ML20148G206
| ML20148G206 | |
| Person / Time | |
|---|---|
| Issue date: | 05/29/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Davidson J NEBRASKA, STATE OF |
| Shared Package | |
| ML20148G213 | List: |
| References | |
| NUDOCS 9706050224 | |
| Download: ML20148G206 (17) | |
Text
Ms. Joyce K. Davidson, Hxith Physicist MAY 2 9 g HHS Regulation and Licensure Radioactive Materials Program 301 Centennial Mall South P.O. Box 95007 Lincoln, NE 68509-5007
Dear Ms. Davidson:
We have reviewed the proposed amendrnents to Title 180 NAC Chapter 1, dated March 1, 1997. The proposed rules were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 20,30, 32,35,40, and 61. We received your regulations on April 10, 1997, and discussed our review with you on April 21,1997, and May 19,1997.
As the result of our review we have seven comments, as enclosed. Please note that under our current procedure, a finding that a rule meets the compatibility criteria may be made 4 only based on a review of the adopted final rule. However, we have determined that if your proposed rules were adopted incorporating our comments and without other significant change, they would meet the current compatibility criteria.
The Commission is currently considering a revised policy and implementing procedure for determining compatibility. Under the proposed revision, a number of your regulations would be subject to less restrictive compatibility criteria. While your proposed amendments would be compatible under thic proposed policy and procedure (please note, however, parts of 10 CFR 35.32 would be required based on health and safety considerations associated with the proposer! policy), please recognize the Commission has not rendered a final decision.
We request that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiahliaht Chanaes to Aareement State Fleputations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the comments or any of the NRC rules used in the review, please contact me or Mr. Richard Blanton of my staff at (301) 415-2322.
Sincerely, Original Signed By:
PAUL H. LOHAUS 9706050224 970529 Paul H. Lohaus, Deputy Director PDR STPRGESGNhng Office of State Programs i
Enclosure:
As stated
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DIR RF (7S-99) DCD (SP08) PDR (YES)
PMLarkins Nebraska File I
DOCUMENT NAME: G:\RLB\NE7S99L2.RLB
- See Previous Concurrence. )
Tm receive a copy of this document, indicate be be bos: "C' = Copy without attachment / enclosure 'E' = Copy with attachment / enclosure "N' = No copy OFFICE OSP lC OSP:DD l OGC l OSP:D[fGl . l NAME RLBlanton:nb PLohaus FXCameron RLBangart IN DATE 04/24/97
- 04/28/97* 05/09/97* 05/J//97 S" ' ' " S "~ ^ ~ '
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Ms. Joyca K. Devidson, Health Physicist HHS Regulation and Licensure Radioactive Materials Program ,
301 Centennial Mall South / '
P.O. Bo.< 95007 /
! Lincoln, NE 68509-5007 /
- /
Dear Ms. Davidson:
/
,/
We have reviewed the proposed amendments to Title 180 NAC Chapter 1, dated March 1,
' 1997. The proposed rules were reviewed by comparison to the equiv'alent NRC regulations in 10 CFR Parts 20,30,32,35,40, and 61. We received your regdlations on April 10, 1997, and discussed our review with you on April 21,1997, and'May 19,1997.
/
- As the result of our review we have seven comments, as enclo/ sed. Please note that under ,
i- our current procedure, a finding that a rule meets the comgatibility criteria may be made only based on a review of the adopted final rule. Howevpr, we have determined that if your proposed rules were adopted incorporating our corriments and without other
. significant change, they would meet the current com atibility criteria.
j The Commission is currently considering a revised, olicy and implementing procedure for
- determining compatibility. Under the proposed Gision, your "quiations on which we have
, offered comments concerning compatibility Id carry fewer rt.atrictive compatibility 4
criteria. While your proposed amendments w Id be compatible under this proposed policy I and procedure (please note, however, the hfaith and safety consideration in 10 CFR i j 35.32), we cannot recommend their adoption before the Commission renders a final j decision.
We request that when the proposed ules are adopted and published as final rules, a copy
, of the "as published" rules be prov' ed to us for review. As requested in our All i Agreement States Letter SP-96-0 7, "Recuest to Hiahlicht Chanaes to Aareement State Reaulations Submitted to NRC f. r Compatibility Review" (March 1,1996), please highlight the final changes and send o copy in a computer readable format, if possible, i
( If you have any questionsJ garding the comments or any of the NRC rules used in the 1 review, please contact mer or Mr. Richard Blanton of my staff at (301) 415-2322.
i Sincerely, i
i Paul H. Lohaus, Deputy Director Office of State Programs l-
Enclosure:
As stated Dist bution:
Dip RF (7S-99) DCD (SP08) PDR (YES)
Philar' kins Nebraska File DOCUMENT NAME: G:\RLB\NE7S99L2.RLB
- See Previous Concurrence.
