ML20237A561
| ML20237A561 | |
| Person / Time | |
|---|---|
| Issue date: | 07/30/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Kearns K PENNSYLVANIA, COMMONWEALTH OF |
| References | |
| SP-97-067, SP-97-67, NUDOCS 9808140177 | |
| Download: ML20237A561 (30) | |
Text
_ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ - . _ - _ _ - _ _ _ _ _ _ _ _ - _ _ . _ - _ _ . _ - - - __ . . .
90%
p $ UNITED STATES g
j NUCLEAR REGULATORY COMMISSION 'l I
$ Q/s WASHINGTON, D.c. 3008H001
\% .**# July 30, 1998 '
s Mr. Keith Keams, Acting Director .
Bureau of Radiation Protection l Department of Environmental Protection
. Rachel Carson State Office Building P.O. Box 8469
' Harrisburg, PA 17.105-8469
Dear Mr. Keams:
The purpose of this letter is to provide the results of the Office of State Programs' (OSP)-
separate review of all current Pennsylvania regulations that will be needed to support your request for an Agreement as explained in our letter to you dated May 19,1998. The review covered the final regulations in Title 25, Environmental Protection, Chapters 215-221, Voiume 1, February 22,1997; Chapters 223-230, Volume 2, February 22,1997; and Chapter 236, November 23,1996. The final regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,31,32,33,34,35,36,39,40,61,70,71 and 150. This review is exclusive of the review of the February 14,1998 proposed amendments that was sent to the Environmental Quality Board in a letter dated April 15,1998.
The review followed the standard procedure as outlined in OSP Internal Procedure D.7,
" Procedure for Reviewing State Regulations." In addition, we have not limited our review to regulations required for compatibility and/or health and safety. All NRC regulations with a compatibility category "D" designation are not required for purposes of compatibility. All comments on regulations designated compatibility category "D" are for your consideration, only.
We have enclosed an explanation of the compatibility and health and safety categories identified in our comments.
We have identified 68 comments, as enclosed. Of these,13 are category "D" and an additional L five close NRC comments on the proposed amendments dated February 14,1998 that were l already addressed by Pennsylvania. The comments include 19 regulations, either entirely or partially, that must be adopted for Pennsylvania to become an Agreement State. In addition, for completeness, we have indicated "No comments," when we had no comments and for those provisions that are not subject to the Agreement under Section 274b of the Atomic Energy Act of 1954, as amended, we have indicated, "Not reviewed." The 50 comments (not including category "D" and comments relating to proposed amendments) must be addressed to meet the compatibility and health and safety categories as indicated in the OSP Internal Procedure B.7,
" Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program Elements." A revised listing is included in SP-97-067, dated September 15,1997. /
These comments result from a review conducted only by the Office of State Programs. Other I NRC offices will review your regulations when they are' submitted with your draft Agreement
' State application.
As discussed in our March 10,1998, conference call, and reiterated in our letter of May 19, 1998, we also asked that you conduct a similar review to ensure that your regulations are P 3 3 *""I 9808140177 900730 ~; WW f " ~ Y h-f/bl'1 PDR STPRO ESOPA PDR j
? .
i 1
l Keith Kearns JUL 3 01998 up-to-date and complete. Given the number of comments and number of NRC sections that appeared to have not been incorporated into the final and proposed Pennsylvania regulations, we believe such a review is important. We suggest that after your review is completed, we
! meet to discuss any additional modifications that may be needed in your regulations. At that time we can also discuss development of a draft agreement application, schedule for submittal, and NRC initial review of that draft application for completeness.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NHC regulations needed for compatibility and health and safety, I please contact me or Dr. Stephen N. Salomon of my staff at (301) 415-2368 or i
E-mail: SNS @ NRC. GOV.
erely,
)
k s Paul H. Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated
)
l l
l l
4 1
i i
I
Keith Kearns JUL 8 01998 1998, we also asked that you conduct a similar review to ensure that your regulations are up-to-date and complete. Given the number of comments and number of NRC sections that appeared to have not been incorporated into the final and proposed Pennsylvania regulations, we believe such a review is important. We suggest that after your review is completed, we j meet to discuss any additional modifications that may be needed in your regulations. At that I time we can also discuss development of a draft agreement application, schedule for submittal, and NRC initial review of that draft application for completeness.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations needed for compatibility and health and safety, please contact me or Dr. Stephen N. Salomon of my staff at (301) 415-2368 or E-mail: SNS @ NRC. GOV.
Sincerely, Orl0lnalSigned By:
PAULH.LOHAUS Paul H. Lohaus, Deputy Director )
Office of State Programs 1
Enclosure:
As stated Distribution:
DIR RF (8S-54) RBlanton DCD (SP05)
SDroggitis DWhite, RI PDR (YES_f_ NO )
KHsueh LBolling BUsilton Pennsylvania File
- SEE PREVIOUS CONCURRENCE.
DOCUMENT NAME: G :\SN S\K E AR N S.WPDr G :\S N S\PAFR E G S.S N S Ta receive a copy of this document. Indicate in the bar: "C" = $rNhout attachment / enclosure i "E' = Copy with attachment / enclosure "N' = No copy l OFFICE OSP OSI $$l OSP:D [. .
