ML20236M136
| ML20236M136 | |
| Person / Time | |
|---|---|
| Issue date: | 06/18/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Quillin R COLORADO, STATE OF |
| References | |
| NUDOCS 9807130309 | |
| Download: ML20236M136 (5) | |
Text
l j
1 Mr. Robert M. Quillin, Director Laboratory and Radiation Services Division Colorado Department of Public Health and l
Environment 8100 Lowry Boulevard Denver, CO 80220-6928 I
Dear Mr. Quillin:
As requested, we have reviewed the proposed revisions in two sections of Part 3 to the l
Colorado Rules and Regulations Pertaining to Radiation Control, RH 3.12.14, Registration of Product Information. and RH 3.24, Reciorocal Recognition of Licenses, dated May 12,1998.
The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 32.210 and 150.20.
1 As a result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. 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 without other j
significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
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, "Reauest to Highlight Changes to Aareement State Regulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or Ms. Cardelia H. Maupin of my staff at (301) 415-2312 or e-mail at CHM @NRC. GOV.
Sincerely, ggSigned By:
PAULH.LOHAUS 9807130309 980618 PDR STPRG ESGCO Paul H. Lohaus, Deputy Director PDR Office of State Programs cc: Jake Jacobi Colorado Material Licensing and Inspection l
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- June 18, 1998 Mr. Robert M. Quillin, Director Laboratory and Radiation Services Division Colorado Department of Public Health and Environment 8100 Lowry Boulevard Denver, CO 80220-6928
Dear Mr. Quillin:
As requested, we have reviewed the proposed revisions in two sections of Part 3 to the Colorado Rules and Regulations Pertaining to Radiation Control, RH 3.12.14, Registration of Product Information. and RH 3.24, Reciorocal Recognition of Licenses. dated May 12,1998..
The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 32.210 and 150.20.
As a result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. 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 without other significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
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, "Reauest to Hiahlicht Chances to Aareement State Regulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or Ms. Cardelia H. Maupin of my staff at (301) 415-2312 or e-mail at CHM @NRC. GOV.
' Sincerely,
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h Paul H. Lohaus, Deputy Director Office of State Programs cc: Jake Jacobi Colorado Material Licensing and Inspection
e Mr. Robert M. Quillin, Director Laboratory and Radiation Services Division Colorado Dep..nment of Public Health and Environ. sit 8100 Lowry Boulevard Denver, CO 80220-6928
Dear Mr. Quillin:
As requested, we have reviewed the proposed revisions n two sections of Part 3 to the Colorado Rules and Regulations Pertaining to Radiatio Control, RH 3.12.14, Registration of Product Information. and RH 3.24, Reciorocal Recoan' on of Licenses. dated May 12,1998.
The regulations were reviewed by comparison to the edluivalent NRC regulations in 10 CFR 1
Parts 32.210 and 150.20.
1 i
As a. result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. 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 proposfd regulations were adopted without other significant change, they would meet the compati ility and health and safety categories established in OSP Intemal Procedure B.7.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be prgvided to us for review. As requested in our All l
Agreement States Letter SP-96-027, "Reauest to Highlight Chanaes to Aareement State Regulations Submitted to NRC for ComoatibWity Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the c mments, the compatibility and health and safety categories, or any of the NRC regulation used in the review, please contact me or Ms. Cardelia H. Maupin of my staff at (3 1) 415-2312 or e-mail at CHM @NRC. GOV.
Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs cc: Jake Jacobi Colorado Material Licensin and Inspection Distribution:
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ROUTING AND TRANSMITTAL SLIP DATE: JUNE 12,1998 CONCURRENCE REQUESTED INITIALS DATE F. CAMERON, OGC 6/ 98 LETTER TO:
ROBERT M. QUILLIN, DIRECTOR l
LABORATORY AND RADIATION SERVICES DIVISION l
COLORADO DEPARTMENT OF PUBLIC HEALTH & ENVIRONMENT FROM:
PAUL H. LOHAUS, DEPUTY DIRECTOR OFFICE OF STATE PROGRAMS i
SUBJECT:
REVIEW OF PROPOSED COLORADO REGULATIONS
" REGISTRATION OF PRODUCT INFORMATION" AND
" RECIPROCAL RECOGNITION OF LICENSES" DATED MAY 12,1998 YOUR COMMENTS / CONCURRENCE ARE REQUESTED BY C.O.B JUNE 26,1998.
