ML20216H486
| ML20216H486 | |
| Person / Time | |
|---|---|
| Issue date: | 02/04/1999 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20216H047 | List: |
| References | |
| FRN-64FR40295, RULE-PR-170, RULE-PR-171, RULE-PR-30, RULE-PR-31, RULE-PR-32 AG03-1-010, NUDOCS 9910010396 | |
| Download: ML20216H486 (7) | |
Text
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%q FOR g k. UNITE 3 STATES j j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20e06 4001
% ***** ! February 4,1999'
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1 MEMORANDUM TO: Donald A. Cool, Director !
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Division of Industrial and Mer8; cal Nuclear Safety, NMSS
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3 FROM: Paul H. Lohaus, Director Office of State Programs
SUBJECT:
OFFICE REVIEW AND CONCURRENCE: PROPOSED RULE TO l AMEND 10 CFR PARTS 30,31,32,170, AND 171," REQUIREMENTS I FROM CERTAIN GENERALLY LICENSED INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" We have reviewed the proposed rule and offer the following comments:
(1) We spggest that each time a specific Agreement State regulation or type of Agreement State licensee is mentioned that the word " equivalent" be used. For example, item (3) on page 10 of the Federal Reaister Notice should read "a provision to allow transfers to specific licensees authorized under Part 30, or eauivalent Agreement State regulations, '
as waste collectors, in addition to currently allowed transfers to Part 32 (and Agreement State eaulvalent) licensees..." In addition, the Eederal Reaister Notice appears to be inconsistent in its treatment of Agreement State responsibility and authority. In some z cases (as with the example above), the Agreeme State participation expected by NRC i is fully explained. In other cases, however, only L L participation is mentioned. For example, item (3) on page 12 of the Federal Reoister Notice states that the transfer of a device to other specific licensees would require NRC approval.
(2) The second and third sentences found on page 16 of the Federal Reaister Notice under
" Requirements for Manufacturers and initial Distributors of Devices," should be deleted and should be included in the section on Agreement State Compatibility (see comment (3)).
(3) The section of the Federal Reaister Notice entitled " Agreement State Compatibility" i needs to be expanded to identify each Section of the proposed rule, the proposed I compatibility or health and safety component assigned, and the rationale for the assignment. The following paragraphs are suggested for your consideration:
The compatibility of this proposed rule is determined in accordance with NRC's " Policy Statement on Adequacy and Compatibility of Agreement State Programs" that was published on September 3,1997 (62 FR l 46517). [ Add details on the compatibility category assigned to each rule I section, see Attachment.]
l 9910010396 990928 PDR PR 30 64FR40295. PDR h 7 /[Ol O bh
Donald A. Cocl FP. 4 - pgg Specific information about the NRC's Compatibility Policy and the compatibility or health and safety components assigned to the present rule may be found at the Special Documents area of the Office of State Programs web site, htto://www.hsrd.orn!.aov/nrc/home.html.
(4) Some Agreement States N .:nre the devices described in 631.5 under a specific license.
Thus, the fifth line of the revis,ed 31.5(b) should be amended to state "...an Agreement ,
State which authorizes distribution of the devices to persons generally or specifically )
~ licensed..." 1 (5) 931.5(c)(15) states that a general licensee "shall not hold devices that are no! In use for longer than two years," yet the rule does not provide a definition of the word " hold" or give specific instructions as to what should be done with devices once they have been held for two years.
If you have any questions, please contact me or Lance Rakovan at 415-2589, E-mail:
LJR2@ NRC. GOV.
Attachment:
As stated 1
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l COMPATIBILITY CATEGORIES AND JUSTlFICATION Section Compatibility Justification Category 930.31 C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), this provisior, was identified as a Category C because its absence could potentially impair effective communication regarding the different types of licenses used on a nationwide basis. The essential objectives of this provision are the identification and definition of the two types of licenses- general and specific.
630.34(h)(1) D/H&S Based upon Handbook 5.9, Part 11, " Categorization Criteria,"
Section (E), Paragraph (h)(1),is designated "H&S." This provision assists in establishing a minimum level of safety for agreement materials by reducing the likelihood of a public overexposure. The essential objective of this requirement is to assure that general and specific licensees provide the appropriate regulatory agency notification of a petition for bankruptcy under any chapter of title 11 of the United States Code.
