ML20141G349

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Informs of Review of California Proposed Rules Noticed Under Dept Regulation Control Number R-53-94.Offers No Specific Comments Re Review.Agreement State Regulations Review Record Encl
ML20141G349
Person / Time
Issue date: 05/07/1997
From: Lohaus P
NRC OFFICE OF STATE PROGRAMS (OSP)
To: Casey Smith
CALIFORNIA, STATE OF
References
NUDOCS 9705220311
Download: ML20141G349 (57)
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M- Charles Smith '

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l Cc, ce of Regulations-Department of Health Services 3 '

714 P Street, Room'1000 x _

P.O.TGox 942732 ..

Sacramento, CA .94234 7320 -

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Dear Mr. Smith:

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We have reviewed the California proposed rules noticed under the Department regulation .,

control number R-53-94. The proposed rules v sere reviewed by comparison to the - j equivalent NRC regulations in 10 CFR Parts 30, li1,34,.40, and 70. '

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' Based on'the results of our review we'aave no specific comments. - As a' general comment,-

please note that under our current pro':odure, a final compatibility determination must be. ,

based on a review of the adopted final rule. However, we have" determined that if the

. proposed rules were adopted without pignificant change; they would meet the current "

compatibility criteria. -

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1We request that when the proposed rules are adopted and published as final rules, a copy i of the "as published" rules be provided to us .for review. As requested in our All  !

Agreement States Letter SP-96-027, "Reauest to Hiahliaht Chanaes to Aareement State l Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight .i the final ct.anges arsi send one copy in a computer.reariable format, if possible.

if you have any que<,tions regarding the review or sny of the NRC rules used ir, me ruview, please contact me or Mr. Richard Blanton of my staff at (301) 415-2322.  ;

Sincerely, i i

. Ol0 lnalSigned G/1

. PAUL H. LOHAUa Paul H. Lohaus, Deputy Director ,

Office of State Programs e

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pa mer p  % UNITED STATES g

j NUCLEAR REGUL.ATORY COMMISSION WASHINGTON. D.C. enmaa anni

% + May 7, 1997 '

j Mr. Charles Smith Ot/ ice of Regulations ,

Departrnent of Health Services '

714 P Street, Room 1000 i P.O. Box 942732 ,

Sacramento, CA 94234-7320 I l

Dear Mr. Smith:

j We have reviewed the California proposed rules noticed under the Department regulation l control number R 53 94. The proposed rules were reviewed by comparison to the ,

equivalent NRC regulations in 10 CFR Parts 30, 31, 34, 40, and 70. l l

Based on the results of our review we have no specific comments. As a general comment, I please note that under our currer:t procedure, a final compatibility determination must be l based on a review of the adopted final rule. However, we have determined that if the I proposed rules were adopted without significant change, they would meet the current j compatibility criteria.

We request that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP 96-027, "Reauest to Hiahliaht Chanaec to Aareement State Reaulations Subrnitted to NRC for Comoatibility 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 review or any of the NRC rules used in the review, please contact me or Mr. Richard Blant3n of my staff at (301) 415-2322.

erely,

, \r nw Paul H. Lohaus, Deputy Director Office of State Programs

4 Mr. Charles Smith Office of Regulations ,

Department of Health Services  !

714 P Street, Room 1000 .j P.0, Box 942732 Sacramento, CA 94234-7320

Dear Mr. Smith:

)

I We have reviewed the California proposed rules qoticed under the Department regulation  !

control number R-53 94. The proposed rules werle reviewed by comparison to the  !

j equivalent NRC regulations in 10 CFR Parts 30, 1, 34, 40, and 70. 4 l

Based on the results of our review we have no s ecific comments. As a general comment, I

please note that under our current procedure, a 1 inal compatibility determination must be f based on a review of the adopted final rule. Hojvever, we have determined that if the -

proposed rules were adopted without significant change, they would meet the current compatibility criteria.

I

. , . We request that when the proposed rules are adopted and published as final rules, a copy )

of the "as published" rules be provided to us for review. As requested in our All l

+

Agreement States Letter SP-96-027, "BinuRf,t b Hiahliaht Chanaes to Aareement State Reaulations Submitted to NRC for Comoyjhilitd Review" (March 1,1996), please highlight the final changes and send one copy in a com uter readable format, if possible, if you have any questions regarding the revie or any of the NRC rules used in the review, please contact me or Mr. Richard Blanton of y staff at (301) 415-2322.

i Sin erely, 4

4 P ul H. Lohaus, Deputy Director O fice of State Programs f

4

, Distribution:

DlR RF (7S-108) DCD (SPO ) PDR (YES)

California File 4

DOCUMENT NAME: G:\RLB\CA7S108L.RLB

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DATE 04/11,4/97 Y 04Pj97 O(/ / /97 04/ /97 JV OSP FILE CODE: SP-AG-4

-l AGREEMENT STATE REGULATIONS REVIEW RECORD California R-35-94 3/18/97

}

April 1997

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Rule Package: California R-35-94 3/18/97 -

Division and CFR citation Rule subiect State citation Comments 10 CFR Part 30 RULES OF GENERAL APPLICABlUTY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL -

2 30.35 Financial assurance and recordkeeping for [30195.1(a)] :except 30.35(g) decommissioning 2 ' 30.35(g) - recordkeeping [30256(a)]  :

2 30.50 Reporting requirements [30295]  :

2* 30.51[except Records [30293]  :

(e))

10 CFR Part 31 GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 1 31.3 Certain devi s and equipment [30192] .

.2 31.5 Generally licensed devices [30192.11  :

2 31.7 Luminous safety devices for aircraft [30192.2]  :

3 31.8 . Calibration or reference sources [30192.3]  :

2 31.10 General license for strontium-90 ice detectors [30192.41  :

