ML20217J827

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Forwards Final Review of California Regulations in R-53-94, Which Became Effective on 970909.Result of NRC Review Determined That California Regulations Meet Compatibility, Health & Safety Categories Established OSP Procedure
ML20217J827
Person / Time
Issue date: 04/01/1998
From: Lohaus P
NRC OFFICE OF STATE PROGRAMS (OSP)
To: Bailey E
CALIFORNIA, STATE OF
References
NUDOCS 9804070028
Download: ML20217J827 (48)


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d-6 APR - 11996, Edgar D. Bailey, C.H.P., Chief Radiologic Health Branch Food, Drugs & Radiation Safety Division State Department of Health Services P.O. Box 942732 Sacramento, CA 94234-7320

Dear Mr. Bailey:

We have reviewed the final California regulations in R-53-94. which became effective on September 9,1997. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 30,31,34,40, and 70. These regulations had also been reviewed as proposed rules, and the results communicated to Mr. Charles Smith on May 7,1997.

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As a result of the NRC review, we have determined that the California regulations, as adopted, meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.

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 Mr. Richard Blanton of my staff at (301) 415-2322, or by Internet at RLB@NRC. GOV.

.s Sincerely, OriginalSigned By:

PAULH.LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs l

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lh Edgar D. Bailey, C.H.P., Chief Radiologic Health Branch ..

Food, Drugs & Radiation Safety Division State Department of Health Services P.O. Box 942732 Sacramento, CA 94234-7320

Dear Mr. Bailey:

We have reviewed the final Califomia regulations in R-53-9d , which became effective on September 9,1997. The regulations were reviewed by co parison to the equivalent NRC l regulations in 10 CFR Parts 30,31,34,40, and 70. These egulations had also been reviewed -

as proposed rules, and the results communicated to Mr. C arles Smith on May 7,1997.

- As a result of the NRC review, we have determined that t Califomia regulations, as adopted, meet the compatibility and health and safety categories e ablished in OSP Intemal Procedure B.7. '

4 If you have any questions regarding the comments, the mpatibility and health and safety categories, or any of the NRC regulations used in the re iew, please contact me or Mr. Richard Blanton of my staff at (301) 415-2322, or by Internet at F LB@NRC. GOV.

Sincerely, Paul H. Lc haus, Deputy Director Office of Ltate Programs Distnbution

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Edgar D. Bailey, C.H.P., Chief Radiologic Health Branch Food, Drugs & Radiation Safety Division State Department of Health Services P.O. Box 942732 Sacramento, CA 94234-7320

Dear Mr. Bailey:

We have n tviewed the final Califomia regulations in R-53-94, which became effective on -

September 9,1997. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 30,31,34,40, and 70. These regulations had also been reviewed as proposed rules, and the results communicated to Mr. Charles Smith on May 7,1997.

As a result of the NRC review, we have determined that the Califomia regulations, as adopted, meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.

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 Mr. Richard Blanton of my staff at (301) 415-2322, or by internet at RLB@NRC. GOV.

rely, I

hW Paul H. Lohau\ rs, De uty Director Office of State Programs l

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R-53-94 December 31, 1996 TITLE 17. PUBLIC HEALTH DIVISION 1. DEPARTMENT OF HEALTH SERVICES CHAPTER 5. SANITATION SUBCHAPTER 4. RADIATION

1. Repeal section 30131 as follows:
30131. "ccords--t< Sc Mainteinedr Every persen who pcccccccc c reportable cource of radiat-len chall keep-reccrda chewing the receipt ' for---any courec rcccived v..__ en ,ne,1

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_ s4 4 source of--radict-lear u_ ....u__1.. _: _a _ ___ enn __2 ,ce,, ,_, u__, u ~_2 av vv sa a s u a. s v 6 6 gwj p aaw, usa waa saaasa av v se s. e aasswaavsAwy w a s w sa w w w s. A v a a w n_c-_-___. e - _4. 4 _ _ era,efLs u _ 1 4. u ~_a c _ c _ 6...

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wu 4. w w g n_A,e wvws a s w. a. w a w a s w w. e w ww w 4va a as svAsgupp a a sa ss a w e a seaaws u sa 4. w w y C-eder 1

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R-53-94 December 31, 1996

2. Amend section 30191.as follows:

5: 30191. General Licenses-Source Material.

(a) A general license is hereby issued to commercial firms, education, and medical institutions and government agencies, authorizing the possession and use of not more than 15 pounds of source material at any one time, for research, development, educational, commercial or operational purposes. Persons authorized to possess and use source material, pursuant to this general license, may not receive more than a total of 150 pounds of source material in any one calendar year. Any person shall, with respect to such source material, be exempt from the provisions of Group 3 of this subchapter, except for Sections 30253, 30254 and 30293(a)fGt, unless such person also possesses source material.under a specific license.

