ML20217M699
| ML20217M699 | |
| Person / Time | |
|---|---|
| Issue date: | 04/13/1998 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| Shared Package | |
| ML20217M597 | List: |
| References | |
| NUDOCS 9805050088 | |
| Download: ML20217M699 (14) | |
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_ f' UNITED STATES '
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' NUCLEAR REGULATORY COMMISSION.
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2 WASHINGTON, D.C. 20066 0001
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Apri1 13, 1998 D
' MEMORANDUM' TO:
' RicharcW. Bangart, Director' Office of State Programs L FROM::
Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
PENNSYLVANIA PROPOSED REGULATIONS
[
Your memorandum of March 31,1998, requested review, concurrence, and comments on :
Pennsylvania's proposed regulation changes published in a recent Pennsylvania Bulletin, and on a draft letter to Keith Keams, Acting Director, Bureau of Radiation Protection, Department of
- Environmental Protection.
In' response to your request, I have attached comments on the proposed regulations and the
- draft letter to _Keith Kearns. ln general, our review of the package accompanying your.
memorandum was cursory, because of the State's comment closure date of April 15,1998. We primarily considered technical accuracy and clarity. There was insufficient time to coordinate a '
review by NMSS Divisions, o'her than the Division of Industrial and Medical Nuclear Safety,
'which we would need to perform in a more thorough evaluation.
Because the State is not requesting review of the complete set of Pennsylvania regulations, at this time, and because we need more time to perform a through review, it is too early to judge '
the compatibility 'of the proposed regulation changosc Howaver,'we request that our comments be provided to Pennsylvania for their consideration and incorporation into their regulations.
Attachment:
' ' As stated CONTACT:
Joe DeCicco, NMSS/IMNS '
.(301) 415-7833 8
4 W
i hO m
- mi PDR
B Comments regardiiig Pennsylvania's Bulletin, Volume 28, Number 7, dated Saturday, February 14,1998, containing proposed rulemaking:
General comments
- 1. The attempt to determine compatibility of the proposed rule for the purpose of establishing 4
an Agreement with a State, when provided with only part of the whole rule, is difficult and could be misleading. The portion of the proposed rule seems to conform to the compatibility criteria; however, the compatibility of the remainder of the requirements is undetermined. There is also j
a possibility that two items in a paragraph separately could meet the compatibility requirements, i
but placed together may create a conflict. There are also numerous areas in this published section of the proposed rule that make reference to other areas, tables and appendices that are j
~
not available. This makes it difficult to validate compatibility.
'l
- 2. In reference to the draft letter to Mr. Keith Kearns, Acting Director, Bureau of Radiation Protection for Pennsylvania: The second paragraph contains a statement, "a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC l
regulation may only be made based on a review of the final State regulation." The next I
sentence indicates that a determination has been made "that if your proposed regulations were adopted incorporating the comments and without other significant change, they would meet the compatibility and health and safety categories as indicated in the OSP Internal Procedure..."
These two statements seem to conflict.
- 3. In general, when additions or amendments were made to the proposed rule in this Bulletin, I
English units were placed first with SI units in parentheses, while unchanged text has SI units first and English units in parentheses. This use of English and SI units is inconsistent throughout the proposed changes. (This is also true for Title 10 Code of Federal Regulations Parts 1-199.) There are inconsistencies in expressing units throughout the document, such as spelling out the units in some places while abbreviating units in others. (See for example pages 894 and 895, and the definition of misadministration and recordable event.)
Specific comments
- 1. On page 886, paragraph 215.12, indicates that major medical facilities, including hospitals, are to be inspected at least every 3 years. Although no NRC regulations exist on inspection i
frequency, the inspectioa of major licensees at a three year interval seems to be a major
]
deviation from the annual medical institution broad scope, annual brachytherapy remote j
afterloader, and annual nuclear pharmacy' inspection frequency requirements of NRC, stated in
)
l Inspection Manual Chapter 2800.-
- 2. On page 890, Appendix E discrepancies found are:
- a. American-241 should be Americium-241;
- b. Nickel-50 should be Nickel-59; Attachment i
1 m.
2 I
- c. Palladium-106 and 108 should be Palladium-103 and 109, respectively;
- d. Phosphorus-33 should be Phosphorus-32;
- e. Radium-236 should be Radium-226; l
- f. Rhenium-136 and 138 should be Rhenium-186 and 188, respectively;
- g. Rhodium-106 should be Rhodium-105; 1l
- h. Rubidium-66 should be Rubidium-86;.
- l. Rubidium-97 should be Rutheniurn-97; J. Silver-106 should be Silver-105;-
- k. The quantity for Silver-111 should be 100 microcuries instead of 111 microcuries;
- l. 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..."
- 3. Page 897, paragraph 224.61 (e) indicates that the licensee shall furnish the modification to.
the appropriate regional office; this proposed rulemaking does not indicate that there are regional offices for the Department of Environmental Quality.
e
- 4. Page 898, in paragraph 224.104(1)l 555 mBq should be 555 MBq.
~
- 5. Page 920, in paragraph 230.2, un' der the definition of low specific ahtivity material, under (i)
LSA-II,(C), should state that the average specific activity of the solid does not exceed 2 x 10-8
- A/g, not 2000 A/g, as stated in the proposed regulations.
- 6. Page 923, in table A-1, Ba-133 is not listed.
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UNITED STATES y'j'
,j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30066 4 001
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Mr. Keith Keams, Acting Director Bureau of Radiation Protection Department of Environmental Protection Rachel Carson State Office Building t
P.O. Box 8469 Harrisburg, PA 17105-8469
Dear Mr. Keams:
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.
j 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 23C. Packaging of and Transportation of Radioactive Material; and Chapter j
232. Licenses and Ftediation 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 you, Mr. Stuart Levin, and Ms. Mary Lou Barton on March 10,1997, and with Mr. Levin on other occasions.
As a result of our review we have 26 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 i
for purposes of compatibility. All comments on regulations designated compatibility category "D" are for your consideration, only. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC q
regulation may only be made based on a review of the final State regulation. However, we j
have determined that if your proposed regulations were adopted incorporating the comments and without other significant change, they would meet the compatibility and health and safety categories as indicated in the OSP Intemal Procedure B.7, " Compatibility Categories and f
Health and Safety Identification for NRC Regulations and Other Program Elements. "
{
J We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Recuest to Hiohlicht Chances to Aoreement State j
Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the j
final changes and send one copy in a computer readable format, if possible.
We also want to document an important point from our March 10,1998, conference call. The adoption of our comments on the provisions cited should not be interpreted to mean that the entire regulation meets the compatibility and health and safety categories of the equivalent
.NRC regulation. The staff of the Office of State Programs is conducting a separate review of all
Mr. Keith Kearns current Pennsylvania regulations that will be needed to support your agreement, exclusive of the proposed amendments We will provide you the results of the review as soon as it is completed.
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.
3 Sincerely, 1
Paul H. Lohaus, Deputy Director I
Office of State Programs
Enclosure:
As stated j
l l
i i
i I
j
COMMENTS ON PROPOSED P2NNSYLVANIA REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateaorv Regulation Regulation Sublect and Comments CHAPTER 215 GENERAL PROVISIONS A
215.2 20.1003 Definitions No comments 215.12 Inspections No comments i
215.32 Exemption qualifications No comments 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 enor that may cause confusion and should be corrected.
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 j
and was inappropriately used for Appendix A, as well.
Tt e proper references to the Appendices should be made in paragraph 217.58(f)(2).
ee 2
State NRC Category Regulation Regulation Subject and Comments 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.
D ll.A.3 II.A.(3)
Crheria 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 typcgraphical 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.
~
3 i
State NRC CateSQ1Y Regulation Regulation Sublect and Comments 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.
To satisfy the health and safety requirement, the underlined text should be added:
(a)(2) That, prior to each administration the patient's gt 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 patient and human research subject administrations.
D 224.253 35.315 Safety precautions The words, " human research subject" are omitted in many places.
The underlined text should 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.
The underlined text should be added: (3) is certified by the American Board of Medical Physics in radiation oncology physics.
i
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4 State NRC Category Regulation Regulation Sublect and Comments D
224.466.
35.980 Training for an authorized nuclear pharmacist The word " radiation" is omitted.
The underlined text should be added to section (a)(2)(ii)(A)
Shipping, receiving and performing related radiation surveys.
. CHAPTER 225 Part 34 RADIATION SAFETY REQUIREMENTS FOR 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 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 j
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.
5 State NRC Category Regulation Regulation Sublect and Comments B
225.72 and 34.43 Training and Testing D, para 225.73 (0)(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."
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 ph'ase must r
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 nwei 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, sach 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 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
6 i
State NRC Cateaorv Regulation Raaulation subiect and Comments I
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, "If a film badge or TLD is lost or damaged...
- is omitted. The missing paragraph should be adopted to meet the compatibility category.
l 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 radiographer's assistants.
A paragraph equivalent to 34.46 presented in the 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 comparison list could not be found in the proposed regulations. These paragraphs must be adopted to meet the compatibility category, j
l C
227.72(c) 34.79(a)
Records of training and certification.
J A paragraph equivelent to 34.79(a) presented in the comparison list cculd not be found in the proposed regulations. This paragraph must be adopted to meet the j
compatibility category.
j C
None 34.61 Copies of operating and emergency procedures.
I A paragraph equivalent to 34.81 presented in the j
comparison list could not be found in the proposed j
regulations. This paragraph must be adopted to meet the compatibility category.
i
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7 State NRC Category Regulation Reaulatiolt Sublect and Comments C
225.153(e) 34.83 Records of personnel monitoring procedures.
A paragraph equivalent to 34.83 presented in the comparison list could not be found in the proposed regulations. This paragraph must be adopted to meet the compatibility category.
I CHAPTER 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 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.
CHAPTER 230 Part 71 PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL B
230.2 71.4 Surface contaminated object (SCO) i The word " accessible" in sections (I)(c) and (ii)(c) is i
incorrect and appears to be a typographical error. The j
word should be changed to " inaccessible." The term j
- 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.
1 1
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)
a o
8 State NRC Cateaorv Regulation Regulation Sublect and Comments 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.
CHAPTER 232 Part 36 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR 1RRADIATORS j
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.
l
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l
Mr. Keith Kearns current Pennsylvania regulaibns that will be needed to support your agreement, exclusive of l
the proposed amendments. We will provide you the results of the review as soon as it is completed.
If you have any questions regarding the comnants, 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, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
' As stated Distribution:
DIR RF (8S-54)
DCD (SP05)
SDroggitis PDR (YES_f_ NO
)
SSalomon LBolling KHsueh RBlanton BUsilton DWhite, RI Pennsylvania File DOCUMENT NAME: G:\\SNS\\PAPREGS.SNS
- SEE PREVIOUS CONCURRENCE.
T4 recchre a copy of this document, Ind6cate in the box: "C" a Copy without attachment / enc. sure "E" = Copy with attachtnent/ enclosure "N" = No copy b
OFFICE OSP l
OSP:DD l
NMSS:D l OGC l
Ri OSP:D NAME.
SSalomon:nb PHLohaus/ CHM CPaperiello JGray HMiller RLBangart DATE 03/26/98
- 03/26/98
- I
/98
/
/98
/
/98 04/
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8 i
' Ja ce.cy, 4
UNITED STATES
- 5 j
NUCLEAR REGULATORY COMMISSION
\\,,,,, /g WASHINGTON D.C. 20666-0001 March 31, 1998 MEMORANDUM TO:
Carl J. Paperiello, Director Office of Muclear Material Safety l
and Safeguvds i
Joseph R. Gray, / ssociate General Counsel for l
Licensing and Regulation Office of the General Counsel Hubert J. Miller, Regional Administrator Region i FROM:
Richard L. Bangart, Director
./
//
f Office of State Programs
///l46
/s b fly (
SUBJECT:
PENNSYLVANIA PROPOSED REGUl.ATIONS The State of Pennsylvania is promulgating regulations necessary to establish a compatible regulatory program, as it prepares to beenme an Agreement State. For your review and concurrence is a package that includes Fonnsylvania proposed regulations published in the Pennsylvania Bulletin, Volume 28, Number 7, February 14,1998. These regulations cover portions of 10 CFR Parts 19,20,30,31,32,34,35,36,39, and 71. The proposed additions are highlighted in bold face type, whereas deletions are highlighted in bold face type with brackets. OSP staff has completed its review and listed 26 comments in a proposed draft letter to Keitri Kearns, Acting Director, Bureau of Radiation Protection, Department of Environmental Protection (at+ ached).
We would appreciate your comments by COB, Monday, April 13,- 1997, so that we can respond to Pennsylvania by COB, Wednesday, April 15,1997, their requested response date. OSP conducted its review by using tic equivalent NRC regulations; the NRC Policy Statement on Adequacy and Compatibility of Agreement State Programs; and OSP Internal Procedure B.7, (Rev.1), Compatibility Categories and health and Safety identification for NRC Regulations and Other Procram Elements.
As pointed out in the draft letter, we intend to review ai current Pennsylvania regulations that 1
will be needed to support the Agreement. However, we wiil not be forwarding a package with those regulations until after we meet with the State.
Any questions on this review should be directed to Stephen N. Salomon at (301) 415-2368. His E-mail ID is SNS.
Attachments:
As stated l
cc:
F. Cameron, OGC i
D. Cool, NMSS OGC 001357 4epo;wc7 a fy
t f p cs UNITED STATES
- p j
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20S66 0001
%,.....f
- Mr. Keith Keams, Acting Director.
Bureau of Radiation Protection Department of Environmental Protection Rachel Carson State Office Building P.O. Box 8469 Harrisburg, PA 17105-8469
Dear Mr. Keams:
.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 71. We also discussed our review of the regulations with you, Mr. Stuart Levin, and Ms. Mary Lou Barton on March 10,1997, and with Mr. Levin on other occasions.
As a result of our review we have 26 comments that are identified in the enclosure. P ease note that we have not limited our review to regulations required for compatibility and/or health and safety. All NRC regulations with a ccmpatibility category "D" designation are not required for purposes of compatibility. All comments on regulations designated compatibility category "D" are for your consideration, only. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted incorporating the comments and without other significant change, they would meet the compatibility and health and safety categories as indicated in the OSP Internal Procedure B.7, " Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements. "
. We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Recuest to Hiahlight Changes to Aareement State Regulations 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.
1 N
We also want to document an important point from our March 10,1998, conference call. The s
adoption of our comments on the provisions cited should not be interpreted to mean that the
-entire regulation meets the compatibility and health and safety categories of the equivalent NRC regulation. The staff of the Office of State Programs is conducting a separate review of all b
Mr. Keith Kearns current Pennsylvania regulations that will be needed to support your agreement, exclusive of the proposed amendments. We will provide you the results of the review as soon as it is completed.
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, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated i
i
COMMENTS ON PROPOSED PENNSYLVANIA REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateaorv Regulation Regulation Subiect and Comments CHAPTER 215 GENERAL PROVISIONS A
215.2 20.1003 Definitions No comments 215.12 Inspections No comments 215.32 Exemption qualifications No comments 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)
Th< 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 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-l guarantees.
q Appendix F to Chapter 217 corresponds to Appendix C #[
7 and was inappropriately used for Appendix A, as well.
C.d(D CFdkv]30 P
G
\\g 3p The proper references to the Appendices should be made in paragraph 217.58(f)(2).
l
2 State NRC Cateaorv Regulation Regulation Sublect and Comments i
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.
D ll.A.3 II.A.(3)
Criteria Relating to Use of Financial Tests Appendix F Appenaix C 217.58 Part 50 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.
]
l 3
State NRC Cateaorv Regulation Regulation Sublect and Comments CHAPTER 224 Part 35 MEDICAL USE OF RADIOACTIVE MATERIAL D
224.61 35.32 Quality management program
-H&S-(1), (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:
(a)(2) That, prior to each administration th' p006idh DI 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 patient and human research subject administrations.
)
D 224.253 35.315 Safety precautions The words, " human research subject" are omitted in many places. g,pg A
J~f 6 f# 3 W i Il*U 4
he nderlined text % added:
(a) For each patient or human research sub_iect 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 i
sics" is.omitted.
The word "phy(vUw%
~ t%Df' derlined text sh5t(be added:
h 5 good h@n (3) is certified by the American Board of Medical Physics in radiation
/
oncology chvsics, i
i 4
l State NRC Category Regulation Regulation Subject,4nd Comments D.
224.466 35.980 Training for an authorized nuclear pharmacist The word " radiation" is omitted.
N[ Shipping, receiving and performing rel
- 1).5 t ue he ndert ne text ded to section (a)(2)(ii)(A).
surveys.
CHAPTER 225 Part 34 RADIATION SAFETY REQUIREMENTS FOR
. 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 UndenNater 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.
i 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.
l 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.
c I
.g 5
State-NRC Categorv Regulation Regulation Sublect and Comments
'B' 225.72 and 34.43-Training and Testing 1
D, para.
The following phrases are omitted from 34.43:
'225.73 J
(a)(2) and (c)'
Paragraph 225.71(a)(D omits 3443(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 j
previously submitted to and approved by the Commission."
Although not required to meet the compatibility category,
)
we are pointing this phrase out for your consideration.
l
-I 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 4
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 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
6 State NRC Cateaorv Regulation Regulation Sublect and Comments 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, "If 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 radiographer's assistants.
& & ch ff # h.erkA.(WS^^g3q'Yg7l
)
9 (Mh equivalent to 34.46 presented in the e.7Mcd (t. "
comparison list could not be found in the proposed J4/e's 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 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 comparison list could not be found in the proposed regulations. This paragraph must be adopted to meet the j
compatibility category.
C None 34.81 Copies of operating and emergency procedures.
A paragraph equivalent to 34.81 presented in the comparison list could not be found in the proposed regulations. This paragraph must be adopted to meet the compatibility category.
]
7-State NRC Category Regulatien Regulation Subject and Comments
)
-C' 225.153(e) 34.83 Records of personnel monitoring procedures.
A paragraph equivalent to 34.83 presented in the 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 WELL 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.
CHAPTER 230 Part 71 PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL 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.
l
8 State NRC Category Bagulation Bagulation Sublect and Comments 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.
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.
-l 1
1
i Mr. Keith Keams current Pennsylvania regulations that will be needed to support your agreement, exclusive of the proposed amendments. We will provide you the results of the review as soon as it is completed.
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.
I Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated Distribution:
DIR RF (8S-54)
DCD (SP05) l SDroggitis PDR (YES f_ NO ' )
SSalomon LBolling KHsuch RBlanton BUsilton DWhite, RI Pennsylvania File DOCUMENT NAME: G:\\SNS\\PAPREGS.SNS
- SEE PREVIOUS CONCURRENCE.
TJ receive a copy of thle document, indicate in the box: "C" = Copy without attr$ ment /e: closure "E" =
attachment / enclosure "M's No copy OFFICE -
OSP l
OSP:DD l
NMSS:D l DG$f b4 RI OSP:D NAME-SSalomon:nb PHLohaus/ CHM CPaperiello JGrdy '
(\\
HMiller RLBangart DATE 03/26/98
- 03/2Cl38 *
/
/98 4 /P/98 ~
/
/98 04/
e-f I
~p.
.y Pennsylvania Department of Environmental Protection i
Rachel Carson State Office Building P.O. Box 8469 Harrisburg, PA 17105-8469 February 19, 1998 Bureau of Radiation Protection 717-787-3720 Fax: 717-783-8965 m
cc Stephen N.
Salomon, Ph.D.
n Mail Stop O-3-H2O Office of State Programs N
U.S. Nuclear Regulatory Commission W
gin Washington, D.C.
20555-0001 c
.c-Rn: Review of Proposed Rulemaking in Pennsylvania Bulletin h
a
Dear Dr. Salomon:
I am enclosing the PA Bulletin and several other reference documents which if not helpful Tow, will be later.
As I stated in my last e-mail, we only need a review of the proposed rulemaking in the Bulletin, NOT the entire PA Code. My estimate is less than 3 person-days.
It is important that the Preamble be read first because it states where the proposed regulations are verbatim from 10 CFR.
HELP! HELP!
I need to know to restore any references for fissile material that an Agreement State needs in its regulations.
Please send your comments to the Environmental Quality Board as directed in the Bulletin.
Existing regulation is in normal font except where noted.
Example: The new Al/A2 Tables and Chapter 232 (relating to irradiators 10 CFR 36) is in normal font for readability.
Deleted regulation is in bolded font and [ bracketed).
Additional or amended regulation is in bolded font Please do not hesitate to contact me about the prcposed rulemaking.
Sincerely, f.
Stuart R.
Levin Chief Division of Radiation Control Enclosures cc:Duncan White 4
pn Equal Oppor1uruty Affirmatwe Acton Employer http.//www dep. state pa us Pnnted on Recycled Paper 'w
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l Volume 28 Number 7 Saturday, February 14,1998-Harrisburg, Pa.
Part II This part contains the Environmental Quality Board's Radiological Health m
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g PENNSYLVANIA BULLETIN published weekly by Fry Communications, Inc. for the Commonwealth of Pennsylvania, Legislative Reference Bu-(ISSN 0162-2137) reau, 647 Main Capitc1 Building, State & Third Streets, Harrisburg, Pa.17120, under the policy supervision and direction of the Joint Committee on Documents pursuant to Part II of Title 45 of the Pennsylvania Consolidated Statutes (relating to publication and efTectiveness of Com-monwealth Documents). Subscription rate $80.50 per year, postpaid to points in the United States. Individual copies
$2. Checks for subscriptions and individual copies should be made payable to " Fry Communications, Inc." Periodicals postage paid at Harrisburg, Pennsylvania.
Postmaster send address changes to:
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(717) 766-0211 ext. 340 Mechanicsburg, PA 17055-3198 (800) 334-1429 ext. 3/0 (toll free, out-of-State) sdOO) 524-3232 ext. 34 0 (toll free, in State)
Copyright c 1998 Cornmonwealth of Pennsylvania ISBN 0-8182-0004 9 Editorial preparation, composition, printing and distribution of the Pennsylvania Bulletin is effected on behalf of the Commonwealth of Pennsylvania by FRY COMMUNICATIONS, Inc., 800 W. Church Road, Mechanicsburg, Pennsylvania 17055-3198.
L
L 881 PROPOSED RULEMAKING ENVIRONMENTAL QUALITY Commewea th for radiation pmtation. Presently, Penn-sylvania is responsible for the regulation of naturally BOARD
""="8 ""d *"* "at r produced radioactive material (NARM) and radiation producing equipment. Under The At mic Energy Act of 1954 (42 U.S.C.A. 6 2021), the NRC (25 PA. CODE CHS. 215, 217, 219' 220, 224 - 226' is authorized to enter into an agreement with the Gover-230 and 232]
nor of the Commonwealth to discontinue NRC regulatory Radiological Health authority with respect to most by-prmiuct materials, source materials and special nuclear materials in The Environmental Quality Board (Board) proposes to amounts insufficient to form a critical mass.
amend Chapters 215, 217, 219, 220, 224--226, 230 and The proposed amendraents are based on the current 232. The proposed amendments update the standards for NRC radiation protection regulations at 10 CFR Parts protection against radiation.
1g_71'
.This proposal was adopted by the Board at its regular meeting on December 16,1997.
As required by section 301(cX14) of the act (35 E S.
A. Effective Date 6 7110.301(cX14)) the Department provided the Radiation Protection Advisory Committee (Committee) with an op-
)
These proposed amendments will be effective in.nedi-portunity to review the proposed amendments and to etely upon publication in the Pennsylvania Bullenn as advise the Department prior to submittal to the Board.
j final rulemakm' g.
The proposal was provided to the Committee for review j
B. "ontact Persons n August 20, 1997. The Committee provided oral and l
written comments at the meeting.
1
'or further infonnation, the contact persons are Stuart R. Levin, Chief, Division of Radiation Control, Bureau of E. Summary of Regulatory Requirements Radirtion Protection,13th Floor, Rachel Carson State The proposed amendments revise current radiation Offics Building, R O. Box 8469, Harrisburg, PA 17105-protection regulations to reflect compatibility with NRC 8469, (717) 787-3720; and Mary Lou Barton, Assistant radiation protection regulations. The revisions are requi-Counsel, Bureau of Regulatory Counsel, Rachel Carson site to the Commonwealth's attainment of Agreement State Office Building,9th Floor,400 Market Street, R O.
State status from the NRC. A description of the proposed Box 8464, Harrisburg, PA 17105-8464, (717) 787-7060.
amendments is provided as follows:
C. Statutory Authority Chapter 215, General Provisions These amendments are proposed und, r the authority of f 215.2. Definitions. The definitions of "A," "A."
i thi following statutes:
" misadministration," " prescribed dosage," " prescribed Sections 301 and 302 of the Radiaaon Protection Act dose," " radiological physicist" and " written directive" were (ret) (35 E S. $$ 7110.301 and 7110.302), which, respec.
deleted. The following definitions were updated to be tivily, direct the Department to develop and conduct compatible with the NRC: " member of the public,""NRC,"
]
comprehensive programs for the registration, licensing,
" occupational dose" and "public dose " A new definition for control, management, regulation and inspection of radia.
" reclaiming" was added.
tion sources and radiation source users, and delegates t
- 215.12. I ctions. The target inspection frequency ths Board the power to adopt the regulations of the for major meiiYal facilities was changed from every 2
- Dep:rtment of Environmental Protection (Department) to years to every 3 years.
impl; ment the act.
i Section 1920-A of The Administrative Code of 1929 (71 521522 hempt qualifications. The new Chapter 232
)
was added to the }ist of chapters.
R S. l 510-20), which authorizes and directs the Board to td:pt regulations necessary for the proper performance of Chapter 217. Licensing of Radioactive Material the work of the Department.
f 217.1 (purpose and scop 3) and 6 217.2 (address) were i
D. Background and Purpose updated to include the new Chapter 232 and the new In 1995, the Board updated its radiological health Department maliing address.
]
regulitions to provide for compatibility with other states 6 217.42(d) was amended by adding additional require-c.nd to serve as a basis for the Commonwealth to assume ments for general licenses.
authority from the United States Nuclear Regulatory C:mmission (NRC) for radioactive material licensees in 5 217.58 (financial assurance an'angeme,nts for re-cleanup money for certain h, ion which provides for site claiming sites) is a new sect this Commonwealth as an Agreement State. These up.
eensees and is compatible dates were published at 25 Pa. B. 5088 and 5200 (Novem.
ber 18,1995). Technological advances in the use of with the NRC regulation.
radioictive material and the need to establish and main-0 217.65 (specific licenses for the use of sealed sources tain r:diation protection standards at least as stringent in industrial radiography) was updated to be compatible as the NRC standards provide the basis for these revi-with the NRC regulations.
sions to the existmg radiological health regulations.
9 217.84 (licensing the manufacture and distribution of The proposed amendments are necessary for the Com-measuring, gauging or controlling devices) was amended m:nwealth to acquire Agreement State status from the to be compatible with the NRC regulations.'
NRC. Under section 201 of the act, the Governor of the Commonwealth is authorized to enter into agreements A new Appendix E (quantities for use with 6 217.58),
with the NRC transferrL.g regulatory authority to the and a new Appendix F (criteria relating to use of financial PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
s 882 PROPOF NLEMAKING tests and self guarantees of providing reasonable assur-6 224.60 (suppliers) was reworded to be compatible ance of funds for decommissioning) were added to support with the NRC regulations.
j the new 9 217.58.
Q 224.61(quality management program) was added for Chapter 219, Standards for Protection Against Radiation compatibility with the NRC regulations.
6 219.3 (definitions) was amended by adding a defini-9 224.101(bX3) (possession, use, calibration and check tion for, " constraint (dose constraint)."
of dose calibrators) was added for compatibility with the l
NRC regulations.
@ 219.21(a) (radiation protection programs) was amended to clarify the scope of the required radiation 6 224.103(1), (2), and (3Xiii) (measurement of pharma.
protection program.
ceutical dosages) was amended for cornpatibility with the i 219.21(f) was added for compatibility with the NRC NRC regulations.
requirement for a constraint on air emis< ions for radioac.
Q 224.104(1) (authorization for calibration and refer-tive material.
ence sources) was amended to include 25 millicuries each
@ 219.51(aX1) (dose limits for individual members of of acceleratbr produced material.
the public) was amended to be compatible with the NRC.
@ 224.108(e) (surveys for contamination and ambient 6 219.51(aX2) was deleted and 9 219.51(aX3) was re-radiation exposure rate) was amended for compatibility numbered as (2).
with the NRC regulations.
s 219.51(aX2). (2). The new 219.5i(a) was updated Q 224.109 (release of patients containing radiopharma-for compatibility with the NRC regulations.
ceuticals or permanent implants) was rewritten to be I
' $ 219.114 (further restrictions on the use of respiratory compatible with the NRC regulations.
protection equipment) was added for compatibility with
% 224.112 (decay-in-storage) was amended to allow the NRC.
sealed sources of accelerator produced radioactive mate-6 219.223(2Xvi) was added to the list of reports in rial with a physical half-life of up to 300 days to be held 6 219.223 (reports of exposures, radiation levels, and for decay m-storage.
concentrations of radioactive material exceeding the lim-6 224.113 (possession, use, calibration, and check of its). The phrase "ALARA constraints" was added t instruments to measure dosages of alpha or beta.
I 219.223(bXIXiv).
emitting radionuclides) was added for compatibility with Chapter 220. Notices, Instructions and Reports to Workers; NBC regulations.
I"8P'C#5 "8
(( 224.151,224.201, and 224.251 which involve the use 69 220.2 and 220.3 were updated for compatibility with of radiopharmaceuticals for diagnosis and therapy were the NRC.
amended for compatibility with NRC regulations. The radiopharmaceutical may be obtained from a licensed
@ 220.8 was updated to reflect the Department's name an authorized manufacturer, beensed preparer or from,s (,New Drug change.from Envirr6nmental Resources to Environmental nuclear pharmacist. References to NDA Protection.
Application") and IND's (" Notice of Claimed Investiga-Chapter 224. Medical Use of Radioactive Material tional Exemption for a New Drug") were deleted.
s 224.2 (definitions) was amendd by adding definitions 224.152 and 224.204 regarding the possession of for " authorized nuclear pharmacist," " diagnostic clinical survey instruments was updated for compatibility with procedures manual," " prescribed dosage," " prescribed NRC regulations.
(( 224.252, 224.253, 224.305, 224.306, 224.352, 24.406 tr ti of e ic e" was ded to d uma and 224.408 were updated for compatibility with the NRC research subjects under the supervision of an authorized user." The definition of " misadministration" was updated.
regulations, r" 224.6(2) (license amendments) and 224.7 (notifica-Subchapter,J (training and experience requirements) tio'ns) were amended by adding the phrase,"or authorized was amended in two main areas. First, additional certify-nuclear pharmacist" A new subsection (b) was added to ing bodies were added. They are: the American Board of 6 224.6 to be compatible with 10 CFR 35.15 (relating to Medical Phystes, the Royal College of Physicians and exeraptione regarding Type A specific licenses of broad Surgeons of Canada, Arnerican Osteopathic Board of Radiology, and the American Oste apathic Board of scops).
Nuclear Medicine. Also, 6 224.454(2XiiXF) was added for
{ 224.9 (specific exemptions) was amended by changing compatibility with the NRC regulations and 6 224.465 the name of the advisory committee from Advisory Com-(recentness of training) was amended for compatibility mittee on Medical Uses of Radioactive Material to Radia-with NRC regulations.
tion Protection Advisory Committee.
Second, two new sections, g 224.466 (training for an Q 224.10 (provisions for research involving human sub-
- authorized nuclear pharmacist) and g 224.467 (training jects) and Q 224.11 (FDA, other Federal, State require-for experienced nuclear pharmacists) were added for ments) were added for compatibility with the NRC regu-compatibility with the NRC regulations.
lations.
chapter K (enforcement) was deleted because it is 6 224.53(2Xii) (radiation safety committee) was ob u'
amended by adding the phrase "an authorized nuclear phz.rmacist."
Chapter 225. Radiation Safety Requirements for Indus-a ogmp e Opedons 6 224.55 (a) (supervision) was amended by adding two sections regarding the authorized use of radioactive mate-Chapter 225 was renamed " Radiation Safety Require-rial by auxiliary personal.
ments for Industrial Uses and Radiographic Operations."
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14,1998
PROPOSED RULEMAKING 883 a
6 225.1 (purpose and scope) was amended to include devices, locking and relocation of exposure devices, stor-industrial radiographic operations as well as traditional age precautions, leak testing of and replacement of sealed industrial radiography.
sources, physical inventories, inspection and maintenance
@ 225.2 (definitions) was amended by updating and f exposure devices, utilization logs, radiation surveys cdding some definitions. Updated definitions are: " cabinet and records, supervision of radiographer's assistants, and X-r y system," " radiographer," " radiographer's assistant, radiograpluc operations, security and posting.
cnd " temporary job site " New definitions are: " annual Chapter 226. Radiation Safety Requirements for Wireline J
refresher safety training," " associated equipment," "certi.
Service Operations and Subsurface I)acer Studies j
fying entity;" "collimator" " control cable," " control drive Chapter 226 was renamed " Radiation Safety Require-j tube (projection si eath),, device, m:chanism,, " crank-out exposure head, " guide ments for Well Logging."
l
" individual s certification," " lock-1 out survey"
- personal supervision" and
- radiographic op-5,226.1 (purpose and scope) was generally u,pdated and crations," "S-tube,"
- source assembly," " storage facility" revised to mclude persons using uraruum smker bars.
end " transport container."
$ 226.2 (definitions) was amended by revising, adding A new @ 225.10 (application for a specific license or and deleting some definitions. Definitions that were re-
)
registration) was added which requires a person using vised are: logging supervisor, personal supervision, radio-X riy machines for industrial radiography to get Depart.
active marker and well logging. New definitions em fresh ment approval before commencing operations.
water aqmfer, logging assistant, logging tool, sety re-ers,' temporary j. casing for protecting fresh water aqui-
- "" 8" The heading " Sealed Source Requirements," was de-
, obsite, uranium sinker bar and well.
lited and. General Provisions.,1,2 were brouE t under t.he QQ 225.11 and. 225.
h Deleted definitions are: mineral logging and wireline
- herding,
$ 225.11 (storage position service operation.
ridiitton level limits) was rewritten as " reciprocity" re-quirements. Section 225.12 (radiation source locks) was Other minor revisions were made to %g 226.3, 226.11 -
rewritten as a prohibition against using radiation sources 226.17, 226.19, 226.21 - 226.23, 226.31, 226.33 - 226.34, regulated by Chapter 225 for human use.
226.41--226.43 and 226.51 for compatibility with NRC Ngulation
$$ 225.13-225.18, 225.21-225.23, 225.31-225.33 and 225.41 - 225.44 were deleted because they were obsolete.
A new g 226.20, " radioactive markers and uranium sinker bars," is added for compatibility with the NRC The headm.g, " Precautionary Procedures,,, was replaced regulations' by " General Administrative Requirements." Section 225.51 was renamed as " Duties of Personnel." This new Appendix B, " Example of Plaque for Identifying Wells section describes the duties of the radiation safety officer, Containing Radioactive Material Abandoned Downhole,"
ridiographer, radiographer's assistant and radiography was deleted.
j trainee.
Chapter 230. Packaging of and 7>ansportation of Radioac.
l Ntw il 225.71 and 225.72 describe the training and tive Material te: ting requirements for radiographers and radiographer 9 230.2 (definitions) was amended by revising, adding,
)
assistants. A new $ 225.73 describes the required audits and deleting some definitions. Definitions that were re-I cnd safety reviews of radiographers and radiographer vised are: "A2," " exclusive use,"
- fissile material," " low assistants. A new 9 225.74 describes the reporting re-specific activity material" and " transport index." New 1
quirements, including those for incidents involving radio-definitions are: " containment system," " conveyance," " low gr:pluc equipment.
toxicity alpha emitters," " maximum nonnal operating A new heading, " General Technical Requirements," in.
pressure,"" natural thorium,"" surface contaminated object cludes requirements for certification of personnel, require.
(SCO)" and," uranium (natural, depleted, enriched)." De-I m:nts for an independent certifying organization, require, leted definitions a,re:" closed transport vehicle" and " fissile I
m:nt, for certification programs, requirements for written material package.
examinations, permanent radiographic installation, oper-6 230.12 and Appendix A were updated for compatibil-r< ting requirements, records required at temporary job ity with NRC regulations.
sites, and operating and emergency procedures. These
$$ 230.25 and 230.26 were deleted. Section 230.41 requirements are m $ 225.101-225.108 respectively.
(fissile material: assumptions as to unknown properties)
A new heading, " Radiation Survey Instrument and was deleted and replaced as the section for " applicability Pzrsonnel Monitoring," includes requirements for radia-of operating controls and procedures" for compatibility tion survey meters, radiation survey meter calibration, with NRC regulations.
4 personnel monitoring control and personal alarm rate A new Q' 230.48 (opening instructions) was added for meters. These requirements are in 96 225.151 - 225.154.
compatibility with NRC regulations.
ments,, m, heading, " Radiation Producing Machine Require-Tables I-IV were deleted and replaced with new Tables A new ejudes requirements for cabmet X-ray systems, shi;1ded room X-ray machine radiography, field site radt-A-1 and A-2 for compatibility with NRC regulations, ography, surveys ind survey records, utilization logs, Chapter 232. Licenses and Radiation Safety Requiremen, ts bomb detection and baggage X-ray systems and X-ray for 1rradiators i
calibration systems. These requirements are in Chapter 232 is a new chapter which is compatible with
$$ 225.201-225.207, 10 CFR Part 36, " Licenses and Radiation Safety Require.