2 31.11 General license for in-vitro use [30192.5]  :

10 CFR Part 34 LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS 2 34.30 Reporting requirements [30332.8)  :

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Rule Package: Califomia R-35-94 3/18/97 -

Dmsion and -

CFR crtahon Rule subiect State citation Comments 10 CFR Part 40 DOMESTIC LICENSING OF SOURCE MATERIAL 1~ 40.22 Small quantities of source material 1301911  : '

3 40.25 General license for depleted uranium 30192.6]  :

2 40.36 Financial assurance and recordkeeping for. [30195.1(b)] :except 40.36(f) decommissioning 2 40.36(f) - recordkeeping {30256(all  :

10 CFR Part 70 DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL 3 70.19 Calibration or reference sources [30192.3]  :

ALL OTHER RULES UNCHANGED 3

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i TASK # - 7S108 DATE- 04/17/97 . . ...

MAIL CTRL. --1997 I TASK STARTED - 04/17/97

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TASK DUE - 05/23/97

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TASK COMPLETED - 05/22/97

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TASK DESCRIPTION - CA PROPOSED REGULATIONS COVERING 10 CFR 30.35, 30, 37,

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30.51, 30.50, AND 34.30 REQUESTING OFF. - CA REQUESTER - WITS - 0 FYP - N

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PROG.- RLB PERSON - STAFF LEAD - RLB PROG. AREA -

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PROJECT STATUS - OSP DUE DATE: 5/23/97 ,

PLANNED ACC. -N I LEVEL CODE - 1 I I

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YO TITLE 17 IFORNIA DEPARTMENT OF HEALTH SERVICES 97 APR 16 Afil0: 09 ACTION: Notice of Proposed Rulemaking '

SUBJECT:

Radioactive Materials Record, Reporting and Notification Requirements (R-53-94). ,

s PUBLIC PROCEEDINGS: , Notice is hereby given that the California Department of Health Services will conduct written public proceedings during which time any interested person or such  ;

person's duly authorized representative may present statements,  ;

arguments or contentions relevant to the action described in this -

notice. Any written statements, arguments or contentions must be  ;

received by the Office of Regulations, Department of Health -

Services, 714 P Street, Room 1000, P.O. Box 942732, Sacramento, CA 94234-7320, by 5:00 p.m. on June 9, 1997, which 16 hereby

. designated as the close of the written comment period. It ic ,

! requested but not required that written statements, arguments or contentions sent by mail or hand-delivered be submitted in triplicate. Comments by FAX (916-657-1459) must be received before ,

5
00 p.m. on the last day of the public comment period.

CONTACT: Inquiries concerning the action described in this notice l may be directed to Charles Smith of the Office of Regulations at ]

(916) 657-0730. In any such inquiries, please identify the action by using the Department regulation control number R-53-94. j Persons wishing to use the California Relay Service may do so at no )

cost. The telephone numbers for accessing this service are:  ;

l-800-735-2929, if you have a TDD, or 1-800-735-2922, if you do not l have a TDD.  !

INFORMATIVE DIGEST: The Radiation Control Law, Health and Safety l Code, sections 114960 et. seq. , authorizes the Department of Health Services (Department) to promulgate radiation control regulations for the protection of the health and safety of the public and radiation workers. The regulations established under the provisions  !'

of the Radiation Control Law are in title 17, California Code of Regulations, sections 30100 through 30397.

The Legislature of the State of California ratified and approved the State entering into an agreement with the United States Atomic Energy Commission, the predecessor to the United States Nuclear Regulatory Commission (NRC) (Health & Saf. Code section 115230). A provision of the agreement specifies: "The State will use its best efforts to maintain continuing compatibility between its program ,

and the program of the (United States Atomic Energy) Commission for I the regulation of like materials...." (Health & Safety Code I 115235, art. V.) )

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' i The NRC has adopted and amended title 10, Code of Federal Regulations dealing with disposition of records, decommissioning funding requirements and reporting requirements. Accordingly, the State of California proposes to adopt and amend title 17, California Code of Regulations so as to maintain compatibility with the NRC Program. Specifically, the State of California proposes to:

(1) Repeal section'30131_to. avoid duplication.that would be caused by adoption of the proposed subsection 30293(a);

l (2) Amend section 30191 to achieve consistency with the proposed I adoption of subsection 30293(a) and renumber the authority and reference citations in the Note; l

(3) Amend section 30192 to achieve consistency with the proposed adoption of subsection 30293(a), delete references to nonexistent sections and renumber the authority and reference citations in the Note 1

(4) Amend section 30192.1, 30192.2, 30192.3, 30192.4, 30192.5, and 30192.6 to achieve consistency with the proposed adoption of subsection 30293 (a), delete references to nonexistent sections and renumber the authority and reference citations in the Note; (5) Amend section 30195.1 to incorporate by reference United States, title 10, Code of Federal Regulations, sections 30.35 and j 40.36, as revised January 1, 1996. The source documents are ,

published in the December 29, 1993, Federal Register (58 FR 68726) ,

January 12, 1994, Federal Register (59 FR 1618) and July 26, 1995, Federal Register (60 FR 38235). In addition, two exceptions to the incorporation by reference are taken. The first deals with making the incorporation by reference consistent with California regulations. The second is a timeline adjustment; (6) Amend section 30256(a) to achieve consistency with NRC's amendment of title 10, Code of Federal Regulations subsections 30.35(g) and 4 0. 3 6 ( f) , as documented in the May 16, 1996 issue of the Federal Register (61 FR 24669);

(7) Adopt new section 30293 to achieve consistency with NRC's amendment of title 10, Code of Federal Regulations section 30.51, as documented in the May 27, 1988, February 9, 1993, and May 16, 1996, issues of the Federal Register (53 FR 19245, 58 FR 7736, 61 FR 24669);

(8) Adopt new section 30295 to achieve consistency with NRC's amendment of title 10, Code of Federal Regulations section 30.50, as documented in the August 16, 1991, and December 13, 1991, issues of the Federal Register (56 FR 40757, 56 FR 64980) ; and

.(9) Adopt.new section 30332.8 to achieve consistency with NRC's l amendment of title 10, Code of Federal Regulations section 34.30, as documented in the January 10, 1990, and August 16, 1991, issues .

of the' Federal Register (55 FR 853, 56 FR 40768).