(b) A general license described in Section 30191(a) shall not authorize human use; or the use in any device or article which is intendgd to be placed on or in the human body; or the use of any instrument or apparatus (including component parts and accessories thereto) intended for human use.

Note: Authority cited: Sections G46 100275 and 25011 115000, Health and. Safety Code.

Reference:

Sections 25001 114965, 25002 114970, 25005 'g)- 114985 (c) , 25011 115000, 25015 115060, 25055 115165 and 25076 115235, Health and Safety Code. q 2

3 o

)

+

R-53-94 December 31, 1996 {

3. Amend section 30192 as follows:

5 30192. General License-Static Elimination or Ion Generation Devices.

(a) A general license is hereby issued to any person authorizing possession of radioactive material incorporated in any of the following items when manufactured pursuant to a specific license which authorizes distribution to general licensees:

(1) Static eliminators containing sealed sources of up to 500 microcuries of polonium 210 per device.

(2) Air ionization devices containing, as sealed sources, up to 500 microcuries of polonium 210 or 50 nillicuries of hydrogen 3 per device.

(b) Possession of radioactive material listed in this section is exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, and 30293 (a) (2) , 20204, 20205 and 30207. s. .

Note: Authority cited: Sections BGB 100275 and 25011 115000,

' Health and Safety Code.

Reference:

Sections 25001 114965, 25002

'114970, 25005(g) 114985(al, 25015 115060, 25055 115165 and 25075 115235, Health and Safety Code.

3

9-4-

R-53-94 December 31, 1996

4. Amend section 30192.1 as follows:

5 30192.1. General Licenses--Gauging and controlling.

(a) A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and government agencies to possess and use radioactive material when contained'in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, qualitative or quantitative. chemical composition or for producing light or an ionized atmosphere when such devices are manufactured pursuant to a specific license authorizing distribution to general licensees provided that each such device:

(1) Is labeled in accordance with the provisions of the specific license which authorizes distribution of the device; (2) Bears a label containing the following or substantially similar statement:

"The receipt, possession, use and transfer of this device, Model- , Serial No. , :are subject to a general license or equivalent and the regulations of the United States Nuclear

. Regulatory Commission or of a state with which the United States 4

i

e 4

R-53-94 December- 31, 1996 Nuclear Regulatory Commission has entered into an agreement =for the exercise of regulatory authority. Removal of this label is prohibited.

CAUTION--RADIOACTIVE MATERIAL (Name of Supplier)"

.The-model,. serial number and name of supplier may be omitted from this label provided they are elsewhere specified in labeling affixed to the device; and (3) Is installed on the premises of the general licensee by a person having a specific license which authorized installation of such devices when required by the label on the device.

(b)-Persons'who possess a device pursuant to the general license contained in Section 30192.1(a) shall:

(1) Within.30 days of the receipt of any such device, register

'with the Department and within 30 days of transfer of any such device, notify'the Department in accordance with the provisions of Group 1.5 of this subchapter (Registration of Radiation Sources).

. (2) Not transfer, abandon or dispose of the device, except by

' transfer to a person holding a: specific. license to receive such dhvice. '

5

. . .e

)

s R-53-94

'y December 31, 1996 (3) Transfer'the device to another general licensee only; s

(A) Where the device remains in use at a particular location.

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In such case the transferrer shall give the transferee a copy of this section and any safety documents identified in the label of the device, or ,

(B)-Where the device is held in storage in the original

" shipping container at its intended location.of use prior to initial use by the general licensee.

(4) Assure that all labels affixed to the device at the time of receipt and bearing the statement, " Removal of this label is prohibited" are maintained thereon and comply with all instructions contained in such labels.

(5) Have the device tested for leakage of radioactive material

.and proper. operation of the on-off mechanism and indicator, if any, at the time of installation of the device or replacement of radioactive material on the premises of the general licensee and thereafter at no longer than sin month intervals or at such longer intervals as may be specified in the specific license

s. .

which authorized distribution of the device to general licenses.

Devices containing only krypton need not be tested for leakage.

Devices containing only tritium or not more than 100 uCi of other

r.

beta and/or gama emitting material or 10 uCi'of alpha emitting material and' devices. held _in storage in the original shipping 6

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l R-53-94 J December 31, 1996 I container prior to initial installation need not be tested for any reason.

-(6) Have the test required by Section 3 0192.1(b) (5) and all other services involving the radioactive material, its shielding and containment performed:

(A) In accordance with the instructions provided by the label; or (B) By a person holding an appropriate license therefor.

