ML20237E322
| ML20237E322 | |
| Person / Time | |
|---|---|
| Issue date: | 08/12/1998 |
| From: | Lohaus J NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Floyd W NEW MEXICO, STATE OF |
| References | |
| NUDOCS 9808310143 | |
| Download: ML20237E322 (150) | |
Text
'
'AUG 121998 Mr. William Floyd, Progr:m Manag:r 3
Radiation Progr:m L
s#
' Bureau cf Hazardous and Radioactive Materials L te
~ Water and Waste Management Division ~
- New Mexico Department of Environment 2044 Galisteo Road i
a P.O. Box 26110 D
Santa Fe, NM 87502
Dear Mr. Floyd:
m As requested, we have reviewed the proposed " Compatibility Amendments, numbers 1 to 11" j
< received by the Office of State Programs on June 30,1998. These amendments were i
prepared in response to the July 14-18,1997 Integrated Materials Performance Evaluation
. Program review.:The regulations were reviewed by comparison to the equivalent NRC
' regulations in 10 CFR Parts 19,20,30,32,35,61, and 71.
As a result of our review, we have several comments that are identified in the enclosure. Under obr current procedure, a finding that a State regulation meets the compatibility and health and l
safety categories of the equivalent NRC regulation may only be made based on a review of the l
L
" final State regulation. However, we have determined that if your proposed regulations were adopted (incorporating the comments and without other significant changes, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
We have included comments on regulations not required for compatibility for information u
_ purposes only. Action on these comments will not affect adequacy or compatibility, i
. We re' quest that when the proposed regulations are adopted and published as final regulations,
- a copy of the "as published" regulations be provided to us for review. As requested in our All
. Agreement States Letter SP-96-027, "Recuest to Hiahlicht Chanaes to Aareement State Jagplations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight final l
changes and send one copy in a computer readable format, if possible.
l 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 Lance Rakovan of my staff at (301) 415-2589.
. Sincerely, OdginalSigned By:
^
PAULH.LOHAUS 99083I0143 990812
?
Paul'H. Lohaus,' Deputy Director
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PDR STPRO DR Office of State Programs l
'4 Enclosure;
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' As stated '
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f DOCUMENT NAME: G:\\LJR\\ AMEND.NM
- SEE PREVIOUS CONCURRENCE.
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OFFICE ~
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NAME LRakovan:nb PHLohaus -
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- Mr. Willi:m Floyd, Progrrm Man:g:r g
Hadiation Program Bureau of Hazardous and Radioactive Materials Water and Waste Management Division
/
New Mexico Department of Environment
/
2044 Galisteo Road
/
P.O. Box 26110
/
Santa Fe, NM 87502
/
Dear Mr. Floyd:
As requested, we have reviewed the proposed " Compatibility Amendments, numbers 1 to 11" received by the Office of State Programs on June 30,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Pa/
rts 19, 20, 30, 32, 35, 61, and 71.
As a result of our review, we have several comments tlya/
t are identified in the enclosure. Under our current procedure, a finding that a State regulatioJ(meets the compatibility and health and safety categories of the equivalent NRC regulation rpay only be made based on a review of the final State regulation. However, we have determirled that if your proposed regulations were adopted incorporating the comments and withou)'other significant changes, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
/
\\
We request that when the proposed regulations are adopted and published as final regulations, l
a copy of the "as published" regulations byprovided to us for review. As requested in our All Agreement States Letter SP-96-027, "Recuest to Hichliaht Chanaes to Aareement State Regulations Submitted to NRC for Com6atibility Review" (March 1,1996), please highlight final changes and send one copy in a comp' uter readable format, if possible.
If you have any questions regarding he comments, the compatibility and hualth and safety
- categories, or any of the NRC reg 6lations used in the review, please contact me or Lance Rakovan of my staff at (301) 415-2589.
Sincerely, 1
Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated Distribution:
DlR RF (8S.197)
DCD (SP08)
SDroggitis/
PDR (YES_f_ NO
)
LMcLeanf RIV BUsilton New Me'xico File SSalomon CMaupin, ASPO DOCUMENT NAME: G:\\LJR\\ AMEND.NM
[i To recolwo e copr of tble document, Indicate in the bog: 'C"Obdyhhout attachment / enclosure 'E's Copy with attachment /anciosure "N" = No copy OFFICE OSP
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OGC OSP:D NAME LRakovan:nb '_-
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FXCameron RLBangart DATE 07/d/98 07/d/98 07/b/98 07/ /98 OSP FILE CODE: SP-AG-19
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NUCLEAR REGULATORY COMMISSION 2
g WAf HINGToN, D.C. 30806-0001
+o August 12, 1998 Mr. William Floyd, Program Manager Radiation Program Bureau cf Hazardous and Radioactive Materials Water and Waste Management Division New Mexico Department of Environment 2044 Galisteo Road P.O. Box 26110 Santa Fe, NM 87502
Dear Mr. Floyd:
As requested, we have reviewed the proposed " Compatibility Amendments, numbers 1 to 11" received by the Office of State Programs on June 30,1998. These amendments were prepared in response to the July 14-18,1997 Integrated Materials Performance Evaluation Program review. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Paris 19,20,30,32,35,61, and 71.
As a result of our review, we have several comments that are identified in the enclosure. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the -
' final State regulation. However, we have determined that if your proposed regulations were adopted incorporating the comments and without other significant changes, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
We have included comments on regulations not required for compatibility for information purposes only. Action on these comments will not affect adequacy or compatibility.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All A reement States Letter SP-96-027,"Recuest to Hiahliaht Chanaes to Aareement State 0
Regulations Submitted to NRC for Compatibility Review" (March 1,1990), please highlight final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or Lance Rakovan of my staff at (301) 415-2589.
S' cerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated
COMMENTS ON PROr)OSED NEW MEXICO REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateaorv Reaulation Reaulation Sublect and Comments The following sections, as written, do not appear to include NPS licensees since the NRC reference has been eliminated. For completeness, these sections should include a reference to licensees of the Department, other Agreement States, and the NRC.
B 9315.G.2.e 32.72 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs Containing Byproduct Material for Medical Use.
D 6701.D.2 35.2 Definition of " Authorized Nuclear Pharmacist."
6701.D.3 D
9703.C.1 35.52 Possession, Use, Calibration, and Check of instruments to Measure Dosages of Alpha-or Beta-Emitting Radionuclides.
D(H&S) 9704.A 35.100 Use of Unsealed Byproduct Material for Uptake, Dilution and Excretion Studies.
D(H&S) 6705.A
.35.200 Use of Unsealed Byproduct Material for Imaging and Localization Studies.
D(H&S) 9708.A 35.300 Use of Unsealed Byproduct Material for Therapeutic Administration.
C 6701.J 35.2 Definition of " Misadministration."
The revised New Mexico regulations remove the word " wrong" from several lines in this definition. The word " wrong" should consistently be included in the phrase " involving the wrona individual or wrong..."
COMMENTS ON PROPOSED NEW MEXICO REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateoorv Reculation Reculation Subject and Comments in the following sections, the NRC section number is referenced instead of the proper New Mexico section.
The proper section of New Mexico regulations should be placed in the regulations as appropriate.
B 6466 Appendix G 20 Appendix G Requirements for Transfers of Low-Level A.5.a Radioactive Waste Intended for Disposal at A.5.i Licensed Land Disposal Facilities and A.S.]
Manifests.
A.S.q A.S.r A.6.c(12)
A.6.d(4)
C.1.a C.1.b C.1.c C.2.f C.3.c C.3.d
]
C.3.e C.3.1 C
1002.A.6 19.12 Instructions to Workers.
C 457.B 20.2205 Notifications and Reports to individuals.
B 466 Appendix G 20 Appendix G Requirements for Transfers of Low Level B
Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests.
As written, the section requires adherence to only Department of Transportation and NRC regulations. The section should be reworded to require adherence to New Mexico regulations.
D(H&S) 6311.E.4 30.35 Financial Assurance and Recordkeeping for Decommissioning.
This section states that the rule will go into effect on November 24,1995. This section should be reworded with a phrase such as "this regulation goes into effect on..." (or similar language).
COMMENTS ON PROPOSED NEW MEXICO REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateaorv Reaulation Reaulation Subject and Comments D(H&S)
$325.A.1 71 Preparation of Radioactive Material for Transport.
Reference to 10 CFR 71 as a US Department of Transportation regulation should be changed to state that 10 CFR 71 is a US NRC regulation.
L 1
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EXECUTIVE TASK MANAGEMENT SY3 TEM
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<<< PRINT SCREEN UPDATE FORM >>>
TASK # - 8S197
--; ;_;;;;;, ___ - DATE- 07/07/98 ; -
MAIL CTRL. - 1998 TASK STARTED - 07/01/98 TASK DUE - 08/07/98 TASK COMPLETED -
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TASK DESCRIPTION - REVIEW NEW MEXICO REGULATIONS THAT WERE ADDRESSED WHEN
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IMPEP REVIEW WAS DONE-11 REGULATIONS I
REQUESTING OFF. - NM REQUESTER - W. FLOYD WITS -
0 FYP - N
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PROG.- LJR PERSON -
STAFF LEAD - LJR PROG. AREA -
PROJECT STATUS -
OSP DUE DATE:
8/7/98 I
1 PLANNED ACC.
-N LEVEL CODE -
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l COMPATIBILITY AMENDMENT #1:
Iitig: Decommissioning Recordkeeping'and License Termination: Documentation Additions,10 CFR '
Parts 30,40,70, and 72
(
)
Federal Raeinter-Volume 58, No.141, July 26,1993 (58FR39628)
Due Date. October 25,1996 Rationale: The Nuclear Regulatory Commission (NRC) is amending its regnations to require holders of a specific license for possession of certain byproduct material, source material, special nuclear material, or for independent storage of spent nuclear fuel and high-level radioactive waste to prepare and maintain additional documentation that identi6es all restricted areas where licensed materials and equipment were stored or used, all areas outside of restricted areas where documentation is required under current decommissioning regulations for unusual occurrences or spills, all areas outside of res.ixted areas where waste has been buried, and all aress outside of restricted areas containing material such that if the license were terminated, the licensee would be required to decontaminate the area or seek special approval for disposal. The-final rule also requires licensees to submit speci6c infonnation at the time of fmal decommissioning on decontaminated equipment that has been m' volved in the licensed activity that will remain onsite at the time oflicense termination. The information required by thesie==aadmaats will provide greater assurance that decontamination and decommissioning of licensee facilities have been carried out in accordance with the Commission's regulations.
NRC NMRPR
{30.35
{311.G.3 and 4, page 3-32
.{30.36 Q318, page 3-53, change done under Federal Register Vol. 59, No.135, July 15,1994 (subset #3) u
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l t-L F.
Prior to the hearing the Secretary may, upon request by a party, or upon the 2
Secretary's own initiative, require any party to submit the names of witnesses it proposes to call at 3
a hearing, together with a summary of testimony expected to be given by each witness. Any party 4
may likewise be required by the Secretary upon request to submit for examination or copying any 5
exhibits that party anticipates using. Such information when requested shall become subpart of the 6
record and shall be made available to the Secretary at least 10 days prior to the hearing.
7 G.
The Secretary may appoint a hearing officer to conduct the hearing.
8 H.
The Department will arrange for transcription of the hearing by a certified reporter.
! 9 Copies of the transcript shall be paid for by those requesting them.
10 I.
At th: hearing, all interested persons shall be given a reasonable opportunity to 1 l' submit relevant data, views, or arguments orally or in writing, and to examine witnesses testifying
)
12 at the hearing concerning any aspect of the license.
l 13 J.
The record shall include the application and amendments thereto, all correspondence 14 between the Department and the applicant conceming the application, all public comment on the 15 application received by the Secretary, all written staffreports on the application, the transcript of any 16 public hearings on the application, and any other information before the Secretary regarding the 17.
application. The Secretary shall consider all relevant evidence in the record. The Secretary shall 18 notify the applicant, and other parties requesting such notice, of the Secretary's decision and the 19 reasons therefore.
20 311.
FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING.
21
" Decommissioning" means to remove (as a facility) safely from service and reduce residual
)
- bioactivity to a level thst permits release of the property for unrestricted use and tennination of 22 ra 23-
-license.
24 A.
Each applicant for a specific license authorizing the possession and use of unsealed 25 byproduct material of half-life greater than 120 days and in quantities exceeding 105 times the most 26 current applicable quantities set forth in Appendix F Subpart 4, shall submit a decommissioning 27 funding plan as described in paragraph (E) of this section. The decommissioning funding plan must
- 28 also be submitted when a combination ofisotopes is involved if R divided by 105 is greater than 1
-29 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the 30 applicable value in Appandir F Subpart 4.
31 B.
Each applicant for a specific license authorizing Possession and use of byproduct material of half-life greater than 120 days and in quantities speci6ed in paragraph (D) of this section 32 -
33 shall either: -
34 1.
Submit a decommissioning funding plan as described in paragraph (E) of this 35 section; or 20 NMAC 3.1 3-29 Revision Date 1
r 1
' 2.
Submit a certification that financial assurance for decommissioning has been 2
. provided in the amount prescribed by paragraph (D) of this section using one of the methods 3
described in paragraph (F) of this section. For an applicant, this certification may state that the
- 4
- appropriate assurance will be obtained after the application has been approved and the license issued 5-but prior to the receipt oflicensed material. As subpart of the certification, a copy of the financial 6
instrument obtained to satisfy the requirements of paragraph (F) of this section is to be submitted 7-to the Department.
8 C.
1.
Each holder of a specific license issued on or after the effective date of these 9
regulations which is of a type described in paragraph (A) or (B) of this section, shall provide 10-financial assurance for decommissioning in accordance with the criteria set forth in this section.
I1 2.
Each holder of a specific license issued before the effective date of these 12 regulations, and of a type described in paragraph (A) of this section shall submit, on or before the 13 effective date of these regulations, a decommissioning funding plan or a certification of financial 14
' assurance for decommissioning in an amount at least equal to $750,000 in accordance with the
-15 criteria set forth in this section. If the licensee submits the certification of financial assurance rather.
16 than a decommissioning funding plan at this time, the licensee shall include a decommissioning 17 funding plan in any application for license renewal.
18 3.
Each holder of a specific license issued before the effective date of these 19 regulations, and of a type described in paragraph B of this section shall submit, on or before the 20.
effective date of these regulations, a certification of financial assurance for decommissioning or a 21 decommissioning fimding plan in accordance with the criteria set forth in this section.
-22 23 D.
Required amounts of financial assurance for decommissioning by quantity of 24 material:
25-
' l.
greater than 10' but less than or equal to 10 times the applicable quantities 5
26 of Appendix F., Subpart 4 in unsealed form. (For a combination ofisotopes, if R as defined in Q311 27
. A., divided by 10' is greater than 1 but R divided by 105 is less than or equal to
.28 1).....................................................................................................................................$750,000; 29 2.
greater than 105 but less than or equal to 10d times the applicable quantities 30 of Appendix F Subpart 4 in unsealed form. (For a combination ofisotopes, if R, as defined in Q311
-31 A, divided by 10' is greater than 1 but R divided by 10' ia less than or equal to 1) 32_
...........................................................................................................................................$150,000; l
-33' 3.
greater than 105 imes the applicable quantities of Appendix F Subpart 4 in t
'34 sealed sources or plated foils. (For a combination ofisotopes, if R, as defined in Q311 A, divided by 5
-35 10 is greaterthan 1)............................................................................................................$75,000.
20 NMAC 3.1 3-30 Revision Date l
F '
.e J.
F Each decommissioning funding plan must contain a cost estimate for l
2 decommissioning and a description of the method of assuring funds for decommissioning from L
3.
paragraph (F) of this section, including means of adjusting cost estimates and associated funding 4.'
levels periodically over the life of the facility.
5-F.
Financial assurance for decommissioning must be provided by one or more of the
'6 following methods:
7.
1.
Prepayment. Prepayment is the deposit prior to the start of operation into an 8
account segregated from licensee assets and outside the licensee's administrative control of cash or 9
liquid assets such that the amount of funds would be sufficient to pay decommissioning costs.
10 Prepayment may be in the form of a tmst, escrow account, govemment fund, certificate of deposit, 11.
or deposit of govemment securities.
12 2.
A Surety Method, Insurance, or Other Guarantee Method. '.These methods 13 guarantee that decommissioning costs will be paid should the licensee default. A surety method may
' 14 -
be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of l15 funds for
- commissioning costs based on a financial test may be used if the guarantee and test are
,16 as contained in Schedule A to this Subpart. A parent company guarantee may not be used in
-17 combination with other financial methods to satisfy the requirements of this section. Any surety 18 method or insurance used to provide financial assurance for decommissioning must contain the L
19 following conditions:
20'
- a. ' -
The surety method or insurance must be open-ended or, if written for 21 a specified term, such as five years, must be renewed automatically unless 90 days or more prior to 22 the renewal date, the issuer notifies the Department, the beneficiary, and the licensee ofits intention 23 not to renew. The surety method or insurance must also provide that the full face amount be paid 24 to the beneficiary automatically prior to tiae expiration without pmorof forfeiture if the licensee fails 25_
, to provide a replacement acceptable to the Department within 30 days after receipt of notification 26-
. of cancellation; 27-b.
'Ihe surety method or insurance must be payable to a trust established 28 for decommissioning costs.' The trustee and trust must be acceptable to the Department. An
- 29 acceptable trustee includes an appropriate State or Federal govemment agency or an entity which L30 -
has the authority to act as a trustee and whose trust operations are regulated and examined by Federal
- 31 or State agency; and 32 i
~33.
c.
The surety method or insurance must remain in effect until the 34 Department has terminated the license.
35
- 3.
An extemal sinking fund in which deposits are made at least annually, coupled 36' with a surety method or insurance, the value of which may. decrease by the amount being
-37
. accumulated in the sinking furd. An extemal sinking fund is a fund established and maintained by 20 NMAC 3.1 :
3 31 Revision Date p
w c:
[l setting aside funds periodically in an account segregated from licensee assets a.d outside the licensee's administrative control in which the total amount of funds would be sufficient to pay 2
decommissioning costs at the time termination ofoperation is expected. An extemal sinking fund 3
. may be in the form'of a trust, escrow account, govemment fund, certificate of deposit, or deposit of
.4 5-govemment securities. The surety or insurance provisions must be as stated in paragraph (F)(2) of 6
this section.
7 4.
In the case of Federal, State, or local govemment licensees, a statement of p'
8 intent containing a cost estimate for decommissioning or an amount based on the Table in paragraph 9
(D) of this section, and indicating that funds for decommissioning will be obtained when necessary.
10; G.
- Each person' licensed under this Subpart or Subparts 5, 7. 12,'13, 15 of these 11.
regulations shall keep records ofinformation important to the safe and effective decommissioning 12_
of the facility in an identified location until the license is terminated by the Department. If records 13 ofrelevant information are kept for other purposes, refemnce to these records and their locations may 14_
be used. Information the Department considers important to decommissioning consists of:
15 1.
Records of spills or other unusual occurrences involving the spread of 16 contamination in and around the facility, equipment, or site. These records may be limited to 17
. instances when contamination remains after any cleanup procedures or when there is reasonable
.18 likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage l
19 into porous materials such as concrete. These records must include any known information on L
20 identification ofinvolved nuclides, quantities, forms and concentrations.
-21 2.
As-builtdrawingsandmodifica b M'6 3 I5 dCi mtin restricted 22 areas where radioactive materials are used and/or sto: 30 W W le inaccessible 23 contamination such as buried pipes which may be sul aired drawings 24 are referenced, each relevant document need not be Aw 3/t 4 4 /5 Ad twings are not I
'25 available, the licensee shall substitute appropriate reco 30. 'a AgW neeming these
-26 areas and locations.
3, g g7 27 l
28
- <3.
Records of the cost estimate performed for the decommissioning funding plan 29 or of the amount certi6ed for decommissioning, and records of the funding method used for assuring
_30 funds if either a funding plan or certification is used.
i 1
31 4.
Except for areas containing only sealed sources ~(provided the sources have
'32 not leaked or no contamination remains after any leak) or radioactive materials having only half-33
_ lives ofless than 65 days, a list contained in a single document and updated every two years, of the 34' following:
[
- 35 a.
All areas designated and formerly designated restricted areas as E
'36
' defined in Subpart 1 of these regulations (for requirements prior to the effective date of these I
37-regulations,'see New Mexico Radiatior, Protection Regulations, filed March 10,1989);
l
' 20 NMAC 3.I' 3-32 Revision Date L
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Mi areas outside of restricted areas that require documentation under 2
(31I G 1; 3
c.
All areas outside ofrestricted areas where current and previous wastes i
4 have been buried as documented under Q448; and 5
d.
All areas outside of restricted areas which contain material such that, 6
if the license expired, the licensee would be required to either decontaminate the area to unrestricted 7
release levels or apply for approval for disposal under {434.
i t
[
l 20 NMAC 3.1 3-33 Revision Date
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1 I COMPATIBILITY AMENDMENT 2:
I Iids: Self-Guarantee as an Additional Financial Assurance Mechanism; 10 CFR Parts 30,40,50, 70,72
- \\.
Fada al Rani =*ar:
Volume 58, No. 248, December 29,1993 (58FR68726) and Volume 59, No. 8,
~
January 12,1994 (59FR1618)
Due Date: January 28,1997 Rationale:
-58FR68726/The Nuclear Regulatory Commission is amending its regulations for decommissioning licensed facilities to allow certain non-electric utility licensees to use self-guarantee as a means of financial assurance. The rule reduces the cost burden of financial assurance while providing the NRC with sufficient assurance that decommissioning costs will be funded.
19FR1618/This document corrects a final rule that appeared in the Federal Register on December 29,1993 (58FR68726), that amended NRC regulati9ns for decommissioning licensed L
facilities to allow certam non-electric utility licensees to use self-guarantee means of financial assurance.
This action is =~~ - y to correct the designation of an appendix in the final rule.
NRC Eh0LER 630.35 (f)(2)
. {311.F.2, page 3-31; references to A,apandir B are corrected to read Appaadir C by 59FR1618 Appendix A,10 CFR Part 30 6334. Appendix-A,page3-88(newaddition) l,
. Appendix C,10 CFR Part 30 6335. Appandir C, page 3-90 (new addition) i 4
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I' section, including means of adjusting cost estimates and associated funding levels periodically over 1
the life of the facility.
2 l
3 4
F.
Financial assurance for decommissioning must be provided by one or more of the 5
following methods:
l 5
7 1.
Prepayment. Prepayment is the deposit prior to the stan of operation into an i
l 8
account segregated from licensee assets and outside the licensee's administrative control of cash or l
liquid assets such that the amount of funds would be sufficient to pay decommissioning costs.
9 Prepayment may be in the form of a trust, escrow account, govemment fund, certificate of deposit, 10 11 or deposit of govemment securities.
l 12 13 2.
A Surety Method, Insurance, or Other Guarantee Method. These methods guarantee that decommissioning costs will be paid should the licensee default. A surety method may 14
)
be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of is i
funds for decommissioning costs based on a fmancial test may be used if the guarantee and test are 16 as contained in Odik M A to this subpart. A parent company guarantee may not be used 17 in combination with other financial methods to satisfy the requirements of this section.PW la 19 ofhadshgrM e grbelumed if the aussetse auguurgupyMjaeggggdqgg(Wautgust. i A genmusse by the 20 21 appheaster Seusstatansteds to esamfy the requhussenes afeds66 has a pensit company 22 23 heinesaMassenesteth Any surety method or insurance used 24 to provide fmancial assurance for decommissioning must contain the following conditions:
25 26 a.
The surety method or insurance must be open-ended or, if wTitten for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to 27 28 the renewal date, the issuer notifies the Department, the beneficiary, and the licensee ofits intention 29 not to renew. The surety method or insurance must also provide that the full face amount be paid 30 to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails 31 to provide a replacement acceptable to the Department within 30 days after receipt of notification 32 ofcancellation; l.
33 34 b.
The surety method or insurance must be payable to a trust established 35 for decommissioning costs. The tmstee and trust must be acceptable to the Department. An 36 acceptable trustee includes an appropriate State or Federal govemment agency or an entity which l
37 has the authority to act as a trustee and whose trust operations an regulated and examined by Federal 38 or State agency; and 39 40 c.
The surety method or msurance must remain in effect until the l
41 Department has tenninated the license.
20 NMAC 3.1 3-31 May 3,1995 l-
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12
?.
i either 13 3
m 14 g
15 act weedi 4ess,63
_Nio
_M dagentlen, and 16 amaseammaina;g
.t; _1magepagungsqppset m to cunen: liabilities 17 greaturement.531gd J
18 N6ast westh each at least six 19 taasesabs is used);
20 and 21 g
e' l
22 g
... -. 90 23 24 6
1 25 g
l l
26 g
ofAAA, AA, 27 A,
,t
.. MMoody's;and 28 g
W. onnent 29 t
30 g
20 NMAC 3.1 3-88 Revision Date i
l
t 6
T' 3M. NA 2
M
_m to at least 90 3_
pacept
,@(orprescribed 4
6 5
g
, p wh 6
osaqpasedW.
M. h the i
7 die auments in 8
sush_
indum NRC within 9
90 daysof es believe that the 10 data specnnedhedge asAmagerpasses the test.
11 3,
p.
gaggiumy must speat the 12 passess ofthem pesq 13 g
.,gfpenpaph 14 A WM.,.. "
.g 15 16 assR[.,. j 17.
Sun,wE ;
a 18 19 g
.. which an 20
..J._ -
21 1.
pamatorsends 22 acties of annaeusalung
'Causslistion may not 23 occur, hperever, desantes ofcancellation 24 by both 25
-3 1.in the t
26
+
27
.6 such 28 l
29 3
30 4
31 g
l 32 be -
or Federal 33 Govammassa h trust operations 34 are reguispeded,..
20 NMAC 3.1 3-89 Revision Date r
l
9
'g I'
385.
AfWegg MpC.
1 2
s
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- ,yggs 3
5 g
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testW Spfthis appendix.
9 ThisM-gasmmessand esemblishes 10 deedsmup6 I
11 B.
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12 1;
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13 g
l 14 qupp1_.
i 15 16 g
i 17 1.
gament 18 19 is.
20 p;
Mhwinuusse,dAAA, AA,or A 21 asissued_by 66 l
22 2.
hadditional l
23 nMpessoasuer.
i 24 3
,peoutubes l
25 26 3
27
.~7 28 29 30 31 in$1s 20 NMAC 3.1 3-90 Revision Date
i 4
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f' '
308 6 2
5 meteupsetpassageofthe 3
testwinsa emepaar.
4 K
Ifitseggeses,askisagermesses,tunt..asqmrammense of Sootion B.1 of this 5
appener,1bs liesmassment'esud h astseAeqH9emenission ofits. intent to establish 6
alemannen amannignamumusses'apumMed in dueGammaissheshkseguistions widnin 120 days of such 7
- notWe, 8
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10 g
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13
..as
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14
-"" in ahe 15
- sf a metice of 16 6
17 Sw 1hegium(ukeled 9lInq%8 tuutperisiums temst sumunisia eSect until the 18 Casupuiq$na Wmmuninessandbadasseptable to the 19 20 g.
Jiosasse's 21 22
.peomities
- - and 23 6
24
/3 25 rated in 980Wie 26
.W hy 27 mW ostegory of
-28 "A$ L i
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31 (a
~
at 32 tbs}.
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~
20 NMAC 3.1 3 91 Revisior Date l
C.