The existing heading, " Sealed Source Requirements,"
ments for Irradiators."
containing 6 225.11 - 225.225.18 is replaced with a new Subchapter A (general provisions) contains the sections group of $9 225.251-225.261 which are compatible with for " purpose and scope" and " definitions."
the NRC radiography regulations. These sections melude requirements for performance of radiography equipment, Subchapter B (specific licensing requirements) contains limits on levels of radiation for radiog'aphic exposure requirements for addressing application for a specific PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14,1998
)
(
884 PROPOSED RULEMAKING license, specific licenses for irradiators, start of construc-period. The notification shall specify the regulatory re-tion, applications for exemptions and request for written view criteria which have not been met by that portion.
statements.
The Regulatog Review Act specifies detailed procedures f r review by the Department, the Governor and the Subchapter C (design and performance requirements General Assembly before final publication of the regula-for irradiators) contains requirements for addressing per-tions.
formance criteria for sealed sources, access control, shielding, fire protection, radiation monitors, control of I. Public Comments source movement, irradiator pools, source rack protection,
%'ritten Comments-Interested persons are invited to power failures, design requirements, and construction submit comments, suggestions or objections regarding the monitoring and acceptance testmg.
proposed amendments to the Environmental Quality Subchapter D (operation of irradiaton) contains re-Board, P. O. Box 8477 Harrisburg, PA. 17105-8477 (ex-quirementa for addressing training, operating and emer-press mail: Rachel Carson State Office Building,15th gency procedures, personnel monitoring, radiation sur-floor, 400 Market Street, Harrisburg, PA 17101-2301).
veys, detection of leaking sources, inspection and Comments submitted by facsimile will not be accepted.
maintenance, pool water purity, attendance during opera-Comments, suggestions or objections must be received by tion, entering and leaving the radiation room, and irra-the Board by April 15,1998 (within 60 days of publication diation of explosive or Dammable materials.
In the Pennsylvania Bulletin). Interested persons may also submit a summary of their comments to the Board.
Subchapter E (records) contains requirements for ad-The summary may not exceed one page in length and dressing records and retention periods, and reports.
must be received by April 8,1998 (within 60 days F. Benefits Costs and Compliance following publication in the Pennsylvania Bulletin). The Executive Order 1996-1 requires a cost / benefit analysis one-page summary will be provided to each member of of the ;roposed amendments.
the Board in the agenda packat distributed prior tn the-meeting at which the final-form regulation will be consid-Benefits e7,g.
l As set forth in this proposal, users of radioactive Electronic Comments-Comments may be submitted material will be required to comply with radiation protec-electronically to the Board at RegComments.dep. state.
tion standards that will not only protect employes but pa.us and must also be received by the Board by April 8 will also protect the general pubhe.
1998. A subject heading of the proposal and a returr!
l Compliance Costs name and address must be included in each transmission.
If an acknowledgment of electronic comments is not There are no compliance costs because the licensees are received by the sender within 2 working days, the currently complying with these proposed amendments by e mments should be retransmitted to ensure receipt.
1 virtue of their NRC licenses, JAMES M. SEIF, Compliance Assistance Plan Chairperson Compliance assistance is available to all existing hold-Fiscal Note: 7-335. No fiscal impact; (8) recommends I
ers of a license through the use of NRC gmdance which
- adoption, they use currently.
Annexa Paperwork Requirements TITLE 25. ENVIRONMENTAL PROTECTION The proposed amendments will not change paperwork PART L DEPARTMENT OF ENVIRONMENTAL requirements because the licensees are already complying PROTECTION '
with the identical NRC requirements.
O. Sunset Review Subpart D. ENVIRONMENTAL HEALTH AND SAFETY These amendments will be reviewed in accordance with ARTICLE V. RADIOLOGICAL HEALTH the sunset review schedule published by the Department to determine whether the amendments effectively fulfill CHAPTER 215. GENERAL PROVISIONS the goals for which they were intended.
GENERAL PROVISIONS J
H. Regulatory Review Act f
Under section 5(a) of the Regulatory Review Act (71.
I 215.2. Definitions
- P. S. 6 745.5(a)), on January 20, 1998, the Department submitted a copy of the proposed amendments to the The following words and terms, when used in thS,
Independent Regulatory Review Commission (IRRC) and article, have the following meanings, unless the context the Chairpersons of the Senate and House Environmental clearly indicates otherwise:
Resources and Energy Committees. In addition to submit-ting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a
[ A,-The maximum activity of special form radio-detailed Regulatory Analysis Form prepared by the De-active material permitted in a Type A package.]
panment. A co;f of this material is available to the public upon request.
[ A,-The maximum activity of radioactive mate-rial, ther than special form radioactive material, If the Committee have objections to any po" ion of the permitted in a Type A package. These values are pro sed amendments, they will notify the Department either listed in Chapter 230, Appendix A (relating to wi n 20 days uf the close of the pubhc comment period.
packaging and transportation of radioactive mate-If IRRC has any objections to any pcrtion of the rials), Table I, or may be derived in accordance proposed amendments, it vill notify the Department with the procedure prescribed in Chapter 230, Ap-within 10 days of the close of the Committees' comment pendix A. ]
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 885 (D) When the calculated administered dose lif-Member of the publie-An individual [in a controlled t
p do e er unrestricted area. An individual is not a member cf thi public during any period in which the]
(vi) A diagnostic radioplarmaceutical dosage, excipt when that individual [ receives ] is receiving other than quantities greater than 30 microcuries an occupational dose.
(1.11 MBq) of either sodium iodide I 125 or I.131, when the conditions in clauses (a) and.(b) apply:
(A) Involving the wrung patient, wrong
[Mi: administration-The administration to a hu.
radiopharmaceutical, wrong route of administra-man being of:
tion or when the administered dosage differt from the prescribed dosage.
(1) A radiopharmaceutical dosage greater than 30 microcuries (1.11 MBq) of either sodium iodide (B) When the dose to the patient exceeds 5 rem I.125 cr I 131 under one of the following conditions:
(50 mSv) effective dose equivalent or 50 rems (0.5 j
eq a n any in wgan.
(A) Involving the wrong patient or wrong phar-miciutical.
(vil) An X-ray therapy dose (with energies less an un e ne o e
owing conditions:
(B) When both the administered dosage differs from the prescribed dosage by more than 20% of the (A) Involving the wrong patient, wrong' mode of prescribed dosage and the difference between the treatment, wrong treatment site, wrong tube poten-c.dministered and prescribed dosage exceeds 30 tial or wrong filtration.
microcuries (1.11 MBq).
(B) When the treatment consists of three or fewer (ii) A therapeutic radiopharmaceutical dosage, fractions and the calculated total administered cthsr than sodium iodide I-125 or I-131 under one dose differs from the total prescribed dose by more cf the following conditions:
than 10% of the prescribed dose.
(A) Involving the wrong patient, wrong radiophar-(C) When the calculated weekly administered mac:utical, or wrong route of administration.
dose is 30% greater than the weekly prescribed dm.
(B) When. the administered dosage differs from tha prescribed dosage by more than 20% of the (D) When the calculated total administered dose prescribed dosage.
differs from the total prescribed dose by more than (iii) A gamma stereotactic radiosurgery radiation 20% of the total prescribed dose.
dosa under one of the following conditions:
(viii) A radiation therapy dose using X-rays or electron s with ene@ d 1 MeV and abe (A) Involving the wrong patient or wrong treat- -
under one of the following conditions:
m:nt cite.
(B) When the calculated total administered dose (A) Involving the wrong patient, wrong mode of treatment, wrong treatment site, wrong photon or diff:rs from the total prescribed dose by more than electron beam energy, wrong applicator or wrong 10% cf the total prescribed dose.
treatment geometry.
(iv) A teletherapy radiation dose under one of the (B) When the treatment consists of three or fewer -
f211 swing conditions:
fractions and the ' calculated total administered (A) Involving the wrong patient, wrong mode of dose differs from the total prescribed dose by more treitmsnt or wrong treatment site, than 10% of the total prescribed dose.
(B) When the treatment consists of three or fewer (C) When the calculated weekly administered fracti:ns and the calculated total administered dose is 30% greater than the weekly prescribed dose differs from the total prescribed dose by more dose.
th:n 10% of the total prescribed dose.
(D) When the calculated total administered dose (C) When the calculated weekly administered differs from the total prescribed dose by more than doss is 3% greater than the weekly prescribed 20% of the total prescribed dose.]
0**
(D) When the calculated totjal administered dose diff.rs from the total prescribed dose by more than NRC-United States Nuclear Regulatory Commission 20% cf the total prescribed dose. -
or its authorized representatives.
(v) A brachytherapy radiation dose under one of
~
the f2 flowing conditions:
Occupational dose-The dose received by an individual (A) Involving the wrong patient, wrong radioiso-in [ a restricted area or in ] the course of employment t:pe, er wrong treatment site-excluding, for per-in which the individual's assigned duties involve exposure manrnt implants, seeds that were implanted in the to sources of radiation, whether in the possession of the correct site but migrated outside the treatment site.
liennsee, registrant or another person. The term does not include dose received: from background radiation, as a (B) Involving a sealed source that is leaking.
patient from medical practices, from exposure to indi-i
- (C) When, for a temporary implant, one or more viduals administered radioactive material and re-J seiled sources are not rc
- noved upon completion of leased in accordance with 6 224.109 (relating' to the procedure.
release of patients containing radiopharmaceu-PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998' I
886 PROPOSED RULEMAK!NG ticals or permanent implants), from voluntary partici-that permits release of the property for unre-pation in medical research programs or as a member of stricted use and termination of the license),
the public.
[ Written directice-An order in writing for a
. [ Prescribed dosage-The quantity of radiopharma-specific patient, dated and signed by an authorized ceutical activity as documented in one of the fol-user prior to the administration of a lowing methods:
radiopharmaceutical or radiation, except as speci.
fled in subparagraph (vi), containing the following
~ (i) In a written directive.
information:
(11) Either in the diagnostic clinical procedures W Fw Mmuistration of quantities greater manual or in any appropriate record in accordance than 30 microcuries (1.11 MBq) of either sodium with the directions of the authorized user for diag-iodide I-125 or I 131: the dosage.
nostic procedures.
(ii) For a therapeutic administration of a Prescribed dose-One of the following:
radiopharmaceutical other than sodium iodide I.
(i) For gamma stereotactic radiosurgery, the total 125 or I-131: the radiopharmaceutical, dosage and dose as documented in the written directive.
route of administration; (ii) For teletherapy, Lray therapy, and electron (iii) For gamma stereotactic radiosurgery: target beam therapy, the total dose and dose per fraction coordinates, collimator size, plug pattern and total as documented in the written directive.
dose.
(iii) For brach' therapy, either the total source (iv) For teletherapy: the total dose, dose per frac-y strength and exposure time or the total doce, as tion, treatment site and overall treatment period.
3 documented in the written directive. ]
(v) For high dose rate remote afterloading Public dose-The dose received by a member of the brachytherapy: the radioisotope, treatment site and public from exposure to [ sources of radiation either total dose-within a licensee's or registrant's controlled area or (vi) For all other brachytherapy the following j
in unrestricted areas } radiation sources under the apply:
control of the licensee or registrant. The term does (1) Prior to implantation: the radioisotope; num.
not include occupational dose, dose received from back-ber of sources; source strengths; and number, type ground radiation, dose received as a patient from medical and size of applicator.
i practices, from exposure to individuals administered,
I radioactive material and released in accordance (2) After implantation but prior to completion of i
with 6 224.109, or dose trom voluntary participation in the procedure: the radioisotope; treatment site; and medical research programs total source strength and exposure time (or, equiva-lently, the total dose).
(vil) For Lray therapy at potentials less than 1
[RadioIogical physicisf-An individual who com-MeV: the total dose, dose per fraction, treatment plies with one of the following:
site, field ' size, tube potential and filtration and overall treatment period.
(1) Is certified by the American Board of Radiol-ogy in therapeutic radiological physics, radiological (viii) For X-ray and electron beam therapy at physics or x. and gamma ray physics, energies of 1 MeV and above: the total dose, dose Per fraction, treatment site, field size, beam type (ii) Has a bachelor's degree in one of the physical and enem, applicator, use of beam blocking or sciences or engineering and 3 years full-time expe-shaping devices, treatment geometry and overall rience working in therapeutic radiological physics treatment period.]
under the direction of a physicist certified by the American Board of Radiology. The work duties shall include duties involving the calibration and RIGHTS AND RESPONSIBILITIES OF THE spot checks of a medical accelerator or a DEPARTMENT teletherapy unit.
I 215.12. Inspec&ns.
(111) Has a master's or a doctor's degree in phys.
ics, biophysics, radiolegical physics, health physics or engineering; has had 1 year's full-time training (c) Inspections by the Department.
in therapeutic radiological physics; and has had 1 syear's full time work experience in a radiotherapy (1) The Department. Its employes and agents may facility where that person's duties involve calibra.
conduct inspections of the facilities of registrants of tion and spot checks of a medical accelerator or a radiation-producing machines and licensees of radioactive teletharapy vnit.].
material at the following frequencies:
(1) For major medical facilities, including hospitals, at least once every [ 2 ] 3 years.
Reclaiming-Returning property to a condition where the property no longer presents a public health or safety hazard or threat to the environ.
EXEMPTIONS ment. The term includes but is not limited to those activities necessary to decommission the licensed i 215.32. Exemption qualifications.
facility (that is, to remove the facility safely from The following sources, uses and types of users are service.and reduce residual radioactivity to a level exempt from Chapters 216-[ 230 ] 232:
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 887 (iii) For each individual that the licensoe permits CHAPTER 217. LICENSING OF RADIOACTIVE to use a portable device, the licensee shall maintain.
MATERIAL a record showing the type of device use permitted and the basis for that authorisation such as train.
Subchapter A. GENERAL ing certificates. An individual's record shall be kept i 217.1. Purpose and scope..
for at least 3, years after the individual terminates association with the licensee.
(iv) Portable devices shall be secured against (b) A licensee is subject to Chapters 215,219 and 220 access by unauthorized personnel when not under (ultting.to general provisions; standards for protection the direct surveillance of an indivianal authorized against radiation; and notices, instructions and reports to to use the device.
work:rs;-inspections). A licensee engaged in industrial rs.diographic operations is subject to Chapter 225 (relat-(v) The licensee shall maintain current logs, ing to radiation safety requirements for industrial radio-which shall be kept available for inspection by the hphic operations). A licensee using radioactive material Department for 3 years from the date of the event, y
human use is subject to Chapter 224 (relating to showing for each portable device the following midical use of radioactive material). A licensee using applicable information:
se: led sources in well logging is subject to Chapter 226 (A) The modeliand serial number of the device.
(reltting to radiation safety requirements for I wireline (B) The name of the assigned user, service operations and subsurface tracer studies ]
wall logging ). A licensee using irradiators is sub-(C) Locations and dates of use.
ject to Chapter 232 (relating to licenses and radia-(vi) Emergency instructions shall accompany ti:n safety requirements for irradiators),
each portable device taken off the premises of the
- licensee, i 217.2. Address.
An application for a license. license renewal and license SPECIFIC LICENSES-GENERAL CONDITIONS amendments and other communications under this chap-6 217.58. Financial assurance arrangements for re-ter shall be addressed to the Bureau of Radiation Protec-claiming sites, tion, Department of Environmental [ Resources] Pro-tectizn, Post Office Box [ 2063 ] 8469, Harrisburg, (a) Each applicant for a specific license authoris-lug the possession and use of unsealed radioactive Pennsylvania [ 17120 ] 17105-8489.
material of halflife greater that 120 days and in 8
Subchapter C. LICENSES quantities exceeding 10 times the applicable quan.
tities set forth in Appendix E -(relating to GENERAL LICENSES: MATERIAL OTHER THAN quantitites for use with 6 217.58) shall submit a SOURCE MATERIAL decommissioning funding plan as described in sub-0 217.42. Certain measuring, gauging or controlling section (e). The decommissioning funding plan shall devices.
also be submitted when a combination of isotopes le 5
involved if R divided by 10 is greater than 1 (unity rule), where R is defined here as the sum of the (d) A person who owns, receives, acquires, possesses, ratios of the quantity of each isotope to the appli-uses or transfers radioactive material in a device under cable value in Appendix E.
thi grneral license in subsection (a):
b Each applicant for a specific license authoria-
'n(g ) possession and use of radioactive material of i
(10) Shall conduct a physical inventory every 6 half. life greater than 120 days and in quantitles m nths to account for all sources or devices, or specified in subsection (d) shall do one of the both, received and possessed under subsection (a) following-*
and do the following:
(1) Submit a decommissioning funding plan.
(1) Maintain the physical inventory records for 3 (2) Submit a certification that financial assur-years from the date of each inventory.
ance for decommissioning has been provided in the (ii) Furnish a report to the Department annually am unt prescribed by subsection (d) using one of sh: wing to the extent practical, the make, model, the methods described in subsection (f). For an serial number, footope, source activity and location applicant, this certification,,may state that the ap-of each device. The report shall list an individual to propriate assurance shall be obtained after the coltact regarding questions about this report.
application has been approved and the license.
Issued bat before the receipt oflicensed material If (11) For portable devices, shall also comply with the applicant defers execution of the financial in-tha f411owing:
strument until after the license has been issued, a (1) A person who initiates acquisition of a por.
signed original of the financial instrument obtained t satisfy the requirement of subsection (f) shall be tabla device and does not already hold a license und:r subsection (a) shall notify the Department submitted to the Department before receipt of 11-within 15 days of their action.
censed material. If the applicant does not defer execution of the financial instrument, the applicant (11) Portable devices may only be used by or shall submit to the Department, as part of the undir the direct su rvision of individuals who certification, a signed original of the financial in-hsve been instrue in the operating and emer-strument obtained to satisfy the requirements of gency procedures necessary for ensuring safe use.
subsection (f).
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
888 PROPOSED RULEMAKING (c) Each holder of a specific license shall do one sioning and a signed original of the financial in-of the following:
strument obtained to satisfy the requirement of subsection (f).
"(1) If the license was issued on or after (Editor's Note: The blank refers to the effec.
(f) Financial assurance for decommission. ' g shall tive date of adoption of this proposal), which is of a be provided by one or more of the following meth-type described in subsection (a) or (b), the licensee ods:
shall provide financial assurance for decommission.
(1) Prepoyment. Prepayment is the denosit prior lag in accordance with the criteria set forth in this to the start of operation into an account segregated section.
from licensee assets and outside the licensee's ad.
(2) If the license was issued before (Edi-ministrative control of cash or liquid assets so that for's Note: The blank refers to the effective date of the amount of funds would be sufficient to pay adoption of this proposal) and of a type described decommissioning costs. Prepayment may be in the in subsection (a), the licensee shall submit, on or form of a trust, escrow account, government fund, before (Editor's Note: The blank refers to a certificate of deposit or d it of government date 1 year after the effective date of adoption of securities in a form approv by the Department.
this proposal) a decommissioning funding plan as (2) A surety method. A surety method, insurance described in subsection (e) or a1 certification of or other guarantee method. These methods guaran-fim.ncial assurance for decommissioning in an tee that decommissioning costs will be paid. A amount at least equal to $750,000 in accordance surety method may be in the form of a surety bond, with the criteria set forth in this section. If the letter of credit or line of credit. A parent company licensee submits the certification of financial assur-guarantee of funds for decommissioning costs ance rather than a decommissionine funding ple-based on a financial test may be used if the guaran-the licensee shall include a deconusissios.; innd-tee and test are as contained in Appendix F (relat-ing plan in an application for license renewal.
ing to criteria relating to use of omcial tests and j
self guarantees of providing reasonable assurance
', (3) If a specific license was issued before (Editor's Note: The blank refers to the effec' of funds for decommissioning). A parent company guarantee may not be.used in combination with
)
tive date of the adoption of this proposal), and of 8 other financial methods to satisfy the requirements type described in subsection (b) the licensee shall of this section. A guarantee of funds by the appil.
- submit, on or before (Editor's Note: The blank refers to a date 1 year after cant or licensee for decommlaaloring costs based of adoption of this proposal), a the effective date on a financial test may be used if th guarantee and decommissioning test are as contained in Appendix V A guarantee by funding plan as described in subsection (e), or a the applicant or licensee may not be used in combi-certification of financial assurance for decommis-sioning in accordrace with the criteria set forth in nation with any other financial methods to satisfy this section*
the requirements of this section or in any situation
. where the applicant or licensee has a parent com-(d) If the required amounts of financial assur-pany holding majority control of the voting stock of ance for decommissioning by quantity of material the company. Any surety method or insurance used g.
to provide financial assurance for decommissioning shall contain the following conditions:
4 (1) Greater than 10 but less than or equal to 10 times the applicable quantities of A pendix E in (i) The surety method or insurance shall be open-unsealed form (for a combination of ectopes, if R, ended or, if written for a specified term, such as 5 as defined in subsection (a), divided by 10 is years, shall be renewed automatically unless 90 4
greater than I but R divided by 10 is less than or days or more prior to the renewal date, the issuer 8
equal to 1), the required amount is $ 750,000, notifies the Department, the beneficiary and the licensee of its intention not to renew. The surety 8
4 method or insurance shall also provide that the full (2) Greater than 10 but less than or equal to 10 times the applicable quantities of Appendix E in face amount be automatically paid to the beneft.
un=== led foem (for a combination of Isotopes, if R, ciary prior to the expiration without proof of forfel-as defined in subsection (a), divided by 108 is ture if the licensee fails to provide a replacement greater than 1 but R divided by 104 is less than or acce table to the Department within 30 days after equal to 1), the required amount is $150,000.
rece pt of notification of cancellation.
(3) Greater than 10 ' times the applicable quanti.
(11) The surety method or insurance shall be pay-2 ties of Appendix E in sealed sources or plated foi!s able to a trust established for decommissioning (For a combination of isotopes, if R, as defined in costs. The trustee and trust shall be acceptable to subsection (a),- divided by 10 ' is greater than 1),
the Departraent. An acceptable trustee includes an 2
the required amount is $75,000.
- ppropriate State or Federal government agency or an entity which has the authority to act as a (e) Each decommissioning funding plan shall con-trustee and whose trust operations are regulated tain a cost estimate-for decommissioning and a and examined by a Federal or State agency.
description of the method of assuring funds for (iii) The suret method or insurance shall remain decommissioning from subsection (f), including in effect until the Department has terminated the means for adjusting cost estimates and associated g g **"**
- funding levels periodically over the life of the facility. The comml==ioning funding plan shall also (3) An external sinking fhnd. An external sinking contain a certification by the licensee that financial fund in which deposits are made at least annually, assurance for decommissioning has been provided coupled with a surety method or insurance, the in the amount of the cost estimate for decommis-value of which may decrease by the amount being PENNSYLVANIA BULLETIN, VOL. 28, No. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 889 cecumulated in the sinking fund. An external sink-tive material having only half-lives of less than 65 ing fund is a fund established and maintained by days, a list contained in a single document and f
setting aside funds periodically in an account'seg-updated every 2 years, of the following:
r:gited from licensee assets and outside the licens.
(i) All areas designated and formerly desigsated se's cdministrative control in which the total restricted areas as defined in i 215.2 (relating to amsunt of funds would be sufficient to pay decom*
definitions)*
missi:ning costs at the time termination of opera.
ti n is expected. An external sinking fund may be (ii) All areas outside of restricted areas that re-in tha form of a trust, escrow account, government quire documentation under paragraph (1).
fund, certificate of deposit or deposit of govern-(iii) All areas outside of res+ricted areas where
(
m:nt securities in a format approved by the De-current and previous wastes have been buried as I
artment. The surety or insurance provision shall documented under i 219.209 (relating to records of cs stated in subsection (f)(2).
waste disposal).
(4) Statement of intent. In the case of Federal, (iv) All areas outside of restricted areas which l
Stata or local government licensees, a statement of contain material such that, if the license expired, intent containing a cost estimate for decommission-the licensee would be required to either decontami-
)
ing er an amount based on subsection (d), and nate the area to unrestricted release levels or apply j
1:diciting that funds for decommissioning will be for approval for disposal under i 219.182 (relating cbtained when necessary.
to method of obtaining approval of proposed dis-posal procedures).
{
(5) Alternate financial assurance arrangements.
Alternate financial assurance arrangements not (4) Records of the cost estimate performed for the i
lhted in this section may be accepted by the De-decommissioning funding plan or of the amount partment, provided the alternate arrangements are certified for decommissioning, and records of funde submitted to the Department in writing and ap-ing method used for assuring funds if either a preval for the alternate arrangement is granted by funding plan or certification is used, j
th3 Department in writing.
(h) the following specific licensees are required j
(g) Each person licensed under this article shall to make financial surety arrange nents:
keep records of information important to the de-(1) Major processors.
)
commissioning of a facility in an identified location until the site is released for unrestricted use. Be.
(2) Waste handling licensees.
fire licensed activities are transferred or assigned (3) Former United States Atomic Energy Commis-in cecordance with il 217.51-217.57 (relating to sion or NRC licensed facilities, epecific licenses-general conditions), licensees (4) All others except persons exempt under sub-ch:ll transfer all records described in this subsec-sectgon (g).
tien to the new licensee. In this case, the new licensee will be responsible for maintaining these (i) The following persons are exempt from the ree:rds until the license is terminated. If records requirements of subsection (a):
important to the decommissioning of a facility are (1) Persons authorized to possess no more than k:pt for other purposes, reference to these records 1,000 times the quantity specified in Appendix B and their locations may be used. Information the (relating to exempt quantities).
Dep:rtment considers important to decommission-ing consists of:
(2) Persons authorized to possess radioactive noble gasses in sealed sources with no radioactive (1) Records of spills or other unusual occurrences daughter product 'with half-live greater than 30 inv:lving the spread of contamination in and days.
creund the facility, equipment or site. These records may be limited to instances when contami.
I 217.65. Specific licenses for the use of sealed niti:n remains afte'r any cleanup procedures or sources in industrial radiography.
wh:n there is reasonable likelihood that contami-In addition to the requirements of 6 217.52 (relating to ntnts n'ay have spread to inaccessible areas as in general requirements for the issuance of specific licenses),
the case of possible seepage into porous materials a specific license for use of sealed sources in industrial such as concrete. These records shall include any radiography will be issued if:
9 kn2wn information on identification of involved (1) The apph.eant has an adequate program for traimng nuclides, forms and concentrations.
radiographers and radiographer's assistants and submits
- 12) As-built drawings and modifications of struc-to the Department a schedule or description of the tures and equipment in restricted areas where program which specifies the following:
radi: active materials are used or stored, or both, (i) Initial trauung.
1
. and cf locations of possible inaccessible contamina-ti:n such as buried pipes which may be subject to (a) After May 28, 1999, an applicant need not c:ntamination. If required drawings are refer-describe its initial training and examination pro-enced, each relevant document need not be indexed gram for radiographers in the subjects outlined in individually. If drawings are not available, the 11-Appendix A, Chapter 225 (relating to radiation c nsee shall substitute appropriate records of avail-safety requirements for industrial uses and radio-'
chla information concerning these areas and loca-graphic operations).
ti:ns.
(b),From.
(Editor's Note: The blank refers to
. (3) Except for areas containing only sealed the effective date of adoption of this proposal) to sources (provided the sources have not leaked or May 28,1999, an applicant may affirm that all co contamination remains after a leak) or radioac-individuals acting.as industrial radiographers will PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
890 PROPOSED RULEMAKING be certified in radiation safety by a certifying testing, operating and safety instructions and potential entity before commencing duty as radiographers.
hazards of the device to provide reasonable assurance This affirmation substitutes for a description of its that:
initial training and examination program for radiographers in the subjects outlined in Appendix A, Chapter 225 (relating to radiation safety require.
.(ii) Under ordinary conditions of handling, storage and ments for industrial uses and radiographic opera-use of the device, the radioactive material contained in tions).
the device will not be released or inadvertently removed from the device, and it is unlikely that a person will receive in a period of [ one calendar quarter] 1 year (vi) The procedures for verifying and document.
[ a dose in excess of 10% of the limits specified in ing the certification status of radiographers and for ensuring that the certification of individuals acting the table in i 219.11(a) (Reserved)] a dose in excess as radiographers remains valid.
of 10% of the annual. limits specified in-6 219.31 (relating to occupational dose limits f<.
adults).
(vil) The inspections of the job performance of each radiographer and radiographer's a@ ant at Intervals not to exceed 6 months, as dem ed in (Editor's Note: Appendices E and F are proposed to be i 225.73 (relating to audits and safety re Aws of added. They are printed ~ regular type to enhance radiographers and radiographers' assistants).
readability).
gg APPENDIX E (5) The applicant who desires to conduct the re uired leek tests of sealed sources or of exposure devices QUANTITIES FOR USE WITH 6 217.58 i
containing depleted uranium personally has estab-Afaterial Microcuries lished adequate procedures to be followed in testing 7 merican -241
.01 A
sealed sources for possible leakage and contamination and submits to the Department a description of the Antimony-122 100 procedures to be used including the following:
Antimony 124 10 Antimony-125 10 Arsenic-73 100 l
(8) The applicant identifies and lists the qualifi.
Arsenic-74 10 cations of the individual designated as the radia.
Arsenic.76 10 tion safety officer under 6 225.51(a) (relating to Arsenic-77 100 radiation safety officer for industrial radiography)
Barium-131 10 and potential designees responsible for ensuring Barium-133 10 that the applicant's radiation safety program is Barium-140 10 implemented in accordance with approved proce.
Bismuth-210 1
dures.
Bromine-82 10 (9) If the applicant intends to perform "in house" m
calibrations of survey instruments, the description Cadmium 115 -
100 of the methods to be used and the relevant experi-Calcium-45 10 ence of the individual who will perform the calibra-Calcium-47 10 tions. Calibrations shall be performed according to Ca-bon-14 100 the procedures described and at the frequency Cerium 141 100 described in i 225.152 (relating to radiation survey Cerium 143 100 meter calibration requirements).
Cerium 144 1
(10) The applicant identifies and describes the Cesium 131 1,000 i
locations of all field stations and permanent radio.
Cesium 134m 100 l
graphic installations.
Cesium-134 1
(11) The applicant identifies the locations where Ces}um-135 10 Cestum-136 10 all records required by this article and Chapter 225 Cesmm M 10 i
(relating to radiation safety requirements for in.
dustrial uses and radiographic operations) will be
{$
(
m nta ud.
Chromium 41 1,000 l
5 217.84. Licensing the manufacture and distribu-Cobalt-58ra 10 j
tion of measuring, gauging or controlling devices.
Cobalt-58 10 Cobalt-60 1
(a) An application for a specific license to manufacture or distribute devices containing radioactive material, ex-Copper-64 100 cluding special nuclear material, to persons generally Dysprostum 165 10 j
licensed under 6 '217.42 (relating to certain measuring, Dysprostum 166 100 j
Erbium 169 100 4
gauging or controlling devices) or equivalent regulations Erbium-lil 100 of the NRC, an agreement state or a licensing state will be approved if:
Europium-152 9.2h 100 Europtum-15213 yr 1
Europium-154 1.*
(2) The applicant submits sufficient information relat-Europium-155 10 Fluorme-18 1,000 ing to the design, manufacture, prototype testing, quality Gadohnium-153 10 control, labels, proposed uses, installation, servicing, leak PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 891 Material Microcuries biaterial Microcuries Gadolinium-159 100 Rubidium-87 10 Gallium 72 10 jRubidium-97 100 Germanium-71 100 r Ruthenium-103 10 Gold-198 100 Ruthenium-105 10 Gold 199 100 Ruthenium-106 1
Hafnium 181 10 Samarium-151 10 Holmium-166 100 Samarium 153 100 Hydrogen-3 1,000 Scandium-46 10 Indium 113m 100 Scandium-47 100 Indium-114m 10 Scandium-48 10 Indium-115m 100 Selenium-75 10 Indium-115 10 Silicon 31 100 Iodine 125 1
Silver-106 10 Iodine-126 1
Silver-110m 1
Iodine-129 0.1 j Silver-111 -
111 lodina-131 1
' Sodium-24 10 Iodine 132 10 Strontium-85 10 Iodine-133 1
Strontium-89 1
Iodine-134 10 Strontium-90 0.1 Iodine-135 10 Strontium-91 10 Iridium-192 10 Strontium-92 10 Iridium 194 100 Sulphur-35 100 Iron-55 100 Tantalum-182 10 Iron-59 10 Technetium-96 10 Krypton-85 100 Technetium-97m 100 Krypton-87 10 Technetium-97 100 Lanthanum-140 10 Technetium-99m 100 Lutetium-177 100 Technetium-99 10 Mangsnese-52 10 Tellurium 125m 10 Manganese-54 10 Tellurium-127m 10 Manganese-56 10 Tellurium-127 100 Mercury-197m 100 Tellurium-129m 10 Mercury-197 100 Tellurium 129 100 Mercury-203 10 Tellurium-131m 10 Molybdenum-99 100 Tellurium-132 10 Neodymium-147 100 Terbium 160 10 Neodymium 149 100 Thallium-200 100
/ Nickel-50 100 Thallium-201 100 Nickel-63 10 Thallium-202 100 Nickel-65 100 Thallium 204 10 Niobium 93m 10 Thorium (natural)1 100 Niobium-95 10 Thulium-170 10 Niobium-97 10 Thulium 171 10 Osmium 185 10 Tin-113 10 Osmium 191m 100 Tin-125 10 Osmium 191 100 Tungsten-181 10 Osmium-193
~
100 Tungsten-185 10 7 alladium 106 100 Tungsten-187 100 P
f alladium-108 100 Uranium (natural) 8 100 P
Phosphorus-33 10 Uranium-233
.01 Platinum-191 100 Uranium-234 and Uranium
.01 Platinum-193m 100 235 Platinum-193 100 Vanadium-48 10 Platinum-197m 100 Xenon-131m 1,000 Platinum-197 100 Xerion-133 100 Plutonium-239
.01 Xenon-135 100 Polonium-210 0.1 Yttrium-175 100 Potassium-42 10 Yttrium-90 10 Praseodymium-142 100 Yttrium-91 10 Praseodymium-143 10 Yttrium-92 100 Promethium 147 10 Yttrium'-93 100 Promethium-149 10 Zine-65 10 g/ adium-236 R
.01 Zine-69m 100 henium-136 100 Zinc-69 1,000 Rhenium-138 100 Zirconium 93 10
/ Rhodium-103m 100 Zirconium-95 10 Rhodium-106 100 Zirconium-97 10
/ ubidium-66 10 R
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
I i
892.
PROPOSED RULEMAKING Material.
Microcuries
' (2) The company's independent certified public accoun-tant must have compared the data used by the company Any alpha emitting 0.01 in the financial test which is derived from the indepen-radionuclide not listed dently audited, yearend financial statements for the dove or mixtures of alpha latest fiscal year, with the amounts in the financial cmitters of unknown statement, in connection with that procedure. The licen-composition.
Any radionuclide other that 0.1 see shall inform the Department within 90 days of any alpha emitting matters coming to the attention of the auditor that cause 0nu s,
d the auditor to believe that. the data specified in d e
, 9y ta financial test should be adjusted and that the company no smitte.rs of unknown 1 nger passes the test.
composition.
o*
(3) After the initial financial test, the company must (1) Basedhalpha disintegration rate of TH-232, TH-repeat passage of the test within 90 days after the close S
of each succeeding fiscal year.
230 and thelidayghter products.
(2) BasedMalpha disintegration rate of U.233, U-234
- c. If the licensee no longer, meets the requirements of and U-235' v Section II, A, of this Appendix, the licensee shall send immediate notice to the Department of its intent to Note-For purposes of g 217.58(a) (relating to finan-establish alternate financial assurance as specified in the cial assurance arrangements for reclaiming sites), where Department's regulations within 120 days of such notice.
there is involved a combination of isotopes in known amounts, the limit for the combination should be derived III. Company Self Guarantee.
as follows: Deterinine, for each isotope in the combina-
~
tion, the ratio between the quantity present in the The terms of a self-guarantee which an applicant or combination and the limit otherwise established for the licensee furnishes shall provide that:
specific isotope when not in combination. The sum of the ritios for all the isotopes in the combination equals *R."
- a. The guarantee will remain in force unless the APPENDDC F licensee sends notice of cancellation by certified mail to the Department. Cancellation may not occur, however, CRITERIA RELATING TO USE OF FINANCIAL during the 120 days beginning on the date of receipt of TESTS AND SELF GUARANTEES OF PROVIDING REASONABLE ASSURANCE OF FUNDS FOR the notice of cancellation by the Department, as evi-DECOMMISSIONING denced by return rer L Introduction,
- b. The licensee shall provide alternative financial as-An applicant or h.eensee may provide reasonable assur-surance as specified in the Depadment's regulations sace of the availability of funds for decommissiomng within 90 days following receipt by the Department of a based on furnishing its own guarantee that funds will be notice of cancellation of the guarantee.
available for decommissioning costs and on a demonstra-tion that the company passes the financial test of Section
- c. The guarantee and financial test provisions shall 11 of this Appendix,. The terms of the self-guarantee are remain in effect until the Department has terminated the in Section III of this Appendix. This A pendix establishes license or util another financial as assurance method criteria for passing the financial test for the self guaran-acceptable to the. Department has been put in effect by tee and establishes the terms for a self-guarantee.
the licenseo.
IL Finanetal Test.
