ML20195H006
| ML20195H006 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1999 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Mcmahon C RHODE ISLAND, STATE OF |
| References | |
| NUDOCS 9906160246 | |
| Download: ML20195H006 (7) | |
Text
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l CE*u UNITED STATES g
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NUCLEAR REGULATORY COMMISSION f.
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WASHINGTON. D.C. sostH001 j
June 3, 1999 i
Mr. Charles McMahon, Supervisor Radioactive Materials and X-Ray Programs Division of Occupational and Radiological Health Rhode Island Department of Health 3 Capitol Hill, Room 206 Providence, Rl 02908-5097
Dear Mr. McMahon:
As requested, we hava reviewed the proposed amendments for April 1999 to Part A, Definitions:
General Provisions of the Regulations; Standards for Protection Against Radiation; Notices, Instructions and Reports to Workers; inspections, Part C Licensing of Radioactive Materials and Use of Radionuclides in the Healing Arts and Part E Radiation Safety Requirements for Industrial Radiographic or Wireline Service Operations and Analytical X-Ray Equipment to the Rhode Island Rules and Regulailon for the Control of Radiation. The regulations were received in a letter dated March 29,1999, from Marie Stoeckel. The proposed regulations are in response to the 17 amendments identified in the enclosed Regulation Assessment Tracking System (RATS)
Data Sheet. The regulations were re'.lewed by comparison to the equivalent NRC regulations in -
10 CFR Parts 19,20,30,32,34, and 35. We have also discussed our review of the regulations with William Dundulis on April 23 and 29,1999.
As a result of our review, we have three comments that have been identified in the enclosure.
Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that a Rhode Island 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 Rhode Island regulation. However, we have determined that if your proposed regulations were adopted incorporating the comments and without other significant change, they would meet the compatibility and health and safety categories established in OSP Procedure SA 200 (formerly, B.7),
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided for our review. As requested in OSP Procedure SA 201, Review of State Reaulations (November 10,1998), please highlight the final changes and send one copy in a computer readable format, if possible.
We have also summarized on the RATS Data Sheet our knowledge of the status of other Rhode Island regulations. Please let us know if you note any inaccuracies or have any comments on the information contained in the RATS Data Sheet.
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- SP-MT M 9906160246 990603 PDR STPRG ESGRI I
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Charles McMahon JilN 31998 If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in this review, please contact me or Duncan White, Regional State Agreements Officer, Region 1 at (610) 337-5042.
rely,.
f k
6 P tul H. Lohaus, Director Office of State Programs
Enclosures:
' As stated 1
b'
Charles McMahon jyy 3,gg If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in this review, please contact me or Duncan
~ White, Regional State Agreements Officer, Region 1 at (610) 337-5042.
Sincerely,.
@FAULH.LOHAUSSigned By:
Paul H. Lohaus, Director Office of State Programs
Enclosures:
< As stated :
+
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t h
1 i
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l Distribution:
DIR RF DCD (SP05)
SDroggitis PDR (YES/)
BGUsilton Rhode Island File
- See previous concurrence DOCUMENT NAME: G:\\SNS\\STOECKEL.WPD T+ receive a copy of this document, indicate in the bor: *C' = Copy without attachment / enclosure "E" = Cosy with attachm Md osu
l NAME ADWhite:gd SNSalomon 5'nd SATreby PHLoha6M DATE 05/13/99*
05/13/99* 5 p]
06/3 /99
Charl;s McMahon If you have any questions regarding the comments, the compati Ility and health and safety categories, or any of the NRC regulations used in this review, pl ase contact me or Duncan White, Regional State Agreements Officer, Region 1 at (610) 3 -5042.
Sincerely, Paul H. Lohaus, Jirector Office of State rograms
Enclosures:
As stated I
Distribution:
DIR RF DCD (SP05)
SDroggitis-PDR (YES/)
BGUsilton -
RhodeIsland ile i
- See previous concurrence DOCUMENT NAME: G:\\SNS\\STOECKEL.WPD attachm nt/.nciosure s -copy with attaenmAceosud u - No copy T,,.e.i.. em or eni docum.nt. indie.t. in en. mori c - copy wit OFFICE OSP-lE OSP
/lE OGC CM4// l NAME ADWhite:gd SNSalomon #M SATreby ol//f-PHLo6a6(2 DATE 05/13/99*
05/13/9h* 5 )?]
CW8/99 05/M/99 OSP FILE' CODE: SP-AG 24
If you h:va cny quegtions r:gtrding the comm::nts, the compatibility and hn lth and sif ty categories, or any of h3 NRC regulations used in this rcview, piriss contact m3 or Duncan White, Regional State greements Officer, Region 1 at (610) 337-5042.
Sincerely, i
Paul H. Lohaus, Director Office of State Programs 1
Enclosures:
As stated i
4 i
i l
j
' Distribution:
DIR RF DCD (SP05)
SDroggitis PDR (YES/)
BGUsilton Rhode Island File DOCUMENT NAME: G:\\SNS\\STOECKEL.WPD To receive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / closure "N" = No copy OFFICE -
OSP Q1q l6 OSP ghgl 6 OGC OSPy NAME ADWhite:gd &
SNSalomon SATreby PHLohaus\\
DATE 05/ g/99 05/3/99 05/ /99 051 /9h OSP FILE CODE: SP-
-24
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COMMENTS ON PROPOSED RHODE ISLAND REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State' NRC-
- Category Regulation Regulation Subject and Comments A.
A.O.
20.1003 Definitions of Occupational Dose and Public Dose.
The definitions do not include reference to individuals administered radioactive materials and released in accordance with Section C.8.24 of the Rhode Island regulations.
Unless this reference is included, these definitions would not meet the compatibility category.
B C.5.5.0)(2) 32.72(b)(3)-(5)
Manufacture, preparation or transfer for commercial distribution of radioactive drugs containing byproduct materials for medical use, 10 CFR 32.72(b)(3) through (5) was -
omitted from Section C.5.5.0)(2) of the proposed regulations. Unless the section is adopted, the regulation would not meet the compatibility category.
C none 20.2205 Reports to individuals of exceeding dose limits.
This section was omitted. Unless the essential objectives of the missing section are adopted, the regulation would not meet the essential objectives of 20.2205.
l
REGULATION ASSESSMENT TRACKING SYSTEM RATS DATA SHEET State: Rhode Island Tracking Ticket Number:
'17 proposad amendments (April 1999) identified by *)
Date:
NRC Chronologyidentification FR Notice RATSID Due Date State Status (Effective Date)
Standards for Protection Against Radiation 56 FR 23360 1991-3 1/1/94 Final (4/21/95) plus others Safety Requirements for Radiographic Equipment 55 FR 843 1991 1 1/10/94 RATS ID 1997-5 supercedes ASNT Certification of Radiographers 56 FR 11504 1991 2 none Not required Notification of incidents 56 FR 64980 1991-4 10/15/94 No record of promulgation Quality Management Program and 56 FR 34104 1992 1 1/27/95 June 1995 Misadministrations Eliminating the Recordkeeping Requirements for 57 FR 45566 1992-2 none Not required Departures from Manufacturer's Instructions Licensing and Radiation Safety Requirements for 58 FR 7715 1993-2 7/1/96 Not applicable irradiators Definition of Land Disposal and Waste Site OA 58 FR 33886 1993-3 7/22/96 Not applicable Program
- Decommissioning Recordkeeping: Documentation 58 FR 39628 1993-1 10/25/96 Proposed Additions (4/99)
QSelf-Guarantee as an Additional Financial 58 FR 68726 1994-1 1/28/97 Proposed Mechanism 59 FR 1618 (4/99)
Uranium Mill Tallings: Conforming to EPA Standards 59 FR 28220 1994-2 7/1/97 Not applicable OTimeliness in Decommissioning 59 FR 36026 1994-3 8/15/97 Proposed (4/99)
QPreparation, Transfer for Commercial Distribution, 59 FR 61767 1995-1 1/1/98 Proposed Cnd Use of Byproduct Material for Medical Use 59 FR 65243 (4/99) 60 FR 322 QFrequency of Medical Examinations for Use of 60 FR 7900 1995-2 3/13/98 Proposed Respiratory Protection Equipment QLow-Level Waste Shipment Manifest Information 60 FR 15649 1995-3 3/1/98 Proposed and Reporting 60 FR 25983 (4/99)
QPerformance Requirements for Radiography 60 FR 28323 1995-4 6/30/98 Proposed Equipment (4/99) l CRadiation Protection Requirements: Amended 60 FR 36038 1995-5 8/14/98 Proposed Definitions and Criteria (4/99)
QClarification of Decommissioning Funding 60 FR 38235 1995-6 11/24/98 Proposed Requirements (4/99)
QMedical Administration of Radiation and 60 FR 48623 1995 7 10/20/98 Propostd Radioactive Materials (4/99)
r NRC Chronology identification FR Notice RATS ID Due Date Ctste Status (Effective Date) 10 CFR Part 71: Compatibility with the Intemational 60 FR 50248 1996-1 4/1/99 Waiting for SSR Atomic Energy Agency 61 FR 28724 Part T One Time Extension of Certain Byproduct, Source 61 FR 1109 1996-2 none Not required Gnd Special Nuclear Materials Licenses OTermination or Transfer of Licensed Activities:
61 FR 24669 1996 3 6/17/99 Proposed Recordkeeping Requirements Resolution of Dual Regulation of Airbome Effluents 61 FR 65119 1997 1 1/9/00 of Radioactive Materials; Clean Air Act Fissile Material Shipments and Exemptions 62 FR 5907 1997-4 none Not required Recognition of AgreerNnt State Licenses in Areas 62 FR 1662 19974 2/27/00 Under Exclusive Federal Jurisdiction Within an Agreement State QCriteria for the Release of Individuals 62 FR 4120 1997-3 5/29/00 Proposed Administered Radioactive Material (4/99)
CLicenses for Industrial Radiography and Radiation 62 FR 28948 1997-5 6/27/00 Proposed Safety Requirements for Industrial Radiography (4/99)
Orerations Radiological Criteria for License Termination 62 FR 39057 1997-6 8/20/00 CExempt Distribution of a Radioactive Drug 62 FR 63634 1997 7
%/01 Proposed Containing One Microcurie of Carbon-14 Urea (4/99)
Deliberate Misconduct by Unlicensed Persons 63 FR 1890 1998 1 2/12/01 63 FR 13773 Self-Guarantee of Decommissioning Funding by 63 FR 29535 1998-2 none Nonprofit and Non-Bond-issuing Licensees License Term for Medical Use Licenses 63 FR 31604 1998-3 none QLicenses for Industrial Radiography and Radiation 63 FR 37059 1998-4 7/9/01 Proposeo Safety Requirements for Industrial Radiographic (4/99)
Operations CMinor Corrections, Clarifying Changes, and a 63 FR 1998-5 10/26/01 Proposed Minor Policy Change 393477 (4/99) 63 FR 45393 QTransfer for Disposal and Manifests: Minor 63 FR 50127 1998-6 11/20/01 Proposed Technicai Conforming Amendment (4/99) 2
l STATE OF RHODE ISLAND OVIDENCE PLANTATIONS DEPARTME OF HEALTH t
E Sqfe and Healthy thes in Sqfe and Healthy Communities N
29 March 1999 O
C3 Paul H. Lohaus, Deputy Director Cn US Nuclear Regulatory Commission
$T Office of State Programs e
Washington, DC 20555-0001 y
r.n
Dear Mr. Lohaus:
in accordance with NRC/OSP Procedure SA-201 (revised 10 November 1998) the Rhode Island Radiation Control Agency is requesting comments from NRC/OSP regarding the j
attached proposed amendments to the Rules and Reaulations for the Control of Radiation.
These amendments have been reviewed and accepted by our Radiation Advisory Commission and are scheduled for a formal Public Hearing on Tuesday 20 April 1999. In addition to this Public Hearing, the formal comment period will extend an additional two (2) weeks unt;l 4 May 1999. While we would appreciate any NRC/OSP comments by the Public Hearing date (so thei can be entered into the hearing transcript), our rule-making procedures allow consP'iration of any comments received by the closing date (i.e.,4 May 1999).
The majority of these proposed changes are taken directly from the Federal Register announcement of the specific Final Rule. The only exceptions are as follows: (1) Licensure of Nuclear Pharmacists is also regulated by the State Board of Pharmacy. Our proposed amendments have been coordinated with their regulatory requirements.
(2) Training /
supervision of subordinate users for human use of radioacHve material. RI has a Technologist licensing requirement which is incorporated by reference. Possession of such a license is recognized as meeting certain radiation safety training requirements. (3) Adoption of 10 CFR 34 equivalent regulations. These amendments are based on the most current version of SSRCR Part E. This will allow us to properly regulate X-ray and accelerator radiography.
Although not covered under the Agreement, our proposed changes to Part F are based on current working versions of SSRCR Part F and additional FDA guidance published in the Federal Register. Similarly, our proposed addition of Part H is based on SSRCR Part X, with only minor changes to address Rl-specific requirements.
Please provide your written comments (not later than 4 May 1999) to: Charles McMahon, Supervising Radiation Control Specialist: RI Radiation Control Agency; 3 Capitol Hill-Room 206: Providence, RI 02908 5097.
If you have any further questions concerning the technical content of the amendments, or need any aduitional clarification on these proposed changes, please contact William Dundulis at (401) 222-4948, Ext. 2107.
Sincerely,
)[(.hd M
Marie Stoeckel, MPH, ClH, Chief Office of Occupational and Radiological Health pc:
Charles McMahon William Dundulis CANNON BUILDING, 'Ihree Capitol Hill, Providence, Rhode Islan.d 02908-5097 Hearing / Speech Impaired, Call 1800-745-5555 ('ITY)
Web Site: www. health.rtate.ri.us NoL-(C)$Q1@
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STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS RhodeIsland Department ofHealth l
NOTICE OF PUBLic HEARING l
he Director of the Rhode Island Department of Health has smder consideration the Rules andRegulatio for the Control ofRadiation (R23-1.3-RAD) promulgated pursuant to the' authority conferred in Chapters 2
.1.3-2 and 42-35 of the Rhode Island General Laws, as amended. These regulations are established for the purpose of adopting standards compatible with those promulgated in 10 Code offcderal Regt.lations (CF Parts 20,34, and 35 by the United States Nuclear Regulatory Commission (NRC), as required per agreem with the NRC and pursuant to section 23-1.3-2 of the Rhode Island General Laws, and furthermore to
~
standards as prescribed by the Conference of Radiation Control Program Directors (CRCPD) which are contairied in the most recent revisions to Parts "E", "F", and "X" of the Suggested State Regulations for the l
Control of Radiation (SSRCR).
Notice is hereby given in accordance with the provisions of Chapter 42-35 of the Rhode Island General Law as amended, that the Director will hold a public hearing on the above mentioned matter, in the
~ AUDITORIUM of the Cannon Building (on the lower level), Rhode Island Department of Health,3 Capitol Hill, Providence, Rhode Island on TUESDAY, april 20,1999 AT 10:00 A.M. at which time and place all persons interested therein will be heard.
