ML20195J582
| ML20195J582 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1999 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Vietticook A NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20195J506 | List: |
| References | |
| FRN-64FR11508, RULE-PR-170, RULE-PR-171, RULE-PR-30, RULE-PR-31, RULE-PR-32 SECY-99-108-C, NUDOCS 9906210047 | |
| Download: ML20195J582 (13) | |
Text
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1 NOTATION VOTE RESPONSE SHEET i
TO:
Annette Vietti-Cook, Secretary FROM:
COMMISSIONER MCGAFFIGAN 1
SUBJECT:
SECY-99-108 - PROPOSED RULE: 10 CFR PARTS 30,31, 32,170, AND 171
" REQUIREMENTS FOR CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" Approved Y Disapproved Abstain Not Participating COMMENTS:
See attached comments.
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Commissioner McGalfiaan's Comments on SECY-99-108
~ l ' pprove publication of the proposed rule for generally-licensed (GL) devices in the a
Federal Register (FR) for public comment.' I generally agree with the comments of Commissioner Diaz and Commissioner Merrifield and offer the following for the staffs consideration.-
Press Release: In addition to the press release sugCested by Commissioner Diaz, the
. staff should also consider issuing a press release on the Commission's decision on this paper, consistent with the staff requirements memorandum on the earlier staff paper on this subject (SECY-97-273).
Fees: Based on fees information provided in the earlier paper and this paper, discussions during the briefing and subsequent information supplied informally by staff in the Office of the Chief Financial Officer,1 Join Commissioner Diaz in approving the proposal to collect a fee per Fcensee to maintain the GL program. However, consistent with my vote on the earlier paper, the FR notice should be revised to briefly discuss the other two fee options considered by NRC-a fee per device or sliding scale-and solicit comment on them. Moreover, the FR notice would benefit from a fuller discussion of the basis for the staff's preferred approach as is provided in sections 4.J. and 6.0 of the
-draft Regulatory Analysis.
NationalDatabase: While e national GL device database has some advantages, I support the staff's current plan not to implement a national database based in part on the disruptive effect that it would have on some Agreement Stato progra'ms to change 1
the rule compatibility designation from C to B, and the fact that some States may consider the information in the database " proprietary" and thus may be prohibited under State law from entering or using the database thereby limiting its utility. However, as
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' NRC's GL program is implemented, the staff should keep abreast of changes in Agreement State programs that might make them more amenable to a national database at some time in the future.
1 Taxpayerldentification Number: It has been suggested that requiring registrants to provide their taxpayer identification number may increase NRC's ability to track certain j
generallicensees. The staff should determine the utility of such information and whether it is feasible to modify the registration system at this time-recognizing that this i
.~may not be possible since a final decision on the information technology business case is pending-or at some time in the future when other system enhancements are needed.
Backup. Responsible Individual: Based on comm.ents by the State representative, Ms.
Jill Lipoti, during the briefing, I suggest that the FR notice be revised to solicit comment i
on whether general licensees should be required to identify a " backup responsible individual"in addition to the " primary" responsible individual. This approach may help ensure that institutional memory is not lost, particularly in cases where the primary responsible individual departs abruptly.
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Risk Management: While I am sensitive to the concerns raised by the State
- representatives during the briefing regarding such issues as device design and limitations on types and quantities of licensed material, I agree with Commissioner Diaz that these issues must continue to be addressed separately, consiste' t with earlier n
Commission guidance on this issue, so as not to derail the progress being made in the L
GL program.
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Effective Date for Agreement States: While I recognize that the FR notice solicits i
l comment on this issue, I would support decreasing the effective date of the rule for Agreement States from the standard 3 years to immediately effective so as to institute a compatible program nation-wide in a more timely manner and thus further reduce the probability of a GL device inadvertently entering the public domain in an uncontrolled manner.
l Draft NUREG: I agree with Commissioner Diaz that the draft NUREG should be revised to include additional safety guidance. This approach would also be responsive to concerns raised by a State representative during the Commission briefing that more
' information needs to be provided to the purchaser up front so as to further reduce l
accidents, unintended exposures, and lost or abandoned sources.
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Specific Comments on the FR Notice:
L 1.