AUTHORITY: Sections 100275 and 115000, Health and Safety Code.

REFERENCE:

Sections 114965, 114970, 114985(g), 115000, 115060,

'115105, 115110, 115165, 115230, 115235, 115091 and 115092, Health and Safety Code.

FISCAL IMPACT ESTIMATE:

A. Fiscal Effect on Local Government: No fiscal impact exists.

B. Fiscal Effect on State Government: No fiscal impact exists. ,

C. Fiscal Effect on Federal Funding of State Programs: No fiscal impact exists.  ;

} D. Fiscal Effect on Private Persons or Businesses Directly l Affected: No fiscal impact exists. .

i DETERMINATIONS: The Department has determined that the regulations I would not impose a mandate on local agencies or school districts, I nor are there any costs for which reimbursement is required by part 7 (commencing with section 17500) of division 4 of the Government Code.

. The Department has determined that the regulations would not have a significant adverse economic impact on businesses, including the ability of California businesses to compete with businesses in other states.

The Department has determined that the regulations would not i l

significantly affect the following:

(1) The creation or elimination of jobs within the State of

. California.

(2) The creation of new businesses or the elimination of existing businesses within the State of California.

(3) The expansion of businesses currently doing business within the State of California.

The Department has determined that the regulations would not affect small business because small business would not be required to comply with or enforce the proposed regulations nor, would any benefit or detriment to small business result from enforcement of the proposed regulations.

Y A

AVAILABILITY OF STATEMENT OF REASONS AND TEXT OF REGULATIONS: . The Department has prepared and has available for public review an -

initial statement of. reasons for the proposed regulations, all the information upon which the proposed regulations are based, and the text of the proposed regulations. A copy of the initial statement of reasons and a copy of the text of the proposed regulations are  ;

available upon request by writing to the Office of Regulations at the address noted above, which address will also be the location of public records, ' including reports, documentation, and other material related to the proposed regulations.

AVAILABILITY OF CHANGED OR MODIFIED TEXT: The full text of any regulation which is changed or modified from the express terms of the proposed action will be made available by the Department's Office of Regulations at least 15 days prior to the date on which the Department adopts, amends, or repeals the resulting regulation.

ADDITIONAL STATEMENTS AND COMMENTS: In accordance with Government Code section 1134 6. 5 (a) (12) the Department must deternine that no alternative considered by the Department would be more effective in carrying out the purpose for which the action is proposed or would be as effective and less burdensome to affected private' persons than the proposed action.

Any interested person or his or her duly authorized representative may request, no later than 15 days prior to the close of the written comment period, a public hearing pursuant to Government Code section 11346.8.

Reasonable accommodation or sign language interpreting services at a public hearing will be provided upon request. Such request should be made no later than 15 days prior to the close of the written comment period.

DEPARTMENT OF HEALTH SERVICES R-53-94 Dated: March 18, 1997 S. Kimberly Belshd Director R-53-94 INITIAL STATEMENT OF REASONS The Radiation Control Law, Health and Safety Code, sections 114960 et. seq., authorizes the Department of Health Services (Department) to promulgate radiation control regulations for the protection of the health and safety of the public and radiation workers. The regulations that were established under the provisions of the Radiation Control Law are in title 1Y.

California Code of Regulations, sections 30100 through 30397.

The State regulation of radioactive material in California is accomplished in close coordination with the regulation of such material by the federal government. The Legislature of the State of California ratified and approved the State entering into an agreement with the United States Atomic Energy Commission, the predecessor to the United States Nuclear Regulatory Commission (NRC) (Health & Saf. Code 115230). This agreement provides for the discontinuance of certain of the federal Government's responsibilities with respect to sources of ionizing radiation in California and the assumption thereof by the State. By such action California became what is called an Agreement State.

According to the agreement, the State is to use its "best efforts to maintain continuing compatibility between its program and the program of the (United States Atomic Energy) Commission for the regulation of like materials...." (Health & Saf. Code 115235, art. V.) The proposed regulations dealing with disposition of records, decommissioning funding requirements and reporting requirements reflect the efforts of the State to maintain  ;

continuing compatibility between it's program and the federal i government's program.

With minor exceptions, NRC has determined that these regulations  !

require the adoption of State regulations that are no less stringent than the NRC regulations. Failure by the State to adopt these regulations may result in withdrawal of findings by the NRC of adequacy and compatibility. Such a withdrawal of favorable findings of adequacy to protect public health and safety and maintenance of compatibility with the NRC regulatory ,

program would be a necessary precedent to revocation of the l California agreement by the NRC. The achievement of compatibility  ;

with the revised NRC regulations is therefore a necessary and '

primary goal of this revision of State radiation control regulations.

The revised state regulations apply to all regulated sources of l radiation including sources not covered by California's agreement '

with the NRC. This inclusion of non-agreement sources of radiation, as subject to the revised NRC regulations, is consistent with the Department's legislative mandate (Health &

Saf. Code 114970) to maintain regulations that are compatible with other states. The corresponding requirements being adopted 1

R-53-9,4 '.

i by most states are contained in the " Suggested State Regulations (SSR) for Control of Radiation" prepared by the Conference of Radiation Control Program Directors, Inc., U.S. Nuclear Regulatory Commission, U.S. Department of Health and Human Services.

