ML20210N058
| ML20210N058 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1997 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20210N041 | List: |
| References | |
| SECY-97-139-C, NUDOCS 9708220331 | |
| Download: ML20210N058 (11) | |
Text
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N OT ATIO N VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER MCGAFFIGAN
SUBJECT:
SECY-97-139 - PROPOSED RULE: LICENSE APPLICATIONS FOR CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL (10 CFR PART 32)
Approved X' JDisapproved M Abstain Not Participating Request Discussion COMMENTS:
i See attached comments.
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SIGNATURE [' " ' 'd
,fs Release Vote / </ / ' l/ .I DATE Withhold Vote / /
Entered on "AS" Yes / No sige2ggg 7;gga CORRESPONDENCE PDR _
COMMISSIONER McGAFFIGAN'S COMMENTS ON SECY-97-139:
I approve for publication the proposed rule amending Part 32 to modify the prototype testing requirements for devices containing tritium, and I suggest the following edits to various documents in the rulemaking package,
- 1) Page 9 of the proposed Federal Reaister notice should be modified to reflect the new compatibility designation (reserved to-NRC) as described in the " Policy Statement on Adequacy and Compatibility for Agreement State Programs" approved by the Commission in an SRM dated June 30.
-1997.
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- 2) The public announcement should be modified as indicated on the attached to emphasize the relatively low risk of these devices and the cost savings realized by the proposed rule.
-Other suggested edits to the Federal Reaister notice, Regulatory Analysis and letter to Representative Schaefer.are attached.
I agree with'the comments of Commissioner Diaz regarding the benefit of
. expanding the discussion on the health and safety effects of this rulemaking and including dose estimates for both devices under various conditions (normal use versus accidental release). The expanded discussion should include the basis for stating that GTLS have a lower tritium leak rate and that the skin doses from equal or comparuble amounts of tritium contained in GTLS are significantly lower than those from paint. To the degree that it enhances the public's understanding of this rulemaking, additional health effects or dose-
-related information should be added to the public announcement.
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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 evaluations conducted by both the licensee 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 tritiurr 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 Mce n) l s proposing to resolve the petition by initiating this rulemakind Thie-miemcking 3 4 ha Y incorporates the petition in part. Rather than revise the specific testing requirements in the
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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 i
handling. By making these modifications to 5 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, b lio ,
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The licensing process is more burdensome to potential distributors of timepieces Y under 10 CFR 30.19 than vrai. en opphvai;en :: d!:Mbute t t .phee fc: u: nder 10 CFR 30.15(a)(1). Changing the prototype testing reouirements 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 V Thus, timep!:::: u6;; CTL0e uvuuiu La visuibuiwd end ured S under[10 CFR 30.15(a)(1 3
-tmdef the same requirements of the regulations as timepieces using tritium painj!
L Effects of the Proposed Amendments cd bd The effect of this proposed amendment would fer!! tet# distribution of self-illuminated timepieces that utilize a new technologyd (G-T LG) edu W se e<* ,
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Electronic Access Comments may be submitted electronically, in either ASCll text or Wordperfect 6
l DRAFT REGULATORY ANAL.YSIS i
FOR PROPOSED RULEMAKING
' LICENSE APPLICATIONS FOR CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 10 CFR PART 32
- 1. Backaround 1.1 Statement of the Problem I
Dn 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. microtecpetitionedtheNRCtoamenditsregulationg"to include timepieces containing gaseous tritium light sourcesfoYtN same x regulatory 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, 1993 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 technclogy 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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! The current requirements for GTI.Ss are more r,tringent 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 e painted watch but that the additional l requirements to get a GTLS watch approved for distribution results in manufacturers not using this tecMology.
l 4.2 Tflg.JAC'sAssessment l
(a) Cost Savinus Associated with Amendmant to 10 CFR Part 32 The proposed rdie 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 manafacture 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 trii.ium light-setwedS in U.S. dollars.
