ML20217M592
| ML20217M592 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | PENNSYLVANIA, COMMONWEALTH OF |
| Shared Package | |
| ML20217M597 | List: |
| References | |
| NUDOCS 9805050057 | |
| Download: ML20217M592 (14) | |
Text
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. Environmerital Quality Board M 15 951 Rachel Carson State Office Building 400 Market Street,15th Floor -
Harrisburg, PA 17101-2301
Dear Board Members:
Pursuant to a request dated February 19,1998, from Stuart R. Levin, Chief, Division of
' Radiation Control, Bureau of Radiation Protection, we have reviewed the proposed regulations that appeared in the Pennsylvania Bulletin, Volume 28, No. 7, February 14,1998. These are contained in Chapter 215. General Provisions; Chapter 217. Licensing of Radioactive Material; Chapter 219. Standards for Protection Against Radiation; Chapter 220. Notices, instruction and Reports to Workers; Inspections; Chapter 224. Medical Use of Radioactive Material; Chapter 225. Radiation Safety Requirements for Industrial Uses and Radiographic Operations; Chapter 226. Radiation Safety Requirements for Well Logging; Chapter 230. Packaging of and Transportation of Radioactive Material; and Chapter 232. Licenses and Radiation Safety
~ Requirements for Irradiators. The proposed regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,31,32,34,35,36,39 and 71f We also discussed our review of the regulations with Mr. Keith Kearns, Acting Director, Bureau of Radiation Frotection, Mr. Stuart Levin, and Ms. Mary Lou Barton on March 10,1998, and with Mr. Levin on other occasions.
As a result of our review, we have 30 comments that are identified in the enclosure. Please -
note that 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.
If you h' ave 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 i
Dr. Stephen N. Salomon my staff at (301) 415-2368 or E-mail: SNS@NRC. GOV.
P incerely.'nal Signed By:
p, S.
Origi giO-PAUL H. LOHAUS 9905050057 990415 Paul H. Lohaus, Deputy Director PDR STPRO ESGP
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Office of State Programs
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Enclosures:
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f C3 As stated t1 l
J t ec:. Keith Kearns, BRP, PA d Distribution:
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BUsilton -
HNewsome, OGC Pennsylvania File DWhite, RI DCool, NMSS DOCUMENT NAME: G.\\SNS\\ PAREGS.WPD SEE PREVIOUS CONCURRENCE.
To receive a cop > of this document, incl 6cate in the b I "/ Cop r without attachment'pnclosure "E" = Copy with attachment / enclosure "N" a No copy
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C OFFICE OSP-l O@ M OSP:l i dl' l
l NAME SSalomon:nb PLohauf RLBanga r't' DATE 04/15/98
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UNITED STATES g
j NUCLEAR REGULATORY COMMISSION 1
2 WASHINGTON, D.C. 2056M001 April 15, 1998 Environmental Quality Board Rachel Carson State Office Building 400 Market Street,15th Floor Harrisburg, PA 17101-2301
Dear Board Members:
Pursuant to a request dated February 19,1998, from Stuart R. Levin, Chief, Division of Radiation Control, Bureau of Radiation Protection, we have reviewed the proposed regulations that appeared in the Pennsylvania Bulletin, Volume 28, No. 7, February 14,1998. These are i
contained in Chapter 215. General Provisions; Chapter 217. Licensing of Radioactive Material; Chapter 219. Standards for Protection Against Radiation; Chapter 220. Notices, Instruction and Reports to Workers; Inspections; Chapter 224. Medical Use of Radioactive Material; Chapter 225. Radiation Safety Requirements for Industrial Uses and Radiographic Operations; Chapter 226. Radiation Safety Requirements for Well Logging; Chapter 230. Packaging of and Transportation of Radioactive Material; and Chapter 232. Licenses and Radiation Safety Requirements for Irradiators. The proposed regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,31,32,34,35,36,39 and 71. We also discussed our review of the regulations with Mr. Keith Kearns, Acting Director, Bureau of Radiation Protection, Mr. Stuart Levin, and Ms. Mary Lou Barton on March 10,1998, and with Mr. Levin on other occasions.