D. The ll:ensee will promptly forward to the Depart-A. To pass the financial test, a company must meet all ment and be licensee's independent auditor all reports of the following criteria:
covering tL latest fiscal year filed by the licensee with
}
the Securides and Exchange Commission under the re-
- 1. Tangible net worth at least 10 times the total current decommissioning cost estunate (or the current quirement of section 13 of the Securities and Exchange Act of 193 6' amount required if certification is used) for all decommis-sioning activities for which the company is responsible as E. If, at any time, the licensee's most recent bond self. guaranteeing licercee and as parent-guarantor.
issuance : eases to be rated in any category of"A" or above
- 2. Assets located in the United States amounting to at by either Standard and Poors or Moodys, the licensee will 1:ast 90% of total assets or least 10 times the total provided notice in. writing of that fact to the Department current decommissioning cost estimate (for the current with 20 days after publication of the change by the rating amount required if certification is used) for all decommis-services. If the licensee's most recent bond issuance i
sioning activities for which the company is responsible as ceases to be rated in any category of A or above by both
(
self.guaranteemg licensee and as parent-guarantor.
Standard and Poors and Moody's the licensee no longer
- 3. A current rating for its most recent bond issuance of meets the requirements of Section II, A, of this Appendix.
AAA, AA or A as issued by Standard and Poors (S&P), or l
AAA, AA or A as issued by Moody's.
F. The apph.eant or licensee must provide to'the De B. To pass the financial test, a company must meet all partment a written guarantee (a written commitment by of the followmg additional requirements:
a corporate officer) which states that the licensee will fund and carry out the required decommissioning activi-(1) The company must have at least one class of equity ties or, upon issuance of an order by the Department, the securities registered under the Securities Exchange Act of licensee will set up and fund a trust in the amount of the 1934.
current cost estimates for decommissioning.
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998 l
PROPOSED RULEMAKING 893 CHAPTER 219. STANDARDS FOR PROTECTION from exposure to radiation from diagnostic radia-AGAINST RADIATION tion machines does not exceed 5 mSv (0.5 rem).]
Subchapter A. GENERAL PROVISIONS
[(3)] (2) The dose in any unrestricted area from ex-6 219.3. Definitions.
ternal sources exclusive of the dose contributions from patients administered radioactive material chapter, have the followm,and terms, when used in this The following words and released in accordance with 6 224.109,(relating g meanmgs, unless the context to release of patients containing radiopharma-cl:arly indicates otherwise:
ceuticals or permanent implants) does not exceed 0.02 mSv (0.002 rem) in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />, if an individual were continuously present in the area.
Constraint (dose' constraint)-A value above which specified licensee actions are required.
Subchapter H. RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURE Subchapter B. RADIATION PROTECTION IN RESTRICTED AREAS PROGRAMS i 219.114. Further restrictions on the use of respi-i 219.21. Radiation protection programs.
ratory protection equipment.
(a) The licensee or registrant shall develop, document The Department may impose restrictions in addi-and implement a radiation pmtection program commen.
tion to those in il 219.112 and 219.113 (relating to curate with the scope and extent of the licensee's or use of other controls; and use of individual respira-registrant's activities and sufficient to ensure compli.
tory equipment) and Appendix A to:
r.nce with this chapter.
(1) Ensure the respiratory protection program of the licensee is adequate to limit exposures of indi-viduals to airborne radioactive material.
(f) To implement the ALARA requirements of sub-(2) Limit the extent to which a lic,nsee may use section (b) and notwithstanding the requirements respiratory protection equipment i itead of pro-in i 219.51 (relatin to dose limits for individual m:mbers of the puglic), a constraint on air emis-cess or other engineering controls.
si:ns of radioactive material to the environment, Subchapter M. REPOi excluding Radon-222 and its daughters, shall be i 219.223. Reports of exposures, radiation levels established by licensees so that the individual and concentrations of radioactive material ex-
. mzmber of the public likely to receive the highest ceeding the limits.
dose will not be expected to receive a total effective
' dose equivalent in excess of 10 mrem (0.1 mSv) per (a) Reportable events. In addition to the notification year from these emissions. If a licensee subject to required by i 219.222 (relating to notification of inci-this requirement exceeds this dose constraint, the dents), each licensee or registrant shall submit a written licensee shall report the exceedence as provided in report within 30 days after learning of one or more of the i 219.223 (relating to reports of exposures, radia, followmg occurrences:
tiin levels and concentrations of radioactive mate-rial exceeding the limits) and promptly take ap ro.
(2) Doses in excess of one or more of the following:
pri:te corrective action to ensure aga not recurrence.
Subchapter D. RADIATION DOSE LIMITS FOR (vi) The ALARA constraints for air emissions es.
INDIVIDUAL MEMBERS OF THE PUBLIC tablished under i 219.21(0 (relating to radiation protection programs).
i 219.51. Dose limits for individual members of the public.
(b) Contents bpods.
(a) The licensee or registrant shall conduct operations so that the following conditions are met:
(1) Each report required by subsection (a) shsll de-scribe the extent of exposure of individuals to radiation (1) [ Except as provided in paragraph (2), the]
and radioactive material, including, as appropriate:
Tha total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of (iv) Corrective steps taken or planned to ensure the dose [ contribution ] contributions from back-against a recurrence, including the schedule for achieving ground radiation, from any medical administration conformance with applicable limits, ALARA constraints, thi individual has received, from exposure to indi-generally applicabl,e environmental standards, and associ.
viduals administered radioactive material and re.
ated heense or registration conditions.
leased in accordance with 6 224.109 (relating to CHAPTER 220. NOTICES, INSTRUCTIONS AND rel:ase of-patients containing radiopharmaceu-REPORTS TO WORKERS; INSPECTIONS ticals or permanent implants), from voluntary par-ticipation in medical research programs and from i 220.2. Posting of notices to workers.
the licensee's or registrant's disposal of radioactive mate-rial into sanitary sewerage in accordance with 9 219.183 (relating to disposal by release into sanitary sewerage).
(d) Department documents posted under subsection (aX4) shall be posted within [5] 2 working days after
. [(2) The total effective dose equivalent to indi-receipt of the documents from. the Department; the vidual members of the public in unrestricted areas licensee's or registrant's response shr.ll be posted within 5 i
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
894 PROPOSED RULEMAKING working days after dispatch from the licensee or regis-tions-by which the licensee performs clinical diag-trant. The documents shall remain posted for a minimum nostic procedures; where each diagnostic clinical
- of 5 working days or until action correcting the violation procedure has been approved by the authorized has been completed, whichever is later, user and includes the radiopharmaceutical dosage and route of administration.
i 220.3. Instructions to workers.
(a)' An individual [ working in or frequenting a
. #'M ""-I". the practice of medicine, the inten-tional admirustration (external or internal) of radioactive portion of a restricted area] who is. likely to material, or the radiation therefrom, to. human beings or receive in a year an occupational dose in excess of human research subjects under the supervision of 100 mrem (I mSv) shall be:
an authorized user.
(1) Informed of the storage, transfer or use of radiation j
sources [in the portion of the restricted area ].
g gg gg,gg following:
(b) The extent of the instruction shall be commensu-
[(i) A radiopharmaceutl' cal or radiation from a rate with potential radiological health protection prob-radiation source other than the one intended or lems in the [ restricted area ] work place.
prescribed.
i 5 220 8. Inspections not warranted; informal re-(ii) A radiopharvnaceutical or radiation therapy view.
to a wrong patient.
(a) If the Bureau of Radiation Pmtection determines (iii) A radio harmaceutical or radiation by a
]
that an inspectionis not warranted for a complaint made route of admin stration other than that intended by under 6 220.7 (relating to requests by workers for inspec-tions) because there are no reasonable grounds to beheve the prescribing physician or radiation therapy to an organ other than that prescribed by the physi-
~
that a violation exists or has occurred, the Bureau of clan.
Radiation Protection will notify the complainant in writ-ing of the determination. The complainant may obtain (iv) A dlagnostie dosage cia radiopharmaceutical review of the determination by submitting a written differing from the prescrbe dosage by more tLan statement of position to the Office of the Secretary, 50 %
Department of Environmental [ Resources] Protec-(v) A therapy dosage of a radiopharmaceutical tion. The Department will provide the licensee or regis-differing from the prescribed dosage by more than trant with a copy of the statement by certified mail, 10 %
he c p t c lai L
lice ee or eg stmnt ma bm t (vi) A therapy radiation dose from a radiation an opposing written statement of position with the De.
source such that errors in the source calibration, partment which will provide the complainant with a copy time of exposure and treatment geometry result in of the statement by certified mail.
a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 %
CHAPTER 224. MEDICAL USE OF RADIOACTIVE MATERIAL (vil) Radbactive material not speelfically autho.
rized for humos use, or medical irradiation by Subchapter A. GENERAL sources whose ch =ncteristics do not meet estab-6 224.2. Definitions.
11shed criteria for that type of radiation source.]
The following words and terms, when used in this (i) A radiopharmaceutical dosage greater than 30 chapter, have the following meanings, unless the context pCi (1.11 MBq) of either sodium iodide I-125 or I-131 clearly indicates otherwise:
under one of the following conditions:
j (A) Involving the wrong individual or wrong j
Authorized nuclear pharmacist-A pharmacist pharmaceutical.
f who meets one of the following requirements:
(B) When both the administered dosage differs (i) Is board certified as a nuclerr phannacist by from the prescribed dosage by more than 20% of the the Board of Pharmaceutical Specialties.
prescribed dosage and t,he difference between the (ii) Is identified as an authorized nuclear phar-administered and prescribed dosage exceeds 30 pCi (1.11 MBq).
I macist on a Department, NRC or agreement state license that authorizes the use of radioactive mate.
(ii) A therapeutic radiopharmacauHeal dosage, j
rial in th~e practice of nuclear pharmacy.
Other than sodium iodide I 125 or 1131 under one of the following conditions:
_i (iii) Is identified as an authorized nuclear phar-macist on a permit issued by the Department, NRC (A) Involving the wrong individual, wrong or agreement state specific license of broad scope radiopharmaceutical or wrong route of administra.
that is authorized to permit the use of radioactive tion.
j material in the practice of nuclear pharmacy.
(B) When the administered dosage differs from the prescribed dosage by more than 20% of the Iliagnostic clinical procedures manual-A collec-prescribed dosage.
tion of written procedures that describes each (iii) A gamma stereotactic radiosurgery radiation 1
method-and other instructions and precau-dose under one of the following conditions:
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998 a
i PROPOSED RULEMAKING 895
. (A) Involving the wrong individual or wrong tement she.
Recordable event-The administration of:
(B) When the calculated total administered dose diff;rs from the total prescribed dose by more than (i) A radiopharmaceutical or radiation without a 10% cf the total prescribed dose.
written directive when a written directive is re-quired.
(iv) A teletherapy radiation dose under one of the fillrwing conditions:
(ii) A radiopharmaceutical or radiation when a (A) Involving the wrong individual, wrong mode written directive is required without daily record-Ing of each administered radio harmaceutical dos.
cf trettment or wrong treatment site.
age or radiation in the appropr ate record.
(B) When the treatment consists of three or fewer fractirns and the calculated. total administered (111) A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I-125 or dose differs from the total prescribed dose by more I 131 when both:
than 10% of the total prescribed dose.
(C) When the calculated weekly administered (A) The administered dosage differs from the pre-dose is 30% greater than the weekly prescribed scribed dosage by more than 10% of the prescribed
- dose, dosage.
(D) When the calculated total administered dose (B) The difference between the administered dos-diff;rs from the total prescribed dose by more than age and prescribed dosage exceeds 15 microcuries.'
20% cf the total prescribed dose.
(iv) A therapeutic radiopharmaceutical dosage,
. (v) A brachytherapy radiation dose under one of other than sodium iodide I-125 or I-131, when the tha f:llowing conditions:
administered dosage differs from the prescribed (A) Involving the wrong individual, wrong radio.
dosage by more than 10% of the prescribed dosage, isotope, or wrong treatment site excluding, for-(v) A teletherapy radiation dose when the calcu-permanent implants, seeds that were implanted in lated weekly administered dose exceeds the weekly ths carrect site but migrated outside the treatment prescribed dose by 15% or more of the weekly site)*
prescribed dose.
(B) Involving a sealed source that is leaking.
(vi) A brachytherapy radiation dose when the (C) When, for a temporary implant, one or more calculated administered dose differs imm the pre-sealed sources are not removed upon completion of scribed dose by more than 10% of the prescribed the procedure.
dose.
(D) When the calculated administered dose dif-
. firs from the prescribed dose by more than 20% of tha prescribed dose.
Written directioe-An order in writinvl for a spe-cific patient or human research subjert, dated and (vi) A diagnostic radiopharmaceutical dosage, signed by an authorized user prior to the adminis-othIr than quantities greater than 30 pCi (1.11 tration of a radiopharmaceutical or radiation, ex-MBq) cf either sodium lodide e125 or I 131, when cept as specified in subparagraph (vi), containing tha cmditions in clauses (A) and (B) apply:
the following information:
(A) Involving the wrong individual, wrong radispharmaceutical, wrong route of administra-(i) For any administration of quantities greater tiin, er when the administered dosage differs from than 30 pCi (1.11 MBq) of either sodium iodide I 125 tha prescribed dosage.
or I 131 the dosage.
(B) When the dose to the individual exceeds 5 (ii) For a therapeutic administration of a radio-rem (50 mSv) effective dose equivalent or 50 rems pharmaceutical other than sodium iodide I 125 or (0.5 Sv) dose equivalent to any individual organ.
1131: the radiopharmaceutical, dosage and route of administration.
Prescribed dosage-The quantity of radiopharma-(iii) For gamma stereotactic radiosurgery: target ceutical activity as documented in one of the fol-coordinates, collimator size, plug pattern and total dose.
lowing methods:
(i) 13 a written directive.
(iv) For teletberapy: the total dose, dose per frac-n, Ma med 8 a
Wera 8 men peM-(ii) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance (v) For high-dose-rate remote afterloading with the directions of the authorized user for diag-brachytherapy: the radioisotope, treatment site and nostic procedures.
total dose.
Prescribed dose-One of the following:
(vi) For all other brachytherapy the following (i) Fer gamma stereotactic radiosurgery, the total apply:
dose as documented in the written directive.
(A) Prior to implantation: the ~ radioisotope, num.
(11) For teletherapy, the total dose' and dose per ber of sources and source strengths, fracti:n as documented in the written directive.
(B) After implantation but prior to completion of (111) For brachytherapy, either the total source the procedure: the radioisotope, treatment site, and strength and exposure time or the total dose, as total source strength and exposure time (or, equiva-documented in the written directive, lently, the total dose).
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
\\
x PROPOSED RULEMAKING 896 l 224.6. Licenkamendments.
Subchapter B. GENERAL ADMINISTRATIVE REQUIREMENTS (a) A licensee shall apply for and receive a license amendment before it:
6 224.53. Radiation safety committee.
N.
A medical institution licensee shall establish a radia-tion safety committee (committee) to oversee the use of (2) Permits anyone, except h visiting authorized user radioactive material.
described in 6 224.56 (relating to visiting authorized user), to work as an authorized ' user or authorized nuclear pharmacist under the licenss.s (2) To oversee the use oflicensed material, the commit-
.'y tee shall:
(b) Alicensee possegsing a Type A specific license (ii) Review, on the basis of safety and with regard to f bro scope for medical use is exempt ham the the training and experience standards in Subchapter J g:
N (relating to traimng and experience requirements), and approve or disapprove an individual who is to be listed as (1) Subsection (a)(2).
an authorized user, the radiation safety officer, an autho-(2) Subsection (a)(5) regarding additions to or rized nuclear pharmacist or a teletherapy physicist s
changes in the areas of use only at the addresses before submitting a license application or request for specified in the license.
amendment or renewal.
I 224.7. Notifications.
N A licensee shall notify the Department by letter within i 22m Supenision.
30 days when an authorized user, radiation safety officer (a) A licensee that permits the receipt, possession, use or teletherapy physicist or authorized nuclear phar-or transfer of radioactive material by an individual under macist permanently discontinues performance of duties the supervision of an authorized user as allowed by under the license or has a name change, or when the Q 224.4(b)(relating to license required) shall:
licensee's mailing address changes. The licensee shall 4
mail the report to the appropriate address identified in x
6 224.5(c)(relating to application for license, amendment (4) Permit only auxiliary personnel who have met or renewal).
the applicable requirements of 49 Pa. Code, Part I, 6 224.9. Specific exemptions
- Subpart A (relating to ' professional and occupa-tional affairs) to use radioactive materials for diag-The Department may, upon application of an interested nostic or therapeutic purposes.
person or upon its own initiative, grant exemptions from (5) Permit only auxiliary personnel employed by this article as it determines are authorized by law and a health care facility regulated by the Department wili not endanger life or property or the common defense of Health, the Department of Public Welfare or the and security and are otherwise in the public interest. The Federal government to use radioactive materials Department will review requests for exemptions from for diagnostic or therapeutic purposes in accord-trainmg and experience requirements with the assistance ance with written job descriptions and employe of its Radiation Protection Advisory Committee [ on qualifications.
the Medical Uses of Radioactive Material].
I 224.10. Provisions for research involving human 6 224.60. Suppliers for sealed sources or devices for subjects.
medical use.
A licensee may conduct research involving human A licensee may use the following for medical use only:
subjects using radioactive material if the research is conducted, funded, supported or regulated by a W [ RadiMin mhlal mufactd WM' Federal agency which has implemented the Federal Packaged and distributed in accordance with a policy for the protection of human subjects. Other-license issued under Chapter 217 (relating to licens-wise, a licensee shall apply for and receive ap.
ing of radioactive material) or the equivalent regu-proval of a specific amendment to its license before lations of an agreement state or the NRC.] Sealed conducting the research. Both types of licensees sources or devices manufactured, labeled, packaged shall, at a minimum, obtain informed consent from and distributed in accordance with a license issued the human subjects and obtain prior review anci under Chapter 217 (relating to licensing of radioac-4 approval of the research activities by an "institu.
tive material), the equivalent regulations of an
{
tional review board"in accordance with the mean.
agreement state or the NRC.
i e
poHey u jects.
[(2) Reagerit kits that have been manufactured, r e protecti ohm n labeled, packaged and distributed in accordance j
$ 224.11. FDA, other Federal and State require.
with an approval by the Department under i 217.91 ments.
(relating to manufacture and distribution of gen.
erators or reagent kits for preparation of radio.
This chapter does not relieve the licensee from pharmaceuticals), an agreement state or the NRC, complying with applicable FDA, other Federal and under equivalent regulations for the preparation of State requirements governing radioactive drugs or radiopharmaceuticals for medical use. ]
devices, and 49 Pa. Code Chapter 27 (relating to State Board of Pharmacy).
[ (3) ) (2)
- PENNSYLVANIA BULLETIN. VOL 28, NO. 7, FEBRUARY 14, 1998
l PROPOSED RULEMAKING 897 l'224.61. Quality management program.
(d) The licensee shall retain:
(a) An appilcant or licensee under this chapter, (1) Each written directive, es epplicable, shall establish and maintain a writ.
(2) A record of each administered radiation dose ten quality management program to provide high confidence that radioactive material or radiation or radiopharmaceutical dosage when a written di-from radioactive material will be administered as
.rective is required in subsection (a)(1), in an audit-directed by the authorized user. The quality man-able form, for 3 years after the date of administra-tion.
eg: ment program shall include written policies and
- procedures to meet the following specific objec-(e) The licensee may make modificitions to the tives:
quality management program to iner iase the pro-(1) Except as provided in subsections (h)-(j) gram's efficiency so long as the progra m's effective-th:t, prior to administration, a written directive is ness is not decreased. The licensee shril furnish the prepared fort modification to the appropriate regional office
- (i) Any teletherapy radiation dose.
h, e o days aner the modmeadon has kn n
(11) Any gamma sterotactic radiosurgery dose.
(f) An applicant for a new license as applicable
-(111) Any brachytherapy radiation dose.
shall submit to the Department a quality manage.
(iv)'Any administration of quantitles greater than ment program as part of the application for a 30 microcuries of.either sodium iodide I.125 or license and implement the program upon issuance of the license.
(v) Any therapeutic adminis} ration of radiophar-I.131.
'(g) An existing licensee shall submit to the De-t maceutical other than sodium iodide I.125 or I 131.
partment a written certification that the quality management program has been implemented along (2) That, prior to each administration the pa-with a copy of the program.
~j tirnt's identity is verified by more than one method as the individual named in the written directive.
(h) If, because of the patient's condition, a delay in order to provide a written avision to an existing (3) That final plans of treatment and related written direction would jeopardize the patient's calculations for brachytherapy, teletherapy and health, an oral revision to an existing written gamma stereotactic radiosurgery are in accordance directive will be acceptable, so long as the oral with the respective written directives, revision is documented humediately in the patient's
. (4) That each administration is in accordance record and a revised written directive is signed by with the written directive, the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral
- 'VI*I'"*
.(5) That an unintended deviation from the writ-ten directive is identified and evaluated and appro-(1) A written revision to an existing written direc-priite action is taken, tive may be made for any diagnostic or therapeutic (b) The licensee shall:
procedure so long as the revision is dated and signed by an authorized user prior to the adminis-
)
(1) Develop procedures for and conduct a review tration of the radiopharmaceutical dosage, the cf the quality management program including, brachytherapy dose, ' the gamma stereotactic cince the last review, an evaluation of the following:
radiosurgery dose, the teletherapy dose or the next (1) A representative sample of patient administra.
teletherapy fractional dose.
tiens.
(j) If, because of 'the emergent nature of the
-(11) AN. ecordable events.
patient's condition, a delay in order to provide a written directive would jeopardize the patient's (111) All misadministrations to verify compliance health, an oral directive will be acceptable, so long
..with all aspects of the quality management pro-
. as the information contained in the oral directive is gram; these reviews shall be conducted at intervals documented immediately in the patient's record no greater than 12 months, and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> (2) Evaluate each of these reviews to determine of the oral directive.
' the effectiveness of the quality management pro-Subchapter C. GENERAL TECHNICAL graan and, if uired, make modifications to meet ME thyobjectives subsection (a).
(3) Retain records of each review, including the i 224.101. Possession, use, calibration and check of dose calibrators.
cvaluations and findings of the review, in an audit, cble form for 3 years.
. (c) The ' licensee ' shall evaluate and respond (b) Alicensee shall-'
within 30 days after discovery of the recordable svant, to each recordable event by:
(1) Assembling the relevant facts including the (3) Test each dose calibrator for linearity upon installa-tion and at least quarterly thereafter over the range ofits
~
can.Se.
'2, Identifying what, if any, corrective action is use between the highest dosage that will be administered required to prevent further recurrence.
to a patient and [10] 30 microcuries ([370 kBq] 1.1 (3) Retaining a record, in an auditable form Ar 3
' * ~
- years of the relevant facts and the corrective action tak,a if any was taken.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY-14,'1998
l i
898 PROPOSED RULEMAKING
$ 224.103. Measurement of radiopharmaceutical radiopharmaceuticals are routinely pr pared for use or f
- dosages, administered and each week where radioactive materials A licensee shall do the following:
are stond.
- ~*
(1) Measure the activity of each radiopharmaceutical
[ dosage that contains more than 10 microcuries i 224.109.' Release of patients containing radiophar.
(370 kBq)] of a photon-emitting radionuclide before maceuticals or permanent implants, medical use.
(a) [ A licensee may not authorize release from
[(2) Measure the activity of each radiopharma.
confinement for medical care a patient adminis-ceutical dosage with a desired activity of 10 tered a radiopharmaceutical until one of the follow-microcuries (370 kBq) or less of a photon-emitting ing conditions have been met:
radionuclide before medical use to verify that the (1) The measured dose rate from the patient is dosage does not exceed 10 microcuries (370 kBq).]
less than 5 millirem (50 pSv) per hour at a distance i
Measure by direct measurement or by combination of 1 meter.
of measurements and calculations, the activity of each dosage of an alpha. or beta-emitting (2) The activity in the patient is less than 30 radionuclide prior to medical use except for unit millicuries (1.11 GBq) ]. The licensee may authorize dosages obtained from a manufacturer or preparer the release from its control df an individual who licensed under i 217.90 (relating to manufacture has been administered radiopharmaceuticals or and distribution of radiopharmaceuticals for med.
permanent implants containing radioactive mate-t ical use under ~ group licenses) or equivalent agree.
rial if the total effective dose equivalent to another ment state requirements.
Individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).
(3) Retain a record of the measurements required by this section for 3 years. To satisfy this requirement, the (b) [ A licensee may not authorize release from record shall contain the followmg:
confinement for medical care of a patient adminis-i I
tered a permanent implant until the measured dose rate from the patient is less than 5 millirems (50 (iii) The prescribed dosage and activity of the dosage at pSv) per hour at a distance of 1 meter..] The the time of measurement, or a notation that the total licensee shall provide the released individual with activity is less than [10] 30 microcuries [(370 kBq)]
instructions, including written instructions, on ac-l (1.1 MBq).
tions recommended to maintain doses to other l
Individuals ALARA if the total effective dose
.~
equivalent to another individual is likely to exceed i 224.104. Authorization for calibration and refer-1 mSv (0.1 rem). If the dose to a breastfeeding ence sources.
Infant or child could exceed 1 mSv (0.1 rem) assum.
A person authorized by 6 224.4 (relating to license ing there were no interruption of breast feeding, required) for medical use of radioactive material may the instructions shall also include both of the receive, possess and use the folbwing radioactive mate.
following:
rial for check, calibration and reference use:
(1) Guidance on the interruption or discontinua.
(1) Sealed sources mani
' dd and distributed by a tion of breast feeding.
person licensed under ( 2 pdating to manufactun (2) Information on the consequences of failure to s
and distribution of equrds c : key containing radioae.
follow guidance.
agreement state' regulations and(WJ do not exceed 15tive material for mddical urg, l e MtC or equivalent
~
g (c) The licensee shall maintain a record of the millicuries (555 mBq)'each of b$ roc uct material or 25 basis for authorizing the release of an individual,
-millicuries %sch of' accelerator produced material for 3 years after the date of release, if the total effective dose equivalent is calculated by any one of the following:
5 224.105. Requirements for possession of sealed (1) Using the retained activity, rather than the sources and brachytherapy sources.
activity administered.
{
(2) Using an occupancy factor less than 0.25 at 1
{
(f) A licersee is not required to perform a leakage test meter.
on the following sources:
(3) Using the biological or effective half-life.
(4) Considering the shielding by tissue.
(4) Sounes stored and not being ur.ed. The licensee shall, however, test these sources for leakage before the (d) The licensee shall maintain a record, for 3 l
years after the date of release, that instructions use or transfer unless it has been leakage-[ treated ]
were provided to a breastfeeding woman if the tested within 6 months before the date of use or transfer.
radiation dose to the infant or child from continued breastfeeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).
I 224.108. Surveys for contamination and ambient radiation exposure. rate.
i2 n 1 h @ -m m (a) A licensee may hold sealed sources of accelera-(e) A licensee shall survey for removable contamination tor produced radioactive material with a physical
[ each day of use the areas ] once each week where half. life of up to 300 days armd any radioactive mate-rial with a physical half-life of less than 65 days for l
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 899 deczy-in-storage before digsal in ordinary trash and is ment capable of detecting dose rates over the range 0.1 crempt from the requiremer af $ 219.181 (relating to millirem (1 pSv) per hour to [ 50 ] 100 millirem ([ 0.5 ]
gIneral requirements) if it:
1.0 mSv) per hour.
Subchapter E. IMAGING AND LOCALIZATION I 224.113. Possession, use, calibration and check of 6 224.201. Use of radiopharmaceuticals[, generators instruments to measure dosages of alpha. or beta-and reagent kits] for imaging and localization stud-emitting radionuclides.
ies.
(s) This section does not apply to unit dosages of
[(a)] A licensee may use for imaging and localiza.
ej ha-or beta emitting radionuclides that are ob-tion studies any unsealed radioactive material [in a p
t:.ined from a manufacturer or preparer licensed undir 6 217.90 (relating to manufacture and distri-diagnostic radiopharmaceutical or a generator or buti:n of radiopharmaceuticals for medical use reagent kit for preparation and diagnostic use of a undir group licenses) or equivalent.
radiopharmaceutical containing radioactive mate-rial provided for which the FDA has accepted a i
(b) For other than unit dosages obtained to sub-
" Notice of Claimed Investigational Exemption for a i
secti:n (a), a licensee shall possess and use instru-New Drug" or approved a "New Drug Application")
l mIntation to measure the radioactivity of alpha or prepared for medical use that is either:
j beta-emitting radionuclides. The licensee shall have procedures for use"of the instrumentation. The
[(b) A licensee shall elute generators and re-licensee shall measure by direct measurement or by pare reagent kits in accordance with the manufac-combination of measurements and calculations, the.
turer's instnictions. ]
am:unt of radioactivity in dosages of alpha or (1) Obtained from a manufacturer or p arer beta emitting radionuclides prior to administration licensed under i 217.91 (relating to manufacture to ' cach patient.or human research subject. In and distribution of generator or reagent kits) or I
addition, the bcensee shall do both of the following:
equivalent NRC or agreement requirements.
L (1) Perform tests before initial use, periodically, I
cist, a phhared by an authorized nuclear pharma-(2) Pre cud folicwing repair, on each instrument for accu-sician who is an authorized user and who I
racy, hnearity, and geometry dependence, as appro-meets the requirements specified in 6 224.454 (re-pritto for the use of the instrument; and make lating to training for imaging and localization stud-a4ustments when necessary.
les). or an individual under the supervision of (2) Check each instrument for constancy and either specified in i 224.55 (relating to supervi' proper operation at the beginning of each day of sion).
use.
i 224.204. Possession of survey instruments.
Subchapter D. UPTAKE, DILUTION AND A licensee authorized to use radioactive material for i
EXCRETION imaging and localization studies shall have in its posses-sion a portable radiation detection survey instrument j
l 224.151. Use of radiopharmaceuticals for uptake capable of detecting dose rates over the range of 04 dilution and excretion studies.
millirem (1 pSv) per hour to [ 50 ] 100 millirem ([ 0.5 J A licensee may use radioactive material in a 1.0 mSv) per hour, and a portable radiation measurement radiophannaceutical and for a diagnostic use involving survey instriunent capable of measuring dose rates over mrasurements of uptake, dilution or excretion [ for the range 1 millirem (10 pSv) per hour to 1000. millirem
' whi h the FDA lias. accepted " Notice of Claimed (10 mSv) per hour, j
Investigational Exemption for a New Drug" (IND)
Subchapter F. RADIOPHARMACEUTICALS FOR cr cpproved a "New Drug Application" (NDA)] that THERAPY is either:
6 224.251. Use of radiopharmaceuticals for therapy.
(1) Obtained from a manufacturer or preparer A licensee may use [ a' radioactive mat'erial in a licensed under i 217.90 (relating to manufacture radiopharmaceutical and for a therapeutic use for and distribution of radiopbarmaceuticals for med-which the FDA has accepted a " Notice of Claimed ical use under group licenses) or equivalent NRC or agreement state requirements, Investigational Exembtion for a New Drug" (IND),
or approved a "New rug Application" (NDA). The (2) Prepared by an authorized nuclear pharma-licensee shall comply with the package insert in-cist, who meets the training criteria specified in structions regarding indications and method of g 224.466 (relating to training for an authorized administration.] for therapeutic administration nuclear pharmacist) or i 224.467 (relating to train-any unsealed radioactive material prepared for
. ing for experienced nuclear pharmacists), a physi.
medical use that is:
ci n who is an authorized user and who meets the requirements specified in i 224.453 (relating to (1) Obtained from a manufacturer or preparer licensed under 6 217.92 (relating to manufacture training for uptake, dilution and excretion studies) and distribution of sources or devices for medical er an individual under the supervision of either cpecified in i 224.55 (relating to supervision).
use) or equivalent NRC or agreement state require-ments.
I 224.152. Possession of survey instrument.
(2) Prepared by an authorized nuclear pharma-A licensee authorized to use radioactive material far cist, who meets.the training criteria specified in uptake, dilution and excretion studies'shall have in its i 224.466 (relating to training for an authorized possession.a portable radiation detection survey instru-nuclear pharmacist)'or 5 224.467 (relating to train-PENNSYLVANIA' BULLETIN, VOL. 28, NO. 7, FEBRUAR '14,'I998
900 PROPOSED RULEMAKING ing for experienced nuclear pharmacists), a physi-Subchapter H. SEALED SOURCES FOR clan who is an authorized user and who meets the DIAGNOSIS requirements specified in 6 224.454 (relating t 5 224.352. Availability of survey instrument.
training for imaging and localization studies) or an individual under the supervision of either specified A licensee authorized to use radioactive material as a l
in i 224.55 (relating to supervision).
sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument i 224.252. Safety instruction.
capable of detecting dose rates over the range 0.1 mil-lirem (1 pSv) per hour to [ 50 ] 100 millirem ([ 0.5 ] 1.0 mSV) Per hour or a rtable radiation measurement (1) Patient or human research subject control-survey instrument capa le of measurmg dose rates over i 224.253. Safety precautions.
the range 1 millirem (10 pSv) per hour to 1000 millirem l
(10 mSv) per hour. The instrument shall have been (a) For each patient receivm.g radiopharmaceutical calibrated in accordance with 6 224.102 (relating to cali-therapy and hospitalized in comph,ance with 6 224.109 bration and check of survey instruments).
(relatmg to release of patients containing radiopharma-ceuticals or permanent implants), a licensee shall:
Subchapter I. TELETHERAPY 5 224.406. Possession of survey instrument.
A licensee authorized to use radioactive material in a
[(6) Provide the patient with ' radiation safety teletherapy unit shall have in its possession a portable guidance that will help to keep radiation dose to radiation detection survey instrument capable of detect-household members and the public ALARA before ing a dose rate over the range of 0.1 millirem (1 pSv) per authorizing release of the patient. ]
hour to [ 50 ] 100 millirem ([ 0.5 ] 1.0 mSv) per hour or a portable radiation measurement survey instrument ca-
[ (7) ] (6)
- pable of measuring dose rates over the range 1 millirem (10 pSv) per hour to 1000 millirem (10 mSv) per hour.
[ (8)] (7)
- f 224.408. Full calibration measurements.
j j
Subchapter G. SOURCES FOR BRACHYTHERAPY (b) To satisfy the requirement of subsection (a), full i 224.305. Safety precautions.
calibration measurements shall include determination of the foHowing:
(a) For each patient or human research subject receiving implant therapy, a licensee shall comply with the following conditions:
(6) The accuracy of all distance measuring and local-(1) The patient may not be quartered in the same room ization device.: in medical use.
j with a patient who is not receiving radiation therapy
[ unless the licensee can demonstrate compliance with 6 219.51 (relating to dose limits for individual Subchapter J. TRAINING AND EXPERIENCE REQUIREMENTS members of the public) at a distance of 1 meter from the implant J.
I 224.451. Radiation safety officer.
1 Except as provided in 0 224.452 (relating to traming for experienced radiation safety officer), the licensee shall i
[(5) The patient shall be provided with radiation require an individual fulfilling the responsibilities of the i
safety guidance that will help to keep radiation radiation safety officer as provided in 6 224 54 (relating dose to household members and the public ALARA to statements of authority and responsibilities) to be an before releasing the patient if the patient was individual who meets one of the following requirunents:
j administered a permanent implant. ]
(1) Is certified by one of the following:
[(c) Nonoccupationally exposed individuals hav-(vi) The American Board of Medical Physics.
ing incidental contact with patients having im.
(vil) The Royal College of Physicia ts and Sur-planted or applied sealed sources-for example, geons of Canada in Nuclear Medicine.
visitors nurses and other patients-may not receive doses in excess of doses specified in 219.51 (relating (viii) The American Osteopathic Board of Radio)
I to dose limits for individual members of the public) ogy.
j as a result of their contact with the patients.]
(lz) The American Osteopathic Board of Nuclear j
Medicine.
j i 224.306. Possession of survey instrument.
j A licensee authorized to use radioactive material for implant therapy shall have in its possession a portable i 224.453. Training for uptake, dilution and excre-j tion studies.
radiation detection survey instrument capable of detect-ing dose rates over the range 0.1 millirem (1 pSv) per Except as in Q 224.463 or 6 224.464 (relating to train-hour to [ 50 ] 100 millirem ([ 0.5 ] 1.0 mSv) per hour, ing for experienced authorized users; and physician train-and a portable radiation measurement survey instrument ing in a 3-month program), the licensee snail require the capable of eneasuring dose rates over the range 1 millirem authorized user of a radiopharmaceutical in @ 224.151 (10 pSv) per hour to 1000 millirem (10 mSv) per hour.
(relating to use of radiopharmaceuticals for uptake, dilu-PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998 o
l PROPOSED RULEMAK!NG 901 tion and excretion studies) to be a physician who meets i 224.458. Training for use of brachytherapy one of the following requirements; sources.
(1) Is certified in one of the following:
Except as provided in i 224.463 (relating to training for experienced authorized users), the licensee shall re-quire the authorized user of a brachytherapy source listed (iii) Diagnostic radiology or radiology by the Ameri.
in 6 224.301 (relating to use of sources for e-n Osteopathic Board of Radiology.
brachytherapy) to be a physician who meets one of the (iv) Nuclear medicine by the Royal College of following requirements:
Physiilans and Surgeons,of Canada.
(1) Is certified in one of the following-(v) American Osteopathic Board of Nuclear Medi-(i) Radiolo or therapeutic radiology or radiation oncology by$e American Board of Radiology, cina in nuclear medicine.
i 224.454. Training for imaging and localization studies.
