impose new or increased reporting, application, or recordkeeping requirements subject to clearance by the Office of Management and Budget; (3) Have a significant economic impact on a substantial number of small entities (see discussion of Regulatory Flexibility Act requirements in sectdons 3.19 and 5.19 of this handbook),

PETITIONS FOR RULEMAKING 232 MARCH 1991 f.

(,. .,

l l- ,

(4)- Have a significant impact on NRC staff and resource connitments ; .or . ,

(5) Result in denial of the petition for rulemaking.

e l

l l

ll

, ws,

' PETITIONS FOR RULEMAKING- 233 MARCH 1991 f

PART 32 o PETITIONS FOR RULE MAKING 3

. {3) The label affixed to the source or 8. In l 32.210. peregraphs (a). (c) thru h *===al Suggested Alternative device, or replacement source and (e) and the introductory text of 1. In i 32.1. the introductory text of device; or to the permanent storage. paragraph (f) are revised to read as paragraph (a)is revised to read as container for the source or device, or follows: goggows:

replacement pource and device, contains information on the radionuclides quantity 9 32.210 flogistration of product g 32.1 purpees and acepe.

WWormonen (a) This part prescribes requirements and date of assey, and a statement that the U.S. Nuclear Regulatory Commission (a) Any manufacturer or initial for the issuance of specific licenses to has approved distribution of the (name distributor of a sealed source or device, persons who manufacture or initially of source or device. or replacement including replacement sources and transfer items containing byproduct source and device), to persons licensed devices, containing a sealed source material for sale or distribution to use byproduct materialidentified in whose product is intended for use under (including those a who il 35.58,35A00, or 35.500, as a specific license may submit a request manufacture cement parts, devices, appropriate. and to persons who hold an to NRC for evaluation of radiation or sources designated for units originauy equivalentlicense issued by an safety information about its product and manufactumd or initially transformt hv __

Agreement State.However, labels for its registration. others) to:

+ -* * *

  • I worded in accordance with . . . . .

requirements that were in place on Deted at Rockville Maryland, this 4th day March 30,1987, may be used until March (c)W mined fw mview d a seaW of October seet.

surce or device, including replacement For the Nuclear Rasulatory t'a== lesion.

30.1909. sources and devices, must include (b}(1)In the event the applicant t informede aW es Mgn,

. desires that the source or device, Secredstyofde Comeursion.

manufactum, pmWpe teedng, quah including replacement sources and cetrol pmgram, labehng, proposed uses devices, be required to be tested for and leak testing and, for a device or l leakage of radioactive material at intervals longer than six months, he/she Nplacment dwice, the mguest must sha'l include in his application sufRcient also include sufficient information about installation, service and maintenance, i information to demonstrate that such operating and safety instructions, and longer intervalis justified by its potential hazards to provide performance characteristics of the source, device or replacement source or reasonable assurance that the radiation safey properties of the source or device ,

device or similar sources or devices and by design features that have a or aplacement source or device are g ,

significant bearing on the probability or adequate to protect health and =lal=l=

consequences ofleakage of radioactive danger to life and property.

material from the source. (d)The NRC normally evaluates a 10 CFR Port 32

. . . . . sealed source or a device, including replacement sources and devices, using [ Docket Na pMS-32-4)

7. In 6 32.110, paragraph (a) is revised tim e teri accepted to read as follows: g mb-nderstec(USA) Receipt of PoHuon for Rulemeldng g as.11e aa- r ====

a sempene presseums and criteria do not readuy apply to a under eerman spessas seeness- particular case, the NRC formulates AcescV: Nuclear Regulatory (a) A random sample shaR be taken reasonable standards and criteria with Commission.

from each ' lot of devices, the help of the manufacturer or Am Pdidon fw rulanaking: nonce including repl'acescent devions, licensed distributor. %e NRC shall use criteria Mmalpt.

under il 32.14,32.53, or 32.81 of this part and standards sufficient to ensure that for which testing is required pursuant to the radiation safety properties of the suomeAftv:The Nuclear R ulatory ll 32.15. 32.55 or 32.82 la accordance device or sealed source including Commission (NRC)is puhishing for with the appropriate SamplingTable in replacement sources and devices, are public comment a notice of receipt of a this section determined by the adequate to protect health and maalml= pention for rulemaking, dated July 30; designated LotTolerance percent danger to life and property. 1993, which was filed with the Defective. If the number of defectives in (e) After completion of the evaluation. Commission by mb-microtec (USA). The ne sample does not exceed the the Commission issues a certificate of petition was docketed by the NRC on

  • ** ' registration to the person making the August 9,1993, and has been assigned g g"g,," Tab eis I request.De certificate or registration Docket No. PRM-32-4. The titioner
  • hall be ed.lf the her of acknowledges the availability of the requests that the NRC amen ts ldectiv sample &e submitted information for inclusion in regulations to place timepieces with unpunasu M nee A an Application for a specific license gaseous tritium light sourms (GTLSs) on Sampling Table in &ls ecuan, Proposing use of the product or the same regulatory basis as timeploms entire ' ~"- lot shall be rejected. with luminous tritium paint.

t*P lacement product.