In the development of the rules and regulations, consideration was given to the following: (1) attemative approaches; (2) overlap or duplication with other statutory and regulatory provisions; and (3) significant economic impact on small business, as' defined in Chapter 42-35 of the Rhode Island General Laws, as amended, which may result from the regulations. No attemative approach or duplication or overlap was identified based upon available information. The health, safety, and welfare of the public precludes any economic impact that may be incurred as a result of these regulations.
For the sake of accuracy, it is requested that statements to be made relative to any aspect of the regula'tion including altemative approaches, overlap, or significant economic impact, be submitted in writing at the time of the headng or mailed prior to the hearing date to: Patricia A. Nolan, M.D., M.P.H., Director, Rhode Island Department ofHealth, #401 Cannon Building,3 Capitol Hill, Providence, Rhode Island 02908-5097.
Copies of the regulations are available for public inspection in the Cannon Building, Room #410, Rhode Island Department of Health,3 Capitol Hill, Providence, Rhode Island.
The Cannon Building is accessible to the handicqpped. Individuals requesting interpreter servicesfor the he: ring ingpaired must notify the Oplce of Health Services Regulation at 222-6015 (Hearing / speech ingpaired, call 1-800-745-5555 [ TTY]) at least 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> prior to the hearing.
i Signed this.2f8 day of March 1999 i
e i
Afnn W Hb NPH fI atricia A. Nolan, M.D., M.P.H.'
Director ofHealth R
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STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DEPARTMENT OF HEAL %'g, -
PROPOSED AMENDMENTS TO RULES AND REGULATIONS FOR THE CONTROL OF RADIATION (R231.3-RAD]
JUNE 1978 'iseJ h F,
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' ' 17L o c, 3AS AMENDED:
wir#,t cd on FEBRUARY 1979 SY PJUNE 1981 OCTOBER 1984 "S*d fkFEBRUARY 1990 FEBRUARY 1990 (E)
To Be Added
? ", s JANUARY 1991 (E)
AUGUST 1991 Tc Oc Oc'c;cd
,a py DECEMBER 1993 (E) c FEBRUARY 1994 JUNE 1995 APRIL 1999 iPROPOSEDI al CO~
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p PROPOSEU FOR COMMENT-april 1999 PART A DEFINITIONS, GENERAL PROVISIONS OF THE REGULATIONS: STANDARDS FOR PROTECTION AGAINST RADIATION: NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS;lNSPECTIONS A.0 DEFINITIONS Wh,enever used in these rules and regulations, the following terms shall be construed as follows:
Annuel refresher safety trainino means e review conducted or orovided bv the licensee or recietrent fer its l
emolovees on rechetion saietv ascects of industrialraciocrechv. The review may incluce es encrocriete. the results of interna insoecutons. new crocedures or eauroment. new or revised reculattens. accidents or errors that have been e sservec. and sloJld also orovide oDoortunities for emo oveen to ask safety outstions.
ee.
. ANSI means the American National Standards Institute.
.' :R=c; m;;n; e Z..;;.;; ich ch nd ;M;; :h; ;4;n; ef th; ;;;;; men; f ;ld ;; e ;.;;. d:;;;n;; f;;m the g;,.e: ;;.;;e ;.d s.h;;h mei;; me, nM :neerpern; ;he b;;m ::m:::n; d;si;e.
.e Associated coulement means ecruioment that is used in coniunction with a rad'oorachie exoosure device to make radicaraonic exoosures t 1at drives. ouides. or comes in contact with t ie source. (e.o. oulde tube.
control tu ne. control (drivel ca 3le. removable source stoo. "J" tube and collimator when ft is used as an exoosure lead.
Authorized rucles r charmacist means a charmacist who is identified as an authorized nuciear charrracist on an Acenev. J.S. Muclear Reculatorv Commission. Acreement State or Licensino State license. anc who ts:
l 1
Q Board certified as a nuclear charmacist bv the Board of Phiirmaceutical Soeciattiest or g identified as an authorized nuclear charrnacist on an Acenev. U.S. Nuclear Reculatorv Commission.
Acreement State or Licensino State scense t1st authertres the use of radioactive material in t le oractice of nuclear charmaevi or 1
'g Identified as an authorized nuclear charmacist on a nermit issueel bv an Acenev. U.S. Nuclear Heou aterv Commission. Aoreement State or Ltcensino State soec fic itense of 3 road stone that is authorizac to nermit; he use of radioactive material in the oractice o" nuc ear charmaev.
Authorized user means an individual who is:
(1) identified as an authorized user on an Agency, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission license. The authorized user for medical use of radioactive material m.e: b; e p;;G:;;en;i ef ;h;. h;;,::n; er;; means a ohvsician. dentist or codig g Board certified bv at least one of the boards I sted in Para oraeh fa) of Sections C.B.64. C.B.65.
C.B.66. C B.67. C.B.69. C E.70 or C B.76 o" these reau ations!
@ Identifiec as an authorire d user or' an Acenev. U.S. Nuctear Reoufatorv Commission. Acreement.
State or _tcensino State icense t 1at authortres the mec ical use of radioactive materia : or g}
Identified as an authorized user on a cermit issued bv an Acenev U S. Nuclear Reculatorv I-2 L
PROPOSED FOR COMMENT APRIL 1:29 Commissbn. Anreement Stat's or Licensino State noecific license of broad scone that is authorizac to nermit the medica use of radtonctive material.
er (2) qualified as an authorized user under an Agency registration by satisfying the training requirements
...cf 0;;;;ene I.7.00 e; I.O.00 Paraorneh H.3.3 of these regulations.
ee.
Eur. x n:5.; '"=: a.;;n; e 1:h;; ;;d :n ;;d;; ;; ;;;;;;r ; b;;i;, ei ; ;;;ien;.
Cabinet radicorschv means industrialradiography conductedin an enclosure or cabinet so shielded that every location on the exterior meets the ;end;;;;,n; dose limits for individual members of the oublie as specified in Section A+5 A.2.11 Cabinet X-rav svstem means an X-ray system with the X ray tube installadin an enclosure (hereinaftert.ermed
" cabinet") vsh;;h, :ndep;nd;.n;;i that is indeoendent of existing architectural structures except the floor.en veh ;h h in;p b; ple;;d, The cabinet X-rav svstem is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of
- -radiation. Included are all X ray systems designed primarily for the inspection of carry onbaocace at a:tine.
railroad. and bus terminais. and in similar facilities. An X ray tube used within a shielded part of a butcing, or X ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a..c.abinet X ray system.
l Camera see "Radioorachic exoosure device" Certifiable cabinet X rav system means an existino oncertified x rav svstem that has been modified to meej the certification reoutrements soecified in 21 CFR ' 020.40.
Certifvino Entity means an indeoendent certifg crosniza' ion rreetino the reouirements in Accendix A to 3 art E or an Aoreement State meetino the feattyments in Dans and11 of Anoendix A to Part E.
Cc-d m s' S buo a.;;n; ; lln; p;;;:ng ;hre.;h ;h; s;r;a;! ;;ur;; end :h; ;;n;;r ef ;he pien; f;;gr; f.e.rn.;d by ;h; ;ds;. et-;h; f;e; b;; n ;n.h:ns dia:;;.
0 hens;;,L ; I:h;r; n.;;n; ;ni f:h;r, cae:ee:v; ef :nh;;;n; fie; en, seh:;h con b; ;;inesed fren, ;h;.;;f.:
t.;.;n. ;h;e.;h ;ni ;.';;;;en:;, n;; hen:;;.: er phy;;e;: pre;;;e.
Collimator means a radiatier shield tP at is olaced orl the end of the cuide tube or directiv ento a radioorachic exoosure device to restrict t le stre o' the radiation 3eam when the sealed source is erankee into cosition to make a radioc aohic exoosure.
C ^LZt " 2 : L;.,4 2 4 27Z 7 U,;;n; &n i;fefei;2.;; i;i ;I.;ispg ii ih ibe i;fiub; peii p ;;id i.ceni;;;
gh ei s.ah;n :; ;;n;;rn;;;re ;f th; ; ;fe;i. L;;ns ;;;;;;d.
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PROPOSED.FOR COMMENT. AMtfL 1CZ9 Contre,I cable mean t the cable that is connected to the source assembiv and used to drive the so
" rom t ne exoosure ocation.
Controldrive mechanism means a device that enables the source assembiv to b exoosure cevice.
Contro1 tube means a erote ctive sheath for auldino the control cable. The control tube connects the drive mecianism to the rac iocrachic exoosure cevice.
C:m:": d rc;.n;;n; ;. er;;, e.,;;:d; cf ; ;;;;.:;;;d ;;;; ;;,,; :ne:d; :P.; ;;;; Lewnder,, ;;;;.; ;;..t.:;t. ;;n b.;..;rn;;ed t, ;t.; ;;;n;;; er i;;,:;;;;n; fer ;.,.;;een.
Deetated oreanant woman means a woman who has voluntarily informed t.;; ;c.p ;,r er the licensee or rmistrant, in writing, of her pregnancy and the estimated date of conception. The dec aration remains in e~ect until the declared oreanant woman withdraws the declaration in writino or is r o onaer creanant.
Dental use of radioactive material means the intentioral external administration of the radioactive material to h Jman 3einos in the oractice of c ent strv en accordance with a license iss;ed bv a State or Territorv of the Jnited States the District of Co um Sta. or tie Commonwealth of Puerto ico.
Dertist means an individuallicensed bv a State or Territorv of the United States the D or t1e Commonwealth of Puerto Rico to cractice dentistrv.
Drive cable ISee " Control cable"1.
Exoosure head means a device that locates the camma radioormohv sealed source in t cosition. (An exoosure head is also known as a souret stoo.l
" ; d;x cca.i n.;en; ;t.; ;,,;;;;.;l de;; ;;,..; ;n; ;; ;t.; l;ne ef ;t.; ;,; ;; ; ::e; ; d;W nHH3
- r;!.:::: 200.;;!:.,%
";;'d 'Su P.;'"x: n.;;n; e f:::;; ;;d ;; pre.- d; de;;,,n: fern.ai ;;;; ;t,; eree ei e ; f : L;; n ;f ;, se ;
e.;.;. epee;;;;; 0;p;t..
r Field station means a facility where ll;;n;;d ;.;;;..e: sources of radiation may be stored or used and from wh.ich equipment is dispatched ;; ;;a.perei,,etea;;.
Guide tube means a flexible or rioid tube (i.e.
"J" tube) for cuidino tie source arsembiv and the attached.
control cable from the exoosure device to the exoosure head. T ie cuide tu 3e mav also inc ude the connections necessarv for attachment to the exoosure device and to the exoosure head.
t 4
PROPOSED - FOR COMMENT. APRIL 1C9 Hands on exoerience means exoerience in all of those areas considered to be directiv involved radicaraohv orocess.
Hioh radiation aren means an area, accessible to individuals,in which radiation levels from radiation sources 1
external to the bodv could result in an individual receiving a dose equivalent in excess of ' mSv (0.1 rem) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 30 centimeters from ;n, ;;ure; ef ;;d:;;:er. er the radiation source or 30 centimeters from any s.u.rface that the radiation penetrates.
ee.
Indeoendent ce tifyino creeniretion means an indeoendent creenization that meets all of the criteria of Aenendix A to Part E.
i Individual monitorino devices (individual monitorino eouioment) means devices designed to be worn by a single individual for the assessment of dose equivalent 4.ugtt,as. Ier purp;;cs, "pcrecanei des.T.;;;;" end "desrr.;;;r* ;;; ;;u.. ;.';n; ;;;rne.
Exernp ;; cf.ac...0d.T.en::;r:n; de..;c;s are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal ("lanel") air sampling d.e. vices.
hda-i' md:ccanh. rn;ene :h; exe...:ne;;;n of :h;.T.ecres;;p:; e:r.c;ur; ef.T.;;;;;e'; b, nend;;;ruc;..c
.......~., m..Jn; eeerc;e ef iedi;;;en.
Industrial raciooraohv (radicarachv) means an examination of the structure of materials bv nondestructive methods. utiirino ionizino radiation to make radioorachte imsoes.
3 C C C M Ci ii C LT.3 L x i. p; n; a ep;C; CCL;Cd Ci ibC CCniCi O ibC 3.T.; C3i spbCiC ibiOugb ^. ~I. CI. I.C CCniiO e.x..s of the beet.s ps;s;s :n e:: cond:::en.
Lev barce radiocrachv means industrial radicarachv oerformed on anv water vessel used for lavino oice.
Leaksee radiation means radiation emanating from the diagnostic or th; rep;u;;c source assembly except for:
Leaknoe technioue factors means the technique factors associated with the diagnostic;; tbi. rep;ut:c source a.s.s.embly which are used in measuring leakage radiation. They are defined as follows:
(3) For all other diagnostic er th;repcutic source assemblies,the maximum-rated peak tube potential and
...the maximum-rated continuous tube current for the maximum rated peak tube potential, Lens dose ecuivalent (LDE) acclies to the external exoosure of the lens of the eve and is taken as the dose ecuivalent at a tissue deoth of 0.3 centimeter (300 molem%
Mediest use means the intentionalinternat or external a6.;inistration of radioactive material, or the radiation therefrom, to harnene in :he pre;;;ce of :he he;!:ng er;e ostients or human research subieets under the 5
I l
I
\\
PROPOSEO FCR COMMENT-APRlL 1[99 l
suoervision of an authorized user fan defined in these reaulations).
1 I
I l
Member of the oublic means ;n bd:s:ded b. ;en;.;led e; ns;;;,:;;;d ;;;;. !k..e s;;, en bd.;d;;.' :s ne;
- me i.he; ;f the p.,h
- ; d.,;n; ;T.i p;;,ed b ish ;h ;he anv individual excent when that individual tece,ves is receivino an occupational dose.
!.t. ;. hr th;;;.. m;;,; ;;d:;;bn th;;;.p,.s:;h ;;b;.;; d:;pb;;m;;.;;f th;.;;f h;;m ;nd th; p;t;n; d..;;n;.;;;d;; ten. :: b;:.de; ;;; th;.repi, ;k:p :h;; p,,.ad re;;;bc.;: ;her p7 Occuestional dose means the dose received by an individual in ;. ;;;;.:;;;.d ;;e; ;; b the course of employment in which the individual's assigned duties involve exposure to radiation and/or radioactive material from licensed reoistered unlicensed and unreaistered sources of radiation, whether in the possession of the i
licensee, registrant, or other person. Occupational dose does not include dose received: from background l
radiation, ;; e p;,0;n; f;;m n;.dZd p;;;C;;;" rom any medical administration the individual has received, f.r.om. voluntary participation in medical researc i programs, or as a member of the public.
i Offshore otatform radicaraohv means industrialradicarachv conducted from a ofatform over a body of water.
l
";:m:nc r ccd;,c:;d; ',;;;".::; m;;n; ; ;h ;ld;d b;;;";;,en ;; ;;;,,,;;,,,;; d;;;;n;d ;; b;;nded fe;
- d;;;;;ph, ;nd ;n..h;;h ;;d;egraph, Z ;;;.;;; i p;;k;rned.