As a result of our review, we have 30 comments that are identified in the enclosure. Please note that 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.
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 Dr. Stephen N. Salomon my staff at (301) 415-2368 or E-mail: SNS@NRC. GOV.
S' ce ly,
)
e Paul. Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated cc: Keith Kearns, BRP, PA
1 COMMENTS ON PROPOSED PENNSYLVANIA REGULATIONS
^
AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES 1
State NRC Catenorv Rasulatien Regulation Sublect and Commenta l
CHAPTER 215 GENERAL PROVISIONS A
215.2 20.1003 Definitions No comments i
215.12 Inspections Although no NRC regulations exist on inspection frequency, this paragraph indicates that major medical facilities, including hospitals, are to be inspected at least every 3 years. The inspection of major licensees at a 3 year interval seems to be a major deviation from the annual medical institution broad scope, annual brachytherapy remote afterloader, and annual nuclear pharmacy inspection frequencies stated in NRC Inspection Manual Chapter 2800.
215.32 Exemption qualifications No comments J
CHAPTER 217 LICENSING OF RADIOACTIVE MATERIAL I
D 217.42 31.5 Certain measuring, gauging or controlling devices.
l No comments.
{
I 217.58 30.35 Financial assurance arrangements for reclaiming sites.
D 217.58(e) 30.35(3)
l 1
The second sentence introduces a " commissioning" l
funding plan. However, this section deals only with 4
decommissioning plans. The lack of a "de" before
)
commissioning appears to be a typographical error that may cause confusion and should be corrected.
1 I
i
i
'M 2
State.
~NRC Category Regulation Regulation Subject and Comments D-
'217.58(f)(2)
. 30.35(f)(2)
A surety method.
Appendix A to 10 CFR Part 30 gives the criteria relating to financial tests and parent company guarantees. Appendix C gives criteria relating to financial tests and company self-guarantees.
- Appendix F to Chapter 217 corresponds to Appendix C to Part 30 and was inappropriately used for Appendix A to Part 30, as well.
T1e proper references to the Appendices should be made in paragraph 217.58(f)(2).
None 217.58(h)
None Specific licensees that are required to make financial surety arrangements.
There is no equivalent NRC regulation. It is not clear how this provision relates to the preceding ones. It appears to conflict with the earlier provisions specifying which licensees are required to provide financial assurance. For example, (3) refers to formerly United States Atomic Energy
' Commission (AEC) or NRC licensed facilities.
Most NRC materials licensees become Pennsylvania licensees when Pennsylvania becomes an Agreement State so they would be subject to Pennsylvania regulations without this phrase. We do not know whether the former AEC licensees cited refer to the formerly licensed sites under study by the Oak Ridge National Laboratory that may be contaminated and require cleanup.
The provision (h)(4)(1)(1) may conflict with paragraph 217.58(a) because different Appendices are used that list different radionuclides.-
B Appendix E Appendix B We found 12 discrepancies in the table that need to be corrected. American-241 should be Americium-241; Nickel-50 should be Nickel-59; Palladium-106 and 108 should be Palladium-103 and 109, respectively; Phosphorus-33 should be
)
Phosphorus-32; Radium-236 should be Radium-
3 State NRC Cateoory Regulation Regulation Subiect and Comments 226; Rhenium-136 and 138 should be Rhenium-186 and 188, respectively; Rhodium-106 should be Rhodium-105; Rubidium-66 should be Rubidium-86; Rubidium-97 should be Ruthenium-97; Silver-106 should be Silver-105; The quantity for Silver-111 should be 100 microcuries instead of 111 microcuries; and the footnotes indicating that these quantities are based of (sic] alpha disintegration rates of thorium and uranium and their daughter products, should say " based on...".
Given the number of discrepancies, a thorough review of the Tables by Pennsylvania staff should be conducted.