-py-l
\\
- COMPATIBILITY AMENDMENT #3:
.Iills: Timeliness in Decommissioning of Materials Facilities; 10 CFR Parts 2, 30, 40, 70, and 72 Federal Register: Volume 59, No.135, July 15,1994 (59FR36026) k Due Date August 15,1997 -
Rationale. The Nuclear Regulatory Commission _ (NRC) is amendmg its regulations to require timely darnaramination and decommissioning by nuclear material licensees These amendments establish i
specific time periods for decommissioning unused portions of operating nuclear materials facilities and for decommissioning the entire site upon termination of operations. The rule is intended to reduce the -
potential risk to public health and the environment from radioactive material i-.4-Ag for long periods of
- time at such facihties aAer licensed activities have ceased NRC NMRPR j
{30.4
{l06.BZ, page 1-9 (new addition) l
{30.36
- }318, page 3-53 (revise entire section with most current language)
{
..,s 8
.=
y g
9 o
i C~)
I
(
V
i
\\
l BI.
" Lost or missing source of radiation" means licensed [or registered] source of l
2 radiation whose location is unknown. This definition includes but is not limited to material th 3
been shipped but has not reached its planned destination and whose location cannot be readily traced 4
in the transportation system.
l 5
BJ.
" Major processor" means a user processing, handling, or manufacturing radioactive 6
material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B 7
quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial 8
radiographer or small industrial programs. Type A and B quantities are defined in Section 71.4 of 9
10 BK.
" Member of the public" means an my individual except when that individual is 11 receiving an occupational dose.
12 BL.
" Minor" means an individual less than 18 years of age.
13 BM.
" Mixed Waste" means waste that contains both hazardous constituents regulated 14 under the Resource Conservation Recovery Act and radioactive constituents regulated by these 15 regulations.
16 BN.
" Monitoring" means the measurement of radiation, radioactive material
)
17 concentrations, surface area activities or quantities or radioactive material and the use of the results 18 of these measurements to evaluate potential exposures and doses. For purposes of these regulations, 19
" radiation monitoring" aad " radiation protection monitoring" are equivalent terms.
20 BO.
"NARM" means any naturally occurring or accelerator-produced radioactive material.
21 It does not include byproduct, source, or special nuclear material. (NARM refers only to discrete 22 sources of NARM.)
23 BP.
"Natum! radioactivity" means radioactivity of naturally occurring nuclides. NARM 24 refers only to discrete sources ofNARM.
)
25 BQ.
" Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory 26 Commission or its duly authorized representatives.
27 BR.
" Occupational dose" means the dose received by an individual in the course of 28 employment in which the individual's assigned duties for ic licenece er res.4. a involve exposure l
29 to es rece ofradiation
.a:.
l 30 whether er ne: ic eeurece of rr.dia:ica arc in the possession of the licensee, registrant, or other 31 person. Occupational dose does not include dose received from backgmund radiation, er as a patient 32 from acdical y. c:kea l
33 to' r..
3.h er from 34 voluntary participation in medical research programs, or as a member of the public, t
20 NMAC 3.1 1-8 Revision Date l
i t
4 0
1 BS.
" Ore refineries" means all processors of a radioactive material ore including uranium 2
mills or other source material extraction facilities.
3 BT.
" Package" means the packaging together with its radioactive contents as presented 4
for transport.
5 BU.
" Particle accelerator" means any machine capable of accelerating electrons, protons, 6
deuterons, or other charged particles in a vacuum and ofdischarging the resultant particulate or other 7
radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, 8
" accelerator" is an equivalent term.
9 BV.
" Person" means any individual, corporation, partnership, firm, association, trust, 10 estate, public or private institution, group, agency, political subdivision of this State, any other State 11 or political subdivision or agency thereof, and any legal successor, representative, agent or agency 12 of the foregoing, but shall not include federal government agencies.
13 B W. ' " Personnel monitoring equipment" [See Individual monitoring device").
14 BX.
"Phannacist" means an individual licensed by this State to compound and dispense 15 drugs and prescriptions.
16 BY.
" Physician" means an individual licensed by this State to prescribe drugs in the 17 practice ofmedicine.
18 4
..l.
essentialto 19 which no 20 niesen( M desentamination or 21 22 BECA.
"Public dose" means the dose received by a member of the public from I
23 exposure to radiation and g to radioactive material released by the g licensee or registrant, or 24 ega; to 6 sources ofradiation w.d in licened er registerd cFriene under the control 25 of a licensee or registrant. Public dose does not include occupational dose or doseg received from 26 background radiation, er dee; ried ;; ; pd;at nea. ;;; dical pr dece Mipsubsal l
27 C'
28 or dose from voluntary participation in medical l
29 research programs.
l 30 CAS. "Pyrophoric material" means any liquid that ignites ; spontaneously in dry or moist air l
31 at or below 130*F (54.4'C) or any solid material, other than one classed as an explosive, which tmder I
l 32 normal conditions is liable to cause fires through friction, retained heat from manufacturing or 33 processing, or which can be ignited readily and, when ignited, bums so vigorously and persistently 20 NMAC 3.1 19 Revision Date I
E J
a 0-l i
1 as to create a serious transportation, handling, or dispos ! hazard. Included are spontaneously I
2 combustible and water-reactive materials.
3
- CBg. " Qualified expert" means an individual having the knowledge and traming to measure 4
. ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs,
- 5 for example, individuals certified in the appropriate field by the American Board of Radiology, or
~6 the American Board ofHealth Physics, or the American Board of Medical Physics or those having
.7
' equivalent qualifications. With reference to the calibration of radiation therapy equipment, an
-8 individual having, in" addition to the above qualifications, training and experience in the clinical 9
applications of radiation physics to radiation therapy, for e tmple, individuals certified in
~10 Therapeutic Radiological Physics or X-Ray and Radium Physics by the American Board of 11 Radiology, or those having equivalent qualifications. With reference to providing medical physics 12' services tc certified mammographic facilities, such individuals must meet the requirements as
.13 defined by the U.S. FDA.
14' CES. " Quality factor" (Q) means the modifying factor, listed in Tables I and II of { l 17, that 15
, is used to derive dose equivalent from absorbed dose.
'16:
CBg. " Rad" means the special unit ofabsorbed dose. One rad is equal to an absorbed dose
(.
- 17 of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).
118
' Clig. " Radiation" means alpha particles, beta particles, gamma rays, x-rays, neutmns, high-19 speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of 20-these regulations, ionizing radiation is an equivalent term.~ Radiation, as used in these regulations, 21 does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or l
22.
ultraviolet light.
23 Ciq. " Radiation area" means any area, accessible to individuals in which radiation levels 24 could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in I hour
' 25 I
at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
26-CGB. " Radiation dose" [See " Dose").
(
[.
27:
CHl. " Radiation machina" means any device capable of pmducing radiation except those 1
L
' 28-Lwhich produce radiation only from radioactive material.
[
l 29 Cll.
" Radiation safety officer" means one who has the knowledge and responsibility to 30 apply appropriate radiation protection regulations. (For medical use see {712.)
y 31 CJ5. " Radioactive material" means any material (solid, liquid, or gas) which emits
- 32
- radiation spontaneously.
3 20 NMAC 3.1 1-10 Revision Date
}
l s
A
- o 4
1 CML. " Radioactivity" means the transformation of unstable atomic nuclei by the emission 2
ofradiation.
3 CbM. "Radiobioassay" (See " Bioassay").
4 CMg. " Registrant" means any person who is registered with the Department. Registrant 5
also means anyone who is legally obligated to register with the Department pursuant to these 6
regulations and the Act.
7 CNg. " Registration" means registration with the Department in accordance with these 8
regulations.
9 COR. " Regulations of the U.S. Department of Transportation" (U.S. DOT) means the 10 regulations in 49 CFR Parts 100-189.
I1 CPQ. " Rem" means a special unit of any of the quantities expressed as dose equivalent.
12 The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 13 rem = 0.01 sievert).
14 CQS. "Research and development" means: (1) theoretical analysis, exploration, or 15 experimentation; or (2) the extension ofinvestigative findings and theories of a scientific or technical 16 nature into practical application for experimental and demonstration purposes, including the 17 experimental production and testing of models, devices, equipment, materials,' and processes.
'18 Research and development does not include the internal or external administration of radiation or 19 radioactive material to human beings.
20 CRS. " Restricted area" means an area, access to which is limited by the licensee or 21-registrant for purposes ofprotection ofindividuals against undue risks from exposure to sources of 22 radiation. Restricted area does not include areas used as residential quarters, but separate rooms in 23 a residential building may be set apart as a restricted area.
24
. CSS-1" Roentgen" means the special unit of exposure. One roentgen (R) equals 2.58E-4 25 coulombs per kilogram of air (see " Exposure" and {117).
26 C35. " Sealed source" means any container of radioactive material which has been 27 constructed in such a manner as to prevent the escape of any radioactive material.
28)
CUg. " Shallow dose equivalent" (Hs), which applies to the extemal exposure of the skin
.29 or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm ) averaged 2
-30.
over an area ofI square centimeter.
1 i:
L 31-CV3. "SI" means the abbreviation for the Intemational System of Units.
20 NMAC 3.1 1-11 Revision Date t
c _
l 1
e 1~
CWK. " Sievert" meana the SI unit of any of the quantities expressed as dose equivalent. The
' dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 2
3f Sv = 100 rem).
4' CMY. " Site boundary" means that line beyond which the land or property is not owned, 5-leased, or othenvise controlled by the licensee or registrant.
-6 CVE. " Source material" means:
i i
7 1.
uranium or thorium, or any combination thereof, in any physical or chemical f
8' form; or 9:
2.
ores that contain by weight one-twentieth of 1 percent (0.05 percent)or more 10;
' of uranium, thorium or any combination of uranium and thorium. Source material does not include 11.
12 EML
" Source material milling" means any activity that results in the production of 13-byproduct as defined by definition (2) of byproduct material.
14 DQ. " Source of radiation" means any radioactive material, or any device or equipment 15-
' emitting or capable of producing radiation.
16' DBg. "Special form radioactive material" means radioactive material that satisfies the 17 following conditions:
,18 -
1.
It is either a single solid piece or is contained in a scaled capsule that can be 19 opened only by' destroying the capsule;
_20 -
2.
The piece or capsule has at least one dimension not less than 5 millimeters 21
. (0.2 inch); and -
22 3.
It satisfies the test requirements specified by the U.S. Nuclear Regulatory 23:
Commission. A special form encapsulation designed in accordance with the U.S. Nuclear 24-Regulatory Commission requirements in effect on June 30,1983, and constructed prior to July 1, 25 1985, may continue to be used. A special form encapsulation either designed or constructed after -
26 June 30,1985, mwt meet mquirements of this definition applicable ~at the time ofits design or 27-
' construction.
-28.
Dg. "Special nuclear material" means:
-29
. 1.
plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 30;
' 235, and any other material that the Department declares by order to be special nuclear material after 31-
. the U.S. Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic 20 NMAC 31 1-12 Revision Date
l
=
j 1
. Energy. Act of 1954, as amended, determines to be special nuclear material, but does not include
'2 source material; or
~
3 2.
any material artificially enriched by any of the foregoing but does not include
~
'4 source material.
5-DB5. "Special nuclear material in quantities not sufficient to form a critical mass" means
~6
- uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U 235; 7
uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 8
grams: or any combination of them in accordance with the following formula: for each kind of 9
special nuclear material, determine the ratio between the quantity of that special nuclear material and 10 the quantity specified above for the same kind of special nuclear material. The sum of such ratios 11 for all of the kinds of special nuclear material in combination shall not exceed 1 (i.e., unity). For j
12-example, the following quantities in combination would not exceed the limitation and are within the f.
13
_ formula:
l l
N 195 (grams contained U-235) 50(grams U-233) 50 (grams Pu) 350 200 200 I
14 DEq. " State" means the State of New Mexico.
l
.15 DFg. " Survey" means an evaluation of the production, use, release, disposal, transfer or 16
. presence of sources of radiation under a specific net of conditions to determine actual or potential 17
. radiation hazards. When appropriate, such evaluation includes, but is not limited to tests, physical 18 examination and measumments of levels of radiation or concentration of radioactive material 19 present.
20 L
21 DGF. " Test" means a method for determining the characteristics of conditions of sources 22 of radiation or components thereof.
DHf "' These agulations" means all Subparts of 20 NMAC 3.1, Radioactive Materia 23-
~-24 Ldiation Machines.
l i'
[
25 Dig. _ " Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent i
26 for extemal exposures and the committed effective dose equivalent for intemal exposures.
27~
die. " Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent 28 and the committed dose equivalent to the organ receiving the highest dose as described in Q446 A
'29 6 of these regulations.
20 NMAC 3.1 1-13 Revision Date p
- 11 DKL. "U.S. Department of Energy" means the Department of Energy established by Public 2
Law 95-91, August 4,1977,91 Stat. 565,42 U.S.C. 7101 et. seq., to the extent that the Denartment 1
3 exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, unabers, i
. officers and components' and transferred to the U.S. Energy Research and Development 4
5.
' Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the 6
Energy Reorganization Act of 1974 (Public Law 93-438, October 11,1974,88 Stat.1233 at 1237, 7
42 U.S.C. 5814, effective January 19,1975) and retransferred to the Secretary of Energy pursuant 8
to section 301(a) of the Departinent ofEnergy Organization Act (Public Law 95-91, August 4,1977, 9-91 Stat. 565 at 577-578,42 U.S.C. 7151, effective October 1,1977).
10 Dhg. "U.S. EPA" means the Environmental Protection Agency.
I1 DMW. "U.S. FDA" means the Food and Drug Administration.
12-DNS. " Unrefined and w+s-:===M ore" means ore in its natural form prior to any processing 13
- such as grinding, roasting, beneficiating, or refining.
14 DOP. " Unrestricted area" means an area, access to which is neither limited nor controlled 15
' by the licensee or registrant. For purposes of these regulations, " uncontrolled area" is an equivalent 16 term.
17 DPg. " Waste" means those low-level radioactive wastes that are acceptable for disposal in 18 a land disposal facility. For the purposes of this definition, low-level waste has the same meaning 19-as in the Low-Level Radioactive Waste Policy. Act, P.L.96-573, as amended by P.L.99-240,
'20 effective January 15,1986; that is, radioactive waste (a) not classified as high-level radioactive 21 waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy
-22 Act (uranium or thorium tailings and waste) and (b) classi6ed as lo'v-level radioactive waste 23-
. consistent with existing laws' and in accordance with_ (a) by the U.S. Nuclear Regulatory j
24 Commission. Mixed waste streams may also be regulated under the Resource Conservation i
25 Recovery Act requirements or other State or Federal regulations or statutes.
26 DQS. " Waste Disposal Site Operators" means persons licensed to dispose of radioactive 27 waste.
28
. DRS. " Waste handling licensees" means persons licensed to receive and store radioactive 29-wastes prior to disposal and/or persons licensed to dispose of radioactive waste.
j 30 DSg. " Week" means 7 consecutive days starting on Sunday.
1 31 Dig "Whole body" means, for purpose of extemal exposure, head, trunk including male j
132 gonads, arms above the elbow, or legs above the knee.
I I
20 NMAC 3.1 1-14 Revision Date j
i l
l L
j
1
{
.4 r
~l DEN. " Worker" means an individual engaged in work under a license or registration is.
2 by the Depamnent and controlled by a licensee or registrant, but does not include the licensee l
3 registrant.
j 4
DVW. " Working level" (WL) means any combination of short-lived radon daughters in 1 I-5-
liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy.
6 The short-lived radon daughters are - for radon-222: polonium-218, lead-214, bismuth-214, and 7
polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212, 8.
DWg. " Working level month" (WLM) means an exposure to 1 working level for 170 hour0.00197 days <br />0.0472 hours <br />2.810847e-4 weeks <br />6.4685e-5 months <br />s--
9 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours0.00197 days <br />0.0472 hours <br />2.810847e-4 weeks <br />6.4685e-5 months <br /> l
10
. per month.
DMg " Year" means the period of time beginning in January used to determine compliance l
_11 -
12 with the provisions of these regulations. The licensee or registrant may change the starting date of l
13 the year used to determine compliance by the licensee or registrant provided that the change is made l
14 at the beginning of the year and that no day is omitted or duplicated in consecutive years.
l c
I t
l 20 NMAC 3.1 1-15 Revision Date f
i-
e 1
Sldk
..: < : + -
. : L.
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18
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23 g
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26 L
27 3
28 29 g
. astW
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.'M Selbpart A; 32 g
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20 NMAC 3.1 3-53 Revision date l
e 1
WiMansukfof;the tnost recent 2
Dgusluges4.
_M;18.1996,have boen:
3 g
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9 the holdsse.hmes:
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18 f / Waghegdepuesgpegymesukshisforrelease 19 in assuadeeps.,,
3 20 D.
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26 27 3
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-31 6
20 NMAC 3.1 3-54 Revision date
s 1
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MMMMpbeen;W for aperiod of 2
24===dheer 3
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12 L
_ inhaAnnadad 13 east 14 18====*arW 15 g
16
.. ath 17 3-18 E
.2 i.
in 19 i
health and i-20 sedutysadis Nthan 30 days 21 bedues notatsstion,
+p6dagesanussioning set 22 fort. in.6MigyJAR6.sultig'Bappluneet has made a l
23 detuadnalitutem4 24 g,
pendition 25 ar L
. prasparate 26
~
27 gthe 1
i 28 6
l 29 3
1.tn-30 m
31 g
y
- aufsoe 32 sounggelep-m
, during 33 opesueless 20 NMAC 3.1 3-55 Revision date 1
5 I
eG 6,Ngnalerauborneconcentations 1
- I R
3 ppsissess ofradioactive 4
matgeis%2 5
g 6
.;. J#pteshesstest of a datunnmes 7
that operations and 8
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yp assess with pa*-atial 11 beabhand sainty Wanyactjupesupe$
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12
(,
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14 g
~
15
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16 g
17 g
18 envissumstut and the 19 memey; sud 20 a;
mg;W comparison 21 of that..estimmes,h
.far,pseuung the 22 a6 y.
23 3
~.
of 24 for 25 26 27
- 1 as 28 29 g
g
~
.,dmN complete 30 but no later 31 Gust -
20 NMAC 3.1 3-56 Revision date
I 2.
EmmptfasJapyjded,4n pes)3rapl@ef#ds section, when decommissioning 2
involm tbs estre-h;ahsil,ang=* jia==.N as soon as practicable but no 3
laterthem.24 6
4 L
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decenamissitoing.
- , clhuess tWan if 1
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aussted 24-anometgestads 10 2.
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);
wiH be 13 schiseud A, _
14 Awedges oes4pe 15
. n.1 16 y-17
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21 J.
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. - fann or 24 6
25 3
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26
~
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-_,,,...s 29
~ ~.
30 31
- istweser, 32 and l
20 hWAC 3.1 3-57 Revision date i
1 h
SpoodythesurveyWWWand%hMhat 2
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3 E
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WAIS bocume'nt Retrieval Page1of4
[ Code of Federal Regulations]
[ Title J0, Volume 1, Parts 0 to 50)
- [Reviset. as of January 1, 1997)
From the U.S. Government Printing Office via GPO Access
[ CITE: 10CFR30.36)
(Page 441-444) p TITLE 10--ENERGY CHAPTER I--NUCLEAR REGUIATORY COMMISSION I
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIA
.3/$.
c4p.s I::. $136 Expiration and termination of licenses.andM~-i--i.ir.;; cf -i he_an A. -* l. +
A. ?.
(a)(1) Except as provided in paragraph (a) (2) of this section, each specific license expires at the end of the day on the. expiration date stated in the gcg g M icensee has filed an application for un renewal under than 30 days before the expiration date statedj g the existing license (or, for those licenses subject to
. paragraph ra')T2)_of this section, 30 days before the deemed expiration
(
date in that 3aragraph). If an application for renewal has been filed at least 30 days before the expiration date stated the existing license (or, for those licenses subject to paragraph
(-
of this section, 30
)
days before the deemed expiration date in that paragraph) Q he existing license expires at the end of the day on which the Conunidition makes a final determination to deny the renewal application or, it une I
determination states an expiration date, the expiration date stated in the determination.
-942.(41 Each specific license that has an expiration date afty) July 1, 1995, and is not one of the licenses described in paragraph (Y 3) of this section, shall be deemed to have an expiration date that is five years after the expiration date stated in the current license.
l
., /tt) The following specific licenses are ngt subject to, or otherwise
{
j affected by, the provisions of paragraph (f)Tt) of this section:
)
- ))> a(44 Specific licenses for which, on February 15, 19 6 puation4-As4d or an emergency plan is-required in accordance with t
&.(14) Specific licenses whose holders are subject to the financial
. assurance requirements specified in le c??
" ' ' '. and on February 15, 1996,' the holders either:
'W*
W M m.J (d,,
1
' h 0)(A) Have not submitted a de:0nunissioning funding plan or I
certification of financial assurance for deconunissioning; or Q)(D) Have not received written notice that the deconunissioning funding plan or certification of financial assurance for deconunissioning is acceptable; l
c.(4M ) Specific licenses whose holders are listed in the SDMP List I
T published sabcum % */
l
((Page 442))
g/g
-in NUREG 1444, Supplement 1 (November 1995);
I
,j J.Mv) Specific licenses whose issuance, amendment, or renewal, as of f
Q ary 15, 1996,-is not a categorical exclusion under o crA N 51.22 (c, um and, therefore, need an environmental asses _smen o environmental impact statement pursuant to par O of P_ art 31 of this chapter; A.
e,prf" Specific licenses whose holders have not had at least one NRC inspection of licensed activities before February 15, 1996; 9
't.priT Specific. licenses whose holders, as the result of the most recent NRC inspection of licensed activities conducted before February 15, 199 D ve been:
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WAIS Documeht Retrieval Page 2 of 4 Cd(Jt) Citad for a ssverity L_eypl Wr III violation in a Notice l.
of Violations g,,Q i
(,,Q UH Subject to an order issued by the N3GJI or
.=w(,b)(97 Subject to a ConTrmatory Action Letter i ssued by they, l
g e g(vii) Specific licenses with expiration dates before July 1,
- 1995, b for which the hold rs have submitted applications for renewal under 10-e 30_.37 of this art.
pL N
D (h) Each specific license revoked b eCommisbionexpiresatthe end of the day on the date of the Commis n's final determination to revoke the license, or on the expir'aTion date state or as otherwise provided by CommiDd$g.in the determination, dn Order.
C (rt Each specific license continues in effect, 'beyond the expiration date if necessar with respect to possession of byproduct material until-the Co on notifies the licensee in writing that the license is terminat D ing this time, the licensee shall--
f.(.M Limit actions involving byproduct material to those related to decommissioning; and
~ ),(E) Continue to control entry to restr et d areas until they are
.2 /,
suitable for release in accordance with NR quirements.
g, A //[p D.Ld) Within 60 days of the occurrence'of any of the following, consistent with the administrative direction (Tin writing of suchi licensee shall provide notification to the NM occurrence, and either begin decommissioninif"iTs site, or any separate building or outdoor area that contains residual radioactivity so that building or outdoor area is suitable for release in accordance with irements, or submit within 12 months of ot fication a commissioning plan, if required by paragraph -
) of this section, and begin decommi:ssioning upon approval of that pAan if-g d.
/. ( )
secti)on; orThe license has expired pursuant to paragraph te9'~or (>f of this 2.(25 The licensee has decided permanently cease principal activities, as defined in this
% t the entire site or in any separate building or outdoor area at contains residual radioactivity such that the build g or outdoor area is unsuitable for release in accordance with requirements; or 3.(3) No princ pal activities under the license have been conducted for a period of 24 months; or
{
ff,(4) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that.contains residual radioactivity such that the bu iding or outdoor area is unsuitable for release in accordance with N requirements.
fication required by paragraph {)1 of
[J(ei Coincident with the no decormnissioning M W
- p g this section, the licensee shall maintain in effect all unancial assurances established by the licensee pursuant to Sesc3Aa5 g
(,
in conjunction.with a license issuance or renewal or as requireo oy cars section..The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for deconnaissioning established pursuant to paragraph (g) (4) (v( of this section.
G. 4. 8 L M.Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the deconsnissioning plan shall do so when this rule becomes effective November 24, 1995.
J (2) rollowing approval of the decommissioning plan, a licensee may
)
reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Consniss
((Page 443)]
L j
[(t) The Commissi may(grant a reques(tp'n determines that thisextend the time periods l
established in paragraph (W) if the CommiMte relief is not detrimental % the public health and safety and is otherwiseinthepublicinterest.Therequestmustbesy@bmittednolater
'than 30 days before notification pursuant to paragraph of this http://frwebgate l. access.gpo. gov /cgi-bin /waisgate.cgi?WAISdocID=355721010+ 1 +O+0&WAIS d19dW98etrieve 4
WAIS Document Retrieval Page 3 of 4
- ssction..The cchsdule for d3 commissioning set forth in prragrrph of this section may not commence until the Cs - a p has made a determination on the request.
- 6. (T)$+) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate bui1Q ng or outdoor area
. have not been previously approved by the Conni@lp4Dn and these procedures
'could increase potential health and safety. impacts to workers or to the
-public, such as in any of the following cases:
a Gt7 Procedures would involve techniques not applied routinely d6 ring cleanup or maintenance operations;
&(44) Workers would be entering areas not normally occupied where surface contamination.and radiation levels are significantly higher than routinely ~ encountered during' operation; clikt7 Procedures.could result in significantly greater airborne concentrations of. radioactive materials than are present during operations-or L(Ami Procedures could result in significantly' greater releases of radioactive material to the environment than those associated with operation..
)
A.G) The Commi n may approve an alternate schedule fgr submittal
. of a decomadssioning. plan required pursuant to parmaranh (E of this seq 11on if the C_o Q on determines that the alternative schedule is necessary to the ers-uuive conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is'otherwise in the public interest.
3.91 Procedures such as those listed in paragraph (6, /
a)(1) of.Jhis section with potential health and' safety ~ impacts may not be carried out L
prior ~to approval of the decommissioning plan.
l gbH The proposed decommissioning plan for the site or separate building or outdoor area must include:
p e Ge) A description of the conditions of the site or separate building l
or outdoor area, sufficient to evaluate the* acceptability of the plan; 6641) A description of planned decommissioning activities;-
g(iii) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning; f(iv) A description of the planned final radiation survey; and g(v) An' updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan'for assuring the availability of adequate-funds for completion of decommissioning.
4.(vi) For deconsnissioning plans calling for completion of l
_ decommissioning later than 24 months after plan approval, ' the plan shall include a justification for the delay based on the criteria in paragraph
-(i) of 'this section.
f.d5) The proposed decommissioning plan. will be approved by the
. Co Ammi if the information therein demonstrates that the E
decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately N.(AI4k1: Except as provided in paragraph (f* f this'section, protected.
.1 ) o licensees shall complete. decommissioning or the site or. separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of.dec q sioning.
J24f). Except as provided in paragraph m of this section, when decommissioning involves the entire site, the licensee shall request
' license 1 termination _as soon as practicable but no later than 24 months fol wing the-in impion of decommissioning, yge:
The C
@n may approve's request for an alternative schedule f
completion o commissioning of the site or separate building or outdoor area,.and license termination if appropriate, if the Commi determines that the alternative is warranted by consideration of the'~
following:
l F
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'((Prg3 444))
/ kdd Whether ~1t is technically. feasible to complete decommissioning within the allotted.24-month period; R M(41 whether sufficient waste disposal-capacity is available to allow letion of-decommissioning within the allotted 24-month period;
-comp /(16 whether. a significant. volume reduction in wastes requiring
-3
' disposal will be achieved by allowing short-lived radionuclides to decay;-
,4/ W Whether a significant reduction in radiation exposure to workers e achieved by allowing short-lived radionuclides to decay and 1cagf(X) other site-specific f actors which the conehadon may co;nsider ct-
- 5 appropriate on a case-by-case basis, such as the regula' tory requirements of.other government. agencies, lawsuits, ground-water treatment activities,' monitored natural ground-water restoration,-actions that j
could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.