Ta ,eceive a copy of thle document. Indicate in the hos: "C* = Copy without attachment /enclosu,e *E' = Copy with attachment / enclosure "N" = No copy OFFICE OSP [C OSP:DD OGC OSP:D l l NAME RLBlanton:nb PLohaus FXCameron RLBangart DATE 04/24/97
i Ms. Joycs K. Davidson, Hxlth Physicist HHS Regulation and Licensure Radioactive Materials Program 301 Centennial Mall South )
i P.O. Box 95007 l Linco;a, NE 68509-5007 1
Dear Ms. Davidson:
We have reviewed the proposed amendments to Titl 180 NAC Chapter 1, dated March 1, 1997. The proposed rules were reviewed by compa son to the equivalent NRC regulations in 10 CFR Parts 20,30,32,35,40, and 61. We ac nowledged receipt of the rules for review on April 21,1997, by telephone conversatio between Mr. Richard Blanton and yourself. l l
As the result of the review we have seven comme ts, as enclosed. Please note that we I are only providing comments on issues that deal ith Division 1 or 2 compatibility requirements. Also, note that under our current plocedure, a final finding that a rule meets the compatibility criteria may be made only basecf on a review of the adopted final rule. 1 However, we have determined that if your propoped rules were adopted incorporating our j comments and without other significant change they would meet the compatibility criteria.
]
We request that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All l Agreement States Letter SP-96-027, "Reauest to Hiahliaht Chanaes to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one copy in a co nputer readable format, if possible.
If you have any questions regarding the cornments or any of the NRC rules used in the review, please contact me or Mr. Richard lanton of my staff at (301) 415-2322.
Sincerely, 4
/
/ Paul H. Lohaus, Deputy Director
,/ Office of State Programs
Enclosures:
/
As stated I
/
l h
1 1
Distribution: !
DIR RF (7S-99) DCD (SP08) PDR (YES) !
PMLarkins Nebraska File l I DOCUMENT NAME: l G:\RLB\NE7SO99L.RLB Ta receive a copy of this document, indicate in the box: "C" h)[tpy p'without attachment / enclosure "E" = Copy with attachment*See Fevious
/ enclosure concurrence.
- N" = No copy OFFICE OSP a ntC OSMQA l OGC OSP:D l l NAME RLBlanton:nbgfed) PLohauV ' FXCameron RLBangart i DATE 04ft/9A
~
/ 04f2)f97 05/9/97
/
/
Ms. hyce K. Davidson, H::alth Physicist HHS Regulation and Licensure Radioactive Materials Program 301 Centennial Mall South P.O. Box 95007
- Lincoln, NE 68509-5007
Dear Ms. Davidson:
We have reviewed the proposed amendments to Jitle 180 NAC Chapter 1, dated March 1, .
1997. The proposed rules were reviewed by corpparison to the equivalent NRC regulations l
, in 10 CFR Parts 20,30,32,35,40, and 61. We acknowledged receipt of the rules for i review on April 21,1997, by telephone convers'a tion between Mr. Richard Blanton and l yourself.
i As the result of the review we have seven comments, as enclosed. Please note that we l
) are only providing comments on issues that deal with Division 1 or 2 compatibility !
requirements. Also, note that under our cur /ent procedure, a final finding that a rule meets I i
the compatibility criteria may be made only jbased on a review of the adopted final rule.
However, we have determined that if yourj proposed rules were adopted incorporating our I comments and without other significant c ange, they would meet the compatibility criteria.
) We request that when the proposed rules are adopted and published as final rules, a copy 3 of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP-96 027, "Reauest to Hiahlicht Chances to Aareement State i
1 Reaulations Submitted to NRC for Comoatibility 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 or any of the NRC rules used in the review, plea.:e contact me or Mr. Ric,hard Blanton of my staff at (301) 415 2322.
i
/
1 3
.f Sincerely,
/
l Paul H. Lohaus, Deputy Director I
- Office of State Programs
Enclosures:
/
As stated /
l l
l
/
/
1 l
l Distribution:
DIR RF (7S-99) DCD (SP08) PDR (YES)
PMLarkins ,
Nebraska File DOCUMENT NAME: G:\RLB\N SO99L.RLB .