Permanent radioorachie installation means al enclosed shielded room. cett. or vauft. not located at a 1
emocrarv tobsite in which radicarachv ts cer"ormec I
M e
l j
Pharmacist means an individual reoistered to eramoe in the oractice of enarmaev in this State oursua I
l l
Section 51919 of the Genera Laws of Rhode slanc! as amended. entit ed "Pharmaev" PracticalExamination means a demonstrsti3nthrouch oractical sooliention of the safetv rules and orinciofe I
in industrial raciocraohv incluaina use o' a i amorooriate eouioment and crocedures.
j Projection sheath ISee Guide tube"1.
Proieetor see "Radicarachie exoosure device" I
i i
Public done means the dose received by a member of the public from exposure to radiation or radioactive i-material released by a licensee or registrant, or to any other ;;.;;,;.; dih;;.. :h:n e ik;.n;.;;.'; ;,; ses ;;;enn l
- n;.;;;;d ;;;; ;; b.n;;;;,%;;d ;;;;; source of radiation under the control of the licensee or reoistrant. It i
Public dose does not include occupational dose, dose received from background radiation, d;,;e re;;..;d e;
- p;;,;n; ;;; n rc.;d
- ;;,', p;;;S;;; from any medical administration the individual has received, or dose from vo.luntary participation in medical research programs, j
i 6
i 1
PROPOSEO - FOR COMMENT-april FM ee.
Radiation Safetv Officer for inc usnriaf radiocraohv means an individual with the resoonsibilitv for the overall gation safety orocram on 3elaf" of the licensee or reoistrant and who meets the reouirements o" E. 2. 21.
ese i
";d;;;i:.zh. a.;;;.; ;ai :nd:;:d 5keh; p;;fe T.u, ;; p:;;:d;a p;;au!.; ;ep;e;hk. ;f, :nd ;;i.;;;;,dtg;;,
epe,;;;4,.n; er,d veh,e,_b.; pen.:Li t,e the ;Zer...;. er ;;;,h;.en;ier W.; ;;c.g een.p ba;e ;s:;h the rec,.re...ph2
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Radicaracher means anv individu,!! wie nerforms or whs. In attendance at the site where the sourcefn) of rac ntion are beino used. Dersona v suoervises induttria radicarao lic coerations and who is resoonstb e to j
the icensee or reoistrant for assurino comolia nee witi the recuirements of the Aoenev's reaulations and the concitions ef the license end/or certificate o" recistration.
Radiocrecher certification means written scorovalreceived from a certifvino entity stetino that en individual 1as satisf actorilv met certain establishec radmtion safety testino. and exnerience criteria.
Radicaracher's assistant means any individual who, under the p;;.ene; supervision of a radiographer, 4
uses sources of radiation, radicarachic exoosure devices. related an ing tools, or gghgl2.'J survey instruments in industrial radiography.
Radicarachic exoosure device (also called a camera. or a orojector) means any instrument containing a sealed source f astened or contained therein, in which the sealed source er shielding thereof may be moved, or o.t.herwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.
Radicarachic coerations means att activities associated with the cresence of sources of radiation durino use of the device or transoort (exceot when beino transoorted bv a common or contract transoort). to include suivevs to confirm the adecuacy of boundaries. settino uo eouioment and any activity inside restricted area bounc aries.
"cdad; ^ do;;
Et; ' ; cc-t ;C; rn;;ne ; ;;rnb:n;,;;;n of ;.s; d;;; n.;n;;;i.c.;;,;;;a,e :n v.hkh b;;h
- ys.;; a; ei; erre g;d ;;;;....;ne;;; ired;;;bn!. e;;;iden; as.;h e pi; e;k;;;d nun.b;i ef de;e inen
- ;;i.,n::;.
S-tube means a tube throuch which the radioactive source travels when inside a radioorachie exoosure device.
C;id :.u ; a.;;n; r;dbe;; ;; a.;;;ib :he; b p;ia,;.;n;:,-bend;d er fN;d in e ;;pe k bi in;;is d;;;gned
- pie.;n; sek;;; e.d d
- epereei of
- h; ;;dbe;;;ve n ;;ik und;;:h; 77.;;; ee;;ie ;;nd;;.ene vshkh ei;im;ly
- , b; e.;e n;;i;d :n nein.e: e; end hendl;ng.
Seated source means any radioactive materlat that is encased in a caesule desianed to orevent leakaoe escaoe of the radioactive material.
g CCCCGdC^. dC32 -,3 iLi C. 2' 172-.ii.;;nd w w y.icin ;.I, ;I.,. N iciii.;,$; si.ed vi ;,
- I. ;J;,1 si ;$$ui; s
c.i :h; pi..,.ui, ;, ;;;n..
LE;~ i U A e i.;; e e d;E ;; eii;Cb;d is b; i;d ;$!;is,;wd1; ;up[-;ii euA si ^ e.;;as -. I i'.g iTnwici ;!.
y 7
~
PROPOSED FOR COMMENT
- april 10 Shieldad oosition means the location wl"hin the radicarachic exoosure device or source c sealec source is secured and restricted " rom movement.
e..
Source assembiv means an as sembfv that consists of tFe sealad source and a connector that attaches the source 13 the contro cable. T1e source assemb v may a so ine ude a ston bal usec the shie ded oosition.
to secure the source in Source stoo TSee "Exoosure head"1..
..s Ex:.r. i;; - t;:x. n;.;,n; ;;d ;;.en th;;;p,..thee; ;; ;;.s; d:;p:;;;.cn;c.; ef :he u;;f.; he.c. ;nd ;he
-.e..n; 3.;;n;,;.;;;;;;en.
p ;,;
Storace area means any location, facility, or speetel vehicle ;; er ;n which is used to store or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to the device, container, or source. prevent accidental exposure tampering with, or unauthorized removal of Stornoe container means a container in which sealed' sources are ;;;n;per;;d er 6 stored.
Temocrarv iobsite means a location where radiocrachic coerations are conducted and where licensed m or recistered machines may be stored other than those location (s) o" use authorized on the scense and/or certificate of recistration.
Underwater radicaraohv means indust >ial radicarachv oerformed when the radiocrachie exoosure device and/or related eouioment are beneath t 1e surf ace o' the water.
- Unrestricted area means an area, access to which is neither limited nor controlled by the licensee or r,e,Distrant, re; p.;pe;;;. "un;;ni.;";d esee" ;; en ;;u.seien; ;;;;n.
Verv hich radiation area means an area, accessible to individuals, in which radiation levels from radiation sources externalto the bodv could result in an individuatreceiving an absorbed dose in excess of 5 Gy (500 r.ad.) in i hour at 1 meter from a source of radiation or 1mtleI from any surf ace that the radiation penetrates.
8 3
)
/
PROPOSED-FOR COMMENT april TC33 A.1 GENERAL. PROVISIONS A.1.1 Puronse and scene.
(a)
. radiation hazards,. notices, instructions and reports to workers, and m specifically provided Except as otherwise i
acquire any source o, these regulations apply to all persons who receive, possess, use, transfer, own f radiation. The limits ir tFit Part do not soolv to doses due to backoround radiaton.
due to any medical administration the indivic ua nas received. or c ue to voluntarv oarticioation in mec ical research crocrams; provided, however, that nothing in these regulations shall apply to any person to th gt,ent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.
t e...
A.2 STANDARDS FOR PROTECTION AGAINST RADIATION A. 2 2 Radiation Protection Proorams.
-(b)
The licensee or registrant shall use, to the extent practicable, procedures and engineerin
' based upon sound radiation protection principles to achieve occupational doses and W.; de;;;g controls members of the oublic that are as low as is reasonably achievable (ALARA).
doses to A.2.3 Decuoational Dese Limits for Adults.
(a) s.pe.cial exposures pursuant to A.2.8, to the following dose limits:The licensee orj (2) The annuallimits to the lens of the eye, to the skin, and to the extremities which are:
(i)
Aw }ggg dose equivalent of 0.15 Sv (15 rem), and (c) receiving the highest exposure 1detfM es f;::;.se:The assigned deep dose equivalent an (1) The deep dose equivalent,ste lgg3 dose equivalent and shallow dose equivalent may be assess from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dore limits,if the individualmonitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or A.2.5 Determination of Extemal Dose from Airbome Radioactive Material.
(a)
Licensees or registrants shall, when determining the dose from airborne radioactive matarial, include the contribution to the deep dose equivalent, eye 1gg3 dose equivalent, and shallow dose equivalent fr e t,ernal exposure to the radioactive cloud. (See Appendix B to this Part, footnotes 1 and 2.)
A.2.7 Determination of Prior Occusational Done.
(a) For each individualwho rney en;;r th; ::;;;.;.;;'e ;; ;;ps;;en'!; ;;;t.;;;;d er cen.;";d er;; ;nd is likely s.h.a.ll:to receive,in a year, an occupationaldose requiring monitoring pursuant to A 9
PROPOSEO - FOR COMMENT APRIL 1:99 e..
A.2.8 Planned Sometal hosures. A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for saparately from the doses received under the limits specified in A.2.3 provided that each of the following conditions is satisfied:
(a) The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the hyh;r e,ge;ere dose estimated to result from the olanned soecial exoosure a.r.e. unavailable or impractical.
e..
A.2.10 Dose to an EmbrvofEstus.
(a) The licensee or registrant shall ensure that the dose truivetent to an embryo / fetus during the entire pregnancy, due to occupationalexposure of a declared pregnant woman, does not exceed 5 mSv (0.5 rem).
(S.e.e A.5.7 for record keeping requirements.]
(c) The dose 12Mi115211o an embryo / fetus shall be taken as the sum of:
(1) The deep dose equivalent to the declared pregnant woman; and (2) The dose coulvalent to the embryo / fetus resoftino from radionuclides in the embryo / fetus and radionuclides in the declared pregnant woman.
(d) If by the time the woman declares pregnancy to the licensee or registrant,the dose ecuivalent to the embryo / fetus has exceeded 4.5 77.0 (0.45 i;ro; 5 mSv (0.5 rem) or is within 0.5 mSv (0.05 remi of this g223, the licensee or registrant shall be deemed to be in comphance with A.2.10(a) if the additional dose eouivalent to the embryo / fetus does not exceed 0.5 mSv (0.05 rem) during the remainder of the pregnancy.
A.2.11 Dose Limits for Individual Members of the Public.
(a) Each licensee or registrant shall conduct operations so that:
(1) L;;pt ;; pic.;d;d ir. A.2.11 e';2;, The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of the dose contribution from backoround radiation. any medical administration the individual has received. exoosure t 3 individuals administered radioactive material and te eased n acco dance with Section C.8.24 o' these reculations. voluntarv oarticioation in medica researc 1 oroiects. and the bcensee's disposal of radioactive materialinto sanitary sewerage in accordance with A.4.3; and (3) The dose in any unrestricted area from externalsources, exclusive of the dose contributions from individuals administeredradioactivematerialand releasedin accordance with Section C.8.24 of these gggAM22L does not exceed 0.02 m5v (0.002 rem) in any one hour.
(b) If the licensee or registrant permits members of the public to have access to ;;r.ts;";d ILitutled areas, the limits for members of the public continue to apply to those individuals.
feligl The Agency may impose additional restrictions on radiation levels in unrestricted areas and on the totaTquantity of radionuclides that a licensee or registrant may release in effluents in order to restrict the c.o.llective dose.
10
PROPOSED - FOR COMMENT-april 18:9 ee.
A.2.12 comollanes with Dom. Urr.hm for !r.dMdaal **:.i.srs of the pa=.
(a)
- nd ;;;;at
- areas and radioactive materials in effluents rel grnonstrate compliance with the dose limits for individual members of the public in A.2.
ee.
A.3 PRECAUTIONARY PROCEDURES ee.
A.3.2 General survav and Manhar:no Raou!rstr.sa:n.
(a)
Each licensee or registrant shall make, or cause to be made, surveys that:
(1) Are necessary for the licensee or registrant to comply with this Part; and (2) Are n;;;;;;.
radiation levels, c/ ggggggggg under the c,ircumstances,to evalua,te the maanitude and extent o hazards it.;; ;e ld b; p;;;;n;.oncentrations or quantities of radioactive material, and the potent
-A.3.3 C.gnditions Raouirino individual Monitorino of External and internal Ocmaational Done demonstrate compliance with the cccupational dose limits of th (a) Each licensee or registrant shall monitor occupationalexposure to radiation from unlicensed and unreaistered radiation sources under t se control of the licensee or reoistrant and shall supply l
and require the use of individual monitoring devices ay:
percent of the limits in A.2.3(a); and(1) Adults likely to receive, in 1 year from s 12; !.i:n;;e ;nd d;;l;.;d pr ;n;n;..en.;n lL', te.;; :.;
.1,;;; f; era ;em:;;;
b;d,. e de;; :n e,.;;.ee ef 1 O p;;;;n; ef en, ;I ;t.; ;pp':;;,L'; l%n: ; ln A.2.2 er A.2.10;
- ,.;;;r.e' ;; ;t.;
Q Minors likelv to re ceive. in 1 year. from radiation sourc es ex;ternal to t1e bodv. a denn dose eouivalent in excess o" 1 m5v (O.
remL a tens cose eouiva ent in excess o" 1.5 mSv (0.15 remL or a shallow dose eautvalent to the skin or to the extremities tn excess of S mSv (0.5 remL g Dee ared oreanant women likelv to receive durino the entire oreomanev extema to the bodv. a deen dose ecurvalent in excess of 1 mSv (D.
rem)" and fBt $ individuals entering a high or very high radiation area; and (b) of radioactive material by and assess the committed effective dose e 1, Columns 1 and 2, of Appendix B to this Part; and(1) Adults likely to l
equivalent in excess of G:61 mSv (9:95 M rem); Rad (2) Minors Declared oreenant women likelv to receivm durino the entire creonan ose eouivalent in excess of 1 m5v 10.
rem 1 All of the occupational doses in Sece as the embryo / fetus dose limit is not exceeded.A.2.3 continue to be applicable to the declared pregnant worker as 11
NOPOSED. FOR COMMENT-AMit 1::9 A.3.9 Use of individual Resolratorv Protection radarnant.
(a) If the licensee or registrant uses respiratory protection equipment to limit intakes pursuant to A.3.8.
(3) The licensee or registrant shall implement and maintain a respiratory protection program that includes:
(v) Determination by a physician prior to gg initial fitting of respirators, and et4eest gg* hg every 12 months thereafter tr meriodically at a "reousney determined Sv a ohvsician, that the individual user is ph,;:U.::, ;t:; rnedicativ 'it to use the respiratory protection equipment.
A.3.10 security of stored sources of Rediction. The licensee or registrant shall secure from unauthorized removal or access licensed or registered sources of radiation that are stored in een;;;%d er unrestricted areas.
A.3.11 Control of sources of Radiation Not in Storace.