[{/ft)
(j) Aslthe final step in decommissioning,.the licensee shallf-Certify the disposition of all licensed material, including accumulated wastes,;by submitting a completed NRC Form 314 or equivalent L
information and
~~'
I' 2,CE) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results cc this survey unless the licensee demonstrates that the premises are suitable for release in some other manner.'The licensee.shall, as appropriate--
4.Lk) Report levels of ganum radiation in units of millisieverts t -
.(microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters--
removable and' fixed--for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids
.such as soils or concrete; and L
b(44) Specify the survey instrument (s)..used and certify that each uinstrument is properly calibrated and tested.
LLk) Specifi.c licenses, including expired licenses, will be terminated by written notice to the licensee when the C g ion.
determines that:
f.W) Byproduct material has been properly disposed;
, g Lai. Reasonable effort has been made to eliminate residual radi*oac ive contamination, if present; and
),(A1
-A~ radiation survey has been performed which demonstrates that 1
the premises are suitable.for release in accordance with NRC requirements; orAut1 other information submitted by the M nsee is
' sufficient to demonstrate that the premises are suitable for release in l"
- accordance' wii;h NRC requirements.
4(4) Records' required by Sec. 30.51 (d) and (f),have been received.'
- [59 FR 36034, July 15,-1994, as' amended at 60 FR 33238, July 26, 1995; 61 FR 1114, Jan. 16, 1996;'61 FR 24673, May 16, 1996; 61 rR 29637, June
'12,u1996)-
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COMPATIBILITY AMENDMENT #4:
1 l
Ijilg: Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use; 10 CFR Parts 30,32, and 35 Federal Register:
Volume 59, No. 231, December 2,1994 (59FR61767); Volume 59, No. 242, December 19,1994 (59FR65243); Volume 60, No. 2, January 4,1995 (60FR322)
Due Date: January 1,1998 Rationale: 59FR61767/The Nuclear Regulatory Commission (NRC) is amending its regulations for the medical use of byproduct material. This action is being taken in response to a petition for mlemaking.
This final mie is intended to provide greater flexibility by allowing properly qualified nuclear pharmacists and authorized users who are physicians greater discretion to prepare radioactive dmgs containing byproduct material for medical use. This final rule, while allowing research involving human subjects using byproduct material, requires NRC licensees who conduct such research to obtain the informed consent of the human subjects and the prior review and approval of an " institutional review board" within the meaning of the Federal Policy for the Protection of Human Subjects. This final mle also allows j
medical use of radiolabeled biologics. In addition, this final rule contains other miscellaneous and i
conforming amendments necessary to clarify or update the current regulations.
)
1 59FR65243/This document corrects a final rule, published in the Federal Register on December 2,1994 (59FR61767), that amends the regulations for the medical use of byproduct material.
This action is necessary to correct language in the preamble to reflect regulatory text, remove an obsolete cross-reference, and specify a date certain in document text.
l 60FR322ffhe Nuclear Regulatory Commission (NRC) is amending regulatory text and the response to a public comment c.ontained in a final rule published in the Federal Register on December 2, 1994, entitled " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use." This action is necessary following reconsideration by the NRC regarding the requirements for the information to be included on labels for radioactive drugs to be transferred for commercial distribution. The effect of this action is to reduce regulatory burden and uncertainty for licensees that manufacture and distribute radiopharmaceuticals that contain byproduct material for medical use.
NRC NMRPR 59FR61767 Q32.72.
{315.G, page 3-48 (changes reflect most current CFR language)
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~ Q35.6; Q35.7; #5:1-1; Q35.12; Q700.B; 700.C; 700.D.1 & 3; 700.E.1-5 (current la2guag3; Q35.13; Q35.14; Q35.15 Q700.F.2.a-d; 700.G.1-3; Q700.H.1-4, page 7-1 g
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{35.22; {35.25; {35.32 702.C.2; 702. E.2; 702.F.1.b and 702.F.2.a.(1); page 7-11
{35.33;{35.49 702.G, page 7-17 (revise in entirety); 702.H, page 7-19 135:50~-
703.A., Q703.A.I.a, 703.A.I.c, {703.A.4.b-d, page 7-20 35.52; {35.53.
703.C, (new addition); Q703.D; page 7-22
{35.60; Q35.75
{703.G, page 7-25; {703.J, page 7-27 Q35.100; 35.200; {35.300;
{704, page 7-31...;{705; {708;
{35.310; {35.15; 35.404;
{708.C; 708.D; 709.B; Q35.406; {35.410; {35.415 709.C; Q709.D; 709.E
{35.610; Q35.615 Q710.D; {710.E Q35.900; Q35.910; {35S20; Q712.A, page 7-42...; {712.C; Q712.D;
$35.930;, 35.940; Q35.950 712.E, page 7-46...; 712.F; Q712.H Q35.960; 35.980; Q712.I.2.c.(3), page 7-52; Q712.N (new text), page 7-53;
$35.981s Q712.0 (new text), page 7-54
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the applicant satisfies the general requirements of Q308, and 2
2, the applicant satisfies the requirements of10 CFR 32.57,32.58,32.59,32.102, 3
and 10 CFR 70.39 or their equivalent.
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28 20 NMAC 3.1 3-50 Revision Date l
M 6
1-D.
Notifications. A licensee shall notify the Department in writing within 30 days when 2
an authorized user, Radiation Safety Officer, or Teletherapy Physicist, permanently discontinues 3
performance of duties under the license.
4 701.
DEFINITIONS.
1
(
5 A.
" Address of use" means the building or buildings that are identified on the license and l
6 where radioactive material may be prepared, received, used, or stored.
!l i
7 B.
" Area of use" means a portion of a physical structure that has been set aside for the 8
purpose of preparing, receiving, using, or storing radioactive material.
9 C;
10 4
h of Phannaceutical 11 Spealattime; i
12~
2.
orAgreement 13 Staesiinges.
pheumacy; er 14 4
.f W by, a 15
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. te use 16 l
l 17.
4
" Authorized user" means a physician, dentist, or podiatrist who ist iden;ified as an i
18 auierized ucer en ; Ocpe.... cat, N"C cr Agrecraca: State licence ia; ;uierizca ic medice: asc l
19 cf radioactive m;;cdel.
l 20' E
iD., E., F., H.,
21 or L l
22 MmW Assommaant State license 1
23 that 24 3
+
~
$gpttseentor 25 atssef 26 6
27 95
" Dedicated check source" means a radioactive source that is used to assure the constant 28 operation of a radiation detection or measurement device over several months or years.
- 29 Eg.
" Diagnostic clinical procedures manual" means a collection of written procedures that 30.
describes each method (and other instructions and precautions) by which the licensee performs 20 NMAC 3.1 7-5 Revision Date l
L
y diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the I
2 authorized user and includes the radiopharmaceutical, dosage, and route of administration.
3 FG.
" Management" means the chief executive officer or that individual's designee.
4 GM.
" Medical Institution" means an organization in which several medical disciplines are 5
practiced.
6 14
" Medical use" means the intentional internal or extemal administration of radioactive 7
material, or the radiation therefrom to patients or human research subjects under the supervision of 8
an authorized user.
9 II.
" Misadministration" means the administration of:
10 1.
A radiopharmaceutical dosage greater than 30 microcuries (1.11 MBq) of either 11 sodium iodide I-125 orI-131:
I 12
- a..
Involving the wrong pahent hedessi or wrong radiopharmaceutical; 13 or j
b 14 b.
When both the administered dosage differs from the prescribed dosage
)
15 by more than 20 percent of the prescribed dosage and the difference between the administered dosage
)
16 and prescribed dosage exceeds 30 microcuries (1.1 IMBq).
{
I 17 2.
A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or 18 I-131:
19 a.
Involving the me..g pe;ist M, wrong radiopharmaceutical, 20 or wrong route of administration; or 21 b.
When the administered dosage differs from the prescribed dosage by 22 more than 20 percent of the prescribed dosage.
23
.24 -
3.
A gamma stereotactic radiosurgery radiation dose:
25 l
26 a.
Involving the wer.g pe:is: M or wrong treatment site; or 27 l
\\
l 28 b.
When the calculated total administemd dose differs from the total I
29 prescribed dose by more than 10 percent of the total prescribed dose.
30 4.
A teletherapy radiation dose:
20 NMAC 3.1 7-6 Revision Date 4
- 1 a.
Involving the wrong paint M, wrong mode of treatment, or 2
wrong treatment site; 3
b.
When the treatment consists of three or fewer fractions and the 4
calculated total administered dose differs from the total prescribed dose by more than 10 percent of 5
the total prescribed dose; I
6' When the calculated weekly admmistered dose is 30 percent greater c.
j 7
than the weekly prescribed dose; or I
8 d.
When the calculated total administered dose differs from the total 9
prescribed dose by more than 20 percent of the total prescribed dose.
10 5.
A brachytherapy radiation dose:
11 a.
Involving the w.eng p;&nt M, wrong radioisotope, or wrong 12 treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but 13
- migrated outside the treatment site);
I 14 b.
Involving a scaled source that is leaking; 15 c.
When, for a temporary implant, one or more sealed sources are not 16 removed upon completion of the procedure; or 17 18 d.
When the calculated administered dose differs from the prescribed dose 19 by more than 20 percent of the prescribed dose.
{
20 6.
A diagnostic radiopharmaceutical dosage, other than quantities greater than 21 30 microcuries (1.1 IMBq) of either sodium iodide I-125 or I-131, both:
22 a.
Involving the wTeng paint M, wrong radiopharmaceutical,
{
23 wrong route ~ of admmistration, or when the administered dosage differs from the prescribed dosage; l
24 and I
25 b.
When the dose to the pate t g exceeds 5 rems (50 mSv) en 26 effective dose equivalent or 50 rems (500 mSv) dose equivalent to any individual organ.
27 35-
" Mobile nuclear medicine service" means the transportation and medical use of 28 radioactive material.
I f
29 Yq.
" Output" means the exposure rate, dose rate, or a quantity related in a known manner 30 to these rates from a teletherapy unit for a specified set of exposure conditions.
t 20 NMAC 3.1 7-7 Revision Date l
J
1-16 SmugMy agtetspr Tamiessy,of the Umsed States,
.2 the Disedst6 tegenstesephasmacy.
3 EN.
" Prescribed dosage" means the quantity of radiopharmaceutical activity as 4
documented:
{
5 1.-
In a written directive; or i
4
'6 2.
Either in the diagnostic clinical procedures manual or in any appropriate record i
7 in accordance with the directions of the authorized user for diagnostic procedures.
l 8
Mg.
" Prescribed dose" means:
1 9-1.
For gamma stereotactic radiosurgery, the total dose as documented in the 10 written directive; 11 2.
For teletherapy, the total dose and dose per fraction as documented in the
'12 written directive; or 13 3.
For brachytherapy, either the total source strength and exposure time or the 14' total dose, as documented in the written directive.
15 NR.
" Recordable event" means the administration of:
16 1.
A radiopharmee#ical or radiation without a written directive where a written 17
~ directive is required; J
18 2.
A radiopharmaceutical or radiation where a written directive is required 19 without daily recording of each administered radiopharmaceutical dosage or radiation dose in the 20-
. appropriate record; 22 3.
A radiopharmaceutical dosage greater than 30 microcuries (1.11 MBq) of either 23 sodium iodide I-125 or I-131 when both:
24 a.
'Ibe administered dosage differs from the prescribed dosage by more 25 than 10 percent of the prescribed dosage; and
.26-
.27
- b.
Ibe difference between the administered dosage and prescribed dosage 28' exceeds 15 microcuriet.
I 20 NMAC 3.1 7-8 Revision Date i
I L
s
- 1 4.
A therapeutic radiopharmaceutical dosage, other than sodium iodide 1-125 or 2
1-131, when the administered dosage differs from the prescribed dosage by more than 10 percent of 3-the prescribed dosage; 4
5.
A teletherapy radiation dose when the calculated weekly administered dose is 5
15 percen; gee;;r ien aussues the weekly prescribed dose 415 passent or more of the weekly 6
pe===eaddams; or 7
6.
A brachytherapy radiation dose when the calculated administered dose differs 8
- from the prescribed dose by more than 10 percent of the prescribed dose.
9 Og.
" Teletherapy" means therapeutic irradiation in which the source of radiation is at a 10 distance from the body.
I1 PS.
" Teletherapy Physicist" means an individual identified as the qualified teletherapy 12 physicist on a Department license.
13 Q.
"Vi;Yng sici~d u;;r" racea; r.n c.uierisd user r.te is ne; iden;!fied en i; 14 iicene; cf1;licenea being sided.
15 RS.
" Written directive" means an order in writing for a specific patient or bassem seseasob 16 smW, dated and signed by an authorized user prior to the administration of a radiopharmaceutical 17_
or radiation, except as specified in paragraph (6) of this definition, containing the following 18 information:
19 1.
For any administration of quantities tgeater than 30 microcuries (1.11 MBq) 20 of either sodium iodide I-125 or I-131: the dosage; 21
'22 2.
For a therapeutic administration of a radiopharma:eutical other than sodium 23-iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration; 24
^ -3.
For gamma stereotactic radiosurgery: target coordinates, collimator size, plug 25 pattem, and total dose;
-26 4.
For teletherapy: the total dose, dose per fraction, treatment site, and overall 27 treatment period;
)
28' 5.
For high-dose rate remote afterloading brachytherapy: the radioisotope, I
29-treatment site, and total dose; or
{
30 6.
For all other brachytherapy:
~
20 NMAC 3.1 7-9 Revision Date i
A
FY lp t
l-
- 1 a.
Prior to implantation: the radioisotope, number of sources, and source 2
strengths; and 3
b.
After implantation but prior to completion of the procedure: the -
!~
4 radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total 5
dose).
I I
20 NMAC 3.1 7-10 Revision Date
.g
=
s 1
SUBPART 7 2
MEDICAL USE OF RADIONUCLIDES 3
700.
GENERAL REGULATORY REQUIREMENTS.
4 A.
Purpose and Scope. This Subpart establishes requirements and provisions for the 5
preparation and use ofradionuclides in the healing arts and for issuance oflicenses authorizing the 6
medical use of this material. These requirements and provisions provide for the protection of the 7
public health and safety. The requirements and provisions of this Subpart are in addition to, and not 8
in substitution w others in these regulations. The requirements and provisions of these regulations 9
apply to applicants and licenses subject to this Subpart unless speci5cally exempted. Other federal, 10 state or local regulations may apply.
11 g
12 13 suppenbu%
~
ist 14 lies.
s 3ef4 15 16 17 18 6
19 20 21 J-22 6
23 BD.
License required.
24 1.
No 3 person shall 3 manufacture, produce, acquire, receive, possess, use, 25 or transfer radioactive material for medical use except in accordance with a specific license issued 26:
by e-
- to he Esdotions-r 27 2.
Unless prohibited by license condition, an individual may receive, possess, 28 use, or transfer radioactive material in accordance with the regulations in this subpart under the 29 supervision of an authorized user as provided in 6702E.
l 30 g
31 32 I
20 NMAC 3.1 71 Revisien Date
n.
l
.I E-AMIUWWW$ammpues 2
3
- Ang!du(lue$uties, only the 3
6.
M-ia a mannoal 4
66 5
g l
6 in (.-
i T. p l
7 A.
)
8 4
9 10 g
11 in W in 12 13 ND appernate as g i
14 intesteg l
l 15 g
i 16 l
l 17 g
18 g,g l
19 GE.
License Amendments. A licensee shall apply for 3f./2 + 2de.E tent:
3s.13. Zo* A 20 1.
Before using radioactive material {3ss./ - 7006 3f.,f. m #
. cal use not 21 permitted by the license issued under this Subpart; 22 2.
Before permitting anyonc, caces work as an 23 authorized user M under the lic64is:
i 24 g
in {712.C.,
25 6
26 E
27 6
28 g-29 es 30 20 NMAC 3.1 7-2 Revision Date
.u 1
N.tetral$ades(4ppppuneensised maalear phannacist 2
on a spesiScitosenes st3ugestgespentto asthunned to pennit the 3
useofM6espdioal,useerinthopensessf ' __,f - =y,respectively.
4 3.
Before changing a Radiation Safety Officer or Teletherapy Physicist; 5
4.
Before receiving radioactive material in excess of the amount authorized on 6
the license; 7
5.
Before adding to or changing the areas of use or address or addresses of use 8
identified in the application or on the license; and 9
6.
Before changing statements, representations, and procedures which are 10 incorporated into the license.
I1 95.
Notifications. A 'icer.ex dat actif ic Ocp...ca:in w.. c.; sciila 30 days ;< hen f
12 an auieriud usc, I':Aktion Safe:y Of"ccr, er Tcicthe. yy I'hysicie;, F....encady dieccadauca 13 F;fera.r.nu ef dude; undc; ;he lianec.
14 15 16 or 17 18 3
19 3
20 As hoonse 21 6
22 3
23 3
. A to the 24 25 g
26 27 g
M 28 3
29, 20 NMAC 3.1 7-3 Revision Date i
9 I
k I
I.
l70$E.Ij!Ebd i
2 4
M& Apr an auenommed user or au maharized nuclear 3
pharuneelsk i
e, I
20 NMAC 3.1 7-4 Revision Date l
l
j 4
1 I
(6)
Taking emergency action ifcontrol of radioactive material is l
2
. lost;.
' 3'-
(7)
Performing periodic radiation surveys; 4
i 5
(8)
Performing checks and calibrations ofsurvey instruments and l
6
- other safety equipment; 7
(9)
Disposing of radioactive material; -
8 1
9 (10)
Training personnel who work in or frequent areas where
{
1 10
- ~adioactive material is used or stored; and 11 (11)
Keeping a copy of all records and reports required by the 12 Department regulations, a copy of these regulations, a copy ofeach licensing request and license and 13 amendments, and the written policy and procedures required by the regulations; and
.14 c.
For medical use not sited at a medical institution,' approve or L
15 disapprove radiation safety program changes with the advice and consent of management prior to 16-submittal to the Department for licensing action; or 17~
d.
For medical use sited at a medical institution, assist the Radiation 18-Safety Committee in the performance ofits 'dutiesi 19 -
C.
Radiation Safety Committee. Each medical institution licensee shall establish a
-20 Radiation Safety Committee to oversee the use of radioactive material.
21'
'l.
The Committee shall meet the following administrative requirements; 22-a.
Membership must consist ofat least three individuals and shall include l:
23 an authorized user of each type of use permitted by the license, the Radiation Safety Officer, ~a 24 representative'of the nursing service, and a representative of management who is neither an 25 authorized user nor a Radiation Safety Officer. Other members may be included as the licensee 26 deems appropriate; 27 28.
b.
The Committee shall meet at least once each calendar quarter; l1 29 c.
, To establish a quorum and to conduct business, one-half of the L
L30' Committee's' membership shall be present, including the Radiation Safety Officer and the
'31 management's representative.
l-
~
32 d.
The minutes of each Radiation Safety Committee meeting shall 4
33-include:
20 NMAC 3.1 7-11 Revision Date j-L
4 1
(1)
The date of the meeting; 2
(2)
Members present; 3
(3)
Members absent; l
i 4
(4)
Summary of deliberations and discussions; l
5-1 6
(5)
Recommended actions and the numerical results of all ballots; 7
and 8
(6)
Document any reviews required in ALARA Program 9.
Reviews; 10
- 11 e.
The Committee must promptly provide each member with a copy of 12 the meeting minutes, and retain one copy for the duration of the license.
13 2.
To oversee the use oflicensed material, the Committee shall:
l l
14' a.
Be responsible for monitoring the institutional program to maintain 15 occupational doses as low as reasonably achievable; 16 b.
W Review, on the basis of safety and with regard to the training 17 and experience standards of this Subpart, and approve or' disapprove any individual who is to be 18 listed as an authorized user,6 the Radiation Safety Officer, or a 19 Teletherapy Physicist before submitting a license application or request for amendment or renewal; 20 or 21.
g 36ofthe boant 22 any 23
? '
/;
. anoiear 24 M
25 c.
Review on the basis of safety and approve or disapprove each 26-proposed method of use of radioactive material; i
27 d.
Review on the basis of safety, and appmve with the advice and consent 28 of the Radiation Safety Officer and the management representative, or disapprove procedures and l
~29
. radiation safety program changes prior to submittal to the Department for licensing action;
.-30 e.
Review quarterly, with the assistance of the Radiation Safety Officer, j
31 occupational radiation exposure records of all personnel working with radioactive material; j
l l
20 NMAC 3.1 7-12 Revision Date l
l i
L
l.
1-f.
Review quarterly, with the assistance of the Radiation Safety Officer, 2
all incidents involving radioactive material with respect to cause and subsequent actions taken; 3
~4 g.
Review annually, with the assistance of the Radiation Safety Officer, 5
the radioactive material program; and 6
h.
Establish a table ofinvestigational levels for occupational dose tiat, 7'-
= when exceeded, will initiate investigations and considerations of action by the Radiation Safety 8'
Officer.
l L
'9 D.
Statement of Authorities and Responsibilities 10 1.
A licensee shall pmvide sufficient authority and organizational freedom to the 11_
Radiation Safety Officer and the Radiation Safety Committee to:
12 a.
Identify radiation safety problems;
,:13-
- b.
Initiate, recommend, or provide solutions; and 14 15 c.
Verify implementation of corrective actions.
16 17 2.
A licensee shall establish in writing the authorities, duties, responsibilities, 12 and radiation safety activities of the Radiation Safety Officer and the Radiation Safety Committee.
g 19 20 E.
Supervision 21 1.
A licensee that permits the receipt, possession, use, or transfer of radioactive 22 material by an individus.1 under the supervision of an authorized user shall:
23
. a.
Instruct the supervised individual in the principles of radiation safety 24 appropriate to the individual's use of radioactive material and in the licensee's written quality 25 management 1xogram; 26,
~27 b.
Require the supervised individual to follow the instructions of the 28 supervising authorized user, follow the written radiation safety and quality management procedures 29 established by the licensee, and cornply with the regulations of this Subpart and the license 30 conditions with respect to the use of radioactive material; and
.31 c.
. Periodically review the supervised individual's use of radioactive
- 32 material and the records kept to reflect this use.
l
- 20 NMAC 3.1 7 13 Revision Date
- i
i.
l
.I 2
Ahtbaguessence of bypsedmet mehuial for medical use 2
byat pbesuppet erpigsicianwho is an 3
4 g
p j
5 6
. L w;
7 g
l 8
s gggggurand l'
9 6
i 10 g
erphysician 11 M esit patams 12 to 3
M l
13 28.
A licensee who supervises an individual is responsible for the acts and i
14 omissions of the supervised individual.
15 F.
Quality Management Prog.am.
4 l
16 1.
Each applicant or licensee under this Subpart, as applicable, shall establish 17 and maintain a written quality management program to provide high confidence that radioactive 18 material or radiation from radioactive material will be administered as directed by the authorized l
19 user. The quality management program must include written policies and procedures to meet the 20 following specific objectives:
21 a.
that, prior to administration, a written directive (see NOTE 1 on the l
22 following page)is prepared for:
l 23 (1) any teletherapy radiation dose; t
24 (2)
Any gamma stereotactic radiosurgery radiation dose; 25 (3)
Any brachytherapy radiation dose; l
26 (4)
Any administration of quantities greater than 30 microcuries 27 (1.11MBq) of either sodium iodide I-125 or I-131; or
.28 (5)
Any therapeutic administration of a radiopharmaceutical, other 29 than sodium iodide I-125 orI-131; 20 NMAC 3.1 7-14 Revision Date t
l
.I NOTE 1:
2 If, because of the patient's condition, a delay in order to provide a written revision to an existing 3
written directive would jeopardize the patient's health, an oral revision to an existing written 4
directive will be acceptable, provided that the oral revision is documented immediately in the 5
patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of 6
the oral revision.
l 7.
Also, a written revision to an existing written directive may be made for any diagnostic or 8
therapeutic procedure provided that the revision is dated and signed by an authorized user prior to 9
the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma 10 stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.
I1 If, because of the emergent nature of the patient's condition, a delay in order to provide a written 12 directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the 13 information contained in the oral directive is documented inunediately in the patient's record and a 14 written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
15 b.
That, prior to each administration, the patient's N 16 a6 identity is verified by more than one method as the individual named in the written 17 directive; 18 c.
That final plans of treatment and related calculations for 19 brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the 20 respective written directives; 21 d.
That each admmistration is in accordance with the written directive; 22 and 23 c.
That any unintended deviation from the written directive is identified 24 and evaluated, and appropriate action is taken.
25 26 2.
The licensee shall:
27 a.
Develop procedures for and conduct a review of the quality 28 management pmgram including, since the last review, an evaluation of:
29 (1)
A representative sample cfpatient M 30 administrations; 31 (2)
All recordable events; and l-20 NMAC 3.1 7-15 Revision Date t
e
[
t.
in.
1-(3)-
All misadministration to verify compliance with all aspects i.
b 2
- of the quality management program; these reviews shall be conducted at intervals no greater than
. 3
' 12 months.
p i
t i
L l
f.
f l
1
?
20 NMAC 3,1 7-16 Revision Date 1
I
t
- 2 g
m 3
g 4
-nolatereten 5
g derssement within 6
15 5Nissende the lisensee's 7
asumes ans event sesumed; 8
assmoeded 9
10
+
11 12 13 14 15 g
16 17 18 19 20
. a4pemmihw 21 22 Mi...
e s
23 24 6
25 g
~
26 27 g
28 29 3
30 31
~
to 32-33 3
. ; yees.
34 35 diet 36 20 NMAC 3.1 7-17 Revision Date
d s
3 i
l i
1 se l
l 20 NMAC 3.1 7-18 Revision Date
{
I
t 1
l 6
1
!o l
- 1 4
Records ofall miadministrations. Each licensee shall maintain for Department i
2 inspection, for 5 years, records of all misadministration of radiopharmaceuticals or radiation from I
3 teletherapy or brachytherapy sources. These records shall contain the names of all individuals l
4 involved in the event (including the physician, allied health personnel, the patient, and the patient's l
5 referring physician), the patient's social security number, a brief description of the event, the effect 6
on the patient, and the action taken to prevent recurrence.
I 7
5.
Rights and duties oflicensees Aside from the notification requirement, 8
nothing in this section shall affect any rights or duties oflicensees and physicians in relatian to each 9
other, patient or responsible relatives (or guardians).
10 H.
Suppliers 's...
i A licensee may use for l'
11 medical use only:
i 12 1.
Radiagn e m i i.1 manufactured, labeled, 13 packaged, and distributed in accordance with a license issued pursuant to these regulations or the 14 equivalent regulations of another Agreement State, a Licensing State or the NRC; I5 2.
"e-gent kii. :L; l-ve t~c.ii u-I-mimi, i.baJ, pK'% ei,.ud di.hi'ur. red 16 in,kwid.uw win..u.pyie.I h-+i by de U.S. Tved.ud Diog Adniden.iion (FDA);1md 17 3l.
Teletherapy sources manufactured and distributed in accordance with alicense 18 issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a 19 Licensing State, or the NRC.
l 20 I.
Mobile Nuclear Medicine Service.
21 1.
The Department will license mobile nuclear medicine services in accordance l
l 22 with this Subpart and other applicable requirements of these regulations.
23 2.
Mobile nuclear medicine service licensees shall obtain a letter signed by the l
24 managementpfeach client for which services are rendered that authorizes use ofradioactive material l
25 at the client's address of use. The mobile nuclear medicine service licensee shall retain the ic:ter for 26 three years after the last provision of service.
l 27 3.
If a mobile nuclear medicine service provides services that the client is also 28 authorized to provide, the client is responsible for assuring that services are conducted in accordance
-29 with the regulations in this Subpart while the mobile nuclear medicine service is under the client's 30 direction.
31 4.
A mobile nuclear medicine service shali not have radioactive material delivered 32 directly from the manufacturer or the distributor to the client's address of use.
20 NMAC 3.1 7-19 Revision Date i
A c
I L
- 1 703.