(7) Maintain records of all tests performed on the devices as required under this section, including the dates and results of these' tests and the names and addresses of the persons conducting-the test.

(8) Upon occurrence of a failure of or damage to, or any indication of a possible failure of or damage to the shielding or containment of the radioactive material, or of the on-off mechanism or indicator, immediately suspend operation of the device-until it has been repaired by or disposed of to a person holding ,a specific license therefor.

(9) Within 30 days after the occurrence of a failure.of or damage to the shielding or containment of radioactive material or the on-off mechanism or indicator or upon the detection of 0.005 microcuries or more of removable radioactive material, furnish to the Department a complete description of the device 7

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- ,. I 1 R-53-94 December 31, 1996 (manufacturer, type, serial number) and a'brief description of the event and'the remedial action taken.

(c) Persons who possess a device pursuant to the general license contained un Section 30192.1(a) shall with respect theretc be exempt'from the requirements of Group 3.of this subchapter except

< for Sections 30253, 30254, and 30293 (a) (2) , 20204, 20205 and 20207.

Note:: Authority cited: Sections GOG 100275 and 25011 115000, Health and Safety Code. Reference Sections GG661 114965, 25002 114970, 25005(g)'114985(c), 25015 115060, GGGGG 115165,-25S75 1152 3 0 and 456% 11523 5, Health and Safety Code.

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R-53-94 December 31, 1996

5. Amend section 30192.2 as-follows:'

5'.30192.2. General Licenses--Aircraft. Safety Devices.

(a).A general license is hereby issued to any person to possess and use tritium or promethium 147 contained in luminous safety devices designed for use in aircraft provided that each such device contains not more than 10 curies of tritium or 300 millicuries of promethium 147 and has been manufactured, assembled or imported in accordance with a specific license authorizing distribution to general licensees.

(b) The general license contained in Section 30192.2(a) does not authorize:

(1).The' manufacture,' assembly, disassembly, repair or disposal of such devices.

i (2) The use of such devices other than in aircraft.

(3) The possession of promethium 147 in instrument dials.

(c) Persons who possess a device pursuant to the general license

. contained in Section.30192.2(a) shall, with respect thereto, be exempt;from.the requirements of Group 3 of this subchapter except

' for Sections 30253, 30254, and 30293 (a) (2) , 10204, 30205 and 30207.

9 1 d' _

. m R-53-94 '

' December 31, 1996 Note:' Authority cited: Sections 40s 100275 and~25011 115000, Health and Safety Code. Reference Sections 25001 1].49 H , 25002 114970, '25S05 (g) :114985 (a) , 25011' 115000, - 25015 115060, 25055 115165;-and 25S75 115235, Health and Safety Code.

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. ~l R-53-94 December 31, 1996.

'6. ' Amend section 30192.3 as follows:

9'30192.3. General Licenses-Calibration or Reference Source.

(a) A. general license is hereby issued to persons who hold either-a specific license issued by the Department for any radioactive

. material or a specific license issued by the United States Nuclear Regulatory, Commission for any special nuclear material, to possess americium-241 or plutonium in the form of calibration or reference sources. Calibration or reference sources shall be manufactured in accordance with the specifications contained in an appropriate specific license which authorizes distribution under a general license. Each source possessed pursuant to the-r

- general license or its storage container shall bear a label which includes.-the information required in the following statement: i "The receipt, possession, use and transfer of this source, Model , Serial No. , are subject to a general license or

'equivaEent and the regulations of the United States Nuclear Regulatory-Commission or of a state with which the United States Nuclear Regulatory Commission has entered into an agreement for pthe. exercise of regulatory authority. Removal of this label is

' prohibited.

11

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'R-53-94 December 31, 1996 i

l CAUTION--RADIOACTIVE MATERIAL--THIS SOURCE CONTAINS (AMERICIUM 241 OR PLUTONIUM, whichever is appropriate). DO!NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

It (Name of Manufacturer or Importer)

(b) Persons who possess a source pursuant to the general license contained in Section 30192.3(a) shall:

(1) Not have,Jat any one time, at any one-location of storage or use more than 5 microcuries of americium-241 and 5 microcuries of plutonium' contained in such sources.

(2) Not transfer, abandon or dispose of such sources except by transfer to a person authorized by a license to receive the source.

(3) With respect to each such source when not in use, store the source in a closed container adequately designed and constructed to contain any of the radioactive material in case the source is ruptured or leaks.

(4) Not use such source for any purpose other-than calibration of radiation detectors or standardization of other sources.

