ML20210N449
| ML20210N449 | |
| Person / Time | |
|---|---|
| Issue date: | 07/07/1997 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-97-139, SECY-97-139-01, SECY-97-139-1, SECY-97-139-R, NUDOCS 9708250235 | |
| Download: ML20210N449 (29) | |
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RULEMAKING ISSUE (Notation Vote)
July 7, 1997- SECY-97-139 EQR: The Commissioners FROM: L. Joseph Callan, Executive Director for Operations
SUBJECT:
PROPOSED RULE: LICENSE APPLICATIONS FOR CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL (10 CFR PART 32)
PURPOSE:
To obtain the Commission's approval for publication of a proposed rule amending Part 32.
BACKGROUND:
l By negative consent, the Commission approved a rulemaking plan to amend the prototype testing requirements for hands, dials, and pointers containing tritium (used primarily in timepieces) contained in Part 32. This rulemaking plan was submitted to the Commission on February 4, 1997, SECY-97-028, "Rulemaking Plan for Revision of Prototype Testing Requirements for Hands, Dials, and Pointers Using Tritium: Response to PRM-32-4 to Put Timepieces with Gaseous Tritium Light Sources on the Same Regulatory Basis as Timepieces with Luminous Paint." The )roposed rule responds to a petition received from mb-microtec. Inc., docceted on August 9, 1993, that requested timepieces containing gaseous tritium light sources (GTLS) be regulated on the same basis as timepieces containing tritium paint in regard to their distribution.
DJSCUSSION: ,
In response to the petitioner's request Part 32 would be amended to remove specific prototype testing recuirements for hands, dials, and pointers using tritium from S 32.14(d)(1) anc to modify but not change the intent of the existing performance standard in S 32.14(d)(1). Guidance on meeting the standard will be provided in an appendix to draft NUREG-1562. " Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License," This guidance will be CONTACT: NOTE:
Mary L. Thomas, RES To BE MADE PUBLICLY AVAILABLE WHEN n) q rq C THE FINAL SRM IS MADE AVAILABLE L /
415-6230
. The Commissioners 2 available for use by licensees at the time the rule becomes final. These modifications will provide increased flexibility to licensees, and will accommodate any future developments in technology and design of tritium illuminated timepieces. The guidance will not be incoporated into a regulatory guide, as the staff had previously stated, since NMSS plans to use the NUREG series to provide guidance to licensees on the preparation of license applications.
Currently. NRC requires licensees who commercially distribute gaseous tritium light sources to apply for a license in accordance with S 32.22, To distribute timepieces under this provision an applicant must submit detailed analyses of the product. The proposed amendment would simplify the licensing process for distributors of timepieces containing gaseous tritium light so'.a ces (GTLS) that contain no more than 25 mci of tritium by allowing them to 3pply for a distribution license in accordance with S 32.14, which would only require the applicant to demonstrate that d prototype would meet the perfcimance standard in S 32.14(d)(1). Thus, timepieces using GTLSs coataining small quantities of tritium would be distributed and used in a:,cordance with the same sections of the regulations as timepieces using ludnous tritium paint, that is. S 30.15(a)(1).
Vendors who desire to continue marketing self-luminous watches containing greater than 25 m1111 curies of tritium could continue to do so in accordance with the provisions of S 32.22.
COORDINATION:
The Office of the General Counsel has no legal objection to the proposed rulemaking. The Office of the Chief Financial Officer has no objection to the resource estimates associated with the rulemaking. The Office of the Chief Information Officer concurs that there will be no information technology impacts.
RECOMMENDATION:
That the Commission:
- 1. Acorove for publication in the Federal Reaister the proposed amendments
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to 10 CFR Part 32 (Enclosure 1).
- 2. Nota; '
- a. That the proposed amendments will be published in the Federal Reaister allowing 75 days for public comment. l
- b. That the Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification and the
, reasons for it, as required by the Regulatory Flexibility Act.
5 U.S.C. 605(b).
- c. A draft regulatory analysis has been prepared for this rulemakino (Enclosure 2).