GENERAL TECHNICAL REQUIREMENTS. Quality Control ofDiagnostic Equipment 2
Each licensee shall establish written quality control procedures for all diagnostic equipment used for 3
radionuclides studies. As a minimum quality control procedures and frequencies shall be those 4
recommended by equipment manufacturers or procedures which have been approved by the j
-5 Dersio.cr.:. The licensee shall conduct quality control procedures in accordance with written 6-procedures.
7 A..
Possession, Use, Calibration, and Check ofDose Calibrators. A medical use licensee 8
authorized to administer radiopharmaceuticals shall a dose calibrator and use it to measure l
9-the w.ui of activity administered l
-10 to each patient o 11 1.
Alicensee shall:
3s.r0. 23J Ic.
12 a.
Check each dose calibrator for consta 13 source at the != ginning ofeach day ofuse. To satisfy the requirements c 73,( 9, g,
)
j 14-be done on a frequently used setting with a sealed source ofnot less tha p 4,j,. g fr*J l
15 of radann-226 or 50 microcuries (1.85 MBq) of any other photon-emitt 67-T 16 1 ar e= Ces ^~^ i.-i,
i 17' b.
Test each dose calibrator for accuracy upon installation and at intervals 18 not to exceed 12 months thereafter oy assaying at least 2 sealed sources containing different 19-radionuclides, the activity ofwhich the manufacturer has determined within 5 percent of the stated l
20 activity, with minimum activity of10 microcuries (370 kBq) for radium-226 and 50 microcuries (1.85 21 MBq) for any other photon-emitting radionuclides, and at least one of which has a principal photon 22 energy between 100 kev and 500 kev; 23 24 c.
Test each dose calibrator for linearity upon installation and at intervals 25 not to exceed 3 months thereafter over ofuse between 30 microcaries (1.11 MBq) and the 26.
higher.. dosage that will be administered
- and 27 d.
Test each dose calibrator for geometry dependenca upon installation
.s 28 over the range of volumes and vohnne configurations for which it will be used. '1he licensee shall 29 keep a record of this test for the duration of the use of the dose calibrator.
L 30 2.
A licensee shall mathematically correct dosage readings for any geometry or 31 linearity error that exceeds 10 percent ifthe dosage is greater than 10 microcuries (370 kBq) and shall 32 repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.
33 3.
A licensee shall also perform checks and tests required by this section 34 following adjustment or repair of the dose calibrator.
9 20 NMAC 3.1 7-20 Revision Date
)
^
i i~ '
~ l 4.
A licensee shall retain a record of each check and test required by {703 for 3 2
years. The records required shallinclude:
3 a.
For Subparagraph 1.a., the model and serial number of the dose 4
calibrator, the identity and calibrated activity of the radionuclides contained in the check source, the 5
date ofthe check, the activity measured, the instrument settings, and the initials ofthe individual who
(
6 performed the check; 7
b.
For Subparagraph 1.b., the model and serial number of the dose 8
calibrator, the model and serial number of each source used, and the identity of the radionuclides 9
contained in the source and its activity, the date of the test, the results of the test, the instrument 10 settings, and the initials E of the individual who performed the test; 1
11 c.
For Subparagraph 1.c. the model and serial number of the dose 12 calibrator, the calculated activities, :he measured activities, the date ofthe test, and the initials E 13 of the individual who performed the test; and 14 d.
For Subparagraph 1.d. the model and serial number of the dose I
15 calibrator, the configuration i d dl,r.ie Ki;vity ofthe source measured, t!w EGviiy ufi!w www, 16 the activity measured ord t!w irmirm.-.i mdug for each volume measured, the date of the test, and 17 the imtrais El of the individual who performed the test.
l I
I 20 NMAC 3.1 7-21 Revision Date
~.
4
- 1 5.
The licensee shall retain a record of each calibration for 3 years. The record 2
shallinclude:
1 3
a.
A description of the calibration procedure; 4
b.
A description of the source used and the certified dose rates from the 5
source, ;nd the rates indicated by the instrument being calibrated, the correction factors deduced 6
from the calibration data, the signature of the individual who performed the calibration, and the date 7
ofcalibration; and 8
c.
The licensee shall obtain the services ofindividuals certified by the 9
Department to perform calibrations of survey instruments. Records of calibrations which contain 10 information required by Paragraph B.5 shall be maintained by the licensee.
I1 Bosqys e(
12 13 4,
6My6, atha W andning 14 W pquamuut W $M S.O ar 15 16 3
17 m.
l,hm 18 rShs 19 20 ete 21 22 g
a 23 aus eN 24 s..
25 3
at the 26 6
27 q.
Te m-xx; ef radiept_...:.ca::ce dea,a, e liaar.ec 2.r. :: p of 28 e
A licensee shall:
-29 l
30 1.
Measur,kJa;u.edice:eac,theactivityofeach;;.diept
- ~
- ice dosage 31 0.e: a./
mee O.ea 10 misc ~ is G70 W of a photon-emitting radionuclides M 32 m
33 h
20 NMAC 3.1 7-22 Revision Date m
0 1
2.
Measure tcforc acdical use,$gldingsnaampasset or by combination of I
2 6 the activity of each radiophannaccu:ical dosage wie a dc2 ired 3
ac:ivity of 10 micreed.c3 (370 kOq) cr cs3 cf a pho:ca-cmi::ing radicauclide :c verify the: thc 4
dosage decs as; cxcc~d 10 micrecurica (370 kOq) of anhar a M H*: radionuclides prior 5
to medentMMAdshpedhypopasarMoonsed ymsuant 6
to $315;G er6 _m 7
3.
Retain a record of the measurements required by this section for 3 years. To I
8 satisfy this requirement, the record shall contain the:
9 a.
Generic name, trade name, or abbreviation of the radiopharmaceutical, 10 its lot number, and expiration dates and the radionuclides; 11 b.
Patient's M name, and identification number k
i 12 ifone has been assigned; 13 c.
Prescribed dosage and activity of the dosage at the time of 14 measurement, or a notation that the total activity is less than M N microcuries (390 hBq Liang);
15 d.
Date and time of the measurement and administration; sad 16 Initials of the individual who performed the measuremen,t.,
e.
17 Dg.
Authorization for Calibration and Reference Sources. Any person authorized by 18 Subpart 3 of these regulations for medical use ofradioactive material may receive, possess, and use 19 the following radioactive material for check, calibration and reference use:
30 1.
Scaled sources manufactured and distributed by persons specifically licensed 21 pursuant to Subpart 3 of these regulations or equivalent provisions of the NRC, or other Agreement 22 State and that do not exceed 15 millicuries (555 MBq) each; o
23
- 2.
Any radioactive material listed in schedule C, Subpart 3 of these regulations 24 with a half-life of 100 days or less in individual amounts not to exceed 15 millicuries (555 MBq);
25 3.
Any radioactive material listed in schedule C, Subpart 3 of these regulations 26 with a half-life gmater than 100 days in individual amounts not to exceed 200 micmcuries (7.4 MBq) 27 cach; and 28 4.
Technetium-99m in individual amounts not to exceed 50 millicuries (1.85 29 GBq).
30 Eg.
Requirements for Possession of Scaled Sources and Brachytherapy Sources.
20 NMAC 3.I' 7-23 Revision Date
s
.a -
1
- 1 1.
A licensee in possession of any sealed source or brachytherapy source shall
]
2 follow the radiation safety and handling instructions supplied by the manufacturer and shall maintain
.3 the instructions for the duration ofsource use in a legible form c.onvenient to users.
4 2.
A licensee in possession of a sealed source shall assure that:
5 a.
The source is tested for leakage before its first use unless the licensee
- 6 has a certificate from the supplier indicating that the source was tested within 6 months before 7
. transfer to the licensee; and L
8 b.
The source is tested for leakage at intervals not to exceed 6 months f
9 or at intervals approved by the Department.
i 10 3.
To satisfy the leak test requirements of this section, the licensee must:
j 11-a.
Take a wipe sample from the sealed source or from the surfaces of the 12 device in which the sealed source is mounted or stored on which radioactive contamination might j
13 be expected to accumulate, or wash the source in a small volume of detergent solution and treat the
{
14 entire volume as the sample-l 1
15 b.
Take teletherapy and other device source test samples when the source
~16 is in the "off' position; and Measure the sample so that the leakage test can detect the presence of
)
17
- c, 18 0.005 microcurie (185 Bq) of radioactive material on the sample.
19 4.
A licensee shall retain leakage test records for five years. The records must 20 contain the model number, and serial number if assigned, of each source tested, the identity of each ; source radionuclides and its estimated activity, the measured activity of each test sample expressed 32 in microcuries, a description of the method used to measure each test sample, the date of the test, and t
. - 23 the signature of the Radiation Safety Officer.
24 5.
. If the leakage test reveals the presence of 0.005 microcurie (185 Bq) or more 25 of removable contamination, the licensee shall:
26 t.
Immediately withdraw the sealed source from use and cause it to be 27
' decontaminated and repaired or disposed ofin accordance with these regulations.
. 28;
- b. '
File a report within five dsys of the leakage test with the Department
-29 describing the equipment involved, the test results and the action taken.
30-
' 6.'
A licensee need not perform a leakage test on the following sources; 20 NMAC 3.1 7-24 Revision Date
.a.--.-.a
s 1
- I Sources containing only radioactive material with a half-life ofless a.
2 than 30 days; 3
b.
Sources containing only radioactive material as a gas; 4
c.
Sources containing 100 microcuries (3.7 MBq) or less of beta or 5
gamma-emitting mateiial or 10 microcuries (370 kBq) or less of alpha-emitting material; 6
d.
Sources stored and not being used. The licensee shall, however, test 7
each such source for leakage before any use or transfer unless it has been leakage tested within six 8
months before the date of use or transfer; and 9.
e.
Seeds ofiridium-192 encased in nylon ribbon.
10 7.
A licensee in possession of a sealed source or brachytherapy source shall 11 conduct a quarterly physical inventory of all such sources in its possession. The licensees shall 12 retain each inventory record for five years. The inventory records must contain the model number 13 of each source, and serial number ifone has been assigned, the identity of each source radionuclides
)
14 and its nominal activity, the location of each source, and the signature of the Radiation Safety i
15.
Officer.
{
I 16 8.
A licensee in possession of a sealed source or brachytherapy source shall 17 measure the ambient dose rates quarterly in all areas where such sources are stored. This does not 18 apply to teletherapy sources in teletrugy units or sealed sources in diagnostic devices.
19-9.
A licensee shall retain a recorti of each survey required in paragraph 8 of this 20 section for three years. The record must include the date of the survey, a plan of each area that was 21 surveyed, the measured dose rate at several points in each area expressed in millirem ( Sv) per hour, 22 the survey instrument used, and the signature of the Radiation Safety OfEcer.
23 F$.
Syringe Shields and Labels.
24 1.
A licensee shall keep syringes that contain radioactive material to be 25 administered in a radiation shield.
l 26 2.
To identify its contents, a licensee shall conspicuously label each syringe, or 27 syringe radiation shield that contains a syringe with a radioplwmaceutical. The label must show the 28 radiopharmmtical name or its abbreviation, the clinical procedure to be performed, or the patient's l
29 6 name.
l l
30-3.
A licensee shall require each individual who prepares a radiopharmaceutical l
31 kit to use a syringe radiation shield when preparing the kit and shall require each individual to use i
1 l
20 NMAC 3.1 7-25 Revision Date I
u
lx h
.I a synnge radiation shield when administering a radiopharmaceutical by injection unless the use of j
2-the shield is contraindicated for that patient or 6 L
3 GE.
Vial Shields and Labels.
'4 1.
A licensee shall require each individual preparing or handling a vial that
.5 contains a radiopharmaceutical to keep the vial in a vial radiation shield.
- 6
- 2.
To identify its contents, a licensee shall conspicuously label each vial 7:
radiation shield that contains a vial of a radiopharmaceutical. The label must show the i
- 8:
radiopharmaceutical name or its abbreviation.
9-Hl.
Surveys for Contamination and Ambient Radiation Exposure Rate.
10 1.
A licensee shall survey with a radiation detection survey instmment at the end l
11 of each day of use all areas where radiopharmaceuticals are routinely prepared for use or L
12 administered.
I 13 2.
A licensee shall survey with a radiation detection survey instmment at least l
.14 once each week all areas where radiopharmaceuticals or radioactive wastes are stored.
l 15
- 3.
A licensec shall conduct the surveys required by paragraphs 1 and 2 so as to i=
'16
' be able to measure dose rates as low as 0.1 millirem (1 pSv) per hour.
i
..'17 4.
A licensee shall establish dose rate action levels for the surveys required by t
18
. Paragraphs 1 and 2 and shall require that the individual performing the survey immediately notify 19
. the Radiation Safety Officer if a dose rate exceeds an action level.
l l
20
. 5.
A licensee shall survey for rcmovable contamination each day of use all areas 21-where radiophannaceuticals are routinely prepared for use or administemd and each week where 22
< radioactive materials are stored.
23 6.
A licensee shall conduct the surveys required by Paragraph 5 so as to be able 24 to detect contamination on each wipe sample of 2000 disintegrations per minute (33.3 Bq).
)
[
25-7.
A-licensee shall establish removable contamination action levels for the 26 surveys required by Paragraph 5 and shall require that the individual performing the survey 27; imMately notify the Radiation Safety Officer if contamination exceeds action levels.
)
5 28 8.
A licensee shall retain a record of each survey required by Paragraph 1,2 and l
29:
5 for 3 years. The record must include the date of the survey, a sketch of each area' surveyed, action
-30:
' levels established for each area, the measured dose rate at several points in each area expressed in 31
. millirems (microsieverts) per hour or the removable contamination in each area expressed in
)
20 NMAC 3.1 7-26 Revision Date
3 disintegrations per minute (becquerels) per 100 square centimeters, the serial number and the model 1
2 number of the instrument used to make the survey or analyze the samples, and the initials of the 3
individual who perfonned the survey.
4 H.
Release of";;icn:o IndivWanla Containing Radiopharmaceuticals or Permanent 5
Implants.
6 1.
.. licensa shal: r.e: r.eieria rc:cesc ne... cordincmen; for medice cerc eny
^
pe:!ca;erh ar.n tr=-eh autja:
'r' Mer.d e albph n.ecca: ice un;il lics. Wany 7
8 9
s, r.
/-
10
..f M en 11 6
12 M
13 14 t
i 15 e.
The dex m;c ne... ic pe:icr.: er a h n;r.a scuch ;ubja is bas ien l
16 5 mil'i...as (50 pSv) per hour et e di;;er.a of 1 meter, or
{
17 h.
n.c ac ;vity in :hc pe:!ca er human rcecemh subja; is ics; i 30 18
_._ I.t t !._. _* _ _ / te.11#_"9 n _y\\.,J i
19 c.
The desc 1.J:s in iis aa:ba tr,kc y.eceder.cc cycr ic lim;;3 20 um..e.r.w... p. i v4.rt.._5'***S'***********
J-__,
_J_
- est, 1
21 2.
,A, 1 '
._2 t as au
._..I.cesc,re... ce e=no.er me.J.'.1. cerc aey j
L t 4
it e
ir
... = - -
22 pe !;,n; er hx= n mes.sh subjec; 'r';Mered a p...ancr.: in.pir.; un'd ic de;c re:c Sen. ic 23 petica:is Icea i= 5 mi'L
.s (50 Sv)pa hour et e d!.; cc ofI me:
6 24 i
25 Jose 26 to a 27 tusse ao 28 i
29 5
" and 30 3
31 3
32 33 -
6 20 NMAC 3.1 7-27 Revision Date
9
'I g
qm, 2
g i,,,,,,
3 g
7,,.
,4 4
%geNAssus.
5 g
yni
, gag 6
i L.
gas, _
7 L
8 M
i 9
35 Mobile Nuclear Medicine Service Technical Requirements. A licensee providing
{
10 mobile nuclear medicine service shall:
I1 1.
Transport to each address of use only syringes or vials containing prepared
{
12 radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of J
13 radiopharmaceutical kits; j
14 2.
Bring into each location of use all radioactive material to be used and, before 15 leaving, remove all unused radioactive material and associated radioactive waste; 16 3.
Secure or keep under constant surveillance and immediate control all 17 radioactive material when in transit or at a location of use;
-18 4.
Check survey instruments and dose calibrators as required in Q703. A.1 a.,
19 A.3, A.4, and B.4 and check all other transported equipment for pnper function before medical use 20 at each location ofuse; 21 5.
Carry a calibrated survey meter in each vehicle that is being used to transport 2.2 radioactive ' material, and, before leaving a client location of use, survey all areas of 23 radiopharmaceutical use with a radiation detection survey instrument to ensure that all 24 radiopharmaceuticals and all associated radioactive waste have been removed; and 25 6.
Retain a record of each survey required by Paragraph $ for 3 years. The 26 record must include the date of the survey, a plan of each area that was surveyed, the measured dose l
27 rate at several points in each area of use expressed in millirems (microsieverts) per hour, the model l
28 and serial number of the instrument used to make the survey, and the initials of the individual who 29 performed the survey.
'30 Fcg.-
Storage of Volatiles and Gases.
20 NMAC 3.1 7-28 Revision Date
s
.I 1.
A license shall store volatile radiopharmaceuticals and radioactive gases in
- 2 the shipper's radiation shield and container.
3 2.
A license shall store and use a multidose container in properly functioning 4
fumehood.
q
)
5 LM.
Decay-in-Storage.
{
l f
,6-1.
A licensee shall hold radioactive material for decay-in-storage before disposal 7_
in ordinary trash and is exempt from the requirements of Subpart 4 of these regulations if the l'
-8 licensee:
L 9i Holds radioactive material for decay a minimum of 10 half-lives; a.
s10 b.
Monitors radioactive material at the container surface before disposal g
11 as ordinary trash and de-mi-that its radioactivity cannot be distinguished from the background I
12-radiation level with a radiation detection survey instmment set on its most sensitive scale and with I
13--
no interposed shielding; Monitoring Procedures must be approved by the Department;
{
l
'14 c.
Removes or obliterates all radiation labels; and L
l.
15 d.
Separates and monitors each generator column individually with all 16 radiation shielding removed to ensure that its contents have decayed to background radiation level
[
'17, before disposal.
l 18 2.
For radioactive material disposed in accordance with Paragraph I the licensee 19
. shall retain a record ofeach disposal for 3 years. The record must include the date of the disposal,
-20 the date on which the radioactive material was placed in storage, the radionuclides disposed, the 21 model and serial number of the survey instrument used, the background dose rate, the radiation dose 22-rate measured at the surface of each waste container, and the name of the individual who perfonned
~
23-the disposal.'
g
- /.
24 MW. Possession of Survey Instrument.
L 25 1.
A licensee authorized to use radioactive material for uptake, dilution and 26 excretion studies shall possess a portable radiation detection survey instrument capable of detecting L
L 27-dose rates over the range 0.1 millirem (gSv) per hour to 100 millirem (1 mSv) per hour.
~ 28' i 2.
A licensee authorized to use radioactive material for imaging and localization 29
. studies, radiopharm
_M therapy or implant therapy shall possess'a portable radiation detection 30' survey instmment capable of 4 Mag dose rates over the range of 0.1 millirem (1 pSv) per hour 31 to 100 millirem (1 mSv) per hour and a portable radiation measurement survey instrument capable 4
.20 NMAC 3.1 ~
7-29 Revision Date 1
________._______._i_____.--
3 1
9 I
of measuring dose rates over the range 1 millirem (10 Sv) per hour to 1000 millirem (10 mSv) per 2-hour.
3-
-3.
. A licensee authorized to use radioactive material in a teletherapy unit shall possess'either a portable radiation detection survey instrument capable of_ detecting dose rates over
.. 4 5
the range of 0.1 millirem (1 uSv) per hour to 100 millirem (1 mSv) per hour or a portable radiation
' measurement survey instrument capable of measuring dose rates over the range 1 millirem (10 6
' 7 Sv)per hour to 1000 millirem (10 Sv) per hour.
)
b
- 20 NMAC 3.1 7-30 Revision Date
[
i
s
)
~~
c,,
1 5.
The licensee shall retain a record of each calibration for 3 years. The record 2
shallinclude:
i 3
a.
A description of the calibration procedure; 4
b.
A description of the source used and the certified dose rates from the 5
source, and the rates indicated by the instmment being calibrated, the correction factors deduced 6
from the calibration data, the signature of the individual who performed the calibration, and the date 7
of calibration; and t
8 c.
The licensee shall obtain the services ofindividuals certified by the 9
Department to perform calibrations of survey instruments. Records of calibrations which contain 10 information required by Paragraph B.5 shall be maintained by the licensee.
11 massges of t
i 12 W~ 6 13 g.
6#mW$mges4 hah audslag 14 mMpeggedgussmaat to pl5.G er 15 ageludsuB 6 16 3
17
~
gr 18 19
.20 21 yes j
1 22 3
23
-gfen 24 25 g
. N at the 26 6
)
27 Eg.
Te.r - -
. of ir.dieph...x;;;;;;! deng;;, a liccaa; ehe!!: M af 28 A licensee shall:
29 30 1.
Measm,t,1. medie :;;;,theactivityofeachideph...acneeldosage 31 ir.: ~.t
- n. mer; ir.; 10 m ;ra k; 070 kOq) of a photon-emitting radionuclides M J
32 g
33' 20 NMAC 3.1 7-22 Revision Date i
,v 1
2.
Measure tcfe.c nicdical use,3Gggesenspesset or by combination of 2-6 the activity of each rr.diophaisiesu:ic# dosage veis a dc;; red 3
ectiviri of 10 niisarica (370 k"O er kaa of a phe:enanii;;ing radienuclide to-verify ne; :hc 4
de;;ge deca ne; caad 10 reicecnica (370 k",$ a(@.or att -
^ :--g radionuclides prior 5
to sus deel m orguepasarlicensed pursuant 6
to $3t9A3 er, 7
3.
Retain a record of the measurements required by this section for 3 years. To 8
satisfy this requirement, the record shall contain the:
9 a.
Generic name, trade name, or abbreviation of the radiopharmaceutical, 10 its lot number, and expiration dates and the radionuclides; 11 b.
Patient's m name, and identification number 12 if one has been assigned; 13 c.
Prescribed dosage and activity of the dosage at the time of 14 measurement, or a notation that the total activity is less than M N microcuries (370 k"q L.1 MBq);
15 d.
Date and time of the measurement and administration; and 16 e.
Initials of the individual who performed the measurement.
i l
17 D5 Authorization for Calibration and Reference Sources. Any person authorized by l
18 Subpart 3 of these regulations for medical use of radioactive material may receive, possess, and use 19 the following radioactive material for check, calibration and reference use:
20 1.
Scaled sources manufactured and distributed by persons specifically licensed 4
21 pursuant to hubpart 3 of these regulations or equivalent provisions of the NRC, or other Agreement 22-State and that do not exceed 15 millicuries (555 MBq) each; 23
' 2.
Any radioactive material listed in schedule C, Subpart 3 of these regulations 24 with a half-life of 100 days or less in individual amounts not to exceed 15 millicuries (555 MBq);
25-3.
Any radioactive material listed in schedule C, bubpart 3 of these regulations 26 with a half-life greater than 100 days in individual amounts not to exceed 200 microcuries (7.4 MBq) 27-each; and 28-4.
Technetium-99m in individual amounts not to exceed 50 millicuries (1.85 29' GBq).
I 30 EE.
Requirements for Possession of Scaled Sources and Brachytherapy Sources.
t 20 NMAC 3.1 7-23 Revision Date I
i i
L__________
j
V 1
1.
A licensee in possession of any sealed source or brachytherapy source shall i~
2 follow the radiation safety and handling instmetions supplied by the manufacturer and shall maintain 3
the instructions for the duration of source use in a legible form convenient to users.
4 2.
A licensee in possession of a sealed source shall assure that:
J f
5 a.
The source is tested for leakage before its first use unless the licensee l
has a certificate from the supplier indicating that the source was tested within 6 months before 6
-7 transfer to the licensee; and 8
b.
The source is tested for leakage at intervals not to exceed 6 months l
9 or at intervals approved by the Department.
l 1
'10 3.
To satisfy the leak test requirements of this section, the licensee must:
11 a.
Take a wipe sample from the sealed source or from the surfaces of the 1
.12 device in which the sealed source is mounted or stored on which radioactive contamination might -
-13 be expected to accumulate, or wash the source in a small volume of detergent solution and treat the 14' entire volume as the sample; 15 b.
T ake teletherapy and other device source test samples when the source l
16.
- is in the "off' position; and 17' c.
Measure the sample so that the leakage test can detect the presence of 18 0.005 microcurie (185 Bq) of radioactive material on the sample.
t l'
19 4.
A licensee shall retain leakage test records for five years. The records must 20
- contain the model number, and serial number if assigned, of each source tested, the identity of each
~21 source radionuclides and its estimated activity, the measured activity of each test sample expressed 22 in microcuries, a description of the method used to measure each test sample, the date of the test, and 23 the signature of the Radiation Safety Officer.
24 5.
If the leakage test reveals the presence of 0.005 microcurie (185 Bq) or more 25
. of removable cordaminrkion, the licensee shall:
l 26 a.
Immediately withdraw the sealed source from ur,e and cause it to be
- 27-decontaminated and repaired or disposed ofin accordance with these regulations.
L
~ - 28 '-
' b.
File a report within five days of the leakage test with the Department 29,
' describing the equipment involved, the test results and the action taken.
30..
6.
A licensee need not perform a leakage test on the following sources;
' 20 NMAC 3.1
'7-24 Revision Date y
e i
l y
l I
a.
Sources containing only radioactive material with a half-life ofless 2
than 30 days; 3
b.
Sources containing only radioactive material as a gas; 4
c.
Sources containing 100 microcuries (3.7 MBq) or less of beta or 5
gamma-emitting material or 10 microcuries (370 kBq) or less of alpha-emitting material; 6
d.
Sources stored and not being used. The licensee shall, however, test i
7 each such source for leakage before any use or transfer unless it has been leakage tested within six 8
months before the date of use or transfer, and 9
e.
Seeds ofiridium-192 encased in nylon ribbon.
I 10 7.
A licensee in possession of a sealed source or brachytherapy source shall
.I1 conduct a quarterly physical inventory of all such sources in its possession. The licensees shall
'12 retain each inventory record for five years. The inventory records must contain the model number i
13 of each soume, and serial number if one has been assigned, the identity of each source radionuclides 14 and its nominal activity, the location of each source, and the signature of the Radiation Safety 15 Officer.
16 8.
A licensee in possession of a sealed source or brachytherapy source shall 17 measure the ambient dose rates quarterly in all areas where such sources are stored. This does not 18 apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
19 9.
A licensee shall retam a record ofeach survey required in paragraph 8 of this 20' section for three years. The record must include the date of the survey, a plan of each area that was 21 surveyed, the measured dose rate at several points in each area expressed in millirem ( Sv) per hour, 22 the survey instmment used, and the signature of the Radiation Safety Officer.
23 Fg.
. Syringe Shields and Labels.
24 1.
A licensee shall keep syringes that contain radioactive material to be 25 administered in a radiation shield.
l 26
- 2. _
To identify its contents, a licensee shall conspicuously label each syringe, or 27 syringe radiation shield that contains a syringe with a radiopharmaceutical. The label must show the 28 radiopharmaceutical name or its abbreviation, the clinical procedure to be performed, or the patient's 29 6 name.
f 30-3.
A licensee shall require each individual who prepares a radiopharmaceutical 31 kit to use a syringe radiation shield when preparing the kit and shall require each individual to use j
20 NMAC 3.1 7-25 Revision Date
)
lb
I ty l
1-a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of 2
the shield is contraindicated for that patient or
-3 GB.
Vial Shields and Labels.
i
~4' l.
A licensee shall require each individual preparing or handling a vial that i
i 5
contains a radiopharmaceutical to keep the vial in a vial radiation shield.
6 2.
To identify its contents, a licensee shall conspicuously label each vial 7
ruliation shield that contains a vial of a radiopharmaceutical. The label must show the
-8 radiopha:maceutica! vame or its abbreviation.
