ML20236L833
| ML20236L833 | |
| Person / Time | |
|---|---|
| Issue date: | 06/19/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Quillin M COLORADO, STATE OF |
| Shared Package | |
| ML20236L835 | List: |
| References | |
| NUDOCS 9807130195 | |
| Download: ML20236L833 (5) | |
Text
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JUN 191998 Mr. Robert M. Quillin, Director Laboratory and Radiation Services Division Colorado Department of Public Health and Environment 8100 Lowry Boulevard Denver, CO 80220-6928
Dear Mr. Quillin:
As requested, we have reviewed the proposed revisions to Part 1, General Provisions. Part 3, Licensina of Radioactive Materials. and Part 7, Use of Radionuclides in the Healina Arts. dated May 20,1998. The regulations were reviewed by comparison to the equivalent NRC l
regulations in 10 CFR Parts 30,32, and 35.
l As a result of our review, we have three comments that have been identified in the enclosure.
Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your l
proposed regulations were adopted incorporating the comments and without other significant j
change, they would meet the compatibility and health and safety categories established in OSP l
Internal Procedure B.7.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Highlight Chances to Aareement State Regulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the i
final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or Ms. Cardelia H. Maupin of my staff at (301) 415-2312 or e-mail at CHM @NRC. GOV.
Sincerely, NN
[
Q f
f Paul H. Lohaus, Deputy Director l-Office of State Programs
Enclosure:
As stated cc: Jake Jacobi, Colorado Material Licensing and Inspection Distribution:
l DIR RF (8S153)
DCD (SP08)
SDroggitis I 2 8 _*"~Z PDR (YES_f_ NO
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i SSalomon Q
im m.,a %l N2 BUsilton Colorado File
- See previous concurre,,x.
DOCUMENT NAME: G:\\ CHM \\CO. REG
.3 Te receive a cop ' of this document, Indicate in the 'Jox: "C" = Copy wthout attachment /enclospre' YE't Cop r uth attachtnent/ enclosure "N" = No copy OFFICE Q]p p l
OSPQh 0%C%
OGC OSP:D/'l o NAME CHM 4fpiBh SSalomon' '
PHLdhiub '
FXCameron RLBangarWb DATE-66/U/98 06/4 /98 06/1 /98 06/15/98*
06/ff'/98 CD0010 SP FILE CODE:. SP-AG-5 L.
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UNITED STATES s
j NUCLEAR REGULATORY COMMISSION
't WASHINGTON, D.C. 2066H001 k,,,, #
June 19, 1998 Mr. Robert M. Quillin, Director Laboratory and Radiation Services Division Colorado Department of Public Health and Environment 8100 Lowry Boulevard Denver, CO 80220-6928
Dear Mr. Quillin:
)
As requested, we have reviewed the proposed revisions to Part 1, General Provisions, F irt 3, Licensina of Radioactive Materials. and Part 7, Use of Radionuclides ir> the Healina Arts, dated May 20,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 30,32, and 35.
j l
As a result of our review, we have three comments that have been identified in the enclosure.
l Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted incorporating the comments and without other significant change, they would meet the compatibility and health and safety categories established in OSP i
internal Procedure B.7.
1 We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027,"Recuest to Hiahliaht Chanaes to Aareement State Regulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
l If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or Ms. Cardelia H. Maupin of my staff at (301) 415-2312 or e-mail at CHM @NRC. GOV.
Sincerely, I
s c /
d-Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated cc: Jake Jacobi, Colorado Material Licensing and Inspection J
COMMENTS ON PROPOSED REVISIONS TO PART 1,3, AND 7 WASHINGTON REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Categorv Regulation Reaulatien Subiect and Comments NRC 3.3.3.5.3 30.21(c)
Radioactive drug: Capsu!es containing carbon-14 urea for "In vivo" diagnostic use for humans. Paragraph (c).
The proposed rule change deals with an area reserved to the NRC. The Colorado regulation indicates that a specific license can be obtained for the manufacture and commercial distribution of the exempt urea capsules. This provision should be revised to indicate that a specific license can be obtained from the NRC pursuant to regulation 10 CFR 32.21. Under the Atomic Energy Act of 1954, as amended, certain regulatory functions are reserved to the NRC. Arnong these are the distribution of products to persons exempt from licensing.