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-The Commissioners 3
.d. An Environmental Assessment has not been prepared for this rulemaking. The NRC has determined <that the proposed rule-is the type of action described as a categorical exclusion in i 51.2hc)(2),
- e. - The app opriate Con ressional committees will be informed of this action Enclosure 3 .
- f. The proposed rule modifies existing information collection requirements that are subject to review by OMB. U)on approval, request for review and clearance will be sent to 018.
j g. That a public announcement will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Enclosure 4).
- h. That resources to complete and implement this rulemaking are included in the current budg t.
l L. J iseph Calla Ex tive Director for Operations
Enclosures:
As stated (4)
Commissioners' comments or consent should be provided directly to the office of the secretary by cob Tuesday, July 22, 1997.
Commission Staff office comments,_1f any, should be submitted to the Commissioners NLT July 15, 1997 -with an information copy to the Office of the Secretary. If the-paper is of such a nature that it requires-additional review and comment, the Commissioners and the Secretariat should
.be apprised of when comments may be expected. '
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[ - NUCLEAR REGULATORY COMMISSION j
- RIN: 3150 AF76
- License Applications for Certain items Containing Byproduct Materiali 4
l AGENCY: ' Nuclear Regulatory Commission.
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- ACTION:'. Proposed rule. :
- i s
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SUMMARY
- The Nuclear Regulatory Commission (NRC) is resolving a petition for 1
4 j - rulemaking submitted by mb-microtec, Inc. (PRM 32-4) by proposing to amend its i
regulations to permit the distribution of timepiecas containing gaseous tritium light sources l' (GTLS) to be regulated in accordance with the sa me requirements as timepieces containing
! tritium paint. The proposed rule would remove from the regulations the specific >
t requirements for prototype testing of these products containing tritium, and provide guidance for prototype testing in a separate document. - If adopted, this proposed e
F ' amendment would simplify the licensing process for distribution of certain timepieces containing tritium and would facilitate the use of a new technology in self illuminated 7
Lt imepieces. .
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DATES: Submit comments by .[ Insert the de- '5 days after publication in the Federal.
l I Register].. Comments neceived after this dat will be considered-if it is practical to do so, i but the Commission is able to assure cor seration only for comments received on or
. before this date.
- ADDRESSES: Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington,- D.C. 20555 0001. ATTN: Rulemaking and Adjudications Staff.
Deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm, Federal workdays.
- Examine comments received, the regulatory analysis, and other documents related-to this rulemaking at the NRC Public Document Room, 2120 L Street NW., (Lower Level),
Washington, DC.
Single copies of this proposed rulemaking may be obtained by written request or telef ax ((301) 415 5389) from Mary L. Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001. These same documents also may be viewed and downloaded electronically via the Electronic Bulletin Board established by NRC for this rulemaking as indicated in the Supplementary Information section.
FOR FURTHER INFORMATION CONTACT: Mary L. Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001, telephone (301) 415 6230, e mail MLT1@NRC. GOV.
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O SUPPLEMENTARY INFORMATION:
Background
The Petition for Rulemaking 1
. 1 In a letter dated July 30,1993, mb-microtec, Inc. petitioned the NRC to amend its regulations "to include timepieces containing gaseous tritium light sources (GTLS) on the same regulatory basis as those with tritium paint in regard to their distribution exempt from the requirements of 10 CFR 32,14(d)."
In the petition, the petitioner stated the following:
With new technology greater illumination could be achieved with less radioactivity than needed for a painted watch but that the additional requirements to get a GTLS watch approved for distribution results in manufacturers not using this technology, On August 9,1993, the NRC docketed the letter as a petition for rulemaking (Docket No. PRM 32-4). A notice of receipt of petition for rulemaking was published for public comment in the Federal Register on October 29,1993 (58 FR 52670). No public comments were received on the notice concerning the petition.
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Current NRC Regulations for Certain items Containing Byproduct Material Section 30.15(a)(1) states that if a timepiece containing byproduct materialis to be distribt ed to persons exempt from the NRC's licensing requirements, it may not contain more than 5 millicuries per hand, not more than 15 millicuries in the dial, and not more than 25 millicuries of tritium in total. Section ',2.14(d)(1) contains overall performance requirements for the binding of tritium to watch hands, pointers, and dials, as well as specific prototype testing requirements for tritium-painted watch hands, pointers, and dials.