- T, ,.c.iv. . ..py , thi, e. cum.nt. inac.t. in ih. 6 c c /%[witnout .rt. chm.,+ . ieto.or.A - copy witn .tt.cnm.nti N" = Noncio.ur.
copy
- OFFICE OSP a dQ OSMQM l OG(T l OSP:D l l l NAME RLBlanton:nbgM) PLohauls' _ ' FXCame1ron RLBangart ;
1 DATE 04M/9A / 04/2)97 04/6 /97 04/ /97 l
...o l i
I j' COMMENTS ON NEBRASKA MARCH 1997 REGULATIONS L Comments from the Review of the Reautations Aaainst Comoatibilitv Division 1 and 2 Criteria s *!
State NRC f b !
i h Rule fMg_ Subject and Comments g5f 1 007.02 35.2 Definition of " Prescribed dosage" We believe that the pr sed definition, in effect, d
1iuUioJr t f a licensee to document the l deletes quantity oth(f raciopharmaceutical activity to be administered to an individual for therapeutic purposes in the form of a written directive (i.e., a prescription or order for medical services) from an authorized user.
With this change, the definition will not meet the current division 1 compatibility criteria. We suggest that the definition NOT be amended as proposed.
1 007.02 35.2 Definition of " Recordable event" Definition of " Written directive" Equivalent definitions were not included in the rules l submitted. Unless the definitions are included i elsewhere, the Part 7 rules do not meet the current I division 1 compatibility criteria, if not included elsewhere, we suggest that the definitions be adopted.
2 007.13 35.25 Supervision i
Subsection:, 007.13A1, OO7.13A2, and 007.13B1 do not include the requirements related to the licensee's quality management program found in the NRC rule. As a result, rule 007.13 does not meet the curre 2 compatibility criteria. We suggest thaty ,egt divisji ndhCN requirements be adopted.
(
- none - 35.32 G 2 Quality management program t}(Mj.,g A rule equivalent to 10 CFR 35.32 was not included in the rules submitted for review. While NRC is not currently evaluating rules equivalent to 10 CFR 35.32 for the purpose of determining the compatibility of an Agreement State program, we nevertheless suggest that the adoption of an equivalent rule be considered.
I
i s@ Gtiv p t UNITED STATES
[ &
] NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30eeH001 .
%*****$ May 29, 1997 '
4 Ms. Joyce K. Davidson, Health Physicist HHS Regulation and Licensure Radioactive Materials Program 301 Centennial Mall South P.O. Box 95007 Lincoln, NE 68509-5007 3
Dear Ms. Davidson:
i We have reviewed the proposed amendments to Title 180 NAC Chapter 1, dated March 1, 1997. The proposed rules were reviewed by comparison to the equivalent NRC regulations In 10 CFR Parts 20,30,32,35,40, and 61. We received your regulations on April 10,
- 1997, and discussed our review with you on April 21,1997, and May 19,1997. l l
, As the result of our review we have seven comments, as enclosed. Please note that under j i our current procedure. a finding that a rule meets the compatibility criteria may be made only based on a review of the adopted final rule. However, we have determined that if your proposed rules were adopted incorporating our comments and without other
- significant change, they would meet the current compatibility criteria.
- The Commission is currently considering a revised policy and implementing procedure for i determining compatibility. Under the proposed revision, a number of your regulations
, would be subject to less restrictive compatibility criteria. While your proposed
- amendments would be compatible under this proposed policy and procedure (please note, l however, parts of 10 CFR 35,32 would be required based on health and safety ;
i considerations associated with the proposed policy), please recognize the Commission has not rendered a final decision.
We request that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be providad to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiahliaht Chanaes to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
if you have any questions regarding the comments or any of the NRC rules used in the 3 review, please contact me or Mr. Richard Blanton of my staff at (301) 415-2322.
3' S' ce ely, 1T :
Paul H. Lohaus, Deputy Director Office of State Programs i
Enclosure:
As stated I
3
l l
COMMENTS ON NEBRASKA MARCH 1997 REGULATIONS l L Comments from the Review of the Reoulations Aaainst Comoatibility Division 1 and 2 Criteria State NRC Div. Rule Rule Subiect and Comments 1 007.02 35.2 Definition of " Prescribed dosage" We believe that the proposed definition, in effect, deletes the responsibility of a licensee to document the l quantity of radiopharmaceutical activity to be !
administered to an individual for therapeutic purposes in l the form of a written directive (i.e., a prescription or order for medical services) from an authorized user.