! NAME SSalomon:kk PHLohdus' RLBangart l*D DATE 07/02/98* 07/02/98* 07$/98 07/21/98
- 07/27/98 ,
l l 1
- i l.
/
Keith Kearns 1998, we also asked that you conduct a similar review to ensure that your regulations are up-to-date and complete. Given the number of comments and numbep/of NRC sections that appeared to have not been incorporated into the final and proposed Pennsylvania regulations, we believe such a review is important. We suggest that after your review is completed, we meet to discuss any additional modifications that may be needed inhour regulations. At that time we can also discuss development of a draft application, schedule for submittal, and NRC initial review of that draft application for completeness.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations needed for compatpility and health and safety, please contact me or Dr. Stephen N. Salomon of my staff at {301) 415-2368 or E-mail: SNS @ NRC. GOV.
Sincerely, i
Paul H. Lohaus, Deputy Director ffice of State Programs
Enclosure:
As stated Distribution:
DIR RF (8S-54) RBlant DCD (SP05)
SDroggitis DWhit , RI PDR (YES_/_ NO )
KHsueh LBolling BUsilton Pennsylvania File I
- SEE PREVIOUS CONCURRENCE.
/
DOCUMENT NAME: G:\SNS\KEARN .WPD, G:\SNS\PAFREGS.SNS l Ta receive a cop f of this document, indicate in the box: pC" = Copy without attachment "E" = Copy with / enclosure attachment / enclosure *N" = No copy OFFICE OSP @ /OSP:DD OSP:D l NAME SSalomon:kk' ' PHLohaus RLBangart DATE 07/02/98* / 07/02/98* 07/ /98 ;
07/11/98 07/ /98 l OSP FILE CODE: SP-NA-17 r
j
\
l
[
( Keith Kearns '
appeared to have not been incorporated into the final and proposed PennsylvaniaJe'gulations, we believe such a review is important. We suggest that after your review is copipleted, we ]
meet to discuss any additional modifications that may be needed in your re letions. As a final point, I would like to emphasize the significance of your ensuring the com eness and quality ,
of your final, regulations prior to your submitting ihem to NRC for review./ Regulations that are I complete and editorially correct reduce both the time and effort require,d for our review, but more importantly, eliminate the need for additional effort required on youffart to prepare revisions and complete regulations that would be acceptable to support yodr request for an Agreement.
If you have any questions regarding the comments, atibility and health theand compsafety / 1 categories, or any of the NRC regulations needed for compatibility and health and safety, i please contact me or Dr. Stephen N. Salomon of my staff at (301) 415-2368 or E-mail: SNS@NRC. GOV.
Sincerely,
/ Paul H. Lohaus, Deputy Director
/
/ Office of State Programs
Enclosure:
j/
As stated
/
/
/
Distribution /
DIR RF (8S-54) RBlanton DCD (SP05)
GDroggitis DWhite, RI PDR (YES_/ NO )
KHsu,eh LBoltIng BUsilton pennsylvania File DOCUMENT NAME: G:\SNS\KEARNS.WPD, G:\SNS\PAFREGS.SNS *See previous concurrence. .
Ta receive a cop r of this document, Indicate in the box: *C" = Copy without attachment / enclosure "E" = Cop / with attachment /erdosure "N" = No copy j OFFICE OSP Q4 ggypD1 OSP:D NAME SSalomon:kk Pld.6W5Iiii' A RLBangart DATE 07/J/98* 07/d/98* 07/ /98 j OSP FILE CODE: SP-NA-17 l l
~
Compatibility Cateaory and H&S Identificalig.0 for NRC Regulations Key to categories: A= Basic radiation protection standard or related definitions, signs, labels or terms necessary for a common understanding of radiation protection
, principles. The State program element should be ,
essentially identical to that of NRC.
B= Program element with significant direct transboundary implications. The State program element should be essentially identical to that of NRC.
C= Program element, the essential objectives of which should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed need not be the same as NRC provided the essential objectives are met.
D= Not required for purposes of compatibility.
NRC = Not required for purposes of compatibility. These are NRC program elemer
- 4 of regulation that cannot be relinquished to rper* ent States pursuant to the AEA or provisi s , of Title 10 of the Code of Federal Regulations. The State should not adopt these program elements.
HSS = Program elements identified as H&S are not required for purposes of compatibility; however, they do have particular health and safety significance. The State should adopt the essential objectives of such program elements in order to maintain an adequate program.
J
COMMENTS ON FINAL PENNSYLVANIA REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateaory Reaulation Reaulation Subject and Comments CHAPTER 215 GENERAL PROVISIONS
~
D 215.1 3
0.1 Purpose and Scope
L l
No comments 215.2 Definitions l
A 30.4 Alert
- The definition of Alert is omitted and the 30.4 Cefinition should be adopted to meet the compatibility category.
C 30.4 Decommission l
I The definition, Decommission, is omitted and a l definition with the essential objectives as the
! definition in 30.4 should be adopted to meet the compatibility category.
A 215.3 20.1004 Units of exposure and dose. j l
No comments.
l l A 215.4 20.1005 Units of activity. I l
No comments.