D ll.A.3 il.A.(3)
Criteria Relating to Use of Financial Tests
]
Appendix F Appendix C 217.58 Part 30 The nomenclature for Moody's bonds is Aaa, Aa, or A. Pennsylvania's provision uses all A's. This may be a typographical error but should be corrected to be consistent with Moody's to avoid confusion.
CHAPTER 219 Part 20 STANDARDS FOR PROTECTION AGAINST RADIATION No comments.
CHAPTER 220 Part 19 NOTICES, INSTRUCTION AND REPORTS TO WORKERS; INSPECTIONS No comments, CHAPTER 224 Part 35 MEDICAL USE OF RADIOACTIVE MATERIAL i
D 224.61 35.32 Quality management program H&S (a), (b) & (c)
The words, " human research subject" are omitted in many places.
To satisfy the health and safety requirement, the underlined text should be added:
4
4 State NRC Category Regulation Regulation Sublect and Comments (a)(2) That, prior to each administration the patient's or human research subiect's identity is verified by more than one method as the individual named in the written directive.
(b)(1)(1) A representative sample of patient and human research subiect administrations.
D 224.253 35.315 Safety precautions The words, " human research subject" are omitted in many places.
We recommend that the following underlined text be added:
(a) For each patient or human research subiect receiving radiopharmaceutical therapy and hospitalized in compliance with 224.109 (relating to release of patients containing radiopharmaceuticals or permanent implants), a licensee shall: (a)(6),
(a)(7).. patient or the human research subiect.
D 224.462 35.961 Training for teletherapy physicist The word " physics" is omitted.
We recommend that the following underlined text be added: (3) is certified by the American Board of Medical Physics in radiation oncology chvsics.
D 224.466.
35.980 Training for an authorized nuclear pharmacist The word " radiation" is omitted.
We recommend that the following underlined text be added to section (a)(2)(ii)(A) Shipping, receiving and performing related radiation surveys.
5 State NRC i
Category Regulation Regulation Subject and Comments CHAPTER 225 Part 34 RADL% TION SAFETY REQUIREMENTS FOR INDUSTRIAL USES AND RADIOGRAPHIC OPERATIONS B
225.2 34.3 Definitions The following terms are omitted: Controltube, Field station, Hands-on experience, Lay-barge radiography, Offshore platform radiography, Practical Examination, Radiation Safety Officer for industrial radiography and Underwater radiography.
The missing definitions should be adopted to meet the compatibility category for these definitions since radiographers may work in multiple jurisdictions (e.g., other Agreement States or where NRC has jurisdiction).
B 225.251 34.20 Performance requirements for radiography equipment.
Paragraph 34.20 (a)(2) is omitted and should be added to meet the compatibility category.
B-225.261(a) 34.41 Radiographic operations, security and posting.
Paragraphs 34.41 (b) and (c) are omitted and should be added to meet the compatibility category.
B 225.254 34.35 (c)
Storage precautions.
Paragraph 34.35(c) omits the phrase: "The licensee shall store licensed material in a manner which will minimize danger from explosion or fire."
The revised text should be added to meet the compatibility category.
1 6
State NRC Category Regulation Regulation Sublect and Comments B
225.72 and 34.43 Training and Testing D, para 225.73 (L)(2) and (c)
The following phrases are omitted from 34.43:
Paragraph 225.71(a)(1) omits 34.43(a)(1) ".. in addition to a minimum of 2 months of on-the-job training..." This must be adopted to meet the compatibility category.
Paragraph 225.72(a)(2) omits 34.43(a)(2) "... and demonstrated an understanding of these subjects.
by successful completion of a written examination that was previously submitted to and approved by j
the Commission." Although not required to meet the compatibility category, we are pointing this phrase out for your consideration.
Paragraph 225.73(b)(2) omits from 34.43(e)(2)"...a practical examination before these individuals can next participate in a radiographic operation." This phrase must be adopted to meet the compatibility category.
Paragraph 225.73 (a) requires observation of the performance of each radiographer and radiographer's assistant at intervals not to exceed 1-calendar year. This is less stringent that the 6 month or less interval required by 33.43(e)(1). The period of 6 months or less must be adopted to meet the compatibility category.