The revision of existing state radiation control regulations in title 17, California Code of Regulations is needed to achieve compatibility with the revised NRC regulatory framework. Also ,

included in the proposed changes are revisions necessitated by the recodification of.the California Health and Safety Code as well as previous amendments to title 17, California code of Regulations. The changes to the existing state regulations are explained as follows:

1. Section 30131. Repeal of this section is necessary to avoid duplication which would be caused by the proposed adoption of 30293(a).

j 2. Section 30191. The amendment of subsection (a) is necessary in order to achieve consistency with the proposed adoption of 30293(a). The authority and reference citations in the Note are renumbered to be consistent with the recodification of the Health and Safety Code pursuant to Chapter 415, Statutes of 1995.

3. Section 30192. The amendment of subsection (b) is necessary to delete references to nonexistent sections and to be consistent with proposed section 30293. Also, authority and reference citations are changed, see 2. above.
4. Sections 30192.1, 30192.2, 30192.3, 30192.4, 30192.5, and 30192.6. The amendment of subsection (c) in each of these sections is necessary for the same reason given in 3. above.
5. Section 30195.1. As previously described, it is necessary to achieve compatibility with the revised NRC financial assurance regulations. In view of the earlier incorporation by reference of the NRC regulation, it would be cumbersome and impractical to publish the complete document in the California Code of Regulations. Therefore, amendment of section 30195.1(a) is proposed in order to incorporate by reference, with specified exceptions, the title 10, code of Federal Regalations, section 30.35 as published in the Special Edition of the Federal Register dated January 1, 1996. Such Special Edition has been available from the office of the Federal Register, National Archives and Records Administration commencing in 1996 and is available from the Department as a public record. An explanation of the revised federal regulation may be found in the source documents published in the December 29, 1993, Federal Register (58 FR 68726),

January 12, 1994, Federal Register (59 FR 1618]) and July 26, 1995, Federal Register (60 FR 38235).

2

. R-53-94 1

Amendment of Section 3 0195.1 (a) ( 5) is necessary in order to substitute section 30194 for title 10, Code of Federal Regulations section 30.37 which is not incorporated by reference.

As an Agreement State, California is permitted by the NRC to make i provisions for applications for radioactive material licenses in l its own regulations. California does so in 30194. l

' Amendment of Section 3 0195.1 (a) ( 6) is necessary in order to allow the regulated community adequate time to come into compliance  ;

following the adoption of these proposed regulations. The '

projected date of January 1, 1998 is based on giving the regulated community 120 days from the estimated effective date of the proposed regulations in order to achieve timely compliance.

The 120 days is based on the amount of time NRC allowed it's licensees to come into compliance.

The amendments to section 30195.1(b) parallel the amendments to section 30195.1(a) and the rationale for these changes is the same as that given for the changes to 30195.1(a).

6. Section 30256. The amendment of section 30256(a) is  !

! necessary in order to achieve compatibility with NRC's amendment of title 10, Code of Federal Regulations, section 30.35(g). NRC published the final rule in the May 16, 1996 issue of the Federal Register (61 FR 24669).

1 7. Section 30293. The adoption of section 30293 is necessary in order to achieve compatibility with NRC's amendment of title 10, Code of Federal Regulations, section 30.51.. NRC has published final rules relative to this section in the May 27, 1988, February 9, 1993 and May 16, 1996 issues of the Federal Register (53 FR 19245, 58 FR 7736, 61 FR 24669). The text of the proposed state regu]ation parallels the text in the federal regulation with editorial changes made to conform the to the nomenclature and format found in the California Code of Regulations.

8. Section 30295. The adoption of section 30295 is necessary in order to achieve compatibility with NRC's amendment of title 10, Code of Federal Regulations, section 30.50. NRC has published final rules relative to this section in the August 16, 1991 and December 13, 1991 issues of the Federal Register (56 FR 40757, 56 FR 64980). The text of the proposed state regulation parallels the text in the federal regulation with editorial changes made to conform the to the nomenclature and format found in the California Code of Regulations.
9. Section 30332.8. The adoption of section 30332.8 is necessary in order to achieve compatibility with NRC's amendment of title 10, Code of Federal Regulations, section 34.30. NRC has published final rules relative to this section in the January 10, 1990 and August 16, 1991 issues of the Federal Register (55 FR 853, 56 FR 40768). The text of the proposed state regulation 3

. s R-53-94 * <

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parallels'the text in the, federal regulation with' editorial i changes made to conform ~the to the nomenclature and format found l in the-California Code of Regulations.

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(-* R-53-94 1 December 31, 1996 /

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.i STATEMENTS OF DETERMINATIONS  ;

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e The. Department has' determined thaE the regulations would'not  ;

. impose a' mandate on local agencies or school districts, nor are  ;

there any costs for which reimbursement is required by Part 7  ;

i.

(commencing- with Section 17500) of- division 4 of the Government  !

Code. ll .

The' Department'has. determined that the regulations would not have l a significant^ adverse economic impact on businesses, including. .i the ability of California businesses to compete with businesses  :

- in other states., j The Department'has determined that the regulations would not i significantly affect the following:  !

l (1) The creation or elimination of jobs within the State of  !

California. i (2),The creationuof new businesses or the elimination of existing .

n - businesses within the State of California.

(3). The expansion of businesses currently doing business within -!

' the State of California.

The Department has determined that there would be no affect on o

small. business. Small business is not required to comply, or enforcejthese regulations nor will any benefit or detriment-be ,

derived from enforcement. I No. alternative would be more effective in carrying out the )

purpose for which the. regulation was adopted or would be as l

- effective and less burdensome to affected private persons than i the regulation.