(a) The licensee shall control and maintain constant surveillance of licensed radioactive material that is in og ;en;;;%d er unrestricted area and that is not in storag; ;r ln ; pe;;;n;.
(b) The registrant shall maintain control of radiation machines that are in a ;en;;;% der unrestricted area a.n.d.that are not in storage.
A 314 Exenotions to Postino Renuirements.
e (b) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution' signs pursuant to A.3.13 provided that the patient could be released from ;enf:nen,;n;licanaat g pursuant to C.B.24.
g A licensee or reoistrant is not recuired to cost caution storis in rooms in honohals or clinics that are usec "or telethernov er externa 3eam radiation thernov. if each o" the followino concitions is met:
, Q Access to the room is controlled oursuant to C.B.50: and
@ kers other oatients. and members of the oub ic to radiationin excess of the imits estables med inPersonnel in attendance take necessarv oracautions to oreve wor this 3 art.
A.4 WASTE DISPOSAL A.4.6 Transfer for Disoosal and Manifests.
(a) The requirements of A.4.6 and Appendix D to this part are designed to; W Control transfers of low level radioactive waste bv anv waste cenerator. waste collector. or waste orocessor licensee. mit defined in this Part. who shios low level waste either direct v. or indirectiv throuch a waste co actor or waste orecessor. to gn;;ng;d fe;.;peee: ei a licensed low-level' red.ee;;..e waste g disposal facility; 12
~
PROPOSED FOR COMMENT-APRIL 1C9 1
g Establish a manifest tracking system; and i
@ Supplement existing requirements concerning transfers and record keeping for those wastes.
(b) Ce;h sh:pment ;f redicents;..;n; d;s:saned f;r d:ep;;;; a e l:;;n;;d ;; i !ri; red:;;G,.;.sen; d;sp;;; fe;;;;;y ehd! b; e;;;mpenkd by e shipmen; men: fen es epedf!;d h S;n:en l ef App;nds O ;; th;;
Port-f ac'g 'Fiust c ocument the information reouired on N RC"s Jni"3rm Low. eve Radioactive Waste N anifestAnv licensee shiocino radioacti 3r tritimate disoos it at a licensed land ciscosal ity anc transfer t16s recorded manifest information to the intendec consionee in accordance with Accendix 3
to this Part.
l (c) Each shipment manifest shallinclude a certification by the wreste generator as specified in Section 11 of Appendix D to this Part.
(d) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Section lli of Appendix D to this Part.
A.4.7 Comoliance with Environmental and Health Protection Reaulations. Nothing in A.4.1 A.4.2. A.4.0, A.4.4, A.4.5, ;; A.4.0 this Subcart relieves the licensee from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials that may be disposed of grsuant to A.4.1. A.4.2, A.4.0, A.S.4, A.4.5, ;i A.4.0 this Suboart.
A.5 RECORDS, REPORTS AND ADDITIONAL REQUIREMENTS A.5.1 Grneral Provisions.
(a) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this Part.
(b) The licensee or registrant shall make a clear distinction among the quantities entered on the records required by this Part h, sah as, total effective dose equivalcat,t;;d ;rgan d;s; ;wed;nt, shallow dose e.qu.ivalent, eye lggg cose equivalent, deep dose equivalent, er cornmitted effective dose equivalent).
A.S.7 Becords of Individual Monitorino Results.
(a) Record keeoino Reouirement. Each licensee or registrant shall maintain records of doses received by allindividuals for whom monitoring was required pursuant to A.3.3, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before 1 January 1994 need not be changed. These records shallinclude, when applicable:
(1) The deep dose equivalent to the whole body, eye gn,g dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities; and (2) The estimated intake of radionuclides [See A.2.4]; and (3) The committed effective dose equivalent assigned to the intake of radionuclides; and (4) The specific information used to ;d; 'n; the committed effective dose equivalent pursuant to A.2.613.LinJ;l (c). and when recuired v,.3:and 13
1 PROPOSED FOR COMMENT APRIL 19:9 e..
A.5.13 Notification of incidents.
)
(a) Immediate Notification. Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or 1
registrant that may have caused or threatens to cause any of the following conditions:
(1)
Immediately notify the Agency of each event involving a source of radiation possessed by the licensee or registrant that rnay have caused or threatens to cause any of the fo!!owing conditions:
(i)
An individual to receive:
(al A total effective dose equivalent of 0.25 Sv (25 rem) or more; or (h) Ameye ig,n;g dose equivalent of 0.75 Sv (75 rem) or more; or
)
(b) Twenty Four Hour Notification. Each licensee or registrant shall, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery of the event, report to the Agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:
(1) An individual to receive, in a period of 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />s:
(i)
A total effective dose equivalent exceeding 0.05 Sv (5 rem); or (ii) Ameye ig,n,g dose equivalent exceeding 0.15 Sv (15 rem); or A 6 NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTIONS A.6.3 Instructions to workers.
(a) A11 individuals who in the course of emolevment are likely to receive an Annua.1 occupational doseig excess of 1 mSv (100 mrem) shall be:
(1) Kept informed of the storage, transfer, or use of radiation or radioactive materist sourcca of red:; dor. :r eah perder.; cf :he r;str;c:;d arcs; (2) Ir.structed in tha health protection problems associated with exposure to radiation or radioactive material;; the ;.d;v;dd er,d p.,;;r.da' ef fspr;r.;i, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; (3) Instructed in, and ir,strated reovired to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material; (b) In determinino those individuals subiect to the reouirements of Paraormoh A.E.3(a). licensees and reoistrants shall take into consideration assioned activities durino normal and abnorma situations involvino exoosure to radiation and/or rtdioactive material which can reasonably be exoected to occur durino the hfe of a heensed or reoistered f sci itv. Tne extent of these instructions shall be commensurate with the potential re.oiological health protection problems cresent in the work olace.
14
F PROPOSED FOR COMMENT-APRIL 129 i
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J Ashlic Hearing Note: The existing Part A - Appendix D is intended to be deleted k its entirety and repInced with new text shown below. However, because of the large nwnber of text pages hwolvedin this deletion, only the Appendix dtle actually appears hr this document.
PART A - APPENDIX D REQU REMENTS FOR TRANSFER OF LOW-LEVEL RADIOACTIVE WASTE FO R DISPOSAL AT LAh D DISPOSA
. :ACILITIES AND MA VIFESTS L
Manifans 4
r n
i n
I i
n
\\'g LLW for orocessino,ind oxeect its return fi.e. for storace under their license) orior to disoonal at a icensed land deseosa fact itv:
g LLW that is beino returned to the licensee who is the " waste oenerator" or eenerator." as defined in this i
ELAI 1; QI g Radioactive!v contaminated material to a " waste crocessor" that becomes the orecessor's " residual l
EAllRJ.
For c uidance in comotetino these forms. refer t 3 the instructions 9 hat accomoany the forms. Cooies of manr ests te cuired bv ties accendix may be eoib e car 30n cooles c lotocooies Dr comouter orintou"s that "e sroduce t ie data in the format of the uni' orm mani1 est. NRC Forms 540. 5 LOA. 541._541 A. 5L2 and 542 A. and the accomoanvino :n structions. ir 1ard conv.11av be obtain ed from 1he Iriforriation and Records Vianacement 3 ranch. Office of rr ormation Resottrees N anacement. L.S. h u! ear F eau atorv Commis sion.
Nashinoton. DC 20555. telechone (301) 415 723 2. This nonendix includes 'n"ormation reouireme 'tts o' uhe 3enartment of Transoortation, as codi"ied in 49 C ;R oart ' 72. Information on hazardot s. medica. or ot ier waste. recuired to meet Environmental Protection Acencv reculat# 3ns. as rodifiedin 40 CF R carts 259.251 or elsew1er e. is ne t addressed in t its section. ar d "nurt se n'ovic ec ont,e recurred EPA "orms. H o w e'rer.
nie reautrec EPA ' orms must accomoany t1e L ni"orm.o w..evelFac ioactive Waste Manifest recuitec bv i
t lese reculations.
An used in this annendix. the followino definitions acolv:
Chelatino acent means amine nelvearbornlie acids la e.
EDTA. DTPA). hydroxv carboxvlie acids and no vcarboxvinc acids (e.o. citric acid. carbo ic acid, anc o ucinic acid).
Chemicaldescriotion means a descriotion of the erincion! chemical characteristics of a low-level radioactive W.allL 9
Comouter readablemedium means that the reoufatorv noenev's comouter can transfer the information from the medium ento its memerv.
I 15
PROPOSED FOR COMMENT-april 1C99 Consionee means the desionated receiver of the shioment of low-level radioactive waste.
Decontaminationfacility means a facil tv ooerat no under an Acenev. U.S. Nuclear Raoulatorv Commission.
Aoreerr ent State or Licensin s State scense w 1ose orincies euroote is decontamination of eouio"nent or materie a to accomolish reeve e. reuse. o' St 1er waste manacement o Diectives.and for eurooses of tits cart.
's not considered to 3e a constonee for
. E shioments.
Disoonal container means a mntaine nrineinalfv used to confine low leve' indic active waste d Jrino discotal comratic ns at a land discosa
'aci ity l also see "hich inteority container" N ote Mhat "or some s lioments. t le disoosa container mav 3e t ie transoort onckaoe.
EPA identification number means the number received bv a tra.isoorter followine anoliestion to the Aermnistrator of EPA es reauired bv 40 CFR oert 263.
Generate,r means a licensee coerttino under an Acenev. U S. Nuclear Reculatorv Commission. Aoreement State or _icensino 5 tate license w lo_(1 i is a waste c eneraitor as defin ed @s cart. or (2) ts the icensee to whort was' e can be attri 3uted wig
,, t le contcxt o"the _ow-Level F adioactive Waste Poliev Amendments Act o" 1985 (e o. waste ceneratec as a result of decontamination or reevele activities).
Hioh inteority coltaine' (HIC) means a conta ner commentv desioned to meet the strue" ural stabilitv reautrements of ' O CF R 6'.56. and to meet Oeoartment of Transoortation reouirements ' or a Tvoe A SAEAAES.
_and' dis cosalf aciitv rieans the land. buildinos and structures and mouioment which are intended to be used or t ie c iscosa o"rac ioactive wastes.
r WRC Forms 540. 540A. 541. 541 A. 542. and 542A are official NRC Forms referenced in this nonendex.
1
_icensees need not use oricinals of these NRC Forms as ono as nnv substi"ute "orms are eouivalent to the 3ricinal dccumentation in resoect to content. c aritz size. and ocani3n o" information. L oon ac reement 3etween t he shioner and consionee. NRC Forms 54' (and 541 Al anc
\\lRC Forms 542 (anc 542A I mav 3e comoleted. transmitted. and stored in e ectronic media.
~he electronic mec ia must h ave the canabi itv ' or oroducino teoible. accurate. and comolete records in the "ormate o" the unr orm manr est.
Packnoe means the assembiv of comoonents nec essarv to ensure comoliance with the oncknoino recruirements of DO reautations. tocether with its rac ioactive contents. as cresented for transoort.
Physicaldescriotion means the items called for on NRC Form 541 to describe a low-level radioactive waste.
Residual waste means low-levet radioactive waste resultino from erocessino or decontamination activities that cannot be easily secerated into cistinct batc les attributabte ter sc ecific waste cenerators. "his waste is attributable to the orocessor or decontamination f acilitv. as ano tea 3te.
Source material has the same meanino as that civen in Suboart A.O of these reculations.
Shicoer rienris the licensed entitv fi e.. the waste cenerator. waste collector. or waste croces tor) who offers low-eve radioactive waste for transoortat en. tvoically consionino this tvoe of waste to a icensed waste
~
collector. waste crocessor. or land diseosa f acility coerator.
Shineino oneer means b RC Ferri 540 and. If reouired. NRC Form 540A which includes the information gouwed by DDT in 49 C ;R nart 72.
Soecial nuclear material has the same meanino as that civen in Submart A.O of these reaulations.
'Jniform _ow-level Radioactive Waste Manifest or uniform manifest means the corib' nation of h RC Forms 540. 54' and. if necessarv. 542. and their resoective continuation sheets as neec ec. or eautva e nt.
Waste collector mea ns an entitv. coeratino under an Acenev. U.S. Nuclear Reoulatorv Commission.
Acreemenn Sta"e or
.icensino State scense. whose orincical euroose is to ce lect and consolidate waste cenerated av ot lers. and to transf er t iis waste. wit icut orocessino or reoack noina the cellected waste. to-l another licensed waste collector. icensed waste crocessor. or licensed land c iscosat < aci itv.
Waste descriotion means the ohvsical. chemical and radiolooicaldescriotion of a low-level radiosetive waste 16 J
PROPOSED - FOR COMMENT APRIL 1999 as celled for on NRC Form 541.
Weste eenerator means en entitv. ooeretino unc'er en Acenev. U.S. Nuclear R Acreement State or Licensino State hcense. who i1) oossesses env meterial or c rBdioactivity or is radioactivelv contaminstea for which the licensee foresees no further use. and (2) transfer mis meterial or comoonent to e licensed lend disposal f acilitv or to e licensed weste collector or orocessor or handlino or treatment orior to disoosal. A heensee cerformino crocessino or decontemmation services
]e e "weste cenerator" if the transfer of low level radioactive weste from rts facility is defined es "r EAllL."
esidual Weste crocessor means en entity.
ooeretino under en Acenev. U.S. Nuclear Reculatorv Commission.
Acreement State or Licensino State beense. whose orincioel ourcose is to crocess re greet low-level radice;.tive meteriel or weste ceneretec t'v others crior to eventuai transigt of weste to e Eycea low level repoective weste tena c'snotei feemtv.
Weste tvoe means a weste within a discosei container havino e unioue ohvsical descriotion (i e scecific Weste descriotor code or descriotion; or e Weste serbed on or solidified in e soecificeliv defined medtel L INFORMATION REQUIREMENTS 6 GeneralInformation The shicoer of the radioettive weste. sheit crovide the followino information on the unifor
$ The neme f acility address end telechone number of the licensee shionino the weste:
i Q An exoticit declaretion indicatino whether the shicoer is actino es a weste cenerator Drocessor or e combination of these identifiers for Durcoses of the manifested shioment: and g 3T name. address. and teleobone number. or the name end EPA identification number for the carrier Moortino tne weste.
L gy;nt information The shir >er of the radioective weste shall orovide the followino information reoerdino the on the diform men!fest:
y The date of the weste shioment:
Q The tetet number of oseksces/disocsel containers:
Q The total discosal volume end discosel weicht in the shioment!
$ The total radionuclide activity in the shioment
$ The activity of each of the radionuclides H 3. C-14. Tc 99 end 1-129 contained in the shioment: end g The total messes of U-233. U 235. end clutonium in soecis1 nuclear material. end the total mess of uranium end thorium in source material.