The H&S two or fewer failure test scenario: If a licensee does not provide the notification of bankruptcy, there is the possibility that the regulatory agency will not be alerted to a potential abandonment of licensed material. The abandonment of licensed materials could lead to the potential for exposures in excess of 10 CFR Part 20 limits.
631.1 D Does not meet any of the criteria of Categ ary A, B, C or D/H&S.
@31.2 D Does not meet any of the criteria of Category A, B, C or D/H&S.
631.5(a) C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), this provision was identified as a Category C to assure accountability for devices containing certain quantities of specific radionuclides which are distributed on a nationwide basis. In addition, accountability should decrease the number of these devices which are abandoned, and thus reduce the number of incidents that could result in unnecessary radiation exposure. The essential objectives of paragraph (a) are to assure the proper identification of the devices addressed by this provision (e.g., devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling l thickness), the identification of the persons who can receive these devices, and the regulations of these devices through a general or specific licensing regulatory mechanism.
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Section Compatibility Justification Category
$31.5(b) C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), (2)(f), this provision was identified as a Category C to establish a minimum level of safety for the devices identified in paragraph (a). The essential objective of paragraph (b) is to assure that the receipt of the devices listed in paragraph (a) are limited to those who receive them through an authorized transfer.
631.5(c)(1) C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), (2)(f), this provision was identified as a Category C to establish a minimum level of safety for the devices identified in paragraph (a). The essential objective of paragraph (c)(1) is to assure that persons who acquire, receive, possess, use or transfer the devices listed in ,
I paragraph (a) ensure that the devices are labeled at the time of receipt and bearing a statement that removal of the label is prohibited. Another objective is to assure that these persons comply with all instructions and precautions provided by the labels.
$31.5(c)(2) C Based upon Handbook 5.9, Part il, " Categorization Criteria,"
Section (C), (2)(f), this provision was identified as a Category C to establish a minimum level of safety for the devices identified in paragraph (a). The essential objective of paragraph (c)(2) is to assure that persons who acquire, receive, possess, use or transfer the devices listed in paragraph (a) ensure that the devices are leak tested at the appropriate intervals, if applicable, and that the devices are operating properly, i
$31.5(c)(3) C Based upon Handbook 5.9, Part il, " Categorization Criteria,"
Section (C), (2)(f), this provision was identified as a Category C to establish a minimum level of safety for the devices identified in paragraph (a). The essential objective ;
of paragraph (c)(3) is to assure that persons who acquire, l receive, possess, use or transfer the devices listed in paragraph (a) ensure that the devices are serviced by i '
persons authorized by a specific license to perform tests in (c)(2) and other servicing activities.
$31.5(c)(4) ' D Does not meet any of the criteria of Category A, B, C or D/H&S. 1 l
$31.5(c)(5) C Based upon Handbook 5.9, Part 11, " Categorization Criteria," -
Section (C), (2)(f), this provision was identified as a ;
Category C to establish a minimum level of safety for the I devices identified in paragraph (a). The essential objective j of paragraph (c)(5) is to assure that a device that is not 1 operating properly is removed from use and is repaired or disposed of by an authorized individual. In addition, the essential objectives include notifying the appropriate regulatory agency of the event and ensuring proper decontamination following an incident.
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Section Compatibility Justification Category L $31.5(c)(6)- C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
- Section (C), (2)(f), this provision was identified as a
!- Category C to establish a minimum level of safety for the devices identified in paragraph (a). The essential objective of paragraph (c)(6) is to assure that the device is not abandoned.
! $31.5(c)(7) C Based upon Handbook 5.9, Part ll, " Categorization Criteria,"
- Section (C), this provision was identified as a Category C to l- assist in the establishment of a national program for the l accountability of the devices identified in paragraph (a) and to assure compliance with the export requirements in 10 CFR Part 110. The essential objective of paragraph (c)(7) is to establish that persons who acquire, receive, possess,
- use or transfer the devices covered by paragraph (a)
- assure that the devices are exported in accordance with 10 CFR Part 110.
631.5(c)(8) C Based upon Handbook 5.9, Part 11, " Categorization Criteria,"
L Section (C), this provision was identified as a Category C to ,
assist in the establishment of a national program for the accountability of the devices identified in paragraph (a).