215.11 30.51 Records. t C-(a) &(b) 1 D-(c)
D 31.12 The discussion of the maintenance of records is not j complete and is brought to your attention for l consideration. The essential objectives of Section
( 30.51, paragraphs (a) and (b), should be adopted to meet the compatibility category.
D 215.12 30.52 Inspections.
Although no NRC regulations exist on inspection frequency, paragraph 215.12(c) indicates that major medical facilities, including hospitals, are to i
State NRC 2
,qateoory Reaulation Reaulation Subiect and Comments be inspected at least every 2 years. The inspection of major licensees at least every 2 years seems to be a major deviation from the annual medical institution broad scope, annual brachytherapy remote afterloader, and annual nuclear pharmacy inspection frequency requirements of NRC, stated in inspection Manual Chapter 2800. A similar comment was made in our letter to the Environmental Quality Board, dated 4/15/98, on the proposed regulations where the proposed interval was at least every 3 years. The program may want to consider developing inspection frequencies in a similar guidance document, as opposed to a regulation.
D 215.13 30.53 Tests.
No comments.
None 215.14 Availability of records for public inspection.
No comments.
None 215.15 Additional requirements.
We believe it may be inappropriate to use the term
" person" in this section because the definition of
" person"is broad and includes entities that are not subject to Pennsylvania regulatory authority, e.g.,
another State. The words " licensee or registrant" should be used instead to avoid confusion.
Although not required for compatibility, this recommendation is brought to your attention for consideration.
None 215.21 Sale or installation of radiation sources.
None 215.22 Prohibited uses.
None 215.23 Penalties.
None 215.24 Human use.
l No comments.
L_ ____ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ i
l State NRC 3 Cateaory Reaulation Reaulation Sublect and Comments C New 30.10,40.10, Deliberate Misconouct by Unlicensed Persons 61.9b, 70.10 The previous regulation was omitted. This location may be an appropriate place to insert the new ,
amended regulation, Deliberate Misconduct by Unlicensed Persons,63 FR 1890; 1/13/98; 63 FR ,
1372; 3/23/98, effective 2/12/98.
{
D 215.31 20.2301, Granting exemptions.
30.11,34.111, 39.91,40.14 (a),
61.6,71.8 No comments.
B 215.32 30.12 Exemption qualifications.
l The word " prime" before " contractor" is omitted '
from paragraph (1)in Section 215.32. Also, this paragraph uses the phase,"otherwise {
appropriate," rather than " authorized by law." To 1 meet the compatibility category, this section needs to follow more closely the language of Section 30.12.
l D 215.41 30.6 Address. I No comments.
CHAPTER 216 REGISTRATION OF RADIATION PRODUCING MACHINES Not reviewed.
CHAPTER 217 LICENSING OF RADIOACTIVE MATERIAL Subchapter A. General D 217.1 30.1 Purpose and scope.
C 30.3 Paragraph 217.1(b) omits language and reference to Chapter 236 of Pennsylvania's regulations which relate to low-level radioactive waste management and disposal. To meet the compatibility category, language such as, "A licensee for the disposal of low-level radioactive waste received from other l
Shh NRC 4 Catenory Reaulation Regulation Subiect and Comments persons is subject to Chapter 236," should be added to correct the omission.
.None 217.2 Address.
No comments.
Subchapter B. EXEMPTIONS B 217.11 30.13 Source material.
B 40.13 Some words are missing from this section. From paragraph (1) " solution" is omitted after
" compound." From paragraph (3)(iii) "or ceramic" is omitted after "other glass." In paragraph (6), "does not" should follow " exemption" and " authorize" should replace " authorizes." in paragraph (7)(iii)
"from this requirement"is omitted after" exempt." In paragraph (8) " Natural or depleted" is omitted before " Uranium." These words and phrases need to be adopted to meet the compatibility category.
B 217.12 30.14 Exempt concentrations.
B 30.18 Paragraph 217.12 (b) omits the phrase, " knowing or having reason to believe that it will be transferred" after the phrase "no person may introduce radioactive material." This phase should be adopted to meet the compatibility category.
B 217.13 30.18 Exempt quantities.
Paragraph 217.13(b) omits the phrase, " knowing or having reason to believe that such quantities of radioactive material will be transferred" after the 1 l
phrase," transfer radioactive material." The phrase, "for distribution," should be deleted. These phases !
should be adopted and deleted to meet the ,
compatibility category.
I B 217.14 30.19 Self-luminous products containing radioactive ;'
material.
No comments.
State NRC 5 Cateaorv Reaulation Reaulation Sublect and Comments B 217.15 30.20 Gas and aerosol detectors containing radioactive material.
The introductory paragraph to section 217.15 omits the phrase "from fires and airbome hazarde" after the phrase "to protect life or property." This phase should be adopted to meet the compatibility category.
B None 30.21 Radioactive drug: Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.
The regulation, Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea,62 FR 63634,12/2197, effective 01/2/98, is omitted and should be adopted to meet the compatibility category.
B 217.16 30.16 Resin containing scandium-46 and designed for f sand consolidation in oil wells.
No comments.
B 217.17 30.15 Other items containing radioactive material.
No comments.
B 217.18 40.13(c)(9) Limitations on exemptions.