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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:

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.R-53-94 4

December 31, 1996- -  !

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2. .' Amend section 30191 as follows:

l; if30191.-' General Licenses-Source Material. l

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,. (a).A general license is hereby issued to commercial firms, j education, and medical. institutions and government agencies, j i

authorizing the. possession and use of not.more-than 15 pounds of'  ;

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isource material at any one time, for research, development,  !

educational,: commercial or operational purposes. Persons i 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, i with respect to such source material, be exempt from the  !

1 provisions.of Group 3 of this subchapter, except for sections l 30253, 30254 and 30293(a)fet, 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 intended to be placed on or in the human body; or the use of any instrument-or apparatus (including component parts and i

accessories-thereto) intended'for human use. )

Note:EAuthority cited: Sections aos 100275 and G6641 115000, Health'and Safety Code.

Reference:

Sections 46691 114965, G6694 1 114970, 25005(g) 114985fa),.468&+ 115000, 45815 115060, 45665 l

115165 and 46676 115235, Health and
Safety Code. i

, , 2 u  ; ._, 1

. - - - , . _ . . . . .. = . . .- . _ _ , _ . ~ . . _ . , _ -_ -

r <

. c 1~ -

~~

-R-53-94: . .

'l December 31, 1996 -

'i i

3.. Amend sectionL30192 as follows:

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

~ Devices. j i

(a) A general license is hereby issued to any person authorizing- ]

possession'of radioactive material incorporated in any of the i

following items when manufactured pursuant to a specific license 1

which authorizes distribution to general licensees:

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

(2) Air ionization devices containing, as sealed sources, up to 500 microcuries of polonium 210 or 50 millicuries 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), 20:04, 20:05 :nd 4&E94. . 4 Note:' Authority cited: Sections see 100275 and a6844 115000, Health and-Safety code.

Reference:

Sections 468M 114965, 96604 114970, 25000'g) 114985foi, 46&h6 115060,-G6665 115165 and 968 %

115235, Health and Safety Code.

3 i

. - . ~_

R-53-94 December 31, 1996 ,

4. Amend section'30192.1 as follows:  !

$ 30192.1. General Licences--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

4

t

.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 l

device, notify the Department in accordance with the provisions j 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 device.

5 1

R-53-94 December 31, 1996 -

(3) Transfer the device to another general licensee only; (A) Where the device remains in use at a particular location.

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 t'

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 six month intervals or at such longer intervals as may be specified in the specific license 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 beta and/or gama emitting material or 10 uci of alpha emitting material and devices held in storage in the original shipping 6

-- ... -.= . - . . . - . .. . --. .

l

~

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

(6)' Have the test required by Section 30192.1 (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; ,

1 i or -

4

(B) By a person holding an appropriate license therefor.

.. (7) Maintain. records of all tests performed on the devices as  :

4 required under this section, including the dates and results of  ;

these tests and the names and addresses of the persons conducting I

the test.

c (8) Upon occurrence of a failure of or damage to, or any-l indication of a possible failure of or damage to the shielding or  !

l

. containment of the radioactive material, or of the on-off mechanism or indicator, immediately suspend operation of the 4

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 <

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 thereto be exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, add 30293 (a) (2) , 30204, 30205 cr.d 30207.

Note: Authority cited: Sections GOG 100275 and 25011 115000, Health and Safety Code. Reference Sections &W 114965, G5GGG

~114970, 25005(g) 114985(a), G5645 115060, 24BM 115165, G5845 115230 and G5646 115235, Health and Safety Code.

i 8

4 R-53-94 l December 31, 1996 q 5.'. Amend section 30192.2 as follows:

i 2

S 30192.2. GenerallLicenses--Aircraft Safety Devices.

i I

-(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.

(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 1

-for Sections 30253, 30254, And 30293 (a) (2) , 20204, 30205 :nd 4G494.

1 9

4 e - e

R-53-94 December 31, 1996 -

Note: Authority cited: Sections MG 100275 and 96B M 115000, ~,

Health and Safety Code. Reference Sections GGSM 114965, GGGGG 114970, 25005(g) 114985(a), 25011.115000, G66M 115060, G6666' 115165, and 25075 115235, Health and Safety Code, a

10

, J R-53-94 December 31, 1996

6. ' Amend section 30192.3 as follows: .

5 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 l under.a general license. Each source possessed pursuant to the  !

general license or its storage container shall bear a label which includes the information required in the following statement: )

l l

"The receipt, possession, use and transfer of this source, j 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 Nuclear Regulatory Commission has entered into an agreement for l the exercise of regulatory authority. Removal of this label is prohibited.

11 l

+

e R-53-94 December 31, 1996 CAUTION--RADIOACTIVE MATERIAL--THIS SOURCE CONTAINS (AMERICIUM 241 OR PLUTONIUM, whichever is appropriate)..DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

j. H (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,'at 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. l (2) Not t ansfer, abandon or dispose of such sources except by transfer to a person authorized by a license to receive the l

pource.

(3) With respect to each such source when not in use, store the source in a closed container adequately designed and constructed 4

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

~

R-53-94 December 31, 1996 exempt from the requirement of Group 3 of this subchapter except for Sections 30253, 30254, and 30293 (a) (2) , 20204., 30205 cr.d 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 25801 114965, G5694

-114970, 25005(g) 114985(c), GSB-R 115000, G5&M 115060, G6855 115165, G5645 115230 and 25075 115235 Health and Safety Code.