The discussion on page 9 regarding registration of generallicensees the NRC fails to contact is somewhat nonsensical. If NRC fails to contact a general licensee, it is unclear how NRC can expect to place the burden of not registering on an uninformed licensee who, even under the current rule, has had little or no contact with NRC. While I generally support a provision that would require general licensees to cornplete registration by a certain time frame, I do not q
necessarily support NRC taking enforcement action against a general licensee who, once discovered, may have previously violated the registration provision unknowingly because NRC failed to contact them. It should be recognized that there will likely be a subset of existing general licensees who will never be contacted by NRC or an Agreement State because their existence is not known.
2.
The discussion on pages 22-23 on device information to be provided to general i
licensees is somewhat unclear as to when such information exchange should i
- occur. Specifically, proposed section 32.51(a) requires that certain information be provided to the general licensee before transfer of the device. However, the L
FR notice states that "it is the Commission's intent that ' prior to transfer' would j
L be before a final decision to purchase so that the information can be considered in making the purchasing decision. Based on comments by Ms. Lipoti during the briefing, I support revising the rule to clearly indicate that full disclosure of the required information should occur priorto purchase of the device. If a majority of the Commission does not support this position, the FR notice should explicitly j
solicit comment on this issue.
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3.
The staff should consider duplicating all the questions in the FR notice into a i
siragle, new section while retaining the questions in their current locations so as.
to leave them in context. This approach will facilitate the public review and
- comment process and is consistent with that used in the FR ndtices for the p
prcposed rules on Parts 35 and 63.
j 4.
More minor editorial changes to the FR notice, press release and Congressional letters are indicated on the attached pages.
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Agreement States would also be required. Some States have alrudy instituted some form of enhanced oversight for these general licensees, in a few cases, States have instituted a registration program. A few States have a higher level of control on these devices through requiring specific licenses. Under the proposed level of compatibility for 9 31.5, the essential objectives oi the regulation should be adopted by the State to avoid conflicts, duplications, or gaps. However, the manner in which the essential objectives of the regulation are addressed need not be the same as NRC. Strict compatibility would only be required for revisions to the requirements applicable to distributors because of interjurisdictional distribution.
Discussion The December 2,1998, proposed rule would provide one of the key elements in improving the accountability and control over devices of particular concem through the.
1 institution of a registration process. However, current regulatory provisions are inadequate to allow for the NRC to treck general licensees and the specific devices they possess. The NRC needs to track these general licensees in order that they can be contacted or inspected when appropriate. The NRC also needs to trackM.eNo c
generally licensed devices, so that the
)c responsible party can be identified when a device is found in an inappropriate situation.
Tracking devices would also allow the NRC to contact the appropriate general licensees if a generic defect in a group of devices is identified. As noted, that proposed rule would not i
require Agreement State regulations to be compatible.
There are other means for reducing the likelihood of incidents of lost sources. The L
Commission has reconsidered the provisions in its 1991 proposed rule, evaluated the
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l with this group of general licensees in an equitable way, as required by law. Those who are 1
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' allowed to use devices under the general license would bear the cost o(the pr am instead of, '
t those who hold specific licenses. b< N f64 keted N % bhd fage X
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Rather than provide blank forms such as are used in other of the Commission's pa-id h cuned %\\d,oc registration programs, it is planned to send a registration form or certificate with the information d
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recorded in the Commission's database in a request for registration, which would ask the u(, m,3 ssted b general licensee to verify, correct, and/or add to the information provided. This would be similar y,gd l to the approach typically used by States for the renewal of automobile registrations. This is intended to be more efficient for the general licensees and the Commission.
i The first registration that would be carried out under 9 31.5(c)(11) would depend on the NRC's ability to contact generallicensees because the NRC must request th' information. This i
e proposed rule also specifies that the general licensee would complete registration by verifying, correcting, and/or adding to the information in a request for registration received from the Commission. It is silent on when or how general licensees should register if the Commission fails to contact the general licensee. The Commission seeks comment on whether the registration requirement should include a provision that would require the generallicen.see to i
complete registration by a certain time, such as 15 months after: the date of the previous registration certificate, the receipt of a device subject to registration, or the effective date of this rule for an unregistered device possessed at the time of the effective date of a final rule enacted in response to this proposed rule. This would put the burden of registering on general licensees who have not been notified by the NRC of the requirement.
l The time of year for registration would vary for licensees. However, requests for l
renewal of registration would be made approximately 1 year after the previous registration j
request for that licergsee. Although registration would not be required before the receipt of a 9
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J license to devices authorized for distribution by an Agreement State who has no general license i
covering the use of such devices with!n that State.