Although 10 CFR 30.15(a)(1) does not specify a form for tritium in timepieces, the prototype testing requirements in 10 CFR 32.14(d)(1) -- the section of the NRC's regulations under which a specific license to distribute watches exempt under 10 CFR 30.15(a)(1) is granted -- are only applicable to timepieces employing tritiunt paint.
Watches containing greater than 25 millicuries of tritium in GTLSs may be I distributed to persons exempt from licensing requirements in accoidance with 10 CFR 30.19, "Self-luminous products containing tritium, krypton-85, or promethium-147,"
which, unlike 10 CFR 30.15(a)(1), specifies neither a limit on the amount of tritium that may be incorporated into self luminous products nor the end use of the product. However, to distribute a self luminous watch containing tritium to persons exempt from licensing requirements in 10 CFR 30.19, a specific license must be obtained in accordance with 10 CFR 32.22. To manufacture, process, produce, or initially transfer self luminous products containing unrestricted amounts of tritium under 10 CFR 32.22(a)(2), the applicant must submit detailed information and analyses concerning the particular product in order to obtain approval for distribution. The information required by 10 CFR 32.22 must be sufficient to demonstrate that the product meets a number of specific safety
criteria, including dose criteria for use and disposal. The application must include proposed prototype testing procedures, which must be approved by the NRC. Further, the ev6ations conducted by both the licenses and the staff, as well as the prototype testing proposed, apply to the entire product rather than its components. Conversely, approval for distribution of timepieces containing less than 25 millicuries of tritium to persons exempt from licensing requirements in 10 CFR 30.15(a)(1)(i) requires a specific license under 10 CFR 32.14, but only requires satisfaction of the prototype testing requirements contained in 10 CFR 32.14(d). Consequently, it is less burdensome upon a licensee to distribute watches employing tritium illumination under 10 CFR 32.14 than under 10 CFR 32.22.
Proposed Amendments The NRC has carefully reviewed the arguments presented by the petitioner. The NRC is proposing to resolve the petition by initiating this rulemaking. This rulemaking incorporates the petition in part. Rather than revise the specific testing requirements in the regulations as proposed by the petitioner to accommodate both tritium paint and GTLSs, the NRC is proposing a more performance-based approach by removing the existing specific testing procedures from the regulations. Guidance on specific prototype testing procedures will be provided in draft NUREG-1562, " Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License," which will be issued for public comment. Further, the proposed rule would modify but not change the intent of the existing general performance standard. This modification will state that the method of containment or binding of the byproduct be such that the radioactive material will be bound and will not become detached from the product 5
under the most severe conditions which are likely to be encountered in normal use and handling. By making these modifications to 6 32.14(d), increased flexibility in the regulations will be provided and future developments in technology and design of tritium illuminated timepieces will be accommodated. These modifications will not decrease the level of radiation protection provided to users of tritium illuminated timepieces.
Rationale
.The licensing process is more burdensome to potential distributors of timepieces under 10 CFR 30.19 than with an application to distribute timepieces for use under 10 CFR 30.15(a)(1). Changing the prototype testing requirements in 10 CFR 32.14(d)(1) would simplify the licensing process for distributors of timepieces containing small quantities of tritium in the GTLS form by allowing them to apply to distribute these timepieces for use under 10 CFR 30.15(a)(1). Thus, timepieces using GTLSs would be distributed and used under the same requirements of the regulations as timepieces using tritium paint.
Effects of the Proposed Amendments The effect of this proposed amendment would facilitate distribution of self illuminated timepieces that utilize a new technology.
Electronic Access Comments may be submitted electronically, in either ASCll text or Wordperfect 6
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format (version 5.1 or later), by calling the NRC Electronic Bulletin Board (BBS) on FedWorld. The bulletin board may be accessed using a personal computer, a modem, and one of the commonly available communications software packages, or directly via Internet.