Except as provided in $$ 224.463 and 224.464 (relating i 224.460. Training for use of sealed sources for to tral,ing for experienced authorized users; and physi, diagnosis.
clan ti dning in a ' month pmgram), the licensee shall Except as provided in 6 224.463 (relating to traming require the authoi A user of a radiopharmaceutical, for experienced authorized users), the licensee shall re-generztor or reager. kit in g 224.201(a) (relating to use Suire the authorized user of a sealed source in a device of r:diopharmaceuticals, generators and reagent hits for hsted in 6 224.351 (relating to use of sealed sources for imaging and localization studies) to be a physician who diagnosis) to be a physician, dentist or podiatrist who meets one of the following requirements:
meets one of the followmg requirements:
- (1).Is certified in one of the following:
(1) Is certified in one of the following:
(1) Radiology, diagnostic radiology or therapeutic radiol-(iii) Diagnostic radiology or radiology by the Ameri-ogy or radiation oncology by the American Board of ccn Osteopathic Board of Radiology.
Radiology.
(iv) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
(iv) Nuclear Medicine by the Royal College of (v) American Osteopathic Board of Nuclear Medi-Physicians and Surgeons of Canada.
cim in nuclear medicine.
(2) Has had classroom and laboratory training in basic redi: isotope handbng techniques applicable to the use of I 224.461. Training for teletherapy.
prep +. red radiopharmaceuticals, generators and reagent Except as provided in 6 224.463 (relating to training kits, work experience and has had supervised clinical for experienced authorized users), the licensee shall re-czperience as follows:
quire the authorized user of a sealed source listed in I 224.401 (relating to use of a sealed source in a (11) Five hundred hours of supervised clinical experi-teletherapy unit) in a teletherapy unit to be a physician snca under the supervision of an authorized user and that who meets one of the following requirements:
includts the following:
(1) Is certified in one of the following:
(i) Radiology or therapeutic radiology or radiation U
- 87' (f) Eluting Technetium.99" from generator sys-t:m?, measuring and testing the eluate for Molybdenum 99 and Alumina contamination and processing the eluate with reagent kits to prepare i 224,462. Tralning for teletherapy physicist.
' Technetium-99" labeled radiopharmaceuticals.
The licensee shall require the teletherapy physicist to be an individual who meets one of the following require-ments:
6 224.455. Training for therapeutic use of radiopharmaceuticals.
Except as provided in 6 224.463 (relating to training (3) Is certified by the American Board of Medical for experienced authorized users), the licensee shall re-Physics in radiation oncology.
quire the authorized user of radiopharmaceuticals in
$ 224.251 (relatmg to use of tadiopharmaceuticals for i 224.465. Recentness of training.
tinrapy) to be a physician who meets one of the following The training and experience specified in this chapter aquirements:
shall have been obtained within the [ 5] 7 years preced.
(1) Is certified by one of the following:
ing the date of application or the individual shall have had related continuing education and experience since the required training and experience was completed.
(iii) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada, f 224.466. Training for an authorized nuclear phar-macist.
(lv e
erican Osteopathic Board of Radiol.
(a) The licensee shall require the authorized
'EY -
nuclear pharmacist to be a pharmacist who meets one of the following requirements:
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
902 PROPOSED RULEMAKING (1) Has current board certification as a nuclear apply. However, if that licensee exercises its privi-pharmacist by the Board of Pharmaceutical Spe--
lege to make minor changes in its radiation safety cialties.
procedures that are not potentially important to
'(2) Has complet-
) hours in structured educa-safety under i 224.58 (relating to radiation safety tional program e
.ng of both of the following:
program changes), the portion changed shall com-ply with this chapter. At the time oflicense renewal (1) Didactic tras, in the following areas:
and ther9after, this chapter applies.]
(A) Radiation ph, sics and instrumentation.
CHAPTER 225. RADIATION SAFETY REQUIREMENTS (B) Radiation protection.
FOR INDUSTRIAL USES AND RADIOGRAPHIC (C) Mathematics pertaining to the use and mea-OPERATIONS surement of radioactivity.
GENERAL PROVISIONS (D) Chemistry of byproduct material for medical i 225.1. Purpose and scope.
Use.
(a) This' chapter establishes radiation safety req ments for persons utihzmg radiation sources for m, uire (E) Radiation biology.
dus-
- (ii) Supervised experience in a nuclear pharmacy trial [ radiography ] uses and radiographic opera-involving the following:
tions. Licensees and registrants who use radiation
/A) Shipping, receiving and peiforming related sources for industrial [ radiography ] uses and radio-graphic operations shall comply with this chapter. The surveys.
(B) Using anh performing checks for proper op-requirements of this chapter are in addi, tion to and not,a eration of dose calibrators, survey meters, and, if substitution for other applicable requirements of this article. This chapter does not apply to medical appropriate, instruments used to measure alpha or beta-emitting radionuclides.
diagnosis or therapy.
(C) Calculating, assaying. and safely pre (b) Persons who use particle accelerators to per-dosages'for patients or human research su$aring f8.rm radiographic operations shall also comply
- jects, with Chapter 228 (relating to particle accelerators).
- (D) Using administrative controls to avoid mis-takes in the administration of byproduct material.
6 225.2. Definitions.
(E) Using procedures to prevent or minimize con.
The following words and terms, when used in this tamination and using proper decontamination pro.
chapter, have the following meanings, unless the context cedures.
clearly indicates otherwise:
(b) A pharmacist meeting the requirements of Annual ivfresher safety training-A review con-subsection (a)(2) shall obtain written certification, ducted or provided by the licensee or registrant for signed by a preceptor authorized nuclear pharma-its employes on radiation safety aspects of indus-cist, that the above training has been satisfactorily trial radiography. The review may include, as ap-completed and that the pharmacist has achieved a propriate, the results of internal inspections, new level of competency sufficient to independently procedures or equipment, new or revised regula-operate a nuclear pharmacy, tions, accidents or errors that have been observed, i 224.467. Training for experienced nuclear phar-and should also provide opportunities for employes macists.
to ask safety questions.
Associated equipmen'-Equipment used in con-A licensee may apply for and must receive a t
license amendme:it identifying an experienced junction with a radiographic exposure device to nuclear pharmacist as an authorized nuclear phar.
make radiographic exposures when the equipment macist before it allows this individual to work as drives, guides or comes into contact with the an authorized nuclear pharmacist. A pharmacist source.
who has completed a structured educational pro Cabinet X-ray system-An X-ray system with the X-ray gram as specified in, i 224.466(a)(2) (relating t training for an ' authorized nuclear pharmacist) be-tube installed in an enJosed, interlocked cabinet, de-signed to exclude personnel from its interior dur-fore (Editor's Note: The blank refers to the effective date of adoption of this proposal), and Ing 8Peration. The term includes X ray statems who is working in a nuclear pharmacy would designed primarily for the inspection of baggage or qualif,y as an experiebced nuclear pharmacist. an packages. The term does not include an X-ray tube experienced nuclear pharmacist need not comply used within a shielded part of a building or X-ray equipment which may temporarily or occasionally with il 224.465 and 224.466(b) (relating to rec,ent-incorporate portable shielding.
ness of training) to qualify as an author red nuclear pharmacist.
[ Subchapter K. ENFORCEMENT ] (RESERVED)
Certifying entity-An independent certifying or-i 224.501. [ Resolution of conflictinE requirements ganizadon meet {ng the reqdaments of 6 225.102 (relating to requirements for an independent certi-during transition period ] (Reserved).
fying organization) or an agreement state which
[If this chapter conflicts with the licensee's ra.
meets the same requirements as 6 225.102.
diation safety program as identified in its license, Collimator-A radiation shield made of lead, and if that license was approved by the Department tungsten or other heavy metal which is placed on before June 20, 1992 and has not been renewed the end of a guide tube or directly onto a radio-since June 20,1992, the requirements in the license graphic exposure device to restrict the size and PENNSYLVANIA BULLETIN. VOL. 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 903 shape of the radiation beam when the sealed source machine or. transport (except when being trans-is moved into position to make a radiographic ported by common carrier or contract transport), to exporure.
include surveys to confirm the adequacy of bound-
. Control cable-The cable which is connected to aries, setting up equipment and any activity inside restricted area boundaries.
the source assembly and used to drive the source to and from the exposure location. The term may be S-tube-A tube through which the radioactive al:o referred to as the drive cable.
source travels when inside a radiographic exposure Control drive mechanism-The device that en-device.
chlss the source assembly to be moved to and from the exposure device.
Source assembly-A component to which the Crank-out device-The cable, protective sheath sealed source is affixed or in which the sealed and handcrank used to move the serled source source is contained. The source assembly includes from the shielded to the unshielded position to the sealed source.
make an industrial radiographic exposure.
Exposure head-A device that locates the gamma Storage facility-A location, area or vehicle which radiography sealed source in the selected workiry is used to store, transport or secure a radiographic position. An e*Posure head is also kc awn as 2 exposure device, a sto age container, or a sealed tource stop, source when it is not in use, and which is locked or Guide tube (projection sheath)-A flexible or rigid has a physical barrier to prevent accidental or tube (that is, "J"-tube) for guiding the source as-inadvertent exposure, tampering with or unautho-sembly and the attached control cable from the rized removal of the device, container or source.
expo 1ure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the Temporary job site-A location where Indostrial radiog-exposure head.
raphy ia performed for 180 days or less during any consecutive 12-months other than the location listed in Individual's certification-Written approval re-ceived from a certifying entity stating that an a specific license or registration.
Individual has satisfactorily met certain established 7ransport container-A package that is designed radiation safety, testing and experience criteria.
and constructed to provide radiation safety and security when a sealed source is transported and which meets applicable provisions of Chapter 230 Lock-out survey-A radiation survey performed to (relating tc packaging and transportation of radio-datermine that a sealed source is in its shielded active material).
i Po2ition.
6 225.10. Application for a specific license or regis-tration.
Personal supervision-The provision of guidance (a) A person who intends to use sealed sources in r.nd instruction to a radiographer's assistant by a industrial uses or radiographic operations shall file radiographer who is:
an application in accordance with il 217.51 and (i) Physically present at the site.
217.65 (relating to filing application for specific j
license; and specific licenses for the use of sealed (11) In visual contact with the radiographer's as-sources in industriel radiography).
sixtznt while the assistant is using radiation (b) A person who intends to use X ray machines cources.
for industrial radiography shall have a program for (iii) In proximity so that immediate assistance training personnel, written operating and emer-can be given if required.
gency procedures, an internal review system, and an organizational structure which includes speci-fied delegations of authority and responsibility for Radiographer-An individual who performs, or [ pro-operation of the program. This program shall be vidte personal supervision of,] who, while in t.tten-approved by the Department before commencing dance at the site where the radiation source is industrial radiography, being used, personally suprvises industrial radio-
[ SEALED SOURCE REQUIREMENTS ] GENERAL graphic operations and who is responsible to the PROVISIONS licansee or registrant for assuring compliance with part and the conditions of the license or 6 225.11. [ Storage position radiation level limits.]
- this, tration.
regu Reciprocity.
Radiographer's casistant-An individual who, under the
[ (a) Radiographic exposure devices that have the personal supervision of a radiographer, uses radio-sealed source storage pos; tion located less than 4 graphic exposure devices, radiation sources, related inches (10 centimeters) from an exterior surface of handhng tools or radiation survey mstruments m indus-the device shall have radiation levels not exceeding trial radiography, 50 milliroentgens (12.9 pC/kg) per hour at 6 inches (15 cat.timeters) from an exterior surface of the d y ce w en the sealed source is in the shielded-Radiographic operations-All activities associated o - Posi on, with the presence of radiation sources in a radio, graphic exposure device or in a radiation-(ii) Radiographic exp< are devices that have the producing machine during use of the device or sealed source storage position located more than 4 PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBPUARY 14, 1998
e 904 PROPOSED RULEMAKING
' inches (10 centimeters) from an exterior surface of (1) Each entrance that is used for personnel ac.
the device, and storage containers for sealed cess to the high radiation area in a permanent sources or outer containers for radiography expo-radiographic installation shall have visible and au.
sure devices, shall have radiation levels not exceed.
dible warning signals to warn of the presence of ing 200 milliroentgens (51.6 pC/kg) per hour and radiation. The visible signal shall be activated by not exceeding 10 milliroentgens (2.58 pC/kg) per radiation whenever the source is exposed. The hour at I meter from an exterior surface when the audible signal shall be actuated when an attempt is sealed source is in the shielded-off-position. ]
made to enter the installation while the source is exposed.
Out.of-State users of sealed source radiographic exposure devices or Lray machines shall meet the (2) The control device or alarm system shall be requirements of i 216.7 or 217.121 (relating to out, tested for proper operation at the beginning of of state radiation producing machines; and reci.
each day of use.]
procity of licenses of by product, source, and eye-(a) The radiation sr.fety officer (RSO) shall be an cial nuclear materials in quantitles not sufficient to individual who shall ensure that radiation safety form a critical mass), as appropriate.
activities are being performed in accordance with j 225.12. [ Radiation source. locks ] Prohibitions.
approved procedures and requirements in the daily operation of the licensee's or registrant's program,
[(a) A radiation source shall be kept in a lock.
and in compliance with Department requirements, able radiographic exposure device'or in a lockable and who has the authority to suspend or terminate source changer to prevent unauthorized removal operations which are not being conducted in ac-of, or accidental exposure from, the radiation cordance with license or registration conditions.
source. The radiographic exposure device, source (b) The radiogra her shall be an individual who changer and storage container shall be kept locked performs or who is in attendance at a site where a when containing a radiation source except when under the direct surveillance of a radiographer or source is being used, who personally supervises radiographer's assistant, or as may be otherwise radiographic operations, and who is responsible to the licensee or registrant for ensuring compliance authorized under i 225.52 (relating to security).
with this article and conditions of a license or (b) Radiographic exposure devices, source chang-registration.
ers and storage containers, prior to being moved (c) The radiographer's assistant shall be an indi.
from one location to another and also prior to vidual who, under the personal supervision of a being secured at a.given location shall be locked and surveyed to assure that the sealed source is in radiographer, uses radiographic exposure devices, the shielded position. ]
sealed sources or X. ray machines, related handling tools or radiation survey instrumentation.
Human use of the radiation sources covered by (d) The radiography trainee is an individual who this chapter is not permitted.
is in the process of becoming a radiographer's (Editor's Note: Sections 225.13 - 225.18, 225.21 -
assistant or a radiographer, in accordance with a 225.23,225.31-225.33 and 225.41-225.44 are proposed licensee's or registrant's procedures. The trainee is to be deleted. The current versions of these sections not permitted to operate radiographic exposure appear at pps. 225 225-17, Pennsylvania Code serial devices, sealed sources or X-ray machines, or radia.
pps. (203960)-(200971)).
tion survey instrumentation.
Il 225.13-225.18. (Reserved).
I 225m. Training of peynnel.
.A licensee or registrant may not allow an indl.
[ RADIATION-PRODUCING MACHINE vidual to act as a radiographer or assistant REQUIREMENTd ]
radiographer unless that individual meets the re-Il 225.21-225.23. (Reserved).
quirements of I 225.72 (relating to training and testing), appropriate license or registration re-
[ RADIATION SURVEY INSTRUMENTS AND
}uirements, and operating and emergency proce-
^
"r**-
LOGS]
l ng and testing.
Il 225.31-225.23. (Reserved).
(a) The licensee or registrant may not permit an
[ OPERATOR'S PERSONAL SAFETY individual to act as a radiographer until that indl.
REQUIREMENTS ]
vidual:
il 225,41-225.44. (Reserved).
(1) Has been instructed in the subjects outlined
, in Appendix A (relating to subjects to be covered
[ PRECAUTIONARY PROCEDURES ] GENERAL during instruction of radiographs).
ADMESTRAME REWREMENU (2) Is certified through a radiographer's certifica.
I 225.51. [ Permanent radiographic installation ]
tion program by a certifying entity in accordance Duties of personnel, with the criteria specified in il 225.102 and 225.103 (relating to requirements for an independent certi.
[ Permanent radiographic installations having fying organization; and requirements for certifica.
high radiation area entrance controls of the types tion programs). An independent organization that described in il 219.91 and 219.154 (relating to con.
would like to be recognized as a certifying entity trol of access to high radiation areas; and posting shall submit its request to the Department. The of high radiation areas) shall also meet the follow.
licensee or registrant may allow an individual who ing requirements.
has not met the certification requirements to act as PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14,13C8 1
PROPOSED RULEMAKING 9d5 a radiographer, so long as the individual has re-(2) Provide that, if a radiographer or radiog.
ceived the training required under this subchapter, rapher's assistant has not participated in a radio.
This allowance expires (Editor's Note: The graphic operation for more than 6 months since the blank refers to a date 2 years after the effective last inspection, the individual's performance shall dits of adoption of this proposal).
be observed and recorded when the individual next (3) Has received copies of this chapter, Chapters participates in a radiographic operation.
219,220 and 230. A copy of the license or certificate (c) The licensee or registrant shall maintain cf registration issued to the licensee or registrant records of the training required in subsections (a) and copies of the licensee's or registrant's operating and (b) to include certification documents, written -
cnd emergency procedures.
and field examinations, annual safety reviews and -
(4) Has been instructed in the use of the licens.
annual audits of job performance. These records ee's or registrant's sources of radiation, radio.
shall be maintained by the licensee or registrant graphic exposure devices, radiation. producing ma.
for inspection by the Department for 5 years follow.
chines, related handling tools, radiation survey ing terminat!on of employment by the individual or in:truments, regulations, and operating and emer.
until the radioactive material license or certificate gency procedures, of registration is terminated.
~
(5) Has demonstrnted, to the satisfaction of the i 225.74. Reporting requirements.
licensee or registrant, competency and understand.
ing of the information as, evidenced by having (a) In addition to the reporting requirements in cuccessfully completed a written test and a field Chapter 219 (relating to standards for protection czamination.
against radiation), each licensee or registrant shall.
provide to the Dopartment, within 30 days of its (b) The licensee or registrant may not permit an occurrence, a written report on the following incl.
individual to act as a radiographer's assistant until dents involving radiographic equipment used for that individual:
industrial radiography:
(1) Has received copies of, and instruction in, the (g) Unintentional disconnection of the source as.
I licensee's or regi.strant's operating and emergency sembly from the control cable.
procedures.
(2) Has been instructed in the use, and has dem.
(2) Inability to retract or secure a sealed source en trated, to the satisfaction of the licensee or to its fully shielded position.
regi;trant, that when the individual is under the (3) Failure of a component critical to the' safe direct personal supervision of the radiographer, the operation of a radiographic exposure device to hdividual is competent in the use of sources of perform its intended function properly, radiition, radiographic exposure devices, related handling tools and radiation survey instruments (4) Inability to terminate irradiation with an X.
thtt will be used.
ray machine.
'(3) Has demonstrated, to the satisfaction of the (5) Failure of an interlock in shielded room radi.
licensee or registrant, an understanding of the ography.
information as evidenced by having successfully completed a written or oral test and a field exami.
(b) The licensee or registrant shall include the nati:n on the subjects relevant to being an assis.
following information in each report submitted un.
tant radiographer.
der subsection (a):
~
(c) Itecords of the training required under sub.
(1) A description of the equipment problem, sections (a) and (b), including copies of written tests, dates of oral tests and field examinations, (2) The cause of the incident, if known or deter.
shall be maintained for inspection by the Depart.
mined.
mint for 5 years following termination of employ.
(3) The manufacturer and model number of the m:nt by the individual or until the radioactive equipment involved.
mrtarial license or certificate of registration is t:rminated..
(4) The place, time and date of the incident.
I 225.73. Audits and safety reviews of radi.
(5) The action taken to reestablish normal opera.
ographers and radiographers, assistants.
tions.
(a) The licensee or registrant shall provide safety revisws for radiographers and radiographer's assis.
(6) The corrective action taken or planned to tants at least once during each calendar year.
Prevent reoccurrence.
(b) The licensee or registrant shall conduct an (7) The names and qualifications of personnel annual inspection program for the job performance involved.
cf sich radiogra her and radiographer's assistant (c) Reports of overeuposures, re utred under ta ensure that t is title, license or certificate of i 219.222 (relating to notification of incidents) or of regi:tration requirements and the licensee's or reg.
excessive exposures, required under 6 219.223 (re.
istrents operating and emergency procedures are lating to reports of exposures, radiation levels and fall:wed. This audit program shall:
concentrations of radioactive material exceeding (1) Include observation of the performance of the limits) which involve the failure of safety com.
each radiographer and radiographer's assistant ponents of radiography equipment shall also in-during an actual radiographic operation at inter.
clude the information specified under subsection vils not to exceed 1. calendar year.
(b).
PENN:,,e LVANIA BULLETIN, VOL 28, NO. 7, FEBRUARk N,1998
906 PROPOSED RULEMAKING GENERAL TECHNICAL REQUIREMENTS (14) Provide a description to the Department of I
i 225.101. Certification of personnel.
It8 Procedures for choosing examination sites,and for providing an appropriate examination environ-I Radiographers and assistant radiographers shall ment.
1 meet the examination criteria in the license appil-cation and procedures defined in the license appli-6 225.103. Requirements for certification programs.
cation.
Certification programs shall meet the following j
e nditions:
$ 225.102. Requirements for an independent' certify.
j ing organization.
(1) Require that individuals meet the following:
{
An independent certifying organization shall (1) Receive training in the topics in Appendix A meet the following conditions:
(relating to subjects to be covered during the in.
(1) Be an organization such as a society or asso-structi n of radiographers).
clation, whose members participate in, or have an (11) Complete satisfactorily a written examination interest in, the fields of industrial radiography or covering the topics in Appendix A.
nondestructive testing.
(2) Require applicants for certification to provide (2) Make its membership available to the general documentation that demonstrates that the appil-public Nationwide that is not restricted because of cant has met the following:
e r, religion, sex, age, national origin or (1) Received training in the topics in Appendix A.
(3) Have a certification program open to. non-onh ejo t
ining.
members.
(4) Be an incorporated, Nationally recognized or-(111) Received verification by an agreement state ganization, that is involved in setting National r NRC licensee that the applicant has demon.
standards of practice within its fields of expertise, strated the capability of independently working as a radiographer.
(5) Have an adequate, full time staff, a viable (3) Include procedures to ensure that all exami-system of finsacing its, operations, and a poli,cy.
nation questions are protected from disclosure.
and decisionmaking review board.
(6) Have a set of written organizational bylaws (4) Include procedures for denying an applica-and policies that provide adequate assurances of
)* revoking, suspending and reinstating a certifi-lack of conflict or interest and a system of monitor-ing and enforcing those bylaws and policies.
(5) Provide a certification period of not less than (7) Have a committee, whose members can m 3 years n r m re than 5 years.
out their responsibilities imsiartially, to review and (6) Include procedures for renewing the certifica-improve the certification guidelines and proce-tions and, if the procedures allow renewals without dures, and to advise the organization's staff in examination, require evidence of recent active, full-implementing the certification program.
time employment and annual refresher training.
(8) Have a committee, whose members can carry (7) Include procedures whereby an individual's out their responsibilities impartially, to review certification may be revoked, suspended or re.
complaints against certified individuals and to de-stricted for willful or significant failure to comply termine appropriate sanctions.
with his employer's operating and emergency pro-(9) Have written procedures describing all as-cedures, or the Department's, the NRC's or an pects of its certification program, maintain records agmment state's ngulations.
of the current status of each individual's certifica.
(8) Provide for automatic suspension of an indl.
tion and the administration of its certification pro-vidual's certification, based on the Department's, gram.
NRC's or an agreement state's action prohibiting (10) Have procedures to ensure that certified in-the individual from acting as a radiographer.
dividuals are provided due process with respect to (9) Provide the sanctions imposed against the the administration of its certification program, in-certified individuals that are at least as severe as cluding the process of beccming certified, and any any action taken by the Department, NRC or an aanctions imposed against certified individuals.
agreement state.
(11) Have procedures for proctoring examina.
(10) Provide a timely response to inquiries, by tions, including qualifications for proctors. These telephone, letter or electronic nmns, from mem-procedures shall ensure that the individuals proc-bers of the public, about an in6 lual's certifica-toring each examination are not employed by the tion status, same company or corporation or a wholly-owned i 225.104. Requirements for written examinations.
subsidiary of the company or corporation as any of the examinees.
Examinations shall meet the following conditions:
(12) Exchange information about certified indi-(1) Be designed to test an individual's knowledge viduals with the Department, other independent and understanding of the topics listed in Appendix certifying organizations, the NRC or agreement A (relating to subjects to be covered during the
- states, instruction of radiographers) or equivalent NRC or (13) Allow periolic review of its certification pro-agmment state mquinments, gram and its related records.
(2) Be written in a multiple-choice format.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 907 (3) Have test items drawn from a question bank (2) At least one operable, calibrated radiation c:ntr.ining psychometrically valid questions based survey instrument.
en the materialin Appendix A.
(3) A current whole body individual monitoring
.I 225.105. Permanent radiographic installation.
device (" film badge" or "TLD") for each worker.
j
~ (s) Permanent radiographic installations having
(*4) An operable, calibrated pocket ionization.
' high radiation area entrance controls of the types chamber (that is, " pocket dosimeter") with a range 1
described in il 219.91 and 219.154 (relating to con-of zero to 51.6 pC/kg (200 milliroentgen) for each trol cf access to high radiation areas; and posting worker.
high ad ion areas) shall also meet the follow.
(5) An operable, ca*ibrated alarm rate ineter for "I
each worker who performs industrial radiography
. (1) Each entrance that is used for personnel ac-with a sealed source.-
cess to the high radiation area in a permanent
- radiographic installation shall have both visible (e) An industrial radiographic operation may not
, and audible warning signals to warn of the pres-be performed if any of the items in subsection (d) saca of radiation. The visible signal shall be acti-are not available at the job site or is inoperable.
vrted by radiation whenever the source is exposed i 225.107. Records required at temporary job sites.
cr when the X-ray tube is energized. The audible signal shall be actuated when an attempt is made Each licensee or registrant using a source of ts enter the installation while the source la exposed radiation at a temporary job site shall maintain er ths X ray tube is energized.
and have available at that job site, for inspection by the Department, the following records or docu-(2) The entrance control device or alarm system ments:
shell be tested for proper function prior to begin-ning operations on each day of use.
(1) The radioactive materials license, certificate of registration or equivalent document and person-(3) The radiographic exposure system may not be nel certifications, used if an entrance control device or alarm system is n:t operating properly. If an entrance control (2) Operating and emergency procedures, j
device or alarm system is not functioning properly, (3) Relevant regulations of the Department.
It thr.ll be removed from service and repaired or repliced immediately. If no replacement is avall-(4) Surve.y records required under this chapter chla, the facility may continue to be used so long as for the period of operation at the site.
^
the licensee or registrant implements the continu-(5) Daily pocket ionization chamber records for cus surveillance of Il 225.52 and 225.53 (relating to the period of operation at the site.
security; and costing) and, if the permanent radio-graphic instalh tion uses sealed sources, i 225.261 (6) If sealed sources are used at the site, daily (relt. ting to radiographic. operations, security and alarm rate meter records for the period of opera.
tion at the site, posting) and uses an alarming ratemeter. Before tha satrance control device or alarm system is (7) Both the latest radiation survey meter call.
returned to service, the radiation safeity officer or bration records and sealed source leakage or con-en individual designated by the radiation safety tamination test records for specific devices in use efficsr shall validate the repair.
at the site. Acceptable records include tags or
-(b) Records of the tests performed under subsec.
labels that are affixed to the device or survey meter tien (a) shall be maintained for inspection by the and decay charts showing leakage or contamina-tion test results for the sources that have been Department for 5 years.
manufactured within the last 6 months.
I 225.106. Operating requirements.
I 225.108. Operating and emergency procedures.
(n) When radiography is performed at a location othtr than a permanent radiographic installation, a N he's or registrant's operating and emer-minimum of two radiographic personnel shall be gency procedures shall include instruction in at present to operate the radiographic exposure de-least the following:
~ vica. At least one of the radiographic personnel (1) Handling and use of sources of radiation to be shall be a certified radiographer. The other indi-employed so that no individual is likely to be vidual may be either a certified radiographer or'a exposed to radiation in excess of the limits estab-redi:grapher's assistant.
lished in Chapter 219 (relating to standards for (b) Collimators shall be used in industrial radio.
pmtection against radiation).
gr:phic systems that use crank-out devices except (2) Methods and occasions for conducting the
. whsn physically impossible.
radiation surveys.
(c) Other than a
radiographer, or a
(3) Methods for controlling access to areas where radirgrapher's assistant who is under the personal radiographic operations are being conducted.
tupervision of a radiographer, an individual may (4) Methods and occasions for locking and secur-ntt manipulate the controls or operate the equip.
Ing sources of radiation.
msnt used in industrial' radiographic operations.
(5) Personnel monitoring and the use of indi-(d) At each job site, the following shall be sup-vidual monitoring devices, including steps that are plied by the licensee or registrant:
to be taken immediately by radiographic personnel (1) The appropriate barrier ropes and warning if of an ionization chamber (that is, " pocket dosim-cign eter") is found to be off-scale.
PENNSYLVANIA BULLETIN, VOL. 28. NO. '7, FEBRUARY 14. 1998
908 PROPOSED RULEMAKING (6) Transportation to field locations, including (6) By a person authorized by the Department, packing of sources of radiation in the vehicle, the NRC or an agreement state.
placarding of the vehicle if necessary, and control (c) Records of calibration shall be maintained for of sources of radiation during transport.
5 years after the calibration date for inspection by (7) Methods and procedures for minimizing expo.
the Department.
sure of individuals in the event of an accident, 9 225.153. Personnel monitoring control.
including procedures to follow in the event of a j
disconnect accident, a transportation accident or (a) A licensee or registrant may not permit an j
the loss of a sealed source.
Individual to act as a radiographer or as a j
radiographer's assistant, unless, at all times during (8) The procedure for notifying proper personnel radiographic operations, each individual wears a in the event of an accident or loss of a sealed combination of dinct-reading pocket dosimeter, an
- source, op4 rating alarm ratemeter and either a film badge (9) Maintenance of records required by the De.
or a thermoluminescent dosimeter (TLD). The indl.
paetment.
vidual shall wear the personnel monitors on the trunk of the body. Registrants are exempted from
)
(10) The inspection and maintenance of radio-requiring the use of alarm rate meters. Each film graphic exposure devices, source changers, storage badge or TLD shall be assigned to and worn by only containers, transportation containers, source guide one individual.
tubes, crank.out devices and radiation-producing i
machines.
(b) Film badges shall be replaced at intervals not to exceed I month and thermoluminescent dosim-RADIATION SURVEY INSTRUMENT AND eters (TLDs) shall be replaced at intervals not to PERSONNEL MONII'ORING REQUIREMENTS exceed 3 months.
I 225.151. Radiation survey instruments.
(c) The use of pocket dosimeters is subject to the (a) A licensee or registrant shall maintain suffi, following requirements:
cient calibrated and operable radiation survey in-(1) Pocket dosimeters shall have a range of 0 to struments to make physical radiation surveys as 51.6 pC/kg (200 mR) and shall be recharged at least required by this chapter and Chapter 219 (relating daily or at the start of each work shift. Electronic
. to standards for the protection against radiation).
personal dosimeters may only be used in place of (b) A radiographic operation may not be con.
lon-chamber pocket dosimeters.
ducted unless calibrated and oiwrable radiation (2) Pocket dosimeters shall be read 'and expo-survey instrumentation is available and used at sures recorded at least at the beginning and end of each site where radiographic exposures, and each worker's shift involving the use of a source of radiation. producing machines are used.
radiation.
(c) Immediately prior to use, a radiation survey
('l) Packet dosimeters shall be checked for cor.
Instrument shall be checked to ensure that it is rect response to radiation at periods not to exceed operating properly by bringing it near a source of 1 year, and acceptable dosimeters shall read within radiation and observing its response. Instruments 230% of the true radiation exposure. Records of that fall to respond may not be used.
pocket dosimeter calibration shall be maintained 6 225.152. Radiation survey instrument calibration for inspection by the Department for 5 years.
requirements.
(4) If an individual's pocket dosimeter is dis-(a) In addition to the requirements of i 225.151 charged be ond its range (that is, "off. scale"), le (relating to radiation survey instruments), instru-dustrial ra lographic operations by that indi,via,ual ments required by this chapter shall be capable of shall cease immediately and the individuals film measuring 0.516 pC/kg (2 mR) per hour through 258 badge or TLD shall be sent immediately for pro-pC/kg (1 R) per hour.
cessing. The individual may not use sources of radiation until the individual's radiation dose has (b) Each radiation instrument shall be calibrated:
been determined.
I (1) At energies appropriate for nae.
(d) Reports received from film badge or TLD processors and workers with daily pocket dosim-(2) At intervals not to exceed one of the follow" eter readings shall be kept for inspection by the ing:
. Department until the radioactive materials license (1) For radioactive materials,6 months, or certificate of registration is terminated or until the Department authorizes their disposition, in (11) For radiation producing machines,6 months.
writing, following a determination by the Depart-(3) After each instrument servicing, other than ment that the records contain inaccurate personnel battery replacement.
monitoring information.
(4) So that accuracy within a20% can be demon.
I 225.154. Personal alarm rate meters.
strated.
(a) In addition to other requirements of this sub-ces snal w7a u$e ap rbmIt ly on ith seal so an ope abl I
t I
d t
f full scale on each scale; for logarithmic scale instru.
and functiomng alarm rate meter. Each alarm rate meter shall:
1 ments, at mid range of each decade, and at two i
polats of sst least 1 decade; and for digital instru.
(1) Be checked prior to use at the start of each ments, at three points between 0.516 pC/kg (2 mR) shift to ensure that the alarm functions properly :
and 258 pC/kg (1 R) per hour.
(sounds).
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
PROPOSED RULEMAKING 909
- (2) Be set to give an alarm signal at a preset dose dures for the unit and has demonstrated an under-rcta cf 5 millislevert (500 millirem) per hour or less.
standing of the operating procedures and compe-(3) Require special means to change the preset tency in the use of the unit.
at:rm function.
(c) The registrant shall provide personnel moni-(4) Be checked for proper response to radiation toring equipment to every individual who operates, et irtarvals not to exceed 1 year. The alarm rate positions material for irradiation or performs main-tenancs on a radiation-producing machine for thill clarm within s20% of the true radiation dose rets. Records of alarm rate meter calibration shall shielded nom radiography.
be maintained for inspection by the Departtaent for (d) The operator shall conduct a physical radia-5 ytars.
tion survey to determine that the radiation ma.
(b) The alarm rate meter shall be used in addi.
chine X-ray tube is de-energiz.ed prior to each entry tien to, and not.as substitute for, the portable into the radiographic exposure area.
redistien survey instrument required by this chap-(e) Shielded room radiography using radiation-i tir. The. alarm rate meter is intended to provide producing machines shall.be exempt from I
cdditional assurance that the radiation exposure il 225.251-225.262 (relating to sealed source re-Izvsls tre within regulatory limits.
quirements).
RADIATION PRODUCING MACHINE i 225.203. Field site radiography.
REQUIREMENTS (a) The operator shan conduct a physical railla-0 225.201. Cabinet X ray systems, tion survey to determine that the radiation ma-(a) It shall be impossible to energize a cabinet chine X-ray tube is de-energized prior to each entry X r.y system unless all openings are securely into the radiographic exposure area. Survey results closed and the openings meet the requirements of and records of the boundary location shall be i 219.31 (relating to occupational dose limits for maintained and kept available for inspection by the I
cdults). Each access door to the cabinet shall have Department for 5 years.
an int rlock that terminates the exposure when.
(b) Mobile or portable radiation producing ma.
svzr the door is opened. The enclosure shall be chines shall be physically secured to prevent tam-chizided so that every location on the exterior pering or removal by unauthorized personnel.
micts the conditions for an unrestricted area.
(c) Other radiography using radiation-producing (b) A registrant may not permit an individual to machines shall be exempt from 15 225.251 - 225.262 cperets a cabinet X-ray system until the individual (relating to sealed source requirements).
has received a copy of, and instruction in, the cp:riting procedures for the system and has dem.
6 225.204. Surveys and survey records.
en trated an understanding of the operating proce-(a) A survey with a calibrated radiation survey dures and competency in the use of the cabinet instrument shall be made after each radiographic X-ray system.
exposure to determine that the radiation producing (c) The registrant shall evaluate the cabinet X.
machine X ray tube is de-energized.
~
ray system to assure compliance with 6 219.31 (re-(b) Records of the surveys required by subsection Itting to occupational dose limits for adults) and (a) shall be maintained for inspection by the De-with 21 CFR 1020.40 (relating to cabinet X ray partment for 5 years. If the survey has been used to syttsms) if the system is a certified cabinet X-ray determine an individual's exposure, the records of sy ttm. The records of these evaluations shall be the survey shall be maintained until the Depart-m;intained for ins tion by the Department for 5 ment authorizes their disposition.
6 225.205. Utilization logs.
- (d) The registrant shall test the on off switch, the unit interlocks and safety devices at intervals not A registrant shall maintain current logs, which exceeding 1 year, and make repairs as necessary, shall be kept available for inspection by the Depart-Records of these tests shall be maintained for ment for 5 years from the date of the event, show-J in:pection by the Department for 5 years.
ing for each radiation producing machine, the fol.
]
lowing applicable information:
(s) Cabinet X ray systems are exempt from all othtr provisions of this chapter.