No comments.
Subchapter C. LICENSES j 1
C 217.21 30.31 Types of licenses. l C 40.20(a) l No comments.
C - (b) 217.22 30.34 Specific terms and conditions of licenses. l D - (a),(c),
l (d),(e)(2),(e)(4),
l (f) & (g)
H&S-(h) Paragraph 217.22 omits 30.34(h) that deels with a ,
I bankruptcy provision from the regulation, Bankruptcy Filing; Notification Requirements,52 FR 1292,1/12/87, effective 2/11/87. Notification of 1
{
State NRC 6 Cateaory Reaulation. Reaulation Sublect and Comments bankruptcy will alert the agency to the possible abandonment of licensed facilities at which there is potential for exposure in excess of Part 20 limits.
Such a paragraph should be added to meet the health and safety category.
D 217.23 30.61 Modification, revocation and termination of licenses.
Paragraph 217.23(b) uses the term, " false statement," instead of the term, " material false statement," used in 30.61(b) and therefore adopts a more stringent standard. Although not a compatibility category that requires adoption, we are bringing this fact to your attention for consideration.
None 217.24 Persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the FederalRegister.
No comments.
GENERAL LICENSES: SOURCE MATERIAL B 217.31 40.22 General.
Paragraph 40.22(c) that deals with human use is omitted from section 217.31. The paragraph should be adopted to meet the compatibility category.
C 217.32 40.25 Depleted uranium in industrial products and devices.
l No comments.
GENERAL LICENSES: MATERIAL OTHER THAN SOURCE MATERIAL B 217.41 31.3 Certain devices and equipment.
No comments.
l
State NRC 7 Catenory Reaulation Reaulation Sublect and Comments D 217.42 31.5 Certain measuring, gauging or controlling devices.
No comments.
B 217.43 31.7' Luminous safety devices for aircraft.
No comments.
D 217.44 31.8 Calibration and reference sources.
Paragraph 217.44(d)(1) omits the phrase,"at any one time, at any one location of storage or use,"
after the phrase "May not possess." The omission of this phrase makes the statement less specific.
Although not a compatibility category that must be adopted, this difference is noted for your consideration.
D 217.45 35.100 Medical diagnostic uses.
The NRC equivalent of Section 217.45 was subsumed into a new Section 35.100. NRC no longer uses an "in-vivo" General License for medical use. The State should consider deleting Section 217.45 and adopt the current NRC format of 10 CFR Part 35.
D 217.46 31.11 General license for use of radioactive material for certain in vitro clinical or laboratory testing.
Paragraphs 217.46(b)(1) and (e) omit " veterinarian" after " physician." The word " veterinarian" should be adopted to be consistent. Also, Cobalt-57 is added to paragraphs (a), (c)(1) and (d)(1) and " Mock lodine-125"is omitted after " person" from paragraph (f) when compared to 31.11. Although not a compatibility category that must be adopted, these inconsistencies are noted for your consideration.
B 217.47 31.10 Ice detection devices.
No comments.
State NRC 8 Catenory Reaulation Renulation Epblect and Comments 217.48 incidental radioactive material produced by a particle accelerator.
Not reviewed.
D 217.49 31.5(d) Limitation on exemptions.
B 31.7(c)
B 31.10(c)
No comments.
SPECIFIC LICENSES--GENERAL CONDITIONS C-(g) 217.51 30.32 Filing application for specific licenses.
H&S-(i)
D-(a),(b), Section 217.51 omits paragraphs 30.32(g) and (c),(d),(e),(f) 30.32 (i) regarding sealed sources and emergency
& (h) plans. They must be adopted to meet the essential objectives of the compatibility and the health and safety categories respectively.
D 217.52 30.33 General requirements for the issuance of H&S specific licenses.
(a)(2)&(a)(3)
No comments.
C-(b) 217.53 30.33(b) Issuance of specific licenses.
D 30.34(e)(2)
D 30.34(e)(4) No comments.
D 217.54 30.36 Expiration and termination of licenses.
H&S-(c),(d),(e), ;
(g),(h),(j), & (k) This section is not current and needs revision to adopt the appropriate provisions in Timeliness in Decommissioning of Material Facilities,59 FR ,
36026, 7/15/94, effective date, 8/15/94; Clarification j of Decommissioning Funding Requirements,60 FR 38325,7/26/95, effective 11/24/95; Termination or Transfer of Licensed Activities; Recordkeeping
! Requirements,61 FR 24669,5/16/96, effective l 6/17/96; and Radiological Criteria for License l
Termination,62 FR 39057,7/21/97, effective 8/20/97.
Shh NRC 9 Catenory Renulation Reaulation Subiect and Comments D 217.55 30.37 Renewal oflicenses.
No comments.
D' 217.56 30.38 Amendment of license at the request of the licensee.
No comments.
D 217.57 30.39 Department action on applications to renew and amend.
No comments.
D 217.58 (new)30.35 Financial assurance arrangements for reclaiming H&S-(a),(b) - sites.