OSP CONTACT: CARDELIA MAUPIN (415-2312) l-i l
PLEASE CALL KATHALEEN KERR (415-3340) FOR PICK UP.
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8S152 DATE- 05/18/98..- - - -
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1998 TASK STARTED - 05/18/98 TASK DUE - 06/10/98 TASK COMPLETED -
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TASK DESCRIPTION - REVIEW PROPOSED REGULATIONS FOR COLORADO - PART 3
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l STK~i O;: CO10MlO Roy Romer, Governor Patti Shwayder, Executive Director Dedicated to protecting and improving the health and environment of the people of Colorado l
I 4300 Cherry Creek Dr. S.
Laboratory and Radiation Services Division
' Y.,m. [
Denver, Colorado 80246-1530 8100 Lowry Blvd.
Phone 003) 692-2000 Denver CO 80220-6928 i
Located in Glendale, Colorado 0 03)692-3090 ColoradoD anment http:Nwww.cdphe. state.co.us C
3 May 12,1998 1
Mr. Paul Lohaus Deputy Director, Office of State Programs United States Nuclear Regulatory Commission Washington, D.C. 20555-0001
Dear Mr. Lohaus,
Attached are the proposed revisions to Part 3 to the Colorado Rules and Regulations Pertaining to Radiation Control. Two sections in Part 3 have been revised. RH 3.12.14, Registration of Product Information. are being revised to be compatible with the NRC regulations. Reciorocal Recognition of Licenses, RH 3.24, are being revised due to the NRC's program review of Colorado's Radiation Control Program. The reviewers identified the need to make more explicit procedures and requirements for persons conducting licensed activities in Colorado under what is called " reciprocity". The additions to RH 3.24 clarify the responsibilities of such a general licensee and clarify how the Department willinspect such a generallicensee.
Please direct any questions or comments to Linda Martin by June 19,1998. She can be reached at (303)692-3057.
Sin r,ely, l
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obert M. Quillin, Director Laboratory and Radiation Services Division c:)
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Attachments: as stated cf: L. McLean I
486 tis m APP
STATEMENT OF BASIS AND PURPOSE FOR COLORADO RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL 6 CCR 1007-1 PART 3 LICENSING OF RADIOACTIF MATERIALS July 15, 1998 OVERVIEW In 1968 the State of Colorado entered into an agreement with the federal government whereby the State assumed the responsibility for the regulation of certain types of radiation and radioactive materials.
i The Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes 1989 (Act) requires the Colorado Department of Public Health and Environment (Department) to license radioactive materials and to develop and conduct programs for evaluation and control of hazards associated with the use of sources of ionizing radiation.
I By the Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes
)
1989 (Act), the Colorado Department of Public Health and Environment (Department) is to develop and conduct programs for evaluation and control of hazards associated with the use of sources of ionizing radiation.
By Section
{
l 25-11-104 of the Act, the state Board of Health is to formulate, adopt, and promulgate rules and regulations pertaining to radiation control.
Section 104 l
provides that "all such regulations shall be modeled after and shall be neither more or less stringent than those proposed by the Conference of Radiation Control Program Directors, Inc. (CRCPD) under the title of Suggested i
State Regulations for Control of Radiation; (SSRCR) except that, in the event said board concludes on the basis of detailed findings that a substantial l
deviation from any said suggested state regulations is warranted..."
In order to maintain its agreement with the federal government, Colorado's radiation regulations, in certain areas, must also be compatible with the regulations of the U.S. Nuclear Regulatory Commission (NRC).
The revisions being made to the Colorado Rules and Regulations Pertaining to Radiation Control (Regulations) herein are regarding notification regarding sealed sources, a matter of compatibility with the NRC, and to improve and clarify regulatory requirements for reciprocity.
The revisions under consideration reflect NRC regulatory' provisions as incorporated into the SSRCR.
Two sections in Colorado's Rules and Regulations Pertaining to Radiation control, Part 3, are revised:
1.
RH 3.12.14, Registration of Product Information.
2.
RH 3.24, Reciorocal Reccanition of Licenses Basis and Purpose May 12, 1998 Page 1 J
O BASIS AND PURPOSE FOR PROPOSED AMENDMENTS 1.
RH 3.12.14, Registration of Product Inf o rmat ion.
The U.S. Nuclear Regulatory Commission (NRC) Title 10, Code of Federal Regulations (CFR) Section 32.210 provides for registration of product information (52 Federal Register 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995).
As stated previously, Section 25-11-104 of Colorado's Act established the SSRCR as the model for Colorado to use in adopting NRC regulatory provisions.