Background documents on the rulemaking are also available, as practical, for downloading and viewing on the bulletin board, if using a personal computer and modem, the NRC rulemaking subsystem on FedWorld can be accessed directly by dialing the toll free number (800) 303 9672.
Communication software parameters should be set as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1). Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem can then be accessed by selecting the " Rules Menu" option from the "NRC Main Menu." Users will find the "FedWorld Online User's Guides" particularly i helpful. Many NRC subsystems and databases also have a " Help /Information Center" option that is tailored to the particular subsystem.
The NRC subsystem on FedWorld can also be accessed by a direct dial phone number for the main FedWorld BBS, (703) 321-3339, or by using Telnet via Internet:
fedworld. gov. If using (703) 321-3339 to contact FedWorld, the NRC subsystem will be accesse6 from the main FedWorld menu by selecting the " Regulatory, Government Administration and State Systems," then selecting " Regulatory Information Mall." At that point, a menu will be displayed that has an option "U.S. Nuclear Regulatory Commission" that will take you to the NRC Online main menu. The NRC Online area also can be accessed directly by typing "/go nrc" at a FedWorld command line, if you access NRC from FedWorld's main menu, you may return to FedWorld by selecting the "Retum to FedWorld" option from the NRC Online Main Menu. However, if you access NRC at FedWorld by using NRC's toll-free number, you will have full access to all NRC systems, 7
but you will not have access to the main FedWorld system.
If you contact FedWorld using Telnet, you will see the NRC area ar.d menus,
-including the Rules Menu. Although you will be able to download documents and leave messages, you will not be able to write comments or upload files (comments). If you contact FedWorld using FTP, all files can be accessed and downloaded but uploads are not allowed; all you will see is a list of files without descriptions (normal Gopher look). An index file listing all files within a subdirectory, with descriptions, is available. There is a i
15 minute time limit for FTP access. -
Although FedWorld al.o can be accessed through the World Wide Web, like FTP that mode only provides access for downloading files ar.d does not display the NRC Rules ,
Menu.
You may also access the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc. gov). This site provides the same access as the FedWorld bulletin board, including the facility to upload commeNs as files (any format), if your web browser supports that function.
For more information on NRC bulletin boards call Mr. Arthur Davis, Systems
-Integration and Development Branch, NRC, Washington, DC 20555, telephone (301) 415-
^
5780; e mail AXD3@NRC. GOV. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (3011415-6215; e-mail CAG@NRC. GOV. 3 Agreement State Compatibility Under the Atomic Energy Act, certain regulatory functions are reserved to the NRC.
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Among these are the distribution of products to persons exempt from licensing, asi
!- discussed in-10 CFR Part 150. Hence, the proposed rule, if adopted, would be a Division 4 e
-i matter of compatibility with regard to the manufacture and initial distribution of watches-p it and other products for use. Division 4 rules address those regulatory functions which are reserved to NRC pursuant to the Atomic Energy Act and 10 CFR %rt 150. Under the new l
- Commission Policy on Agreement State Compatibility, this rule would be treated in the same manner but the category previously known as Division 4 will have a different designation, i
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. Environmental Impact: Categorical Exclusion B
l .The NRC has determined that the proposed rule is the type of action described as a i
! categorical' exclusion in 10 CFR 51.22(c)(2). Therefore, neither an environmental impact i
statement nor an environmental assessment has been prepared for this proposed rule, j-4
! Paperwork Reduction Act Statement b
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- This proposed rule amends information collection requirements that are subject to .
l the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule has been
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submitted to the Office of Management and Budget for review and approval of the 4
- Information collection requirements..
' The public reporting burden reduction for this information collection is estimated to
- average 54 t ours per response, including the time for reviewing instructions, searching _
- existing data ' sources, gathering and maintaining the data needed, and completing and-1 I_
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reviewing the information collection. -The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the information contained in the proposed rule and on the following issues:-
- 1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practicLI utliity?
- 2. Is the estimate of burden accurate?
- 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
- 4. How can the burden of the collection of information be minimized, including the use of automated collection techniques?