With this change, the definition will not meet the current Division 1 compatibility criteria. We recommend that the definition not be amended as proposed.
Under the proposed revision to the compatibility policy, the definition of " prescribed dosage" would be classified as Category C, and the compatibility criteria would be met if the essential objectives of the NRC definition were adopted.
1 007.02 35.2 Definition of " Recordable event" Definition of " Written directive" Equivalent definitions were not included in the rules submitted. Unless the definitions are included elsewhere, the Part 7 rules do not meet the current Division 1 compatibility criteria if not included elsewhere, we recommend that the definitions be adopted.
Under the proposed revision to the compatibility policy, the definition of " written directive" would be classified as Category C, while the definition of " recordable event" would be classified as Category D (not required for compatibility).
2 007.13 35.25 Supervision Subsections OO7.13A1,007.13A2, and 007.13B1 do not include the requirements related to the licensee's quality management program found in the NRC rule. As a result, rule 007.13 does not meet the current Division 2 compatibility criteria. We recommend that these requirements be adopted.
Under the proposed revision to the compatibility policy, 10 CFR 35.25 would be classified as Category D.
2 2 - none - 35.32 Quality management program A rule equivalent to 10 CFR 35.32 was not included in the rules submitted for review. We recommend the adoption of an equivalent rule.
Under the proposed revision to the compatibility policy, 10 CFR 35.32 would be classified as Category D, however, subsections (a), (b), and (c) impose requirements that would be considered necessary as a matter of health and safety. Accordingly, we would continue to recommend the adoption of these subsections even if the Commission adopts the new policy and procedures.
i JL Other comments I State NRC Div. Rule Rule Subiect and Comments 1 001.02 20.1003 Definition of " Occupational dose" 1 001.02 20.1003 Definition of "Public dose" It is noted that the proposed definitions do not include the amendment to the NRC definitions which became effective May 29,1997. In order to assure that the compatibility criteria are met after May 29,2000,we recommend the amended NRC definition be adopted.
1 004.14 20.1301 Dosa limits for individual members of the public lt is noted that the proposed rule does not include the NRC amendment which became effective May 29, 1997. In order to assure that the compatibility criteria are met after May 29,2000, we recommend the i amended NRC definition be adopted. !
2 007.17 35.33 Notifications, reports and records of misadministrations ;
it is noted that the proposed rule does not include the !
4 NRC amendment which became effective October 20, !
1995. In order to assure that the compatibility criteria are met after October 20,1998, we recommend the amended NRC definition be adopted.
Based on telephone conversations between yourself and )
Mr. Blanton of this Office, we understand that you propose to add the above amendments to your current rulemaking. We support that effort.
Date of Review: April 1997 i
Date of Rules: March 1997
32 .
4 (4, l
- j. ROUTING AND TRANSMITTAL SLIP j l
1 DATE: April 28,1997 )
CONCURRENCE / SIGNATURE I. F. CAMERON, OGC - CONCURRENCE 1 i 1' j 4
a j l LETTER TO: JOYCE K.. DAVIDSON, HEALTH PHYSICIST 1 l HHS REGULATION AND LICENSURE I LINCOLN, NE 1 k l FROM: PAUL H. LOHAUS, DEPUTY DIRECTOR l OFFICE OF STATE PROGRAMS )
]
, 1 l
SUBJECT:
PROPOSED AMENDMENTS TO TITLE 180 NAC CHAPTER 1, DATED MARCH 1,1997 l
l YOUR CONCURRENCE IS REOUESTED BY MONDAY. MAY 12. 1997.
1 I,
OSP CONTACT: RICHARD BLANTON, 415.2322 1
4 i
PLEASE CALL NANCY BELMORE. OSP. 415-2326. FOR PICK-UP. j 1
NRC FORM EB W l (7-94) >
NRCMD 3.57 x
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AGREEMENT STATE REGULATIONS REVIEW RECORD l
i Nebraska proposed revisions dated March 28,1997 I
l l
l reviewed April 1997 I
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. . . . ~ . . - . - - . . . . - . - - - . . . - . _ -
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- Rule Package: Nebraska March 28,1997, proposed revisions Dir . Definition CFR Citation State Citation Comments j 1 ~ Byproduct material 20.1003 [001.02] :
1 Member of the public 20.1003 [001.02] :
- 1. Occupational dose 20.1003 [001.02] :does not include NRC amendment effective , !