Colorado's wording mirrors the language being considered for adoption by the Conference of Radiation Control Program Directors, Inc. (CRCPD) for addition to Part C of the suggested State Regulations for control of Radiation (SSRCR).
Timely action to incorporate the proposed 3.12.14 into Colorado's radiation regulations is a matter of compatibility with NRC.
2.
RH 3.14, Recinrocal Recognition of Licenses In the U.S. Nuclear Regulatory Commission program review of Colorado's radiation control program, the reviewers identified the need to make more explicit the procedures and requirements for persons conducting licensed activities in Colorado under what is called " reciprocity".
By reciproci,ty, a licensee of another jurisdiction who holds a specific license from the U.
S.
Nuclear Regulatory Commission or another Agreement State and provideo proper notice is readily permitted to work within the State of Colorado.
The additions to RH 3.24 clarify the responsibilities of such a general licensee and clarify how the Department will inspect such a general licensee.
In particular, certain papers are to be on hand at the work site for inspection. Also, the Department will not charge more than one routine fee annually, but may inspect more frequently.
Incorporate the proposed 3.24 modifications into Colorado's radiation regulations will fulfill the Department's commitments in response to the NRC program review.
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Basis and Purpose May 12, 1998 Page 2
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REGULATORY ANALYSIS FOR COLORADO RULES AND REGbT.ATIONS l
PERTAINING TO RADIATION CMNTT 0L 6 CCR 1007-1 PART 3 l
LICENSING OF RADIOACTIVE MATERIALS l
l July 15, 1998 l
The Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes 1989 (Act) requires the Colorado Department of Public Health and Environment (Department) to license radioactive materials and to develop and conduct programs for evaluation and control of hazards associated with the use of sources of ionizing radiation.
Section 25-11-104 of the Act requires the state Board of Health to formulate, l
adopt and promulgate rules and regulations pertaining to radiation control, and that "all such regulations shall be modeled after and shall be neither more nor less stringent than those proposed by the Conference of Radiation Control Program Directors, Inc. (CRCPD) under the title suggested State Regulations for Control of Radiation (SSRCR); except that, in the event said board concludes on the basis of detailed findings that a substantial deviation from any said succested state regulations is warrantad..."
The Department is revising two sections of Part 3 of the Colorado Rules and Regulations Pertaining to Radiation Control (Regulations), which establishes regn: 'nry requirements for the licensing of radioactive material, which was adopteo by the Board of Health in 1978.
This Regulatory Analysis provides the background information relative to the revision of the Regulations. This analysis is prepared in fulfillment of section 24-04-103 (4.5) (a) of the Colorado Administrative Procedures Act.
The revised regulation contains the following new provisions.
1.
RH'3.12.14, Registration of Product Information.
2.
RH 3.24, Recierocal Reccanition of Licenses Regulatory Analysis of Added Notification and Revised Reciprocity Provisions 1.
A description of the classes of eersons who will bear the costs and/or benefits from the action.
All license applicants and licensees will benefit from the clarifications in these changes, although few licensees will be affected by them.
No significant expected costs are associated with the proposed changes to the Regulations.
No requirement is being imposed that is not already within the Department's authority.
Both licensees and the Department will benefit from making expectations more explicit.
I I
Regulatory Analysis May 12, 1998 Page 1 e-_________-_____
2.
A description of the erobable quantitative and qualitative imoacts of the rule. economic and otherwise. uoan the affected classes.
Quantitative: This revision of Part 3 is expected to have no impact on the overall costs associated with these Regulations, either to the Department or to radioactive material licensees in the State of colorado.
Licensees will know clearly that the fee for a routine reciprocity inspection will be charged only once per year.
qualitative: No adverse impacts to public health and safety are associated with this action.
3.
Probable costs to the Decartment and to local health departments.
Anticipated e.ffects on state revenues.
No addition'al Department staff will be needed to implement these Regulations.
The proposed changes will have no effect on the operations of the colorado Department of Public Health and Environment, local health departments or on state revenues.
4.
A comoarison of the erobable costs and benefits of the rule and erobable costs and benefits of inaction.
There are no additional costs to the licensees or the public related to these revisions to Part 3 of the Regulations.
The changes are minor and a net benefit.
5.
A determination of whether there are less costiv or less intrusive means to achieve the puroese of the rule.
There are no less costly or less intrusive means available to make the changes 6.
A description of alternative methods for achievina the ournose of the rule.