9 Hl.
Surveys for Contamination and Ambient Radiation Exposure Rate.
10 1.
'A licensee shall survey with a radiation detection survey instmment at the end l
11 of each day of use all areas where radiopharmaceuticals are routinely prepared for use or 12; administered.
13_
2.-
A licensee shall survey with a radiation detection survey instrument at least 14 once each week all areas where radiopharmaceuticals or radioactive wastes are stored.
(
15 3.
A licensee shall conduct the surveys required by paragraphs 1 and 2 so as to 16 be able to measure dose rates as low as 0.1 millirem (1 pSv) per hour.
17 4.
A licensee shall establish dose rate action levels for the surveys required by s
18 Paragraphs 1 and 2 and shall require that the individual performing the survey immediately notify 19-the Radiation Safety Officer if a dose rate er.ceeds an action level.
20 5.
A licensee shall survey for removable contamination each day of use all areas 21 where radiopharmaceuticals are routinely prepared for use or administered and each week where 22 radioactive materials are stored.
23 6.
A licensee shall conduct the surveys required by Paragraph 5 so as to be able 24' to detect contamination on each wipe sample of 2000 disintegrations per minute (33.3 Bq).
25 7.
A licensee shall establish removable contamination action levels for the
. 26..
surveys required by Paragraph 5 and shall require that the individual performing the survey-27 immediately notify the Radiation Safety Officer if contamination exceeds action levels.
.) 28 8.
' A licensee shall retain a record of each survey required by Paragraph 1,2 and 29 5 for 3 years. The record must include the date of the survey, a sketch of each area surveyed, action
'30 levels established for each area, the measured dose rate at several points in each area expressed in 31
- millirems (microsieverts) per hour or the removable contamination in each area expressed in 20 NMAC 3.1 7-26 Revision Date
V
'I disintegrations per minute (becquerels) per 100 square centimeters, the serial number and the model 2
number of the inttrument used to make the survey or analyze the samples, and the initials of the 3
individual who performed the survey.
l 4
H.
Release of a".s;;ca:s ludividuals Containing Radiopharmaceuticals or Permanent 5
Implants.
6 1.
A 'icenecc d. " se; euiesh rd== Ovssa corMacaca; for medicd casc any 7
__o
_ _ t. _ _ ___.
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. _ _..... _,. _..,..e _ _.
yestavan va an= =
N s wwvsmavas easyjwg e---
---.a wga - a ssuavyaasnasaasswwnsaswsma maassas wanaava.
8 6
m 9
mesgegungy s
10 m
JEsalyes 11 MM 12 M
g-13 M
~
14 W.
1 15 a a m mes, a s.~
- Um.t _ _., _., v_ _s _ t.._ _ _ _ _ _ _ _ m _ m _ _. 1._,m_._._.t._sa__a i
maw y.s.mo asaa--as - o.~;-..
.as 16
, _ !,,e
_ s e n.. c. A _ _ t. -.. _ _. _
21_. - _ _ _,,
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s assassaawasaa g.<v yv v f ywa aavua subsu usemanasww va a answnwa, vs__
17
,.t_
__._..:.:_.t__._.__,_..
__m_..t__.1.,___.t-__
,n v.
a asw ashta y any saa saaw yestawaab va aswasssasa a wswssawaa otsvjwwt sa abas aassnaa s v 18
_ !,, r _.. _* _ _ e.,.,a a, e
n_s.__;
usuuw.sa m. s
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_2____
.t., r_ :. _
we s aaw uvew asasas se us ba ss e aww ssvaa mesakw y& Wvtavaaww v v wa taab a assas se 20 t _ a !_
ca,,_r,_______
,_a___
uwwwa avvu ass p a s va maswww s wgwasssavase.
21 2e i.
m_,,__._.,_
4 & saw _--'"- a esassas savn ausstaava asA, a bsgemew ha vana vvassasawasawaan sva aaJvsaavana vena w smaay_..
y y..!__.
__t..___
t _..t e _ u _;_.._.___; _ __
.. _., i
,____.t_
.s_,o t _w ov.,, a
.mm va
- - saw - vm e.sv,ww, __-
._ma vsa. y, a massam_, _asyss a.
., o vao.am 23
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, _ 1,..
_,,ne.,__t_.___
- 1m ___ _,, _ _ _
yentawast as as,se assena v saassasawasse gvv pv vf ywa savnes est as waeneensvw va a saawwa.
24 1
25 l
.. _ 4see 26 pp.a 27
. innes am 28 29 g
-. ;and i
30 3
31 3
32
+.
33 -
6 20 NMAC 3.1 7-27 Revision Date
l 4
V l
'l W
6enestey' administered, l
2 n
- tumeur, 3
N 6'er 4
d.
Gpasidemeng m e g,g g ys, 5
g
~
. grelease, that 6
7 gegjem 9
55. Mobile Nuclear Medicine Service Technical Requirements. A licensee providing 10 mobile nuclear medicine service shall:
\\
11 1.
Transport to each address of use only sydnges or vials containing prepared I
12 radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of 13 radiopharmaceutical kits; q
14 2.
Bring into each location of use all radioactive material to be used and, before
}
15 leaving, remove all unused radioactive material and associated radioactive waste; i
16_
3.
Secure or keep under constant surveillance and immediate control all 17-radioactive material when in transit or at a location of use; 18 4.
Check survey instruments and dose calibrators as required in Q703. A.1 a.,
19 A.3, A.4, and B.4 and check all other transported equipment for proper function before medical use 20 at each location ofuse; 21 5.
Carry a calibrated survey meter in eacn vehicle that is being used to transport 22 radioactive material, and, before leaving a client location of use, survey all areas of i
23 radiophannaceutical use with a radiation detection survey instrument to ensure that all 24 radiopharmaceuticals and all associated radioactive waste have been removed; and 25 6.
Retain a record of each survey required by Paragraph 5 for 3 years. The 26 record must include the date of the survey, a plan of each area that was surveyed, the measured dose 27 rate at several points in each area of use expressed in millirems (microsieverts) per hour, the model
-28.
and sedal number of the instrument used to make the survey, and the initials of the individual who 29 o.
performed the survey.
t 30 K$.
Storage ofVolatiles and Gases.
20 NMAC 3.1 7-28 Revision Date I
l s.
- t1
.1 1.
A license shall store volatile radiopharmaceuticals and radioactive gases m
\\
2 the shipper's radiation shield and container.
3 2.
A license shall store and use a multidose container in properly functioning l
4 fumchood.
(
i
- 5 Idd.
Decay-in-Storage.
I 6 -
1.' _
A licensee shall hold radioactive material for decay-in-storage before disposal 7
'in ordinary trash and is exempt from the requirements of Subpart 4 of these regulations if the 8
' licensee:
9 a.
Holds radioactive material for decay a minimum of 10 half-lives; i
10 b.
Monitors radioactive material at the container surface before disposal 11 as ordinary trash and determines that its radioactivity cannot be distinguished from the background 12
' radiation level with a radiation detection survey instrument set on its most sensitive scale and with 13 no interposed shielding; Monitoring Procedures must be approved by the Department; 14 c.
Removes or obliterates all radiation labels; and 15 d.
Separates and monitors each generator column individually with all 16 radiation shielding removed to ensure that its contents have decayed to background radiation level 17 before disposal.
i.
18 2.
For radioactive material disposed in accordance with Paragraph I the licensee 19 -
shall retain a record of each disposal for 3 years. The record must include the date of the disposal, 20
- 21 _
the date on which the radioactive material was placed in storage, the radionuclides disposed, the model and serial number ofthe survey instrument used, the background dose rate, the radiation dose 22 rate measured at the surface of each waste container, and the name of the individual who performed 23
- the disposal.
24 MW.
Possession of Survey Instrument.
25 1.
A licensee authorized to use radioactive material for uptake, dilution and l-26 excretion studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem ( Sv) per hour to 100 millirem (1 mSv) per hour, p
- 28 2.
A licensee authorized to use radioactive material for imaging and localization
_29 studies, radiopharmaceutical therapy or implant therapy shall possess a portable radiation detection
- 30 survey instrument capable of detecting dose rates over the range of 0.1 millirem (1 Sv) per hour 31 to 100 millirem (1 mSv) per hour and a portable radiation measurement survey instrument capable
~
- 20 NMAC 3.1' 7-29 Revision Date
s
).
- ofmeasuring dose rates over the range 1 millirem (10 Sv) per hour to 1000 millirem (10 mSv) per
.1 2
hour.
3 3.
A licensee authorized to use radioactive material in a teletherapy unit shall 4
possess either a portable radiation detection survey instrument capable of detecting dose rates over 5
. the range of 0.1 millirem (1 Sv) per hour to 100 millirem (1 mSv) per hour or a portable radiation 6:
measurement survey instrument capable of measuring dose rates over the range 1 millirem (10 l.
7 ySv)per hour to 1000 millirem (10 Sv) per hour.
l l
l-I i-l l
r 20 NMAC 3.1 7-30 Revision Date l
l
iN l
i
,I d.
Separates and monitors each generator column individually with all 2
radiation shielding removed to ensure that its contents have decayed to background radiation level 3
before disposal.
f l
4 2.
For radioactive material disposed in accordance with Paragraph 1 the licensee 5
shall retain a record ofeach disposal for 3 years. The record must include the date of the disposal, 6
the date on which the radioactive material was placed in storage, the radionuclides disposed, the 7
model and serial number of the survey instrument used, the background dose rate, the radiation dose 8
rate measured at the surface of each waste container, and the name of the individual who performed 9
. the disposal.
i l
10 M.
Possession ofSurvey Instrument.
i l
11 1.
A licensee authorized to use radioactive material for uptake, dilution and 12' excretion studies shall possess a portable radiation detection survey instrument capable of detecting
)
13 dose rates over the range 0.1 millirem ( Sv) per hour to 100 millirem (1 mSv) per hour.
I l
14 2.
A licensee authorized to use radioactive material for imaging and localization 1
l.
15 studies, radiopharmaceutical therapy or implant therapy shall possess a portable radiation detection i
16 smvey instrument capable ofdetecting dose rates over the range of 0.1 millirem (1 Sv) per hour i
17 to 100 millirem (1 mSv) per hour and a portable radiation measurement survey instrument capable 18 of measuring dose rates over the range 1 millirem (10 Sv) per hour to 1000 millirem (10 mSv) per 19 hour2.199074e-4 days <br />0.00528 hours <br />3.141534e-5 weeks <br />7.2295e-6 months <br />.
l 20 3.
A licensee authorized to use radioactive material in a teletherapy unit shall 21 possess either a portable radiation detection survey instrument capable of detecting dose rates over 22 the range of 0.1 millirem (1 ySv) per hour to 100 millirem (1 mSv) per hour or a portable radiation 23 measurement survey instrument capable of measuring dose rates over the range I millirem (10 24 Sv)per hour to 1000 millirem (10 Sv) per hour.
25 704.
USE OF "A"!OP!IA!L'! ACEL'T!CALS
- P:N 26 FOR UPTAKE, DILUTION AND EXCRETION STUDIES. A licensee may use r.ny radicactivc 27 m;;cria in a radieph..=cudcel and for a diagne;;ic use invelving ac;;_.. eats of gr uptake, 28 dilution, or excretion ;; ;p;~ Sed in Sched.!c C, Suhpar: 0 ef:hcoc reguiden N 29 l
1 30 3
s
'~
31 6
1 32 3
4... user l
33 ofenher 20 NMAC 3.1 7-31 Revision Date t
1 705.
IMAGING AND 2
LOCALIZATION STUDIES. Usc of radieph 1cu:icals, ge-e :ere, r.ad scegen: kits fer 3
imaging and k;elia;ka e; dka.
studess any 4
5 A.
A lic;nece may ;;c any byy.du;; me:c;ki in ; diagnes;;c radiepher.c.;;;u;ical or 6
any g...u ;a er r%...; ki; for y..y
- ba ar.d dkgnes;k ue; cf a redkph...;ccu;k;I cen ;ining 7
radice;;we me:csh! e; ;pecif.ed in Scheduk C, Suby ; 3 ofice; regub:iens. Weem a 8
9 er 10 B.
A licenecc :h:!! ch.;; gu.u ;se and
..y r; r;;ge.; id;a in ;;ceidence ceii ic a
11-manuf cr..'s h;;.a;;bne.
y
@ whois an 12 arrAer,the 13 14 706.
PERMISSIBLE MOLYBDENUM-99 CONCENTRATION.
i 15 A.
A licensee shall not administer to humans a radiopharmaceutical containing mote 16 than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m (0.15 kilobecquerel of 17 molybdenum-99 per megabecquerel of technetium-99m).
18 B.
A licensee preparing technetium-99m radiophannaceuticals from molybdenum-19 99/ technetium-99m generators shall measure the molybdenum-99 concentration in each cluate or 20 extract.
21 C.
A licensee who must measure molybdenum concentration shall retain a record ofeach 22 measurement for 3 years. The record shall include, for each elution or extraction of technetium-99m, 23-the measured activity of the technetium expressed in millicuries (megabecquerels), the measured 24 activity of molybdenum expressed in microcuries (kilobecquerels), the ratio of the measures 25 expressed as microcuries of molybdenum per millicurie of technetium (kilobecquerels of 26 molybdenump' r megabecquerel of technedum), the. date of the test, and the initials of the individual e
27 who performed the test.
28 707.
CONTROL OF AEROSOLS AND GASES.
29 A.
A licensee who administers radioactive aerosols or gases shall do so with a system 30 that will keep airborne concentrations within the limits prescribed by Subpart 4 of these regulations.
31 B.
The system shall either be directly vented to the atmosphere though an air exhaust i
32 or provide for collection and decay or disposal of the aerosol or gas in a shielded container. Other 33 federal, state or local regulatory requirements must be met.
i 20 NMAC 3.1 7-32 Revision Date 1
1 C.
A licensee shall only administer radioactive gases in rooms that are at negative 2
pressure compared to surrounding rooms.
3 D.
Before receiving, using, or storing a radioactive gas, the licensee shall calculate the 4
amount of time needed after a release to reduce the concentration in the area of use to the 5
occupational limit listed in Subpart 4 of these regulations. The calculation shall be based on the 6
highest activity of gas handled in a single container and the measured available air exhaust rate.
7 E.
A licensee shall post the time calculated in Paragraph D at the area of use and require 3
8 that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed or the 1
9 concentration in the area of use is reduced below the DAC limit.
10 F.
A copy of the calculations required in Paragraph C shall be recorded and retained for 11 the duration of the license.
I t
12 G.
A licensee shall check the operation of reusable collection systems monthly and 13 measure the ventilation rates in areas of use at intervals not to exceed 6 months.
14 708.
" ^ ' " ^ " " ' ' " " ^ " " " ' " " ^ ' ' ' " ^ " ' " " " ^ " "
WMgM 15 7
.7 Alicensee may use 16 for therapeutic administration any unsealed byproduct material prepared for medical use that is 17 either:
18 A.
U;; ef "='bph
=x :kal; fer n.c..yj. A licen;;; niay un any mdicac;ic; 19 meerial in a redkph =xu:ke r.nd for a ee..yeuti; a;; for ;<hkh i; I'eed and Drag 20
^ :' ',L;..;bn he; eacp ;d a "?!ede; ef C rda.ed b d. hard C;;;pden for i;!!cie Drag" 21 (O!O), er yy. ved a "!!cce Drag App!keden"(?!OA). n.;1i.ex she!! w yly eit 1; packag; 22 inar, i;;rackn; r;; dhg bdk;;ba; and n;;ied of ='n'nL.. bn.
M 23
.c 24 pr 25 B. --
26 27 6
28 Bg.
Safety Instruction.
29 1.
A licensee shall provide eral.nd e.i::en radiation safety instruction for all 30 personnel caring for 3 patients m under;eig g 31 radiopharmaceuticaltherapy 32.
" M.;r:.a ;g;tel:
33 k. vidri et b;;.cel; ne::e exe a d en; r.r..
y 20 NMAC 3.1 7-33 Revision Date
1 2.
Te ;;d;fj l'a.a.,.4h 0.I, thc iaracdon sha!! dcacdbc the liccascc's 2
p.aciaca fer.
l 3
a.
Patient..
1_ control; 4
b.
Visitor control; 5
c.
Contamination control; 6
d.
Waste control; and 7
Notification of the Radiation Safety Ofiicer er ad erir~d user in case e.
8.
of the patient's 6 death or medical emergency.
9 3.
A licensee shall keep for three years a list ofindividuals receiving instruction 10 required by paragraph 1 of this section, a description of the instruction, the date ofinstmetion, and 11 the name of the individual who gave.he instruction.
.12 ER.
Safety Precautions.
13 1.
For each patient m receiving radiopharmaceutical 14 therapy and hospitalized for cornpliance with Q703.1 M a licensee shall:
15 a.
Provide a private room with a private sanitary facility; 16 b.
Post the patient's Mf@ door with a 17 "Caden: Radioactive Materialg" sign and note on the door or in the patient's eNumaan research I8 6 chart where and how long visitors may stay in the patient's N subpest's 19 room; 20 c.
Authorize visits by individuals under 18 years of age only on a case-21 by-case basis-with the approval of the authorized user after consultat6n with the Radiation Safety 22
- Officer, 23 d.
Promptly after administration of the dosage, measure the dose rates 24 in contiguous restricted and univstricted areas with a radiation measurement survey instrument to 25 demonstrate compliance with the requirements of Subpart 4 of these regulations and retain for 3 26 years a record of each survey that includes the time and date af the survey, a plan of the area or list 27 of points surveyed, the measured dose rate at several points expressed in millirem per hour, the 28 instrument used to make the survey, and the initials of the individual who made the survey; 29 e.
Either monitor material and items removed from the patient's er em 30 6 room to determine that M any cea:en.;ae:ien cannot be 20 NMAC 3.1 7-34 Revision Date t
s
- 1 distinguished from the natural background radiation level with a radiation detection survey 2
instrument set on its most sensitive scale and with no interposed shielding, or handle them these 3
n-#cd;L and bra; as radioactive waste; 4
f.
Provide the patient M with radiation saduty 5
guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient $$akpumpassendtsspoet; o
7 g.
Survey the patient's ha room and private 8
sanitary facility for removable contamination with a radiation detection survey instmment before 9
assigning another patient 6 to the room. The room must not be reassigned 10 until removable contamination is less than 200 disintegrations (3.33 Bq) per minute per 100 square 11 centimeters; and 12 h.
Measure the thyroid burden of each individual who helped prepare or 13-administer a dosage ofiodine-131 within 3 days after administering the dosage, and retain for the 14 period required by Subpart 4 of these regulations a record of each thymid burden measurement, date 15 of measurement, the name of the individual whose thyroid burden was measured, and the initials of 16 the individual who made the measurements.
17 2.
A licensee shall notify the Radiation Safety Officer or i; a;.iedr~d ur.cr 18 immediately if the patient or m dies or has a medical emergency.
19 709.
SOURCES FOR BRACHYTHERAPY.
20 A.
Use of Sources for Brachytherapy. A licensee shall use the following sources in 21 accordance with the manufacturer's radiation safety and handling instructions:
22 1.
Cesium-137 as a sealed cource in needles and applicator cells for topical, 23 interstitial, and intracavitary treatment of cancer, 24
- 2.
Cobalt-60 as a sealed source in needles and applicator cells for topical, 25 interstitial, and intracavity treatment of cancer, 26 3.
Gold-198 as a sealed source in seeds for interstitial treatment of cancer, 27 4.
Iodine-125 as a sealed source in seeds for interstitial treatment of cancer, 28 5.
Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of 29
- cancer, 30 6.
Radium-226 as a sealed source in needles or applicator cells for topical, 31.
interstitial, and intracavity treatment of cancer, 20 NMAC 3.1 7-35 Revision Date j
1 7.
Radon-222 as seeds for interstitial treatment of cancer; a
2 8.
Strontium-90 as a scaled source in an applicator for treatment of superficial 3
eye conditions; and 4
9.
Palladium-103 as a scaled source in seeds for the interstitial treatment of 5
cancer.
6 B.
Release ofPatients Treated with TemporaryImplants.
7 1.
Immediately after removing the last temporary implant source from a patient 8
er aduumm6 the licensee shall make a radiation survey of the patient or the human 9
W with a radiation detection survey instrument to confirm that all sources have been 10 removed. The licensee may not release from confinement for medical care a patient er.a human 11 6ated by temporary implant until all sources have been removed.
12 2.
A licensee shall retain a record ofpatient M surveys 13 for three years. Each record must include the date of the survey, the name of the patient h 14 m, the dose rate from the patient m expressed as millirem 15
( Sv) per hour and measured at one meter from the patient 6, the survey 16 instrument used, and the initials of the individual who made the survey.
17' C.
Brachytherapy Sources Inventory.
18 1.
Each :h..e hrahp.c. yj ee; ec; aa m;aned :o en ace of a:cragc Seni an 19 as of un, :he liecna~ ahall M aedh;c y 6apenset er a human
'20 W. area, and count er 21 d.crek verif the number retumed to ensure that all sources taken from the storage area have been f
22 returned.
23 24 2.
A licensee shall make a record ofbrachytherapy source utilization which sent 25 includes:
26 a.
The names of the individuals permitted to handle the sources; 27 b.
The number and activity of sources removed from storage, the room 28 number of use and patient's m name, the time and date they were removed 29 from storage, the number and activity of the sources in storage after the removal, and the initials of 30 the individual who removed the sources from storage; and l
31 c.
The number and activity of sources returned to storage, the room
.32-number of use and patient's m name, the time and date they were retumed 20 NMAC 3.1 7-36 Revision Date
.I to storage, the number and activity of sources in storage after the retum, and the initials of the 2
individual who returned the sources to storage.
3 3.
Immediately after implanting sources in a patient qmmennham resseek autdeat 4
and h. i.cdia:cly ;^.e....ec sf ecure Oe... e pe::cn:, the licensee shall make a radiation survey 5
' of the patient 6 and the area of use to confum that no sources have been 6
misplaced. The licensee shall make a record of each survey.
7 4.
A licensee shall maintain the records required in Paragraphs 2 and 3 for threc 8
years.
9 D.
Safety Instmetion.
10 1.
The licensee shall provide ere: n.d ;.ri;;ca radiation safety instruction to all 11 personnel caring for the patient m realcing M implant therapy.
12 Refresher traming shall be provided at intervals not to exceed one year. To satisfy I' eg yh eds 13 sqq)hgg, the instmetion shall describe:
14 a.
Size and appearance of the brachytherapy sources; 15 b.
Safe handling and shielding instructions in case of a dislodged 16 source; 17 c.
Procedures for patient m control; 18 d.
Procedures for visitor control; 19 e.
Procedures for notification of the Radiation Safety Officer er 20 euded ed usc if the patient 6 dies or has a medical emergency; and 21 2.
Alice 1 - J mil maintain a record ofindividuals receiving instmetion required
-22 by Paragraph '1, a descriptic of the instruction, the date of instmetion, and the name of the 23 individual who gave the instruction for three years.
24 E.
Safety Precautions.
25 1.
For each patient M receiving implant therapy aghast 26 a licensee shall:
27 a.
Notpleeegthepatientm Win the same 28 room with as patient M who is not receiving radiation therapy l unis; ic lianas een 29 demea.. :c ce...y!!a.a ;ciiic r;+:...uc.: ef Suhp ; 4 eficec cg letiens et Histence of en-30e me:cr fem ic L.,p:ea:,
20 NMAC 3.1 7-37 Revision Date l
l 1
I
O
,I b.
Post the patient's N @,s door with a "Cau;ies:
2 R;dk;ien M Materials" sign and note on the door or in the patient's qudagnes seseemh l
3 6 chart where and how long visitors may stay in the patient's WMndiest's 3
t 4
room; i
5 c.
Authorize visits by individuals under 18 years of age only on a case-l 6
by-case basis with the approval of the authorized user after consultation with the Radiation Safety 7
Officer; DMI i
I 8
d.
Promptly after implanting the sources, survey the dose rates in 9
contiguous restricted and unrestricted areas with a radiation measurement survey instrument to 10 demonstrate compliance with Subpart 4 of these regulations and retain for three years a record of 11 each survey that includes the time and date of the survey, a sketch of the area or list of points 12 surveyed, the measured dose rate at several points expressed in millirem ( Sv) per hour, the
{
13 instrument used to make the survey, and the initials of the individual who made the survey.
1 14 c.
"revid; i; p;Sent icii r Edes ;;';;y guidi. ace i;; ;;i!! h;1p k;;p 15 i; r 'kden dea :s heuxhold me kr;.nd i; publi; ;.; ic;; c.; reeeen;.hly whiceil kier; 16 ak ' 5 i; pe:kn; if1; pe:ica: ;;;; ="W::;ied ; p.m.r.aca: L.y's.s. (Remcved 62 FR 4120) 17 2.
A licensee shall notify the Radiation Safety Officer er ;uieriad user 18 immediately if the patient m dies or has a medical emergency.
19 710.
TELETHERAPY. The provisions of this section govem the use of teletherapy units for 20 medical use that contain a sealed source of cobalt-60 or cesium-137.
21 A.
Equipment.
22 23 1.
The housing shall be so constructed that, at one meter from the source, the 24 maximum exposure rate does not exceed 10 mR per hour when the beam control mechanism is in 25 the "off" position. The average exposure rate measured at a representative number of points about 26 the housing,pach one meter from the source, shall not exceed 2 Millie per hour.
27 2.
For teletherapy equipment installed after the effective date of these 28 regulations, the leakage radiation measured at I meter fmm the source when the beam control 29 mechanism is in the "on" position shall not exceed the lesser of 1 R per hour of 0.1 percent of the
'30 useful beam exposure rate.
31 3.
Adjustable or removable beam-defining diaphragms shall allow transmission 32 of not more than five percent of the useful beam exposure rate.
33 4.
The beam control mechanism shall be of a positive design capable of acting 34 in any orientation of the housing for which it is designed to be used. In addition to an automatic 20 NMAC 3.1 7-38 Revision Date l
l' l
.I closing device, the mechanism shall be designed so that it can be manually returned to the "off" 2
position with a minimum risk ofexposure.
3 4
5.
The closing device shall be so designed as to retum automatically to the "off" 5
position in the event of any breakdown or interruption of the activating force and shall stay in the 6
"off" position until activated from the control panel.
7 6.
When any door to the treatment room is opened, the beam contml mechanism 8
shall automatically and rapidly restore the unit to the "otI" position and cause it to remain there until 9
the door is closed and the unit is reactivated from the control panel.
10 l
11 7.
There shall be at the housing and at the control panel a waming device that 12 plainly indicates whether the beam is "on".
13 l
14 8.
The equipment shall be provided with a locking device to prevent 15 unauthorized use.
16 9.
The control panel shall be provided with a timer that automatically terminates 17 the exposure after a pre-set time.
18 19 10.
Provisions shall be made to permit continuous observation of patients during 4
20 irradiation.
21 B.
Operation. Except in an emergency, no individual who is occupationally exposed to 22 radiation shall be in the treatment room during irradiation unless that individual is the patient. No 23 other individual shall be in the treatment room except when it is necessary clinically or for i
24 emergency entrance.
25 C.
Testing for Leakage and Contamination. Teletherapy sources shall be tested for 26 leakage and contammation in accordance with the procedures described in 703 E. Tests of leakage 27 may be made by wiping accessible surfaces of the housing port or collimator while the source is in i
28 the "off" position and measuring these wipes for transferred contamination.
29 3
I J.
j 30 g
a -
31 32 3
y da 33 34 mat
~
20 NMAC 3.1 7-39 Revision Date l
c_-______----____-_-___-_______________________.
I b.