G TLS 6
+- _ I
Regulatory Citation' Current Annual Fees - Regulatory Citation - Proposed Annual Fees I
" 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)pff 8.200 4.162 Annual License Annual License (57 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 .
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It can he seen from the table that the current total fees can vary from 512,500 for an initial application package which includes a $2,400 initial dppl1 Cation 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 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 annual license. This results in a cost savings to the applicant / licensee of
$8,100 ($12,500 - $4,400) for an initial application package and $3,100
($11,300 - 58,200) in annual license and device registration fees. The l discounted annual savings over 10 years would be $1,574 (($2.335 + $3,401) -
l $4,162) expressed in constant dollars. The current number of licensees that would be affected by this rule is 13. The total resultant unnual 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 mC1 or less of tritium. However, a one time cost to NRC would y result from the staff costs involved in terminating a device registration any 9 hr licensees already distributing such timepieces in accordance with 10 CFR 32.22, but who by distributing in accordance with 10 CFR 32.14, could X eliminate annual NRC device registration fees. Thfc'osYYncurredbytheNRC would be $1200 (10h X $120/hr) per licenseQ h & M c o ok % IS j cb
(,+ n cm/ l.<,m. x (b) Health and Safety Effects )%),,emees3 The leak rate of tritien 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 mC1
., Olower than those from timepieces using tritium paint. In fact. ORNL O recently reported that the potential skin dose from a GTLS watch containing 50 mil 11 curies (50 millirem) is four-fold lower than a watch containing 2 mil 11 curies tritium paint (200 millirem). Moreover, the health risk from the 0
i release of 25 mci of gaseous tritium in the event of breakage of the glass vials is not significant, j- TheNRChasconcludedthatthemagu ure and initial distribution of products containing ,;; o= tritie- .,ht crc:^results in insignificant exposures. Therefore, by adopting the proposed rule, the cost savings would be maximized without any measurable adverse effect on public health and safety.
- 5. Decision Rationale Based on the above analysis, the NRC believes that the proposed rule, if adopted, would provide both the manufacturersMigitial distributors-t# E x distribJt? products containing gn^^= tritibTNght seur;c and the NRC
- significan,t savinas with resmt to licer, air; 50ch devicca aith r,%1igib'e #
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. t UNITED STATES
- }t NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30866 4 001
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The Honorable Dan S,naefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives 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 CFR 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 timepieces containing gaseous tritium light sources to be regulated in accordance with the came requirements as timepieces containin tritium paint. If adopted, this proposed amendment would simplify the licensing process, acilitate the use of a new technology in V self-illuminated timeplacer8 ha resu.M
'm ogai9can4 .sSvgs;4 laeoseer 54 -N t& C..
- Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: Representative Ralph Hall
Q' 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).
The proposed rule would remove from the regulations the specific requirements for prototype testing but would continue to contain requirements for overall product perfon Syeees Where appropriate, the NRC staff, as past ofits review oflicense applications, will impose CenWo Ig hnMM .
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 4 -notice. This notice is expected to be published shortly.
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l ,,,,, -August 14. 1997 orrect or THE $ k" stentTAny .
g Ord MEMORANDUM TO: L. Joseph Callan Exec i e Direc or for Operations
'FROM: Joh . Hoy e Secretary
SUBJECT:
ST FF REQUIREMENTS - SECY-97-139 - PROPOSED RULE: LICENSE APPLICATIONS FOR CERTAIN ITEMS l CONTAINING BYPRODUCT MATERIAL
-(10 CFR PART 32) l The Commission has approved the staff *s recommendation to publish the proposed amendments to 10 CFR Part 32 in the Eederal Register subject-to the comments provided below. l 1
- 1. In the Federal Reaister notice, page 5, first sentence under
" Proposed Amendments," replace the period at the end of the sentence and 'The NRC' at the start of the next sentence with_'and ' In line 2, replace the period after-
'rulemaking' and 'This rulemaking' at the start of the next sentence with 'that '
On_page 6, at the end of the first paragraph,._ add a new sentence: Also, the radiation skin dose to an individual from timepieces containing GTLSs has been determined to be-significantly less,-per millicurie of tritium used, than the skin dose from_ timepieces containing tritium paint.