C 225.153 34.47 Personnel monitoring control The statement in 225.153(a) "A licensee or registrant may not permit an individual to act as a radiographer or as a radiographer's assistant, unless, at all times during radiographic operations, each individual wears a combination of direct-reading pocket dosimeter, an operating alarm ratemeter and either a film badge or a thermoluminescent dosimeter (TLD)." This sentence conflicts with another statement in the
4 7
State NRC i
E Category Regulatiort Regulation Subject and Comments i
same paragraph "... Registrants are exempted from requiring the use of alarm rate meters." We recommend that you resolve the conflict.
Paragraph 225.153 (c)(3) reads +/- 30 % instead of plus or minus 20 percent as required in 34.47(c) "...
Acceptable dosimeters must read within plus or.
minus 20 percent of the true radiation exposure."
The tolerance of plus or minus 20 percent should be adopted to meet the compatibility category.
4 Paragraph 34.47 (e) that starts, "lf a film badge or TLD is lost or damaged..." is omitted. The missing paragraph should be adopted to meet the compatibility category.
B 225.251(b)(2) 34.35(b)
. This provision that desis with the transport of licensed material identified in the comparison table could not be found in the proposed regulation. It.
must be adopted to meet the compatibility category.
B 225.26 34.46 Supervision of radiographer's assistants.
A paragraph equivalent to entire paragraph,34.46, presented in the State supplied comparison list could not be found in the proposed regulations.
This paragraph must be adopted to meet the compatibility category.
i
' C 215.11 34.63 Records of receipt and transfer of sealed sources.
Two paragraphs equivalent to 34.63 presented in the State supplied comparison list could not be found in the proposed regulations. These paragraphs must be adopted to meet the compatibility category.-
- C 227.72(c) 34.79(a)
Records of training and certification A paragraph equivalent to 34.79(a) presented in the State supplied comparison list could not be
8 Shh NRC Category Regulatiort Regulation Sublect and Comments found in the proposed regulations. This paragraph must be adopted to meet the compatibility category.
C None 34.81 Copies of operating and emergency procedures.
j A paragraph equivalent to 34.81 presented in the State supplied comparison list could not be found in the proposed regulations. This paragraph must be adopted to meet the compatibility category.
C 225.153(e) 34.83 Records of personnel monitoring procedures.
A paragraph equivalent to 34.83 presented in the State supplied comparison list could not be found in the proposed regulations. This paragraph must be adopted to meet the compatibility category.
CHAoTER 226 -
Part 39 RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING B
226.2 39.2 Definitions Definitions of licensed material and sealed sources are omitted and snould be adopted to meet the compatibility category.
C 226.19 39.43 Inspection, maintenance, and opening of a source or source holder.
The provision in 39.43(a)"Each licensee shall visually check source holders, logging tools, and source handling tools, for defects before each use to ensure that the equipment is in good working condition and that required labeling is present" is omitted and should be adopted to meet the compatibility category.
C 225.21(e) 39.61 The statement in 39.61(d) regarding the record on each logging supervisor's and logging assistant's annual safety review is omitted and should be adopted to meet the compatibility category.
9 State NRC Category Regulation Regulation Sublect and Comments CHAPTER 230 Part 71 PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL B
230.2 71.4 Low Specific Activity Material Subparagraph (ii)(C) for LSA-Il should read that the average specific activity of the solid does not exceed 2x10-8A/g, not 2,000 Agg.
]
i B
230.2 71.4 Surface contaminated object (SCO)
I The word " accessible" in sections (I)(c) and (ii)(c) is incorrect and appears to be a typographical error.
The word should be changed to " inaccessible."
The term " inaccessible" means surfaces that are not readily accessible to an individual, such as the inner surfaces of pipes, or the inner surfaces of glove boxes.
B 230.2 71.4 Natural uranium The term " uranium-238" is missing after the word
" essentially" and appears to be a typographical error and should be added to meet the compatibility category.