'(c) Persons who possess a source pursuant to the general license contained in Section'30192.3(a) shall with respect thereto be 12 9

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R-53-94 December 31, 1996' exempt from the requirem'ent of Group 3 of this subchapter except

- for Sections 30253, 30254, add 30293 (a) (2) , 30204, 30205 and' 20107.

(d) , The' general license in' paragraph-(a) of this section does'not authorize the manufacture, import, or export of calibration or
reference sources containing americium or plutonium.

Note: Authority cited: ' Sections GOG 100275 and 25011 115000, Health and. Safety Code.

Reference:

Sections 25001 114965, 25002 114970, 25005(g) 114985(c), 25011 115000, 25015 115060, 25055 115165, 25075 115230 and GGG44 115235 Health and Safety Code, i

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R-53-94 December 31, 1996

7. Amend section 30192.4 as follows:

5 30192.4. General Licenses--Ice Detection. Devices

'(a)'A general license is hereby issued to any person to possess

~

strontium 90 contained in ice detection devices provided that each device contains not more than 50 microcuries of strontium 90 and each device has been manufactured or imported in accordance with a specific license.which authorizes distribution under a general license.

(b)_ Persons who possess a device pursuant to the general license contained in Section 30192.4(a)'shall:

(1)-Assure _that all labels affixed to the device at the time of receipt and which bear a statement-that prohibits removal of the lab'els are maintained thereon; (2) Upon occurrence of' damage, discontinue use of the device untilsit has been inspected, tested for leakage and repaired by a

. , arson holding a specific license authorizing such testing or repair.

(c) Persons who possess a device pursuant to the general license

~

contained in:Section 30192.4(a) shall, with respect thereto, be-exemptifrom the requirements of Group 3'of this subchapter except for Sections. 30253, 30254, 30235,- and 30293 (a) (2) , 30204, 30205 14

, i,h R-53-94 '

December 31, 1996 and 30207.

(d) This general license does not authorize the manufacture, I I

asr mbly, disassembly or repair of ice detection devices containing strontium 90.

Note: Authority cited: Sections BOG 100275 and 25011 115000, Health and Safety Code Reference Sections 25001 114965, 25002 114970, 25005(gt 114985(c)_, 2664-G 115 060, 25055 115165, BGG 76 115230 and 25075 115235, Health and Safety Code.

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R-53-94 December 31, 1996 1 l

l

8. Amend section 30192.5 as follows:

5 30192.5. General Licenses--in Vitro Testing.

.(a) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to possess and use

. radioactive material in prepackaged units described in Section 30236, Schedule B, Table I, for in vitro clinical testing.

(b) The general licensee shall not possess or use radioactive material pursuant to the general license contained in this section: (1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued by the United States Nuclear Regulatory Commission or a state with

.which the. United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority, and (2) Unless the prepackaged unit bears a label or is accompanied by a package insert.containing the following or a substantially similar. statement:

"This' radioactive material may be received and used only by physicians, veterinarians, clinical laboratories or hospitals and only for . in vitro clinical or laboratory tests not involving

. internal or external administration of the material or the

radiation' therefrom to human beings or animals. The receipt, 9

16

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I R-53-94 December 31, 1996 possession, use and transfer of this material is subject to regulations and general license of.the United States Nuclear

Regulatory' Commission or the state with which the Commission has entered into an agreement for the exercise of regulatory-authority."

-(c) Persons who possess radioactive materia] pursuant to the

general license contained in Section 30192.5(a), shall with respect thereto be exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, and 30293(a)(2), 20204, 20205 and 20207.

Note: Authority cited: Sections see 100275 and 25011 115000, Heath and Safety Code.

Reference:

Sections 25001 114965, 25002 114970, 25005(g) 114985(c), 25011 115000, 25015 115060, 25055 115165, 25075 115230 and 25075 115235, Health and Safety Code.

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R-53-94 December 31, 1996

9. Amend section 30192.6 as follows:

5 30192.6. General Licenses--Depleted Uranium.

(a) A general license is hereby issued to any person to possess and use depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass of the product or device when'such products or devices are manufactured pursuant to a specific license authorizing distribution to general' licensees.

(b) Persons who possess depleted uranium pursuant to the general license contained in Section 30192.6(a) shall:

(1)'Within 30 days of receipt of any such product or device, register with the Department and within 30 days of transfer of any such device, notify the Department in accordance with provisions of Group 1.5 of this subchapter, (2) Not introduce such depleted uranium into any chemical, physical or metallurgical treatment or process except a treatment or process.for repair or restoration of any plating or other covering of the depleted uranium; (3); Maintain procedures designed to establish physical control over such depleted uranium to prevent unauthorized use or transfer, 18

4 ,

-. i e'-

R-53-94 December 31, 1996 (4) Not transfer, abandon or dispose of such depleted uranium except by transfer to a person holding a specific or general license to receive.cuch material.