On page 6,. paragraph 2, line 2, delete 'with an application to distribute timepieces for use ' - In line 6, insert 'the same requirements of the regulations as timepieces using tritium paint' af ter 'under' and place '10 CFR 30.15 (a) (1) '-
in parenthesis, Delete the last sentence: Thus, timepiecea
, .., tritium paint.
On page 6, paragraph 3, line 1, replace ' facilitate' with
' allow'-and in-line 2, at the.end of-the sentence insert
' ' (GTLS) under the same requirements that currently allow-SECY NOTE: THIS SRM, SECY-97-139, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
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1 distribution of timepieces using tritium paint.'
on page 9, modify the Federal Register notice to reflect the l new compatibility designation (reserved to NRC) .as described in the " Policy Statement on Adequacy and Compatibility for Agreement State Programs" approved by the Commission in an SRM dated June 30, 1997.
- 2. The staff should expand the discussion in the Regulatory Analysis (n) the health and safety effects of the amendments and include references, as appropriate. A comparison of skin dose and total effective dose equivalent for different conditicas should be provided for both the 25 mci of tritium paint and tritium in the form of GTLS. This should include the basis for stating that GTLS have a lower tritium leak rate and that the skin doses from equal or comparable amounts of tritium contained in GTLS are significantly lower than those from paint.
In the Draft Regulatory Analysis, on page 1, line 4, insert
'(GTLS)' after ' sources.'
On page 6, replace ' gaseous tritium light sources' with
'GTLS.' On page 7, in the ' Regulatory Citation' column, charge '10 CFR 171.16 (d) (3) (H) ' to ' 10 CFR 171.16 (d) (3) (I) . '
On page 8, paragraph 2, line 4, replace 'any' with 'for' and in line 7,. insert 'one time' before ' cost.' Also, at the end of line 8, insert 'for a total cost of $15,600
($1,200/ licensee x 13 licensees)' at the end of the sentence.
On page 8, last paragraph, line 4, insert 'significantly' after 'are.'
On page 9, paragraph 2, line 2, replace ' gaseous tritium light sources' with 'GTLS.'
On page 9, paragraph 3, line 2, replace 'or' with 'and' and replace 'to' with 'of.' In line 3, delete ' distribute' and replace ' gaseous tritium light sources' with 'GTLS.' In lines 4 and 5, delete everything after ' savings' and place a period after ' savings.' Add the following sentence at the end: Also, it has been determined that the radiological risk from distribution of such devices is negligible and the radiation skin dose from timepieces containing GTLS is significantly less, per millicurie of tritium used, than that from timepieces containing tritium paint.
- 3. In the Congressional letters, last paragraph, line 4, replace 'and' with a comma. At the end of line 5, add 'and result in significant savings to licensees and the NRC.'
- J
- 4. The draft press release should be modified as indicated below to emphasize the relatively low risk of these devices and the cost savings realized by the proposed amendment. To the degree that it enhances the public's understanding of this amendment, additional health effects or dose-related information should be added to the public announcement.
I On page 2, paragraph 2, _line 2, insert at the end of the sentence 'for all timepieces containing tritium.'
l Insert a new paragraph after paragraph 2 and before the l final paragraph which reads: The NRC has concluded that the manufacture and initial distribution of products containing gaseous tritium light sources and the release of gaseous tritium in the event of breakage-of the glass vial do not result in significant radiation exposures. In fact, these exposures are a small fraction of the average exposure from natural background radiation.in the United States.
Therefore, by adopting the proposed rule, the cost savings would be maximized without any measurable adverse effect on public health and safety.
cc: Chairman Jackson Commissioner Dicus Commissioner Dia:
Commissioner McGaffigan OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)