(1) The identity (name and signature) of the op-6 225.202. Shielded room X ray machine radiogra-as ed.
e) A room used for shielded room radiography p
u gm e i chall be shielded so that every location on the exterior meets conditions for an unrestricted area (3) The location and date of use.
and the only access to the room is through open*
(4) The technique factors (tube kilovoltage, tube ings which are interlocked so that the radiation current, exposure time) used for each radiographic I
scurca will not operate unless all openings are exposure.
j securzly closed and meet the requirements of 6 219.91 (relating to control of access to high radia.
I 225.206. Bomb detection or baggage / package X-
)
tien areas).
Ray systems.
]
(b) A registrant may not permit an individual to (a) This section applies to X-ray systems that i
cperate a radiation producing machine for shielded produce an image which may be used to screen room radiography until the individual has received package 1 for the presence of explosive devices or a c:py of, and instruction in, the operating proce.
components, weapons, or other contraband or pro-PENNSYLVANIA BULLETlN. VOL 28. NO. 7, FEBRUARY 14l 1998 A
910
- PROPOSED RULEMAKING hibited items. This section does not apply to cabi.
light shall be illuminated only when the X-ray tube net X-ray systems designed and used primarily for is energized or only when the shutter is open.
the inspection of haggage or ackages at airports.
(e) Fluoroscopic equipment shall be as follows:
X-ray systems used for bomb etection or baggage /
package screening are. exempt from il 225.251 -
(1) Leakage radiation from the source assembly i
225.262 (relating to sealed source requirements).
measured at a distance of 1 meter in any direction
- (b) An X-ray system used for explosives or weap-from the source may not exceed 25.8 pC/kg (100 l
ons detection may not be used on human beings or mR) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> when the X ray tube is operated at animals. X-ray systems whose purpose is the irra-its leakage technique factors. Compliance shall be diation of human beings for medical diagnosis are determined by measurements averaged over an j
covered under Chapter 221 (relating to X rays in area of 100 square centsmeters with no linear j
the healing arts), X-ray systems that irradiate ani-dimension greater than 20 centimeters.
mais for diagnosis or therapy are covered under (2) The X-ray machine shall be labeled with a a
Chapter 223 (relating to veterinary medicine).
readily discernible sign bearing the radiation sym-(c) Training shall be as follows:
bol and the words, " Caution Radiation-T,his equip-ment produces radiation when energized or words (1)' A registrant shall provide training and safety containing a similar warning, near any switch that rules to each individual who operates the energizes the X ray tube.
radiation-producing machines or equipment under his control, including restrictions of the operating (3) To the extent practicable, the X-ray system technique required for the safe operation of the (X-ray tube, imaging system and the object being particular apparatus, and require that the operator irradiated) shall be completely enclosed so that demonstrate familiarity with these rules.
every location on the exterior meets conditions for an unrestricted area and the only access to the (2) An individual may not operate these X-ray room or enclosure is through openings which are systems unless the individual has received training interlocked so that the radiation source will not in, and received a copy of, the operating instruc-operate unless all openings are securely closed and tions for the unit and the operating and emergency meet the requirements of I 219 91 (relating to con-procedures relevant to the use of these systems, trol of access to high radiation areas).
The operator shall demonstrate, to the satisfaction of the registrant, competency in the safe use of this (4) The equipment shall be so constructed that, equipment.
under conditions of normal use, the entire cross-section of the useful beam shall be attenuated by a (d) Radiographic equipment shall conform to the primary protective barrier permanently incorpo-following:
rated into the equipment.
(1) The leakage radiation from the source assem-(5) The X ray control shall have a dead man type bly. measured at a distance of 1 meter in any exposure switch. Activation of the X ray beam shall direction from the source may not exceed 25.8 be possible only by continuous pressure on the pC/kg (100 mR) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> when the X ray tube is
. exposure switch.
operated at 'its leakage technique factors. Compli-ance shall be determined by measurement-aver.
(6) The X ray machine shall be labeled with a aged over an area of 100 square centimett i with readily discernible sign bearing the radiation sym-no linear dimension greater than 20 centlueters.
bol and the words, " Caution Radiation-This equip-ment produces radiation when energized" or words (2) Portable X-ray systems shall be equipped with containing a similar warning, near any switch that collimators which are capable of restricting the energizes the X-ray tube.
useful beam to the area of interest. Collimators shall provide the same degree of protection re.
(7) An easily visible warning light shall be lo-quired in paragraph (1).
cated adjacent to the X-ray tube or on the outside of the enclosure and be labeled with the words (3) A means shall be provided to terminate the "X ray on" or words containing a similar warning.
exposure after a preset time or exposure or a preset This light shall be illuminated only when the X-ray '
l product of exposure time and tube current.
tube is energized or only when the shutter is open.
(4) The X-ray control shall have a dead-man type eEPosure switch, (f) Portable X ray radiographic equipment oper-ating procedures are as follows:
(5) X ray controls shall indicate the technique (1) To the extent practicable, portable X-ray tube factors (that is, kilovoltage, tube current and expo-heads shall be supported by a stand.
sure time or the product of tube current and exposure time).
(2) To the extent practicable, supporting or posi.
(6) The X-ray machine shall be labeled with a t@n g devius fw the mm shah be used for radia-readily discernible sign bearing the radiation sym.
mn eKPoswes.
bol and the words, " Caution Radiation-This equip.
(3) Individuals, other than those whose presence ment produces radiation when energized" or words is necessary to conduct the X ray procedure, shall-containing a similar warning, near any switch that be located at least 5 meters away from.the X ray energizes the X ray tube.
tube and the object being irradiated during expo-(7) For fixed radiographic equipment,'an easily visible warning light shall be located adjacent to (4) An individual may not be regularly employed the X-ray tube and labeled with the words "X ray to support the film or object during radiation on" or words containing a similar warning. This exposures.
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
(.
l PROPOSED RULEMAKING 911 I
(g) Fixed radiographic equipment operating pro-(A) The chemical sy:nbol and mass number of the cedures are as follows:
radionuclide in the device.
(1) A registrant shall test the safety and warning (B) The activity and the date on which this activ-p dxvices, including interlocks, at intervals not to ity was last measured.
exceed 12 months. Records of these tests shal*, be mrintained for inspection by the Department ter 5 (C) The model number and serial number of the y:ars after the test has been conducted.
sealed source.
(2) A safety or warning device which is found not (D) The manufacturer of the sealed source.
to be functioning properly shall be repaired as (E) 'Ihe licensee's name, address und telephone
"***#F' number.
I 225.207. X. ray calibration systems.
WAMW@mehbWMh (a) This section applies to registranta who regu-use as a Type B transport container shall meet the larly, or for commercial purposes, calibrate equip-applicable requirements of Chapter 230 (relating to mint used to measure the output of radiation for transportation of radioactive materials),
medical diagnosis and therapy, or for radiation survey meters and similar instrumentation. X-ray (iii) Modification of an exposure device, source ey:tems used for calibration purposes are exempt changer, source assembly and associated equipment from il 225.251-225.262 (relating to sealed source is prohibited, unless the design of any replacement requirements).
component including source holder, source assem-bly, controls or guide tubes would not compromise (b) A room or enclosure used for calibration shall the design safety features of the system.-
be chielded so that every location on the exterior meets conditions for an unrestricted area and the (3) In addition to the requirements specified in caly access to the room or enclosure is through paragraphs (1) and (2), the following requiremenis cpenings which are interlocked so that the radia-apply to radiographic exposure devices, source as.
tion source will not operate unless all openings are semblies and associated equipment that allow the securely closed and meet the' requirements of source to be moved out of the device for routine i 219.91 (relating to control of access to high radia-operations or to source changers:
tien areas).
(1) The coupling between the source assembly (c) A registrant may not permit an individual to and the control cable shall be designed so that the cpsrate a radiation producing machine for shielded source assembly will not become disconnected if room radiography until the individual has received cranked outside the guide tube. The coupling shall a copy of, an instruction in, the operating proce-be such that it cannot be unintentionally discon-dures for the unit and has demonstrated an under-nected under normal and reasonable, or foreseeable stending of the operating procedures and compe-abnormal, conditions.
tency in the use of the unit.
60 h da M eMW mm &
(d) The operator shall conduct a physical radia-source assembly when it is cranked back into the ti:n survey to determine that the radiation ma-fully shielded position within the device. This se-chine X ray tube is de-energized prior to each entry curing system may only be released by means of a into the radiographic exposure area.
deliberate operation of the exposure device.
(e) As an alternative to the radiation survey re-(iii) The outlet fittings, lock box and drive cable quirement of subsection (d), the registrant may use fittings on each radiographic exposure device shall an independent radiation monitoring system that be equipped with safety plugs or covers which shall dirplays the radiation intensity or displays when be installed during storage and transportation to radiation levels have returned to their pre-protect the source assembly from water, mud, sand irradiation levels.
or other foreign matter.
SEALED SOURCE REQUIREMENTS (iv) Each sealed source or source assembly shall i 225.251. Performance requirements for radiogra-have attached to it or engraved on it a durable, phy equipment.
legible, visible label with the words, " Danger, Ra.
Equipment used in industrial radiographic opera-dioactive." The label may not interfere with the safe tiens shall meet the following minimum criteria:
operation of the exposure device or associated equipment.
(1) Each radiographic exposure device, source casembly and sealed source and all associated (v) The guide tube shall be able to withstand a equipment shall meet the requirements in Amari.
crushing test that closely approximates the crush.
can National Standards Institute N432-1980," Radio, ing forces that are likely to be encountered during logical Safety for the Design and Construction of use, and be able to withstand a kinking resistance Apparatus for Gamma Radiography," published as test that closely approximates the kinking forces NBS Handbook 136 issued January,1981.
that are likely to be encountered during use.
(2) In addition to the requirements in paragraph (vi) Guide tubes shall be used when moving the (1), the following requirements apply to radio-source out of the device.
graphic exposure devices, source changers, source assemblies and sealed sources:
(vil) An exposure head or similar device designed to prevent the source assembly from passing out of (i) Ech radiographic exposure device shall have the end of the guide tube shall be attached to the l
cttsched to it by the user, a durable, legible, clearly outmost end of the guide tube during radiographic visible label bearing the following:
operations.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
912 PROPOSED RULEMAKING (vill) The guide tube err,osure head connection having a minimum diameter of 25 millimeters, and shall be able to withstand the tensile test for the wording: " Caution, Radioactive Material, Notify control units specified in ANSI N4321980.
Civil Authorities (or "Name of Company") or " Dan-(lz) Source changers shall provide a system for ger",
assuring that the source will not be accidentally (b) Each radiographic exposure device shall have withdrawn from the changer when connecting or a lock or outer locked container designed to pre-disconnecting the drive cable to or from a source vent unauthorized or accidental removal of the assembly.
sealed source from a shielded position. The expo-(4) Newly manufactured radiographic exposure sure device or its container shall be kept locked when not under the direct surveillance of a devices and associated equipment acquired by a licensee after January 10, 1992, shall comply with radiographer or a radiogra hers assistant or as thga sectgon.
otherwise may be authorize in i 225.105 (relating to permanent radiographic installations). During i
G Radiographic exposure devices and associated radiographic operations the sealed source assembly equipment in use after January 10, 1996, shall shall be secured in the shielded position each time comply with this section.
the source is returned to that position.
j (6) lutwithstanding paragraphs (1), (4) and (5),
(c) Each sealed source storage container and equipment used in inidustrial radiographic opera-source changer shall have a lock or outer lock tions neel not comply with section 8.9.2(c) of the container designed to prevent unauthorized or ac.
endurance test in American National Standards cidental removal of the sealed source from its Institute N4W-1980, if the prototype equipment has shielded position. Storage containers and source been tested using a torque value representative of changers shall be kept locked vihen containing the torque that an individual using the radiography sealed sources except when under the direct sur-equipment can realistically exert on the lever or veillance of a radiographer or radiographer's assis-crankshaft of the drive mechanism, tant.
i 225.252. Limits on levels of radiation for radio-(d) Radiographic exposure devices, source chang-graphic exposure devices, storage containers and ers and storage containers, before being moved source changers.
from one location to another, shall have the guide (a) Radiographic exposure devices measuring tubes and control cables disconnected, safety plugs less than 10 centimeters (4 inches) from the sealed or covers applied, he locked and physically secured source storage position to any exterior surface of to prevent acci, dental loss, tampering or removal of the device shall have no radiation level in excess of licensed material.
12.9 pC/kg (50 mR) per hour at 15 centimeters (6 (e) A lock-out survey shall be performed before inches) from any exterior surface of the device.
moving the radiographic exposure device, source (b) Radiographic exposure devices measuring a changer or storage container to a new location and minimum of 10 centimeters (4 inches) from the when securing against unauthorized removal.
sealed source storage position to any exterior sur-6 225.254. Storage precautions.
-I face of the device or for radiographic' exposure devices, shall have no radiation level in excess,of Locked radiographic exposure devices, source 51.6 pC/kg (200 mR) per hour at any exterior changers, storage containees and transport contain-surface, and 2.58 pC/kg (10 mR) per hour at 1 meter ers that contain sealed sources shall be secured to from any exterior surface. The radiation level prevent tampering or removal by unauthorized per-rpecified is with the sealed source in its shielded sonnel from its permanent storage facility,
("off") position.
I 225.255. Leak testing and replacement of sealed (c) The maximum exposure rate 1 meter from storage containers and source changers is 51.6 (a) Only persons specifically authorized by the pC/kg (200 mR) per hour at any exterior surface, Department, the NRC or an agreement state, may 1
cad 2.58 pC/kg (10 mR) per hour at I meter from replace or leak test a sealed source fastened to or cny exterior surface when the sealed source is in contained in a radiographic exposure device or its shielded ("off") position.
source changer.
(d) Subsection (a) appiles to all equipment manu.
(b) Each sealed source shall be tested for leakage factured prior to January 10, 1992. After January at intervals not to exceed 6 months. Each sealed 10, 1996, radiographic equipment other than stor-source shall be leak tested prior to its first use age containers and source changers shall meet the unless the supplier furnishes a certificate stating requirements of i 225.251 (relating to performance that. the source has been tested within 6 months i
requirements for radiography equipment),
prior to its first use.
-6 225.253. Locking and relocation of radiographic (c) Each exposure device using depleted (DU) exposure devices, storage containers and source uranium shielding and an "S" tube configuration changers.
shall be tested for DU contamination at intervals ntt exceed 12 months.
(a) A license may not use a source changer or a container to store licensed material unless the (d) The leak test required by subsections (a) and source changer or the storage container has se-(b) shall be capable of detecting the presence of curely attached to it a durable, legible and clearly
.005 microcuries (185 Bq) of the removable contami.
. visible label bearing the standard trefoil radiation nation of the test sample. An acceptable leak test caution symbol conventional colors, that is, ma-for sealed sources in the possession of a radiogra-genta, purple or black on a yellow background, phy licensee would be to test at the nearest acces.
PENNSYLVANIA BULLETIN, VOL 28. NO. 7 FEBRUARY 14, 1998
PROPOSED RULEMAKING 913 cible point to the sealed source position or other (c) If, during an inventory, a radiation source rppropriate measuring point by a procedure ap-cannot be located or accounted, the licensee shall proved under i 219.65(5) (relating to specific li.
notify the Department as required under i 219.221 censes for the use of sealed sources in industrial (relating to reports of stolen, lost or missing 11-radiography).
censed sources of radiation).
(a) Records of leak test results shall be kept in 6 225.257. Inspection and maintenance of radio-units of becquerels or microcuries and be main-Kraphic exposure devices, storage containers, as-t:Ined for 5 years from the date of the test for sociated equipment and source changers.
in:pection by the Department.
(a) A licensee shall ensure that checkis for obvi.
(f) A leak test conducted under subsection (b) ous defects in radiographic exposure devices, trans-which reveals the presence of 0.005 microcuries port containers, source changers, source guide (185 Bq) or more of removable contamination is tubes and crankaut devices are performed at the considered evidence that the sealed source is leak-beginning of each day of use.
ing. The licensee shall immediately withdraw the (b) At intervals not to exceed 3 months, each equipment involved from use and cause it to be licensee shall conduct a program of inspection and d:c:ntaminated and repaired or to be disposed of, maintenance of the radiographic exposure devices, in recordance with li 217.101 and 219.61-219.66.
transport containers and source changers to assure Within 5 days of the test that reveals the leakage, proper functioning of components. Appropriate tha licensee shall file a report with the Department parts shall be maintained in accordance with describing the equipment involved, and the test manufacturer's specifications. The licensee shall results and the corrective action taken.
have written procedures for the conduct of this r
(g) If the testing of an exposure device using pmgram.
dipleted uranium shielding reveals the presence of (c) A licensee shall have a written program for DU contamination, the exposure device shall be inspection and maintenance of the Type B packag-removed from use until an evaluation of the wear ing used to transport radiosctive materials. This cf the S-tube has ' bsen made. If this evaluation program shall include procedures to assure that reveals that the S-tube is worn through, the device Type B packages are shipped and maintained in m:y not be used again.
accorc'ance with the certificate of compliance or ther approval, (h) Sealed sources that are stored and not being used shall be leak tested within 6 months prior to (d) Records of inspection and maintenance shall tha date of transfer, and the maximum interval be maintained for inspection by the Department for between leak tests may not exceed 3 years.
5 yaars.
(1) Depleted uranium shielding devices that are (e) If an inspection conducted under subsection st: red and not being used need not be tested for (a) or (b) reveals damage to components critical to dipleted uranium contamination while in storage radiation safety, the licensee shall remove the de-and not in use. The device shall be tested for DU vice fmn service until repairs have been made, contamination prior to use or transfer of the devies (f) Opening, repair or umodification of any sealed if the interval of storage exceeds 12 months. A source shall be performed by persons specifically rec:rd of the depleted uranium leak test shall be authorized by the Department, made in accordance with subsection (e).
$ 225.258. Utilization logs.
(j) A sealed source which is not fastened to or A licensee shall maintain current logs, which contained in a radiographic exposure device shall shall be kept available for 5 years from the date of hr.va a durable tag permanently attached to it. This the recorded event, for inspection by the Depart-tag shall have a dimension of at least 1 inch (2.5 ment, at the address specified in the license, show.
centimeters) square and bear the prescribed radia-ing for each sealed source the following informa-tirn caution symbol in conventional colors, ma.
tion:
thefn (1) The make, model and serid number of the et ons " nge a t ve at s
rit!-D,o not handle-Notify civil authorities if radiographic exposure device or source container found.
in which the sealed source is located.
e i enthy and signaun of de 4
t 225.256. Physical inventories.
radiagrapher to whom assigned.
(t) A licensee shall conduct a physical inventory (3) The plant or site where used and dates of use.
Et intervals not to exceed 3 months to account for cil sources of radiation received or possessed. The i 225.259. Radiation surveys and records.
invrntory shall cover all sources or radiation, in-(a) After each radiographic exposure, a survey cluding, but not limited to, sealed sources, source with a calibrated radiation survey instrument shall chtngers and radiographic exposure devices con-be made to determine that the sealed source has talning depleted uranium as shleiding.
returned to the shielded position. The entire perim.
(b) Records of the inventories shall be main-eter of the radiographic exposure device,shall be tained for 5 years from the date of the inventory for surveyed. If the radiographic exposure device has a guide tube or collimator, the survey shall include in:pection by the De(artment and shall include the manufacturer, mode serial number, radionuclide the guide tube or collimator, or both.
and activity,if applicable, location of each source of (b) A physical radiation survey shall be made to l
radhtlon, date of the inventory and the name of determine that each sealed source is in its shielded i
ths individual performing the inventory.
position prior to securing the radiographic expo.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14. 1998
914 PROPOSED RULEMAKING sure device or storage container as specified in source to its safe position in the event of unautho-6 225.253 (relating to locking and relocation or rized or accidental entry by an individual.
radiographic exposure devices, storage containers and source changers).
(f) Barricades shall be provided around the pe-rimeter of the restricted area and shall be posted (c) Records of the surveys required by subsection with sufficient conspicuous warning signs to pre.
(b) shall be maintained for inspection by the De-vent unauthorized entry. Radiation levels at the partment for 5 years. If the survey has been used to boundary of the restricted area may not be greater determine an individual's exposure, the records of than 0.516 pC/kg (2 mR) in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />.
the survey shall be maintained until the Depart-APPENDIX A ment authorizes their disposition.
Subjects to be Covered Daring the i 225.260. Supervision of radiographer's assis-Instruction of Radiographers tant (s).
Except when a radiographer's assistant uses ra' diographic exposure devicea, uses sealed sources or II. Radiation Detection Instrun.entation to be Used related source handling tools, or conducts physical radiation surveys required under i 225.259(a) and C. Use of personnel monitoring equipment (b) (relating to radiation surveys and records) to determine that the sealed source has returned to the shielded position after an exposure, a
- 2. Thennoluminescent dosimeten, (TLDs) radiographer's. assistant shall be under the per.
sonal supervision or a qualified radiographer. The
- 3. Pocket dosimeters and alarm ratemeters peraonal supervision shall include the radiog-rapher's physical presence at the site where the CHAPTER 226. RADIATION SAFETY REQUIREMENTS '
sealed sources are being used at a proximity that FOR [ WIRELINE SERVICE OPERATIONS AND immediate assistance can be given if required and watching the performance of the radiographer's SUBSURFACE TRACER STUDIES ] WELL assistant.
LOGGING i 2'25.261. Radiographic, operations, security and Subchapter A. SCOPE AND DEFINITIONS posting.
GENERAL (a) Whenever radiography is performed at ' loca-5 226.1. Purpose and scope.
a tion other than a permanent radiographic installa*
tion, a radiographer shall be accompanied by at This chapter establishes radiation safety requirements least one other quallfled radiographer or an indl.
fu Pe sg un es b [ Mb e -
vidual who has'at minimum met the requirements vice operations including mineral logging] well of i 225.72(b) (relating to training and testing of logging in a single well, radioactive markers, uranium radiographer's assistant). The additional qualified sinker bars and subsurface tracer studies. Persons who individual shall observe the operations and be use radiation sources for [ wireline service ] well log-capable of providing immediate assistance to pre-ging operations shall comply with this chapter, which is vent unauthorized entry. Radiography may not be in addition to and not in sub titution for other applicable performed if only one qualified individual is requirements of this article.
- present, i 226.2. Definitions.
(b) During each radiographic operation, a The following words and terms, when used in this radiographer or a radiographer's assistant shall maintain constant direct visual surveillance of the chapter, have the following meanings, unless the context clearly indicates otherwise; operation to protect against unauthorized entry into a high radiation area, except where one of the following exists:
Fresh water a9uifer-A geologic formation that is (1) The high radiation area is equipped with a capable of yielding fresh water to a well or spring.
control' device or alarm system as described in i 219.91 (relating to control of access to high radia-tion areas).
Logging assistant-An individual who, under the personal supervision of a logging supervisor, (2) The high radiation area is locked to protect handles sealed sources or tracers that are not in against unauthorized or accidental entry.
logging tools or shipping containers or who per-forms surveys required by this chapter, (c) Areas in which radiography is being er-formed shall be conspicuously posted as requfred legging supervisor-The individual who uses radioac.
by i 219.153 or i 219.154 (relating to radiation ar-tive material or provides personal supervision of the eas; and high radiation areas), as appropriate.
utilization of radiation sources at the temporary jobsite, and who is responsible for assuring compliance hl) A licensee or registrant shall keep sufficient with this chapter and license conditions.
calibrated and operable radiation survey instru-ments at the location of use oflicensed material or Logging tool-A device used beneath the surface a radiation-producing machine.
to perform well logging.
(e) A radiographer or an assistant radiographer
[ Mineral logging-Logging performed for the shall be located near the crank handle of the purpose of mineral exploration other than oil or radiographic exposure device to return the sealed gas. ]
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14,199c
1 PROPOSED RULEMAKING 915 l
Personal supervision-Guidance and instruction by the i 226.13. Radiation survey instruments.
supervisor who is physically present at the temporary (a) Afaintenance. The b.eensee o registrant shall main.
jobsite and watching the performance of the operation in
[ cuch ] proximity so that contact can be maintained and tain sufficient calibrated and operable radiation survey immediate. assistance given as required-to make physical radia@ tion surveys as required unen s at a site w radiadon soums am esent y this Radioactive marker-Radioactive material placed be.
' chapter and by 9 219.71 (relating to general). Instrumen.
neith the surface or on a structure intended for subsur-tation shall be capable of measuring 0.1 milliroentgen face use to determine depth or direction. The term (25.8 nC/kg) per hour through at least 50 milliroentgens includes radioactive collar markers and radioactive (12.9 pC/kg) per hour. [ Survey instruments acquired irza nails.
before December 19, 1987, and capable of measur-Safety reriew-The periodic review provided by ing 0.1 milliroentgen (25.8 nC/kg) per hour through tha licensee for its employes on radiation safety at least 20 milliroentgens (5.16 pC/kg) per hour also asycts of well logging. This review may include, as satisfy this requirement until July 14,1992.]
cypropriate, the results of internal inspections' (b) Calibration.
nsw procedures or equipment, accidents or errors th;t have been observed or reported, and opportu.
nities for employes to ask safety questions.
(3) For linear scale instruments, at two points located approximately 1/3 and 2/3 of full scale on Subsurface casing for protecting fresh water aqui.
each scale; for logarithmic scale instruments, at fers-A pipe or tube used as a lining in a well to midrange of each decade, and at two points of at
]
isolate fresh water aquifers from the well.
least I decade; and for digital instruments, at ap.
propriate points.
(c) Time period. Calibration records shall be main-f nmporaryjobsite-A place where radioactive ma.
tained for [ a period of 5] 3 years or until the
{
t: rials are present for the purpose of performing Department authorizes their disposal.
w211 logging or subsurface tracer studies.
(d) The licensee shall have available additional Uranium sinker bar-A weight containing de-plated uranium used to pull a logging tool toward calibrated and operable radiation survey instru.
tha bottom of a well.
ments sensitive enough to detect the low radiation j
and contamination levels that could be encountered j
W;ll-A drilled hole in which well logging may be if a source ruptured. The licensee may own these Pedtrmed.
Instruments or may have a procedure to obtain Well[.] logging-The use of measuring devices or tools them quickly from another person.
which may contam radiation sourco in well-bores or i 226.14, Leak testing of sealed sources.
cavitirs to obtain information about the well or adjacent formitions, or both. The term includes subsurface tracir studies.
(b) A sealed soarce shall be tested for leakage at
[ Mireline serrice operation-An evaluation or me, intervals not to exceed 6 months. The sealed source shall chanical service which is performed in the well.
be leak-tested prior to its fint use unless the supplier bore using logging tools with electrical or elec-fumshes,thm, certificate stating that the source has been a
tronic cable assemblies. ]
suspected that a sealed source may be leakm, use. If it is tested wi 6 months prior to its first g, it shall be i 226.3. Prohibition.
removed from service immediately and tested for leakage.
The leak test shall be capable of detecting the presence of A h.eensee may not perform [ wirel.tne service opera.
.005 microcuries (185 Bq) of removable contamination on ti:ns ] well logging with a sealed source unless, prior to the test sample. An acceptable leak test for sealed sources commencement of the operation, the licensee has a writ-would be to take the test sample from the surface of the ten agreement with the well operator, well owner or source, soun e holder or the surface of the device in which dnihng contractor that:
the source is stored or mounted and on which one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries-or EQUIPMENT CONTROL becquerels-and maintained for [ 5] 3 years from the date of the test or until the Department authorizes their i 226.11. Limits on levels of radiation.
disposal.
The licensee or registrant shall use, store and transport radiation sources in accordance with 69 219.31-219.38, 219.51 (relating to occupational dose limits; and (e) The method of testing a sealed source for radiation dose limits for individual members of the i
gen 1ral public) and Chapter 230 (relating to packag-leakage shall be performed using a leak test kit or ing and transportation of radioactive material).
method approved by the Department, an agreement state or the NRC. The wipe sample shall be taken i 226.12. Storage and transport precautions.
from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample shall be analyzed for radioactive con-(c) Transport containers shall be locked ard physi-tamination. The analysis shall be capable of detect.
cally secured to the transpotting vehicle to prevent ing the presence of 185 Bq (.005 pCl) of radioactive accidental loss, tampering or unauthorized removal of the material on the test sample and shall be performed rzdiation sources.
by a person approved by the Department, the NRC PENNSYLVANIA BULLETIN, VOL 28, NC. 7, FEBRUARY 14, 1998
~_.-
916 PROPOSED RULEMAKING or'an agreement state to perform the analysis, if (v) The test source shall be subjected to an exter-
~ the licensee does not possess suitably sensitive nal pressure of 24,600 pounds per square inch equipment, absolute (1.695 x 10 pascals).
7 5 226.15. [ Quarterly ] Physical inventory.
[(b) For a sealed source, except one containing
. v radioactive material in gaseous form, acquired af-(a) A' heen..see or registrant shall conduct a [ quar
- ter December 19, 1988, in the absence of a certifi-f terly ] - semiannual physical inventory of radiation cate from a transferor certifying that an individual sources to account for all sources of radiation re.
sealed source meets the requirements of subsection ceived or possessed. Records of inventories shall be (a), the sealed source may not be put into use until maintained for [ 5 ] 3 years from the date of the inven-the - determinations and testing have been per-tory or'until the Department authorizes their disposal formed.
[ and ]. Records shall include the quantities and kinds (c) A sealed source, except those cont.:..dng ra-of radiation sources, the location where raliation sources dioactive material in gaseous form, used in are assigned, the date of the inventory and the name of downhole operations after December 19,1989, shall j
the individual conducting the inventory.
be certified by the manufacturer or other testing (b) Physical inventory records may be combined rganization acceptable to the Department as meet-with leak test records
- ing the sealed source performance requirements for oil well-logging as contained in the American Na-p 226.16. LTillization records, tional Standard N542, Scaled Radioactive Sources, A licensee or registrant shall maintain curnmt records, which shall be kept available for inspection by the (d) Certification documents shall be maintained Department for [ 5] 3 years from the date of the for a period of 5 years after source disposal or until recorded event, showing the following information for the Department authorizes their disposal. If the each mdiation source:
source is abandoned downhole, the certification documents shall be maintained until the Depart-ment authorizes their disposition. ]
(4) In the case of tracer materials and radioactive i 226.19. Inspection and maintenance, markers, the radionuclide and quantity of activity used in a particular well and the disposition of any unused (a) A licensee or registrant shall conduct, at intervals tracer materials.
not to exceed 6 months, a program of inspection and 6 226.17. Design [,) and performance [ and, ertifica-maintenance of source holders, logging tools, source han-dling tools, storage containers, transport containers, ura-tion ] criteria for sealed sources [ used in downhch, nium sinker bars and injection tools to assure [ proper operations ].
labeling and physical condition ] that the required
[ (a)] A licensee may not use a sealed source, except labeling is legible and that no physical damage is those containing radioactive material in gaseous form, visible. Records of inspection and maintenance shall be
[ used ] in [ downhole operations and manufactured maintained for [ a rarlod of 5] 3 years or until the after December 19, 1988, shall be certified by the Department authorizes their disposal.
manufacturer, or other testing organization accept.
(b) If any inspection conducted under subsection (a) able to the Department, as meeting the] well log.
reveals damage to labeling or components critical to-ging unless the sealed source meets the following radiation safety, the device shall be removed from service minimum criteria.
until repairs have been made. A record shall be made, listing the following informatiom (1) [ Be ] Is of doubly encapsulated construction.
Wh a b hk (2) The name of the inspector.
(3).[Has been individually pressure tested to at least 24,600 pounds per square inch absolute (170 (3) The equipment involved.
MN/m") without failure ] The sealed source's proto.
(4) Defects found.
. type has been tested and found to maintain its (5) Repairs made.
integrity after each of the following tests:
(i) The test source shall be held at -40*C for 20 minutes,600*C for 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />, and then subjected to a (d) Records required under subsection (b) shall thermal shock test with a temperature drop from be maintained for 3 years after the defect is found.
q 600*C to 20'C within 15 seconds.
j (e) Removal of a sealed source from a source
]
(11) A 5 kg steel hammer,2.5 cm in diameter, shall holder or logging tool, and maintenance on sealed be dropped from a height of 1 meter onto the test sources or holders in which sealed sources kre contained may not be performed by the licensee source.
unless a written procedure developed under
.(ilD The test source shall be subject to a vibra-t 226.22 (relating to operating and emergency pro-tion from 25 Hz to 500 Hz at 5g amplitude for 30 cedures) has been approved by the Department, the minutes.
NRC or an agreement state or a licensing state.
(iv) A 1 gram hammer and pin, 0.3 cm pin diam.
(f) If a sealed source is stuck in the source holder, J
eter, shall be dropped from a height of 1 meter onto the licensee may not perform any operation, such j
the test source.
as drilling, cutting or chiseling, on the source
]
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUAM 14, 1998
PROPOSED RULEMAKING 917 h Idtr unless the licensee is specifically approved radiation) including handling and use of sealed by the Department, the NRC or an agreemen! state sources in wells without surface casing for protect-
' to perform the actions, ing fresh water aquifers, if appropriate.
I 226.20. Radioactive markers and uranium sinker (2) [ Radiation surveying] Methods and occa-bars.
sions for conducting radiation surveys, including
( ) The licensee may use radioactive markers in surveys for detecting contamination, as required w2112 only if the individual markers contain quanti-under 6 226.41 (relating to radiation surveys and tira cf licensed radioactive material not exceeding contamination control).
thos:a quantities specified in Chapter 217 Appendix B (relating to exempt quantitles). The use of mark.
srs is subject only to the requirements of i 226.15 (5) Transportation of radiation sources to field sta.
(rel: ting to physical inventories).
tions or temporary jobsites, packaging of radiation (b) The licensee may use a uranium sinker bar in sources for transport in vehicles, placarding of
'w211 logging only if it is legibly impressed with the vehicles when needed and physically securing ra-wrrds, " Caution-Radioactive-Depleted Uranium" diation sources in transport vehicles during trans-and " Notify Civil Authorities (or name of company) portation to prevent accidental loss, tampering or if Fcund."
unauthorized removal.
REQUIREMENTS FOR PERSONNEL SAFETY I 226.21. Training requirements.
(8) Maintaining records, including those generated an by logging personnel at temporary jobsites, (a) [ No] A licensee or registrant may not permi individual to act as a logging supervisor as defined in (9) Inspecting and maintaining sealed sources, source i 226.2 (relating to definitions) until the individual has:
holders, loggmg tools, source handling tools, storage con'ainers, transport containers, [ and ] injection tools (b) The demonstrated competence required under ard uranium sinker bars, as required under subsection (a)(1) and (2) shall be determined by the i 226.19 (relating to 8.u'nction and maintenance).
individual's successful completion of a written test.
The demonstrated competence required under cubsection(a)(3) shall be determined by the success-(11) Procedures to be used for icking up, receiving and ful competion of a field evaluation of the indi-opening packages containing rad oactive material, under vidual.
i 219.162 (relating to procedures for receiving and
[(b) No ] (c) A licensee or registrant may not permit opening packages),
an individual to assist in the handling of radiation (12) Use of remote handling tools for handling sources until the individual hasi sealed sources and radioactive tracers (except low (1) Read or received instruction in the licensee's or activity calibration sources).
registrant's operating and emergency procedures, this (13) Minimizing ersonnel exposure, including
. ch:pter and applicable sections of Chapters 219 exposures from inhalation or ingestion of licensed end 220 (relating to standards for protection
- " *I* rial **
ag; inst radiation; and notices, instructions and reports to workers) and demonstrated an understand-(14) Decontamination of the environment, equip-ing thereof.
ment and personnel when using tracers.
(15) Actions to be taken if a sealed source is (3) The demonstrated understanding required un-ruptured including actions to prevent the spread of d:r paragraph (1) shall be determined by the indi-contamination and minimize inhalation and inges-vidual's successful completion of a written or oral tion of licensed materials and actions to obtain test. The demonstrated competence required under suitable radiation survey instruments as required paragraph (2) shall be determined by the individu.
by 6 216.13 (relating to radiation survey instru.
cl's cuccessful demonstration by a field evaluation.
ments).
[(c)](d) The licensee or registrant shall maintain (16) Identifying and reporting to the Department employe training records for [ 5) 3 years following defects and noncompliance as required by this l
termination of employment or until the Department article.
authorizes their disposal.
6 226.23. Personnel monitoring.
(s) The licensee shall provide safety reviews for (a) [No] A licensee or registrant may not permit an logging supervisors and logging assistants at least cace during each calendar year.