The W to h h y:
2 W
Ip%eMesm ofmisakon 3
off jg ej 4
g
..,,. m g 5
. py 6
6 7
g
~~
., g g 8
9 gMlkWMg M mooiving 10 insposaien M % Ihe date d 11 i
12 M
13 E
14 asepapp
. :.. m e 15 g
M 16 m
'17 g
18 6
19 g
enemmee 20 deer 6 21 g
. ;. KeNameeg j
22
.. angs 23 6
i 24 g
i 25 6
26 3
27 28 g
29
.am 30 20 NMAC 3.1 7-40 Revision Date
e 1
lh Ah manitarmust.be equipped with a backup power supply 2
separats b NAstghs.hinit.lMAsuppppielersupply may be a battery 3
syuema 4
g
,,u,,,
5 for.
.. [_erimanen 6
6 7
g 8
denttbs 9
1
..I
,who 10 N
11 W
NMW shall requue any 12 individus4e@
gNer andlMe slana personal 13 aguttin am 14 15 2
16 17 l
. Wit 18 is q 19 3
20
- dusing 21 i6 4
22 711.
SEALED SOURCES FOR DIAGNOSIS.
23 A.
Use of Scaled Sources for Diagnosis. A licensee shall use the following sealed 24 sources in accordance with the manufacturer's radiation safety and handling instructions:
)
4 25 1.
Iodine-125 as a sealed source in a device for bone mineral analysis; 26 2.
Americium-241 as a sealed source in a device for bone mineral analysis; 27 3.
Gadolinium-153 as a scaled source in a device for bone mineral analysis; and j
28 4.
Iodine-125 as a sealed source in a portable device for imaging.
29 B.
Availability of Survey Instrument. A licensee authorized to use radioactive material 30 as a sealed source for diagnostic purposes shall have available for use a portable radiation detection j
31 -
survey instrument capable of detecting dose rates over the range 0.1 Millie (1 Sv) per hour to 100 j
20 NMAC 3.1 7-41 Revision Date a
1 millirems (1 mSv) per hour or a portable radiation measurement survey instrument capable of 2
measuring dose rates over the range 1 Millie (10 Sv) per hour to 1000 millirems (10 mSv) per hour.
3 The instrument shall be operable and calibrated in accordance with Q703.B.
4 712.
TRAINING AND EXPERIENCE REQUIREMENTS.
5 A.
Radiation Safety Officer. Except as provided in (712.B, GlWGemasersheB mutume 6
an individual fulfilling the responsibilities of the Radiation Safety Officer as pmvided in Q702.B 7
shah 6 8
1.
Be g certified by the:
9 a.
American Board ofHealth Physics in Comprehensive Health Physics; 10 or 11 b.
American Board of Radiology in Pdicicgical Physics, Ther.ycu:ic 12 Radic!cgica: Physics, or Mcdical Nue:cer Physics; or 13 c.
American Board of Nuclear Medicine; or 14 d.
American Board of Science in Nuclear Medicine; or 15 e.
Board ofPharmaceutical Specialties in Nuclear Pharmacy or Science; 16 or 17 f.
American Board of Medical Physics in Radiation Oncology Physics; 18 or 19 g.
Royal College of Physicians and Surgeons of Canada in Nuclear 20 Medicine; or 21 N
22 l
I 23 2.
Have 3 had 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training covering:
24 a.
Radiation physics and instrumentation; 25 b.
Radiation prutection (health physics);
26 c.
Mathematics pertaming to the use and measurement of radioactivity; 20 NMAC 3.1 7-42 Revision Date L---
.I d.
Radiation biology; 2
Radiopharmaceutical chemistry; and c.
3 f.
One year of full-time experience in radiation safety at a medical 4
institution under the supervision of the individual identified as the Radiation Safety Offica on a 5
Department, Agreement State, or NRC license that authorizes the medical use of radioactive 6
material; or 7
3.
Be an authorized user for those radioactive material uses that come within the 8
Radiation Safety Officer's responsibilities.
9 B.
. Training for Experienced Radiation Safety Officer. An individual identified as a 10 Radiation Safety Officer on a Department, Agreement State, or NRC license before October 1,1986 11 who oversees only the use ofradioactive material for which the licensee was authorized on that date 12 need not comply with the training requirements of Q712.A.2.
13 C.
Traming for Uptake, Dilution, or Excretion Studies. Except as provided in Q712.K 14 and L the licensee shall require the authorized user of a radiopharmaceutical listed in 0704 to be a 15 physician who:
16 1.
Is certifiedin:
17 a.
Nuclear Medicine by the American Board ofNuclear Medicine; 18 b.
Diagnostic Radiology by the American Board of Radiology; or I
- 19 c.
Diagnostic Radiology or Radiology by the American Osteopathic 20 Board of Radiology; q
21 d.
Nuclear Medicine by the Royal College of Physicians and Surgeons 22-of Canada; or -
(
23 g
g g esiser l
24-a6
{
1 25 2.
Has completed 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of instruction in basic radionuclides handling
{
26 techniques applicable to the use of prepared radiopharmaceuticals, and 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />'of supervised 27-clinical experience.-
28-a.
To satisfy the basic instruction requirement,40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> ofclassroom and 29 labentory instmetion shall include:
l 20 NMAC 3.1 7-43 Revision Date I
i t
i
~
- 1 (1)
Radiation physics and instrumentation; 2
(2)
Radiation protection;
-3 (3)
Mathematics pertaining to the use and measurement of 4
radioactivity; 5
(4)
Radiation biology; and :
4 6
(5)
Radiophannaceutical chemistry.
7 b.
To satisfy the requirement for 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of supervised clinical 8'
experience, training must be under the supervision of an authorized user and shall include:
~9' (1)
Examining patients or human research subjects and reviewing 10<
their case. histories to determine their suitability for radionuclides diagnosis, limitations, or 11' contraindications; 12 (2)
Selecting the suitable radiopharmaceuticals and calculating and
-13 measuring the dosages; i
14 (3)
Administering dosages to patients or human research subjects 15 and using syringe radiation shields; 16 17'_
(4)
Collaborating with the authonzed user in the interpretation of
- radionuclides test results; and
-18:
(5)
Patient or human research subject follow-up; or (19 3.
- Has successfully completed a six-month training program in nuclear 20' medicine as part of a traming program that has been approved by the Accreditation Council for-
- l 21L Graduate Medical Education and that included classroom and laboratory trainmg, work experience, 22 and supervised clinical experience in all the topics identified in Paragraph 2.
- 23 D.
Training for Imaging and localization Studies.
424
.1.
Except as provided in {712.K and L the licensee shall require the authorized
- 25.
user of a r-LW-*ie*( generator, or reagent kit in 6705 to be a physician who is certified in:
i 126' a.
Nuclear Medicine by the American Board of Nuclear Medicine; i
- 27
. b.
Diagnostic Radiology by the American Board of Radiology; or 20 NMAC 3.1 7-44 Revision Date l.
)
p i
A
1
.I Diagnostic Radiology or Radiology by the American Osteopathic c.
2 Board of Radiology; er 3
d.
Nuclear Medicine by the Royal College of Physicians and Surgeons 4
of Canada; or 5
.A fufh, Edici=* in nuclear 6
aasduksg.ar i
7 2.
Has had classroom and laboratory training in basic radioisotope handling 8
techniques applicable to the use of prepared radiopharmt.ceuticals, generators, and reagent kits, 9
supervised work experience, and supervised clinical experience as follows:
1 10 a.
200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory trammg that includes:
1 11 (1)
Radiation physics and instnunentation; 12 (2)
Radiation protection; 13 (3)
Mathematics pertaining to the use and measurement of
)
14 radioactivity; 1
15 (4)
Radiopharmaceutical chemistry; and l
16 (5)
Radiation biology; and 17 b.
500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an 18 authorized user that includes:
19 (1)
Ordering, receiving, and unpacking radioactive materials safely 20 and performing the related radiation surveys; 21 (2)
Calibrating dose calibrators and diagnostic instruments and j
22 performing checks for proper operation of survey meters; l
23 (3)
Calculating and safely preparing patient tr uh=== "
a 24 g dosages; 25 (4)
Using administrative controls to prevent the misadministration 1
26 ofradioactive material; 27 (5)
Using procedures to contain spilled radioactive material safely 28 and using proper decontamination procedures; and 20 NMAC 3.1 7-45 Revision Date
.1 (6)
Eluting technetium-99m from generator systems, measuring 2
and testing the cluate for molybdenum-99 and alumina contamination, and processing the eluate with 3
reagent kits to prepare technetium-99m labeled radiopharmaceuticals.
4 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical experience under the supervision of c.
5 an authorized user that includes:
6 (1)
Examming patients or human research subjects and reviewing 7
their case histories to determme their suitability for radioisotope diagnosis, limitations, or l
8 contraindications; J
9 (2)
Selecting the suitable radiopharmaceuticals and calculating and 10 measuring the dosages; 11 (3)
Administering dosages to patients M subjects
(
12 and using syringe radiation shields; 13 (4)
Collaborating with the authorized user in the interpretation of I
14 radioisotope test results; and 1
15 (5)
Patient 6 follow up; or I
\\
l 16 3.
Has successfully completed a six-month trainmg program in nuclear medicine 17 that has been approved by the Accreditation Council for Graduate Medical Education and that I
18 included classroom and laboratory training, work experience, and supervised clinical experience in f
19 all the topics identified in paragraph 2 of this section.
{
20 E.
Trrining for Therapeutic Use of"ediep.c.c.cedah N Metenal.
I 21 1.
Except as provided in !712 K the licensee shall require the authorized user 22 of a radiopharmaceutical listed in {708 for ieyj to be a physician who is certified by:
23 a.
The American Board of Nuclear Medicine; er 24 b.
The American Board of Radiology in Radiology, Therapeutic 25 Radiology, or Radiation Oncology; or 26 g
27 M
28 3
1 20 NMAC 3.1 7-46 Revision Date I
i l
4
l
- 1 2.
Has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of instmetion in basic radionuclides handling 2
techniques applicable to the use of therapeutic radiopharmaceuticals, and has had super ised clinical 3
exp4nce:
4 a.
To satisfy the requirements for instruction,80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and 5
laboratory training shallinclude:
6 (1)
Radiation physics and instrumentation; 7
(2)
Radiation protection; 8
(3)
Mathematics pertaining to the use and measurement of 9
radioactivity; and 10 (4)
Radiation biology; 11 b.
To satisfy the requirement for supervised clinical experience, training 12 shall be under the supervision of an authorized user at a medical institution and shall include:
13 j
14 (1)
Use ofiodine-131 for diagnosis of thyroid function and the 15 treatment of hyperthyroidism or cardiac dysfunction in ten individuals; 16 (2)
Use of soluble phosphorus-32 for the treatment of ascites, 17 polycythemia vera, leukemia, or bone metastases in three individuals; I8 (3)
Use ofiodine-131 for treatment of thyroid carcinoma in three 19 individuals; and 20 (4)
Use of colloidal chromic phosphorus-32 or of colloidal gold-21 198 for intracavitary treatment of malignant effusions in three individuals.
22 F. " ' Training for Use of Brachytherapy Sources.
1 23 1.
Except as provided in {712 K the licensee shall require the authorized user 24 of a brachytherapy source listed in Q709 for therapy to be a physician who is certified in:
l 25 a.
Radiology l or therapeutic radiologyg M by the 26 American Board of Radiology; 27 b.
Radiation Oncology by the American Osteopathic Board of Radiology; 28 c.
Radiology, with specialization in Radiotherapy, as a British " Fellow
[
29 of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or 20 NMAC 3.1 7-47 Revision Date l
)
1 d.
Therapeutic Radiology by the Canadian Royal College of Physicians 2
and Surgeons; or 3-2.
Is in the active practice of therapeutic radiology, has had classroom and 4
laboratory training in radioisotope handling techniques applicable to the therapeutic use of 5
' brachytherapy sources, supervised work experience, and supervised clinical experience as follows:
6 a.
200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:
7
_ 1)
Radiation physics and instrumentation;
(
8-(2)
Radiation protection; I
9 (3)
Mathematics pertaining to the uses and measurement of l
10 radioactivity; l
t i
11 (4)
Radiation biology; 1
12 b.
500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an I
13 authorized user at a medical institution that includes:
14 (1)
Ordering, receiving, and unpacking radioactive materials safely 15-and perfonning the related radiation surveys; i
- 16 (2)
Checking survey meters for proper operation; i
17.
(3)
Preparing, implanting, and removing sealed sources; 4
1 18 (4)
Maintaining running inventories of material on hand; 19 (5)
Using administrative controls to prevent the mi-ministration 20-ofradioactive tnaterial; and 21 (6)
Using emergency procedures to control radioactive material; l
22 and 23 c.
Three years of supervised clinical experience that includes one year
)
24 in a formal training program approved by the Residency Review Committee for Radiology of the 25 Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training
]
26
.of the American Osteopathic Association, and an additional two years of clinical experience in l
27' therapeutic radiology under the supervision of an authorized user at a medical institution that 28' includes:
1 20 NMAC 3.1 7-48 Revision Date j
l l
l l
t________.___________
__1._____.____.._
{
[...
i l
- 1.
(1)
Examining individuals and reviewing their case histories to 2
determine their suitability for brachytherapy treatment, and any limitations or contraindications; 3-(2)_
Selecting the proper brachytherapy sources and dose and 4
method of administration; L
5 (3)
Calculating the dose; and 6
(4)
Post-administration follow-up and review of case histories in 7
collaboration with the authorized user.
8 G.
Training for Ophthalmic Use of Strontium-90.
.9
'1.
Except as provided in {712 K, the licensee shall require the authorized user I
g 10 ofonly strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of l
H
-11 therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic 12 radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, 13
- and a period of supervised clinical training in ophthalmic radiotherapy to consist of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of 14 classroom and laboratory training that includes:
15 a.
Radiation physics and instrumentation; 16 b.
Radiation protection; 17 c.
Mathematics pertaining to the use and measurement of radioactivity; l
and l
18-19 d.
Radiation biology; 20:
- 2.
Supervised clinical trainmg in ophthalmic radiotherapy under the supervision 21 of an authorized user at a medical institution that includes the use of stmntium-90 for the ophthalmic 22 treatment offve individuals that includes:
l l
23 a.
Examination of each individual to be treated; 24 b.
Calculation of the dose to be administered;
-25 c.
Administration of the dose; and
'26.
d.
Follow-up and review of each individual's case history.
i 27 H..
Training for Use of Scaled Sources for Diagnosis.
20 NMAC 3.1 7-49 Revision Date
- 1-1.
Except as provided in Q712 K the licensee shall require the authorized user 2_
of a sealed source in a device listed in {711 to be a physician, dentist, or podiatrist who is certified 3
in:
4 Radiology, Diagnostic Radiology, Therapeutic Radiology or Radiation a.
5
' Oncology by the American Board of Radiology; 6_
b.
Nuclear Medicine by the American Board of Nuclear Medicine; er 7
c.
Diagnostic Radiology or Radiology by the American Osteopathic 8.
Board of Radiology; or 9
d.
- Nuclear Medicine by the Royal College of Physicians and Surgeons 10 of Canada; or 11-2.
Has had eight hours ofclassroom and laboratory traimng in basic radioisotope 12 handling techniques specifically applicable to the use of the device that includes:
13 a.
Radiation physics, mathematics pertaining to the use and measurement 14 of radioactivity, and instrumentation; 15 b.
Radiation biology; 16-c.
Radiation protection; and 17'
- d.
Training in the use of device for the uses requested.
j 18
. I.
Training for Teletherapy.
19 1.
Except as provided in {712 K the licensee shall require the authorized user 20.
of a sealed source listed in 6710 in a teletherapy unit to be a physician who is certified in:
21 a.-
Radiology, Therapeutic Radiology or Radiation Oncology by the-l 221
. American Board ofRadiology; I
H 23' b.
Radiation Oncology by the American Osteopathic Board of Radiology; 24l c,
Radiology, with' specialization in radiotherapy, as a British " Fellow
--25
- of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or
[
26L d.
' Therapeutic radiology by the Canadian Royal College of Physicians 27-
. and Surgeons; or 20 NMAC 3.I' 7-50 Revision Date l
ll 1
_o
- 1 2.
Is in the active practice of therapeutic radiology, and has had classroom and 2-laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a 3~
teletherapy unit, supervised work experience, and supervised clinical experience as follows:
4 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:
a.
5 (1)
Radiation physics and instrumentation; 6:
(2)
Radiation protection; 7
(3)
Mathematics pertaining to the use and measurement.of 8
radioactivity; and 9
(4)
Radiation biology; 10' b.
500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an 11 authorized user at a medical institution that includes:
12 (1)
Review of the full calibration measurement and periodic spot 13-checks; j
14' (2)
Preparing treatment plans and calculating treatment times; 15 (3)
Using administrative controls to prevent misadministration; 16 (4)
Implementing emergency procedures to be followed in the 17 event of the abnormal operation of a teletherapy unit or console; and 18 (5)
Checking and using survey meters; and 19 :-
c.
Three years of supervised clinical experience that includes one year 20L in a formal training program approved by the Residency Review Committee for Radiology of the 21 Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training 22 of the American Osteopathic Association and an additional two years of clinical experience in 23 therapeutic radiology under the supervision of an authorized user at a medical institution that 24-includes:
,25 (1)
Examining individuals and reviewing their case histories to
.26 determine their suitability for teletherapy treatment, and any limitations or contraindications; 27 (2)
Selecting the propw dose and how it is to be administered; 20 NMAC 3.1 7-51 Revision Date
[
o I-V
4
- 1 (3)
Calculating the teletherapy doses and collaborating with the 2
authorized user in the review of patients' 6 progress and consideration of 3
the need to modify originally prescribed doses as warranted by patients' epummt sesesseh ashiests' 4
reaction to radiation; and l
~ 5 (4)
Post-administration follow up and review of case histories.
l 6-J.
Training for Teletherapy Physicist.
7 1.
The licensee shall require the teletherapy physicist to be an individual who:
I 8
9 a.
Is certified by the American Board of Radiology in:
10 (1)
Therapeutic radiological physics; I
t 11-(2)
Roentgen ray and gamma ray physics; 12.
(3)
X-ray and radium physics; or
-13 (4)
Radiological physics; or 14 b.
Is certified by the American Board of Medical Physics in Radiation 15 Oncology Physics; or 16 c.
Hold. a master's or doctor's degree in physics, biophysics, radiological 17 physics, or health physics, and has completed one year of full time training in therapeutic 18
, radiolog%al physics and an additional year of full time work experience under the supervision of a 19 teletherapy physicist at a medical institution that includes the tasks listed in {703.E.
20 K.
Training for Experienced-Authorized Users. Practitioners of the healing arts 21 identified as' authorized users for the human use of radioactive material on a Department, NRC or i
22 Agreement State license on April 1,1987, who perform only those methods of use for which they 23 were authorized on that date need not comply with the training requirements of {712.
l-
.24 L.
Physician Training in a Three-Month Program. A physician who, before July 1, 25 1984, began a three-month nuclear medicine training program approved by the Accreditation 26 Council for Graduate Medical Education and has successfully completed the program, is exempted 27 from the requirements of {712.C and D.
l 28 M.
Recentness of Training. The training and expenance specified in this section must
.29 have been obtained within the seven years preceding the date of application or the individual must 20 NMAC 3.1 7-52 Revision Date t -
l.
i l1
[-
l a
e l
'I have had related continuing education and experience since the required training and experience was 2
completed.
l 3
E NWh.absE sapire the
.4 authedend 5
1.
Mas, cesumet 4Wuped asudepsegues a;mmelane pluumacist by the Board of 6
Ph Speshdhus,er 7
1; p
gig;gggysspaammad mammedanni psogram 8
consisliggeftseu l
9 g
l 10 W
m f
l 11 E
M l
~12 g
13 ofsedneandeepr, 14 W
trpedissi use; and I
l 15 g
M i
j 16 g
~
ving te 17
&Moudgy
~~
18 M
l 19 aum 20 g
21 22 j1er 23 g
for 24 25 g
Sheessemisesin the 26 27 3
__u,
28-20 NMAC 3.1 7-53 Revision Date L
-V 4
s 1
3 4
g
- w ' ~2=ln:~ m _:
7 pluumassen NM Odki4888EIEin W pharmacast. A 8
ggg NesgeniAndia)712.N.2.a of e ist 10 sessuteses of traming 1I 12 713.799.
[ Reserved.]
f i
I j
i i
4 20 NMAC 3.1 7-54 Revision Date i
r C_
r-
- - COMPATIBILITY AMENDMENT #5:
Iitle: Low-Level Waste Shipment Manifest Information and Reporting,10 CFR Parts 20, and 61 Federal Register: Volume 60, No. 58, March 27,1995 (60FR15649); Volume 60, No. 94, May 16,1995
'(60FR25983) l Due Date March 1,1998 Rationale. 60FR15649/fhe Nuclear Regulatory Commission (NRC or Commission) is amending its regulations to improve low-level waste (LLW) manifest ' formation and reporting. The amendments m
l will:. Improve the quality and uniformity of information contained in manifests that are required to control transfers of LLW that is ultimately intended for disposal at a land disposal facility; establish a set L
of fonns that allows LLW to be tracked from its origin, and serves as a national Uniform Low-Level Radioactive Waste Manifest to meet NRC, Dip ius.st of Transportation (DOT), and State and Compact information requirements; require LLW disposal site operators to electronically store container-specific manifest information; and require the disposal site operators to be capable of reporting the stored Uniform Manifest information on a computer-readable medium (e.g., magne'.ic disks or tapes).
l 60FR25983/fhis document corrects a notice appearing in the Federal Register on March 27, 1995 (60FR15649). The action is necessary to correct an error of omission. The text of paragraph III E to Appendix G to Part 20 was inadvertently omitted from the codified text of the final rule. The wording L
for this paragraph is identical to the existing correspondmg paragraph III E to Appendix F to Part 20.
L The text paragraph was not changed in the proposed rule and should have been repeated verbatim as part of the new Appendix G that was added in the final rule.
E]LC NMRPR 60FR15649 (20.2006-
$438, page 4-32
{20.2101
$440, page 4-34 Appendix G to 10 CFR Part 20 5466, page 4-141 Q61.12; 661.80 -
{1305.N (new text), page 13-6; {l334.C., D., E., F., G., H., I., and J., reflects current text from {61.80, page 13 24...
m co
=
O m
-7 7
Ic 9
9 1
\\
-1 B.
Excreta fmm individuals undergoing medical diagnosis or therapy with radioactive 2
material are not subject to the limitations contained in Q435 A.
3 436.
TREATMENT OR DISPOSAL BY INCINERATION. A licensee or registrant may treat 4
or dispose of licensed or registered material by incineration only in the form and concentration 5
specified in Q437 or as specifically approved by the Department pursuant to Q434.
l 6
437.
DISPOSAL OF SPECIFIC WASTES.
7 A.
A licensee or registrant may dispose of the following licensed or registered material 8
as ifit were not radioactive:
l 9
1.
0.05 Ci (1.85 kBq), or less, ofhydrogen-3 or carbon-14 per gram ofmedium 10 used for liquid scintillation counting; and i.
11 2.
0.05 Ci (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of animal
~12 tissue, averaged over the weight of the entire animal.
l 13 B.
A licensee or registrant shall not dispose of tissue pursuant to Q437 A 2 in a manner l
14 that would permit its use either as food for humans or as animal feed.
15 C.
The licensee or registrant shall maintain records in accordance with Q448.
16 438.
TRANSFER FOR DISPOSAL AND MANIFESTS.
17 A.
The re.;i ata ef QC sd Appa.dk 0 c.rc de;igned :s w..;..! :rnefer; ef kw-18 kvc: redisec:ive w=; in s_-i ' fu dhpcal et a naneei kw-kv;! redbadv; we;;c dispese:
19 faility, c bibh a ur.nif tre;Eng ;y;;;m, sd ; yrkma. ;nb;hg re i... a.:s coacrabg 20-
- ..sfer; and I;;ad.eepbg fa ise; w e. ee.
21 3.
Eech ;tJ...a.: ef redientive w=; de.igne;;d fa db seal at a licenad kw-Icvc r
y 22 redbade; wi;;c dbpeu! fuln y i ' te ecce...ya.kd by a eidy. en manif ; es spuined in 23 S;; den I of Appa.dk O.
l l
24 C.
"=' d:;n= -
n'....i.".t
....e-.t.,--... -..,......,- _--
a
^ ' ' ' '
25
.y..-. -.--
l 26
"__'.y.--.-..'....'..."^.'..'.".,.'...y-'-'."....y-..*..,
^n.
L 27 hchd=;i; wr.m=
a, w ":;ence:.r, w=; y..se.,2d dkpea! faility epue;a, she::
j l
28 l
an.y y wit i; sq.d.
.a.:. ; pained in S=bn III of Appa.dh 0.
l 29 mal 466) 30 es6 20 NMAC 3.1 4-32 Revision Date
[;
l 1
1
4
'I W
MfMMMMJedeggtive waste by any waste 2
MMM.MhM1MeetA% aubps4 who stups 3
tiggt.gpegner, to a 5
E 6
g
?
7
'~
'g' 4 g 8
g
. ygg 9
$pstjqq q pJ g _
7 g.g, 10 QQ,,
- py 44 11 6 1.
B.2 of this 12 sosties 13 g;
1;
.gg 14
,.j 15 m
~
16 3
17
'18 i.
'ge, 19 20 o
21 22 g
23
.W_ generator as j
.-Sea paragraph 24 25 g-.
.me 26
,ude 27 28 29 439.
COMPLIANCE WITH ENVIRONMENTAL AND HEALTH PROTECTION 30 REGULATIONS. Nothing in {433, {434, Q435, Q436, {437, or Q438 relieves the licensee or 31 registrant from complying with other applicable Federal, State and local regulations governing any 32 other toxic or hazardous properties of materials that may be disposed of under Q433, Q434, 5435, 33
{436, {437, or Q438.
20 NMAC 3.1 4-33 Revision Date
i
,1 440.
RECORDS / GENERAL PROVISIONS.
1 2
A.
,byil438A, each 3
liosamengt SI ra; becquerel, gray, sievert 4
and coulomb per kilogram, or M the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required 5
6 by Subpart 4.
t 7
B.
The licensee or registrant shall make a clear distinction among the quantities entered
)
8 on the records required by Subpart 4, such as, total effective dose equivalent, total organ dose 9
equivalent, shallow dose equivalent, eye dose equivalent, deep dose equivalent, or committed i
10 effective dose equivalent.
l l
11 441.
RECORDS OF RADIATION PROTECTION PROGRAMS.
12 A.
Each licensee or registrant shall maintain records of the radiation protection program, 13 including:
j 14 1.
The provisions of tiie program; and
.)
15 2.
Audits and other reviews of program content and implementation.
I l,
16 B.
The licensee or registrant shall retain the records required by {441 A 1 until the l
17 Department terminates each pertinent license or registration requiring the record. The licensee or 18 registrant shall retain the records required by Q441 A 2 for 3 years after the record is made.
pj6 suuV'& A fas MO.d.
4e.A. un M M.1W G.,v o Ic. es 5 "
y 440. 4 1
I l
l' 20 NMAC 3.1 4-34 Revision Date l
O
l 16 l
i t l
- f M
l.
1-w 2
.1 t
i 3
+'AND m
i l
4 A.
Mauts 5
1; M
,ygggtsuggyes, or ofnns for l
6 6y6 3,W low-level 7
%gM 3150-0164, 8
MM (Unifmn l
9 10
~
. g. Level
.le 11
,1 -.
12 t
13
~ _
and i
14 t
15 l
16 7.
17 6
i i
18 g
kpesange under their 19
. C;;;- A 20 3
i-
- .is,the " waste
. / _..
21 22 g
a n
that 23 24
-;3
__, i., l 25
. aggess, 26
- .y -
l 27 g
.... ying 28
- .. Brunoh, 29 30 6
Vda$m 31
' " of 32
- Jlmeste, 33
,M1 20 NMAC 3.1 ~
4-141 Revision Date 1
1 l
o M
M
\\
1 2
jkk a'
,,- w ge 3
4 5,
WMggdemnisiens apply:
l 5
NMte.smukausamingAs that given in Sec. 61.2 of l
6 EauMhqpeur.
7 E
chemical l
8 9
5 10 11 3
12 m
13 g
j_
.4
...l:
. 1 6, ender a 14 6_ :.,
._e(guguipmaant 15 pusposes 16 eM',.._
f.
