ML20249B886
| ML20249B886 | |
| Person / Time | |
|---|---|
| Issue date: | 06/09/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-62FR49173, RULE-PR-32 NUDOCS 9806240393 | |
| Download: ML20249B886 (11) | |
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kFOSEDRilk DOCrEir0 DoRFM915' [7590-01-P]Lr'r" NUCLEAR REGULATORY COMMISSION
'96 JUV 10 NO;04 10 CFR Part 32 OF R._ _
RIN 3150-AF76 AD;L License Applications for Certain items Containing Byproduct Material Nuclear Regulatory Commission.
AGENCY:
ACTION:
Final Rule.
The Nuclear Regulatory Commission (NRC) is amending its regulations that
SUMMARY
govern licensing requirements for persons who incorporate byproduct material into ce or who initially transfer certain items containing byproduct material. This action is being ta in response to a petition for rulemaking submitted by mb-microtec, Inc. (PRM-32-4), to distribution of timepieces that contain less than 25 mci of gaseous tritium light sources (G to be regulated according to the same requirements that regulate timepieces containin paint. Tnis final rule simplifies the licensing process for distribution of certain timepieces containing tritium paint and accommodates the use of a new technology for self-illuminate timepieces.
/?i l'198 EFFECTIVE DATE: ( 60 i,. em, puucm.vi. in iim Feuemi Rupis) u FOR FURTHER INFORMATION CONTACT: Donald O. Nellis, Office of Nuclear Material O-i i
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Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington DC 20555, Telephone (301) 415-6257 (e-mail address don @nrc. gov).
Os 11 7 64 L - h-i e,3 2 6tl.,, elider 9806240393 990609 4,172 con of G3FR 329b9
SUPPLEMENTAL INFORMATION:
' t.-
Background.
' 11.
Public Comments on the Proposed Rule.
Ill.
Response to Public Comments IV,
. Agreement State Compatibility V.
Environmental Impact: Categorical Exclusiori i
VI.
Paperwork Reduction Act Statement Vll.
Regulatory Analysis Vill.
Regulatory Flexibility Certification
. IX.-
Backfit Analysis X.
Small Business Regulatory Enforcement Fairness Act 4
1. Background
A petition for rulemaking was received from mb-microtec, Inc. (PRM-32-4), and no for public comment on October 29,1993 (58 FR 53670). This petition requested that tho timepieces having GTLS be placed on the same regulatory basis as timepieces with lum tritium paint. No public comments rere received on the notice.
NRC regulations that are relevant to this petition are the following:
- 1. Under 10 CFR 30.15(a)(1), persons who receive, possess, use, transfer, own, or acquire timepieces containing byproduct material are exempted from NRC's licensing requirements provided that not more than the following quantities of byproduct material are contained in the timepiece or hands or dials:
- (1) -
25 mci of tritium per timepiece;
(ii) 5 mci of tritium per hand.
15 mci of tritium per dial (bezels, when used, shall be considered part of (iii) the dial).
Quantity limits for timepieces containing promethium-147 are also included.
- 2. Broad general requirements in 32.14(d)(1) are applicable to the method of I
containment or binding of the byproduct material incorporated into the products specified in l
10 CFR 30.15. Specific prototype testing requirements for tritium-painte.d dials, watch hands and pointers are also provided in @ 32.14(d)(1). No protetype testing procedures are p 1
for timepieces containing GTLS.
- 3. An exemption from licensing requ;rements in @ 30.19 is similar to that found in 10 CFR 30.15(a)(1) with respect to self-luminous products containing tntium, krypton-85, or promethium-147; but unlike @ 30.15(a)(1), it does not limit the quantity of these rad;o that may be incorporated into various parts of the product. However, it does require persons who manufacture, process, produce, or initially transfer such products to apply for a specific license under & 32.22.
- 4. An extensive list of requirements in S 32.22 must be met in order to obtain a specific license to distribute such products, and @ 32.23 and @ 32.24 provide safety criteria that must b demonstrated prior to issuance of a license to distribute such products.
The petitioner stated that current regulations were overburdensome and counterproductive, and that watch manufacturers do not want to become involved with the present licensing procedures required under 6 32.22 concerning GTLS watches.