Individual to act as a logging supervisor or to assist in the handling of radiation sources unless the individual i 226.22. Operating and emergency procedures.
wears either a film badge or a thennoluminescent dosim-The licensee's or registrant's operating and emergency eter (TLD). The film badge or TLD shall be assigned to procidures shall include instructions in at least the and worn by only one individual. A film badge shall be following:
replaced at least monthly and TLDs replaced at least quarterly. After replacement, each film badge (1) Handlm.g and use of radiation sc.urces to be em-or TLD shall be promptly processed.
ployId so that no individual is likely to be exposed to radirtion doses in excess of the standards established in Chapter 219 (relating to standards for protection against PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
918 PROPOSED RULEMAKING PRECAUTIONARY PROCEDURES IN WELL LOGGING disposal] If the licensee has reason to believe that,
[ AND SUBSURFACE TRACER ] OPERATIONS as a result of any operation involving a sealed source, the enca
(
l 226.31. Security, could be damageksulation of the sealed source by the operation, the licensee j
(a) During a well logging [ or tracer application ]
shall conduct a radiation survey, including a con.
operation, the logging supervisor or other designated tamination survey, during and after the operation.
employe shall maintain direct surveillance of the opera-(f) If the licensee detects evidence that a sealed tion to protect against unauthorized and unnecessary source has ruptured or that radioactive materials entry into a restricted area.
have caused contamination, the licensee shall im-I (b)'A logging supervisor shall be physically mediately initiate the emergency procehres re.
present at a temporary jobsite whenever radiation quired under i 226.22 (relating to operating and sources are being handled or are not stored and emergency procedures).
locked in a vehicle or storage place. The logging (R) If contamination results from the use of radio-supervisor may leave the jobsite to obtain assist-active material in well logging operations, the 11-
.i ance, such as if a source becomes lodged in a well censee shall decontaminate all work areas, equip.
or if a medical emergency arises.
ment and unrestricted areas. At a minimum, the 6 226.33. Subsurface tracer studies and use of sealed decontamination efforts shall achieve the require-sources in wells without surface casings.
ments of 5 219.51 (relating to dose liMts for indl.
(a) Protective gloves and other ap ropriate protective vidual members of the public),
clothing and equipment shall be use by personnel han-(h) During efforts to recover a sealed source dling radioactive tracer material. Precautions shall be lodged in the well, the licensee shall continuously taken to avoid ingestion, inhalation a contamination monitor, with an appropriate radiation detection
[ of] by radioactive material of personnel, field sta.
Instrument or a logging tool with a radiation detec.
tions and temporary jobsites.
tor, the circulating fluids from the well, if any, to check for contamination resulting from damage to (b) [ No } A licensee may not inject radioactive mate-the sealed source, rial into [ potable] fresh water aquifers without prior (1) Records reqrired under subsections (a)-(g) written authorization from the Department and other shall include the dates, the identification of indi-responsible State or Federal [ agency ] agencies.
viduals making the survey, the survey instrumenta-(c) The licensee may use a sealed source in a well tion used and an exact description of the location without a surface casing for protecting fresh water of the survey. Records of these surveys shall be aquifers only if the licensee follows a procedure for maintained for 3 years after completion of the reducing the probability of the source becoming survey or until the Department authorizes their lodged in the well. The procedure shall be approved disposal.
by the Department under the conditions of the i 226.42. Documents and records required at field license or by the NRC or an agreement state.
stations.
6 226.34. Particle accelerators.
A licensee or registrant shall maintain, for inspection (a) [No] A licensee or registrant may not permit by the Department, the following documents and records I# '
specific devices and sources used at the field aboveground testing of particle accelerators designed for station.-
use in well-logging which results in the production of radiation, except in areas or facilities controlled or shielded so that the requirements of f 219.51 (relating (6) [ Quarterly ] Physical m.ventories required under to dose limits for individual members of the public)
[li 219.11 and 219.21 (relating to radiation dose to g 226.15 (relating to [ quarterly ] physical inventory).
individuals and maximum permissible levels of ra.
diation from external sources) protection programs; (10) Training records required under.f 226.21 (re-as applicable,) are met.
lating to training requirements).
(b) The use of particle accelerators for well log-6 226.43. Documents and records required at tem-ging Shall be conducted under the licensing provi-porary jobsites.
sions of Chaptei 228 (relating to radiation safety requirements for particle accelerators).
A licensee or registrant conducting operations at a temporary jobsite shall have the following documents and RADIATION SURVEYS AND RECORDS records available at that site for inspection by the g 226 41. Radiation surveys and contamination con.
Department:
trol.
(1) Operating and emergency procedures required un-(a) Radiation surveys shall be made and recorded for der i 226.22 (relating to operating and emergency an area where radioactive materials are used and stored.
procedures).
(2) Survey records required under 5 226.41 (relating to e
e e
radiation surveys and contamination control) for the l
(e) [ Records required under subrections (a)-(d) period of operation at the site.
shall include the dates, the identification of indi.
viduals making the survey, the survey instrumenta-tion used and an ez,act description of the location (5) The shipping papers for the transportation of of the survey. Records of these surveys _ shall be radioactive materials required under Chapter 230 maintained for 5 years after completion of the (relating to packaging and transportation of radio-survey or until the Department authorizes their active material).
PENNSYLVANIA BULLETIN,. VOL 28, NO. 7, FEBRUARY 14,1998
1 PROPOSED RULEMAKING 919 NOTIFICATION A -The maximum activity of radioactive material, 2
material, pspecial form, [ radioactive ] LSA and SCO other than i 226.51. Notification of incidents, abandonment ermitted in a Type A package. These values cnd lost sources.
are either listed in Appendix A, Table I (relating to packaging and transportation of radioactive mate-(b) The licensee shall immediately notify the Depart.
rials) or may be derived in accordance with the procedure ment by telephone and subsequently by confirming letter Prescribed in Appendix A.
if the licensee knows or has reason to believe that-r:dio:ctive material has been lost in or to an under-ground [ potable ] fresh water source. The notice shall
[ Closed transport oehicle-A transport vehicle design te the well location and shall describe the equipped with a securely attached exterior enclo.
[ magniture ] magnitudo and extent of loss of radioac-sure that during normal transportation restricts tme access unauthoM pemns to the cargo tiva miterial, [ access ] assess the consequences of the 1:ss cnd explam. efforts space containing the radioactive material. The en-gita these consequences. planned or being taken to miti-closure may be temporary or permanent, but shall i
limit access from the top, sides and ends. In the (c) If a sealed source or device containing radioactive case of packaged materials, the enclosure may be of material is lodged downhole, the licensee shall:
the see-through type. ]
(1) Monitor at the surface for the presence of radioac-Containment system-The assembly of compo-tive c:ntamination with a radiation survey instrument or nents of the packaging intended to retain the radio-logging tool during logging tool recovery operations, as active material during transport.
required under 5 226.41 (relating to radiation sur.
vsys rnd contamination control).
Conoeyance-Any of the following:
(2) Notify the Department immediately by telephone if (1) For transport by public highway or rail, trans-r:diractive contamination is detected at the surface or if Port vehicle or large freight container.
the source appears to be damaged, as required under (11) For transport by water, vessel or hold, com-1 226.41.
partment or denned deck area of a vessel including transport vehicle on board the vessel.
(e) If a sealed source containing radioactive material is (iii) For transport by air, any aircraft.
tbzndoned downhole, the licensee shall provide a penna-Exclusive use-The sole use of a conveyance by a single nent plaque [-an example of a suggested plaquo is consignor and for which initial, ir.termediate and final sh:wn in Appendix B--] for posting the well or loading and unloading are carried out in accordance with well-bore. The plaque shall:
the direction of the consignor or consignee. [ The term is used interchangeably with the terms " sole use" or
" full load" in other regulations, such as 49 CFR (2) Contain the following information engraved on its (relating to transportation).] The consignor and ftce:
the carrier shall ensure that any loading or unload.
ing is performed by personnel having radiological training and resources appropriate for safe han-(viii) An appropriate warning, depending on the spe-dling of the consignment. The consignor shall issue cific circumstances of the abandonment. Appropriate specific instructions, in writing, for maintenance of warnings may include:
exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.
(C) 'Do not re-enter the hole," followed by the words "before contacting the Pennsylvania Department of Envi-Fissile material-[ Special nuclear material consist.
ronmintal [ Resources ] Protection."
ing of or containing one or more fissile radio-nuclides. Fissile radionuclides are plutonium ]
(3) Be at least 7 inches (17cm) square and 1/8-inch Plutonium 238, plutonium 241, uranium-233, [ and ] plutonium-239, (3mm) thick.
uranium-235 or a combination of
[ APPENDIX B ] (Reserved) these radionuclides. The term does not include unir-(' Editor's Note: As part of this proposal, the Board is radiated natural uranium [ or ] and depleted uranium, and natural uranium or depleted uranium that has proposing to delete Appendix B (re,lating to example of been irradiated in thermal reactors only. Depart-pl:qus for identifymg wells contalmng radioactive mate-ment jurisdiction extends only to special nuclear material nal abandoned downhole) which appears at 25 Pa. Code in quantities not sufficient to form a critical mass as page 226-15, serial page (203991).)
defined in Chapter 215 (relating to general provisions).
CHAPTER 230. PACEAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL
[(1) Fissile Class I-A package which may be transported in unlimited numbers and in any ar-Subcliapter A. SCOPE AND DEFINITIONS rangement, and which requires no nu:: lear critical-6 230.2. Definitions.
ity safety controls during transportation. A trans-port index is not assigned fer purposes of nuclear Tht following words and terms, when used in this criticality safety but may be required because of ch pter, have the following meanings, unless the context external radiation levels.
clearly indicates otherwise:
(ii) Fissile Class H-A package which may be transported together with other packages in any PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
920 PROPOSED RULEMAKING arrangement but, for criticality control, in numbers (11) LSA.II is any of the following:
which do not exceed an aggregate transport index (A) Water with tritium concentration up to 0.8 of 50. These shipments require no other nuclear TBq/ liter (20.0 ci/ liter)*
criticality safety control during transportation. In-dividual packages may have a transport index not (B) Material in which the radioactive material is less than 0.1 and not more than 10.
distributed throughout, and the average a ecific Fissile material package-A fissile material pack.
[,f[,,*F,,Ns"hyo qui s i
, aging together with its fissile contents as presented for transport.]
(iii) LSLIII solids (for example, consolidated wastes, activated materials) in which all of the following are met:
l Low specific activity material-[ Includes one or (A) The radioactive material is distributed l
more of the following:
throughout a solid or a collection of solid objects or (1) Uranium or thorium ores and physical or is essentially uniformly distributed in a solid com-chemical concentrates of those ores.
pact binding agent (such as concrete, bitumen, ceramic, and so forth).
U diate atural or depleted uranium or -
(B) The radioactive material is relatively in-l soluble, or it is intrinsically contained in a (iii) Tritium oxide in aqueous solutions provided relatvely insoluble material, so that, even under the concentration does not exceed 5.0 millicuries loss of packaging, the loss of radioactive material (185 MBq) per milliliter.
per package by leaching, when placed in water for (iv) Material in which the radloactivity is essen, 7 days, would not exceed 0.1 A.
2 tially uniformly distributed and in which the esti-
/ (C) The average; ific activity of the solid does mated average concentration per gram of contents
( not exceed (2,000 A /g.
2 does not exceed one of the following:
Loss toxicity alpha emitters-Natural uranium, de-(A) 0.0001 millicurie (3.7 kBq) of radionuclides for pleted uranium, natural thorium; uranium 235, which the A, quantity in Appendix A of this part is uranium-238, thorium-232, thorium-228 or thorium-not more than 0.05 curie (1.85 GBq).
230 when contained in ores or physical or chemical (B) 0.005 millicurie (185 kBq) of radionuclides for contrates or tailings; or alpha emitters with a which the As quantity in Appendix A of this part is half-life ofless than 10 days.
more than 0.05 curie (1.85 GBq) but not more than 1 Maximum normal operating pressure-The maxi-
, curie (37 GBq).
mum gauge prescure that would develop in the (C) 0.3 millicurie (11.1 MBq) of radionuclides for containment system in 1 year under the heat condi-which the As quantity in Appendix A of this part is tion s ified in 10 CFR 71.71(c)(1) (relating to more than I curie (37 GBq).
no conditions of transport) in the absence of venting, external cooling by an ancillary system, or (v) Objects of nonradioactive material externally operational controls during transport.
contaminated with radioactive matenal, if the ra.
dioactive material is not readily dispersible, and Natural thorium-Thorium with the naturally oc.
the surface contamination, when averaged over an curring distribution of thorium isotopes-essen-
, area of I square meter, does not exceed 0.0001 tially 100 weight percent thorium-232.
millicurie per square centimeter (3.7 kBq/cm*) of radionuclides for which the quantity in Appen.
dix A is not more than 0.05 e e (1.85 GBq) or 0.001 Surface contaminated object-A solid object that millicurie per square centinveter (37 kBq/cm*) for itself is not classed as radioactive material, but other radionuclides.] Radivactive material with which has radioactive material distributed on any I
of its surfaces. SCO shall be in one of two groups limited specific activity that satisfies the descrip-with surface activity not exceding the following tions and limits as follows. Shielding materials limits:
1 surrounding the LSA material may not be consid-ered in determining the estimated average specific (i) SCO 1-A solid object to which all of the fol-I activity of the package contents. LSA material shall lowing conditions apply:
be in one of three groups:
(a) The nonfixed contamination on the accessible (1) LSA-I is any of the following:
surface averaged over 300 cm*-or the area of the surface if less than 300 cm*-does not exceed 4 nuclides, (for, example, uranium, thon,curringradio-Bq/cm* (10-* pC/cm*) for beta and gamma and low (A) Ores containingonlynaturallyoc um) and ura-nium or thonum concentrates of these ores.
toxicity alpha emitters, or.0.4 Bq/cm* (10 s pCl/cm")
for all other alpha emitters.
(B) Solid unirradiated natural uranium or de.
(B) The fixed contamination on the accessible pleted uranium or natural thorium or their solid or liquid compounds or mixtures.
surface averaged over 300 cm*-or the area of the surface if less than 300 cm*-does not exceed 4 x 4
(C) Radioactive material, other than fissile mate.
10 Bq/cm* (1pC1/cm*) for beta and gamma and low rial, for which the A value is unlimited.
toxicity *) alpha emitters, or 4 x 10 3 Bq/cm 8
8 (0.1 2
pCi/cm for all other alpha emitters, (D) Mill tailings, contaminated earth,' concrete, rubble, other debris and activated. material in (c) The nonfixed contamination plus the fixed which the radioactive material is essentially uni-contamination on the accessible surface averaged formly distributed, and the average specific activity over 300 cm*-or the area of the surface ifless than does not exceed 104 A /g.
300 cm -does not exceed does not exceed 4 x 104 8
2 PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
PROPOSED RULEMAKING 921 8
8 Bq/cm (1 pC1/cm ) for beta and gamma and low (d) A licensee is exempt from the requirements of toxicity alpha emitters, or 4 x 10s Bq/cm (0.1 this chapter, other than il 230.13 and 230.44 (relat-8 8
pC1/cm ) for all other alpha emitters, ing to transportation of licensed material; and air (11) SCO 2-A solid object on which the limits tran8Pwt of Mutonium), with respect to shipment FRO SCO 1 are exceeded and on whicht w canlage oMA raaterial in group LSA.1, or SCO in group SCO-1.
( ) The nonfixed contamination on the accessible surf;ce averaged over 300 cm -or the area of the Subchapter C. USE OF APPROVED PACKAGES 8
surf 2ce if less than 300 cm*-does not exceed 400 (Editor's Note: The Department is proposing to delete Bq/cm* (10-8 pCi/cm*) for beta and gamma and low g6 230.25 and 230.26 (relating to Type A Fissile Class II toxicity alpha emitters, or 40 Bq/cm (10-8 pCl/cm*)
package; and restricted, Fissile Class II package) as they f;r all other alpha emitters.
currently appear in the Pennsylvania Code at pages (B) The fixed contamination on the accessible 230-9-230-11 (serial pages (204181)-(204183).
surface averaged over 300 cm -cr the area of the i 230.25. (Reserved).
8 curfac2 If less than 300 cm'.-<loes not exceed 8 x 8 Bq/cm' (20 pCi/cm*) for beta and gamma and i 230.26. (Reserved).
10 1:w toxicity alpha emitters, or 8 x 10 Bq/cm* (2 pC1/cm*) for all other alpha emitters.
Subchapter D. OPERATING CONTROLS AND PROCEDURES
' (c) The nonfixed contamination plus the fixed contamination on the accessible surface averaged I 230.41. [ Fissile material: assumptions as to un-ovIr 300 cm*-or the area of the surface ifless than known properties] Applicability of operating 8
300 cm -does not exceed 8 x 108 Bq/ cms (20 pCi/
controls and procedures.
8 cm ) f:r beta and gamma and low toxicity alpha emitters, or 8 x 10 Bq/cm" (2 pCl/cm") for all other
[ When the isotopic abundance, mass, concentra-4 alpha smitters.
tion, degree of irradiation, degree of moderation or other pertinent property of fissile material in a package is not known, the licensee shall package hansport index-The dimensionless number, rounded the fissile material as if the unknown properties up to the [ first decimal place ] next tenth, placed on had credible values that would cause the maximum tha libel of a package to designate the degree of coutrol nuclear reactivity. ] A licensee subject to this chap-to be czercised by the carrier during transportation. For ter, who, under a general or specific license, trans.
nonfissile material packages, the transport inder is Ports licensed material or delivers licensed mate.
tha number expressing the maximum radiation rial to a carrier for transport, shall comply with liv:1 in mrem per hour at 1 meter from the external this subchapter, Subchapter B and Subchapter E surface of the package or the marimum radiation (relating to general; and quality assurances).
levzl in millislevert per hour at 1 meter from the i 230.42. Preliminary determinations.
externr1 surface of the package multiplied by 100.
Prior to the first use of packaging for the shipment of radioactive material the licensee shall do the following:
Uranium (natural, depleted, enriched)--One of tha following:
(1) Natural uranium-Uranium with the naturally (2) Test the containment system at ::,n internal pres-occurring distribution of uranium isotopes-ap-sure at. least 50% higher than the maximum normal proximately 0.711 weight percent uranium 235, and Perating pressure to verify the capability of that system tha remainder by weight essentially.
to maintain its atmetural integnty at that pressure,
[ where] if the maximum nonnal operating pressure
" (11)' Depleted uranium-Urainium containing les*
will exceed [ 34.3 ] 35 kilopascal (5 psi) gauge.
uranium-235 than the naturally occurring distribu-tion cf isotopes.
(111) Enriched uranium-Uranium con' aining i 230.48. Opening instructions.
t more uranium-235 than the naturally occurring distribution of uranium isotopes.
Before delivery of a package to a carrier for transport, the licensee shall ensure that special Subchapter B. GENERAL instructions needed to safely open the package i 230.12. Exemptions.
have been sent to, or otherwise made availalile to, the consignee for the consignee's use under
$ 219.162(e) (relating to procedures for receiving (c) With the exception of $$ 230.13 and 230.42 (relat-and opening packages).
ing to transportation of licensed material; and prelimi-APPENDIX A nary dzterminations), a licensee is exempt from this chapter, with respect to shipment or carriage of one or DETERMINATION OF A AND A, m:re f the foHowing:
[ L Single Radionuclides.
- 1. For a single radionuclide of known identity, (3) A package in which only the radioactive mate-the values of A and A, are taken from Table I if t
! ' rial is LSA material or SCO, if the external level at listed there. The values A, and A in Table I are also 3 meters from the unshielded material or objects applicable for the radionucilde contained in 2
i does act exceed 10 mSv/hr (1 rem /hr).
(alpha,n) or (gamma,n) neutron sources.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7 FEBRUARY 14,~ 1998
922 PROPOSED RULEMAKING
- 2. For any single radionuclide whose identity is
- 1. For mixed fission products, the activity limit known but which is not listed in Table I, the value may be assumed if a detailed analysis of the mix.
of A, and As are determined according to the ture is not carried out, f Ilowing procedure:
A = 10 C1 (370 GBq) 3
- (a) If the radionuclide emits only one type of A, = 0.4 C1 (14.8 GBq) radiation A is determined according to the appro-i
- 2. A single radioactive de to be a single radionuclide, cay chain is considered priate formula in paragraphs (1) through (4). For when the radionuclides radionuclides emitting different kinds of radiation, As is the most restrictive value of those determined are present ir their naturally occurring propor-for each kind of radiation. However, in either case, tions and no daughter nuclide has a half-life either A is restricted to a maximum of 1,000 curies (37.
longer than 10 days or longer than that of the i
TBq). If a parent nuclide decays into e shorter lived Parent nuclide. The activity to be taken into ac.
daughter with a halflife not greater than 10 days, count and the As or A value from Table I to be An is_ calculated for both the parent and the daugh, applied are those corresponding to the parent ter, and the more limiting of the two values is nuclide of that chain. When calculating A or As 3
assigned to the parent nuclide.
values, radiation emitted by daughters must be considered. However, in the case of radioactive (1) For gamma emitters, A is determined by the decay chains in which any daughter nuclide has a i
expression:
half-life either longer than 10 days or greater than that of the parent nuclide, the parent and daughter A* = 9 curies /Y nuclides are considered to be mixtures of different
+
where y is the gamma ray cor.stant, corresponding nuclides.
to the dose in roentgens per curie-hour at 1 meter,
- 3. In the case of a mixture of different and the number 9 results from the choice of I rem radionuclides, where the identity and activity of per hour at a distance of 3 meters as the reference dose-equivalent rate, each radionuclide are known, the permissible act!v-ity of each radionuclide R, R... R. is such that (2) For x ray emitters, A is determined by the F + F, +... F, is not greater than unity, where:
3 atomic number of the nuclide:
F = Total activity of R / A,(R )
3 i
3 for Z s 55, A = 1,000 C1 (37 TBq); and F, = Total activity of R,/A (R )
i 3
for Z > 55, A = 200 C1 (7.4 TBq)
F, = Total activity of R,/A,(R.) and A (R, R... R ) is the value of An or As as where Z is the atomic number of the nuclide.
i 3
appropriate for the nuclide R, R,... R.
3 (3) For beta emitters, As is determinal by the maximum beta energy (E,._) according to Table II;
- 4. When the identity of each radionuclide is and known but the individual activities of some of the radionuclides are not known, the formula given in (4) For alpha emitters, A is determined by the paragraph 3. is applied to establish the values of A 3
3 expression:
or A, as appropriate. All the radionuclides whose A = 1,000 A individual activities are not known (their total 8
activity will, however, be known) are classed in a where As is the value listed in Table III; single group and the most restrictive value of A 3
and As applicable to any one of them is used'as the (b) As is the more rest,rictive of the following two value of A or A, in the denominator of the fraction.
3 values:
- 5. Where the identity of each radionuclide is (1) The corresponding A ; and known but the individual activity of none of the 3
(2) The value As obtained from Table III.
radionuclides is known, the most restrictive value
)
of As or As applicable to any one of the
- 3. For any single radionuclide whose identity is radionuclides present is adopted as the applicable l
unknown, the value of A is taken to be 2 C1 (74 value.
l GBq) and the value of A, Is taken to be' O.002 C1 (74
- 6. When the identity of none of the nuclides is MBq). However, if the atomic number of the radionucifde is known to be less than 82, the value known, the value of As is taken to be 2 C1 (74 GBq) and the value of A, is taken to be 0.002 Ci (74 MBq).
of An is taken to be 10 C1 (370 GBq) and the value of However,if alpha emitters are known to be absent, As is taken to be 0.4 C1 (14.8 GBq). ] Values of As the value of As is taken to be 0.4 C1 (14.8 GBq). ] For I
and As for individual radionuclides, which are the individual radionuclides whose identities are bases for many activity limits elsewhere in these regulations are given in Table A.I. The curie (Cl) known, but which are not listed in Table A.1, the values a cified are obtained by converting ikom determination of the values of An and Ag requires the tera querel (TBq) figure. The curie values Department approval, except that the values of A 3 and A in Table A 2 may be used without Depart-l are expressed to three significant figures to assure s
ment approval
- that the difference in the TBq and Cl quantities is 1/10 of 1% or less. Where values of A or A, are III. In the calculations of As and A, for a 3
unlimited, it is for radiation control purposes only, radionuclide not in Table A.1, a single radioactive For nuclear criticality safety, some materials are decay chain, in which no daughter nuclides a subject to controls placed on fissile material.
half-life either longer than 10 days, or longer than that of the parent nuclide, shall be considered as a II. [ Mixtures of Radionuclides, Includine Radio-single radionuclide, and the activity to be taken active Decay Chains, into account, and the As or A value to be applied PENNSYLVANIA BULLETIN, YOL. 28, No. 7, FEBRUARY N,1998
1 PROPOSED RULEMAKING 923 shall be those corresponding to the parent nuclide As for mixture = 1/(In F(i)/A (1))
3 cf that chain. In the case of radioactive decay chains in which any daughter nuclide has a half.
where F(i) is the fraction of activity of nuclide I in life alther longer than 10 days, or greater than that the mixture and A (1) is the appropriate A value s
of th2 parent nuclide, the parent and those daugh-for nuclide L ter nuclides shall be considered mixtures of differ-ect nuclides.
An A value for mixtures of normal form material IV. For mixtures of radionuclides whose identi-may be determined as follows:
ties crd respective activities are known, the follow.
A for mixture = 1/(In F(l)/A(1)')
ing conditions apply:
( ) For special form radioactive material, the where F(i) is the fraction of activity of nuclide I in maximum quantity transported in a Type A pack-the mixture and A,(i) is the appropriate A value for
. agI:
nuclide I.
In B(1)/A (1) less than or equal to 1 i
V. When the identity of each radionuclide is
.(b) For nosnal form radioactive material, the known, but the individual activities of some maximum quantity transported in a Type A pack
- radionuclides are not known, the radionuclides
'a#M may be grouped and the lowest As or As value, as I B(1)/A,(1) less than or equal to I appropriate, for the radionuclides in each group wh re B(i) is the activity of radionuclide I and A (i) may be used in applying the formulas in paragraph and A,(1) are the As and A values for radionuclide I, IV. Groups may be based on the total alpha activity
)
respectively.
and the total beta /gn=== activity when these are i
Alternatively, an A 'value for mixtures of special known, using the lowest As or.
values for the i
f:rm material may be determined as follows:
Alpha emitters and beta / gamma e tiers.
(Editor's Note: The Department is proposing to delete Tables I-IV as they currently appear in the Pennsylvania Code pages 230-21-230-30 (serial pages (204193)--(204202)) and replace them with new Tables A-1 and A-2).
TABLE A-1 A, and A. Values for Radionuclides (See Footnotes at End of Table)
Note: Some of the values in Table A-1 are presented in the Computer "E" notation. In this notation a value of 6E-02 i
represents a value of 6 X 10 8 or 0.06,6E+2 represents 6 X 10 or 600, and 6E+0 represents 6 X 10 or 6.
2 Symbol of Element and
' AlBq)
(bi)
(TBq)
(bi)
(TBqlg)
(Cilg)
A A,
A Specific activity
\\
radionuclide atomic number
(
' Actinium (89) 0.6 16.2 1E-2 0.270 2.1E+3 5.8E+4 Ac 227 40 1080 2E 5 5.41E-4 2.7.
7.2E+1 Ac-228 0.6 16.2 0.4 10.8 8.4E+4 2.2E+6 Ag 105 Silver (47) 2 54.1 2
54.1 1.1E+3 3.0E+4 -
Ag 108m 0.6 16.2 0.6 16.2 9.7E-1 2.6El
. Ag 110m 0.4 10.8 0.4-10.8 1.8E+2 4.7E+3 111 0.6 16.2 0.5 13.5 5.8E+3 1.9E+5 Ag26 AI-Aluminum (13) 0.4 10.8 0.4 10.8 7.0E-4 1.9E-2 Am 241 Americium (95) 2 54.1 2E-4 5.41E-3 1.3E1 3.4 Am-242m 2
54.1 2E-4 5.41E-3 3.6E-1 1.0E+1 Am-243 2
54.1 2E-4 5.41E-3 7.4E-3 2.0E-1 Ar-37 Argon (18) 40 1080 40 1080 3.7E+3 9.9e+4 Ar-39 20-541 20 541 1.3 3.4E+1 Ar41' O.6 16.2 0.6 16.2 1.5E+6 4.2E+7
. Ar-42 0.2 5.41 0.2 5.41 9.6 2.6E+2 As-72 Arsenic (33) 0.2 5.41 0.2 5.41 6.2E+4 1.7E+6 As-73 40 1080 40 1080 8.2E+2 2.2E+4 1
As-74 1
27.0 0.5 13.5 3.7E+3 9.9E+4
- As-76 0.2 5.41 0.2 5.41 5.8E+4 1.6E+6 i
As 77 20 541 0.5 13.5 3.9E+4 1.0E+6 At-211 Astatine (85) 30 811 2
54.1 7.6E+4 2.1E+6 Au-193 Gold (79) 6 162 6
162 3.4E+4 9.2E+5 Au-194 -
1 27.0 1
27.0 1.5E+4 4.1E+5 Au 195 10 270 10 270 1.4E+2 3.7E+3 Au 196 2
54.1 2
54.1 4.0E+3 1.1E+5 Au 198 3
81.1 0.5 13.5 9.0E+3 2.4E+5 Au 199 10 270 0.9 24.3 7.7E+3 2.1E+5 B>131 Barium (56) 2 54.1 2
54.1 3.1E+3 8.4E+4 Bd133m 10 270 0.9 24.3 2.2E+4 6.1E+5
' Bd140 0.4 10.8 0.4 10.8 2.7E+3 7.3E+4 Be Beryllium (4) 20 541 20 541 1.3E+4 3.5E+5 PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
924 PROPOSED RULEMAKIN3 Symbol of Element and AlBq)
(bi)
($Bq)
(Ci)
(TBqlg)
(Cilg)
A A
As Specific activity radionuclide atomic number
(
Be-10 20 541 0.5 13.5 8.3E-4 2.2E-2 Bi-205 Bismuth (83) 0.6 16.2 0.6 16.2 1.5E-3 4.2E+4 Bi 206 0.3 8.11 0.3 8.11 3.8E+3 1.0E+5 Bi-207 0.7 18.9 0.7 18.9 1.9 5.2E+1 Bi-210m 0.3 8.11 3E-2 0.811 2.1E-5 5.7e-4 Bi-212
~ 0.3 8.11 0.3 8.11 5.4E+5 1.5E+7 Bk 247 Berkelium (97) 2 54.1 2E-4 5.41E-3 3.8E-2 1.0 Bk-249 40 1080 8E-2 2.16 6.1E+1 1.6E+3 Br-76 Bromine (76) 0.3 8.11 0.3 8.11 9.4E++4 2.5E+6 j
Br-77
~
3 81.1 3
81.1 2.4E+4 7.1E+5 i
Br-82 0.4 10.8 0.4 10.8 4.0E+4 1.1E+6 C-11 Carbon (6) 1 27-0.5 13.5 3.1E+7 8.4E+8 C-14 40
'1080 2
54.1 1.6E 1 4.5 Ca-41 Calcium (20) 40 1080 40 1080 3.1E-3 8.5E-2 Ca-45 40 1080 0.9 24.3 6.6E+2 1.8E+4 t
Ca 47
. 0.9 24.3 0.5 13.5 2.3E+4 6.1E+5 i
Cd-109 -
Cadmium (48) 40 1080 1
27 9.6E+1 2.6E+3 Cd 113m 20 541 9E-2 2.43 8.3 2.2E+2 Cd-115m 0.3 8.11 0.3 8.11 9.4E+2 2.5E+4
)
Cd-115 4
108 0.5 13.5 1.9E+4 -
5.1E+5 Ce-139 Cerium (58) 6 162 6
162 2.5E+2 6.8E+3 i
Ce-141 10 270 0.5 13.5 1.1E+3 2.8E+4 '
Ce-143 0.6 16.2 0.5 13.5 2.5E+4 6.6E+5 Ce-144 '
0.2 5.41 0.2 5.41 1.2E+2 3.3E+3 Cf-248 Californium (98) 30 811 3E-3 8.11E-2 5.8E+1 1.6E+3 Cf-249.
2 54.1 '
2E-4 5.41E-3 1.5E-1 4.1 Cf-250 5
135 5E-4 1.35E-2 4.0 1.1E+2 i
Cf 251 -
2 54.1 2E-4 5.41E-3 5.9E-2 1.6 i
Cf-252 0.1 2.70 1E-3 2.70E-2 2.0E+1 5.4E+2 Cf-253 40 1080 SE-2 1.62 1.1E+3.
2.9E+4 Cf-254 3E-1 8.11E-2 6E-4 1.62E-2 3.1E+2 8.5E+3 Cl-36 Chlorine (36) 20 541 0.5 13.5 1.2E-3 3.3E-2 Cl-38 0.2 5.41 0.2 5.41 4.9E+6 1.3E+8 Cm-240 Curium (96) 40 1080 2E-2 0.541 7.5E+2 2.0E+4 Cm 241 2
54.1 0.9 24.3 6.1E+2 1.7E+4 Cm-242 40 1080 1E-2 0.270 -
1.2E+2 3.3E+3 Cm-243 3
81.1 3E-4 8.11E-3 1.9 5.2E+1 Cm-244 4
108 4E-4 1.08E-2 3.0 Cm 245 2
54.1 2E-4 5.41E-3 6.4E-3.
8.1E+1 1.7E.1 Cm-246 2
54.1 2E-4 5.41E-3 1.1E-2
.3.1E-1 Cm-247 2
54.1 2E-4 5.41E-3 3.4E-6 9.3E-5 Cm-248 4E-2 1.08 SE-3 1.35E-3 1.6E-4 4.2E-3 Co-55 Cobalt (27) 0.5 13.5 0.5 13.5 1.1E+5 3.1E+6 Co-56 0.3 8.11 0.3 8.11 1.1E+3 3.0E+4 Co-57 8
216 8
216 3.1E+2 8.4E+3 Co-58m 40 1080 40 1080 2.2E+5 5.9E+6 Co-58 1
27.0 1.
27.0 1.2E+3 3.2E+4
- Co-60 0.4 10.8 0.4 10.8 4.2E+1 1.1E+3 Cr-51 Chromium (24) 30 811 30 8 11
- 3.4E+3 9.2E+4 Cs 129
' Cesium (55) 4 108 4
108 2.8E+4 7.6E+5 Cs-131 40 1080 40 1080 3.8E+3 1.0E+5 Cs-132 1
27.0 1
27.0 5.7E+3 1.5E+5 Cs-134m 40 1080 9
243 3.0E+5 8.0E+6 Cs-134 0.6 16.2 0.5 13.5 4.8E+1 1.3E+3 Cs-135 40 1080 0.9 24.3 4.3E-5 1.2E-2 Cs-136 0.5 13.5 0.5 13.5 2.7E+3 7.3E+4-Cs-137
-2 54.1 0.5 13.5 3.2 8.7E+1 Cu-64 Copper (29) 5 135 0.9 24.3 1.4E+5 3.9E+6 Cu -
9 243 0.9 24.3 2.8E+4 7.6E+5 Dy-159 Dysprosium (66) 20 541 20 541 2.1E+2 5.7E+3 -
Dy-165 0.6 16.2 0.5 13.5 3.0E+5 8.2E+6 -
Dy-166 0.3 8.11 0.S 8.11 8.6E+3 2.3E+5 Er-169 Ersum (68) 40 1080 0.9 24.3 3.1E+3 8.3E+4 Er-171 0.6 16.2 0.5 13.5 9.0E+4 2.4E+6 Es-253 Einsteinium (99Xa) 200 5400 2E-2 5.41E-1 Es-254 :
30 -
811 3E-3 8.11E-2 Es-254m 0.6 16.2 0.4 10.8 PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
~...
PROPOSED RULEMAKING 925 Symbol of Element and Al*
(bi)
(TBq)
(bi)
JBqlg)
(Cilg)
A A,
A Specific activity radionuclide atomic number
( Bq)
Es-255 Eu-147 Europium (63) 2 54.1 2
54.1 1.4E+3 3.7E+4 Eu 148.
0.5 13.5 0.5 13.5 6.0E+2 1.6E+4 Eu-149 20 541 20 541 3.5E+2 9.4E+3 Eu-150 0.7 18.9 0.7 18.9 6.1E+4 1.6E+6 Eu 152m 0.6 16.2 0.5 13.5 8.2E+4 2.2E+6 Eu 152 0.9 24.3 0.9 24.3 6.5 1.8E+2 Eu-154 0.8 21.6 0.5 13.5 9.8 2.6E+2 Eu-155 20 541 2
54.1 1.8E+1 4.9E+2 i
Eu-156 0.6 16.2 0.5 13.5 2.0E+3 5.5E+4
)
F 16 Fluorine (9) 1 27.0 0.5 13.5 3.5E+6 9.5E+7 Fo 52 Iron (26).
0.2 5.41 0.2 5.41 2.7E+5 7.3E+6
' Fa 55 40 1080 40 1080 8.8E+1 2.4E+3 Fe-59 0.8 21.6 0.8 21.6 1.8E+3 5.0E+4 Fe-60 40 1030 0.2 5.41 7.4E 4 2.0E 2 Fm 255 Fermium (100Xb) 40 1080 0.8 21.6 Fm-257 6
162 6
162 2.2E+4 6.0E+5 10 270 SE-3 21.6E-1 Gn-67 Gallium (31)
Ga-68 0.3 8.11 0.3 8.11 1.5E+6 4.1E+7 G -72 0.4 10.8 0.4 10.8 1.1E+5 3.1E+6 Gd 146 Gadolinium (64) 0.4 10.8 0.4 10.8 6.9E+2 1.9E+4 Gd 148 3
81.1 3E-4 8.11E-3 1.2 3.2E+1 Gd 153 10 270 5
135 1.3E+2 3.5E+3 Gd-159 4
108 0.5 13.5 3.0E+4 1.1E+6 Ge-68 Germanium (32) 0.3 8.11 0.3 8.11 2.6E+2 7.1E+3 Ge-71 40 1080 40 1080 5.8E+3 1.6E+5
)
Ge-77 0.3 8.11 0.3 8.11 1.3E+5 ~
3.6E+6 i
H-3.