The regulations provide the necessary standards, technical guidance and procedures to carry out the intent of the Act.
No alternative method is available which is as effective.
j Regulatory Analysis l
May 12, 1998 Page 2 t
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1 PART 3 2
Licensing of Radioactive Materials
.3 RH 3.12.14 sag 2STRATION OF PRODUCT INFORMATION.
FR-4 0 R a t @ 3' 4
'3.12.14.1 ANY MANUFACTURER OR INITIAL DISTRIBUTOR OF A SEALED SOURCE 5
OR DEVICE CONTAINING A SEALED SOURCE WHOSE PRODUCT IS 6
INTmNDED rOR USE UNDER A SPECIFIC LICENSE MAY SUBMIT A l
7.
REQUEST TO THE DEPARTMENT FOR EVALUATION OF RADIATION SAFETY
-8 INFORMATION ABOUT THE PRODUCT AND FOR THE PRODUCT'S 9
REGISTRATION.
.10 3.12.14.2 THE REQUEST FOR REVIEW MUST BE MADE IN DUPLICATE AND SENT TO i-Il THE DIRECTOR, LABORATORY AND RADIATION SERVICES DIVISION, l
12 COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT, 8100 13 LOWRY BOULEVARD, DENVER, COLORADO 80220-6928.
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3.12.14.3 THE REQUEST FOR REVIEW OF A SEALED SOURCE OR A DEVICE MUST
'2 INCLUDE SUFFICIENT INFORMATION ABOUT THE DESIGN, 3
MANUFACTURE, PROTOTYPE TESTING, QUALITY CONTROL PROGRAM, 4
LABELING, PROPOSED USES AND LEAK TESTING AND, FOR A DEVICE, 5
THE REQUEST MUST ALSO INCLUDE SUFFICIENT INFORMATION ABOUT 6
INSTALLATION, SERVICE AND MAINTENANCE, OPERATING AND SAFETY 7
INSTRUCTIONS, AND ITS POTENTIAL HAZARDS, TO PROVIDE 8
REASONABLE ASSURANCE THAT THE RADIATION SAFETY PROPERTIES OF 9
THE SOURCE OR DEVICE ARE ADEQUATE TO PROTECT HEALTH AND MINIMIZE DANGER TO LIFE AND PROPERTY.
10
'l Il 3.12.14.4 THE DEPARTMENT NORMALLY EVALUATES A SEALED SOURCE OR A 12 DEVICE USING RADIATION SAFETY CRITERIA IN ACCEPTED INDUSTRY 13 STANDARDS. IF THESE STANDARDS AND CRITERIA DO NOT READILY 14 APPLY TO A PARTICULAR CASE, THE DEPARTMENT FORMULATES 15 REASONABLE STANDARDS AND CRITERIA WITH THE HELP OF THE 16 MANUFACTURER OR DISTRIBUTOR. THE DEPARTMENT SHALL USE 17 CRITERIA AND STANDARDS SUFFICIENT TO ENSURE THAT THE 18 RADIATION SAFETY PROPERTIES OF THE DEVICE OR SEALED SOURCE 19 ARE ADEQUATE TO PROTECT HEALTH AND MINIMIZE DANGER TO LIFE 20 AND PROPERTY.
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3.12.14.5 AFTER COMPLETION OF THE E7ALUATION, THE DEPARTMENT ISSUES A 2
CERTIFICATE OF REGISTRATION TO THE PERSON MAKING THE 3
REQUEST. THE CERTIFICATE OF REGISTRATION ACKNOWLEDGES THE 4
AVAILABILITY OF THE SUBMITTED INFORMATION FOR INCLUSION IN 5
AN APPLICATION FOR SPECIFIC LICFNSE PROPOSING USE OF THE 6
PRODUCT.
7 3.12.14.6 THE PERSON SUBMITTING THE REQUEST FOR EVALUATION AND 8
REGISTRATION OF SAFETY INFORMATION ABOUT THE PRODUCT SHALL 9
MANUFACTURE AND DISTRIBUTE THE PRODUCT IN ACCORDANCE WITH:
10 3.12.14.6.1 THE STATEMENTS AND REPRESENTATIONS, INCLUDING QUALITY ll CONTROL PROGRAM, CONTAINED IN THE REQUEST; AND 12 3.12.14.6.2 THE PROVISIONS OF THE CERTIFICATE OF REGISTRATION.
13
\\50'90& 'D'h Reciprocity 14 RH 3.24 Reciorocal Reco<Tnition of Licenses.