L Discosel Container and Weste Information Tho shioner of the radioactive weste shall orovide the fotlowino information on the uniform me She weste and each discosel conteiner of weste in the shiDment:
Q An e!chebetic or numeric identification that unicuelv identifies each discosal centeinerin the s Q A bbvsical descriction of the discosel container. includino the manuf acturer end model of en inteorriv conteiner:
17
Mt0 POSED FOR COMMENT. APRK 1C99
' g The volume disolaced by the dissonal container:
g The aross weicht of the'dissonal container. includino the waste g For waste consioned to a dissonalfacilitv. the maximum radiationlevel at the surface of each disoonal 1921 RID $TJ
.g A chvaleaf and chemical descriotion of the waste
~
i g The total weicht enreentane of chantha acent fer ame waste containino more than 0.1 % chelatino acent bv weicht o us the identity of t se orincina che atino acent g The accrovimate volume of weste within a conteiner:
g The sorbino or solidificationmedia. if env. and the identity of the solidification media vendor and brand DSO2fd g The le e ntities and activities of individt'al radionuelides contahed in each container. the masses of i
U-22 3
. J 235..ind clutonium in soecia nuclear material. and t le masses of uranium arld thorium in source materia For dis 3 rete waste tvoes (i.e.
activated materials, contaminatec eautoment.
j techanical "i ters. sealet source / devices. and wastes in so'idi' ication/stabiliza tion media the i
centities anc activities of and vic L al radionuclides associated wit 1 or contained oni 1ese waste tvoes within a c asoonal container s ial se recorted:
)
g The total radioactivity within each container and
, g For wastes corkiored to a disoonal facilitv. tF e classification of the waste oursuart to Secti3, I o" Aeoendix E to 1 1s Part. @ste not ma etl1a t ie structural stability reautrements o" Section li b) c' Accendix E to this Part mJst be identi" te C
& Uncontainerized Waste information The shionar of the racioactive waste shalf orovide the followine information on the uniform manifest reeardino a waste s lioment de iverec without a discosa container:
Q The mooroximate volume and weicht of the waste:
Q ' A obvsical and chemical descriotion of the waste:
g The total weicht oercentaae e f chelatino acent if the ehelatino acent exceeds 0.1 % bv weicht. olus the toentity of t le orincloal r 1elatino acenti g For waste consioned to a diseosal facilitv. the classificat'on e,f the waste oursuant to Secti3n I of Aenenc ix E to this Part. Waste not meet l1a the structura sta 3ility recuirements of Section I Hb) of Accenc ix E to this Part must be identifiec :
g The dentities and setivities of individualradionuclides contained in the waste. the masses of U-233.
U 22 5. and clutonium in soecial nuclear material and the masses of uranium and t iorium in source material: and g For wastes consionedte a disoonalfacility.the maximum radiationlevels at the surface of the waste.
_ L Multi Generator Disonsal Container information This section aoolies to dis 3 3 sal containert enclosino mixtures of waste cricinatino from different eenerators.
(Note: The orio n of the
_ _W resu tino " rom a crocessor's act vit es mav be attributable to one or meg,g cenerators" (ine udino " waste cenerat 3rs' as defined in this cart). It a so anches to mixtures of wastes shioned -
in an Uncontainerized form. for whic, nortions o' the mixture within the shioment oriainate from entferent ESOSEELL 18
PROPOSED - FOR COMMENT-MRil 1999 g For ho viooeneous mixtures of wante. such an incinerator asi orov'de the waste descriotion acolica s e to the mixture and the vo uma of the waste attributet to eac 1 cenerator.
~
j g F3r heteroceneous mixtures of waste. such a s the corrbined eroducts from a laroe comnactor.
ic entif v enc i oenerator contributina waste to tie disoosa contmner. and. f or discrete waste tvoes O.e.
activa"a d materials. c ontaminated eauiement. mechanica ilters se i ed sourca/ devices. and wastes er so ir ification/ stabilization media). the identities and activities o' individua radionuchdes
~
containee on t1ese waste tvoes within the disoosal container.
For each cenerator. nrovide the followino:
i g The volume of waste within the disoonal container; i
i g A chvsical end chemicel descriotion cf the weste includino the solidificetien scent. if env:
g The total weicht oercentaae of chelatino acents "or any discoral container containino more than O.1 %
cheistino acent bv weicht. olus t ie identity of t ie orincioal cielatino acent g The serbino or solidification media. if anv. and the identitv of the solidification media vendor and brand name if the media es e aimed to meet stability recuirements in Section lifb) of Anoendix E to this Part anc g Radionuclide identities and acti ities contains din the waste. the masses of U 233. U-235. and clutonit.m v
in soecial nue ear matenal. anc the masses o" uranium and thorium in source material of contained in t ie EAsh
& CERTIFICATION An authorized recresentative 04 the waste cenerator. orocessor. or collector shall certifv by sionino and datino the shioment manif est t 781 the transoorted materials are croceriv classified cesenbed.Onc(aced.
rr arked. ano labe ed and are in crecer condition for transoorts tion accordino to the nochte ate reau ations o" the Acencv. the U 5. De Sartment of Transoortation and tie U.S. N JClear Recu aMDry C 3mmission A collector in sionino the certi"#cationis certitvino that nothin:: has been c one to the co ectec waste which would mvalidate the waste cenerator's certification.
E CONTROL AND TRACKING g Anv licensee who transfers radioactive waste to e land diseosa ifacilityor a licensed waste collector shall comotv with ",e recuirements in caraorenhs A.' throuch 9 o' this section. Anv lice 1see w10 transfers waste to a licensed wa ste crocessor "or waste treatment or renack scino shal como v with the recuirements of caracrac1s A.4 throuch 3 of this section. A heensee sha i:
g Precare all wastes so that the waste is classified accordino to Section I of Aeoendir E to this Part and meets the waste characteristics recuirements en Section tilb) o" Accendix E to this Part:
Q Label each disoosal container for transoort oseknoe if co"ential radiation hazards ereclude labelino y the individual discosa contair eri of waste to identifv W1 ether it is Class A w iste. Class E waste.
Dass C waste. or creater then Class C waste. in accordance with Section i e' Annenoix s to this
$&T Q Conduct a cuality assurance crocram to assure comoliance with Aenendix E to this Part (the orocram must include mannaement evaluation o' audit s h g Preoare the NRC Uniform Low level Radioactive Waste Manifest as recuired by this annendix:
j g Forward a conv or efeetronicallvtransfer the Uniform Low-Level Radioactive Wasne Manifest to tie intended consionee so that either h) recevet of the mant"est erececes the LW s itoment or hit t ie manifest is dehvered to the consionee with the waste at the time the waste ts transferred to the consionee. Usino both h) and hi) es also accentable:
19
PROPOSED o FOR COMMENT-april 1C99 g include NRC Form E40 fane h RC Form 540A. If recuired) with the shioment reoardless of the cotion chosen in caracrao, A. 5 o' t its section:
Q Receive acknowledoment of the recelot of the shioment in the form of a sioned conv of NRC 2A1 g Retain a conv of or electronically store the Uniform Low Level Radioactive Waste Manifest and documertation of ackrowledoment of receint as the record of nransfer of icensed material as recuired 3v C.5.14 anc g For any shionants or any eart of a shioment for which acknowledoment of receint has not been received witiin the times set forth in this eccendix, conc oct an investication in accordance vmh cerecreen E of this encenciv.
g Anv waste collector licensee who handles ontv orenseksoed waste shall:
Q Acknowledae recelot :f the waste from the shioner within one week of receiot bv returnino a sioned conv of N RC Form 5L 3:
l g Preoare a new manifest to reflitet consolidited shioments that me et the recuirements of this nonendix. T1e was"e collector s is I ensure t ist. f or eac 1 container o' waste in t1e shioment the manif est identifies t 1e cenerator o~ that container of waste:
2 Forward a conv er electronicallvtransfer the Unif 3rm. Low LevelRadioactiva Was"e Manifest to tie inten ded con sinnee so t 1st either: 0) Receiot cf 11e manifest orecedes the _LW s 1ioment or M t ie mani"est is c e tvered "o the con!;tonee with tie waste at the time the waste is transferred to t ie consionee. L sino boi l h) and hi ts a so accenta 3le:
l g include NRC Form E4C (and NRC Form 540A. if reouired) with the shioment recardless of the cotion chosen in caraorno,E.2 of this section
$ Receive acknowledoment of the receiot of the shioment in the form of a sioned conv of NRC Form 5kW g Retain a conv of or electronicallv store the Uniform Low level Radioactive Waste Manifest and documentation of acknowledoment of receiot as the record of transfer of icensed material as recuired bv C 5.14:
l g For any shioments or anv omrt of a shioment for which acknowledoment of receiot has not been l
received within the times set forth in this accendix. conduct an investication in accordance with carecraoh E of this accendex and g
Votify the shicoer and the Acenev when a ny shioment. or oart of a shioment. has not arrived within 50 cavs after receiot of an advance manr est. unless notified bv t ie shiocer that the shtoment has 3een cancelec l
M Anv licensed waste orocessor who treats or renackaces waste shati:
Q Acknowledoe receiot si the waste from the shioner within one week of receiot bv returnino a sioned conv of NRC Form 500:
l g Precore a n:.w manifest that meets the reouirements of this nonendix. Prensration of the new manr est te ects that thir crocessor is resoonsible for meettna thes e recuirements. For each container 0"
waste in t 1e shioment. the manifest shall ide ntify t ie wa:;te cenerators. the orecrocessec waste volume. and the otherinformatten as recuirec in caracraoh
.E. o" this accendix g Preoare aff wastes so t',at the waste is classified accordino to Section I of Anoendix E to this Part j
ano meets the waste c1aracteristics reautrements en Section ll o" Aeoendix E to t its Part:
i
{
$ Label each oneksee of waste to id<rntify whether it is Class A waste. Class B waste. er Class C waste. in accordance with Section of Anoendix E to this Part:
20 I
i PROPOSED - FOR COMMENT-APRIL 1999 g Conduct a soality assurance orooram to assure comoliance with Anoendix E to this Part (the oro shal incluc e manacement eva untion of auc itsh g Forward a conv. or elecuronica flvtransfer the Uniform low-Leve1 Radioactive Was"e Manifest intended con o snee so t 1st eit 1er: (il Receiot cf the mani"est orecedes the LLW s1iement or (ii) t le manifest is e e Ivered no t he constonee with tie waste at the time the waste is transferred to t constonee.
L sino bot 1 (il and (ie) is a ie so accentab e:
Q include NRC Form E40 f and NRC Form 540A. If reouired) with the sh chosen in caraoran, C. 5 of this section:
g Receive acknowledoment of the receiot of the shioment in the form of a stoned eeov of NA M 91 g Petain a coev of or electronicallv store the Uniform Low-level Radioactive Waste Manifest and documertation of acknowledoment of receiot as the record of transfer of licensed m reoutred av C.5.14:
@ For any shioment er any eart of a thic. ment for which acknowledoment of receiot has not bee l
received wit i n t 1e times set forth in t1is anoendix. conduct an investication in accordance wit Daracraoh E o" this monendir and g
Votify the shioner and the Aoenev when a nv shioment. or omrt of a shi13 ment. has not arrived within 50 davs aft er receiot of an advance mani"est. unless notified bv t1e s1ioner that the shioment 3een cance ec.
g The land disoonal facility coerator shall:
Q Acknowledae receiot of the waste within one week of receiot bv returnino. a coev of NRC Form 540 to the shicoer. The shioner to tit notified is the licensee who 1he waste and transferred the w me to the coerator.
isted on the Uniform Low Leve any discrecancv exists between materia s electronic transfer of the affected "orms must be returnec inc; adioactive Waste Via nif est and materrats received. cooies or icatino the discrecanev:
Q Maintain conies of all comoteted manifests and electronicallv store the inform Accendix (exceot for shiocer and carrier te echene numbers and s 1soner and consionee certificaMionst the c ate the shioment of radioactive waste was received at t date of ciscosalof t ie diso ssal f actistv. the 1e waste. a traceable shioment manifest number. a cescriotion o" any enoineer ed Darrier or structura overoack crovided for discosal of the waste. the location of discosal at tle iscosat site. the containment c
inteoritv of the waste disoosal containers ciscrecancies between materials hsted on the manifest an d those received. the volume of anv onllets as received. any bracino or other shionino or onsite cenerated materials tlat are contominated. and as contaminated materials or susoect materials and anv evidence o" leakino 3r damsoed disoosal containers or radiation or contamination h mits soecifned in Acenev. L 5.
Deoartment of Transoortationer U.S. Nuclear Reaulatorv Commission reou ations entil the Acenev terminates the license: and g
Motifvthe shioner and the Acency when anv shioment. or eart of a shioment. has not arrived within 50 davs att.er receiot of an advance manifest. unless notified by t1e slicoer that the shioment has 3een cance ed.
Ig} Anv shioment or eart of a shioment for which acknowledomentis not received within the times set in this section must:
$ Be investicatedbv the shioner if the shioner has not received notification or rece after transfer: and g Be traced and recor"ed The investication shall inefude tracina the shiorrent and filino a recort with the Acenet. Each scensee who conducts a trace investication shal Acency within 2 weeks of comoletion of the investtostion.
fi e a written recort with the '
21
s PROPOSED FOR COMMENT-april 12:9 PARTB REGISTRATION OF X-RAY EQUIPMENT FACILITIES AND B.3 APPLICATION FOR REGISTRATION OF X-RAY EQUIPM s.pe.cifically exempted in B.2, shall:Each person who owns or possesses and B.3.1 lb) Prior to construction, the floor plans and equipment' arrangement of all modifications of existing facilities, utilizing X ray equipment and/or accelerators for radiography, research and development gr medical / veterinary diagnostic or the submitted to the Agency for review. The required information for all X rav ecuiemen excent thereceutic radiation machines. is denoted in Appendix A of this part.
thernoeutic radiation mac1:nes is contained in Anoendix A to Part H The recuired information for
[ REMAINDER OF PAGE INTENTIONALLY LEFT BLANK 1 0
e 22
PROPOSED = FOR COMMENT-april FCC9 eee PART C.
LICENSING OF RADIOACTIVE MATERIAL AND USE OF RADIONUCLI eee C.2 EXEMPTIONS e.e C.2.2 - R=daeetive untarial other Than Source Mat:-id.
eee eee g Radiometive Drun Ceaules containino Carbon.14 Urea for "in-Vivo" Diaonostle Use for Humans.
W ' Eremot an orovided in Suboaraorneha C.2.2fdif2) and (d)(3). any oerson is exemot from the recuirements for a heense oursuant to Suboert C.5 of these reculations orovided tnet receives cessesses. uses. transfers owns or aceutrescaosules containino 37 kBo (1uCs) ca a Ic wino for nominal variation that may occur dunne the manuf acturino orocess) each. for "in. vivo" use "or qumans.
Q Anv norson who desires to use the cannufen for research inve tvino human subjects shall anolv for and receive a soecific license oursuant to Suboart C.5 of these reou ations.
J Anv norso n who desires to 'nanufacture. or snara. nrocess. eroduce. Onckana. >enacka Se. or "rar sfer "or commercia c ist1bution suc 1 caosules shal a sc v "or and receive a soecific icense rom t ie J.S.