& (d)
The Pennsylvania proposed regulations,2/14/98, addresses the NRC regulations, Self-Guarantee as an Additional Financial Mechanism,58 FR 68726, 12/29/93, effective 1/28/94, Clarification of Decommissioning Funding Requirements,60 FR 38235,7/26/95, effective 11/24/95, and Termination or Transfer of Licensed Activities: Recordkeeping Requirements,5/16/96, effective 5/16/96. Since publication of the Pennsylvania proposed regulations, NRC amended its regulations, Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing Licensees,63 FR 29535,6/1/98, effective 7/1/98. The amendment is category D and is brought to your attention for consideration.
SPECIAL REQUIREMENTS FOR CERTAIN SPECIFIC LICENSES l
C 217.65 34.11 Specific licenses for the use of sealed sources in industrial radiography.
No comments. The Pennsylvania proposed regulations,2/14/98, addresses the revision to the
~
radiography regulation, Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations,62 FR 28947, 5/28/97, effective 6/27/97.
State NRC 10 Catenorv Reaulation Reaulation Subiect and Comments LICENSES OF BROAD SCOPE D 217.71 33.11(a) Type A application.
D '
33.13 ,
D 33.17(b)
No comments.
i l D 217.72 33.11(b) Type B application.
D 33.14 D 33.17(c)
No comments.
D 217.73 33.11(c) Type C application. -
D 33.15 D 33.17(d)
No comments.
D 217.74 33.17 License restrictions.
No comments.
SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR j DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES WHICH CONTAIN RADIOACTIVE MATERIAL C-(a)&(b) 217.81 32.11 Licensing the introduction of radioactive material I B-(c) into products in exempt concentrations.
C 32.12 The provision in 32.12(e) that relates to the maintenance of reports is omitted. The time .
required for record retention may vary in accordance with the type of facility being licensed. )
Such a provision should be adopted to meet the compatibility category, i
! 217.82 None Licensing the distribution of NARM in exempt quantities.
l Not reviewed.
217.83 None Licensing the incorporation of naturally occurring and accelerator-produced radioactive material into gas and aerosol detectors.
Not reviewed.
State NRC 11 Catenory Reaulation Reaulation Sublect and Comments B 217.84 32.51 Licensing the manufacture and distribution of measuring gauging or controlling devices.
No comments.
B 217.85 32.53 Special requirements for the manufacture, assembly or repair of luminous safety devices for use in aircraft.
No comments.
B 217.86 32.57 Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226.
No comments.
B 217.87 32.72 Manufacture and distribution of radioactive material for medical use under general license.
Section 32.72 of the NRC equivalent regulation was revised to delete references to an in-vivo General License for medical use. All in-vivo medical uses are captured under Part 35 Specific Licenses. The State should consider deleting this section and follow the format of 10 CFR 35.72.
B 217.88 32.71 Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license.
No comments.
B 217 89 32.61 Licensing the manufacture and distribution of ice detection devices.
No comments.
l B 217.90 32.72 Manufacture and distribution of radiopharmaceutical for medical use under group licenses.
Paragraph 217.90 needs to be revised to include the provisions of Section 32.72 of the radiopharmacy regulation, Preparation, Transfer for I
State NRC 12 Category Reaulation Reaulatign Subiect and Comments Commercial Distribution, and Use of Byproduct Material for Medical Use, 59 FR 61761,12/2/94, effective 1/1/95, to meet the compatibility category.
B 217.91 32.72 ' Manufacture and distribution of generators or reagent kits for preparation of radiophamaceuticals.
Paragraph 217.91 needs to be revised to include the provisions of Section 32.72 of the radiopharmacy regulation, Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use, 59 FR 61761,12/2/94, effective 1/1/95, to meet the compatibility category.
A preferred approach may be to combine paragraphs 217.90 and 217.91.
B 217.92 32.74 Manufacture and distribution of sources or devices containing radioactive material for medical use.
To meet the compatibility category, the references to radiophamaceuticals in Section 217.92 should be removed because Section 32.74 refers only to sealed sources and devices containing sealed sources for medical uses in Sections 35.400 and 35.500 and as calibration and reference sources.
B-(a)(2) & (a)(3) 217.93 40.34 Manufacture and distribution of industrial products D-(a)(1),(b), & (c) containing depleted uranium for mass-volume B-(b) & (c) 40.35 application.
C-(a)
D(d),(e), & (f) Paragraph 217.93(d)(2)(i) omits the phrases, "or initial transferor" and "or initially transferred" after
" manufacturer" and " manufactured" respectively.
These phrases should be adopted to meet the compatibility category of 40.35(b).
Subchapter D. TRANSFER OF RADIOACTIVE MATERIAL C-(a),(b)(1) 217.101 30.41 Transfer of material.
thru (b)(5), 40.51 (b)(7),(c)&(d) No comments.
NRC-(b)(6) l
State NRC 13 Catenory Reaulation Reaulation Sublect and Comments Subchapter F. RECIPROCITY C-(a) & (b) 217.121 150.20 Reciprocity of licenses of byproduct, source NRC-(c) & (d) and special nuclear materialin quantities not sufficient to form a critical mass.
Section 217.121 is r.ot current and needs revision to meet the compatibility category. The essential objectives in the appropriate provisions in the regulations, Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction within an Agreement State,62 FR 1662,1/13/97, effective 2/27/97, and Licenses for Industrial Radiography and Radiation Safety-Requirements for Industrial Radiography Operations,62 FR 28947,5/28/97, effective 6/27/97, shall be adopted.