. Hydrogen (1)
See T-Tritium Hr 172 Hdnium (72) 0.5 13.5 0.3 8.11 4.1E+1 1.1E+3 i
Hf-175 3
81.1 3
81.1 3.9E+2 1.1E+4 Hf-181 2
54.1 0.9 24.3 6.3E+2 1.7E+4 Hf182 4
108 3E-2 0.811 8.1E-6 2.2E-4 Hg 194 Mercury (80) 1 27.0 1
27.0 1.3E1 3.5 Hg-1A5m 5
135 5
135 L5E+4 4.0E+5
)
Hg-107m 10 270 0.9 24.3 2.5E+4 6.7E+5 Hg-lb7 10 270 10 270 9.2E+3 2.5E+5 Hg-203 4
108 0.9 24.3 5.1E+2 1.4E+4 Ho-163 Holmium (67) 40 1080 40 1080 2.7 7.6E 1 Ho-166m 0.6 16.2 0.3 8.11 6.6E-2 1.8 Ho-166 0.3 8.11 0.3 8.11 2.6E+4 7.0E+5 I123 Iodine (53) 6 162 6
162 7.1E+4 1.9E+6 I124 0.9 24.3 0.9 24.3 9.3E+3 2.5E+5 I125 20 541 2
54.1 6.4E+2 1.7E+4
'I-126 2-54.1
- 0.9 24.3 2.9E+3 8.0E+4 I 129 Unlimited Unlimited 6.5E-6 1.8E-4 I131 3
81.1 0.5 13.5 4.6E,3 L2E+5 I132 0.4 10.8 0.4 10.8 3.8E+5 1.0E+7 I-133 0.6 16.2 0.5 13.5 4.2E+4 1.1E+6 I 134 0.3 8.11 0.3 8.11 9.9E+5 2.7E+7 I-135 0.6 16.2 0.5 13.5 1.3E+5 3.5E+6 In-111 Indium (49) 2 54.1 2
54.1 1.5E+4 4.2E+5 In-113m 4
108 4
108 6.2E+5 1.7E+7 In-114m 0.3 8.11 0.3 8.11 8.6E+2 2.3E+4 In-115m 6
162 0.9 24.3 2.2E+5 6.1E+6 Ir-189 Iridium (77) 10.
270 10 270 1.9E+3 5.2E+4 '
Ir 190 0.7 18.9 0.7 18.9 2.3E+3 6.2E+4 Ir-192 1
27.0 0.5 13.5 3.4E+2 9.2E+3 Ir-193m 10 270 10 270 2.4E+3 6.4E+4
' Ir-194 -
0.2 5.41 0.2 5.41 3.1E+4 8.4E+5 K-40 Potassium (19) 0.6 16.2 0.6 16.2 2.4 E-7 6.4E-6 K-42 0.2 5.41 0.2 5.41 2.2E+5 6.0E+6 K-43 1.0 27.0 0.5 13.5 1.2E+5 3.3E+6
- Kr. Krypton (39) 40 1080 40 1080 7.8E-4 2.1E-2 Kr-85m 6
162 6
162 3.0E+5 8.2E+6
' Kr-85 20 541 10 270 1.5E+1 3.9E+2 Kr-87 0.2 5.41 0.2 5.41 1.0E+6 2.8E+7
- La 137 Lanthanum (57) 40 1080 2
54.1 1.6E-3 4.4E-2 PENNSYLVANIA BULLETIN, VOL 28, NO. 7. FEBRUARY 14, 1998
926 PRCPOSED RULEMAKING Symbol of Element and.
A' A
A, A'
Specific activity radionuclide atomic number
($Bq)
. (bi)
(TBq)
(bi)
(TBqlg)
(Cilg)
La 140 0.4 10.8 0.4 10.8 2.1E+4 5.6E+5 Lu 172 '
Lutetium (71) 0.5 13.5 0.5 13.5 4.2E+3 1.1E+5 Lu-173 8
216 8
216 5.6E+1 1.5E+3 Lu 174m 20 541 8
216-
- 2.0E+2 5.3E+3
. Lu 174 8
216 4-108 2.3E+1 6.2E+2 Lu 177, 30 811 0.9 24.3 4.1E+3 1.1E+5 MFP For mixed fisson products,use formulas for mixtures in Table A-2 Mg-28 Magnesium (12) 0.2 54.1 0.2 54.1 2.0E+5 5.4E+6 Mn-52 Manganese (25)
Mn-53 Unlimited Unlimited 6.8E-5 1.8E-3 Mn-54
.1 27.0 1-27.0 2.9E+2 7.7E+3 Mn-56 0.2 5.41 0.2 5.41-8.0E+5 2.2E+7 Mo-93
. Molybdenum (42) 40 1080 7-189 4.1E-2 1.1 Mo-99 0.6 16.2 0.5 13.5(c) -
1.8E+4 4.8E+5 1613.
Nitrogen (7) 0.6 16.2 0.5 13.5 5.4E+7 -
1.5E+9 Na-22 Sodium (22)
- 0.5 13.5 0.5 13.5 2.3E+2 6.3E+3 Na-24 0.2 5.41 0.2 5.41 3.2E+5 8.7E+6 Nb-92m Niobium (41)
' O.7 18.9 0.7 18.9 5.3E+3 1.4E+5 Nb-93m 40 1080 6
162 8.8 2.4E+2 Nb-94 0.6 16.2 0.6 16.2 6.9E-3 1.9E-1 '
Nb-95 1
27.0 1
27.0 1.5E+3 3.9E+4 Nb-97 0.6 16.2 0.5 13.5 9.9E+5 2.7E+7 '
Nd-147 Neodymium (60) 4 108 0.5 13.5 3.0E+3 8.1E+4 Nd-149 0.6 16.2 0.5 13.5 4.5E+5 1.2E+7 Ni-59 Nickel (28) 40 1080 40 1080 3.0E-3 8.0E-2 Ni-63 40 1080 30 811 2.1-5.7E+1 Ni-65 O.3 8.11 0.3 8.11 7.1E+5 1.9E+7 Np-235 Neptunium (93) 40 1080 40 1080 5.2E+1 1.4E+3 Np-236 7
189 IE-3 2.70E-2 4.7E-4 1.3E-2
. Np-237 2
54.1 2E 4 5.41E-3 2.5E-5 7.1E-4 Np-239 6
162 0.5 13.5 8.6E+3 2.3E+5.
Os 185 Osmium (76) 1 27.0 1
27.0 2.8E+2 7.5E+3 -
Os-191m.
40 1080 40 1080 4.6E+4 1.3E+6 1
Os 191 10 270 0.9 24.3 1.6E+3 4.4E+4 Os 193 '
O.6 16.2 0.5 13.5 2.0E+4 5.3E+5 On-194 0.2 5.41 0.2 5.41 1.1E+1 3.1E+2 P-32 Phosphorus (15) 0.3 8.11 0.3 8.11 1.1E+4 2.9E+5 P-33 40 1080 0.9 -
24.3 5.8E+3 1.6E+5 i
Pa-230 Protactinium (91) 2 54.1 0.1 2.70 1.2E+3 3.3E+4 l
Pa 231 0.6 16.2 6E 5 1.62E-3 1.7E-3 4.7E-2 Pa-233 -
5 135 0.9 24.3 7.7E+2 2.1E+4 -
I
. Pb-201 Lead (82) 1
' 27.0 -
1 27.0 6.2E+4 1.7E+6 Pb 202 40 1080 2
54.1 1.4E-4 3.4E l Pb 203 3
81.1 3
81.1 1.1E+4 3.0E+5 1
- Pb-205 Unlimited Unlimited -
4.5E-6 1.2E-4 Pb-210 0.6 16.2 9E-3 0.243 2.8 7.6E+1 Pb-212 0.3 8.11 0.3 8.11 5.1E+4 1.4E+6 Pd-103 Palladium (46) 40 1080 40 1080 2.8E+3 7.5E+4 Pd-107 Unlimited Unlimited 1.9E-5 5.1E-4 Pd-109 -
0.6 16.2 0.5 13.5 7.9E+4 2.1E+6 1
Pm 143 Promethium (61) 3 81.1 3
81.1 1.3E+2 3.4E+3 Pm-144 0.6 16.2 0.6 16.2 9.2E+1 2.5E+3 Pm-145 30 811 7
189 5.2 1.4E+2 Pm 147 40 1080 0.9 24.3 3.4E+1 9.3E+2 Pm-l'48m 0.5 13.5 0.5 13.5 7.9E+2 2.1E+4 '
Pm-149 0.6 16.2 0.5 13.5 1.5E+4 4.0E+5 Pm-151 3
81.1 0.5 13.5 2.7E+4 7.3E+5
' 5.9E+2 Po 209 40 1080 2E-2 0.541 6.2E-1 1.7E+1 Po-210 40 1080 2E-2 0.541 1.7E+2 4.5E+3 Pr-142 Praseodymium (59) 0.2 5.41 0.2 5.41 4.3E+4 1.2E+6 Pr 143.
4 108 0.5 13.5 2.5E+3 6.7E+4 Pt-188 Platinum (78) 0.6 16.2 0.6 16.2 2.5E+3 6.8E+4 Pt 191 3
81.1 3
81.1 8.7E+3 2.4E+5 i
Pt 191m_
.40 1080 9
243 5.8E+3 1.6E+5 f
Pt 193 40 1080 40 1080 1.4 3.7E+1
. Pt 195m 10
'270 2
54.1 6.2E+3 1.7E+5 i
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
I PROPOSED RULEMAKING 927
. Symbol of Element and
'A' A
A' Specific activity
. A"lBq).
(bi)
(7'Bqlg)
(Cilg) radionuclide atomic number -
($Bq)
. (bi)
(
Pt 197m 10'
'270
- 0.9 24.3 3.7h5 1.0h7 Pt-197
' 20 541 0.5 13.5 3.2E+4 8.7L5 Pu 236
- Plutonium (94) 7.
189 7E 1.89E 2 2.0h1 5.3E+2
- Pu-237 20 541 20 541 4.5E+2 1.2h4 Pu 238 2
54.1 2E-4 5.4 R.3 6.3E-1 1.7E+1 Pu 239.
2 54.1 '
2E-4 5.41E-3 2.3E-3 6.2E-2 Pu-240.
2 54.1 2E-4 5.41E-3 8.4E-3 2.3E 1
~ Pu-241 40 1080
'IE-2 0.270 3.8,
1.0E+2 Pu-242 2
.54.1 2E-4 5.41E-3 1.5E-4 3.9E 3
- Pu-244 0.3 8.11 2E-4 5.41E 3 6.7E-7 1.8E-5 Ro 223 -
Radium (88) 0.6-16.2 3E-2 0.811 1.9E+3 5.1E+4 Ra 224.
0.3 8.11 6E-2 1.62 5.9E+3 1.6E+5
'Ro.225 z 0.6 16.2 2E-2 0.541 1,5h3 3.9E+4 Ro-226.
0.3 8.11 2E-2 '
O.541 3.7E-2 1.0 Ra-228 0.6 16.2' 4E-2 1.08 1.0E+1 2.7E+2 Rb81 Rubidium (37) 2 54.1 0.9 24.3 3.1E+5 8.4E+6 Rb83 ;
2 54.1 2
-54.1 6.8E+2 -
1.8E+4 Rb-84 1
27.0 O.9 24.3 1.8h3 4.7E+4 Rb86 0.3 8.11 0.3 8.11 3.0E+3 8.1E+4
. Rb-87 Unlimited Unimited 3.2E-9 8.6E-8 Rb(natural)
Unlimited Unlimited 6.7E+6 1.8E+8 Re-183 -
Rhenium (75) 5' 135 5
135 3.8E+2 1.0E+4 Re 184m 3
81.1 3
'81.1 1.6E+2 4.3E+3 -
' Re-184 1
27.0 1
27.0 6.9h2 1.9E+4 Re 186 4
108 0.5 _
13.5 6.9E+3 1.9E+5 Re-187 Unlimited Unlimited 1.4E-9 3.8E 8 Ra-188 0.2 5.41 0.2 5.41-3.6E+4 9.8E+5 Re-189 4
108 0.5 13.5 2.5E+4 6.8E+5 Re(natural).
Unlimited Unlimited 2.4E-8
' Rh 99
. Rhodium (45) 2 54.1 2
54.1 3.0E+3 8.2E+4 Rh-101 4
108 4
108 4.1E+1 1.1E+3 Rh 102m '
2 54.1 0.9 24.3 2.3h2 '
6.2E+3 Rb102 0.5 13.5 0.5 13.5 4.5E+1 1.2E+3 Rh-103m 40 1080 40 1080 1.2E+6 3.3E+7 Rh 105 10 270 0.9 24.3 3.1E+4 8.4E+5 Rn-222 Radon (86) 0.2 -
5.41 4E-3 0.108 5.7E+3 1.5E+5 Ru-97 Ruthenium (44) 4 108 4
108 1.7E+4
'4.6E+5 '
Ru-103 2
54.1 0.9 24.3 1.2E+3 3.2E+4 Ru-105 -
0.6 16.2 0.5 13.5 2.5h5 6.7E+6 Ru-106 '
O.2 5.41 0.2
- 5.41 1.2E+2 3.3E+4 S _
Sulfur (16) 40 1080 2
54.1 1.6E+3 4.3E+4 -
Sb122 Antimony (51) 0.3 8.11 0.3 8.11 1.5E+4 4.0E+5
-Sb124 06 16.2 0.5 13.5 6.5E+2 1.7E+4
.Sb125 2
54.1 0.9 24.3 3.9h1 -
1.0E+3 Sb-126 0.4 10.8 0.4 10.8 3.1E+3 8.4E+4 Sc-44 Scandium (21) 0.5 13.5 0.5
- 13.5 6.7E+5 1.8E+7.
Sc-46 0.5 13.5 0.5 13.5 1.3E+3 3.4E+4 Sc-47 9
243 C.9 '
24.3 3.1E+4 8.3E+5
' Sc-48 0.3 8.11 0.3 8.11 5.5E+4 1.5E+6 Se-75 Selenium (34) 3 81.1 3
81.1 5.4E+2 1.5E+4 Se-79 40 1080 2
54.1 2.6E-3 7.0E.2,
Si-31 Silicon (14) 0.6 16.2 0.5 13.5 1.4E+6 3.9E+7 -
. Si 32.
40
.1080 0.2 5.41 3.9 1.1E+2 Sm-145 Samarium (62) 20
~541 20 541 9.8E+1 2.6E+3 Sm 147 Unlimited Unlimited 8.5E 1 2.3E+1 Sm 151 -
40 1080 4
108 9.7E-1 2.6E+1 Sm 153 -
4 108 0.5 13.5 1.6E+4 4.4E+5 Sn 113
. Tin (50) 4 108 4
108 3.7E+2 1.0E+4
- Sn 117m 9
162 2
54.1
~ 3.0E+3 8.2E+4
. Sn-119m 40 1080 40 1080 1.4h2 3.7E+3 Sn-121m 40 1080 0.9 24.3 2.0 5.4E+1
- Sn-123 0.6 16.2 0.5 13.5 3.0E+2 8.2E+3 Sn-125 0.2 5.41 0.2 5.41 4.0E+3 1.1E+5 Sn-126 0.3 8.11 0.3 8.11 1.0E-3 2.8E-2
),
Sr-82 Strontium (38) 0.2 5.41 0.2 5.41 2.3E+3 6.2E+4 Sr-85m 5
135 5'
135 1.2E+6 3.3E+7 '
Sr 85 2
54.1 2
54.1 8.8E+2 2.4E4 4 PENNSYLVANIA BULLETIN, VOL. 28, NO 7, FEBRUARY.14 1998
928 PROPOSED RULEMAKIND Symbol of Element and Ar A,
A, A
Specific activity radionuclide ' atomic number (TBq)
(Ci)
(TBq)
(bi)
(TBq/g)
(Cilg)
Sr-87m 3
81.1 3
81.
4.8E+5 1.3E+7 Sr-89 0.6 16.2 0.5 13.5 1.1E+3 2.9E+4 Sr-90 0.2 5.41 0.1 2.70 5.1 1.4E+2 Sr-91 0.3 8.11 0.3 8.11 1.3E+5 3.6E+6 Sr-92 0.8 21.6 0.5 13.5 4.7E+5 1.3E+7.
T Tritium (1) 40 1080 40 1080 3.6E+2 9.7E+3 Ta-178 Tantalum (73) 1 27.0 1
27.0 4.2E+6 1.1E+8.
Ta 179 30 811 30
.811 4.1E+1 1.1E+3 Ta-182
. 0.8 21.6 0.5 13.5 2.3E+2 6.2E+3 Tb-157 Terbium (65) 40 1080 10 270 5.6E 1 1.5E+1
- Tb 158 1
27.0 0.7 18.9 5.6E-1 1.5E+1 Tb-160 0.9 24.3 0.5 13.5 4.2E+2 1.1E +4 Tc-95m Technetium (43) 2 54.1 2
54.1 8.3E+2' 2.2E+4 Tc-96m.
0.4 10.8 0.4 10.8 1.4E+6 3.8E+7 Te-96 0.4 10.8 0.4 10.8 1.2E+4 3.2E+5 Tc-97m 40 1080 40 1080 5.6E+2 1.5E+4 Tc.97 Unlimited Unlimited 5.2E-5 1.4E-3 Tc-98 0.7 18.9 0.7 18.9 3.2E-5 8.7E 4 Tc-99m 8
216 8
216 1.9E+5 5.3E+6 Tc 99 40 1080 0.9 24.3 6.3E-4 1.7E-2 Te-118 Tellurium (52) 0.2 5.41 0.2 5.41 6.8E+3 1.8E+5 Te 121m 5
135 5
135 2.6E+2 7.0E+3 Te 121 2
54.1 2
54.1 2.4E+3 6.4E+4 Te 123m 7
189 7
189 3.3E+2
'8.9E+3 Te-125m 30 811 9
243 6.7E+2 1.8E+4 Te 127m 20 541 0.5 13.5 3.5E+2 9.4E+3 Te 127 20 541 0.5 13.5 9.8E+4 2.6E+6 Te-129m 0.6 16.2 0.5 13.5 1.1E+3 3.0E+4 Te-129 0.6 16.2 0.5 13.5 7.7E+5 2.1E+7 Te-131m 0.7 18.9 0.5 13.5 3.0E+4 8.0E+5 Te-132 0.4 10.8 0.4 10.8 1.1E+4 3.0E+5 Th-227 Thorium (90) 9 243 IE 2 0.270 1.1E+3 3.1E+4 Th-228 0.3 8.11 4E-4 1.08E-2 3.0E+1 8.2E+2 Th-229 0.3 8.11 3E-5 8.11E-4 7.9E-3 2.1E-1 Th-230 2
54.1 2E-4 5.41E-3 7.6E-4 2.1E-2 Th-231 40 1030 0.9 24.3 2.0E+4 5.3E+5 Th-232 Unlimited Unlimited 4.0E-9 1.1E-7 Th-234 0.2 5.41 0.2 5.41 8.6E+2 2.3E+4 Th(natural)
Unlimited Unlimited 8.1E-9 2.2E-7 Ti-44 Titanium (22) 0.5 13.5 0.2 5.41 6.4 1.7E+2 TI-200 Thallium (81) 0.8 21.6 0.8 21.6 2.2E+4 6.0E+5 TI-201 10 270 10 270 7.9E+3 2.1E+5 T1202 2
54.1 2
54.1 2.0E+3 5.3E+4 TI 204 4
108 0.5 13.5 1.7E+1 4.6E+2 Tm 167 Thulium (69) 7 189 7
189 3.1E+3 8.5E+4 Tm-168 0.8 21.6 0.8 21.6 3.1E+2 8.3E+3 Tm 170 4
108 0.5 13.5 2.2E+2 6.0E+3 Tm 171 40 1080 10 270 4.0E+1 1.1E+3 U 230 Uranium (92) 40 1080 IE-2 0.270 1.0E+3 2.7E+4 U-232 3
81.1 3E-4 8.11E-3 8.3E-1 2.2E+1 U-233 10 270 IE-3 2.70E-2 3.6E-4 9.7E-3 U-234 10 270 1E-3 2.70E-2 2.3E-4 6.2E-3 U-235 Unlimited Unlimited 8.0E 8 2.2E-6 U 236 10 270 1E-3 2.7E-2 2.4E-6 6.5E-5 U-238 Unlimited Unlimited 1.2E-8 '
3.4E-7 U(natural)
Unlimited Unlimited 2.6E-8 7.1E-7 U(enriched Unlimited Unlimited (See 5% or less)
Table A-e)
U(enriched 10 270 1E-3 2.7E-2 (See more than Table A-3) 5%)
U(depleted)
Unlimited Unlimited (See Table A-3)
V-48 Vanadium (23) 0.3 8.11 0.3 8.11 6.3E+3 1.7E45 V-49 40 1080 40 1080 3.0E+2 8.1E+3 W 178 Tungsten (74) 1 27.0 1
27.0 1.3E+3 3.4E+4 W-181 30 811 30 811 2.2E+2 6.0E+3 PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14,1998
PROPOSED RULEMAKING 929 Symbol of Element and A
A Ar A
Specific activity radionuclide atomic number
($Bq)
(b0 JBq)
(b0 (TBq/g)
(Cilg)
W 185 40 1080 0.9 24.3 3.5E+2 9.4E+3 W 187 2
54.1 0.5 13.5 2.6E+4 7.0E+5 W 188 0.2 5.41 0.2 5.41 3.7E+2 1.0E+4 Xe 122 Xenon (54) 0.2 5.41 0.2 5.41 4.8E+4 1.3E+6 Xe-123 0.2 5.41 0.2 5.41 4.4E+5 1.2E+7 Xe-127 4
108 4
108 1.0E+3 2.8E+4 Xe 131m 40 1080 40 1080 3.1E+3 8.4E+4 X5133 20 541 20 541 6.9E+3 1.9E+5 Xe-135 4
108 4
108 9.5E+4 2.6E+6 Y-87 Yttrium (39) 2 54.1 2
54.1 1.7E+4 4.5E+5 Y88 0.4 10.8 0.4 10.8 5.2E+2 1.4E+4 Y 90 0.2 5.41 0.2 5.41 2.0E+4 5.4E+5 Y 91m 2
54.1 2
54.1 1.5E+6 4.2E+7 Y-91 0.3 8.11 0.3 8.11 9.1E+2 2.5E+4 Y-92 0.2 5.41 0.2 5.41 3.6E+5 9.6E+6 Y-93 O.2 5.41 0.2 5.41 1.2E+5 3.3E+6 Yb-169 Ytterbium (70) 3 81.1 3
81.1 8.9E+2 2.4E+4 Yb-175 30 811 0.9 24.3 6.6E+3 1.8E+5 Zn-63 Zinc (30) 2 54.1 2
54.1 3.0E+2 8.2E+3 Zn-69tn 2
54.1 0.5 13.5 1.2E+5 3.3E+6 Zn-69 ~
4 108 0.5 13.5 1.8E+6 4.9E+7 Zr-88 Zirconium (40) 3 81.1 3
81.1 6.6E+2 1.8E+4 Zr-93 40 1080 0.2 5.41 9.3E-5 2.5E-3 Zr 95 1
27.0 0.9 24.3 7.9E+2 2.1E+4 Zr-97 0.3 8.11 0.3 8.11 7.1E+4 1.9E+6 (a) International shipments of Einsteinium require objects or materials using gamma radiation. This chapter multiliteral soproval of As and A, values, also contains radiation-safety requirements for operating (b) International shipments of Fermium require multi-irradiators. The requirements of this chapter are in lateral approval of As and As values.
addition to other requirements of this article. Nothing in (c) 20 Ci for Mo-99 for domestic use.
this chapter relieves the beensee from complying with other applicable Federal, State and local regulations TABLE A 2 governing the siting, zoning, land use and building code GENERAL VALUES FOR A AND A requirements for industrial facilities.
8 (b) The re lations in this chapter apply to panoramic Contents A,
As irradiators t at have either dry or wet storage of the (TBq)
(C0 (TBq)
(C0 radioactive sealed sources and to underwater irradiators Only beta-or 0.20 5.00 0.02 0.5 in which both the source and the product being irradiated gamm:-emitting are under water. Irradiators whose dose rates exceed 5 nuclides are Grays (500 rads) per hour at I meter from the radioactive known to be sealed sources in air or in water, as applicable for the present irradiator type, are covered by this chapter.
Alpha-emitting 0.10 2.70 2x10-8 5.41x10-4 nuclides are (c) The regulations in this chapter do not apply to known to be self-contained dry source-storage irradiators (those in present, or no which both the sottree and the area subject to irradiation rehv nt data are are contained within a device and are not accessible by cv.ildle personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing CHAPTER 232. LICENSES AND RADIATION purposes), gauging or open-field (agricultural) irradia.
SAFETY REQUIREMENTS FOR IRRADIATORS ti ns.
subch.
I 232.2. Definitions.
A.
GENERAL PROVISIONS E
The following words 'and terms, when used in this fFSNA QREMENTS FOR - chapter have the following meanings, unless the context E
CE IRRADIATORS clearly indicates otherwise:
[Eo"^gh N OF IRRADIATORS Annually-One of the following:
Subchapter A. GENERAL PROVISIONS (O At intervals not to exceed 1 year.
see.
(10 Once per year, at about the same time each year-232.1 Purpose and scope.
plus or minus 1 month.
i 232.1. Purpose and scope-Doubly encapsulated sealed rource-A sealed source in which the radioactive material is sealed within a capsule
(:) This chapter contains requirements for the issuance and that capsule is sealed within another capsule.
i of c license authorizing the use of sealed sources contain-Irradiator-A facility that uses radioactive sealed ing radioactive materials in irradiators used to irradiate sources for the irradiation of objects or materials and in PENNSYLVANIA BULLETIN, VOL. 28, NO. 7 FEBRUARY 14, 1998
930 PROPOSED RULEMAKING which radiation dose rates exceeding 5 Grays (500 rads) i 232.13. Specific licenses for irradiators.
per hour exist at 1 meter from the sealed radioactive The Department will approve an application for a sources in air or water, as applicable for the trradiator specific license for the use of licensed material in an type, but does not include irradiators in which both the irradiator if the applicant meets the requirements con-sealed source and the area subject to irradiation are tained in this section.
contained within a device and are not accessible to personnel.
(1) The applicant shall satisfy the general require-ments specified in 6 217.51 and 217,52 (relating to filing Irradiator operator-An individual who has successfully application for specific licenses; and general requirements completed the training and testing described in 6 232.51 for the issuance of specific licenses) and this chapter.
(relating to training) and is authorize,d by the terms of the license to operate th. 'tradiator without a supervisor (2) The application shall describe the training provided to irradiator operators including:
present.
(i) Classroom training.
Panoramic dry-source-storage irradiator-An irradiator In which the irradiations occur in air in areas potentially (ii) On the-job or simulator training.
accessible to personnel and ir. which the sources are (iii) Safety reviews, i
stored in shields made of solid materials. The tenn (iv) The means employed by the applicant to test each includes beam-type dry-source-storage,irradiators in wh o y w beam of radiation is produced for operator's understanding of the Department's regulations and licensing requirements and the irradiator operating and emergency procedures.
Panoramic irradiator-An irradiator in which the irra-(v) Minimum training and experience of personnel who diations are done in air in areas potentially accessible to may provide training.
personnel. The term includes beam-type irradiators.
(3) The application shall include an outh.ne of the Panoramic wet. source-storage irradiator-An irradiator written operating and emergency procedures in 6 232.53 in which the irradiations occur in air in areas potentially (relating to operating and emergency procedures) that accessible to personnel and in which the ' sources are describes the radiation safety aspects of the procedures.
stored under water in a storage pool.
(4) The application shall describe the organizational Pool irradiator-An irradiator at which the sources are structure for managing the irradiator, specifically the stored or used in a pool of water including panoramic radiation safety responsibilities and authorities of the wet-source-storage irradiators and underwater irradia.
radiation safety officer and management personnel who tors.
have important radiation safety responsibilities or au-thorities. In particular, the application shall specify who, Product conveyor system-A system for moving the within the management structure, has the authority to product to be irradiated to, from and within the area stop unsafe operations. The application shall also describe where irradiation takes place.
the training and experience required for the position of Radiation room-A shielded room in which irradiations radiation safety officer.
take place. Underwater irradiators do not ha e radiation (5) The application shall include a description of the rooms.
access control systems required by 6 232.23 (relating to access control), the radiation monitors required by
, Radiation safety officer-An individual with responsibil-6 232.29 (relating to radiation monitors), the method of sty for the overall' radiation safety pmgram at the facility.
detecting leaking sources required by 6 232.59 (relating Sealed source-A byproduct material that is used as a to detection ofleaking sources) including the sensitivity of source of radiation and is encased in a capsule designed the method and a diagram of the facility that shows th,e to prevent leakage or escape of the byproduct material.
locations of all required interlocks and radiation mom-J tors.
Seismic area-An area where the probabili,ty of a (6) If the applicant intends to perform leak testing of horizon' al acceleration in rock of more than 0.3 times the t
dry-source-storage sealed sources, the applicant shall accelerstion of gravity in 250 years is greater than 10%,
establish procedures for leak testing and submit a de-as designated by the United States Geological Survey.
scription of these procedures to the Department. The Underwater irradictor-An irradiator in which the description shall include the following:
sources always remain shielded under water and humans (1) Instruments to be used.
do not have access to the sealed sources or the space subject to irradiation without entenng the pool.
(ii) Methods of performing the analysis.
(iii) Pertinent experience of the individual who ana.
Subchapter B. SPECIFIC LICENSING j zes the samples.
y REQUIREMENTS (7) If h.eensee personnel are to load or unload sources, sec.
the applicant shall describe the qualifications and train-232.11 Apphcation for a specific License.
ing of the personnel and the procedures to be used. If the 232.13 Specific bcenses for irradiators.
applicant intends to contract for source loading or unload-N catSYeInptions.
ing at its facility, the loading or unloading shall be done 232.19 Request for wntten statements, by an organization specifically authorized by the Depart-ment, NRC or an agreement state to load or unload i 232.11. Application for a specific license.
irradiator sources.
A person may file'an application for a specific license (8) The applicant shall describe the inspection and authorizing the use of sealed sources in an irradiator as maintenance checks, including the' frequency of the required under 6 217.51 (relating to filing application for checks required by 6 232.61 (relating to inspection and specific licenses).
maintenance).
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
PROPOSED RULEMAKING 931 1 232.15. SMrt of construction. '
(4) Be encapsulated 'n a material resistant to general The app. ant may not begin construction of a new
.c rr sion and to localized corrosion, such as 316L stain-irradiator prior to the submission to the Department of less steel or other matenal with equivalent resistance if both an application for a license for the irradiator and the the sources are for use m irradiator pools.
fee required by Chapter 218 (relating to fees). As used in (5) In prototype testing of the sealed source, shall have this section, the term " construction" includes the con-been leak tested and found leak-free after each of the struction of any portion of the permaneat irradiator tests described in subsections (b)-(g).
structure on the site but does not include: engineering of a site, site sur eys or soil (b) Temperature. The test source shall be hd at -40*C and, design work, purchase,te excavation, ceastruction of for 20 minutes,600*C for 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />, and then be wbjected to testmg, site preparation, si warehouse or aunliary structures and other similar a thermal shock test with a temperature drop from 600*C to 20*C within 15 seconds.
tasks. Any activities undertaken prior to the issuance of a licenae are entirely at the risk of the applicant and have (c) Pressure. The test source shall be twice subjected no bearing on the issuance of a license with respect to the for at least 5 minutes to an external pressure (absolute) requirements of this article, of 2 million Newtons per square meter.
I 232.17. Applications for exemptions.
(d) Impact. A 2-kilogram steel weight, 2.5 centimeters (a) Th Department may, upon application of an inter-in diameter, shall be dropped from a height of 1 meter e es some.
ested person or upon its own Initiative, grant exemptions from the requirements in this chapter that it determines (e) Vibration. The test source shall be subjected three are authorized by la'w and will not endanger life or times for 10 minutes each to vibrations swee[ing from 25 property or the common defense and security and are hertz to 500 Hertz with a peak amplitude o 5 times the otherwise in the public interest, acceleration of gravity. In addition, each test source shall (b) An application for a license or for amendment of a un '
license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed (f) Puncture. A 50-gram weight and pin,0.3-centimeter alternatives for the requirements of this chapter. The pin diameter, shall be dropped from a height of 1 meter Department will approve the proposed alternatives if the onto the test source.
cpplicant provides adequate rationale for the proposed (g) Bend. If the length 'of the source is more than 15 alternatives and demonstrates that they are hkely to times larges than the minimum cross-sectional dimension provide an adequate level of safety for workers and the the test source shall be subjected to a force of 2,00d pubhc.
Newtons at its center equidistant from two support i 232.19. Request for written statements.
cylinders, the distance between which is 10 times the
" " " * * ~ * * *
(s) After the filing of the original application, the Drpartment may request further information necessary to i 232.23. Access control enable the Department to determine whether the applica-(a) Each entrance to a radiation room at a panoramic tion should be granted or demed.
irradiator shall have a door or other physical barrier to (b) Each license is issued with the condition that the prevent inadvertent entry of personnel if the sources are licensee will, at any time before expiration of the license, not in the shielded position. Product conveyor systems upon the Department's request, submit written state.
may serve as barriers as long as they reliably and,
j ments to enable the Department to determine whether consistently function as a barrier. It shall be impossible to the license should be modified, suspended or revoked.
move the sources out of their shielded position if the door i
or barrier is open. Opening the door or barrier while the Subchapter C. DESIGN AND PERFORMANCE sources are exposed shall cause the sources to return REQUIREMENTS FOR IRRADIATORS promptly to their shielded position. The personnel en-sme.
trance door or barrier shall have a lock that is operated 232.21 Performance criteria for sealed sources.
by the same key used to move the sources. The doors and 232.23 Accus comL barriers may not prevent an individual in the radiation
$$ $I room from leaving.
p on, 232.29 Ra&ation monitors.
(b) Each entrance to a radiation room at a panoramic 232.31 Control of source movement-irradiator shall have an independent backup access con-Source rack tection.
trol to, detect personnel entry while the sources are 232.37 Power failures.
exPosen. Detection of entry while t!'e sources ara exposed 232.39 Design requirements.
shall cecse the sources to neturn ao their fully snielded 232A1 construction monitonng and acceptance testing.
positiov and shall also acuvate a hible and audible i 232.21 Performance criteria for sealed sources.
alarm w make the individual entering the room aware of the hazard. The alarm shall also alert at least one other (a) After July 1,1993. Sealed sources installed abr individual who is onsite of the entry. That individual
\\
July 1,1993, shall meet the following requirements:
shall be trained on how to respond to the alarm and j
(1) Have a certificate of registration issued under 10 prepared to promptly render or summon assistance CFR 32.210 (relating to product information).
Fromptly.
(2) Be doubly encispsulated.
(c) A radiation monitor shall be provided to, detect the presence of high radiation levels in the radiation room of (3) Use radioactive material that is as nondispersible a panoramic irradiator before personnel entry. The moni-as practical and that is as insoluble as practical if the tor shall be integrated with personnel access door locks to j
source is used in a wet-source-storage or wet-source-prevent room access when radiation levels are high.
1 change hradiator.
Attempted personnel entry while the monitor measures PENNSYLVANIA BULLETIN, VOL. 2t, NO. 7, FEBRUARY 14, 1998 J
932 PROPOSED RULEMAKING high radiation levels, shall activate the alarm described i 232.27. Fire protection.
in subsection (b). The monitor may be located in the (a) The radiation room at a panoramic irradiator shall entrance (normally referred to as the maze) but not in the have heat and smoke detectors. The detectors shall direct radiation beam, activate an aulible alarm. The alarm shall be capable of (d) Before the sources move from their shielded posi.
alerting a person who is prepared to summon assistance tion in a panoramic irradiator, the.ource control shall promptly. The sources shall automatically become fully cutomatically activate conspicuous visible and a lible shielded if a fire is detected.
alarms to alert people in the radiation room that the (b) The radiation room at a panoramic irradir. tor shall sources will be moud from their shielded position. The be equipped with a fire extinguishing system capable of clarms shall give individuals enough time to, leave the extinguishing a fire without the entry of personnel into room before the sources leave the shielded position.
the room. The system for the radiation room shall have a (e) Each radiation room at a panoramic irradiator shall shut-off valve to control flooding into unrestricted areas.
have a clearly visible and readily accessible control that i 232.29. Radiation monitors, would allow an individual in the room to make the sources return to their fully shielded position.
(a) Irradiators with automatic product conveyor sys-tems shall have a radiation monitor with an audible (f) Each radiation room of a panoramic irradiator shall alarm located to detect loose radioactive sources that are contain a control that prevents the sources from moving carried toward the product exit. If the monitor detects a from the shielded position unless the control has been source, an alarm shall sound and product conveyors shall activated and the door or barrier to the radiation room stop automatically. The alarm shall be capable of alerting has been closed within a preset time after activation of an individual in the facility who is prepared to summon the control.
assistance. Underwater irradiators in which the product m ves within an enclosed stationary tube are exempt (g) Each entrance to the radiation room of e panoramic irradiator and each entrance to the area within the from this paragraph.
personnel access barrier of an underwater irradiator shall (b) Underwater irradiators that are not in a shielded have a sign bearing the radiation symbol and the words, radiation room shall have a radiation monitor over the
" Caution (or danger) radioactive material." Panoramic pool to detect abnormal radiation levels. The monitor irradiators shall also have a sign stating "High radiation shall have an audible alarm and a visible indicator at area," but the sign mcy be removed, covered or otherwise entrances to the personnel access barrier around the pool.
made inoperative when the sources are fully shielded.