Quclear Raoulatorv Commission oursuant to 10 C sF 32.21.
,0 Nothine' in Suboarnaraohs C.2.2fdif11 (dif 2) &fdif 3) relieven eersons from comotvino with moolicable
' TA. Other
- ederal. anc State reouirements covernino receint. administration. and use of druas.
eos C.S.3 Eneelal Raoulrements for lasuance of Certain Sancific L!snsen for Radiometive Mate eee
.e (c) a specific license for use of sealed sources in industrial radiography will be i (1) The applicant ;.::: huse gggjtg an adequate program for training radiographers and radiograph assistants that meets the reouirements of E 2.10. ;nd ;,.5 7,::; ;; :h; A;;ng, e ;;h;d.,:; er d;;;;;p;;;,n
- f ; ;h pi;;;;,T. v.h,;h ;;;;d ;e ;he.
(i)' :n:;;;; ;;;:n'ng, After 27 June 2000. a license monticant need n3t deser be les initial trainino and examination crocram for radicarachers in the su 3:ects out inec in E.2.' O(c (ii) p;;;;d:; ;;;.:r,:ns, From IINSERT EFFECTIVE DATE OF THESE REGULATIONS) to 27 June 2000 a license abolicant m av affirm tha" a i indived Jats actino as industrial radicaranhers will 3e certified in radiation sa' etv bv a certi" vino entitv Sefore commencino duty as radicarachers. T1is affirmatien substitutes for a descriotion of ts initial trainino anc examination crocram "or radicaraolers in the subiects outhned in E.2.10foL e,th; jet;;;7,:ng,
':s; 7.;.n; ;;, L;
- d ti th;
- ;;;,;;; ;; d;;errn'n; th; red:;gr h knc.;;;d;; and
- pe;e;,n;.
- .d ;.,T,;;;en;, pr;;;d ;;e ;f ;he ;pp :;;..;,; ;; ene;nd ::;;n;:n;p ;;.
nde;;;;.,d:ns ;f ;nd ;t::::i;; ee,T.p,..::h A;;nci r;
- w.. err.;n;e, end th;
- ,d
's' r.;.n; ;; Le.;;d t, ;he ::;;;.;;; ;; d;; r,T..; ;h; ;;d:egi;pher'; ;;;;;u ;*; L;,;;;;;d;; ;nd
. g.dr.g;.d;.,; ef.nd ;t :,;i ;e ce.T,p!,.. ;h ;he ep;ie;,n; s.nd ;;ners;nei pre;;.d,.,re; ef th;
.w w....,..
g The anolienn" submits orocecures for verifvino and documentino the certification status of radicarachers and "or ensurino that t le certification of individuals actino as racioorachers remains vahd.
23
PROPOSE 0 - FOR COMMENT-april 1999 is 2 The applicant h;; ;;;;t :;h;d
.d submits :; :ht.'
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,w L4j The neolicant submits a descriotion of a orooram for insoecelons of the lob eerforrrance of each radicaracher and radicaracher's assistant at intervals not to exceec 6 mont is as describec in E.2.10 ten.
44 g The applicant submits :; :h;,* g;n;, a description of Ms the aonficant's overall organizational structure as it aoolies to the radiation cafety resoonsibilities in per;;.n.n, ;; ;r.; industrial radiography preg *em, including specified delegations of authonty and responsibility for sper ;b, ;,1 :he prescem.
g The acclicantidentifies and lists the cualifications of the individuaffs)desionated as the RSO E 2.21) and notential desionees resoonsible for ensurino that the Scensee's radiation safety orocram is imolemented in accordance with acoroved orocedures.
f6) J:;:h; epp! ken:..h; d;;;;;; ; ce.dw;; h:; ecsn k;L :e;;; hee ;;;;b:khed c,d;;w;;; pre;;d re;;;
be '..s;d in k;.L ;;;f ag ;;;kd ;; ;;;; fe p;;;;bk ' ekeg; end ;;,n;;mine:Zn end ewb n::; :; :h;
. ;;n;, e d;;;;;p;bn;f ; ;h pre;;dwree:n;lwd:ng if an acc timntintends to oerform leak testino of seated sources or exoosure devices containino decleted uranium ( 3 J 'shieldino. the mohcant must describe the crocedures for oerformino the test. The descriotion must inc ude the.
(i) Instrumentation to be used; (ii) Method!g} of coffectino the samoles: p;;f;rm:,,:;;;;, ';.g., p;:n;; en ;;,,,:pr;,;n; :; b; sm;;;;d
- nd m;^T,ed ;f iekn, ; n;;il, on;;
(iii)
; ;:n;n; ;-p;;kn;; Qualifications of the person who will analvre the wine samoles p;cisim
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Methodfs) of anafvrino the samoles.
Z :h; lk;.;;; ;he" ;e.dw;; e pregri,-. fer in;p;;;bn,nd me:.;;.;n;; cf ;;dk,rephk ;;peews; d;ske; end ;;;;eg; ;;n:; n;re ; eee ;; p;;.,p;; f n;f.en:n, r.,f ;;,mpe.;.n;e :mp;,7;e.^ ;; ;;f;;y:
{l} !f the acoficant intends to cerform "in-hsuse" calibrations of survev instruments the anoficant mt st c escribe methods to be used and the relevant ex 5erience of the eerson(s) who wi j eerform t e
cahbrations. All cabbrations must be cerformed accorc ino to the crocedures described and at the interva s orescribed in E.2.5.
gj The anoticant identifies and describes the location (s) of all field stations and oermanent radiocrachie installations.
d,QJ The anoticant identifies the location (s) where all records reouired bv this suboart and other carts of these reou ations will be maintained.
Lj,jj If a license acofication includes underwater radicarachv. a descriotion of:
Q Radiation safety orocedures and radicaracher resoonsibilities unioue to the oerformance of unoerwater radicaraohv:
24
~
I PROMSED FOR COMMENT-APRIL 199) g Radicarachie emuloment and radiation safetv eouinment unlaue to underwater radicaraohv g
Methods for cas-tioht encaosulation of souloment; and g ti an nonlication includes offshore olatform and/or lav-baroe radiooraohv. a descriotion of g
Transoort orocedures for radioactive material to be used in industrial radicarachie coeration g
Stormoe facilities for radioactive material and g
Methods for restrictino access to radiation areas.
C.4 GENERAL LICENSES C. 4 2 General Licensen - Radioactive Material other than Source Mategigj.
...b) Certain Measurino. Gauolna and Controllino Devices.
(
(3) (ix) shall comply with the provisions of A:6+ 2 radiation incidents, theft, or loss of licensed matena, ut shall be exempt from the other re of Subparts A.1 - A.6 of these regulations.
C.5 SPECIFIC LICENSES C.S.4 Specia1 Reauirements for Soecific Licenses of Broad Scone. This section prescribes requirements for the issuance of specific licenses of broad sco r.:.gulations governing holders of such licenses. pe for radioactive material (" broad licenses") and certain g A licensee nessessino a Tvoe A soecific license of bread secoe for medical use is exemot from the followino:
$ The orovisions of Paracraoh C.B.2fe) of ?Sese reoufations reoardino additions to areas of use oniv at the address sneerfied en the beense; and g The orovisions of Suboaraoraoh C.B.3fal of these reculations for an authorized user or an authorized nuclear charmaetst.
C.5.5 Snecial Raouirements for a Snecific License to Manufacture. Assemble. Renalr. or Distribute C mmodities. Products. or Devices which Contain Radioactive Material.
4 (j) Menufacture. P'eoaration or Transfer for Commercial and Distribution of ".:.d:,;h;;n ;;w:::.i Con;;;r '..; ".d:;r.;;;.;
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$HIEAnfid-Racioactive Druos for Medical Use Under E;;;:;r.; C.S.20. O.S.30 ;; C.S.M g An application for a specific license to manufacture. creoare. or transfer for commercial distribution hcensed pursuant to C.5.3(a) fer ;h; ;;; ;ath;;;;;d by 0;;;;;n; ;0.0.00,0.0.00 ;; 0 11 :
fH $ The applicant satisfies the general requirements specified in C.5.2 of this part:
25
PROPOSED - FOR COMMENT-april 1G.9 ist E The applicant submits evidence that the anoticant is at least one of the followino
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g reoistered or licensed with the U.S. Food and Druo Administration (FDA)'as a druo rnenutecturer:
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ieensed as a druo manuf acturerin a ceerdance with th e Rules a nd Reoulations Pertainino tet Dharmacists. Pharmacies and Manr acturers Wholesa ers and 3istributors IR5-19-PH ARlo~
Mhe Rhode Island Denartment of ealth; or:
g icensed as a charmaev in a cordance with the Rules and Reaulations Partainino to Pharmacists. Pharmacies and N an facturers. Wholesalers and Distributors IR5 ' 9-PHARlef the Rhode Island Deoartment of I-ealth.
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The applicant submits information on the radionuclide, chemical and physical form, pe;L;;:n;:n;;wd:ng maximum activity per vial. svrince. cenerator or other container of the radioactive drua pede ;, and shielding provided by the packaging et ;he ;;d ee;;..e n
to show it is appropriate for safe handling and storage of r,ed:ephein.;;; ;;;;le the radioactive droos by medical Use licensees e herhd nd;i
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.ar r t e g,} The aceficant satisfies the followino labelino recuirements g} A labelis affixed to each transoort radiation shield. whether it is constructed of lead. ofess.
olast c. or other material of a radioactive drua to be transferred for commerciald'stribu"isn.
The a bel must inc ude the ra: iation symbol a nd the words " CAUTION RAinOAC" VE MAT E RIAL" or "DAhlGE R. RAD OACTIVE N ATE RIAL". the name of the radioactive druc or its a 3 3 revia" ton anc t ie i: uantity of racioac'tvity at a soecified da te and time.
- or radioactive cruos wit 7 a ha
' -life creater than 1-30 days. the time mav 3e omitted.
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tk fabelin affixed to en-h svrince. vial or other ce,tniner used to hold a radioactive drua to 7e trans erred ' or ce mmercial distribution. The la 3e riust inc ace th e radi< nion svmberl and Rhe worc s "C ik JTIO V. RADIDA CTIVE V ATERIAL" or " 3ANG Eli RAD OAC' VE MATEF IAL" and an identner that ensures t 1at the svrince. vial or other container can be correlatec with the information on the transoort radiation shie d labe Q} A licensee described bv Submaracraoh (1)(ii)fe) of this Section:
May crecare radioactive druos for medical use. as defi,ed bv there reaulations. orovidecithat the radioactive c ruc is creSared bv eit 7er an authoriaec nuclear o marmacist as soecifiec in Sub-caraloraoh (2 Heil and (20 1:t) o" this Section. or an inc ividual under the suoervision of an authorized nuc ear charmacist as soect"ied in Section C.B.8 of these reculations.
M Mav allow a charmacist to work as an authorized nuclear charmacist if:
26
a PROPOSED FOR COMMENT-april X.9 g This individualoualifies as an authorized nuclear charmacist as defined in these reculations:
SDG g T11s individual 'neets the rea Jire ments sea cified in Paraorneh C.B.76M and Section c.8.74 o" these re au ntions ard t ie icensee las received an acorovec heense amendment ic enti" vino t lin individua as an aut 1oriret nuclear charmacist.
g A licensee sr di oossess and une instrumentation to measure the ridioactivitv sf radioactive druos.
The icensee sha lave nrocedures for use of the instrurr encation. T1e scensee sha i measure. by c irect tr eastreme.nt or Sv com 3ination of measurements and ca eu ations.the ariount of racion -tivityin r.osacos o" sJola-wta or chote 1-emittino radioactive druos orier to transfer "cr commercia cistribution.
n ade ition the scensee sha Q
Perform tests before initial use. ceriodicelly. and followine receir. on each instrument for eccureev. oneeritv. end oeometrv decencence. Es ecorocriate for the use of the instrument snd gp ediustments when necesserv: and
$ Check each instrument for constanev and oroner coeration at the becinnine of each dav of u Nothino in this section relieves the licensee from comotvine with soolicable FDA. other Federa tate reouirements covernino radioactive druas.
$ Notwithstand ne the forecoino. no I cense shall be issued ourruant to this section until the eroficant ins also receivec a I reautred moorova s from the State Board o" Pharmaev oursuant to the Ru es and aeou ations pertainino to Pharmacists. Pharm scies and Manufacturers. Wholesalers and 1stributors (R5 19-PF AR) o" the Rhode Island Deoartment o' Health.
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PROPOSED - FOR COMMENT-APRIL 1[99 Ol lll
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0.5. B Eroiration and Termination of Licenses and Decommissionine of sites and Seoarate Buildinos or 3ute oor Areas.
In) Each soecifie license revol:ed bv the' Anenev exoires at the end of the dav en the clate of the Aoenev's Fina determination to revoke t,e icense. or on the exoiration date stated in t le cetermination. or as otherwise orovided by Acency C rder.
(b) Each soecifie license continues in effect. bevond the evoirstbn dete if necesserv. with resoect to ocesession c.f redier etive materesi unto the Acencv notifies tne f.censee in writino that the bcense is termmated Juttno t 1is time. the licensee sha 1:
f1) Limit actions involvino radioactive material to those related to decommissionino and (2) Continue to control entrv to restricted areas until thev are suitable for release in accordance with Acenev reautrements.
(c) Within 60 davs of the occurrence of any of the followino. each licensee shall orovide notification to the Ac enev in writina of suc 1 occurrence. and either boorn decommissionine rs site. or anv seoarate bu'tdino j
or outc cor area that contains residual radioactivrtv so t 1st "he buildina or outcoor area is suitab e for te ease h accorrlance with Acency reautrements.or submit wit min ' 2 months of notification a decom misioninciolan.
i" reouired by Subcaracraoh (f Hil of this Section. and beain decommissionino uoon acorova e' that o anif (1) The license has exoired oursuant to Paraormoh fa) of this Section; or (2) The licensee has decid ei to oermanentiv cease erincloat activities. as defined in this cart. at the entire site or in any secarate but c ino or outdoor area that contain:; residual radioactivitv such that the buildino or outdoor area is unsuitable ' or release in accordance wit 1 Aaency reautrements or (3) No orincioal activities under the license have been conducted for a ceriod of 24 months or (4) No orincioal activities have been conducted for a ceriod of 24 months in anv seoarate buildino or-outdoor area that contains residua radioactivity such that the buildina or outdoor area is unsuitable for release in accordance with Acency reouirements.
'd) Coincident with the no"ification reouired by Paraoroch fc) of this Section. the licensee shat maintain in e"fect all eecommissionina "inancial assurances estabhs led av the licensee oursuant to Section C.5.16 of thene reaulations en contunction with a itense issuance or renewa or as reouired by this Section. The amount of t le financial assurance must be increas ed. or may be decreased. a i nec reoriate.to cover the detailed cost estimate for decommissionino esta nhs iec cursuant to Paraoraoh (f L 4 fv. of this Section.
(1) Arv licensee who has not ore vie e1 financial assurance.to cover i
mi with t le decommissionino olan s 1al e o so when this rule Secomes e ective.