C 217.121 150.2 The essential objectives of the compatibility category needs to be included in the regulation, Deliberate Miscenduct by Unlicensed Persons, 63 FR 1890,1/13/98; 6313372,3/23/98, effective 2/12/98.
217.122 Reciprocity of licenses of naturally occurring and )
accelerator produced radioactive material.
1 Not reviewed.
B Appendix A Schedule A Exempt Concentrations 217 30.70 No comments but only spot checked.
B Appendix B Schedule B Exempt Quantities 217 30.71 No comments but only spot checked.
Appendix C Reserved 217 Not reviewed.
D Appendix D Schedule A Limits for Broad Licenses 217 33.100 No comments but only spot checked.
l i
L_--__ __------_------ __ - - - - - - - - - - - -
State NRC 14 Cateaorv Reaulation Reaulation Sublect and Comments CHAPTER 218. FEES Not reviewed.
CHAPTER 219 Part 20 STANDARDS FOR PROTECTION AGAINST RADIATION C-(d) 219.21 20.1101 Radiation protection programs.
D,H&S No comments. The Pennsylvania proposed regulations,2/14/98, address the air emissions constraint regulation, Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act,61 FR 65120,12/10/96, effective 1/9/97.
C 219.228 35.33 Reports of misadministration.
The word " patient" should be replaced by
" individual" to meet the compatibility category in provisions (a)(2), (a)(3), (a)(4), (b) and (c) to meet the compatibility category according to the regulation, Medical Administration of Radiation and Radioactive Materials,60 FR 48623,9/20/95, effective 10/20/95.
C None 20.1401 thru Radiological criteria for decommissioning 20.1406 20.2203 The regulation does not contain the regulations and definitions in Radiological Criteria for License Termination,62 FR 39057,7/21/97, effective 8/20/97. These should be adopted to meet the essential objectiv as of the compatibility category.
B None 20.2006 Transfer for dispot, ' and manifests.
Appendix G The regulation does not contain the regulations and definitions in Low-Level Waste Shipment Manifest Information and Reporting,60 FR 15649,60 FR 25983,3/27/95, effective 3/1/98. These should be adopted to meet the compatibility category.
j l
State NRC 15 Catenory Reaulation Reaulation Sublect and Comments CHAPTER 220 Part19 NOTICES, INSTRUCTION AND REPORTS TO WORKERS; INSPECTIONS D 220.1 19.1 Purpose and scope.
D 19.2 No comments.
C 220.2 19.11 Posting of notices to workers.
No comments. The proposed regulations 2/14/98 addresses that paragraph 19.11(e) requires the posting of documents within 2 working days instead of 5 as stated in 220.2(d).
C 220.3 19.12 Instructions to workers.
No comments. The proposed regulations 2/14/98 addresses that paragraph 19.12(a) is omitted from 220.3(a) and that paragraph 19.12(b) uses the term
" work place" in place of " restricted area."
C 220.4 19.13 Notifications and reports to individuals.
No comments.
C 220.5 19.14 Presence of representatives of licensees or registrants and workers during inspection.
No comments.
C 220.6 19.15 Consultation with workers during inspections.
No comments.
C 220.7 19.16 Requests by workers for inspections.
No comments.
C 220.8 19.17 Inspections not warranted; informal review.
l No comments.
w-_-__----_------------------------
State NRC 16 Catenorv Reaulation Reaulation Subject and Comments C None 19.18 Sequestration of witnesses and exclusion of counsel in interviews conducted under subpoena.
Paragraph 19.18(a) is omitted from section 220.8 and should be adopted to meet the compatibility category.
CHAPTER 221. X-RAYS IN THE HEALING ARTS Not reviewed.
CHAPTER 222. VETERINARY MEDICINE GENERAL PROVISIONS 223.1 None Purpose and scope. ,
No comments.
1 X-RAYS Not reviewed.
RADIOACTIVE MATERIAL D 223.21 33.11(f) In vitro testing.
No comments.
D 223.22 35.400 Sealed sources.
D 35.500 D 35.600 No comments CHAPTER 224 Part 35 MEDICAL USE OF RADIOACTIVE MATERIAL C 224.302 35.404 Release of patients treated with temporary implants.
The words, "or human research subject," should be inserted after the word, " patient," in paragraphs (a) and (b) to meet the compatibility category in the regulation, Preparation, Transfer for Commercial
State NRC 17 Catenory Reaulation Reaulation Subiect and Comments Distribution, and Use of Byproduct Material for
- Medical Use,59 FR 61767,12/24/94, effective 1/1/95.
D 224.55 3'5.25 Supervision.
Although not required to meet the compatibility category, the underlined text should be considered in the following paragraphs in the regulation, l Quality Management Program and
( Misadministration,56 FR 34101, 7/25/91, effective 1/27/92:
224.55(a)(1) ... radioactive material and in the licensee's written auality manaaement oroaram, l j
l 224.55(a)(2) .. radiation safety and auality manaaement '
orocedures established.