B Table A-1 Table A-1 Ba-133 is not listed.
CHAPTER 232 Part 36 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR 1RRADIATORS D
232.25(b) 36.25(b)
The value of 0.0002 Sv should be 0.00002 Sv.
This is apparently a typographical error and should be corrected.
Comoatibility Cateaorv and H&S Identification for NRC Reaulations 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 1
met.
D=
Not required for purposes of compatibility.
NRC=
Not required for purposes of compatibility. These are NRC program element areas of regulation that J
cannot be relinquished to Agreement States pursuant to the AEA or provisions of Title 10 of the Code of Federal Regulations. The State should not adopt these program elements.
H&S =
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.
~ Environmental Quality Board Rachel Carson State Office Building -
400 Market Street,15th Floor Harrisburg, PA : 17101-2301
Dear' Board Members:
Pursuant to a request dated February 19,1998, from Stuart R. Levin, Chief, Division of Radiation Control, Bureau of Radiation Protection, we lave reviewed the proposed regu ions that appeared in the Pennsylvania Bulletin, Volume 28,'No. 7, February 14,1998. Th e are contained in Chapter 215. General Provisions; Chapter 217. Licensing of Radioactiv Material; Chapter 219J Standards for Protection Against Radiation; Chapter 220. Notices, I truction and
' Reports to Workers; inspections; Chapter 224l Medical Use of Radioactive Mat ial; Chapter 225. Ra_diation Safety Requirements for Industrial Uses and Radiographic O 'ations; Chapter.-
226. Radiation Safety Requirements for_Well Logging; Chapter 230. Pack g of and Transportation of Radioactive Material; and Chapter 232. Licenses and iation Safety Requirements for Irradiators." The'p'roposed regulations were reviewed y comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,31,72,34,35' 36,39 and 71. We also -
discussed our review ' f the regulations with Mr. Keith Kearns; Acti Director, Bureau of -
o
' Radiation Protection, Mr. Stuart Levin, and Ms. Mary Lou Barton n March 10,1998, and with Mr. Levin on other occasions.
- As a result of our review', we'have 30 comments that are ide ified in the enclosure. Please note that we have not limited 'our review to regulations req'uired for compatibility and/or health and safety. All NRC r,egulations with a compatibility cat 4 gory "D" designation are not required for purposes of compatibility. A;l comments on regulaflons designated compatibility category "D" are for your consideration, onlyJ-If you have any questions rega' ding the commen'ts[tbe compatibility and health and safety r
categories, or any of the NRC regulations used in the review, please contact me or.
Dr. Stephen N. Salomon my staff at (301)/
415-2368 or E-mail:. SNS@NRC. GOV.
f Sincerely,
[
/
Paul H. Lohaus, Deputy Director -
f' Office of State Programs
Enclosure:
As stated
- cc: Keith Kearns, BRP, PA' Distribution:
' SDroggitis -
KHsueh PDR (YES_f_ NO
)
SSalomon RBlanton LBolling BUsilton Pennsylvania File DWhite, RI
. DOCUMENT NAME: G:\\SNS\\PAREGEQB.SNS
- Ta receive a cop i of thle document, Indicate in the box: "C" = Cop' without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE OSPQ}$l-OSP:DD OSP:D l-l' l
NAME:
SSalomon:nb PLohaus RLBangart DATE-04/15/98 04/
/98 04/- /98 OSP FILE CODE: SP-NA-17
FAX INFORMATION U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS STATE PROGRAMS FAX: (301) 415-3502 NUMBER OF PAGES:
1 dis including this page i
DATE:
April 15,1998 TO:
Stuart R. Levin, Chief d#S : A Division of Radiation Control Bureau of Radiation Protection State of Pennsylvania FAX: 717-783-8965 Information and Information: 717-787-3720 Phone: 717-787-3720 FROM:
Steve Salomon 301/415-2368 INTERNET: SNS@NRC. GOV MESSAGE:
Letter to Environmental Quality Board dated April 15,1998, with cc to Keith Kearns, BRP. Please hand carry to EQB immediately.