(2) Followino sooroval of the decommissionino olan. a licensee may reduce the amount of the financial assurance as decommissionino oroceeds and radioloatcal contamination is reduced at the site with the acorova of the Aaenev.
fel The Acenev mav ara nt a recuent to extend the time oerio is establis heclin Paraoraoh fel of this Section if the Aa rncv determines t 1st this re ie" is no" detrimenta l to t ie ou :lic lea ch and safety and is otherwise n the ou 3hc interest. T 1e reouest must be su bmitted no ater than 2 3davs 3eHore notificatio1 oursuant to Paracrac'1 (c) of this Section.
'he schedule ' 3r decommissionina set forth in
- araormoh (c) o" this Section may not commence until the Acenev has mac e a determination on the reauest.
$ (1) A decommissionino olan must be submitted if recruired bv license condition or if the n'ocedures and activities necessarv to carry out decommissionino o' the site or senarate buildino or outc oor area have not been Drevioustv accroved by t ie Acenev and these orecedures could increase notential health and 30
PROPOSED FOR COMMENT-APRIL 1C99 safetv imoacts to workers or to the oublic. such as in any of the tollowine cases:
g Procedures would involve technioues not moolied routinelv durino cleanuo or maintenance SEldall2QEi g Workers wotid be enterino areas not normally occuoied where surface contamination and radiation leve s are sioni"icant v Nicher than routinelv encountered c urino coeration:
gg Procedures could result in nionificantiv arenter airborne concentrations of radioactive materials than are oresent e urino comration: or g Procedures could resutt in sionificantiv oreater releases of radiosetive materialto the environment then those essociatec with oneration.
(2) The Acenev may accrove an alternate schedute for submittal of a decommissionino olen reedred oursuant to Ptraerich (c) of tPis Section if the Acenev determines tr at the alternative scheou e is necessary to t ie e" factive conc uet of decommitsionino coe rationr anc oresents no undue risk '
radiation to the oublic hea th and safety and is et lerwise in t 1e oub te interest.
rom (3) Procedures such as those listed in Paraoraoh (f)(1) of this Section witF ootential health and safety gets may not be carried out orier to accroval of the decommissionino 'o an.
(4) The cronosed decommissionino olan for the site or seoarate buildino or outdoor area must i A descriotion of the conditions of the site or seoarate buildino er outdoor area sufficient to gte the accentability of the olan:
3 A descriotion of olanned decommissionino activities:
gg A descriotion of methods used to ensure orotection of workers and the environment moninst radiation hazaros durino decommissionino:
M A descriotion of the olanned final radiation survev and M An undated detailed cost estimate for decommissionino. comoarison of 'that estimate with 3 resent funds sltt aside for decommissionino. and a clan for assurino the avai a 3ility o" adeounte "unds for como etion of decommissionino.
M For decommissionircolans callino for comoletion of decommistioninolater than 24 months afte clan sooroval, the o an shallinclude a sustification for the def av Dased on the criteria in Paracraoh (o} o' this Section.
(5) The oreconed decommissionino otan will be aceroved bv the Acenev if the information therein demonstrates t 1st the decommissieruno wi l be comoleted as soon as oracticable and that t ie 1ealth and safety of workers and the oublic wil be aceountelv erotected.
g (1) Exceet as orovid<td in Paraorneh th) of this Section. licensees shall comolete decommiss'enino of tie site or seonrate builcino or outdoor area as soon as oracticable but no later than 24 months 1ollowine t ie initiation o' decommissionino.
L2) heent as orovided in Paraoraoh (h) of this Section. when decommissionino involves the entire site.
1 ie scensee sh hil recuest license termination as soon as oracticablebut no later than 24 months followino n
t Se initiation o" decommissionino.
fh) The Acenev may anorove a 'eauest for an alternative schedule for comoletion of decommissionino of the site or seoarate buildino or ounc oor area. and license terminationif acorocriate if the Acenev determines that the alternative is warranted av consideration of the followino:
(1) Whether it is technica11v feasible to comolete decommissionino within the allotted 24 month oeriod:
f 2} Whether sufficient waste disoosal caoneitv is available to allow comoletion of decommissionine within the allotted 24-month oeriod:
31 i
PROPOSED FOR COMMENT
- AMttL 1C99 f3) Whether a sionificann volume reduction in wastes reouirino discosal will be achieved bv allowino short. tved radionue ic es "odecav:
(4) Whether a storif eart reduction in radiation exoosure to workers can be achieved bv allowino short lived rac ionue ac es "o decav: and (5) Other site soecific factors whicF the Acenev may conalde anorooriateon a case-bv. case basis. such as t is rea Jiatorv reouirements of et 1er covernment ace'ncies. awsuitli crounc-water treatment activities.
rie nitor ec natural around water restorattor. actions 19at ceiu e resu t in more environmental harrg ce"errec cleanuo. and other factors bevonc the contro of t ie icensee.
(i) As the final sten in decommissionino. the licensee shall:
(1) Certify the discosition of all licensect meteriet. inefudino eceumulated wastes bv rubmittine a comoteted Aaenev Form M AJ-7 or eauivalent information: and (2) Conduct a radia" ion su'vev of the oremisas where the licensed activi"ies were carried out and subriit a recort of the resu ts of t les sur'/ev 'Jnless t le scensee demonstrates t ist t le cremises are suitable Jor te ease in some other manner. he scensee shall as anorooriate:
g Reoort levels of camma radiation in un ts of millisieverts (microreentaen) cer hour at one meter "rom surf aces. and recort levels of rac toactivitv. ine udino mecabecouerels (disintearations oer 11inute or microcuries) cer 100 rauare centimeters - removable and fixed) for sur" aces. meaa-3ec 3uere s (microcuries) Der rnilli iter for water. and 3ecouerels (otcoeuries) cer cram for solids suc 1 as soils or concrete anc g Soecifv the survev instruments used and certifv that each instrument is oronerlv calibrated and lama (i) Soecifie licenses. includino exoired licenses will be terminated bv written notice to the licensee when the Aaencv determines that:
(1) Radioactive material has been oroneriv discesed:
(2) Reasonable effort has been made to eliminate residual radioactive contamination. If oresenti and Q Q A radiation survev has be en oerformed which demonstrates that the cremises are suitable for-release in accorc ance wit 1 Aaenev reautrements.
$ Other inf ormation submitted bv the licensee is sufficient to demonstrate that the oremises are suitable "or release in accordance with Aaency recu!rements.
4 Records recuired bv C.5.15fd) and (f) have been received.*
{5,.15 Modification. Revocation. and Termination of Licansas.
g} Prior to l'eanse termination. eneilicensee authorized to e sssess radioactive material with a half life creater than 12 3c avs. in an unsealed "orm. shall forwarc thefo owino records to the Aaenev:
Q Records of disoonal of licensed material made under A.4.2. A 4.3. A.4.4 and A.4.5 and Q Records reouired bv A.S.3(b)(4).
g if licen med activities are transferred e r assioned i, accordance with C.5.7(b). each licensee authorized o Dossess rac ic activa material. with a half.
fi e creater t 1an 120 davs tn an unrealed form. shal forward t ie
'of c wino recorcs to t le new scensee and the new licensee will be resconsible"or maintainint1 these records unti the license is terminatec :
Q Records of disoonal of licensed material made under A.4.2. A.4.3. A.4.4 and A.4.5 and Q Records reouired bv A.5.3(b)(4).
1 32
)
Mt0 POSED
- FOR COMMENT-april 1W3 g Prior to license termination. each licensee shall forward the records reouired bv Section C.S.1Bla) to i
the Acenev.
l l
C.5.16 Finanelal Amaurance and Record Kamolna for Decomminelcr.:r.=,
)
(a) Each applicant for a specific license authorizing the possession and use of unsealed radioactive material of half. life greater than 120 days and in quantities exceeding 10' times the applicable quantities set forth in AppendL 0 Annancir F to Part A of these regulations shall submit a decommissioning funding plan as described in Paragraph Le) of this section. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 10' is greater than 1. (unity rule), where R is
~
defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Append:,, O Agggd to Part A of these regulations.
(b) Each applicant for a specific license authorizing possession and use of radioactive material of half. life greater than 120 days and in quantities specified in Paragraph (d) of_this Section shall either-(1) Submit a decommissioning funding plan as described in Paragraph (e) of this section; or (2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by Paragraph (d) of this Section using one of the methods described in Paragraph (f) of this Section. For an applicant; this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material.
If the aoolicant de ers execution of the financial instrument until after the licente has been insu ed. a d
stoned crecina of t se financial instrument obtainec to satisfv the recuiremento o" Paracraoh (f l o' this i
Se ction must 3e su 3mitted to t ie Acenev bef 3re rec tiot of liconsed material.
ft ie aoolicant c oen not de"e ' execution of t 1e financia instrumenn tie soo icant sha l su 3mit to the Acenev. as cart o~ the certt"ication. a sionec orioinal of the financia instrument obtainec to satisfv the recuirements of Paracraoh 1 (this Section pe,;
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(d) Table of required amounts of financial assurance for decommissioning by quantity of material:
Greater than 10' but less than or equal to 10' times the applicable quantities of App;nd:,, O Aeoendix f to Part A of these regulationsin unsealed form. (For a combination of isotopes, if R, as defined in Paragraph (a) above, divided by 10* is greater than 1 but R divided by 105 is less than or equal to 1.)................................................................................4750,000.
Greater than 108 but less than or equal to 10' times the applicable quantities of App;ndL 0 Anoendix E to Part A of these regulationsin unsealed form. (For a combination of isotopes, if R, as defined in Paragraph (a) above, divided by 10'is greater than 1 but R divided by 10'is less than or equal to 1.)................................................................................6150,000.
Greater than 10 times the applicable quantities of App;nd:;, O Aenendix F to Part A of these regulations in sealed sources or plated foils. (For a combination of isoto Paragraph (a) above, divided by 10 is greater than 1.)............................. pes, if R, as defined in
.475,000.
(e) Each decommissioningfunding plan must contain a cost estimate for decommissioning and a description l
of the method of assuring funds for decommissioning from Paragraph (f) of this Section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. Lhg ecommissionino "undino olan must also contain a ce rtification bv the licensee that financial assurance for c
c ecom11tusionimo las seen orovic ed in the amount & n ie cost estimate f or decomrlisstorino and a stoned cricina o~ the 'inancia instrument obtained to satis"v n ie recurrements o" Paraormo i (f) c this Section.
(f) Financial assurance for decommissioning must be provided by one or more of the following methods:
(1) Prepayment. Prepaymentis the deposit prior to the start of operation into an account segregated from.
licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.
33
PROPOSED FOR COMMENT-APRIL 1Z99 (2) /Lf; ety method. insurance, or other auarantee method. These methods guarantee that decommusioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix E to this Part. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this Section. A orarantee of funds bv the sooficant or licensee for decommissioninct costs based on a financialtest may 3e used if the ousrantee and test are as contained in Accendix E o" Mhis Part A ouarantee by tte acolicant or licensee may not be used in combination with any other "inancia methods to satts"v t M re3uirements of this section or in any situation W 1ere the aoolitant or icensee has a carent comoanv Solcino maiority contro o" the votino stock of the comoanv. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following
... conditions:
(g) Each person licensed under Parts C or E of these regulations shall keep records of information important to the oct; end ;ff;;tN; decommissioning of the facility in an iden.ified location until the beense i; t;;.nineted by th; Aj;;;ncy liite is released for unrestrictec use. Before licensed activities are transferred or assioned in accordance wit, Section C.5.7. licensees shal transfer a ll records described in this caracraoh "o the new licensee, n this case, the new licensee will be resconsible ~or maintainino these records until the scense is terminated, if records of r;;; vent information imoortant to the decommissionino of a f acility are 4ept for other purposes, reference to these records and their locations may be used. Information the Agency c.o.nsiders important to decommissioning consists of:
[ REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
e l
l 34
)
i PROPOSED - FOR COMMENT-APflfL 1999 eee PART C - APPENDIX E FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FO t.
INTRODUCTION An applicant or licensee may provide rea decommissioning based on eb;;:ning ; paren^ ;e.sonable assurance of the availability of funds for available for decommissioning costs and on a demonstration that the Peteftt c tsst of Section ll of this Aeoendix The terms of the self-ousrantee are in Section til of t Appencix establishes criteria for passing the financial tes
. This fer a self cuarantee end I;r eb;;:n ng th; p;;;n;;; rap;n,t for the seif cuarentee end estsbiithes the terms
- s ;;;n;;;.
- 11. FINANCIAL TEST (A)
To pass the financial test, the p;.;;n; ci..;;;; ef shcr Peregreph A.1 er A.2 ef :h:; App;3 company must meet all of the followino criteria: the
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Tv.; ef :h; f;";,.s:ng :hr;; ret:;,;; A re.; ef ;;;.' :;b:::n; :;, n;;.scr h
- h;;n 2.0; ; r;;.; ef th; ;u.T. ef n;; ;n;;.m.;. p!c; d;pr;; kin, d;pk;kn, ;.nd ; r.ern;.;;;n ; ;:;;;;;:;::;;b::dke gr;;;;; : hen O.1; and ; re;.; ef curren ;;;;;; :; c r.;.; ::eb:::2; gr;.;.;;;r : hen 1.5; c.nd l::;
if;;.sciUng ;;;p::;: e.d ;;ng:b'; n;;.ser;h ;;;h ;; k;;. ;L i.;; th; cor.;.; ;;;; ;;; n.e;;.; 'er pr.;;;;b;d er.;an: :f a ;.;;;;fk;2n b a;;d;, end
- T;.ng:bk n;;..;,r;h ;f ;; k;;; 010.T.::::en, end l:.;
- ix
- :.T.;; :h; ;u ;;n d;;; nc.b;;;n:ng;;;;; ;;;;T.;;;; (er4pr ;;r:b;d ;.ne n::A;;;;; b;;;;
1 ; ;;.;.'fke;.;n b u;;;dl, l2; Th;. p;;;n ;e r.p;n, m. ;;; hev;;
Q fi-)and Poor's or Aaa, Aa g A er-Bee as issued by Moody's; andA current ratin i
g fHt Tangible net worth each at least s pr;;;;;b;d ;.a.can; current amount reouitecif a certificationis used) for all decommissionino ac for which the comoany es resconsible as self-ouaranteeino licensee and as carent ouarantor; a
._._,,m.._......._m...........i___m.,._......__.
__2 2 f&r) Assets located in the United States amounting to at least 90 percent of total assets or at lea s1gg times the current decommissioning cost estimates (or pr;.ecr:b;d en.sent the current amount reautred if a certification is used) for all decommissionino activities for which t1e comoany resoonsible as self oueranteeine licensee and as carent-ouarantor.
is (B) To osss the financial test. a comoanv must meet all of the followine additional re Exe$ The commanv must have at least one class of eauitv securities reoistered under lance Act of 1934:
35 I
PROPOSED FOR COMMENT-april.1999 g The perent company's independent certified public accountant must have compared the data used by the perent company in the financial test, which is derived from the independently audited, year end financial statements for the latest fiscal year, with the amountsin such financial statement. In connection with that procedure the licensee shall inform the Agency within 90 days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted
. and that the company no longer passes the test.