(c) Persons who possess depleted uranium pursuant to the general license contained in this section shall with respect there to be exempt from the requirements of Group 3 of this subchapter except

~for Section 30253, 30254, and 30293(a) (2) , 20204, 30205 and 30207.

Note: Authority cited: Sections GG8 100275 and GGG44.115000, Health and. Safety Code.

Reference:

Sections 25001 114965, G6GGB 114970, 25005(g) 114985(c), G6646 115060, 25055 115165, 25575 115230 and GGG46 115235, Health and Safety Code.

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R-53-94 l December 31, 1996

10. Amend section 30195.1 as follows: l

}

5 30195.1. Special Requirements for Issuance of Specific Licenses

-Financial Surety for Decommissioning.

(a) The regulations aoverning financial assurance for decommissioning in Title 10, Code of Federal Regulations, Section 30.35, as revised January 1, 19946, including Appendix A, B and C to Part 30 of Title 10, Code of Federal Regulations, referenced in such Section 30.35, are hereby incorporated by reference with the following exceptions:

(1) Subsection 30.35(g) is not incorporated by reference.

(2) The phrase " byproduct material" shall include all

" radioactive material" as defined in Title 17, California Code of Regulations, Section 30100, except source material which shall be governed by subsection (b).

(3) The date " January 1, 1996" is substituted for the date " July 27, 1990."

(4) Any reference to the United States Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the Department. l (5) Any reference to title 10. Code of Federal Reculations section 30.37 shall be deemed to be a reference to section 30194.

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R-53-94 December 31, 1996 (6) The date " January 1, 199'8" is substituted for the date

" November 24, 1995."

(b) The regulations governing financial assurance for decommissioning in Title 10, Code of Federal Regulations, Section

'40.36, as revised January 1, 19945, including Appendix A to Part 40 of Title 10, Code of Federal Regulations, referenced in such Section 40.36, is hereby incorporated by reference with the following exceptions:

(1) Subsection 40.36(f) is not incorporated by reference.

(2) The date " January 1, 1996" is substituted for the date " July 27, 1990."

(3) Any reference to the United States Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the Department.

(4) Any reference to title 10. Code of Federal Reaulations g,ection 40.43 shall be deemed to be a reference to section 30194.

I l

(5) The date " January 1, 1998" is substituted for the date l

" November 24, 1995." l (c) The following persons shall be exempt from the requirements of this section:

(1) Persons authorized to possess no more than 1,000 times the

. quantity.specified for each licensed material specified in Appendix B to Part 30 of Title 10, Code of Federal Regulations; 21 3 .

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R-53-94 December 31, 1996 (2) Persons' authorized to possess hydrogen-3' contained in hydrogen gas in a sealed source; (3). Persons authorized to possess. radioactive noble gases in sealed sources with.no radioactive daughter product with-half-life greater than 30 days; or (4) Persons authorized to possess no more than 10 mci of source material in any form and source material in any quantity in a non-dispersible form.

Note: Authority cited: Sections 100275 and 115000, Health and Safety Code.

Reference:

Sections 114965, 114970, 115060, 115092, and 115235, Health and Safety Code.

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R-53-94 December 31, 1996 1

11.  : Amend section 30256 as follows: J 5 30256. Vacating Installations: Records and Notice.

(a) Each person granted a specific license pursuant to Group 2 of this Subchapter shall keep records of information important to the cafe and effcetive decommissioning of any a facility whieh may have been contaminated with-radicactive material in an identified location until the licence in terminated site is released for unrestricted use by the Department. Before licensed activities are transferred or assioned in accordance with 30194(c). licensees shall transfer all records described in this section to the new licensee. In this case, the new licensee shall be resognsible for maintainina these records until the license is terminated. If records of rcicvant information important'to the decommissionina of a facility are kept for other purposes, reference to these records and their locations may be used. s,The records shall include the following information important to decommissioning:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. - Th'ese records shall include but not be limited to a description of any instances when contamination remains after any 23 is

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.: i R-53-94 December 31, 1996 l f' l l

\

cleanup procedures or when there is reasonable likelihood that j l

contaminants may have spread to inaccessible' areas, as for l example, possible seepage into porous materials such as concrete. f l

These records shall include any known information on i identification of involved nuclides, quantities, forms, and i I

concentrations.  !