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15 3.24.1 Licccccc cf n = cauct. cc=c-
-H cc:cial ':ucicar 16 RADIOACTIVE Material in Ouantities Not Sufficient to Form a 17 critical Mass.
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3.24.1.1 Subject to these regulations, any person who holds a D
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.2 specific license from the U. S. Nuclear Regulatory 3
commission, e an Agreement State OR A LICENSING STATE, and 4
issued by the agency having jur%sdiction where the licensee 5-maintains'an office for directing the licensed activity and 6
at which radiation safety records are normally maintained, 7
is hereby granted a general license to conduct the 8
. activities authorized in such licensing document within this 9
State for a period not in excess of 18o days in any calendar 10
- year, ovided that:
I 11 3.24.1.1.1 the licensing document does not limit the activity g r - ri....,... - -.
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3.24.1.1.2 the out-of-state licensee notifies the Department in 2
writing at least 3 days prior to engaging in such 3
l' activity.
Such notification shall indicate the I
4' location, period, and type of proposed possession and
. 5
' use within the State, and shall be accompanied by a 6
copy of the pertinent licensing document.
If, f:
7 ep::ifi: ::::, th 2 day.p :ica uculd imp :: an unduc 8
hardship en th; cut f state licer. :c, th; licence:
9
=sy, up:: application : th: c ps::::nt, chtain 10 permissi:n t p:::::a :: ncr.
BASED UPON AN ll-APPLICATION NHICH INCLUDES DOCUMENTATION OF NHY IT IS l
12 NOT POSSIBLE OR IS AN UNDUE-HARDSHIP TO PROVIDE 3 DAYS 13
- NOTICE, THE DEPARTMENT MAY GRANT PERMISSION TO 14 PROCEED SOONER. The Department may waive the 15 requirement for filing additional written 16 notifications during the remainder of the calendar 17 year.following the receipt of the initial notification 18 from a person engaging in activities under the general i
19 license provided in RH 3.24.1.1; l
L 20 3.24.1.1.3 the out-of-state licensee complies with all applicable 21
)
regulations of the Department and with all the terms 22 and conditions of the licensing document, except any L
23 such terms and conditions which may be inconsistent 24 with applicable regulations of the Department; i
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- May 12, 1998 I
3.24.1.1.4 the out-of-state licensee supplies such other 2
information as the Department may request; and 3
3.24.1.1.5 the out-of-state licensee shall not transfer or 4
dispose of radioactive material possessed or used 5
under the general license provided in RH 3.24.1.1 6
except by transfer to a person:
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3.24.1.1.s.1 specifically licensed by the Department, or by 8
the U.
S.
Nuclear Regulatory Commission, AN 9
AGREEMENT STATE OR A LICENSING STATE, to receive 10 such material, or ss 3.24.1.1.5.2 exempt from the requirements for a license for 12 such material under RH 3.3.1.
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1 3.24.1.1.6 THE OUT-OF-STATE LICENSEE SHALL AT ALL TIMES DURING 2
WORK AT ANY WORK LOCATION WITHIN THE STATE HAVE 3
AVAILABLE THE PERTINENT LICENSING DOCUMENT, THE 4
APPLICABLE SECTIONS OF THE STATE RADIATION 5
REGULATIONS, A COMPLETE SOURCE INVENTORY, PERTINENT 6
U.S.
DEPARTMENT OF TRANSPORTATION DOCUMENTATION, LEAK 7
TEST RECORDS, INSTRUMENT CALIBRATION RECORDS, 8
PERSONNEL TRAINING RECORDS, AND NECESSARY 9
DOCUMENTATION REQUIRED BY APPLICABLE SPECIAL 10 REQUIREMENTS OF THESE REGULATIONS.
11 12 3.24.1.1.7 THE OUT-OF-STATE LICENSEE SHALL NOTIFY THE DEPARTMENT
/
13 WITHIN 1 HOUR AFTER ARRIVAL AT THE ACTUAL W'ORK
/ /
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' 14 LOCATION WITHIN THE STATE AND NOTIFICATION WITHIN 1 15 HOUR AFTER ANY CHANGE OF WORK LOCATION WITHIN THE 16 STATE.
17 3.24.1.1.8 IF MULTIPLE PERSONS WORK CONCURRENTLY AT MORE THAN ONE 18 WORK LOCATION UNDER A GENERAL LICENSE GRANTED PURSUANT 19 TO THIS RH 3.24.1, EACH DAY WORKED PER LOCATION SHALL 20 BE COUNTED SEPARATELY TOWARD THE LIMIT OF 180 DAYS PER 21 CALENDAR YEAR.