4 4

4 13

R-53-94 December 31, 1996 -

7. ' Amend section 30192.4 as follows:

f 30192.4. General Licenses--Ice Detection Devices (a) A general license is bereby 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 j receipt and which bear a statement that prohibits removal of the labels are maintained thereon; (2) Upon occurrence of damage, discontinue use of the device  ;

i until it has been inspected, tested for leakage and repaired by a person 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 th3reto, be exempt from the requirements of Group 3 of this subchapter except  ;

i for Sections 30253, 30254, 30205, and 30293 (a) (2) , 20204, 20205 ,

14 1

1 R-53-94 December 31, 1996 .

I l

1 and 200^7. -l (d) This general license does not' authorize-the manufacture, l

. . 1 assembly, disassembly.or repair of ice detection devices containing strontium 90.

Note: Authority cited: Sections Gee 100275 and G6&&& 115000, Health and Safety Code Reference Sections G6601 114965, 94899 114970, 25005(g) 114985(a), 25015 115060, G6866 115165, G6676 115230 and G6674 115235, Health and Safety Code.

i i

l l

15  ;

i i

R-53-94 December 31, 1996 -

i

8. Amend section 30192.5 as follows: i 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.

4 (b) The general licensee shall not possess or use radioactive material pursuant to the general license contained in this l

section: (1) Except as prepackaged units which are labeled in j l

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 )

1 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 l physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving )

I internal or external administration of the material or.the '

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

l

)

16

a 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 l

authority."

(c) Persons who possess radioactive material pursuant to the

general license contained in Section 30192.5(a), shall with respect thereto be exempt from the requirements of Group 3 of .

4 this subchapter except for sections 30253, 30254, And I 3 0293 (a) (2) , 20204, 20205 :nd 30207.

Note: Authority cited: Sections GGG 100275 and G6644 115000, Heath and Safety Code.

Reference:

Sections 25001 114965, G6GGG 114970, G6005(g) 114985(a), 25011 115000, 25015 115060, 96666  ;

115165, G6646 115230 and 25070 115235, Health and Safety Code. j l

j I

1 17 )

R-53-94 December'31, 1996 1

I

9. Amend section' 30192.6 as follows:

. I II30192.6. General Licenses--Depleted Uranium.

(a);A general' license is hereby issued to any person to possess l and use depleted uranium contained in industrial products or-

~ devices for the purpose of providing a concentrated mass of the  !

1

. 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 4

any such device, notify the Department in accordance'with provisions of Group 1.5 of this subchapter, l I

(2) Not introduce such depleted uranium into any chemical, i physical or metallurgical treatment or process except a treatment ,

or. process for repair or restoration of any plating or other l

~ covering of the depleted uranium; (3) Maintain procedures designed to establish physical control over such depleted uranium.to prevent unauthorized use or

-transfer,  !

18 .

i

, ,. , . .. - - - - ~ ___ - . - , . _ , ,

j- .

l 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 such material.

(c) Persons who possess depleted uranium pursuant to the general j 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) , 30204, 20205 nd 30207.

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

Reference:

Sections 25001 114965, G5GGG 114970, 25005(g) 114985(a), 25015 115060, GGGG5 115165, G5675 '

115230 and 25075 115235, Health and Safety Code.

t 19 l

  • i i

R-53-94 .

a December-31, 1996 e i

10. Amand'section 30195.1 as follows:- f t

5.30195.1. Special Requirements for Issuance of Specific Licenses  :

-Financial. Surety for' Decommissioning. ,

l (a) The regulations governing financial assurance for  ;

Ldecommissioning in Title 10, code of Federal Regulations, Section  !

c30.35, as revised January 1, 19941,. including Appendix A, B and C-t to Part 30.of. Title 10, Code of Federal Regulations, referenced  :

i in such Section 30.35, are hereby incorporated by reference with the following exceptions:  ;

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

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

, " radioactive material" as defined in Title 17, California Code of  ;

Regulations, Section 30100, except source material which shall be )

governed by subsection.(b). i (3) The date " January 1, 1996" is substituted for the date " July 27, 1990."  ;

i (4) Any reference to the United States Nuclear Regulatory J j Commission or.any component thereof shall be deemed to be a

-reference to the' Department.

p. (5) Any reference to title'10. Code of' Federal Reaulations

'I section~30.37 shall be deemed to be a reference to section 30194. '

20

,..-[-- , , . u . , , . - . _-r.-, , ,,-- - .,,,-,w,_, ,, ,, ,,

l R-53-94 December 31, 1996 i~ i c l

  • (6) The date " January 1, 1998" is substituted for the date l " November 24'. 1995." ,

(b) The regulations governing financial assurance for F

decommissioning in Title 10, Code of Federal Regulations, Section 4

l 40.36, as1 revised January 1, 19941, including Appendix A to Part 40 of Title 10, Code of Federal Regulations, referenced in such

}

2 Section 40.36,-is.hereby incorporated by reference with the-L 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."

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

reference to the Department.

4 (4) Any reference to title 10. Code of Federal Reculations section 40.43 shall be deemed to be a reference to section 30194.

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

]

^

" November 24, 1995."

(c) The following persons shall be exempt from the requirements of this section:

4

, (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 N

, .r. _ . _ _ , ,,, _ _ . . . , , , . ,____,,m

~

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.

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

Reference:

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

t 1

0 9

4 22 s

~

R-53-94 December 31, 1996 -

11. Amend section 30256 as follows:

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 caf: and effcetive decommissioning of any a facility which

y h ve b :n contamin ted with radicactive act: rial in an identified location until the licence is terminated gite is released for unrestricted use by the Department. Before licensed activities are transferred or assioned in accordance with 3_0194 (c) . licensees shall transfer all records described in this section to the new licensee. In this case, the new licensee shall'be resoonsible for maintainina these records until the license is terminated. If records of relevant information imoortant to the decommissionina of a facility are kept for other purposes, reference to these records and their locations may be used. The records shall include the following information important to decommissioning:

(1) Records of spills or other unusual occurrences involving the spread of csntamination in and around the facility, equipment, or site. Thess' records shall include but not be limited to a

-description of any instances when contamination remains after any 23

4

~

R-53-94 December 31, 1996 4

I cleanup procedures or when there is reasonable' likelihood that  ;

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

These records shall include any known information on identification of involved nuclides, quantities, forms, and 4

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 i 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 sources (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 areas 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; 24

  • t I

6

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

-(B) All areas outside restricted areas that require ]

documentation under (a) (1); .