(2) As-built. drawings and modification drawings of structures and equipment in restricted areas where~ radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing only sealed sourceu (provided the sources have not leaked or no contamination remains after any leak) or any radioactive materials having only half-lives of less than 65 days, a list contained in a single document and updated every.2 years, of the following:

'(A)~All arcas designated and formerly designated restricted areas as: defined in Title 10, Code of Federal Regulations,

-Section. 20.1003 incorporated by reference pursuant to Title 17, California Code of Regulations, Section.30253;

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.R-53-94 l December 31, 1996 (B) All areas'outside restricted areas that require documentation under ' (a) (1) ;

(C) All areas outside of restricted areas where current and previous vastes have been buried as documented under Title 10, Code of' Federal Regulations, Section 20.2108 incorporated by reference pursuant'to Title 17, California Code of Regulations, Section 30253; and.

(D) All. areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under Title 10, code of Federal' Regulations, Section 20.2002 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253.

L (4)-Records of the cost estimate performed for the f

decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assurip,g, funds'if either a funding plan or certification is used pursuant to Section 30195.1.

(b))Each person granted a specific license pursuant to Group 2 of this Subchapter.shall,-no less than 30 days before vacating any Linstallation which may have been contaminated with radioactive material 1as a result of his activities, notify the department in 25 l__'_.m___5m.___E____-_____._________.______________.___ _____.______________________.___m_____.________,___._____________.____.m .

")

i R-53-94 December 31,'1996 writing of intent to vacate. This notice shall be submitted on form RHB 314 (12/95) entitled " Certificate of Disposition of Materials" which is' incorporated by reference herein and shall address all requirements specified in Subsection (c).

(c) If a. licensee does not submit an application-for license renewal under section 30194, the-licensee shall on or before the

expiration date specified in the license:

(1) Terminate.use of radioactive material; (2) Remove radioactive contamination to the extent practicable except for those procedures covered by Subsection (d) of this section; (3) Dispose of radioactive material in accordance with applicable regulations; (4) Submit a completed form RHB 314 (12/95) , which certifies information concerning the disposition of materials; and (5) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the

'results of this survey, unless the licensee demonstrates that the premises'are suitable for release for unrestricted use in some other' manner. The licensee shall, as appropriate:

(A)' Report levels of radiation in units of' microrads- per hour of beta and gamma radiation at one centimeter and gamma radiation at one meter from surfaces, and report levels of radioactivity, 26

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4 R-53-94 December 31, 1996 i

including alpha, in units of disintegrations per minute (or microcuries) per 100 square centimeters removable and fixed for surfaces, microcuries per milliliter for water, and picoeuries per gram for solids such as soils or concrete; and (B) Specify the survey instrument (s) used and certify that each instrument.is properly calibrated and tested.

(d) In addition to the information required under Subsections (c) (4) and-(5), the licensee shall submit a plan for completion of decommissioning if the procedures necessary to carry out decommissioning have not been previously approved by the Department and could increase potential health and safety impacts to workers or to the public such as in any of the following cases:

(1) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; or (2) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely. encountered during operation; or (3)' Procedures could result in significantly greater' airborne concentrations of radioactive materials than are present during operation; or (4) Procedures could result in significantly greater releases of radioactive material to the environment than those' associated t,

27 m---.__

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y R-53-94 December 31, 1996 I

with operation.

-(e)' Procedures with potential health and safety impacts shall not be carried out prior to approval of the decommissioning plan.

(f)' The proposed decommissioning plan, if required-by subsection =

'(d) of this.section'or by license condition, shall include:

(1) Description of planned' decommissioning activities;

.(2) Description of methods used to assure protection of workers and the environment against radiation hazards during decommissioning; (3) A description of the planned final radiation survey; (4) The information required in (a) ~ (3) and any other information required by (a) that is considered necessary to support'the adequacy of the decommissioning plan for approval; and' ,

-(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequata funds for completion of decommissioning.

(g) Thel proposed decommissioning plan will be approved by the DepartmentL if the Department determines that the decommissioning-will_be completed as soon'as is reasonable and that the health

.snd safety of workers and the public will.be adequately

. protected..

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R-53-94 December 31, 1996 (h) Upon approval of the. decommissioning plan by the Department, the' licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning, the licensee shall again submit the information required in Subsection (c) (5) and shall cert'ify the disposition of accumulated. wastes'from decommissioning by completing form RHB 314 (12/95).

(i) If. the information submitted under subsection (c) (5) or (h)

. does not adequately demonstrate that the premises are suitable I

for release for unrestricted use, th6 Department shall inform the licensee'of the appropriato further actions required for )

termination of license.