The NRC believes that the health and safety impact from using timepieces with GTLS would likely be positive because the radiation dose to the public from the use, storage, distribution, etc., of timepieces using GTLS is less than the dose to the public from timepieces 3
containing tntiura paint if the same amount of totium is used in both type i
because the tritium leak rate from timepieces using GTLS is lower than fro tritium paint because of significantly lower tritium leak rates from sealed timepieces containing the same amount of totium as paint. Thus. allowing t distnbution of timepiece 3 using GTLS under the same regulatory requirem for timepieces containi1g tntium paint could result in a lower dose to an ind collective dose to thr, public. The distnbution of timepieces containing large d
@ 32.22,"Self-luminous
. gaseous tritium (up to 200 mci) has been approved for use un er produds? These timepieces have baan evaluated against the safety en
- $$ 32.22,32.23 and 32.24 and have been found acceptable.
32.14(d) to allow their exempt distribution for The NRC believes that including GTLS in use under S 30.15 would reduce unnecessary burdens for both the licensee Without the adoption of this alternative, licensees have to manufacture timep stringent criteria in $@ 32.22,32.23, and 32.24.. The NRC must also rev against these requirements. Because these sinngent requirements are no for smaller quantities of tritium, these burdens could be avoided without aff and safety. Based upon the foregoing, the NRC has concluded that the distrib 9 30.15 and S 32.14 should be allowed.
On September 19,1997 (62 FR 49173), the NRC published a proposed rule incorporated the petition in part, by removing the existing specific testin from the regulations and leaving only a modified first sentence in S 32.14(d)(1):
1 (1) The method of containment or binding of the byproduct materialin t such that the radioactive material will be bound and will not be 4
_ _ - _ _ - - _ _ _ _ _ _ _ _ _ _ _ - _ _ _ - _ _ _ _ _ _ _ = _ _ _ _ _
k product under the most severe conditions v.hich are likely to be encountered in normai use and handling.
This modification of @ 3214(d)(1) represented a performance-based approach by removing the existing specific testing procedures from the regulat:ons and was expected to provide increased flexibility in the regulations and the accommodation of future developments in the technology of tntium illuminated timepieces. as well as other products exempt from the requirements for a license under 30.15 II. Public Comments on the Proposed Rufe The comment period on the proposed rule closed December 3,1997. Three comment letters pertaining to the proposed rule were received. each addressing a different element of the rule. These comments are discussed in the following section.
Ill. Response to Public Comments The first commenter approved the changes made in @ 32.14(d)(1) but requested, as a step toward international harmonization, that the NRC adopt the International System of Units (SI)in presenbing the quantities of byproduct materialincorporated into products distnbuted to 30.15 In addition, the commenter requested persons exempt from licensing as specified in that the quantity limit for tntium specified in @ 30.15(a)(1)(i). 25 mci, be changed to read 27 mci (1 GBq) to correspond to the exempt activity of totium specified in the IAEA Safety Series No.115 standard.
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NRC practice is to use a dual system in describing units; the quantities are given Si system, fo!Iowed by the quantities in parentheses in conventional units. Th is used in this final rule wherever radiation quantities are specified However, no chan S 30.15 is being made at this time so that the quantity limit will remain as 25 mc the request to change the total exernpt activity for timepieces to 27 mci in place now in use, the NRC is currently involved in an overall reevaluation of the exemptions fro licensing in 10 CFR Parts 30 and 40, including 6 3015(a)(1)(i), and will consider the is during that process.
The second commenter stated that the language of @ 32.14(d)(1) of the proposed appeared to recuire 100% containment of the intium in watches using tritium paint commen'er proposed alternative text that would remove this inconsistency and provide t equally applicable to watches that utilize either totium paint or GTLS as to other exem products under S 3015. This commenter's suggestion has been adopted. Sect has been revised in this final rule. As revised, the rule requires that the tntium be proper 32.14(dl(2) of the proposed rule did not make contained. The commenter also noted that sense as presented and proposed amendatory language that contains the same co language proposed by this commenter has been adopted in the final rule. According codified text in 5 32.14(d)(2) has been modified to refer more correctly to existing pratotype testing requirements for automobile lock illuminators.