-(C) All areas outside of restricted areas where current and previous wastes 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.

(4) Records of the cost estimate performed for the 4

decommissioning funding plan or af the amount certified for decommissioning, and records of the funding method used for assuring. funds if either a funding plan or certification is used 4

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 installation which may have been contaminated th radioactive material'as a result of his activities, notify the department in 25

~

. R-53-94 -

December 31,.1996 - !

i

writing of intent to vacate.-This notice shall'be submitted on=

form lRHB 314..(12/95)... entitled " Certificate .of Dispositicn 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-Jrenewal 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 A

section; (3) Dispose ~of radioactive material in accordance with i I

applicable regulations;

-(4)- Submit a completed form RHB 314 (12/95), which certifies  ;

I information concerning the disposition of materials; and t

(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 t other manner.,The licensee:shall, as appropriate: ,

1(A) Report-levels of radiation-in units of microrads per hour of;betaLand gamma radiation at*one centimeter and gamma radiation  !

atione meter'from surfaces, and-report levels of radioactivity,  !

26 l i

4

,,w

R-53-94 December 31, 1996 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 picocuries 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 decommiccioning 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 27

- -. - - . _ _ . - . . ~ - - -. .. - . . .

r

. j R-53-94=- .

, December 31, 1996 with operation.

(e) -Procedures with potential health and safety impacts, shall not j l

. be' carried out prior to approval of the decommissioning plan.

. (f) The proposed decommissioning plan, if: required by Subsection l (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; l (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 adequate funds for completion of decommissioning.

(g)-The proposed decommissioning plan will be approved by the Department.-if the Department determines that the decommissioning will.be completed as soon as is. reasonable and that the health and- safety of: workers and the public will be adequately

)  ; protected.

. 28

-A E

^

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 certify 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 for release for unrestricted use, the Department shall inform the licensee of the appropriate further actions required for termination of license.  ;

i (j) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of j i

residual radioactive material present as contamination until the '

Department notifies the licensee in writing that the license is j i

terminated. During this time, the licensee shall: l l

(1) Limit actions involving radioactive material to those ,

l 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. l (k) Specific licenses shall be terminated by written notice to l l

29 I

- .- - . . . . _ ~ - - . . . . . . . - - - --

. y

~4 R-53-94 December 31, 1996 t-the. licensee when the Department determines that: j (1) Radioactive. material has._been properly disposed;' l (2) Reasonable effort'has been made to eliminate residual.

! l radioactive. contamination, if present; and *

(3): A radiation survey has been performed which demonstrates J

i thatphepremises.aresuitableforreleaseforunrestricteduse; or other information submitted by the licensee is sufficient to ,

demonstrate that the premises are suitable for release for  !

. unrestricted use. .

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

Reference:

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

i 4

+

.f 30 l 4

R-53-94 i December 31, 1996 ' ;

12. . Designate a new Article 3.1. to read:  !

Article 3.1. Records and Notification ,

.i

.l
13. Adopt new section 30293 to read:

i i E 30293. Records

.i (a) Each user shall keep records showina the receint. transfer.

7 and disoosal of each source of radiation which is subiect to licensure or recistration oursuant to aroups 1.5 and 2'of this subchanter as follows:

! I (1) The user shall retain each record of recelot of a source  ;

of radiat1RD as lona as the source of radiation is possessed and I for three years followina transfer or disoosal of the source of l

radiation. 1 i

- (2) The user who transferred the source of radiation shall retain ~each record of transfer for three years after each transfer unless a specific recuirement in another cart of the i'

reaulations in this subchaoter dictates otherwise.

i (3) The user who disoosed of the radioactive material shall  !

retain each record of discosal of the radioactive material until the Denartment terminates each license that authorizes disposal <

, 31

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,. ,, - . ~ 4 , , , . . . . . . . . . - _ . . , . - . .

.o l*' R-53-94

December 31, 1996 4 ,

4 Ef_$De radioactive material.

(b) The user shall retain each record that is reauired by the reaulations in this subchanter or by license condition for the Deriod soecified by the aorrooriate reaulation or license. j 1

condition. If a retention oeriod is not otherwise soecified by-reaulation or license condition, the record shall be retained until the Decartment terminates each license that authorizes the l activity that is subiect'to the recordkeeoina reauirement. ')

(c) (1) Records which shall be maintained oursuant to this l l

subchanter may be the oriainal or a reoroduced conv or microform l l

! if such reoroduced cooy or microform is duly authenticated by authorized oersonnel and the microform is caoable of oroducina a clear and leaible conv after storace for the oeriod soecified by The record may also be stored in

)

Denartment reaulations. l

! electronic media with the caoability for oroducina lealble, j<

accurate, and comolete records durina the reauired retention i

neriod. Records such as letters, drawinas, soecifications, shall j 4

include all certinent information such as stamos, initials, and

[ sianatures. The licensee shall maintain adeauate safeauards aaninst tamoerina with and loss of records.

(2) If there is a conflict between the Denartment's

-rggulations in this subchaoter, license condition, or other i

written Denartment accroval or authorization certainina to the l l

32 1-4

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

retention oeriod for the same tvoe of record, the retention ,

oeriod specified in the reaulations in this subchanter for such ,

records shall acolv unless the Deoartment, cursuant to 30104, has aranted'a specific exemotion from the record retention 1

reuuirements specified in the reaulations in this subchanter.