The essential objective of paragraph (c)(8) is to assure that )
the devices covered by paragraph (a) are transferred to or disposed of by persons authorized to received the device by a specific license or by a general license under paragraph (c)(9).
631.5(c)(9) C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), this provision was identified as a Category C to 1 assist in the establishment of a national program for the accountability of the devices identified in paragraph (a).
The essential objective of paragraph (c)(9) is to establish i that the devices covered by paragraph (a) are transferred l only to generallicensees when the device remains at the !
same location and when the device is held in storage by an l intermediate person at the intended location prior to use by
, the general licensee. In addition, the essential objective includes notification of the transferee by the transferor of the safety documents associated with the device, and the j proper notification of the regulatory agency of the individual .
I j; receiving and responsible for the device.'
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Section Compatibility Justification Category
$31.5(c)(10) - C Based upon Handbook 5.9, Part II, " Categorization Criteria," i Section (C), (2)(c) this provision was identified as a Category C to assist in the establishment of a national program for the accountability of the devices identified in paragraph (a) and to effectively review or evaluate Agreement State programs for agreement material with respect to protection of public health and safety. The essential objective of paragraph (c)(10) is to assure that the devices covered by paragraph (a) are covered by $20.2201 and $20.2202 (or equivalent regulations of the Agreement State).
$31.5(c)(11) This provision number was omitted.
$31.5(c)(12) C Based upon Handbook 5.9, Part II, " Categorization Criteria," l Section (C), this provision was identified as a Category C to assist in the establishment of a national program for the accountability of the devices identified in paragraph (a).
The essential objectives of paragraph (c)(12) are to assure that an individual is appointed to act for the general licensee to ensure day-to-day compliance with the appropriate regulations and requirements and to ensure that the general licensee will continue to retain responsibility for the device.
$31.5(c)(13) C- Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), . this provision was identified as a Category C to assist in the establishment of a national program for the accountability of the devices identified in paragraph (a).
The essential objective of paragraph (c)(13) is to assure the annual registration of devices containing 10 mci of cesium-137,0.1 mci of strontium-90,1 mci of cobalt-60 or 1 mci of americium-241 or any other transuranic, and to assure notification of the appropriate regulatory agency if any licensees possessing these devices file bankruptcy.
631.5(c)(14) C Based upon Handbook 5.9, Part II," Categorization Criteria,"
Section (C), this provision was identified as a Category C to assist in the establishment of a national program for the accountability of the devices identified in paragraph (a). ,
The essential objective of paragraph (c)(14) is to assure I that the location of a device is tracked by the appropriate regulatory agency by informing the agency of a change in address.
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Section Compatibility Justification Category l
l 631.5(c)(15) C Based upon Handbook 5.9, Part II, " Categorization Criteria,"
i Section (C), this provision was identified as a Category C to assist in the establishment of a national program for the accountability of the devices identified in paragraph (a).
The essential objective of paragraph (c)(15) is to assure that devices that are not being used do not remain in storage for a long period of time, where loss of accountability of the device could occur, to assure that the device is stored properly when not in use, and to assure that the device is not leaking and is operating properly before returning to use or being transferred.
632.51 B Based upon Handbook 5.9, Part II, " Categorization Criteria,"
Section (C), these provisions were identified as a Category
$32.51a(a)-(d) B B because they establish requirements for the approval of
$32.52(a)-(c) B Products that are distributed nationwide.
6170 D Does not meet any of the criteria of Category A, B, C or D/H&S.
6171 D Does not meet any of the criteria of Category A, B, C or D/H&S.
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..kN February 10,1999 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 l
Attn: Rulemakings and Adjudications Staff f
RE: Comments on Proposed Rule: " l Requirements for Those Who Possess )
Certain Industrial Devices Containing Byproduct Material To Provide Requested Information"(RIN 3150-AG06)
Dear Secretary:
The Massachusetts Radiation Control Program has reviewed the above identified proposed rule ;
and agrees with the establishment of a registration program and annual reporting requirements for certain categories of generally licensed' devices as described in the proposed rule.
i The Massachusetts Radiation Control Program currently implements a registration program for general licensees in which they are required to provide similar information as would be required in the proposed rule.
Sincerely, Robert M. Hallisey, Director Massachusetts Radiation Control Program RMH:jed ,
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