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Send comments on any aspect of this proposed collection of information, including suggestions for reducing the burden, to the Information and Records Management Branch (T-6F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet e-mail at BJS1@NRC. GOV; and to the Desk Officer, Office of information and Regulatory Affairs, NEOB 10202, (3150-0001), Office of Management and Budget, Washington, DC 20503.
Comments to OMB on the collections of information or on the above issues should be submitted by [ insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.
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' Public Protection Notification -
If a document does not display a currently valid OMB control number the NRC may t
- not conduct or sponsor, and a person is not required to respond to,-a collection of-
~ information.
Regulatory Analysis ;
The NRC has prepared a dra't regulatory analysis for the proposed amendment. The analysis examines the benefits and impacts considered by the NRC. The draft regulatory analysis is available for inspection at the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, DC. Single copies may be obtained from Mary L. Thomas,
_ Office _of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 2055 0001, telephone 301-415-6230 or e mail at MLT1@NRC. GOV.
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- Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the
- Commission certifies that this rule will not have a significant economic impact upon a substantial number of small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic
- _ impact should notify the Commission of this in a comment that indicates the following:
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(a) The lironsee's size and how the regulation would result in a significant economic burden upon the licensee as compared to the economic burden on a larger licensee.
(b) How the regulations could be modified to take into account the licensee's differing needs or capabilities.
(c) The benefits that would accrue, or the detriments that would be evolded, if the regulations were modified as suggest6d by the licensee.
(C How the regulation, as modified, would more closely equalize the impact of regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any individual or group. --
(e) How the regulation, as modified, would still adequately protect public health
, tid safety.
Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this proposed rule, and therefore, a backfit analysis is not required because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects in 10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
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For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendment to 10 CFR Part 32.
PART 32 SPECIFIC DOMESTIC LIC3NSES TO MANUFACTURE OR TRANSFER I CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL l 1,
- 1. The authority citation for Part 32 continues to read as follows:
AUTHORITY: Secs. 81,161,183,186, 68 Stat. 935, 948, 953, 954, as amended, (42 U.S.C. 2111, 2201, 2232,2233); sec. 201,88 Stat.1242, as amended, (42 U.S.C. 5841).
- 2. In i 32.14, paragraph (d) is revised to read as follows:
i 32.14 Certain items containina bvoroduct materlah reauirements for license to anolv or initially transfer.
(d) The Commission determines that:
(1) The method of comainment or binding of the byproduct materialin the product is such that the radioactive material will be bound and will not become detached from the product under the most severe conditions which are likely to be encountered in aormal use and handling.
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(2) Prototype tests for automobito lock illuminators are prescribed by 10 CFR 32.40, Schedule A.
Dated at Rockville, Maryland, this day of .1997.
For the Nuclear Regulatory Commission.
John C. Hoyle, Secretary of the Commission.
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ORAFT REGULATORY ANALYSIS FOR PROPOSED RULEMAKING
- LICENSE APPLICATIONS FOR CERTAIN ITEMS CONTAINING BYPRODUCT MATERIA 10 CFR PART 32
- 1. Backcround l 1.1 Statement of the Problem On August 9, 1993, the Commission docketed a petition for rulemaking (Docket No. PRM 32 4) from mb microtec. Inc. (microtec). In a letter dated July 30, 1993. microtec petitioned the NRC to amend its regulations *to include timepieces containing gaseous tritium light sources on the same regulatcry basis as those with tritium paint in regard to their distribution exempt from the requirements of 10 CFR 32.14(d).*
In the July 30, 1991 petition, the petitioner stated the following:
Over time, improvements in the design of these tubes have increased the efficiency so that less tritium is required for a given luminosity, and as a result, an effective self-luminous timepiece using GTLS. rather than paint, can be manufactured using 25 mci of tritium.
The current requirements for GTLSs are more stringent than requirements for watches with the same millicurie amounts of tritium paint.
With new technology greater illumination could be achieved with less radioactivity than needed for a painted watch but that the additional requirements to get a GTLS watch approved for distribution results in manufacturers not using this technology. '
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1.2 CeLornt upr peQuldi m In 10 CFR Part 32, " Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Materials," 10 CFR 32.14,
- License Applications for Certain items Containing Byproduct Material," paragraph (d)(1) requires prototype testing of timepieces and other devices containing tritium. The prototype tests were developed to ensure that under normal use tritium paint would remain bound to the dials and hands of timepieces, thermostat dials and pointers.