(f)De person submitting the request Specifically, the petitioner requests that for evaluation and registration of safety the regulations be amended to include information about the product shall timepieces with GTLSs and I manufacture and distribute the product subsequently allow their distribution or replacement product in accordena under the same requirements applicable with- to the distribution of timepieces with

  • * * *

PRM-3 October 29,1993

7' . }

~ PART 32 o PETITIONS FOR RULE MAKING EATES: Submit comments by January 3. - ' The Petition $ 32.14 Cortsin items containing 1994. Comments received after this date Th iti I '*9" ***"I*

will be considered if it is practical to do reguist s al o so but the Commission is able to answe ches w th a '. .

cons ders o on r ht have a level of activity up to 200 ... i s

mci T to be distributed only after each y -

watch model is individually approved hh method of containment or-

==aaaaaa: Submit written comments binding of the byproduct material in the by the Commission for exempt to the Secretary of the Commission, U.S. distribution. b petitioner states that Product is such that the radioactive ,

Nuclear Regulatory Commission. this requirement is in contrast to rnswdal w not eased 6 Washington, DC 20555, Attention: removed from the produ der the requirements applicable to feces Docketing and Service Branch. Hand that use tritium paint.The peu oner most severe c nditions are likely to deliver comments to: 11555 Rockville "'*"" """"* ""

believes that the Commission exerts I" in rs if peti , s Rules Review and Disectives Branch, [ tioner believes that cunent there is no visible flaking or c ilpping Division of Freedom ofInfonnation and regula ons do not take into account the and the totalloss of tritium does not Publications Services,OfBos of p exceed 5 percent of the total tritium that GTLS technology has Administration, U.S. Nuclear Regulatory leved over the past 15 years, when prototype dials, hands, t, ors, e as n %gt.,,,

Commission, Washington, DC 20585. According to the tioner,an analog agbasalg are subjected to The tion and copies of comments watch can be wel illuminated with 14 ,specified in 5 32.14(d)(1) (1), (ii), and recol ma heins l ed and copied GTLSs that have a totalIml activit of '(lii). T.tillum is abo considendMe.

for a fee at eNRC ic Document j 25 mci T, the same level of activity ( ' pn2Rerly_ bound Jf it is sontajnedl0 Room,2120 L Street, NW,(Lower is presently permitted in tritium paint asseous form in apeeled vielsfalperal 1

level), Washington, DC, timepieces.  : glassJilha vlaisitonot or POR PURTHER NtPORheafl0N CONTACT: b petitioner believes that watch  ; become dislodged and t IJichael T.14ser, Chief, Rules Review manufacturers do not want to become i tritium does not exceed 5 nCi when Section, Rules Review and Directives involved with the present licensing prototypedials,gha ds, pointers,and Branch, Division of Freedom of procedures that apply to the bezels Me**sab"le'cted to the tests as Information and Publications Services, manufacture and distribution of GTLS specified in 5 32.14(d)(1) (i). (ii), and OfBee of Administration, U.S. Nuclear watches.brefore, the petitioner ,(iii) i Regulatory Commission, Washington, believes that the present regulations are DC 20555. Telephone: 301-492-7758 or count roductive because they . (1) Attachment of dials and berels to a vibrating fixture at a rate of not less TallFree:800-368-5642. withho a better and safer means of than 26 cycles per second and a

, watch illumination from the consumer.

vibration acceleration of not less than Et

~~ -d Suggested Amendments 2G for a period of not less than one hour,

)

In order to put timepieces that use ve gh o Ic n ng f GTLSs on the same regulatory basis as (ii) Attachment of the hub ends of the uct materialin 10 CFR part 30 those that use tritium paint,the hands or pointers to a c,lemp and the domesticlicenses to Petitioner su s that 10 CPR bending of hands or pomtegover,a 1 inch diameter cylinder,'dr

  • manufacture or transfer certain items 32.14(d)(1) amongdedb addingthe weds ,andbesels to Ant sentence containing b uct materialin to (iii) Attachment of the hub ends of the CFR part 32. e lations in these of the introductory text, and by adding a third p oreaMrmurnis hands and pointers to a clamp on a parts govern the in viduals or Arms vibrating fixture and vibration at a rate who cpply uct snatorial to or of not less than to c clos per second lacorporate reduct materialinto a t c]on ained is sealed vial of mineral ans if the vials and a vibration acce erstion of not less uct.These lations also apply to than 2G for a period of not less than one

. tras or individ a who initially do not damaged a dislod hour, and the loss of tritium does ou tsa yprod me a r sale n t exceed 5 nCi when prototype dials, ' (M Totalimmersion of the dials.

or distribution.These regulations hands, pointers, and bezels are hands, pointers, and bezels used in the govern the manufacture and transfer for subjected to the tests as a fledin tests described in 532.14(d)(1) (I), (11), or sale or distribution of self-luminous 5 32.14(d)(1) (i), (11), and 111)." Section (iii)in 100 milliliters of water at room products such as timeplaces that 32.14(d)(1)(lii) would be redesignated as temperature for a period of 24 contain small amounts of tritium. 5 32.14(d)(1)(lv) and a new consecutive hours and analysis of the 5 32.14(d)(1)(lii) would be added to test water for its radioactive materials Discussion - read:" Attachment of the hub ends of content by liquid scintillation counting The petitioner believes that the the hands and pointers to a clamp on a or other equally sensitive methodc )

, regulations that govern the manufacture vibrating fixture and vibration at a rate . . . . .  !

l and distribution for sale of timepieces of not less than 16 cycles per second Dated at Rockville Maryland,this 6th day that contain small amounts of tritium and a vibration acceleration of not less of Octotwr 1993.

[ ase outdated. According to the than 2C for a period of not less than one hour. For the Nuclear Regulatory Commission.

l , petitioner, the NRC's regulations pennit .

l. ' the exempt distribution of timepieces As revised,5 32.14, S****l IN would read as follows: paragraph d(1)Secretaryof the Commission. l' that use small amounts of tritium paint forluminescence but do not consider timeplaces with GTLSs.

gg- 32-PftM-4 '

__