ML20247K479
| ML20247K479 | |
| Person / Time | |
|---|---|
| Issue date: | 05/19/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Kearns K PENNSYLVANIA, COMMONWEALTH OF |
| References | |
| NUDOCS 9805220107 | |
| Download: ML20247K479 (3) | |
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UNITED STATES p
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NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.C. ensam nnny l
.....,o May 19,1998 Mr. Keith Keams, Acting Director Bureau of Radiation Protection l
Department of Environmental Protection i
Rachel Carson State Office Building l
P.O. Box 8469 i
Harrisburg, PA 17105-8469
Dear Mr. Keams:
As you are aware, we sent to the Environmental Quality Board, in a letter dated April 15,1998, our review of the proposed regulations that appeared in the Pennsylvania Bulletin, Volume 28, No. 7, February 14,1998 (Enclosed). The purpose of this letter is to provide additional information regarding our April 15,1998, letter and our March 10,1998, conference call.
Because of the large number of comments and the fragmented nature of most of the proposed regulations, we were unable to follow the standard procedure as outlined in OSP Intemal Procedure D.7, ' Procedure for Reviewing State Regulations." Normally, if your proposed regulations were adopted incorporating the comments and without other significant change, we would conclude they would meet the compatibility and health and safety categories as indicated in the OSP Intemal Procedure B.7, " Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program Elements." However, in this case, we were not able to make that determination As discussed during our March 10,1998, conference call, the Office of State Programs' staff is conducting a separate review of all current Pennsylvania regulations that will be needed to l
support your Agreement, exclusive of the proposed amendments. We will provide you the results of the review as soon as it is completed. This review does not preclude our office or l
other NRC offices from commenting in the future. As discussed, 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 sections that appeared to have not been incorporated into the proposed regulations (see, for example, comments on your equivalent Part 34 rule), we believe such a review is important. We suggest that after the respective reviews are completed, we plan to meet to discuss any additional modifications that may be needed in your l
regulations. As a final point, I would like to emphasize the significance of your ensuring the completeness and quality of your proposed regulations prior to your submitting the rules to NRC for review. Rules that are complete and editorially correct reduce both the time and effort l
required for our review, but more importantly, eliminate the need for additional effort required on
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your part to prepare revisions and complete regulations that would be acceptable to support your request for an Agreement.
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0 Keith Keams MAY 191998 ff you have any questions regarding the comments, the compatibility and heaRh 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.
l
- cerely, q
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}h%Y Paul H. Lohaus, Deput'y Director l
Office of State Programs
Enclosure:
As stated l
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Keith Kearns MAY 19 1998 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, Signed By:
@H.LOHAUS FAUL Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated Distribution:
DIR RF (8S-54)
RBlanton DCD (SP05)
SDroggitis DWhite, RI PDR (YES_(_ NO
)
KHsueh LBolling BUsilton Pennsylvania File DOCUMENT NAME: G:tSNS\\PAPREGS.SNS
- SEE PREVIOUS CONCURRENCE.
i l
To receive a cop, of this document. Indicate i the box: ac = Copy without attachment / enclosure "E" =4op r with attachment / enclosure "N" = No copy l
OFFICE OSP SOS OSP:DD OSP:D('r r /
NAME SSalomon:nb:kk PHLohaus RLBangartiklD DATE 05/C.6/98
- 05/07/98*
05//'/98 b,l3 %
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Environmental Quality Board D 15 W RachelCarson State ONice 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 ig,20,30,31,32,34,35,36,3g and 71. We also discussed our review of the regulations with Mr. Keith Keams, 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 identifed in the enclost.re. 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.
Sincerely'nalSigned By:
Origi PAUL H.LOHAUS Paul H. Lohaus, Deputy Director ONice of State Programs
Enclosures:
s As stated 6
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COMMENTS ON PROPOSED PENNSYLVANIA REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES Shh NRC Category Regulation Regulation subject and Comments CHAPTER 215 GENERAL PROVISIONS A
215.2 20.1003 Definitions No comments 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 i
overy 3 years. The inspection of major licensees at a 3 l
year interval seems to be a major deviation from the I
annual medicalinstitution broad scope, annual l
brachytherapy remote afterloader, and annual nuclear pharmacy inspection frequencies stated in NRC Inspection Manual Chapter 2800.
215.32 Exemption qualifications No comments l
CHAPTER 217 LICENSING OF RADIOACTIVE MATERIAL D
217.42 31.5 Certain measuring, gauging or controlling devices.
No comments.
217.58 30.35 Financial assurance arrangements for reclaiming sites.
D 217.58(e) 30.35(3)
The second sentence introduces a " commissioning" funding plan. However, this section deals only with decommissioning plans. The lack of a "de" before commissioning appears to be a typographical error that may cause confusion and should be corrected.
l 0
2 suk NRC Category Regulation Regulation Subject and Comments D
217.58(f)(2) 30.35(f)(2)
A surety method.
l Append!x A to 10 CFR Part 30 gives the criteria j
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.
The proper references to the Appendices should be made in paragraph 217.58(f)(2).
l None 217.58(h)
None Specific licensees that are required to make l
financial surety arrangements.