(j) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of residual radioactive material present as contamination until the' Department notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving ~ radioactive material to those related to decommissioning; and (2) Continue to control entry to restricted areas until they are suitable for release'for unrestricted use and the Department

- notifies the licensee in writing that the license is terminated.

(k) Specific licenses'shall be terminated by written notice to 29 s

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R-53-94 December 31, 1996 the licensee when the Department determines that:

(1) Radioactive material has been properly disposed; (2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and (3) A radiation survey has been performed which demonstrates that the premises are suitable for release for unrestricted use; or other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release for unrestricted use. t Note: Authority cited: Sections 100275, 115000, Health and Safety Code.

Reference:

Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.

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R-53-94 December 31, 1996

12. Designate a new Article 3.1. to read:

Article 3.1. Records and Notification

13. Adopt new section 30293 to read:

6 30293. Records (a) Each user shall keep records showina the receipt, transfer, and disposal of each source of radiation which is subiect to licensure or reaistration oursuant to aroups 1.5 and 2 of this subchapter as follows:

(1) The user shall retain each record of recelot of a source of radiation as lona as the source of radiation is possessed and for three years followina transfer or disposal of the source of radiation.

(2) The user who transferred the source of radiation shall retain.nach record of transfer for three years after each transfer unless a specific reauirement in another part of the reculations in this subchaoter dictates otherwise.

(3) The user who disposed of the radioactive material shall retain each record of discosal of the radioactive material until the Department terminates each license that authorizes disposal 31

.. . )

R-53-94 December 31, 1996 of the radioactive materialz (b) The' user shall retain each record'that is recuired by the reaulations in this subchaoter or by license condition for the period specified by the anorocriate reaulation or license condition. If a retention oeriod is not otherwise soecified by reculation or license condition, the record shall be retained until-the Department terminates each license that authorizes the activity that is subiect to the recordkeenir,a recuirement.

(c) (1) Records which shall be maintained oursuant to this subchanter may be the oriainal or a reproduced cooy or microform if such recroduced copy or microform is duly authenticated by authorized personnel and the microform is capable of oroducina_a clear and lecible copy after storace for the period soecified by DeDartment reculations. The record may also be stored in electronic media with the capability for oroducina lecible, accurate, and complete records durina the reauired retention oeriod. Records such as letters. drawinas, specifications, shall include all certinent information such as stamos, initials. and sianatures. The licensee shall maintain adeauate safeauards aaainst tamperina with'and loss of records.

(2) If there is a conflict between the Department's reaulations in this subchanter, license condition, or other written Department approval or authorization certainina to the 32

e l R-53-94 December 31, 1996 retention oeriod for the same tvoe of record, the retention oeriod soecified in the reaulations in this subchapter for such records shall acolv unless the Decartment, oursuant to 30104, has aranted a specific exemotion from the record retention reauirements specified in the reaulations in this subchapter.

(d) Prior to license termination, each licensee authorized to ggssess radioactive material with a half-life areater than 120' days,'in'an unsealed form, shall, if reauested by the Department, forward the followina records to the Department:

(1) Records of disposal of licensed material made under title

10. Code of' Federal Reculations, sections 20,2002, 20.2003, 20.2004, 20.2005, incoroorated by reference in section 30253; and (2) Records recuired by title 10, Code of Federal Reaulations, section 20.2103(b)(4), incorocrated by reference in section 302532 (e) If licensed activities are transferred or assioned in accordance with section 30194 (c) , each licensee authorized to oossess radioactive material, with a half-life creater than 120

' days, in an unsealed form, sh'all transfer the followina records

.to 'the new licensee and the new licensee will be responsible for maintainina these records until the license is terminated:

(1) Records of disposal of licensed material made under title- l

10. Code'of Federal Reculations, sections 20.2002, 2 0 .'2 0 0 3 ,

33.

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e R-53-94 December 31, 1996 20.2004, 20.2005, incorporated by reference in section 30253; and (2) Records recuired by title 10. Code of Federal Reculations, section 20.2103(b)(4), incorocrated by reference in section 30253.

(f) Prior to license termination, each licensee shall, if reauested by the Department, forward the records reauired by section 30256(a) to the Department.

Note: Authority cited: Sections 100275 and 115030. Health and Safety Code.

Reference:

Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.

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R-53-94 December 31, 1996

14. Adopt new Section 30295 to read:

6 30295. Notification of Incidents (a) Each user shall notify the Denartment as soon as possible but not later than four hours after the discovery of an event

' that orevents immediate orotective actions necessary to avoid exoosures to radiation or radioactive materials that could exceed reculatory limits.

(b) Each user shall notify the Department within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the followina events involvina radiation or radioactive materials:

(1) An unnlanned contamination event involvina licensed radioactive material that:

(A) Reauires access to the contaminated area by workers or the oublic, to be restricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> by imoosina additional radiolocical controls or by orchibitina entry into the area; ..