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3.24.1.2 Notwithstanding the provisions of RH 3.24.1.1, any person 2
who holds a specific license issued by the U.
S.
Nuclear 3
Regulatory Commission, ee an Agreement State OR A LICENSING 4
STATE authorizing the holder to manufacture, transfer, 5
install, or service a device described in RH 3.6.4.1 within 6
areas subject to the jurisdiction of the licensing body is 7
hereby granted a general license to install, transfer, 8
demonstrate, or service such a device in this State provided 9
that:
10 3.24.1.2.1 such person shall file a report with the Department 11 within 30 days after the end of each calendar quarter 12 in which any device is transferred to or installed in 13 this State.
Each such report shall identify each 14 general licensee to whom such device is transferred by 15 na:ae and e.ddress, the type of device transferred, and 16 the quantity and type of radioactive material 17 contained in the device; 18 3.24.1.2.2 the device has been manufactured, labeled, installed, 19 and serviced in accordance with applicable provisions 20 of the specific license issued to such person by the 21 u.
S. Nuclear Regulatory Commission,--ee an Agreement 22 State OR A LICENSING STATE; 3
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May 12, 1998 1
3.24.1.2.3 such person shall assure that any labels required to l
2 be affixed to the device under regulations of the 3
authority which licensed manufacture of the device 4
bear a statement that " Removal of this label is 5
prohibited"; and i
6 3.24.1.2.4 the holder of the specific license shall furnish to 7
each general licensee to whom the specific licensee S
transfers such device or on whose premises the 9
specific licensee installs such device a copy of the 10 general license contained in RH 3.6.4 or in aquivalent 11 regulations of the agency having jurisdiction over the j
12 manufacture and distribution of the device.
13 3.24.1.3 The Department may withdraw, limit, or qualify its 14 acceptance of any specific license or equivalent licensing 15 document issued by the U. S. Nuclear Regulatory Commission, 16 er an Agreement State OR A LICENSING STATE, or any product 17 distributed pursuant to such licensing document, upon 18 determining that such action is necessary in order to 19 prevent undue hazard to public health and safety or 20 property.
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- May 12, 1998 1
3.24.2 EACH GENERAL LICENSEE GRANTED AUTHORIZATION TO CONDUCT 2 ACTIVITIES WITHIN THIS STATE PURSUANT TO RH 3.24.1 BASED 3 UPON AN ACCEPTABLE LICENSING DOCUMENT WILL RECEIVE WRITTEN 4 ACKNOWLEDGEMENT FROM THE DEPARTMENT. THIS ACKNOWLEDGEMENT l 5 SHALL BE KEPT AT THE SITE OF USE. i 6 3.24.3 EACH GENERAL LICENSEE GRANTED AUTHORIZATION TO CONDUCT 7 ACTIVITIES WITHIN THIS STATE PURSUANT TO RH 3.24.1 BASED 8 UPON AN ACCEPTABLE LICENSING DOCUMENT MAY EE INSPECTED BY 9 THE DEPARTMENT AND SUBJECT TO A BEE FOR THE INSPECTION. l l 10 3.24.3.1 THE FEE FOR A ROUTINE INSPECTION SHALL BE AS PROVIDED BY ll PART 12 OF THESE REGULATIONS AND SHALL NOT BE CHARGED MORE 12 OFTEN THAN ONCE DURING EACH CALENDAR YEAR. 13 3.24.3.2 NOTWITHSTANDING RH 3.24.3.1 ABOVE, FOR A LICENSEE 14 AUTHORIZING USE OF MATERIAL AT MORE THAN ONE ADDRESS, A l 15 SEPARATE FEE WILL BE ASSESSED FOR INSPECTION OF EACH 16 LOCATION, EXCEPT THAT IF MULTIPLE INSTALLATIONS ARE 17 INSPECTED DURING A SINGLE VISIT, A SINGLE INSPECTION FEE 18 WILL BE ASSESSED. 19 3.24.4 EACH GENERAL LICENSEE OPERATING WITHIN THE STATE UNDER 20 RECIPROCITY IN AREAS OF EXCLUSIVE FEDERAL JURISDICTION SHALL 21 COMPLY WITH THE APPLICABLE PROVISIONS OF 10 CFR 150.20. i i 3 - 14 l n}}