17 psed to confine I8
.soe "high 19
~
20 6
21 g
22 23 3
=
24
- jan 25 26 mettdes).
27 l
. ' ?@ aammonly 28-
.and to meet 29 1
20 NMAC 3.1 4-142 Revision Date l
0 M
M 1
3 2
6 ahesin s.c.
3 3
g 4
Poemsjeg$ sensed gya g 5
assur,memensp; e..
, en,ey, 6
sis % M W autsensigase, NRC Fonas 7
M1;$uus.pnApagub(WB_
M, and M in 8
skMegudera aosurate, and 9
emag$ppph 10 g
11 A
'~
12 13 l
+
s 14
~
15 g.
16 3
.nssches 17 sqjesy:
yte-les: pusoessor or 18 66 19
, weste
~
20 es4sygggg.
.typeosily l
~21 22 6
facihty s,
i 23 5
24 i
25 g
26 M
j sf l
27 3
- 28
'f06 29 g
atanifonn 30 31 M and their 20 Nh1AC 3.1 4-143 Revision Date
986 M
r
\\
I l
ij. -
i,y 2
3 ey Mhm 4
5 g
MMp and sedmiogioel 6
deusdption((
7 g,
g gegeraCmmnimainn or 8
Apennualdtps.W' vity 9
ar. ',.
_ this
{
10 1
.gr 11 12 L,
13 14 g
15 erl...
16
~
17 limagend 18 g
tunneminer having a 19 erswaste sorbed 20 an-21 g,
M 22 g
~
23
~-
- shidl 24 g
25 6
l 26 g
l-27 gfthe i
28 6
29 g
name and 30 20 NMAC 3.1 4-144 Revision Date l
e
1
^
4ss, m I
g l
2
... p' aham 3'
g
)
4 (3) containers; 5
g aggitsegenawege,s ightiethe r,__---:,
6 g
,g 7
3
,, f M, To 99, and 8
kt3R_6 l
l 9
3 l
10 i
11 g
12 6..
~
g 13 weste 14 g
unspelyidentifies 15 assh W 6 l
l 16 3
mehuhusthe 17
~
-'r
- as 18 3
c 19 20 l
21 l
i 22 3
I 23 g
24 ana%
gg 25 assut; i
26 g
)
l 20 NMAC 3.1 4-145 Revision Date
)
4 M
M 1
E identity of 2
the 3
M h udes 4
osaminedM
- masenal, 5
eas w.,a 6
matensis, es6 q;esusaggedosa, and wastes in 7
hHdes associated 8
wish orsesNM6ANshshe aposeed; 9
g g
10 g
. g.,
11 af '
,)
E 12-13 g
14 15 16 g
asweste; 17 g
I8 3
- if the cholating 19 assetomaneds;...
20 g
sjassiAcation 21 pts)dity
.7 22 23
.y 24
+. mad 25 26 g
- 7 '" anaximan 27 28 g
happlies 29 todispeedi;
. 4(Note:The 30 o@ ;< J
. p or 'nore l
l 20 NMAC 3.1 4-146 Revision Date
-a
l 9m M
1 g
l 2
. p 3
,t 4
- @es incinemtor ash, 5
povidoens;westeeqsqut$st_
Why attrheesd W 6
enehgsangsum 7
g P)er_M afm such as the. combined 8
Podestupse M anf.
ii 9
,1 ARGE88 ** t 8Posal I
10
, _p l
11 E
12 13 g
l 14 g
i 15 16 g
istany l
17
- Mr@ identity of the l
18 pdesqughesitugqqpg 19 3
yany,.and the 20
,c_
21 l
22 g
em j
23 af 24 25 g
26
~4lse 27 essenism ser 28 the 29 f.
damee the 30 31 S,
6 20 NMAC 3.1 4-147 Revision Date
466.
N 1
N NguendusMaugets_tealandidispenal facility or a 2
licensed 6augg$4vuldt $he sagdujeggNitganguqins.l.a Queugh 1.i of this 3
sectism.a.6,segerte 4 h for wests temmamant or 4
M:1.i.eftis saaden. A 5
licemessetuet 6
g e, sec.
7 MM _ ' ~,..
8 E
- J.
9 10 k,i.
[ '.with 11 BenL_ 6 12 g
emmplinessimidt Seas.
13 61.55 and 61_.96 ef.h, esaudies);
14 Wuutaadimifestas 15 menissety,semamunga 16 g
4.mel 17 18
$1he 19-20 g
,,,,,,,,,.4A.,_
21 l
22 g
23 ofa, 6
. interiorm j
24 3
lI mr4evel 25
.sessed of 26
.. and l
28 29 30 3
20 NMAC 3.1 4-148 Revision Date l
)
886 m
)
1 E
(
unse 2
of 3
W that mostthe 4
seguissegues ofwests in 5
the shipsess; e.aasemW44emmassnagenestelumessrm 6
gengym'q;gue Uniform Low-Level c.
7 Radioastavs Waupp,6gheRMehscMW of the manifest posednemwu/_
en wesesatthe tiump :.
10 g
y 11 12 g
13 et j.
L 1,.
14 g
15 Radinastus-
~ ente sessed of 16 trauduref
- dageur, 17 g
MMMMylWW,for which 18
..tiis appendix, 19 oseductW 20 g
21 22
. has not the 23 m
24 3
i l
25 g
A 26 of ene week j
3 27 3
Jigsendex.
)
28 29 these alem 30 1
o
.. A.6.e I
31 a( M I
20 NMAC 3.1 4 149 Revision Date
M 1
g
. gg, 2
61.35 3
thClass A waste, 4
Class R wasta, er(Busscipussing4ppgegegggggan.45Weems;4E57 of this chapter, 5
esqueuesesempuance with Secs.
6 61.55 asul 61-evaluation of.ambes);
7 g
g Uml>=n Law-Level 8
i
,. ganamfest 9
10 at the I1 3
... gg 12 13 g
14 DWiefemin 15
.sgggis,UmuunfImw-Level 16 Rennestiwo.
.W,m the record of 17 tunediref
, sed @9aftnisahapter, 18
)
,~
gggggh; for. which 19 c-
.M 20 l
21 5
22
.ast 23 24 6
l l
25 g
l l
26 g
~
.gget-of neoeipt by 27 c.
toboastified l
28 ism
, If any 29 f.
. hianifest t-30 an(. -
31 6
20 NMAC 3.1 4-150 Revision Date I
i
9 405, 6 1
B store 2
ths '
tinames;and
..t.
..L 3
M Cemsnission 4
.sgional6Q(6 g af a; shipment,' has not 5
g arived6 tydas shipper that the 6
shipunent -
7 5.
MM orpt.a'shipusepagint which animowledgernent is not 8
received withisensWin.W 9
g mhht es;est received h
10 l
11 N
\\
12
.8ss 13
_ BW 14 l
l I
20 NMAC 3.1 4-151 Revision Date
)
pg :
1 H.
An identification of the known natural resources at the disposal site, whose
-2 exploitation could result in inadvertent intrusion into the wastes after removal of active institutional 3
control; 4
I.
A description of the kind, amount, classification and specifications of the radioactive 5
material proposed to be received, possessed, and disposed of at the land disposal facility; l
6 J.
A description of the quality control program for the determination ofnatural disposal -
7 site characteristics and for quality control during the design, constmetion, operation, and closure of 8
the land disposal facility and the receipt, handling, and emplacement ofwaste; audits and managerial 9
controls must be included; 10 11 K.
A description of the radiation safety program for control and monitoring ofradioactive 12 effluents to ensure compliance with the performance objective in 61317 and occupational radiation.
13 exposure to ensure compliance with the requirements of Subpart 4 ofthese regulations and to control l.
14 contamination of personnel, vehicles, equipment, buildings, and the disposal site; both routine
]
15 operations and accidents shall be addressed; the program description must include procedures, i
16
. instrumentation, facilities, and equipment; i
^17 L.
A description of the environmental monitoring program to provide data to evaluate I
18 potential health and environmental impacts and the plan for taking corrective measures if migration 19 is indicated; and t
20 M.
A description of the administrative procedures that the applicant will apply to control l21 activities at the land disposal facility.
$$$@@MMMM!M$$dEMMliM 22 l
23 1306. TECHNICAL ANALYSES. The specific technical information shall also include the 24 following analyses needed to demonstrate that the performance objectives ofthis Subpart will be met:
25 A..., Pathwaysanalyzedindemonstratingprotectionofthegeneralpopulationfromreleases 26 of radioactivity'shall include air, soil, groundwater, surface water, plant uptake, and exhumation by i.
27 burrowing animals. The analysis shall clearly identify and differentiate between the roles performed
- 28 by the natural disposal site characteristics and design features in isolating and segregating the wastes.
29 The analysis shall clearly demonstrate that there is reasonable assurance that the exposure to humans 30 from the release of radioactivity will not exceed the limits set forth in ll317; 31 B.
Analysis of the protection ofindividuals from inadvertent intrusion shall include 32
. demonstration that there is reasonable assurance the waste classification and segregation requirements 33
.will be met and that adequate barriers to inadvertent intrusion will be provided; 34 C.
Analyses of the protection ofindividuals during operations shall include assessments 20 NMAC 3.1 13-6 Revision Date iL________________
3
I l1 B.
Subsequent changes to the binding arrangements specified in {l334 A relevant to 2
institutional control shall be submitted to the Department for prior approval.
3 1334. MAINTENANCE OF RECORDS, REPORTS, AND TRANSFERS.
4 A.
Each licensee shall maintain any records and make any reports in connection with the 5
licensed activities as may be required by the conditions of the hcense or by the rules, regulations, and 6
orders of the Department.
7 B.
Records which are required by these regulations or by license conditions shall be
,8 maintained for a period specified by the appropriate regulations or by license condition. Ifa retention 9
period is not otherwise specified, these records must be maintained and transferred to the ofHeials 10 specified in { l334 D as a condition oflicense temunation unless the Department otherwise authorizes 11 their disposition.
12 C.
Records which shall be maintained pursuant to this Subpart may be the original or a 13 reproduced copy or micro 61m if this reproduced copy or microfilm is, capable ofprodu '
a copy 14 that..i.y.pys clear a:nd.gy..:. ble at th.e end.,.-e. yof the re:a.:s,p suired reten. tion-
'od.
~
I
.:.3:e -
.g g sw w.
-g
- n..
..c f
18'
' al g adiels a M M [
lan# M '
s i
E saiimII "M5 21 Rir$65(bes$$pe41Q9ehl% tike $dWlWistfgehalleeperiod speeWellistlesW 22 B5.
Notwith*=neEaggl334.A thmugh OE, wpies ofi, vide of 65$i$iEIEidNIIrNoni 23 the location and the quantity of $bMIdi$i wastes contained in the disposal site no,ei im ti neren mi MjA5Ii$iMM upon license termination to the chiefexecutive of the nearest municipality, 24 25
. the chief executive of the county in which the facili is I the coun zo '
board or lan,d 26 de
.and agency,thestategovernor
~
wn n
27 and the Department at the time oflicense termination.
28 F
and acceptanceofa shipp'ofMl waste,theticenseeshall
~
29 record gg- - ~ >
m.
s.,.:.w.,,,
yM:ye::
_ _ ;y the date ofdi ofthe waste, 31
'~
the location if
- 1. agasse rat _.;.Wg-?9overpack.
^v.
30 u
in the disposal site, the wr Hi,en 32 of the waste Wa IGEhlgel' as received discrepancip
~
- ~s 33 bet;ca.a materials listed on the manifest and those received, er g
35 and any evidence ofleaking or damaged sk s f,4,,
36 or radiation or contamination levels in excess oflimits specified in U.S. Department of
& Q.f m llO1. MsJ bib 13-24 h% (, J.30 Revision Date 20 NMAC g
1 l
IMy, C.
fpL IkW~b. **
_ e=<J ase k
-e t w d.
s
Transportation and Depanment regulations. The licensee shall briefly describe any repackaging 1
operations ofany ofthe s w yy[ disp 6LicomialasN included in the shipment, plus any other 2
3 informationyuged by the Department as a license condition. I$dliesNiEMinBNi inididaiE55 IidiiMDepedbleiftsiliairis$iinndfiistSMioidsihidiEihastseenistivitiesdesatedMihii 4
5.
Esotics*.
IN.
Each licensee authorized to dispose ofi$$E$i$ifi waste received from other persons 6
7 shall file a copy ofits financial report or a certified financial statement annually with the Department 8
in order to update the information base for determining financial quali6 cations.
GiI.
Each licensee authorized to dispose of waste IEi$iIii$ received from other persons, 9
l.
10 pursuant to this Subpart, shall submit annual reports to the Department. Reports shall be submitted 11 by the end of the first calendar quarter of each year for the preceding year; l
12 1.
The reports shallinclude:
1 i
13 a.
specification of the quantity of each of the principal contaminants "M released to unrestricted areas in liquid and in airborne effluents during the prWina l
14 l
15 year; I
16 b.
the results of the environmental monitoring program; I
l 17 c.
a summary officensee disposal unit survey and maintenance activities; e
I8 d.
a summary, by waste class, ofactivities and quantities ofradionuclides 19 disposed of;
~
l i
20 e.
any instances in which observed site characteristics were significantly 21 different from those described in the application for a license; and 22 f.
any other information the Department may require.
23'
' 2.
If the quantities ofwaste @*iTm@ifl released during the reporting
- 24 period, monito '
resul.or maintenance *erformed are sienifir**1y different from thoserJMM,
~~
25
.. J*
.'[
L liefjEi?NMM the report must 26 specifically address those differences 27-
"isidd5W M M M [o M M M h$
20 NMAC 3.I 13-25 Revision Date I
u
m
-,,nn,ibst afbnnstion that must b fm e a r - m a,m a n. w m n n n,d is!
mu 1
E.,,,h.
ment
, e
-- -4fgstore.
g emmaw!T"*h.. tve:
ta-u;ysy+
t my 4me~ev~nw -emt 7*
ve n+
a.tregulped. i.n.Subpe:nnr*w-tm.mann~duc G+en ~'.repdations ws.~tht 2
- nomme M;andlceeder tel,ephone mamhers andlWan~;._ d..thos;e:e m.~..sst4 Appen
~
3 exceptionW nd 3
k9"a'd"iTh"at. "n""ib"rus"t*oa"m"*u"ste"d*u"i;*p" ara"g' "ra'p'hf o*~~thiy~ectios",'
~
~~~
~ ~ ~ ~
4 d
s s
f.
mmemme-rnmn-,- m,nn
-,,wx,,,,_-,._._
h 5'i-.d17?WTMyT?hTMWrinationL(pubpagg'gis.M:WpampenwW Wi 6
s Y
l
\\
20 NMAC 3.1 13-26 Revision Date a - _ _ _ _ _ _ _ - _ _ _ _ _ - - - - - - - - - - - - - - _ - - _.. - - - - - - _ _ - - - _ _ - _ - - - - _
Y
\\
COMPATIBILITY AMENDMENT #6:
Titig: Frequency ofMedical Examinations for Use ofRespiratory Protection Equipment,10 CRF Part 20 Federal Renister: Volume 60, No. 28, February 10,1995 (60FR7900)
Due Date: March 13,1998 t
Rationale-The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the frequency _ at which medical fitness determinations are required to ensure the safe use of respiratory protection equipment. Section 10 CRF 20.1703(a)(3)(v) currently requires the determination by a physician prior to initial fitting of respirators, and at least every 12 months thereafter, that the individual user is physically able to use the respiratory protection equipment.
The amended rule requires
' determination by a physician prior to initial fitting of respirators and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment. The final rule reduces the burden on licensees without adversely impacting public health and safety.
NRC NMRPR
.{20.1703
$423.A.3.e, page 4-23 4
'/
C3 0
l Q:n l
T #
3e.
t' s
r.
(
l i
I
l i
1 423.. USE OF INDIVIDUAL RESPIRATORY PROT 2'
A.
If the licensee or registrant uses respiratory protection eq 3
pursuant to f422:
ntakes 4
1.
respiratory protection equipment that is tested a 5
6 NationalInstituteforOccupationalSafetyandHealthandtheMine ne y the 7
and m n stration;
{
a.
2.
4 certified by the National Institute for Occupational 9-10 Administration has not had certification extended by the National 1n yand Health 11 and Health and the Mme Safety and Health Administration, o upational Safety 12
' testing or certification provided the licensee or registrant has submit e u e or 13 demonstration by testing, or a demonstration epartment and the 14-n, m' cluding a 15 performance characteristics of the equipra- -
e materialand 16' protection under anticipated conditions of the proposed degree of 17
/
3.
Thelicenseeorregist is program that includes:
inarespiratoryprotection 19' air sampling s a.
2o equipment selection, and estimate exposures alhazard, permit proper 21 b.
surveys and bionssays, as appropriate, to evaluate actual inta 22 testing ofrespirators for operabilityimmediately prior to ea c.
23 d.
and testing ofrespirators, including testing for opera
'24
-25 and training ofpersonnel; monitoring, ind-Hag air sampling and s on
- and
{
26 e.
determination l
and sticast Eevery 12 months thereafter sician 'or to $ initial fi
- of.r
- irators, 2 7. -
28 that the individual user is physically able 4 to use the respiratory protection equipment.
29.
a 4.
The licensee or registrant shall issue a written policy state 30 usage covering:
k l
31 The use ofprocess or other engineering controls, instead of l
a.
$ /f()d l
20 NMAC 3.1 A>,/743 Revision Date v
\\
_.p C
l Il
.b
}
- v.
y
/
. COMPATIBILITY AMENDMENT #7:
Iitic: Radiation Protection Requirements: Amended Definitions and Criteria,10 CFR Parts 19 and 20
{
F~Iaral Raniatar: Volume 60, No.134, July 13,1995 (60FR36038)
Due Date. August 14,1998 4
Rationale The Nuclear Regulatory Commission (NRC) is amending its regulations to revise the radiation protection training requirements so that it applies to workers who are likely to receive, in a year, occupational dose in excess of 100 mrem (1 mSv); revise the de6nition of" Member of the public" to include anyone who is not a worker receiving an occupational dose; revise the definition of" Occupational l
- Dose" to delete reference to location so that the occupational dose limit applies only to workers whose assigned duties involve exposure to radiation and not to members of the public; revise the definition of "Public Dose" to apply to dose received by members of the public from material released by a licensee or from any other source of radiation under the control of the licensee, assure that prior dose is determined for anyone subject to the monitoring requirements in 10 CFR Part 20, or in other words, anyone likely to receive, in a year,10 percent of the annual occupational dose limit; and retain a requirement that known overexposed individuals receive copies of any reports of the overexposure that are' required to be submitted to the NRC. This change highlights a requirement which requires licensees to inform members
)
of the public that they have been overexposed. These amendments are necessary to clarify criteria that i
determine when radiation protection treioir.g is required and to restore a noti 6 cation requirement.
HEC NMRPR
]
. {19.12.
g1002.A.I.-6., {1002.B, page 10-2 J
- 620.1003 6106.BK, {106.BR, page 1-8; {l06.CA, page 1. 620.2205 f457.B, page 4-42...
t
?
I 1
I i
l response, if any, shall be posted within two worxing days after dispatch from the licensee or i
regir,trant. Such documents shall remain posted for a r'inimum of five working days or until action 2-3 correcting the violation has been completed, whichever is later.
4 1002. INSTRUCTIONS TO WORKERS.
w mnm mm 5
A.
Allindividuals utkwdemmunMe Jame likely to receive S~i a year an a be~ course 6
~occupationaldosekMidesdMjNharedkkE8dsN.:
7 1.
shaEbe Kept informed of the storage, transfer, or use of wnim of radiation i
kkMiihthigl in the licensee's or registrant's work place; l
8 9'
2.
shaEbe Instructed in the health protection problems associated with exposure l
10 to i.ucli i=d;e+dve nieie 1 si i.diei;en 1016 ;>>dividwiJ sad yvi=>iLJ OLy>;us "MMi$NN M3iijli$ii, in precautions or procedures to minimize exposure, and in the purposes and 11 12 functions ofprotective devices employed; 13 3.
shaEbe Instructed in, and in.in ucimi required to observe, to the extent within 14 the worker's control, the applicable provisions ofthese regulations and licenses for the protection of 15 personnel from exposure to radiation ENEor radioactive material; 16 4.
si.idi M Instructed of their responsibility to report promptly to the licensee or 17 registrant any condition which may constitute; lead to or cause a violation of the Act, these 18 regulations, and licenses or unnecessary exposure to radiation hiiitfor radioactive material; 19 5.
shaEbe Instmeted in the appropriate response to warnings made in the event 20 of any unusual occurrence or malfunction that may involve exposure to radiation Etikor radioactive 21 material;'and 22 6.
.:.;; k Advised as to the radiation exposure reports which workers sha&be 23 fuirJelei may request pursuant to {1003.
~
~'EkiiiIIIN@@jg@$ES$
24 B.
1 %geilla g
27
. Adlisyl The extent of these instructions shall itinst be 28 commensurate with potential radiological health protection problems present in the work place.
4 29 1003. NOTIFICATIONS AND REPORTS TO INDIVIDUALS.
30' A.
' Radiation exposure data for an individual and the results of any measurements, 31 analyses, and calculations of radioactive material deposited or retained in the body of an individual 32 shall be reported to the individual as specified in {l003. The ' formation reported shall include m
$ NO$
I 20 NMAC 3.1 10-2 y /gg g,f, g, Revision Date l
/w14.
l
4 i
1 BI.
- Lostormissingsourceofradiation"meanslicensed(orregistered]sourceofradiation 2
whose location is unknown. This defmition includes but is not limited to material that has been 3
shipped but has not reached its planned destination and whose location cannot be readily traced in 4-the transportation system.
5 BJ.
" Major processor" means a user processing, h=dling, or manufacturing radioactive 6
material excMing Type A quantities as unsealed sources or material, or exceeding 4 times Type B 7
quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial
-8 radiographer or small industrial programs. Type A and B quantities are defmed in Section 71.4 of 9-10 CFR Part 71.
~10 BK.
" Member of the public" means an (in) individual except when that individual is Lil receiving an occupational dose.
12 BL.
" Minor" means an individual less than 18 years of age.
13
- BM.
" Mixed Waste" means waste that contains both hazardous constituents regulated under 14 the Resource Conservation Recovery Act and radioactive constituents regulated by these regulations.
15
. BN.
" Monitoring" means the measurement ofradiation, radioactive material concentrations, 16 surface area activities or quantities or radioactive material and the use of the results of these 17 measurements to evaluate potential exposures and doses. For purposes of these regulations, 18
." radiation monitoring" a:xi " radiation protection monitoring" are equivalent terms.
19 BO.. "NARM" means any naturally occurring or accelerator-produced radioactive material.
20 It does not include byproduct, source, or special nuclear material. (NARM refers only to discrete 21.
sources ofNARM.)
22 '
BP.
" Natural radioactivity" means radioactivity of naturally occurring nuclides. NARM 23 refers only to discrete sources ofNARM.
24 BQ., " Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory
- 25. -
Commission or its duly authorized representatives.
26
' BR.
"Occupidies.1 dose" means the dose received by an individual in the course of 27
' anployment in which the individual's assi duties foi de 6---- vi iinvolve exposure 28-to.vv.w. efradiation f
~. [T [7.L;f7" E'[ie.v.u~ ' [Mi$lliO5n,
-29 whether vi i 4 de -w. eri J;.6,e e in the possession of the licensee, registrant, or other p
30 person. Occupational dose does not include dose received from radiati er.y.g.j L
31
. Ov-. eA
- ^ -
isspessee 32~
4 or from 33
~ voluntary participation in medical research programs, or as a member of the public..
V.
n..am 1
20 NMAC 3.1 1-8
/e66 R
. Revision Date lals'I b*
106 CA j
h (ky F6a. h i
l
- a oHw ft.
1 p
[
l
q t
1 l
l
.I BS.
" Ore refineries" means all processors of a radioactive material ore including uranium
' mills or other source material extraction facilities.
2.
i 3
BT.
" Package" means the packaging together with its radioactive contents as presented 4
for transport.
5 BU.
" Particle accelerator" means any machine capable of accelerating electrons, protons, 6
- deuterons, or other charged particles in a vacuum and ofdischarging the resultant particulate or other 17 radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, 8
" accelerator" is an equivalent term.
9 BV.
" Person" means any individual, corporation, partnership, firm, association, trust,
- 10 estate, public or private institution, group, agency, political subdivision of this State, any other State 11 or political subdivision or agency thereof, and any legal successor, representative, agent or agency L
12 of the foregoing, but shall not include federal government agencies.
13 ~
BW.
" Personnel monitoring equipment" [See Individual monitoring device").
.14 BX.
Pharmacist" means an individual licensed by this State to compound and dispense 15 drugs and prescriptions.
l 16 BY.
" Physician" means anindividual licensed by this State to prescribe drugs in the practice
. 17 ofmedicine.
i 2
l Bi504 "Public dose" means the dose received by a member of the public from exposure tom sourc$ to radioactive material released by the $ licens t
23 exposure to radiation and 24l es ofradiation o.M in i;w M ur 4.i..i ey..iieu. under the control 25 of a licensee or registrant. Public dose does not include occupational dose or doses received from i;e.eOving+$Qp.
. M W iiiidisal 26 bac A -.
- 1 M.e e S$EEEdiNN@iiMIiidiNisi'reilidicd5 j
27-l 28-ljit$$3lM or dose from voluntary participation in medical 29
' ruan programs.
- 30 CA$. "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air f
- 31 at or below 130*F (54.4"C) or any solid material, other than one classed as an explosive, which under
(
32 normal conditions is liable to cause fires through friction, retained heat from manufacturing or 33 -
processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently 20 NMAC 3.1 1-9 Revision Date e
1 l q[ ' '
l-i
4 l
Activity' 1-Radionuclides Ci GBq 2
37 3
37 s4 Gold-198 100 3,700 5
37 6
Iridium-192 10 370 7
1,000 37,000 8
Promethium-147 10 370 s
9 Technetium-99m 1,000 37,000 10 The Depanment may require as a license condition, or by rule or regulation, 11 reports frcm licensees or registrants who are licensed or registered to use
-12 radionuclides not on this list, in quantities sufficient to cause comparable 1
<13 radiation levels.
14 B.
Each licensee or registrant in a category listed in $456 A shall submit an annual report 15 of the results ofindividual monitoring carried out by the licensee or registrant for each individual for 16 ~
whom monitoring was required by 6417 during that year..The licensee or registrant may ' clude m
17-additional data for individuals for whom monitoring wra provided but not required. The licensee or 18' registrant shall use Department Form NMED 013 or equivalent or electronic media containing all the 19) information required by Department Form NMED 013.
20:
C.
The licensee or registrant shall file the report required by %456 B, covering the
'21
prWing year, on or before April 30 of each year. The licensee or registrant shall submit the report 22 to the Depanment.
23 457.
NOTIFICATIONS AND REPORTS TO INDIVIDUALS.
24 A.
- Paquirements for notification and reports to individuals of exposure to radiation or
- 25 radioactive material are speciSed in {l003 of these regulations.