Conceming the first of these issues, the NRC has generally, although'not consistently, interpreted t'he general license to apply to any recipient within the group identified in 6 31.5(a),
6, i.e., ".. commercial and industrial firms and research, educational and medical institutions,
, individuals in the conduct of their business, and Federal, Stata or local govemment agencies..",
I even if the device is received through an unauthorized transfer. The proposed language would clearly provide that the general license does not apply if the device is obtained through an unauthorized transfer. In the case of an unauthorized transfer, the recipient would possess the device without a ilcense.
pd A dat.h Paragraph 31.5(b) currently restricts applicability n the case of devices from distributors m Stay uthorize the devices to be used under a in Agreement Stateg those general license within their respective States. To accommodate the occasional distributor in an Agreement State that has no comparable general license, NRC's administrative practice has been to allow the Agreement State to issue specific licenses equivalent to 9 32.51 license liw d C. y d. %.u W -/* c% wt
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-The MP.C 50. :!!r;;;d.; r nf d-t uthorized by these Statepy S St5 genee! >
!!;r.;;;b This approach ' reserved for NRC the ri@t to require distributors in this situation to obtain an NRC distribution license in order to transfer devices into NRC jurisdiction, but did not require them to do so as long as the State issued acceptably equivalent licenses. Through NRC's oversight of Agreement State programs, NRC ensures the safety of these devices.
Given this fact and the experience to date with these few States, the Commission believes that this restriction is no longer necessary.
In addition to the proposed changes to 9 31.5, other amendments are proposed that would clarify which sections of the regulations in part 30 apply to all of the general licensees 16
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9 31.5(c)(15)-Would limit el general licensee can keep an unused Y
device in storage and allow the deferment of testing during the period of storage.
9 32.51(a)(4) and (5) - Would add requirement for an additiona'l label on any separable source housing and a permanent label on devices meeting the criteria for registration.
9 32.51a(a) and (b) - Revision would amend the requirements pertaining to the information distributors must provide to the general licensee. Distributors are now required to provide generallicensees with a copy of 9 31.5 when the device is transferred. The proposed q
rule would require that 9 31.5 be provided before transfer. The distributor would also be f
required to provide copies of additional applicable sections of the regulations, a listing of the
. services that can only be performed by a specific licensee,,and information regarding disposal options for the devices being transferred, including estimated costs of disposal. For transfers to general licensees in Agreement States, the distributor may furnish either the applicable NRC regulations or the comparable ones of the Agreement State. In addition, the distributor would fumish the name, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be, obtained.
9 32.51a(c) - Would make labeling requirements a condition of license 1 year after effective date of rule.
9 32.51a(d)- Would add requirement for distributors to make available records of final disposition of devices to the various regulatory agencies in the case of bankruptcy or
. termination of the distributor's license.
9 32.52(a) and (b) - Revision would add the following information to the existing quarterly transfer reporting requirement: the serial number and model number of the device; the date of transfer; indication.if device is a replacement, and if so, the type, model number, and serial number of the pne retumed; name and license number of reporting company; and the 27
1 Catherine R.. Mattsen, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6264; or e-mail at
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i CRM@nrc. gov.