Section 224.55 omits a paragraph that corresponds to 35.25 (b) in the regulation, Preparation, Transfer for commercial Distribution, and Use of Byproduct Material for Medical Use, 59 FR 61767,12/2/94, effective 1/1/95. Although not required to meet the compatibility category, it is noted for your consideration.
None 224.56 35.27 Visiting authcrized user.
This provision was removed per 59 FR 61767, 12/2/94, effective 1/1/95.
The underlined words dealing with human research subjects are omitted from the following 11 provisions. Although, for most cases, they are not required to mest the compatibility category, they are noted for your consideration.
D 224.101 35.50 Possession, use, calibration and check of dose calibrators.
(a)...each patient and human research subiect.
State NRC 18 Category Regulation Reaulation sublect and Cumt en_ta 1
i D 224.106 35.61 Syringe shields and labels.
(b)...or the patient's or human research subiect's ,
~
name.
'(c)...for that patient or human research subiect.
D 224.253 35.315 Safety precautions.
(a)(2),(a)(5), (b) and (c)... patient or human research sublect D 224.503 35.406 Brachytherapy sources inventory.
H&S-(a)&(c) (a), (b)(2), (b)(3), (c)... patient or human research sublect ..
D 224.304 35.410 Safety instruction.
H&S (a) and (a)(5)... patient or human research subiect D 224.305 35,415 Safety precautions.
H&S (a), (a)(1), (a)(2) & (a)(3)... patient or human research subiect...
D 224.404 35.610 Safety instruction.
(a)(1)... patient or human research subiect D 224.405 35.615 Safety precautions.
(d)(3) and (e)... patient or human research subject...
D 224.453 35.910 Training for uptake. dilution and excretion studies.
(2)(ii)(A), (2)(ii)(C) and (2)(ii)(E)... patient or human research subiect...
D 224.454 35.920 Training for imaging and localization studies.
(2)(ii)(C), (2)(iii)(A), (2)(iii)(C) and (2)(iii)(E) -
i patient (e) or human research subiects..
l
State NRC 19 Aptegory Regulation Reaulation Sublect and Comments D 224.461 35.960 Training for teletherapy.
(2)(iii)(C)... patient's or human research subiect's progress.. ,
Five other omissions include:
D 224.408 35.632 Full calibration measurements.
H&S (b)(6) The accuracy of.pjj distance...
D 224.451 35.900 Radiation safety officer.
(1)(vi) The American Board of Medical Physics iO radiation oncoloov ohvsics:
D 224.454 35.920 Training for imaging and localization studies.
(2) ... reagent kits, supervised work...
D 224.455 35.930 Training for therapeutic use of radiophamaceuticals.
J (1)(ii) ... therapeutic radiology, or radiation oncoloov:
D 224.461 35.960 Training for teletherapy.
(2)(iii)(A) ... treatment, and. pay...
CHAPTER 225 Part 34 RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES AND RADIOGRAPHIC OPERATIONS 4 C 225.52 34.51 Security.
The information in paragraph 225.52 is contained in I the proposed 225.261(b) without being deleted.
This duplication could lead to confusion and j paragraph 225.52 should be deleted to meet the l compatibility category. l C 225.53 34.53 Posting.
The information in paragraph 225.53 is contained in
State NRC 20 Category Renulation Regulation Subiect and Comments the proposed 225.261(c) without being deleted.
This duplication could lead to confusion and paragraph 225.53 should be deleted to nieet the
, compatibility category. ,
C None 34.89(a) Location of documents and records.
A paragraph with the essential objectives of 34.89(a) cannot be found in Chapter 225. The essential objectives of this paragraph should be adopted to meet the compatibility category.
C None 34.73(b) Records of inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.
A paragraph with the essential objectives could not be found in Chapter 225. The essential objectives should be adopted to meet the compatibility category. A place for such a paragraph is 225.257(d) of the proposed regulation,2/14/98.
CHAPTER 226 Part 39 RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING 4 C 226.3 39.15 Prohibition.
The essential objectives of paragraphs 39.15(a)(2),(3),(4) and (5) and (b), (c), and (d) tilat deal with an agreement with the well owner or operator are omitted from section 226.3 and should be adopted to meet the compatibility category.
C 226.16 39.39 Utilization records.
The essential objectives of paragraph 39.39(a)(3) regarding the identity of the logging assistants are omitted and should be adopted to meet the compatibility category.
i b 226 Appendix A 39.61 Subjects to be included in Training Courses for Logging Supervisors '
Paragraph 39.61(e)(5) relating to case histories of i
State NRC 21 Catenorv Reaulation Reaulation Sublect and Comments accidents is omitted and should be Ldopted to meet the compatibility category.
CHAPTER 227. RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT, X-RAY GAUGING EQUIPMENT AND ELECTRON MICROSCOPES Not reviewed.
CHAPTER 228. RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS Not reviewed.
CHAPTER 230 Part 71 PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL B 230.2 71.4 Definitions.
The NRC definitions of " package, fissile material package, and Type B package," should be adopted to meet the compatibility category in the regulation, Compatibility with the intemational Atomic Energy Agency (IAEA), 60 FR 50248, 9/28/95, effective 4/1/96; and 61 FR 282723,6/6/96, effective 4/1/96.