The third commenter remarked that the wording of the first serstence of the proposed
@ 32.14(d)(1) was similar to the opening sentence of the existing rule, and tha the language of 6 32.14(d)(1), which stated that the performance standard is satisfi prototype tests (applicable only to tritium paint) are satisfied, has been removed. The commenter noted that the proposed rule also stated that guidance on specific prototype testinf e
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procedures would be provided in NUREG-1562, ' Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License ' The commenter indicated support for the increased flexibility provided by the proposed rule and for the need for clear and unambiguous means to satisfy stringent performance requirements established in the previous @ 32.14(d)(1). The commenter also noted that the relevant modifications to the guidance document have not yet been made and requested that the final promulgation of tne rule be coincident with the issuance of appropriate guidance. Also this commenter requested that, because many timepieces are manufactured abroad, the NRC acknowledge explicitly in its guidance that comphance with relevant international standards is sufficient to ensure compliance with the NRC performance standard The NRC intends to have the revised guidance document completed by the time this rule becomes effective. Regarding the requirement that timepieces manufactured abroad should meet NRC requirements, those timepieces should fulfill the criteria specified in NUREG -
l 1562 or its equivalent.
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IV. Agreement State Compatibility Under the Atomic nergy Act, certain regulatory functions are reserved to the NRC.
c Among these are the distribution of products to persons exempt from licensing, as discussed in 10 CFR Part 150. Therefore, this final rule will be an "NRC" Category of compatibility with regard to the manufacture and initial distribution of watches and other products for use under i
an exemption for licensing. NRC Category rules address those regulatory areas wNen are reserved to the NRC pursuant to the Atomic Energy Act and 10 CFR Part 150.
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V. EnvironmentalImpact: Categorical Excluniors B
The NRC has determined that this final rule is the type of action described as a L
categorical exclusion in 10 CFR 51.22(c)(2). Therefore, neither an environmenta 1
statement nor an environmental assessment has been prepared for this final rule..
VI. Paperwork Reduction Act Statement This final rule reduces the burden to applicants for licenses to distribute tirnepie allowing them to file an application under the provisions of 5 32.14 rather than und 32.22 that, in practice, also requires that the applicant obtain a registration provisions of certificate. The reduction in burden is estimated to be 21 hours2.430556e-4 days <br />0.00583 hours <br />3.472222e-5 weeks <br />7.9905e-6 months <br /> per response. Because application requirements contained in @ 32.14 and G 32.22 are not being s no Office of Management and Budget (OMB) clearance is required. Part 32 requirement approved by the OMB approval number 3150-0001.
Public Protection Notification The NRC may no' conduct or sponsor, and a person is not required to respond to, an information col'ection unless it displays a currently valid OMB control number.
Vll. Regulatory Analysis The NRC has prepared a regulatory analysis on this final rule. The analysis examine the costs and benefits of the revisions provided by the rule and indicates an annual total 8
l saving to the industry to be approximately 515,000.- This regulatory analysis is available for inspection'at the NRC Public Document Room,2120 L Street, NW (Lower Level),
Washington, D.C.
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Vill. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies.
that this rule does not have a significant economic impact on a substantial number of small entities. The NRC has orepared a regulatory analysis that includes consideration of the impact of this final rule on small entities A copy of this regulatory analysis is available for inspection or i
copying at the NRC Public Document Room,2120 L Street, NW (Lower Level), Washington, D.C. The analysis states that this regulation would currently affect 10 licensees and would l
result in a cost savings for the industry of approximately $15,000 per year.
IX. Backfit Analysis The NRC has determined that the backfit rule does not apply to this final rule and, therefore, a backfit analysis is not required for this final rule because these amendments do rot involve any pmisions that would impose backfits as defined in 10 CFR Chapter 1.
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l X. Small Business Regulatory Enforcement Fairness Act in accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.
1 List of Subjects in 10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authonty of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C.
553; the NRC is adopting the following amendments to 10 CFR Part 32.
PART 32 - SPECIFLC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL art 32 continues to read as follows:
o
- 1. The authority citation for Authority: Secs.81,161,183,186,68 Stat. 935,948,953,954, as amended, (43 U.S.C.
2111,2201,2232,2233); sec.201,88 Stat.1242, as amended (42 U.S.C. 5841).
- 2. In @ 32,14, paragraph (d)is revised to read as follows:
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$ 32.14 Certain items containing byproduct material; requirements for license to apply l
or initially transfer.
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(d) The Commission determines that:
(1) The byproduct material is properly contained in the product under the most severe conditions that are hkely to be encountered in normal use and handling.
(2) For automobile lock illuminators, the product has been subjected to and mee requirements of the prototype tests prescribed by 6 32.40, Schedule A.
fQ /d Dated at Rockville, Maryland, this 7
_ day of June,1998.
For the Nuclear Regulatory Commission.
(.
o Jahrj G' Hoyle,
[
Segtefary of the Commission.
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