1.3 Larlier NRC Actions following the receipt of the petition, a " Notice of receipt of petition for rulemaking" was published for public comment in the Federal Reaister on October 29, 1993 (58 FR 52670), No public comments were received on the notice published concerning the petition,
- 2. Obiective By negative consent, the Commission approved a rule plan to amend the prototype testing requirements for hands, dials, and pointers containing tritium (used primarily in timepieces) contained in Part 32. This rule plan was submitted to the Commission on February 4, 1997 SECY-97-028.
The objective of the rulemaking is to (1) amend 10 CFR Part 32 to remove the prototype testing requirements for hands, dials, and pointers using tritium from 10 CFR 32.14(d)(1) and (2) to provide guidance on the specific requirements for prototype testing in draft NUREG-1562, " Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License," which will again be issued for public comment.
- 3. Alternatives ihree alternatives have been considered in the regulatory analysis: no action, except to deny the petition; amend the regulations; use an information notice. i generic letter, or regulatory guide, l
3.1 No Action. Excent to Deny the Petition Not changing the regulat c r would maintain the current situation, which is:
since the bending test npHAvnt of 10 CFR 32.14(d)(1)(ii) is not appropriate for GTLS. commerc161 distributors must apply for and obtain a l license amendment in accordance with 10 CFR 32.22 for watches using GTLS. with l the attendant cost in time and expense of performing detailed safety analyses not considered necessary for watches employing the same quantities of tritium but in the form of paint. The cost for distributors to initially obtain a distribution license under 10 CFR 32.22 rather than under 10 CFR 32.14 is an unnecesscry expense without commensurate health and safety benefit.
3.2 Amend the Reaulations Revision of the testing requirements of 10 CFR 32.14(d) to accommodate GTLS containing no more than 25 mci of tritium would permit simplification of the licensing process for watches containing GTLS. For vendors who want to continue marketing self luminous watches containing GTLS with greater than 25 mil 11 curies tritium, the provisions of 10 CFR 32.22 would remain.
Watches using GTLS can be produced without exceeding the quantities of tritium specified in 10 CFR 30.15(a)(1). Further, an appropriate test can be devised.
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and has been proposed by the petitioner3 . that would demonstrate that a watch employing GTLS illumination would meet the requirement in 10 CFR 32.14(d)(1) that "... the method of containment or binding is such that it is unlikely that the radioactive material will be released or be removed from the product under the most severe conditions which are likely to be encountered in normal use and handling..."
Within the alternative of rulemaking to accommodate GTLS a variant to the specific proposal of the petitioner has been considered. Thus, the alternatives considered are:
(a) revise the regulations i . *orporate the prototype test specified by the petitioner to accommodate .5:
-(b) remove specific protofyp ;, ting requirements from the regulations and place both the test proposed by Qe petitioner and the current prototype test for painted hands, dials. etc., in an appropriate guidance document, but maintain the overall performance standard in the regulations.
While either approach will grant the intent of the petitioner's request, the second is a more performance based approach that would better accommodate future developments in luminous technology. Specifically, even though the prototype testing procedure proposed by the petitioner is considered acceptable and reasonable for GTLS on watches, other methods or applications may arise where it may not be optimal or appropriate. Hence, with this variant the staff can approve new or different applications and methods The petitioner has pro >osed substituting a vibratory test similar to-that specified for painted cials in place of the bending test for hands and pointers in the case of timepieces using GTLS. to ensure the unit integrity of the GTLS pointers, and hands. As pointed out by the petitioner, this would be consistent with the comparable but somewhat more. flexible prototype testing requirements described in IAEA Safety Series 23. " Radiation Protection Standards for Radio Luminous Timepieces." Attaching only the hub cnd of the hands and pointers to a fixture and subjecting them to vibration as proposed by the petitioner would involve smaller forces than the bending test but would .
still exceed the forces these elements would encounter under the most severe conditions expected in normal use. The NRC staff has reviewed. the petitioner's proposed test, and agrees that the suggested testing would be adequate and acceptable.