B 230.12 71.10 Exemptions for low-level materials.
Provisions equivalent to Sections 71.10(b)(2) and 71.10(c) should be adopted to meet the compatibility category in the regulation cited above..
B 230.22 71.13 Generallicense: NRC-approved package.
Provisions equivalent to sections 71.12(a)(3) and 71.12(b) should be adopted to meet the compatibility category in the regulation cited above.
B 230.24 71.16 Generallicense: Use of foreign approved package.
Provisions equivalent to Sections 71.16(b) and 71.16(d) should be adopted to meet the compatibility category in the regulation cited above.
I
State NRC 22 Cateiporv Reaulation Reaulation Sublect and Comments D 230.25 71.18 Generallicense: Fissile material, limited quantity per package.
Although this provision is not required for purposes' of compatibility, a State that chooses to adopt a provision equivalent to Section 71.18 from the regulation cited above and issue the GL should have provisions essentially identical to those of NRC.
D 230.26 71.20 Generallicense: Fissile material, limited moderator per package. Tables I and ll list quantities of U-235 that are greater than States have the authority to regulate. The tables should be modified to exclude these quantities or other indication made that the State cannot regulate such quantities.
Our comment is similar to the comment for Section 230.45.
B 230.44 71.88 Air transportation of plutonium.
Section 230.44 should be amended to meet the compatibility category by adopting revised provisions equivalent to Section 71.68(b) and (c) in the regulation cited above.
I B 230.47 71.97 Advanced notification of shipment of irradiated J reactor fuel and nuclear waste. '
Section 230.47 should be amended to meet the compatibility category by adopting the revised provision equivalent to Section 71.97 in the i regulation cited above.
CHAPTER 232 Part 36 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR 1RRADIATORS This is a new chapter. No comments.
l l
, i L______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
State NRC 23 Cateoory Reaulation Reaulation Sublect and Comments CHAPTER 236 Part 61 LOW-LEVEL RADIOACTIVE WASTE 236.2 61.2 Definitions ,
[C] Person The definition of " person" is inconsistent in that paragraph (i) refers to a definition in Section 215.2 that conflicts with paragraph (ii). Paragraph (ii) includes all agencies of the Federal government !
other than the NRC whereas paragraph (i) excludes Federal govemment agencies. The definition in Section 215.2 corresponds to the definition in 10 l CFR 150.3(g) that has a compatibility designation j C. To meet the compatibility category, the Section j 150.3(g) definition should be used.
C None 61.9b Deliberate misconduct A paragraph equivalent to 61.9b is required to meet the compatibility category of the regulation, Deliberate Misconduct by Unlicenced Persons, 63 FR 1890,1/13/98, effective 2/12/98.
D 236.208 61.12 (n) Specific technicalinformation.
I Paragraph 236.208 omits 61.12 (n) referring to electronic recordkeeping in the regulation, LLW Shipment Manifest Information and Reporting, 60 FR 15649,3/27/95, effective 3/1/98. Although not required to meet the compatibility category, this paragraph is pointed out for your consideration.
H&S 236.226 61.24 (k)(1) Conditions of the license.
Paragraph 236.226 omits a paragraph on bankruptcy from the regulation, Bankruptcy Filing; Notification Requirements,52 FR 1292,1/12/87, effective 2/11/87. Such a paragraph should be !
added to meet the compatibility category.
D 236.247 61.31(c)(3) Termination of license.
Paragraph 236.247 omits a paragraph on records transfer from the regulation, Termination or
1 l
l~ State NRC 24 i Category Renulation Regulation Subiect and Comments l
Transfer of Licensed Activities; Recordkeeping l Requirements,61 FR 24669,5/16/96, effective 6/17/96. Although not required to meet the compatibility category, this paragraph is pointed out for your consideration.
D 236.322 61.52(a)(6) Long term stability of disposal units Paragraph 236.322 omits a paragraph referring to the radiation dose at closure and transfer from the
- regulation, Standards for Protection Against
- Radiation; Removal of Expired Material,58 FR 67657,12/22/93, effective 1/1/94. Although not j required to meet the compatibility category, this l
paragraph is pointed out for your consideration.
l B 236.532 20.2006 Waste manifest. l and Appendix G l
236.533 Generator requirements.
236.534 Carrier requirements.
236.535 Broker requirements.
236.536 Disposal facility operator requirements.
236.537 Nonacknowledgment.
l Paragraphs 236.532-236.537 require revisions to meet the compatibility category of the regulation, LLW Shipment Manifest, Information and Report, 60 FR 15649, 3/27/95, effective 3/1/98.
C 236.706 (c) 61.80(c) Maintenance of records.
Paragraph 236.706 (c) requires revision to meet the compatibility catege/y of the regulation, Retention Periods for Recorr.s,53 FR 19240,5/27/88, effective 7/26/88 C 236.707 61.80 (f)& (1) Recording receipt of waste shipments.
Paragraph 236.707 requires revision to meet the compatibility category of the regulation, LLW Shipment Manifest Information and Reporting, 60 FR 15649,3/27/95, effective 3/1/98.
End of comments.
i t_______________________________.--____--=-_