There is no equivalent NRC regulation. It is not cietr 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 l
Commission (AEC) or NRC licensed facilities.
Most NRC materials licensees become l
Pennsylvania licensees when Pennsylvania i
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-1 L
7 I *.
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l Suk NRC Category Regulation Regulaticn Subject 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-l 86; Rubidium-g7 should be Ruthenium-g7; 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...".
l 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 Pad 30 The nomenclature for Moody's bonds is Asa, 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.
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CHAPTER 220 Part 19 NOTICES, INSTRUCTION AND REPORTS TO i
WORKERS; INSPECTIONS l
l No comments.
1 CHAPTER 224 Part 35 MEDICAL USE OF RADIOACTIVE MATERIAL.
D 224.61 35.32 Quality management program H&S (a), (b) & (c)
The words,
- human research subject" are omitted in many places.
j To satisfy the health and safety requirement, the I
underlined text should be added:
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4 Suk NRC Category
[tegulation Regulation Subject 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)(l) A representative sample of pasent 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 subinet receiving radiopharmaceutical therapy and hospitalized in compliance with 224.10g (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 gbysics D
224.466.
35.980 Training for an authorized nuclear pharmacist The word
- radiation"is omitted.
We recommend that the following underlined text i
be added to section (a)(2)(ii)(A) Shipping, receiving and performing related radiation surveys.
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Shte NRC l
Catanory Regulation Regulation Subject and Comments l
t CHAPTER 225 Part 34 RADIATION SAFETY REQUIREMENTS FOR l
INDUSTRIAL USES AND RADIOGRAPHIC OPERATIONS B
225.2 34.3 Definitions The following terms are omitted: Control tube, 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 radiographer may work in multiple jurisdictions (e.g., ether Agreement States or where l
NRC has jurisdiction).
B 225.251 34.20 Performance requirements for radiography
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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.
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6 State NRC Category Regulation Regulation Subiect and Comments B
225.72 and 34.43 Training and Testing D, p;ra 225.73 (a)(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 the Commission." Atthough 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 rad!ogrcpher snd 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
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7 State NRC Category Regulation Regulauen subject and comments 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) roads +/- 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.
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 deals 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 radic;rspher'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.
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) 34.7g(a)
Records of training and certification.
A paragraph equivalent to 34.7g(a) presented in the State supplied comparison list could not be
8 State NRC l
Category Regulation Regulation Subject and Comments found in the proposed regulations. This paragraph l
must be adopted to meet the compatibility
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category.
C None 34.81 Copies of operating and emergency procedures.
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, j
i 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.
CHAPTER 226 Part 39 RADIATION SAFETY REQUIREMENTS FOR WEl 8. LOGGING B
226.2 39.2 Definitions Definitions of licensed material and sealed sources are omitted and should 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.
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Suk NRC Category Regulation Regulation Subject and Comments CHAPTER 230 Part 71 PACKAGING AND TRANSPORTATION OF l
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 A/g.
B 230.2 71.4 Surface contaminated object (SCO)
The word " accessible" in sections (l)(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.
l 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.
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Compatibility Cateoorv and H&S Identification 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 th6 essential objectives are met.
D=
Not required for purposes of compatibility.
NRC=
Not required for purposes of compatibility. These I
are NRC program element areas of regulation that cannot be relinquished to Agreement States pursuant to the AEA or provisions of Title 10 of the i
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.
Keith Kearns If you have any questions regarding the comments, the compatib' sty and health and safety categories, or any of the NRC regulations needed for compatibi' y and health and safety please contact me or Dr. Stephen N. Salomon my staff at (301) 415-68 or E-mail: SNS@NRC. GOV.
Sincere,
Pgul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated
/
Distribution:
DIR RF (8S-54)
RBlanton DCD (SP05)
SDroggitis DWhite, RI PDR (YES__/_ NO
)
KHsueh LBolling BUsilton Pennsylvania F' e DOCUMENT NAME: G:\\SNS\\PAPREGS p
- SEE PREVIOUS CONCURRENCE.
To rsesivo a cop" of this document, indicate in the box: "C" =Co y e th>ut attachment / enclosure "E" = Cop r with attachment / enclosure "N" = No copy OFFICE OEP l
OSl[:Ddl OSP:D l
NAME SSalonion:nb PHLohdus
' \\
RLBangart DATE 05/06/98
/
.l
Keith Kearns l l
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 my staff at (301) 415-2368 or E-mail: SNS@NRC. GOV.
Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated f'
d'
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Distribution:
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[RBlanton DIR RF (8S-54)
DCD (SP05)
DWhite, RI PDR (YES_f._ NO
)
SDroggitis KHsueh
/
LBolling BUsilton Pennsylvania File
/
DOCUMENT NAME:.G:\\SNS\\PAPREGS.SNS Ta receive a cop i of this docunsent. Indicate in the box: "C" a Copy without attachment / enclosure "E" = Corn with attachment / enclosure *N" a No copy OFFICE
,OSP %
OSP:DD OSP:D l
NAME SSafomon:nb ~
PHLohaus RLBangart DATE
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05/(g/98 05/ /98 05/ /98 f
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