Regulatory Flexibility Certification As required by the Regulatoy Flexibility Act (5 U.S.C. 605(b)), the Commission has evaluated the impact of this rule on small entities. The Commission certifies that this proposed rule, T* ndopted, would not have a significant economic impact on a substantial number of small entities. The most signitcant cost of this proposed rule would be the fee of $370 to be
%es of assessed with the annual registration.
e proposed rule would apply to the approximately x
45,000 persons possessing products under an NRC general license, many of whom may be classified as small entitles. However, the annual registration requirement and associated fee would apply to about 6000 of these generallicensees, each paying the same $370 irrespective of the number of devices possessed. The NRC believes that the fees will not present a significant economic impact on these licensees and that the economic impact of the additional proposed requirements on any general licensee would be a negligible increase in administrative I
burden. Based on input received previously from small entities who hold materials licenses, the
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NRC believes that the $370 part 170 registration fee would not have a significant economic
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impact on a substantial number of small entities. The NRC is soliciting comment from the general licensees that would be required to register their devices pursuant to part 31 on whether the proposed part 170 fee for their annual registration would have a significant economic impact on their business.
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l after the moving of a device. If it is a portable device, this report only applies to a change in the device's primary place of aorage.
1 (15) May not hold devices that are not in use for longer th@ years. If devices with I
shutters are' not being used, the shutter must be locked in the closed penition. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use.
i PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR
. TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 8. The authority citation for Part 32 continues to read as follows:
i Authority: Sees. 81,161,182,183,68 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).
- 9. In_@ 32.51, paragraphs (a)(4) and (5) are added to read as follows:
$ 32.51 Byproduct material contained in devices for use under 9 31.5; requirements for license to manufacture, or initially transfer.
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UNITED STATES g
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. meeH001
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. hk a Senas ha e.
The Honorable James M. Inhofe, Chairman
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Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommitte'e is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Parts 30. 31,32,170, and 171 to: (a) explicitly require that certain general licensees register certain devices that they have receivedjor use under a general license and (b) add a registration fe NRC plans t'o institute this. registration system X
under an earlier proposed rule for devices usi g certain quantitles of specific radionuclides that are primarily used in commercial and industrial applications. The enclosed rule would also revise requirements for transfers, storage, reporting, recordkeeping, and labeling pertaining to these generally licensed devices.
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., j NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to better account for devices that have been distributed fer use under the general license and thereby reduce the i
potential for incidsnts that could result in unnecessary radiation exposure to the public as well as i
contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, i
l Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham i
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Such a device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of radiation training or experience of each user is not necessary.
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In the past, NRC has not regularly contacted general licensees because of the relatively small radiation risk posed by the devices. However, there have been a number of instances in which generally licensed devices have not been properly handled or od o %r cas c h b c e d ed y
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The proposed registration requirement would apply to generally licensed j
measuring, gauging and controlling devices with quan' titles of certain radioactive materials posing a higher risk to public safety or of property damage if the device were lost than would other generally licensed devices.
The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density, or chemical composition in industries such as petrochemical and steel manufacturing. ' About 6,000 general licensees possessing about 24,000 devices would come under the registration requirement.
General licensees affected by the registration requirement would have to pay the NRC an annual registration fee of $370.
Specific licensees who distribute the measuring, gauging, and controlling devices would be required to provide-before transferring a device to a general licensee-copies of additional applicable sections of the NRC regulations, a listing of the types of service to the device that can only be performed by a specific licensee, and information 2
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regardi disposal options, including the cost for disposal. The amendments would also o odify the reporting, recordkeeping, and labeling requirements for distributors.
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% e Commission stablished an interim enforcement policy for violations of y
NRC regulations that general licensees discover and report during the initial cycle of the registration program. The interim policy provides that enforcement action normally will not be taken for violations so identified and reported, provided appropriate corrective action has been taken. This amnesty period, which will remain'in effect through one complete cycle of the reglistration program, should encourage general licensees to search their facilities to ensure that sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective actions when j
deficiencies are found.
The Commission also plans to increase the civil penalty amounts that would be imposed for violations involving lost or improperly disposed-of devices or radioactive i
material from them. This increase will better relate the civil penalty amount to the costs I
avoided by the failure to properly dispose of the source or device.
Additional details of the proposed revisions to the regulations are contained in a Federal Register notice to be published shortly. Interested persons are invited to submit written comments within 75 days of the Federal Register notice to the Secretary, U.S.
Nuclear Regulatory Commission, Washingtor., D.C. 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments may also be submitted via the NRC's interactive rulemaking web site through the NRC home page at http://www.nrc.aov. Information on this site is available from Carol Gallagher,301/415-5905; e-mail CAG@nrc.aov.
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