(B) Involves a cuantity of material areater than five times the lowest annual limit on intake specified in Accendix B of title 10. Code of Federal Reaulations. cart 20, incorporated by reference in 4 30253 of this reculation for the material; and~

(C) Has' access to the area restricted for a reason other than 35 s

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R-53-94 December 31, 1996 to allow isotones with a half-life of less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to decay prior to decontamination.

(2) An event in which eauioment is disabled or fails to function ~as. desianed when:

(A) The eaulement is reauired by reculation or license condition to Drevent releases'exceedina reculatory limits, to prevent exoosures to radiation and radioactive materials

'exceedina~reculatory limits, or to miticate the consecuences of an accident; .

(B) The eculoment is recuired to be available and coerable when it is disabled or fails to function; and (C) No redundant eauioment is available and operable to perform the recuired safety function.

(3) An event that recuires unclanned medical treatment at a medical facility of an individual with spreadable radioactive l contamination on the individual's clothina or body.

(4) An unolanned fire or explosion damaaina anv licensed I

material.or any device, container, or eauipment containina licensed material-when:

(A) The cuantity of material involved it areater than five

~ times the lowest' annual limit on intake-soecified in Accendix B of' title"10. Code of Tederal Reculations, cart 20, incorporated by-' reference-in 6 30253 of this__reaulation for=the material; and

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R-53-94 December 31, 1996 3 1

(B) The'damaae affects the intearity of the licensed material or its container.

(c) ReDorts made by users in' response to the recuirements of this section shall be made as follows:

(1) Users shall make reports r'eauired by caracraphs (a) 'and (b) of this section by telephone to the Department. To the extent that-the information is available at the time of notification, the information provided in these reports shall include:

(A) The caller's name and call back telephone number; (B) A description of the event, includina date and time; (C) The exact location of the eventi (D) The isotopes, cuantities, and chemical and physical form of the licensed material involved; and (E) Any cersonnel radiation exposure data available.

(2) Written-report. Each user who makes a report recuired by caracraoh (a) or (b) of this section shall submit a written follow-uo report within 30 days of the initial recort. These Written recorts shall be-sent to the Department. The recorts

s. . 1 shall include the followina: <

'(A) A descriotion of the event, includina the probable cause l and-the manufacturer and model number (if apolicable) of any aguisment that failed or malfunctioned; (B) The exact location'of the event; 37 )

\

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t R-53-94 December 31, 1996 (C) The isotooes, cuantities, and chemical and physical form of the licensed material involved; (D) Date and time'of the event; (E)' Corrective actions taken'or planned and the results of any evaluation or assessment; and (F) The extent of exposure of individuals to radiation or to radioactive materials without identification'of individuals by namet Note: Authority cited: Sections 100275 and 115000. Health and Safety Code.

Reference:

Sections 114965, 114970. 115105, 115110.

and 115235. Health and Safety Code,

a. .-

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(')

R-53-94 December 31, 1996-

15. Under " Article 6. Special Requirements for Radiographic Operations Other Than in the Healing Arts," adopt a new section to read:

6 30332.8 (a) In addition to the reportina reauirements soecified in 30295 and under other sections of this subchapter, each licensee shall_grovide a written report to the department

.within 30 days of the occurrence of any of the followina incidents involvino radicaraphic eauipment:

(1) Unintentional disconnection of the source assembiv from the control cable.

(2) Inability to retract the source assembly to its fully i shielded oosition and secure it in this position.

(3) Failure of any component (critical to safe operation of the device) to oronerly perform its intended function.

(b) The licensee shall include the followina information in each recort submitted under subsection (a):

(1) A descriotion of the eauipment'oroblem.

(2) Cause of each incident. if known.

(3) Manufacturer and model number of eauipment involved in the incident.

(4)' Place. time and date of the incident.

(5) Actions taken to establish normal operations.

39

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's e R-53-94 i December 31, 1996 i

l (6) Corrective actions taken or olanned to'orevent recurrence.

(71 Oualifications of personnel-involved in the incident.

(c) Reoorts'of overexposure submitted under title 10. Code of Federal Reaulations section 20.2203, incqroorated by reference in s e c t i'o n '3 0 2'5 3 , which involve failure of safety components of radiocraohv ecuioment shall also include the_information J

soecified'in subsection (b). l

.{

Hgle: Authority cited: Sections 100275 and 115000. Health and Safety Code.

Reference:

Sections 114965, 114970, 115105. 115110, and 115235, Health and Safety Code.

I.

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