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0 without need for either an amendment to or exception from existing regulations, and yet continue to ensure that "...the method of containment or l
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.*
3.3 Use an Information Notice. Generic letter. or Reaulatory Guide These alternatives would be inappropriate since they cannot be used to amend !
what is currently required by the regulations. The rule would still require prototype testing procedures and results to be submitted in a license application. Use of any of these alternatives could not negate the existing rule requirements.
in consideration of the above, the NRC staff intends to proceed with alternative 3.2(b): amending the regulations to accommodate watches employing GTLS by removing the prescriptive prototype testing specification for tritium paint from the existing regulations and placing both that specification and the prototype test proposed by the petitioner in draft NUREG-1562.
- Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License.' which will again be issued for public comment.
- 4. Value-impact Analysis 4.1 The Petitioner's Assessment in the letter dated July 30. 1994 the petitioner stated:
Over time, improvements in the design of these tubes have increased the efficiency so that less tritium is required for a given luminosity, and as a result, an effective self-luminous timepiece using GTLS. rather than paint, can be manufactured using 25 mC1 of tritium.
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The current requirements for GTLSs are more stringent than requirements for watches with the same mil 11 curie amounts of tritium paint.
With new technology greater illumination could be achieved with less radioactivity than needed for a painted watch but that the additional requirements to get a GTLS watch approved for distribution results in manufacturers not using this technology, 4.2- The NRC's Assessment l
(a)- Cost Savinas Associated with Amendment to 10 CFR Part 32 The proposed rule would not present a new cost burden to applicants or licensees, but could eliminate cost burdens associated with-the licensed:
distribution of timepieces using GTLS containing-25 mci or less of. tritium.
There would also be some regulatory savings because the NRC would not have to expend resources reviewing new applications for licenses to manufacture and distribute timepieces containing tritium in accordance with 10 CFR 32.22, which include device evaluations.
The value impact analysis focuses on the benefits of granting relief consistent with Alternative 2 as specified in Section 3 above. The analysis looks solely at changes relative to applying for a license in accordance with 10 CFR 32.22 and applying for a license in accordance with 10 CFR 32.14.
' The following table gives the current and proposed fees associated with licensing products containing gaseous tritium light sources in U.S. dollars, 6
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$ l Regulatory Citation Current Annual Fees Regulatory Citation Proposed Annual Fees Fees Discounted Over Fees Discounted Over 10 Years 10 Years 10 CFR 170.31(3)(H). 2.400 10 CFR 170.31(3)(I). 4.400 Initial Application Initial Application 10 CFR 171.16(d)(3)(H) 4.600 2.335 10 CFR 171.16(d)(3)(H) 8.200 4.162 Annual License Annual License 10 CFR 170.31(9)(A) 3.400 Application - each device 10 CFR 171.16(d)(9)(A) 6.700 3.401 Annual Device Registration 7
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It can be seen from the table that the current total fees can vary from [
$12,500 for an initial application package which includes a $2.400 initial application fee, a $3,400 device application fee, and a $6.700 device registration fee: to $11,300 for an annual license which includes a $4.600 j annual license fee and a $6,700 device registration fee. The proposed fees ;
could vary from $4.400 for an initial application package to $8,200 for an f annual license. This results in a cost savings to the applicant / licensee of l
$8,100 ($12,500' $4,400) for an initial application package and $3.100 l
($11,300 $8,200) in annual license and device registration fees. The discounted annual savings over 10 years would be $1,574 (($2.335 + $3.401) -
$4.162) expressed in constant dollars. The current number of licensees that would be affected by this rule is 13. The total resultant annual cost savings
-for this particular industry would be $20,462. The annual values were ,
discounted over a time period of 10' years to correspond with the time period for which a license is first issued. :
NRC would save staff hour costs by no longer having to review device ,
registration documents for licensed distribution of timepieces using GTLS containing 25 mci or less of tritium. However, a one time cost to NRC would p result from the staff costs involved in terminating a device registration any I
licensees already distributing such timepieces in accordance with 10 CFR 32.22. but who by distributing in accordance with 10 CFR 32.14, could eliminate annual NRC device registration fees. The cost incurred by the NRC [
would be $1200 (10h X $120/hr) per licensee.