Since a capsule containing C-14 urea is an exempt product, the specific license authorizing its manufacture and distribution can only be issued by the NRC.
NRC 3.12.7 thru 32.21 Radioactive Drug: Manufacture, Preparation, or Transfer for 3.12.7.3.2
& 32.21a Commercial Distribution of Capsules Containing Carbon-14 Urea each for "in vivo" diagnostic use for humans to persons exempt from licensing; Requirement for a license; and Same: Conditions of License.
These provisions should be deleted from Colorado regulations, i
These provisions are reserved to NRC; thus, the reason they l
are designated as category "NRC". As noted in the discussion
-)
l above, the licensing of the manufacture and distribution of l
l exempt materials is reserved to the NRC.
B 3.12.10.1 32.72 Manufacturer, preparation, or transfer for commercial l
distribution of radioactive drugs containing byproduct material for medical use.
These provisions should be revised to retain the phrase "by persons licensed pursuant to this part" after the wording
" medical use." This provision is designated as a category B, which should be adopted essentially identical to that of the NRC.
Mr. Robert M. Quillin, Dir:ctor i
Laboratory and Radiation Services Division J
Colorado Department of Public Health and j
En'vironment
/
l 8100 Lowry Boulevard Denver, CO 80220-6928 1
Dear Mr. Quillin:
As requested, we have reviewed the proposed revisions to Part 1 General Provisions. Part 3, Licensina of Radioactive Materials. and Part 7,lige of Radionuc des in the Healina Arts. dated May 20,1998. The regulations were reviewed by comparison td the equivalent NRC regulations in 10 CFR Parts 30, 32, and 35.
As a result of our review, we have three comments that hav been identified in the enclosure.
Please note that we have limited our review to regulationsfequired for compatibility and/or health and safety. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the eqt/ valent NRC regulation may only be made based on a review of the final Stata regulation. However, we have determined that if your
]
j proposed regulations were adopted incorporating the pomments and without other significant change, they would meet the compatibility and health'and safety categories established in OSP Intemal Procedure B.7.
We request that when the proposed regulations e adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiohlicht Chanaes tq Aareement State BApulations Submitted to NRC for Comoatibilith Review" (March 1,1996), please highlight the final changes and send one copy in a compu r readable format, if possible.
If you have any questions regarding the co ments, the compatibility and health and safety '
categories, or any of the NRC regulations sed in the review, please contact me or Ms. Cardelia H. Maupin of my staff at (30 415-2312 or e-mail at CHM @NRC. GOV.
Sincerely, Paul H. Lohaus, Deputy Director l
Office of State Programs
Enclosure:
As stated cc: Jake Jacobi, Colorado Material Licensing and Inspection Distribution:
DlR RF (8S153)
DCD (SP08)
SDroggitis PDR (YES,f_ NO
)
i SSalomon L
BUsilton Colorado File 74 receive a cop ' of this document, indicate in the hdu: 'C" = Copy wthout attachment /encloegre YE")J DOCUMENT NAME: G:\\ CHM \\ COLORADO. REG Cop' with ar#2 e..wre "N" a No copy OFFICE Qjpj f l
NAME CHM 4b4Hb
/ SSalomon' '
PHLdhsuh '
FXCamerpn RLBangart I
l DATE 66/U/98 1
06/A /98 06/' /98
~06 W 98 06/ /98
.)
i EXECUTIVE TASK MANAGEMENT SYSTEM l
l l
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<<< PRINT SCREEN UPDATE FORM >>>
l j
l l TASK # - 8S153 DATE- 05/18/98 MAIL CTRL. - 1998 TASK STARTED - 05/18/98 TASK DUE - 06/12/98 TASK COMPLETED -
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TASK DESCRIPTION - PROPO!'ED REVISIONS ON PARTS 1, 3, AND 7
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REQUESTING OFF. - CO REQUESTER - JACOBI WITS -
0 FYP - N
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PROG., CHM PERSON -
STAFF LEAD - CHM PROG. AREA -
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PROJECT STATUS -
OSP DUE DATE: 06/12/98
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PLANNED ACC. - N LEVEL CODE -
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