5/29/97 !
1 Public dose 20.1003 [001.02] :does not include NRC amendment effective .;
5/29/97 1 Radiation 20.1003 [001.02] : .
'i Source material 20.1003 [001.02]- :
1 Alert 30.4 [003.02] :
2 Principle activities 30.4 [003.02] :
1 Site area emergency 30.4 [003.02] :
1 Authorized nuclear pharmacist 35.2 [007.02] :
1 Authorized user 35.2 [007.02] :
1 Diagnostic clinical procedures manual 35.2 [007.02] :
1 Medical use 35.2 [007.02] :
1 Misadministration 35.2 [007.02] : i 1 Pharmacist 35.2 [007.02] : '
1 Prescribed dosage 35.2 [007.02] :do not make proposed changes' 1 Prescribed dose 35.2 [007.02] :
1 Recordable event 35.2 [none] :NRC amended effective 31/1/95 !
1 Written directive 35.2 Inone] :NRC- amended effective,.1/1/95 ;
1 Uranium milling 40.4 [001.02] : " source material milling" l 9' r ALL OTHER DEFINITIONS UNCHANGED f 2
____m_.. _ _ _ _ _ __.__..mm_. .___m_. _._._-_mm.____.mmm._. _ _ _ _-_.m._m-. -._.______m_-_______.-__-__m.-__.--__.-___m__ _ _ . - _ _ _ - . _ _ _ _ _ _ _ _ - _ - - _ _ _ . _ _ _ _ . - _ . - - _ _ _ _ _ - _ _.m ,_______m ____
1 Rule Package: Nebraska March 28,1997, proposed revisions _.
Division and CFR citation - Rule subiect State citation Comments .
l 10 CFR Part 20 STANDARDS FOR PROTECTION AGAINST RADIATION 1 - 20.1301(a, b) Dose limits for individual members of the public [004.14] :does not include NRC amendment effective 5/29/97 2* 20.2108 Records of waste disposal [004.48) :
10 CFR Part 30 RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL 2 30.35 Financial assurance and recordkeeping for [003.17) :
decommissioning 2 30.36 Expiration and termination of licenses and [003.18] :
[except(a)(2)I decommissioning of sites and separate buildings or outdoor areas 2* 30.51[except(e)] Records [003.29] :
2 30.51(e) Records - transfer to new iicensee [OO3.29F] : ,
10 CFR Part 32 SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL 2 32.72 Requirements for manufacture of -[003.13j] :
Radiopharmaceuticals 10 CFR Part 35 MEDICAL USE OF BYPRODUCT MATERIAL 1 35.2 Definitions [007.02] :see list on page 2 2* 35.5 Maintenance of records [004.50] :
2 35.6 Provisions for research involving human subjects [007.03] :
3
Rule Package: Nebraska March 28,1997, proposed revisions Division and CFR citation Rule subiect State citation Comments 2 35.22(b)(2) RSC personnel review requirements [007.02B2b] :
2 35.25 Supervision [007.13] :does notinclude QM requirements 2 35.32 Quality management program [none] :not currently evaluated to determine compatibility 2 35.33 Notifications, reports and records of [007.17] :does not include amendment effective 10/20/95 misadministrations 2 35.50 Possession, use, calibration and check of dose [007.19] :
calibrators 2 35.52 Possession, use, calibration and check of [007.21] :
instruments to measure alpha- or beta-emmitting nuclides 2 35.53 Measurement of radiopharmaceutical dosages [007.22] :
2 35.75(a)&(b) Release of individuals containing [007.30] :
radiopharmaceuticals or permanent implants 3 35.300 Use of unsealed material for therapy [007.40] :
2 35.920 Training for imaging and localization studies [007.668] :
2 35.972 Recentness of training [007.66L] :
2 35.980 Training for authorized nuclear pharmacist [007.660] :
2 35.981 Training for experienced nuclear pharmacist [007.66P] :
4
. _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ -___-_-- ____-_ - _ _ _ _ _ _ _ _ _ _ _ - _ __ ___ -_ _ _ . ~ . -
10 CFR Part 61 LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE:
2 61.30 Transfer of license [012.19] .:
2 61.31 Termination of license [012.20] :
2 61.40 General performance requirement [012.21) : amended to aviod conflict of 012 22 and 61.41; resolves the previously identified compatibility issue 1 61.41 Protection of the general population from [012.22] :
releases of radioactivity ALL OTHER RULES UNCHANGED s
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NR FORM 8 NRCMD 3.57
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