(b)' Health and Safety Effects The leak rate of tritium from GTLS incorporated into timepieces is lower than that from an equivalent Curie amount of tritium paint incorporated into >
timepieces: thus, the exposures from timepieces using GTLS less than 25 mci are lower than those from timepieces using tritium paint. In fact, ORNL [
recently reported that the potential skin dose from a GTLS watch containing 50 j millicuries (50 millirem) is four-fold lower than a watch containing 2 ;
.m1111 curies tritium paint (200 millirem). Moreover, the health risk from the 8
a m._ _.___ . _ _ . _ _ _ . . . _ . _ . . . _ _ . _ . . _ _ . ___ _ . . . . - ,
release of 25 mC1 of gaseous tritium in the event of breakage of the glass vials is not significant.
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The NRC has concluded that the manufacture and initial distribution of products containing gaseous tritium light sources results in insignificant exposures. Therefore, by adopting the proposed rule, the cost savings would i be maximized without any measurable adverse effect on public health and safety, i
i 5. Decision Rationale Based on the above analysis, the NRC believes that the proposed rule, if adopted, would provide both the manufacturers or initial distributors to distribute products containing gaseous tritium light sources and the NRC
] significant savings with respect to licensing such devices with negligible I radiological risk from distribution of such devices.
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g oa at vy yo #*, UNITED STATES
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,}2 NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. ma -g The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce l United States House of Representatives i Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concerning a proposed amendment to 10 CFil Part 32. This rulemaking is being undertaken in response to a petition for rulemaking PRM 32-4 submitted by mb microtec, Inc.
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to permit the distribution of timeplaces containing gaseous tritium light sources to be regulated in accordance with the same requirements as timepieces containing tritium pulnt. If adopted, this proposed amendment would simplify the licensing process and facilitate the use of a new technology in self illuminated timepleces.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: Representative Ralph Hall J
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Draft press release,6/26/97,2:30 p.m.
NRC CONSIDERS CilANGES TO REOULATIONS ON WATCilES AND CLOCKS CONTAINING RADIOACTIVE TRITIUM l
The Nuclear Regulatory Commission is considering amending its regulations to simplify the licensing process for timepieces containing tritium.- It would permit timepieces containing -
gaseous tritium to be licensed under the same regulatory requirements as those containing tritium paint.
The proposed revisions are in response to a petition for rulemaking submitted by mb microtec, Inc, of North Tonawanda, New York.
Tritium, a self luminescent radioactive material, is used in watches and clocks to make i their hands, numbers or other parts visible in the dark. It may be either in the form of a gas-contained in tiny sealed tubes--or in paint. The planned revisions would not change the level of radiation protection provided to users and wearers of tritium-illuminated timepieces. 1 Currently timepieces containing tritium paint may be licensed under a section of the regulations that contains specific prototype testing requirements. License applications that meet '
those tests, and that do not exceed limits on the total amount of tritium permitted per timepiece, can meet NRC licensing requirements. However, some of the tests, such as a bending test designed to show that paint will not crack off, are probably not suitable for gaseous tritium.-
Therefore applicants for a license to manufacture watches and clocks containing gaseous tritium -
cannot apply under this section of the regulations and must apply for an NRC license under a -
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s separate section of the regulations that requires submittal of much more detailed information (such as engineering drawings containing the overall dimensions, minimum and maximum dimensions of each model or series, and description of constmetion materials). l The propox.i rule would remove from the regulations the specific requirements for prototype testing but would continue to contain requirements for overall product performance. l 1
Where appropriate, the NRC staff, as part ofits review oflleense applications, will impose testing requirements for watch hands and dials through license conditions.
Interested persons are invited to submit written comments on the proposed changes to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, Attention:
Rulemaking and Adjudications Staff, within 75 days after publication of a Federal Register notice. This notice is expected to be published shortly.
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