(d) Prior-to' license termination, each licensee authorized to i

, npssess radioactive material with a half-life areater than 120 l 1

days, in an unsealed form, shall. if reauested by the Decartment, forward the followina records to the Department: ,

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

10. Code of Federal Reaulations. 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 Reculations, i l

section 20.2103(b)(4). incoroorated by reference in section  ;

20253.

(e) If licensed activities are transferred or assioned in accordance with section 30194(c), each licensee authorized to possess. radioactive material, with a half-life areater than 120 days, in an unsealed form. shall transfer the followina records j to the new licensee and the new licensee will be responsible for

~maintainina these records until the license is terminated:

1 I

(1) Records of discosal of licensed material made under title l

10. Code of Federal Reaulations. sections 20.2002, 20.2003.

I 33 l

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. - . . . . - .- ~ . . . ._. - . _ . _.

. l 4

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

i (f) Prior to license termination. each licensee shall, if Igauested by the Department, forward the records recuired by section 30256(a) to the Deoartment.

Note: Authority cited: Sections 100275 and 115000. Health and -

- Safety Code.

Reference:

Sections 114965, 114970. 115105. 115110.

and 115235. Health and Safety Code, a

1 i

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' 4 e

R-53-94 December 31, 1996 )

14. Adopt new Section 30295 to read: )

i i

l E 30295. Notification of Incidents (a) Each user shall notify the Department as soon as Dossible but not later than four hours after the discovery of an event ,

I that Drevents immediate Drotective actions necessary to avoid i

exoosures to radiation or radioactive materials that could exceed reaulatory limits.

(b) Each user shall notify the DeDartment 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 unolanned contamination event involvina licensed radioactive material that:

(A) Recuires access to the contaminated area by workers or the Dublic, 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 radioloaical controls or by Drohibitina entry into the area; (B) Involves a cuantity of material areater than five times the lowest annual limit on intake specified in ADDendix B of title 10. Code of Federal Reaulations. Dart 20. incoroorated by Igference in 4 30253 of this reculation for the material; and (C) Has access to the area restricted for a reason other than 35

_ __ _ _ _ ~

1 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 orior to decontamination. ,

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

(A) The eauioment is reauired by reculation or license condition to orevent releases exceedina reaulatory limits. to orevent exposures to radiation and radioactive materials exceedina reaulatory limits, or to miticate the consecuences of

.an accident; (B) The eculoment is recuired to be available and ooerable when it is disabled or fails to function; and (C) No redundant eculoment is available and operable to Derform the recuired safety function.

(3) An event that recuires unplanned medical treatment at a j i

medical facility of an individual with screadable radioactive contamination on the individual's clothina or body. l 4

l (4) An unnlanned fire or explosion damacina any licensed I l

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

(A) The cuantity of material involvq) is areater than five times the lowest annual limit on intake soecified in Accendix B of title 10. Code of Federp D _qgplations, cart 20, incorporated by reference in 6 30253 of this reculation for the material; and 36 l

1 1

i j

R-53-94 December 31, 1996 (B) The damaae affects the intearity of the licensed material or its container. .

(c) Reports made by users in resoonse to the recuirements of this section shall be made as fo119wg1 (1) Users shall make reports recuired by caraaraohs (a) and (b) of this section by telechone to the Department. To the extent that the information is available at the time of notification, the information orovided in these re7 orts shall include:

(A) The caller's name and call back telechone number; (B) A descriotion of the event, includino date and time; (C) The exact location of the event; (D) The isotones, cuantities, and chemical and Dhysical foria of the licensed material involved; and (E) Any oersonnel radiation exoosure data available.

(2) Written recort. Each user who makes a report reauired by paracraoh (a) or (b) of this section shall submit a written follow-un report within 30 days of the initial report. These written recorts shall be sent to the Department. The recorts shall include the followino:

(A) A description of the event, includina the probable cause g,nd the manufacturer and model number (if aoolicable) of any eauloment that fg.iled or malfunctioned; (B) The exact location of the event; 37

i R-53-94 ,

December 31, 1996- -

(C) The isotones, cuantities, and chemical and ohysical form of the licensed material involved; (D) Date and time of the event; (E) Corrective actions taken or olanned and the results of any evaluation or assessment; and

.a (F) The extent of exoosure of individuals to radiation or to radioactive materials without identification of individuals by name.

4 Note: Authority cited: Sections 100275 and 115000, Health and 4 Safety Code.

Reference:

Sections 114965. 114970, 115105. 115110.

And 115235. Health and Safety Code. ,

i- ,

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38

i 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:

i G-30332.8 (a) In addit _[2p to the reportina recuirements soecified in 30295 and under other sections of this subchanter.

each licensee shall orovide a written recort to the deoartment within 30_davo of the occurrence of any of the followina l

incidents involvina radioarachic eauipment:

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

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

(3) Failure of any component (critical to safe operation of the  !

device) to oronerly cerform its intended function.

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

(1) A descriotion of the eauipment'oroblem.

(2) Cause of each incident, if known. j (3) Manufacturer and model number of eculoment involved in the incident.

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

(5) Actions taken to establish normal operations.

39

R-53-94 December 31, 1996 .

(6) Corrective actions taken or olanned to orevent recurrence, (7) Oualifications of nersonnel involved in the incident.

(c) Reoorts of overexoosure submitted under title 10. Code of Federal Reculations section 20.2203, incorporated by reference in section 30253. which involve failure of safety components of radioaraohv eculoment shall also include the information soecified in subsection (b).

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

Reference:

Sections 114965, 114970.  ;

115105. 115110. and 115235. Health and Safety Code _._ l l

J a

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