The audible alann may have a manual shut-off. The alarm shall be capable of alerting an individual who is (h) If the radiation room of a panoramic trradiator has prepared to respond promptly.
roof plugs or other movable shielding, it shall be impos-sible to operate the irradiator unless the shielding is in i 232.31. Control of source movement.
its proper location. This requirement may be met by (a) The mechanism that moves the sources of a pan-mterbcks that prevent operation if shielding is not,placed oramic irradiator shall require a key to actuate. Actuation properly or by an operating procedure requiring inspec-of the mechanism shall cause an audible signal to tion of shielding before operating-indicate that the sources are leaving the shielded posi-(i) Underwater irradiators shall have a personnel ac.
tion. Only one key may be in use at any time, and only o rators or facility management may possess it. The key cess barrier around the poc1 which shall be locked to a
be attached to a portable radiation survey meter by prevent access when the irradiator is not attended. Only or rators and facility management may have access to a chain or cable. The lock for source control shall be k~ to the personnel access barrier. There shall be an designed so that the key may not be removed if the irausion alarm to detect unauthorized entry when the sources are in an unshielded position. The door to the personnel access barrier is locked. Activation of the radiation room shall requhe the same key.
intrusion alarm shall alert an individual (not necessarily (b) The console of a panoramic irradiator shall have a onsite) who is prepared to respond or semon assistance-source position indicator that indicates when the sources 6 232.25. Shielding.
are in the fully shielded po sition, when they are in transit and when the sources are exposed.
(a) The radiation dose rate in areas that are normally (c) The control console of a panoramic trradiator shall occupied during operation of a panoramic irradiator may have a control that promptly returns the sources to the not exceed 0.00002 Sv (2 mrem) per hour at any location 30 cm or more from the wall of th'e room when the shielded position.
sources are exposed. The dose rate shall be averaged over (d) Each control for a panoramic irradiator shall be l
an area not to exceed 100 square centimeters having no clearly marked as to its function.
linear dimension greater than 20 cm. Areas where the radiation dose rate exceeds 0.00002 Sv (2 mrem) per hour 6 232.33. Irradiator pools.
shall be locked, roped off or posted.
(a) The licensee shall have a method to safely store the (b) The radiation dose at 30 cm over the edge of the s urces during repair of the pool. For licenses initially issued after July 1,1993, irradiator pools shall meet ene pool of a pool irradiator may not exceed 0.0002 Sv (2 M** I U *4 mrem) per hour when the sources are in the fully shielded position.
(1) Have a water. tight stainless steel liner or a liner (c) The radiation dose rate at I meter from the shield mefllurgically compatible with other components in the poo of a dry-source-storage panoramic irradiator when the source is sidelded may not exceed 0.00002 Sv (2 mrem)
(2) Be constructed so that tLere is a low likelihood of per hour and at 5 centimeters from the shield may not substantial leakage and have a surface designed to exceed 0.0002 Sv (20 mrem) per hour.
facilitate decontamination.
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14,199J
PROPOSED RULEMAKING 933 (b) For licenses initially issued after July 1,1993, requirements of 6 232.33(b)(relating to irradiator pools),
irradiator pools shall have no outlets more than 0.5 meter and that metal components are metallurgically compat-~
below the normal low water level that could allow water ible with other components in the pool, to drr.in out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that (4) Water handling system. For pool irradiators, the could act as siphons shall have siphon breakers t licensee shall verify that the design of the water purifica-prevent the siphoning of pool water-tion system is adequate to meet the requirements of 6 232.33(e)(relating to irradiator pools). The system shall (c) A means shall be provided to replenish water losses be designed so that water leaking from the system does from the pool.
not drain to unrestricted areas without being monitored.
(d) A visible indicator shall be provided in a clearly (5) Radiation monitors. For all irradiators, the licensee visibla location to indicate if the pool water level is below shall evaluate the location and sensitivity of the monitor the normal low water level or above the nortnal high to detect sources carried by the product conveyor system wat:r level.
as required by 6 232.29(a) (relating to radiation moni-(a) Irradiator pools shall be equipped with a purifica-tors). The licensee shall verify that the product conveyor tion system designed to be capable of maintainirut the is designed to stop before a, source on the product wat:r during normal operation at a conductivity of 20 e nyey r w uld cause a radiation overesposure to any microsiemens per centimeter or less and with a clarity so person. For pool irradiators, if,the licensea uses radiation thit the sources can be seen clearly.
- nitors to det,ect contamination under i 232.59(b) (re-latm.g to detection of leaking sources), the licensee shall (f) A physical barrier, such as a railing or cover, shall verify that the design of radiation monitoring systems to be used around or over irradiator pools during normal detect pool contamination includes sensitive detectors operation to prevent personnel from accidentally falling located close to where contamination is likely to concen-into the pool. The barrier may be removed during mainte-trate.
nance, inspection and service operations.
(6) Source rock. For pool irradiators, the licensee shall (g) If long-handled tools or poles are used in irradiator verify that there are no crevices on the source or between pools, the radiation dose rate on the handling areas of the the source and source holder that would promote corro-tools may not exceed 0.00002 Sv (2 mrem) per hour.
sion on a critical area of the source. For panoramic i 232.35. Source rack protection.
irradiators, the licensee shall deter nine that. source rack drops due to loss of power will not damage the source If the product to be irradiated moves on a product rack and that source rack drops due to failure of cables conveyor system, the source rack and the mechanism that (or alternate means of support) will not cause loss of mov:s the rack shall be protected by a barrier or guides integrity of sealed sources. For panoramic irradiators, the to prevent products and product carriers from hitting or licensee shall review the design of the mechanism that touching the rack or mechanism.
moves Lae sources to assure that the likelihood of a stuck i 232.37. Power failures.
source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.
(s) If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources shall automati-(7) Access control. For panoramic irradiators, the h. -een-cally return to the shielded position.
see shall verify from the de, sign and logie diagram that the access control system will meet the requirements ci (b) The lock on the door of the radiation room of a 6 232.23 (relating to access control).
anoramic irradiator may not be deactivated by a power (8) Fire protection. For panoramic irrsdiators,'the licen-
"T* -
see shall verify that the number, location and spacing of (c) During a power failure, the area of any irradiator the smoke and heat detectors are appropriate to detect whue sources are located may be entered only when fires and that the detectors are protected from mechanical using an operable and calibrated rad % tion survey meter.
and radiation damage. The licensee shall verify _that the i 232.89. Design requirements-design of the fire extinguishing system provides the necessary discharge patterns, densities and flow charac-Irradiators whose construction begins after July 1, teristics for com;slete coverage of the radiation ' room and 1993, shall meet the design requirements of this section.
that the system is protected from mechanical and.radia-(1) Shielding. For panoramic irradiat
'he licensee tion damage.
chall design shielding walls to meet generally accepted (9) Source return. For panoramic irradiators, tile licen-,
l building code requirements for reinforced concrete and see shall verify that the source rack will automatically j
design the walls, wall penetrations and entranceways to return to tne fully shielded position if offsite power is lost meet the radiation shielding requirements of 9 232.25 for more than 10 seconds.
. relatig to shielding). If the irradiator will use more than (10) Seismic. For panoramic irradiators to'be built in
(
2 x 10 Bq (5 mci) of activity, the licensee shall evaluate the effects of heating of the shielding walls by the seismic areas, the licensee shall design the reinforced irndiator sources.
concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic (2) Foundations. For panoramic irradiators, the licen-requirements of an appropriate source such as American see shall design the foundation, with consideration given Concrete Institute Standard ACI 318-89, " Building Code to soil characteristics, to ensure it is adequate to support Requirements for Reinforced Concrete," Chapter 21, "Spe-thz weight of the facility shield walls.
cial Provisiona for Seismic Design," or local building codes, if current.
(3) Pool integrity. For pool irracliators, the licensee shall design the pool to assure that it is leak resistant, (11) Wiring. For panoramic. irradiators, the licensee
' thtt it is strong enough to bear the weight of the pool shall verify that electrical wiring and elect,rical equipment w-ter and shipping casks, that a dropped cask would not in the radiation room are selected, to minimize failures fall on sealed sources, that all outlets or pipes meet the due to prolonged exposure to radiation.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998 I
934 PROPOSED RULEMAKING
$ 232.41. Construction monitoring and acceptance prevent an irradiator operator from commanding the
- testing, computer to override the access control system when it is required to be operable.
The requirements of this section shall be met for irradiators whose construction begins after July 1,199?.
(11) Wiring. For panoramic irradiators, the ' licensee The requirements shall be met prior to loading sources.
shall verify that the electrical wiring and electrical equipMnt that were installed meet the design specifica-i (1) Shi+1 ding. For panoramic trradiators, the deensee
- tions, shall monitor the construction of the shielding to verify that its construction meets design specifications and Subchapter D. OPERATION OF IRRADIATORS l
generally accepted building code requirements for rein-Sec.
forced concrete.
232.51 Training.
232.53 Operating and emergency procedures.
232.55 Personnet monitoring.
(2) Foundations. For panoramic irradiators, the licen, see shall monitor the constniction of the foundations to 23 g auan s 9o,
ng sources.
verify that their constniction meets design specifications.
232.61 Inspection and maintenance.
232.63 Pool water purity.
I (3) Pool integrtty. For pool.trradiators, the h.censee 232 65 Attendance during operation.
shall verify that the pool meets design specifications and 232.67 Entering and leanng the radiation room.
232.69 Irradianon of explosive or flammable materials.
shall test the integrity of the pool. The licensee shall verify that outlets and pipes meet the requirements of g 232.51. Training.
.6 232.33(b)(relating to irradiator pools).~
(a) Before an individual is pertnitted to operate an (4) Water handling system. For pool irradiators, the irradiator without a supervisor present, the individual licensee shall verify that the water purificaun system, shall be instructed in the following:
the conductivity meter and the water level indicators (1) The fundamentals of radiation protection applied to operate properly.
irradiators including:
(5) Radiation monitors. For,all irradiators, the licensee (i) The difTerences between external radiation and ra-shall verify the proper operation of the monitor to detect dioactive contamination.
sources carried on the product conveyor system and the related alarms and interlocks required by 6 232.29(a)
(ii) Units of radiation dose.
(relating to radiation monitors). For pool irradiators, the (ii) Dose limits.
liceneee shall verify the proper operacion of the radiation monitors and the related alarm if used to meet (iv) Why large radiation doses shall be avoided.
$ 232.59(b) (relating to detection of leaking sources). For (v) How shielding and access controls prevent large underwater irradiators, the licensee shall verify the doses.
proper operation of the over-the-pool monitor, alanns and interlocks required by 9 232.29(b) (relating to radiation (vi) How an irradiator is designed to prevent contami.
nation.
monitors).
(6) Source rock. For panoramic irradiators, the licensee (vii) The proper use of survey meters and personnel dosuneters.
shall test the movement of the source racks for proper operation prior to source loading. Testing shall include (viii) Other radiation safety features of an irradiator, source rack lowering due to simulated locs of power. For and the basic function of the kradiator),
all irradiators with product conveyor systems, the licen-(2) The requirements of the chapter and chapter 219 see shall observe and test the operation of the conveyor (relating to the standards for radiation protection) that system to assure that the requirements m 6 232.35 are relevant to the irradiator.
(relating to sou*ce rack protection) are met for protection of the source uck and the mechanism that moves the (3) The operation of the irradiator.
rack. Testing shall include tests of any limit switches and (4) The operating and emergency procedures in mterlocks used to protect the source rack and, mechanism 6 232.53 (relating to operating and emergency proce-that moves the rack from moving product earners.
dures) that the individual is responsible for performing.
i (7) Access control. For panoramic irradiators, the licen-(5) Case histories of accidents or problems involving see shall test the completed access control system to irradiators' assure that it functions as designed and that all alarms, controls and interlocks work properly, (b) Before an individual is permitted to operate an irradiator without a supervisor present, the individual (8) Fire protection. For panoramic irradiators, the licen-shall pass a written test on the instruction received see shall test the ability of the heat and smoke detectors consisting primarily of questions based on the licensee's to detect a fire, to activate alarms and to cause the source operating and emergency procedures that the individual rack to automatically become fully shielded,. The h,censee is responsible for performing and other operations neces-shall test the operability of the fire extinguishing system.
sary to safely operate the irradiator without supervision.
(9) Source return. For panoramic irradiators, the licen-(c) Before an individual is nermitted to operate an see shall demonstrate that the source racks can be irradiator without a supervia present, the individual returned to their fully shielded positions without offsite shall have received on-the-job training or simulator train-power.'
ing in the use of the irradiator as described in the license a plication. The individual shall also demonstrate the (10) Computer systems. For panoramic irradiators that a ility to perform those portions of the operating and use a computer system to control the access control emergency procedures that he as to perform system, the licensee shall verify that the access control system will operate properly if offsite power is lost and (d) The licensee shall conduct safety reviews for irra-shall verify that the computer has security features that diator operators at least annually. The licensee shall give PENNSYLVANIA DULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
l PROPOSED RULEMAKING 935 sich operator a brief written test on the information.
(3) A radiation alarm from the product exit portal Each s:fety review shall include, to the extent appropri-monitor or pool monitor.
etz, cach of the following:
(4) Detection of leaking sources, pool contamination or (1) Changes in operating and emergency procedures alarm caused by contamination of pool water.
sines th3 last review, if any.
(5) A low or high water level indicator, an abnormal (2) Changes in regulations and license conditions since water loss or leakage from the source storage pool.
tha last review, if any' (6) A prolonged loss of electrical power.
(3) Reports on recent accidents, mistakes or problems thit hr.ve occurred at irradiators, if any.
(7) A fire alarm or explosion in the radiation room.
(4) Relevant results of inspections of operator safety (8) An alarm indicating unauthorized entry into the performance.
radiation room, area around pool or another alarmed area.
(5) R: levant results of the facility's inspection and mainten:nce checks.
(9) Natural phenomena, including an earthquake, a tornado. flooding or other phenomena as appropriate for (6) A drill to practice an emergency or abnormal event the geographical location of the facility.
procidure.
(10) The jamming of automatic conveyor systems.
(3) Th3 licensee shall evaluate the safety performance of u.ch irradiator operator at least annually to ensure (c) The licensee may revise operating and emergency that r gulations, license conditions and operating and procedures without Department approval only if the em:rgency procedures are followed. The licensee shall f 11 wmg conditions are mc discuss the results of the evaluation with the operator (1) The revisions do not reduce the safety of the facility.
c.nd shall instruct the operator on how to correct any mistakes or deficiencies observed.
(2) The revisions are consistent with the outline or summary of procedures submitted with the license appli-(f) Individuals who will be permitted unescorted access cation.
to tha radiation room of the irradiator or the area around the radiat(ion safety officer,(3) The revisions have been review tha pool of an underwater irradiator, but who have not rec:iv;d the training required for operators and the r diatien safety officer, shall be instructed and tested in (4) The users or operators are instructec, and tested on any precautions they should take to avoid radiation the revised procedures before they are put into use.
exposure, any procedures or parts of procedures in
{ 232.53 that they are expected to perform or comply 6 232.55. Personnel monitoring.
with, and their proper response to alarms required in this (a) Irradiator operators shall wear either a film badge chapter. Tests may be oral.
or a thermoluminescent (TLD) dosimeter while operating f
(g) Individuals who shall be prepared to respond to a panoramic irradiator or while in the area around the j
altrms required by' 66 232.23(b) and (1), 232.27(a),
pool of an underwater irradiator. The film badge or TLD 232.29(a) and (b) and 232.59(b) shall be trained and Processor shall be accredited by the National Voluntary tested on how to respond. Each individual shall be Laboratory Accreditation Program for high energy pho-retested at leat once a year. Tests may be oral.
tons in the normal and ac, cadent dose ranges. Each film badge or TLD shall be assigned to and worn by only one i 232.$3. Operating and emergency procedures.
individual. Film badges shall be processed at least (a) The licensee shall have and follow written operating monthly, and TLDs shall be processed at least quarterly.
j procedures for the following:
(b) Other individuals who enter the radiation room of a (1) Operation of the irradiator, including entering and Panoramic irradiator shall wear a dosim,eter, which may j
Inving the radiation room.
be a pocket dosuneter. For groups of visitors, only two people who enter the radiation room are required to wear (2) Use of personnel dosimeters.
dosimeters.. If pocket dosimeters are used to meet the (3) Surveying the shielding of panoramic irradiators.
requirempnts of this subsection, a check of their response to radiation shall be done at least annually. Acceptable (4) Monitoring pool water for contamination while the dcaimeters shall read within 30 % of the true radiation water is in the pool and before release of pool water to dose.
unrestricted areas.
I 232.57. Radiation surveys.
(5) Leak testing of sources.
(a) A radiation survey of the area outside the shielding (G) Inspection and maintenance checks required by of the radiation room of a panoramic inadiator shall be 6 232.61 (relating to inspection and maintenance).
conducted with the sources in the exposed position befon (7) Lo ding, unloading and repositioning sources, if the the facility starts 'to operate. A radiation survey.of the operations will be performed by the licer.see.
area above the pool of pool irradiators shall be conducted after the sources are loaded but before the facility starts (8) Inspection of movable shielding required by to operate. Additional radiation surveys of the shielding i 232.23(h) (relating to access control), if applicable.
shall be performed at intervals not to exceed 3 years and (b) The licensee shall have and before resuming operatioh after addition of new sourtes rbnormal event procedures, appropn. follow emer.gency or or any rnodification to the radiation room shielding or ate for the irradiator type, for the followmg:
structure that might increase dose rates.
(1) Sources stuck m. the unshielded position' (b) If the radiation levels specified in 5 232.25 (relating to shielding) aae exceeded, the facility shall be modified to (2) P;rsonnel overexposures.
comply with Q 232.25.
PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEB5tUADY 14,1998
l 936 PROPOSED RULEMAKING (c) Portable radiation survey meters shall be calibrated product for contamination. If any personnel are found to at least annually to an accuracy of 20% for the gamma be contaminated, decontamination shall be performed energy of the sources in use. The calibration shall be done promptly. If contaminated equipment, facilities or prod-at two points on each scale or, for digital instruments, at ucts are found, the licensee shall arrange to have them one point per decade over the range that will be used.
decontaminated or disposed of by a Department, NRC or Portable radiation survey meters shall be of a type that agreement state licensee that is authorized to perform does not saturate and read zero at high radiation dose these functions. If a pool is contaminated, the licenace
- rates, shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in 10 (d) Water from the irradiator pool, other potentially CFR Part 20, Appendix B, Table 2, Column 2. (See 10 contaminated hqu,ds, and sedunents from pool vacuum-CFR 30.50 (relating to reporting requirements) for report-i ing shall be monitored for radioactive contamination ing requirements.
before release to unrestricted areas. Radioactive concen-t.utions may not exceed those specified in Chapter 219, 9 232.61. Inspection and maintenance.
Appendix B Table 2, Column 2 or Table 3 of, " Annual (a)' The licensee shall perforr.1 inspection and mainte-Limits on Intahe (ALIs) and Derived Air Concentrations nance checks at the frequency specified in the license or (DACs) of Radionuclides for Occ,upational Exporure; Efflu-licer,se appicaticn that include, as a minimum, each of ent,C, oncentrat ons; Concentreuons for Release to Sewer-the following:
age.
(1) Operability of each aspect of the access control (e) Before releasing resins for unrestricted use, they system required by { 232.23 (relating to access control).
shall be monitored before release in an area with a background level less than 0.0005 mSv (0.05 mrem) per (2) Functiening of the source position indicator re-hour. The resins may be released only if the survey does quired by 9 232.31(b)(relating to control of source move-not detect radiation levels above badground radiation ment).
levels. The survey meter used shall be capable of detect-(3) Operability of the radiation monitor for rsdioactive ing radiation levels of 0.0005 mSv (0.05 mrem) per hour.
contamination in pool water required by 6 232.59(b)
(relating to detection of leaking sources) using a radiation i 232.59. Detection ofleaking sources.
check source,if cpplicable.
(a) Each dry-source-storage sealed sourte shall be (4) Operability of the over-pool radiation monitor at tested for leakage at intervals not to exceed 6 months underwater trradiators.as required by { 232.29(b) (relat-using a leak test kit or method a$ proved by the Depart-Ing to radiation monitors).
ment or an ag:eement state. In t e absence of a certifi.
cate from a transferor that a test has been made within (5) Operability of the product exit monitor required by the 6 months before the transfer, the sealed source may 6 232.29(a).
not be used until tested. The test shall be capabl,e of require [rability of the emergency source return contro (6) O d,etecting the cresence of 200 Bq (0.005 pCi) of radioac-by Q 232.31(c) (relating to control of source tive material'and shsil be im.9rmed by a person ap-
" V'* '"t)-
proved by the Departrnent the Nhc or an agreement state to perform tho test.
(7) Leak tightness of systems through which pool wa er circu ates Msual inspec&nk (b) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or (8) Operability of the heat and smoke detectors and has a certificate from a transferor that a leak test has extinguisher system required by l 232.27 (relating to fire been done withir the 6 months befon the transfer. Water protection)--but without turning extinguishers on.
from the pool shall be checked for contamination each day (9) Operability of the means of pool water replenish-the irrrdiator operates. The check may be done either by ment required by 9 232.33(c) (relating to irradiator i
using a radiation monitor on a pool water circulating pooj,)-
system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool (10) Operability of the indicators of high and low pool water, the results of the analysis shall be availabla within water levels required by 9 232.33(d).
24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. If the licensee uses a radiation monitor on a (11) Operability of the intrusion alarm re ired by pool water circulaung system, the detection of above 6 232.23(i)(relating to access control), if applica e.
norm t radiation levels shall activate an alarm. The alarm.,et point shall be set as low as practical, but high (12) Functioning and wear of the system, mecharduns enough to avoid false alarms. The Ibnsee may reset the and cables use.d to raise and lower sources.
alarm set-point to a higher level if necessary to operate (13) Condition of the barrier to prevent products from j
the pwl water purification spem to clean up contamina-hitting the sources or source mechanism as required by tion in the pool if specifically provided for in written
{ 232.35 (relating to soure,: rack protection).
I emergency procedures.
(
water added to the pool to determine if (c) If a leaking source is detected, the license,e shall the 1e g
arrange to reniore the leaking source from service and l'
have it decontaminated, repaired or disposed of by a (15) Electrical wiring on required safety systems for Department, the NRC or agreement state licensee that is radiation damage.
authorized to iform these functions. The licepsee shall (16) Pool water conductivity measurements and analy-promptly chec its personnel, equipment, faculties and sis as required by % 232.63(b) (relating to pooI water irradiated product for radioactive contamination. ho prod-purity).
uct may be shipped until the product has been checked and found free of cont.anination. If a product has been (b) Malfunctions and defects found during inspection shipped that may have been inadvertently contaminated, and maintenance checks shall be repaired without undue the licensee shall arrange to locate and survey that delay.
PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998 I
s..
PROPOSED RULEMAKING 937 5 232.63. Pool water purity.
from the Department. Authorization will not be granted (a) Pool water purification system shall be run sufL
. unless the licensee can demonstrate that detonation of ciently to rnaintain the conductivity of the pool water the explosive would not rupture the sealed sources, injure below 20 microsiemens per centimeter under normal personnel, damage safety systems or cause radiation circumstances.. If pool water conductivity rises above 20 verexposures of personnel.
microsiemens per centimeter, the licensee shall take (b) Irradiation of more than small quantities of flam-prompt actions to lower the pool water conductivity and mable material (flash point below 140*F) is prohibited in shall take corrective actions to prevent future recur-panoramic izTadiators unless the licensee has received rene:s.
prior written authorization from the Department. Autho-(b) The licensee shall measure the pool water conduc-rization will not be granted unlass the licensee can tivity frequently enough, but no less than weekly, to demonstrate that a fire m the radiation room could be assura that the conductivity remains below 20 e ntrolled without damage to sealed sources or safety microsi: mens per centimeter. Conductivity meters shall systems and without radiation overexposures of person-be celibrated at least annually.
"'I-l 232.65. Attendance during operation.
Subchapter E. RECORDS
. (a) Both an irradiator operator and at least one other
$2'.81. Records and retention penods.
Individual, who is trained on how to respond and pre-232.s2.
Reports.
pired to promptly render or summon assistance if the recess control alarm sounds, shall be present onsite as i 232.81. Records and retention periods.
whmever:
The licensee shall maintain the following records at the (1) The irradiator is operated using an automatic prod-irradiator for the pericds specified:
uct conveyor system.
(1) A copy of the license, license conditions, documents (2) The product is moved into or out of the radiation incorporated into a license by reference, and amendments room when the irradiator is operated in a batch mode.
&eret untH superseded by new oocuments or until the Department terminates the license for documents not (b) At a panoramic irradiator at which static irradia-superseded.
tions (no movement of the prod,uct) are occurring, a person who has received the trauung on how to respond (2) Records of each individual's training, tests and to al rms described in i 232.51(g) (relating to training) safety reviews provided to meet the requirements of shtll be onsite.
I 232.51(aW(d), (f) and (g) (relating to training) until 3
' ears after the mdividual terminates work.
v (c) At an underwater irradiator, an irradiator operator shall bs present at the facility whenever the product is (3) Records of the annual evaluations of the safety movtd into or out of the pool. Individuals who move the performance of irradiator opere. tors required by product into or out of the pool of an underwater irradiator 9 232.51(e) for 3 years after the evaluation.
need not be qualified as irradiator operators. The opera-(4) A copy of the current operating and emergency tor shall have received the training described in procedures required by 6 232.53 until supersedod or the 4
6 232.51(f) and (g). Static irradiations may be performed Department terminates the, license. Records of the radia-without a person present at the facility.
tion safety efficer's review and approval of changes in i
i 232.67. Entering and leaving the radiation room.
Procedures as required by g 232.53(cX3) retained for 3 (s) Upon first entering the radiation mom of a pan-years from the date of the change.
orunic irradiator after an irradiation, the irradiator (5) Film badge and TLD results required by 9 232.55 operttor shall use a survey meter to determine that the (relating to personnel monitoring) until the Department i source has returned to its fully shielded position. The terminates the license.
operator shall check the functioning of the survey meter with a radiation check source pnor to entry.
(6) Records of radiation surveys required by 6 232.57 (relating to radiation surveys) for 3 years from the date of (b) Before exiting from and locking the door to the the survey.
~
radiation, room of a panoramic irradiator prior to a plmned trradiation, the irradiator operator shall:
(7) Records of radiation survey meter calibrations re-I quired by 6 232.57 and pool water conductivity meter (1) Visually inspect the entire radiation room to verify calibrations required by 6 232.63(b) (relating to pool thtt no one else is in it.
water purity) until 3 years from the date of calibration.
l (2) Activate a control in the radiation room that per-(8) Records of the results of leak tests required by mits the sources to be moved from the shielded position 6 232.59(a) (relating to detection of leaking sources) and only if the door to the radiation room is locked within a the results of contaminaoon checks required by pr: set time after setting the control.
$ 232.59(b) for 3 years from the date of e.ch test.
(c) During a power failure, the area around the pool of (9) Records of inspection and maintenance checks re.
en und:rwater irradiator may not be entered without quired by i 232.61 (relating to inspection and mairne-using an operable and calibrated radiation survey meter narea) for 3 years.
unless the over-the-pool monitor required by $ 232.29(b)
(relatmg tc radiation monitors) is operating with backup (10) Records of major malfunctions, significant defects, E **#'
operating difficulties or irregularities and major operating problems that involve required radiation safety equip-1 232.69. Irradiation of explosive or flammable ma-ment for 3 years after repairs are completed.
te M s.
3 (11) Records of the receipt, transfer and disposal, of all
,. (a) Irradiation of explosive material is prohibited un-licensed sealed sources as required by 6 217.101(relating
) 1:ss the licensee has received prior written authorization to transfer of radioactive material).
I PENNSYLVANIA BULLETIN, VOL. 28, NO. 7, FEBRUARY 14, 1998
\\
938 PROPOSED RULEMAKING
~
(12) Records on the design checks required by 6 232.39 (b) The report sl.all include a telephone report within >
^
(relating to design reguirements) and the construction 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. To the extent that the information is available control checks as required by 9 232.41 (relating to con-at the time of notification, the information provided in struction monitoring and acceptance testing) until the these reports chall include:
license is terminated. The records shall be signed and (1) The caller's name and call back number, dated. The title or qualification of the person sigmng (2) A description of the event including date and time.
J shall be included.
(3) The exact location of the event.
(13) Records related to decommissioning of the irradia.
tot as required by 6 217.58(g) (relating to financial (4) The isotopes, quantities and chemical and physical assurance _rrangements for reclaiming sites).
form of the licensed material involved, i 232.83. Reports.
(5) Any personnel radiation exposure dat,a available.
1 (a) In addition to the reporting requirements of this (c) A written fcllow. ip report within 30 days of the I
article, the licersee shall report the following events if mitial report. Written reports prepared under other regu-f not reported under other requirements of this article:
lations may be submitted to fulfill this requirement if the reports contain the ne,cessary information. The reports (1) Soune stuck in an unshielded position.
shall melude the followmg:
(2) Any fire or explosion in a radiation room.
(1) A description of the event including the probable (3) Damage to the source racks.
cause and the manufacturer and model number-if appli-cable-of any equipment that failed or malfunctioned.
(4) Failure of the cable or drive mechanism used to move the source racks.
(2) The exact location of the event.
(5) Inoperability of the access control system.
(3) The isotopes, quantities, and chemical and physical f rm of the licensed material involved.
(6) Detection of radiation source by the product exit monitor.
(4) The date and time of the event.
(7) Detection of radioactive convmination attributable (5) Corrective actions taken or planned and the results.
to licensed radioactive material..
of any evaluations or assessments.
(8) Structural damage to the' pool liner or walls.
(6) The extent of exposure ofindividuals to radiation or -
t radioactive materials without identification of individu-(9) Abnormal water loss or' leakage from the source als by name.
storage pool.
(Pa.B. Doc. No. b&287. Fued for pubha inspection February 13,1996,9@ a.m.)
(10) Pool water conductivity exceeding 100 micro-siemens per centimeter.
I I
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i PENNSYLVANIA BULLETIN, VOL 28, NO. 7, FEBRUARY 14, 1998
e4,4 3'
New 34 Vs New 225
]
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Rev 7/15/97 New 34 New 225 34.1 225.1 34.3 225.2 34.5 NA 34.8 NA 34.11 225.10 34.13 217.65 34.20 225.251 34.21 225.252 34.23 225.253 34.25 225.151 and.152 34.27 225.255 34.29 225.256(a) 34.31 225.257 j
34.33 225.105(a) 34.35(a) 225.153NN 34.35(b) 225.251(b)(2) 34.35(c) 255.254 34.35(d) 225.253(d) 34.41 225.261(a) 34.42 225.51(a) 34.43 225.72 and.73 34 43(g)
Appendix A 34.45 225.108 34.46 225.26 34.47 225.153 34.47(g) 225.154 34.49 225.259 34.51 225.201(b) 34.53 225.261(c) 34.61
^
none 34.63 215.11 34.65 225.152(c) 34.67 225.255(e) 34.69 225.256(b) 34.71 225.258 34.73 225.257(d) 34.75 225.105(b) 34.79(a) 227.72(c) 34.79(b) 225.73(c) 34.81 none 34.83 225.153(e) 34.85 225139(c) 34.87 219.211 Page1
1
.s New 34 Vs New 225 i
i t
\\
34.89(a)
NONE 34.89(b) 225.107
\\
l 34.101 225.74 i
34.111 215.31 34.121 Radiation ProteWon Act 34.123 Radiation Protection Act
- Appendix A. l.
225.102 Appendix A.11.
225.103 Appendix A. til.
225.104 i
T l
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i Y
Page 2 I
230 v3 71 NEW j
i l
As of May 2, 1997 Chapter 230 Part 71 Comp Div Comments j
1 71.0 3
2 71.4 1
11 71.3 3
12(a) 30.13 12(b) 71.10(a) 1 12 (c) 71.10(b) 1 13 (a) (1 )
71.5(a) 1 13(a)(2) 71.89 2
13(b) 71.5(b) 1 14 N/A 21 71.12 2
22 71.13 2
23 71.14 2
24 71.16 2
41 71.81 2
42 71.65 2
43 71.87 2 Includes 71.43 and 71.47 44 71.88 2
45 71.91 l
3 46 71.95 I
3 47 71.97 I
2 48 71.89 2
51 71.101 3
l
)
Appendix A Appendix A 1
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)
i Page 1
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WLLL L 0 G GIN G Cross-references, Chapter 10 CFR Part 39 Sheeti I
New8 Old # ik 10 CFR 39 226.1 226.1 v',
39.1 WPurpose & Scope 226.2 M 226.2
(/,
39.2 & Definitions Kn /nl %W 226.3 226.3 t/
N/A Prohibition e nl, ll I,a.a 39.5 D interpretation 39.8 o Jnfo for OMB 39.11 pyApplication for specificlicense 39.13 p1 Specific License forwelllogging 39.15 eLAgreement w/ owner or operator 39.17 ryRequest for material statements 226.11 226.11 t,imits on Levels of Radiation 226.12a 226.12o V
3C.31b1 CSStorageAransport-accurity 226.12b 226.12b V 39.31b1 CsStorage/ transport - fire / explosion 226.12c m 226.12c
$9.31b2 cvTransport containers l 226.13a m 226.13a 39.33a CsSurvey meters-general 226.13b new
/
39.33b WSurvey meters-low level 226.13c M 226.13b 39.33c csSprvoy meters-calibration 1
226.13d 226.13c 39.33d D #urvey meters records retention 226.14a 226.14a 39.35b CN Leak TestMg - authorization 226.14b 226.14b 39.35c csLeak Testing - frequency
_226.14c 226.14c 39.35d c pleak Testing -leaking source l
226.14d 226.14d 39.35e c4 teak Testing - exemptions 22".
- i:
new se m M T:e.g
- M;::rNy 226.15a M 226.15a 39.37 s Quarter 1y Inventory l l
226.15b new NRC-AS Work Group Recommendation 226.16 m 226.16 39.39 C\\Otilization records l
l HG1 $-f7 226.17a 226.17a 39.41a R< Design / performance specs testing f war 226.17b 226.17b Design / performance specs - post 12.19.88 specificationh.d 226.17c 226.17c Design / performance specs p, $ 4 4 226.17d 226.17d Ot sign / performance spect 228.18a 226.18a 39.31a1 DVLabeling source, holder 226.18b 226.18b 39.31a2 o.stabeling transport container 226.19a M 226.19a 39.43b C-Inspection & Maintenance-program
)
226.19b:M 226.190 39.43a C
I & M action upon defects 226.19clM 226.19c 39.43e C l & M specific authorization 226.19dl new 39.43c c
1 & M - removal of sealed source 226.19e new 39.43d C
1 & M source stuck l 226.20 new 39.47,.49 Markers, U sinker bars 4
i
~)
l l
226.21a M 226.21a 39.61a.4 Trahing Requirements logging supervisor 226.21b M 226.21b 39.61b c
Training Requirements - logging assistant 226.21c 226.21c-39.61d c
Training Requirements - records of training 226.21d new:
39.61c C
Training Requirements - annual review 226.22 M 226.22 O 39.63 ' C Operating & Emergency Procedures 226.23a M 226.23a
~
39.65a C
Personnel Monitoring devices, frequency 219.73 39.65b i) Personnel Monitoring - bioassay l 226.23b E ' 23b 39.65c f) Personnel Monitoring - records retention l
l 4
226.31a new 39.71a C Security - supervisor physically present 226.31b 226.31 39.71b
- c. Security - direct surveillance J
226.32 326.32 39.63b C Handling Tools I
i 226.33a M 226.33a' 39.45a C Subsurface Tracer Studies protectjve cloming 226.33b m 226.33b 39.45b C Subsurface Tracer Studies - injection authorization l
226.33c new 39.51 p Subsurface Tracer Studies - use w/o casings 1
226.34 226.34 N/A Particle Accelerators l L
I
)
r,,,
e~
VJ ff L.
LA C G }Al C I.-
226.41a m 226.41a 39.67a O
Radiahme8urveys requirements 226.41b 226.41b 39.67b
(. Radiation Surveys.venicle l
(.*
226.41c 226.41c 39.67c C
Radiation Surveys survey of 100011e tool l
226.41d new 39.67d C
Radiation Surveys sealed source damage 226.41e new 39.69a C
Radiation Surveys sealed source rupture 226.41f new 39.69b c Radiation Surveys work area deconismination
~
226.41g new 39.69c (
Radiation Surveys - monitorino sources downhole 226.41h 226.41d 39.67e C Radiation Surveys traceroperations 226.411 226.41e 39.67f c Radiation Surveys-records i
226.42 m 226.42 39.73 ('
Documents, field stations 226.43 M 226.43 39.75 C Documents, temp. Job sites l
l 226.51a 226.51a 39.77b D Notification of incidents, etc. - general 226.51b 226.51b 39.77a L Notification of incidents, etc. - loss of source 226.51c M 226.51c 39.77c L Notification of incidents, etc. - lodQed downhole 226.51o 226.51d 39.77d L Notification of incidents, etc.- irretrievable source 226.51e m 226.61e 39.77d9 Notification of incidents, etc. plaque /postinC I
j.pp A App A 39.63 C-Training subjects AppB
[ deleted]
abandoned source marker I
215.31 39.91 p Exemptions 215.23 39.101 p Violations l 215.23 39.103 o
Civil Pensities 4
1 Pa9e 2
?