26
. a B; When a liceraee or registrant is required pyrsuant,'to["$((353, MM 27 to to the exposure of an
~ ' ;'
'l 1 J L. ~ T individual, 28-
,' to radiation or radioactive. material,.,e licensee or registrant th IdI0IliiesAdiiM the individual. Such 29' shall also notify FA w n
-20 NMAC 3.1
- 24. 2 M d A
Revision Date l
b
3 S-noticeshsH MTeili[4 be transmitted at a time not later than the transmittal to the Department,
' 1:
2-l and shall comply with the provisions of fl003 of these regulations.
t I
f' t
COMPATIBILITY AMENDMENT #8:
L Iitis: Medical Administration of Radiation and Radioactive Materials,10 CFR Parts 20 and 35 Federal Raoid". Volume 60, No. I82, September 20,1995 (60FR48623)
Dug Date October 20,1998
< Rationale: The Nuclear Regulatory Commission (NRC) is amending its regulations. to clarify that the
- medical administration of radiation or radioactive materials to any individual, even an individual not supposed to receive a medical administration, is regulated by the NRC's provisions governing the medical use of byproduct material rather than by the dose limits in the NRC's regulations concerning standards for protection against radiation. The rule does not represent a change in policy, but is necessary to indicate clearly that this is the NRC's policy and to clarify the relationship ofNRC's regulations.
NILC NMRPR 520.1003
$106.BR and $106.CA, pages 1-8 and I-9; changes done under 60FR36038 (subset #7), and contain most current text
{20.1301 (413.A.1, page 4-12 535.2
{701.J.l.a,
{701.J.2.a,.. 6701.J.3.a,
$701.J.4.a.
{701.J.5.a, -
6701.J.6.a. and b,, page 7-6
\\
{35.33 8702.G, page 7-17; amended under 59FR61767 i
.y u
Om 7
]
w S
l 1
1
I t
1
. Bl.
' " Lost or missing source ofradiation" means licensed [or registered] source ofradiation l
2 whose location is unknown. - This definition includes but is not limited to material that has been 3
shipped but has not reached its planned destination and whose location cannot be readily traced in 4
the transportation system.
5 BL
" Major processor" means a user processing, handling, or manufacturing radioactive L
6 material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B
'7 quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial 3'
radiographer or smallindustrial programs Type A and B quantities are defined in Section 71.4 of
~9.
10, BK.
" Member of the public" means an $5) individual except when that individual is 11:
' receiving an occupational dose.
I 12 BL.
" Minor" means an individual less than 18 years of age.
13-BM.
" Mixed Waste" means waste that contains both hazardous constituents regulated under 14 the Resource Conservation Recovery Act and radioactive constituents regulated by these regulations.
15 BN.
" Monitoring" means the measurement ofradiation, radioactive raaterial c==*ations,
)
l 16 surface area activities or quantities or radioactive material and the use of the resuus of these
)
17 measurements to evaluate potential exposures and doses. For purposes of these regulations, 18
" radiation monitoring" and " radiation protection monitoring" are equivalent terms.
19 BO.
"NARM" means any naturally occurring or accelerator-produced radioactive material.
20' It does not include byproduct, source, or special nuclear material. (NARM refers only to discrete 21 sources of NARM.)
22 BP.
" Natural radioactivity" means radioactivity of naturally occurring nuclides. NARM L
23.
refers only to discrete sources ofNARM 24 BQ.
" Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory 25-Commission or its duly authorized representatives.
26
. BR.
" Occupational dose" means the dose received by an individual in the course of 27 employment in which the individual's assigned duties for A 41 ei rey 4 involve exposure 28 to r.vo.e ofradiation M9filidiisisididif5NINe$iiiIjikis]il$5iiina, l
129 whether v i.wi G
- erri.d;.a;oo.ie in the possession of the licensee, registrant, or other l
30 person Occupationaldoseg^notincludedosereceivedfrom radiatio vi
. p^ "a j
'jdeniilisiiihiiE~
~
'31 fier.. iiC y.G 32 k liibil i i W ' ' ~
i[i ".3nsierials$if.'^
47053) or from 33 voluntary participation in medical research programs, or as a member of the public, i-20 NMAC 3.1 18 Revision Date l
1 BS.
" Ore refineries" means all processors of a radioactive material ore including uranium 2
mills or other source material extraction facilities.
3 BT.
" Package" means the packaging together with its radioactive contents as presented
'4l for transport.
5 BU.
" Particle accelerator" means any machine capable of accelerating electrons, protons, 6
deuterons, or other charged particles in a vacuum and ofdischarging the resultant particulate or other 7
radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, 8
" accelerator" is an equivalent term.
9
- BV.
" Person" means any individual, corporation, partnership, firm, association, trust, 10 estate, public or private institution, group, agency, political subdivision of this State, any other State 11 or political subdivision or agency thereof, and any legal successor, representative, agent or agency 12 of the foregoing, but shall not include federal government agencies.
13-BW.
" Personnel monitoring equipment" (See Individual monitoring device").
14 BX.
" Pharmacist" means an individual licensed by this State to compound and dispense 15 drugs and prescriptions.
16 BY.
" Physician" means an individuallicensed by this State to prescribe drugs in the practice
-17:
ofmedicine.
I
-n w_-
,n
~~.
L 20 :
~
IMnedvisestfiel88MisiMecentalhinedion$6s r
22 BM "Public dose" means the dose received by a member of the public from exposum to"M sourc$ to radioactive material released by the l license 23 exposure to radiation and 24 esofradiation underthe control 25 of a licensee or registrant. Public dose does not include occupational dose or dosd received from L
26 t-- i+s;J
. ---La fium iW ' a;w. WAiih70EiiliEl v,
v 28 Mj$(BX or dose from voluntasy participation in medical l-29
' rm-A programs
. ' CA$. "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air L
= 30 -
L 31' at or below 130*F (54.4*C) or any solid material, other than one classed as an explosive, which under 32 normal conditions is liable to cause fires through tiiction, retained heat from manufacturing or 33
- processing, or which can be ignited readdy and, when ignited, burns so vigorously and persistently 20 NMAC 3.1 1-9 Revision Date
s
.1 C.
The dose to an embryo / fetus shall be taken as the sum of:
2 1.
The dose to the embryo / fetus from radionuclides in the embryo / fetus and 3
radionuclides in the declared pregnant woman; and 4
2.
The dose that is most representative of the dose to the embryo / fetus from 5
. external radiation, that is, in the mother's lower torso region:
6 a.
If multiple measurements have not been made, assignment of the 7
highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo / fetus, 8
in accordance with f409 C; or 9
b.
Ifmultiple measurements have been made, assignment ofthe deep dose 10 equivalent for the declared pregnant woman from the individual monitoring device which is most 11 representative of the dose to the embryo / fetus shall be the dose to the embryo / fetus Assignment of 12 the highest deep dose equivalent for the declared pregnant woman to the embryo / fetus is not required 13
.unless that dose is also the most representative deep dose equivalent for the region of the 14 embryo / fetus.
'15 D.
Ifby the time the woman declares pregnancy to the licensee or registrant, the dose to 16 the embryo / fetus has exceeded 0.45 rem (4.5 mSv), the licensee or registrant shall be deemed to be 17 in comphace with 6412 A ifthe additional dose to the embryo / fetus does not exceed 0.05 rem (mSv) 18
- during the remainder of the pregnancy.
19
-413.
DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC.
20 A.
Each licensee or registrant shall conduct operations so that:
21~
1.
Exceptasprovidedinf413 A3,thetotaleffectivedoseequivalenttoindividual 22 members of the public from the licensed or registered operation does not' exceed 0.1 rem ImSv)~in Iniidd$i$[MlkM $$ihkp%
exclusive of the dose contribution from ik 'k"-- A en
,23 a
b.sk esupe%iadigidedis 24 25 8:elsesad % s[eccoiidasse M I M l$ $ eni.ayo
~
26
" 'lensa iiBeemosalM disposal ofradioactive material 27 into sanitary sewerage in acccn-dscce with {435, (-..ee 'ude ), and 28 2.
'Ihe dose in any unrestricted area from external sources does not exceed 0.002 29:
' rem (0.02 mSv)in any one hour; and 30-3.
The total effective dose equivalent to individual members of the public from 31?
- infrequent exposure to radiation from radiation machines does not exceed 0.5 rem (SmSv).
.32 B.
Ifthe licensee or registrant permits members ofthe public to have access to restricted 20 NMAC 3.1 4-12 Revision Date
[
L.
Ns-(
1 D.
Notifications. A licensee shall notify the Department in writing within 30 days when
~
2 an authorized user, Radiation Safety Officer, or Teletherapy Physicist, permanently discontinues L
3 performance of duties under the license.
4 701.
DEFINITIONS.
5 A. '
" Address ofuse" means the building or buildings that are identi6ed on the license and 6-where radioactive material may be prepared, received, used, or stored.
7 B.
" Area of use" means a portion of a physical structure that has been set aside for the
.8 purpose ofpreparing, receiving, using, or storing radioactive material.
l 9
C.
" Authorized user" means a physician, dentist, or podiatrist who is identified as an 10 authorized user on a Department, NRC or Agreement State license that authorizes the medical use 11-of radioactive material.
12-D.
" Dedicated check source" means a radioactive source that is used to assure the 13 constant operation of a radiation detection or measurement device over several months or years.
14 E.
" Diagnostic clinical procedures manual" means a collection ofwritten procedures that 15 describes each method (and other instructions and precautions) by which the licensee performs 16 diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the 17 authorized user and includes the radiopharmsceutical, dosage, and route of administration.
18
- F.
" Management" means the chief executive officer or that individual's designee.
y i
19 G.
"MedicalInstitution" means an organization in which several medical disciplines are 20 practiced.
21 H.
" Medical use" means the intentional internal or external administration of radioactive 22 material, or the radiation therefrom to patients or human research subjects under the supervision of 23 -
an authorized user.
24 1.
" Misadministration" means the administration of:
25 1.
Aradiopharmaceutical dosage greater than 30 microcuries (1.11MBq) ofeither
'26
- sodium;odide I-125 or I-131:
I Involving the wrong patient IiidEidiil or wrong radiopharmaceutical; 27 a.
28 or 29 b.
When both the administered dosage differs from the prescribed dosage
.30 by more than 20 percent ofthe prescribed dosage and the difference between the administered dosage FA 63 20 NMAC 3.1 7-2
~
iision Date
- 35. 2.
-v 901.i.. H m
,.y I.
l ll
~
I.
.1L and prescribed dosage exceeds 30 microcuries (1.11MBq).
2-2.
A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or
'3
'l-131:
Involving the wrong patient $51ivid5l, wrong radiopharmaceutical, 4
a.
.5 or wrong route of administration; or
'6 b.
When the administered dosage differs from the prescribed dosage by 7
more than 20 percent of the prescribed dosage.
8
.9 3.
A gamma stereotactic radiosurgery radiation dose:
10.
Involving the wrong patient M or wrong treatment site; or 11 a.
12 13 b.
When the calculated total administered dose differs from the total 14 prescribed dose by more than 10 percent of the total prescribed dose.
15
- 4.
A teletherapy radiation dose:
Involving the wrong patient M, wrong mode of treatment, or
- = 16 a.
17 wrong treatment site; 18 b.
When the treatment consists of three or fewer fractions and the 19.
calculated total administered dose differs from the total prescribed dose by more than 10 percent of 20 the total prescribed dose; c.
When the calculated weekly administered dose is 30 percent greater 22 than the weekly prescribed dose; or
'23 d.
When the calculated total administered dose differs from the total 24 prescribed dose by more than 20 percent of the total prescribed dose.
i
-25 5.
A brachytherapy radiation dose:
Involving the wrong patient hdhi$il, wrong radioisotope, or wrong 26'
. a.
27.
treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but 28~
migrated outside the treatment site);
i 29 b.
' Involving a sealed source that is leaking, 30 c.
When, for a temporary implant, one or more sealed sources are not L
31
~ removed upon completion of the procedure; or 20 NMAC 3.1 7-3 Revision Date 4
+
o 9
0
.'l '
d.
When the calculated administered dose differs from the prescribed dose 2
by more than 20 percent of the prescribed dose.
3 6.
A diagnostic radiopharmaceutical dosage, other than quantities greater than 4
30 microcuries (1.1IMBq) of either sodium iodide I-125 or I-131, both:
Involving the wrong patient EiNkNel, wrong radiopharmaceutical, I
5 a.
6 wrong route of administration, or when the administered dosage differs from the prescribed dosage; 7
and 8
b.
When the dose to the patient OI5d5Ili exceeds 5 rems (50 mSv) 9 effective dose equivalent or 50 rems (500 mSv) dose equivalent to any individual organ.
10 J.
" Mobile nuclear medicine service" means the transportation and medical use of 11 radioactive material.
12 K.
" Output" means the exposure rate, dose rate, or a quantity related in a known manner 13 to these rates from a teletherapy unit for a specified set ofexposure conditions.
14 L.
" Prescribed dosage" means the quantity of radiopharmaceutical activity as 25 documented:
16 1.
In a written directive; or 17 2.
Eitherin the diagnostic clinical procedures manual or in any appropriate record 18 in accordance with the directions of the authorized user for diagnostic procedures 19 M.
" Prescribed dose" means:
20 l.
For gamma stereotactic radiosurgery, the total dose as documented in the 21 written directive; 7
22
'2.
For teletherapy, the tot dose and dose per fraction as documented in the 123
- written directive; or 24 3.
For brachytherapy, either the total source strength and exposure time or the 25 total dose, as haanted in the written directive.
26 N. -
- " Recordable event" means the administration of:
27 1.
A radiopharmaceutical or radiation without a written directive where a written 28
' directive is required; 20 NMAC 3.1-7-4 Revision Date l
.J
L-a COMPATIBILITY AMENDMENT #9:
Iitis: Clarification of Decommissioning Funding Requirements,10 CFR Parts 30, 40, 70, and 72 -
l l
Federal Register Volume 60, No.143, July 26,1995 (60FR38235).
l-Due DAts: November 24,1998 -
Bationais: The Nuclear Regulatory Commission (NRC) is amending its regulations applicable to decommissioning funding assurance and the expiration and termination of licenses for. nonreactor
' licensees These amendments clarify requirements that fireciel assurance must be in place during licensed operations and updated when the.. licensee decides ~ to cease operations and begin demnmissioning. These regulations require that licensees who have been in timely renewal since the L
promulgation of the earlier decommissioning funding rule or who have ceased operation without having l
l
' adequate decommissioning funding arrangements in place must provide the NRC with certification of i
adequate financial assurance for decommissioning by the effective date of this rule.
')
t NRC NMRPR
{30.35
. {311.B.2, {311.C.2.-4., page 3-30; {311.E, page 3-30
{30.36 Amended under 59FR36026 (subset #3) r c_
Z O
m 2
e ca C
l i
L n
m
5 u
I F.
Prior to the hearing the Secretary may, upon request by a party, or upon the 2
Secretary's own initiative, require any party to submit the names of witnesses it proposes to call at l
3-a hearing, together with a summary of testimony expected to be given by each witness. Any party l
4.
may likewise be required by the Secretary upon request to submit for examination or copying any 5
exhibits that party anticipates using. Such information when requested shall become subpart of the 6
record and shall be made available to the Secretary at least 10 days prior to the hearing.
7 G.
The Secretary may appoint a hearing officer to conduct the hearing.
8 H.
The Department will arrange for transcription of the hearing by a certified reporter.
p 9
Copies of the transcript shall be paid for by those requesting them.
l l.
10 I.
At the hearing, all interested persons shall be given a reasonable opportunity to submit
!~
11.
relevant data, views, or arguments orally or in writing, and to examine witnesses testifying at the 12.
hearing concerning any aspect of the license.
l.
13 J.
The record shallinclude the application and amendments thereto, all correspondence
.14 -
between the Department and the applicant concerning the application, all public comment on the 15 application recdved by the Secretary, all written staffreports on the application, the transcript ofany l
.16 public hearings on the application, and any other information before the Secretary regarding the 17
' application. The Secretary shall consider all relevant evidence in the record. The Secretary shall 18 notify the applicant, and other parties reques ng such notice, of the Secretary's decision and the 19
. reasons therefore.
~20 311.
FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING.
l 21
" Decommissioning" means to remove (as a facility) safely from service and reduce residual
(
22 radioactivity to a level that permits release of the property for unrestricted use and termination of 23 license h
24 -
A.
Each applicant for a speci6c license authorizing the possession and use of unsealed 25 byproduct material of half-life greater than 120 days and in quantities exemading 10 times the most 5
26 current applicable quantities set forth in Appaadir F_ Subpart 4, shall submit a hammissioning
=27 funding plan as' described in paragraph (E) of this section. The d~ammkalaaing funding plan must 28 also be submitted when a combination ofisotopes is involved if R divided by 10 is greater than 1 5
L 29 (unity rule), where R is defmed here as the sum of the ratios of the quantity of each isotope to the 30 applicable value in Appaadiv F Subpart 4.
31-B.
_ Each applicant for a specific license authorizing possession and use of byproduct 32-material of half-life greater than 120 days and in quantities specified in paragraph (D) of this section 33
!shall either:
34
.1.
Submit a decommissioning funding plan as describai in paragraph (E) of this 35 l section; or 20 NMAC 3.1 3-29 Revision Date L
1 r-y 1_
2.
Submit a certification that financial assurance for decommissioning has been 2
provided in the amount prescribed by paragraph (D) of this section using one of the methods l
3 described in paragraph (F) of this section. For an applicant, this cenification may state that the 4
appropriate assurance will be obtained after the application has been approved and the license issued insinis$dIEEM,t oflicensed material. Ifdahlisent'5NmI5iseudosMM but prior to the receip 5
6
$sedsfy)lksnequissakesiMM"(P)gthisThessinjiis tiihmbesittedMein Depa$nant l
7 insimi$eMM)edel45thstapplicast!ddsfac(kdefer,em betranseceiptid$stelped mest 8
slinifis3biMi ss subpan of the certification, a copy 9
A 10
$3djed$$ ngl ofthe financial instrument obtained to satisfy the requirements ofparagraph (F) ofthis l
11 section is te W -led;i+i te ik bi.-a.
12 C.
1.
Each holder of a specific license issued on or after the effective date of these 13 regulations which is ofa type described in paragraph (A) or (B) of this section, shall provide financial 14 assurance for decommissioning in accordance with the criterk set forth in this section.
t 115 2.
Each holder of a specific license issued before the effective date of these 16 regulations, and of a type described in paragraph (A) of this sectior, shall submit on or before the 17 effegtive date of these regulations, a decommissioning funding plan {IMissisisNiii@i@t(IENW t
ibis; sidled or a certification of financial assurance for decommissioning in an amount at least equal
.18 7
l 19 to $750,000 in accordance with the criteria set forth in this section. If the licensee submits the 20 cenification of financial assurance rather than a decommissioning funding plan.i i;J. iLe, the l
21 licensee shall include a decommissioning funding plan in any application for license renewal.
22 3.
Each holder of a specific license issued before the effective date of these 23 regulations, and of a type described in h B of this sect.i,on shall submi on or b. pore the.-
ef
~
y-u.<
wwe ~- nywn. q-pyg -
sm i
24 effective date of these regulations, g..
Aselhabiasm.
ggy vg, ys>
m.m sph(B)of
'25 R$fsEENIEI$it a certification of financial assurance for decommissioning er. b.wmee:e.J.4 26 f=4r4 p. in accordance with the criteria set forth in this section.
I 31 D.
Required amounts offinancial assurance for decommissioning by quantity of material:
.32-1.
greater than 10' but less than or equal to 10 times the applicable quantities 5
'33 of Appendix F., Subpan 4 in unsealed form. (For a combination ofisotopes, if R as defined in 6311 j
34 A., divided-by 10' is greater than 1 but R divided by 10 is less than or equal to 5
l 35 1)...................................................................................
........ $750,000; 36 2.
greater than 10' but less than or equal to 10 times the applicable quantities l
4 20 NMAC 3.1 3-30 Revision Date l
l l
L
4 r
1 ofAppendix F Subpart 4 in unsealed form. (For a combination ofisotopes, ifR, as defined in {311 2
A, divided by '10 is greater than 1 but R divided by 10* is less than or equal to 1) 5 3~
.......... $150,000; 4
3.
greater than 10 ' times the applicable quantities of Appendix F Subpart 4 in 5
scaled sources or plated foils. (For a combination ofisotopes, ifR, as de6ned in Q311 A, divided by 6
10 is grester than 1).......................................................................
.... $75,000.
7_
E.
Each decommissioning funding plan must contain a cost estimate for deccamissioning 8-and a description of the method of assuring funds for decommissioning from paragr.1 n (F) of this 9
section,includingmeansof cost estimatesandassociated fund levels over 10' the life of the g
[M$li
.. ~ ~
g 14-F.
Financial assurance for decommissioning must be provided by one or more of the 15-following methods:
16-1.
Prepayment. Prepayment is the deposit prior to the start ofoperation into an 17 account segregated from licensee assets and outside the licensee's administrative control of cash or 18 liquid assets such that the amount of funds would be sufBcient to pay decommissioning costs.
19 Prepayment may be in the form of a tmst, escrow account, government fund, certi6cate of deposit, 20 or deposit ofgovernment securities.
21 2.
A Surety Method, Insurance, or Other Guarantee Method. These methods
.22 guarantee that decommissioning costs will be paid should the licensee default. A surety method may 23 be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of 24-funds for decommissioning costs based on a financial test may be used if the guarantee and test are 25 as contained in Schedule A to this Subpart. A parent company guarantee may not be used in
. 26 combination with other financial methods to satisfy the requirements of this section. Any surety 27 method 'or insurance used to provide financial assurance for decommissioning must contain the 28 following conditions:
29 a.-
The surety method or insurance must be open-ended or, ifwTitten for 30f 1 a speci6ed term, such a five years, must be renewed automatically unless 90 days or more prior to i
31.
the renewal date, the issuer notifies the Department, the beneficiary, and the licensee ofits intention
_32 not to renew. The surety method or insurance must also provide that the full face amount be paid 33 to the beneficiary automatically prior to the expiration without proofof forfeiture if the licensee fails 34 to provide a replacement acceptable to the Department within 30 days after receipt of notification of 35'-
emaca+ ion; 36 b.
The surety method or insurance must be payable to a trust established 20 NMAC 3.1 3-31 Revision Date i
L
J 9
N' COMPATIBILITY AMENDMENT #10:
' Iide: Compatibility With the International Atomic Energy Agency (IAEA),10 CFR Part 71 FWal Re-: Volume 60, No.188, September 28,1995 (60FR50248)
Due Date.. April 1,1999 Rationale-The' Nuclear Regulatory Commission (NRC) is revising the regulations governing the l
transportation _ of radioactive material.-- The final rule conforms NRC regulations' with those of the
'l International Atomic Energy Agency, and codifies criteria for packages used to transport plutonium by air. This action is wa==y to ensure that NRC regulations reflect accepted international standards and comply with current legislative requirements.
NRC NMRPR 10 CFR Part 71 Referenced in {325, page 3-59 l
g o
o a
Cn
-o O
9 w
C3 l
l I-
1 i
I 1
i t.
(
1 325.
PREPARATION OF RADIOACTIVE MATERIAL FOR TRANSPORT.
2 A.
For the purpcse of this regulation, a licensee who transports his own licensed material 3
as a private carrier is considered to have delivered such material to a carrier for transport. No licensee 4
shall deliver any radioactive material to a carrier for transpon unless:
5 1.
the licensee complies with the applicable requirements of the regulati.ons
'6
...ro.riate to the mode of trans.yrt of the U.S. Department of Transportation, 7
insofar as such regulations relate to the 8
packaging of radioactive material, and to the monitoring, marking and labeling of those packages; 9-2.
.the licensee has established procedures for opening and closing packages in l
10 which radioactive material is transported to provide safety and to assure that, prior to the delivery j
11 to a carrier for transport, each package is properly closed for transport; and 1
..12 3.
prior to delivery ofa package to a carrier for transport, the licensee shall assure 13 that any special instructions needed to safely open the package are sent to, or have been available to 14 the consignee.
l 15' B.
{325 A shall not apply to the transportation oflicensed material, or to the delivery of l
16 licensed material to a carrier for transport, where such trari.porui6on is subject to the regulations of l-17 the U.S. Department of Transportation or the U.S. Postal Service.
18 C.
No licensee shall deliver any nuclear waste, as defined in Q328, to a carrier for
(
' 19 --
. transport unless that carrier is licensed under {328 or is exempt from such license under {107 D.
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20 326.
ADVANCE NOTIFICATION TO GOVERNORS OF TRANSPORTATION-OF l.
21 NUCLEAR WASTE INCLUDING SPENT FUEL. Prior to the transport of any nuclear waste, 22 as defined in {328, outside of the confines of the licensee's plant or other place of use or storage, or
- 23
' prior to the delivery of any nuclear waste to a carrier for transpon, each licensee shall comply with l'
24 the procedures in {327 for advance notification to the governor of a state or the governor's designee 25 for the transport of nuclear waste to, through, or across the boundry of the State. For the purpose 26 of {326, " Nuclear waste means any large quantity of source, byproduct or special nuclear material 27 required to be in Type B packaging while transported to, through or across State boundaries to a 28 disposal site or to a collection point for transport to a disposal site".
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20 NMAC 3.1 3-59 Revision Date l
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COMPN /IBILITY AMENDMENT #11:
Iitic: Tennination or Transfer of Licensed Activities: Recordkeeping Requirements,10 CFR Parts 20, 30,40,61,70, and 72 Fadaral R=i=*er:. Volume 61, No. %, May 16,1996 (61FR24669)
Due Date May 16,1999 Rationale: ' The Nuclear Regulatory Commission (NRC) is amendmg its regulations pertaining to.the-disposition of certain records when a licensee terminates licensed activities or licensed activities are transferred to another licensee The final rule requires a licensee to transfer records pertaining to decommissioning, and certain records pertaining to offsite releases and waste disposal, to the new licensee iflicensed activities will continue at the same site, and it requires the new licensee to forward these same records to the NRC before the license is terminated.
NRC NMRPR
,{30.35 6311.G, page 3-32 l
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1 costs at the time termination of operation is expected. An external sinking fund may be in the form 2
of a trust, escrow account, government fund, certificate of deposit, or deposit of government 3
securities. The surety or insurance provisions must be as stated in paragraph (F)(2) of this section.
l 4
l 5
4.
In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in paragraph I
6 7
(D) of this section, and indicating that funds for decommissioning will be obtained when necessary.
l 8
i 9
G.
- Each person licensed under this Subpart or Subparts 5, 7. 12, 13, 15 of these
{
10 regulations shall keep records ofinformation important to the safe and effective decommissioning of 11 the facili in an identified location until the Ibi" 12
. Seeded.,sfMdttM[$iiiidBefii$is W5iiiiiiiiii i
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14-cense is terminated by the Department. If l
15 records of s L on Lfeie.Lon l
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.Mielj%iiidare kept for other l
16 purposes, reference to these records and their locations may be used. Information the Department
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17 considers important to decommissioning consists of:
18-19 1.
Records of spills or other t'nusual occurrences involving the spread of 20 contamination in and around the facility, equipment, or site. These records may be limited to l
21 instances when contamination remains after any cleanup procedures or when there is reasonable l
22 likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage 23 into porous materials such as concrete. These records must include any known information on 24 identification ofinvolved nuclides, quantities, forms and concentrations.
25 l
26 2.
As-built drawings and modifications ofstructures and equipment in restricted L
27 areas where radioactive materials are used and/or stored, and oflocations of possible inaccessible
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28 contamination such as buried pipes which may be subject to contamination Ifrequired drawings are 29 referenced, each relevant document need not be indexed individually. Ifdrawings are not available, 3o the licensee shall substitute appropriate records of available information concerning these areas and 31 locations.
32
'/
'3.
Records ofthe cost estimate performed for the decommissioning funding plan
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34; or ofthe amount certified for decommissioning, and records of the funding method used for assuring l
35-funds if either a ka&ag plan or certification is used.
36 37 4.-
Except for areas containing only sealed sources (provided the sources have i
38.
not leaked or no contamination remains after any leak) or radioactive matenals having only half-lives 39
. ofless than 65 days, a list contained in a single document and updated every two years, of the 40 following:
41 42 a.
All areas designated and formerly designated restricted areas as defined 43' in Subpart 1 of these regulations (for requirements prior to the effective date ofthese regulations, see
'44 20 NMAC 3.1 3-32 May 3,1995 l
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