'C;
_ '1; 3 After the initial financial test, the perent company must repeat the passage of the test within 90 days after the close of each succeeding fiscal year.
E Q If the r......
mr..., licans.t.e no longer meets the requirements of Feregreph A Sect on ll. A. of this Appendix, the licensee must send immediate notice to the Agency of jt;; intent to estabhs 1 alternate financial assurance as specified in the Agency's regulations within 120 davs of such not ce. Th; n;nc; i
-.u;. t; 3;n; b, ;;n:f;;d mC....Wn 00 d;,; ef;;r ;h; ;n; cf :n; t;;e.,;;r f;.. A;n :h;,a ;nd 1:n;.de; d;;; ;h;.. :he; :h; peren; ;;mp;., n; lenger rn;;;s h; f;nen;;e: ;;;; rqa.;; n;n;s. Th; R;n;;; mus; pre.:de ;herne;; f nendd ;;;_en;;e.shh;n 120 de,e ef;;r :h; end ef ;ech f:e;d,;;r.
Ill. PA"."TT COMPANY SELF-GUARANTEE The terms of a peren; cemp;ni gglff; guarantee which an applicant or licensee eb;dne furnishes must provide that:
(A)
They.-..
..r
., guarantee will remain in force unless the gueren;;r licensee sends notice of cancellation by certified mail to the l:;;n;;; and :b; Agency. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by be:h the k;n;;; end the Agency, as evidenced by the return receipts.
(B) ll :h; R;n;;; fdl; to The licensee shall provide alternate financial assurance as specified in the Agency's regulations within 90 days af ter receipt by :h; R;n;;;;nd the Agency of the notice of cancellation of the p;.;n; ;;n. pen, guarantee........,..
2 pre. d; eu;h en in;Rv; f;nen;;el
- s.ren;;...
- h; n;-.; ef
- h; k;n;;i.
(C)
The
..r..., guarantee and financial test provisions must remain in effect until the r_m.,
Agency has terminated the license or until another financial assurance method acceotable to the Acenev has been out in effect bv the licensee.
(D) lI e : es e ;;;;bOh;d Ier d;;e am:;ien ng ;;3:3, th; res ;;; end 7 ;; me;; b; e;;;p;;bl; ;;
th; Ag;.;,. An e;;;p:;b!;;iv;;;; :nd des en, ent;,.sh:;.h h;; :h; ea: horn, ;; e;; es e tre;;;; ;-d v. hee; tres; ep;.re;:ene er; r;;.l;;;d end ca; n'n;d b, e I;derel ;r 0;e;; egen;r-g The licensee wii oromotiv forward to the Acency and the licensee's indeoendent auditor all recorts coverino the stest 1: scal year filed by the beensee with 1he Securities and Exchance commission ourcuant to the recuirements of Section 13 of the Securities and Exchance Act of 1934.
@ 11. at anv time. the licensee's most recent bond issuance ceases :o be rated in any cateoorv of "A" or a 3cve by either Standard and Poors or Moodvs. t ie beensee will orovice notice in writino of such f act to the Acency within 20 davs af ter oubhcation of the c 1ance by the ratino service. if the beensee's most recent bond issuance ceases to be rated in anv cateoorv of " A" or above bv both Staldard and Poors and Mooevs.
the beensee no lonaer meets the recuirements of Section ll. A. o" this Aeoendix.
@ The ao slicant or licensee must orovice to the Acerev a written cuarantee (a written commitment bv a corocrate o"ficer) which states that the scensee will "und and carry out the reouired decommissionino ac?ivities or. uoon issuance of an order bv the Acenev. the licensee will set uo and fund a trust in the amount of the current cost estimates "or decommissientna.
36
PROPOSED - FOR COMMENT = april 1C3 C.8 USE OF RADIONUCLIDES IN THE HEALING ARTS C.8.1 Scene. Provisions for Research involvino Human Subleets and FDA. Other Federal and State Reaulraments.
jgj Scone. These requirements and provisions provide for the protection of the public health and safety.
The requirements and provisions of this subpart are in addition to, and not in substitution for, others in these regulations. The requirements and provisions of these regulations apply to applicants and licensees subject to this subpart unless specifically exempted. -
jgj Provisions for Research Involvino Human Subleets. A ficensee mav conduct research involvino ht' man tub'ects usino radioective material oroviced that the reseerch es conc octec. funded succorted. or reou eted
?v e Federal Acency which has imolemented the Feceral Pohrv ' or tne Protection of Human Sobiects, Otnerwise. a heensee shall acolv for and receive acorova o" a soecific ament ment to its Aoency he rnse
- e"rre conductino such research. Both tvoes of heensees st a 1. at a m nimum. ob"ain in' rlrmed conso t ' rom
- 1e luman subiects and obtain orter review and amorova of t le re sear: 1 activities av an
" natitt tic na
- evn w i oard" in accordance wilh the meanino o" these terms as definec anc descri 3ed in the Federa Do icv for t ie
- rotection of Human Su siects.
g FDA. Other Federal arid State Raouiren ents. Nothino in this Suboart relieves th e licensee from como vina with anchca 3 e FDA. other federal. anc State recuirements covernino radioactive c ruos or devices.
jg License Recu red. A carson shall not manufacture. oroduce. acn aire receive. oossess. use ortransfer u
'adie n ttive materia l'or rredica use exceot in accordance with a soect"ic scense issued bv t ie Acenev. t ie J.S. Nuclear Reat storv Commission. an Acreement State or Licensino State. or as allowec bv Paractac 1s C.B.E (a) and C.B. Md) of these reculations.
C.8.2 License Amendments. A licensee shall apply for and receive a license amendment:
510 bN~'sdf$
...................,..f.,? "' " #'"I'
' #' # 'ed "i IVE' 'I #
~ ~ ' "
E'i#' I i #
- ~'"
5 jg} Before 't receives or uses radioactive material fer a clinical orocedure oermitted bv this Suboart but not oermitted 3v the scense issued oursuant to t 1 s Su 3 cart; i
(b) Before permitting anyone, except a visiting authorized user described in Section C.8.9, to work as an a.u.t.horized user nr Ay.thorized nuclear charmacist under the license; 0.0.0 72 2 :f :. 2 :.;. A :;n.n; ehe!: nedf ;h; A;;n;y:n wil;:ng wlth:. 00 d;y;..h;n en ;.;her:nd.nr, i
P.;d: eden 0;fni Off;n;, er P.ed;e;h; epy Ph e ;;;; p;;a.;n;nd, d:nenda.;; p;rferm.;nn ef d.;.;..nir i
th;:;een;;.
@ Notifications. A licensee shall notifv the Acenev'bv letter no later than 30 davs after:vsicist oermanentiv discontinues cerformance o" duties under the license or has a name c a 110 The licensee's mailina address chances. .or C.8.6 Radiation Safety Committee-Each medical institution licensee shall establish a Radiation Safety C..om. mittee to oversee the use of radioactive material. (b) To oversee the use of licensed material, the Committee shall: (1) Be responsible for monitoring the institutional program to maintain occupational doses as low as 37
PROPOSED FOR COMMENT-APRIL 1999 reasonably achievable;. (2) Review, on the basis of safety and with regard to the training and experience standards of this subpart, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nue ear charmacist. the Radiation Safety Officer, or Radiotherapy Physicist before submitting a heense ... app.ication or request for amendment or renewal; C.8.8 Supervision. (a) Unless prohibited by license condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the regulations in this subpart under the supervision of an authorized user as provided below. A licensee that suoervises en individualis resconsible for the ects end emissions of the sucervised individual. (b) A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by this subpart shall: (1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of radioactive material and in the licensee's written cualitv mannaement clant and (2) Periodicativ review the supervised individual's use of radioactive materia l, pres:d; ;;:ne;;a;;;n se n;;;;;hetewew gggg records kept to reflect this use; gg O negr; ;h;; en', ;h;;; 'ndMda ; ;p;df:;;", ;;;:n;d, end d;;;;ne;;d b, ;h; eu;her;;;d u;;., ;h;" b; per.nh;;d ;e ed.:n:;;;; red:ena!;d;;, er red:;;;;n ;; p;;;;n;;. Q If the indvidualis involved in a dministration of radiation /radioactivemavrials to humans. ensure that the individualoosse<sses a current ocense in accorc ance with the Rules anc Reculation i f 3r th e Licensure 3f Radicarachers. h J: lear Medicine Technolocis"s and Radiation hermotsts IR5-68 F A 31 o< the Rhode sland Decartment o" Health. unless the indivious is soect sea v exernoted from licensure bv Section 6.0 i of said reaulations; (c) A licensee shall require the supervised individuat receiving, possessing, using or transferring radioactiw material under this subpart to: . (1) Follow the instructions of the supervising authorized user; (2) Follow the written radiation safety and ouality manacement procedures established by the n;d:;;:en ~ Oef;;, Off;;;r itensee; and (3) Comply with these regulations and the license conditions with respect to the use of radioactive material. g An individual may creoare unseated rad;oactive material for m edical use in accordance with this Subcart under the su 3ervision of an authorized nuclear charmacist or e lvsician w 1o es an authorized us er. l unless crohibited bv icense condition. A licensee t 1st oermits the orecarat on o< radioactive matersti "or medica use by an iniividual under the suoervision o' an authorizec nuclear c iarmacist or ohvstcian w 1o ts an authertred user small: Q ins"ruct tie suoervise d individual in the erettaration of radioactive material for medical use and the erincio es anc crocedures "or rac istion sa fety anc in the licenree's written cuality manaaement orocram. Es accrocriate to that individual's use o' radioactive materia : Q Reouire the sunervisedindividtat to fo low the 'nstructions civer oursuant to Suboarser noh (b)(1) of this Section and to comotv with t ie reau ations o' this Su scart anc icense conditions anc Q Reouire the suoervisino atthorized nuclear onarmacist or ohvsician who is an authorized user tc, deriodically review the work o" the suoervised individual as it certains to orecarino radioactive materia "or medical use and the records keot to ref ect that work. e.e 38
1 PROPOSED FOR COMMENT april.1229 C.8.11 n"-"tv Man==..er.1 h. .T.. . applicable to a quality management program:.(a) in addition to the definition ee. (2) Misadministration means administration of: - (i). A therapeutic radiopharmaceutical dosage, other than nodium iodide f 125 or I-131: (a) Involving the. wrong pottent individual, wrong radiopharmaceutical, or wrong routf administration; or th) h the administereddose 20 percent of the tetel presen e dose dnanna; differs from the prescribed dose dgan (ii) A gamma stereotactic radiosurgery radiation dose: (a) Involving the wrong pottent M or wrong treatment site; or -(h) than 10 percent of the total prescribed dose; orWhen the calculated{ (iii) A teletherapy radiation dose: (a) Involving the wrong pottent individual, wrong mode of treatment ;c.;d;.ll;i, or wr treatment site; or I (iv) A brachytherapy radiatinn dose: l (a) involving the wrong petient individual, wrong radionuclide, or wrong treatment site -(excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or ) (v) A diagnostic radiopharmaceutical dosage, other than cuantities creater than 1.11 meca-becouereis (30 pCi) of either sodium iodide 1125 or 1131, both: (a) Involving the wrong pottent individual, wrong radiopharmaceutical, wrong route of ther. 20 p;;;;.r. ef 0.; A;;.;,;0 d de;ege; andadministration, or when the a (h) When the dose to the petket ndividtat exceeds 50 millisieverts (5 rem) effective dose equivalent or 500 millisieverts ( 50 rem dose equivalent to any individual organ. g} A radiocharmaceuticaldosaan armater than 1.11 meoabecouerels (30 uCi) of e -125 or 1-131: ~ g - Involvino the wrono individual or wrono radiocharmaceuticatt or gg} When both the administered dosaae (iffers from the crescribed dosaae bv more than 20 percent of the crescribed desace and tie difference netween the administered dosaae and crescribed dosaae exceeds 1.11 meonbecouerels (30 uCO. e.. .. 5) Recordable event means the administration of: ( 39
PROPOSED.FOR COMMENT-APRR. FC3 (iii) A radiopharmaceuticaldosage greater than 1.11 megabecquerels (30 pCi) of sodium iodide kgg g 1 131 when both the administered dosage differs from the prescribed dosage thy more than 10 percent of the prescribed dosage, and the difference between the administered dosage and the prescribed dosage exceeds 555 kilobsequerels (15 pCi); (iv) A therapeutic radiopharmaceutical dosage. other than sodium iodide 1125 or 1131. when the administered dosage differs from the prescribed dosage by more than 10 percent of the . prescribed dosage;- (v) A teletherapy radiation dose when the calculated weekly administered dose d;ff;;; f;;ca gnads the ggggg prescribed dose by 15 percent or more of the weekly prescribed dose; (6) Written directive means an orderin writing for a specific patient or human research subieet, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in subitem (vi) below, containing the following information: (i) For any administration of quantities greater than 1.11 megabecquerels (30 pCi) of sodium iodide I-125 or 1-131: the radionuclide and dosage; or (ii) For a therapeutic administration of a radiopharmaceuticalother than sodium iodide I-125 or 1-131: _ the radiopharmaceutical, dosage, and route of administration; or ...b) Seone and Anolicabilitv. ( (3) (ii) Prior to each administration of rediation or radioactive material, the patient's or human research ~ ~ subject's identity is verified by more than one method as the individual named in the written directive; (c) Imolementation of Quality Manaoement Prooram. Each licensee shall: (3) (iii) A representative sample of patient gnd human research subinet administrations; (d) Records and Reoorts of Misadrn:nietistions. The licensee shall take the following actions in response to a misadministration: (1) Notify the Agency by telephone no later than the next calendar day after discovery of the misadministration;- (2) Submit a written report to the Agency within 15 days aftar discovery of the misadministration. The written report shallinclude: the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the petient individual who received the misadministracion; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; w1sther the licensee ~ notified the pottent individual or the p;;.en;'; individunt's responsible . relative or guardian ';h:; pereen.. ll ; t;;;.,en;lj be r;;;;;e; ;; ;; ";he p;;::.n;"), and i" not, why not, and if ;h; p;;;;n;..;; n;;;f;ed there was notificat on, what information was providedi; :he pe;;;n;. The report shall not include the pottent individuars name or other informatiott that could lead to identification of the pet,ent individual. To meet the rec uirements of this Sect on the notifi:ation t;f the individual i re ceivino the misac ministrationmav be mac e instead to that indivic uaf s resconsi k relattve or cuarc ian.. wien accrooriate. (3) Notify :h; ref;;;:n; ph,e;;;;n ;nd ;l;; r.e;;f, the pottent Individual who received the misadministration 4o
PROPOSED FOR COMMENT april 1999 and their referrino ohvsician. id discovery, unless the refernng p1ysician personally informs the licensee either th pee,ent jgggg[gj or that, based on medicaljudgment, telling the pottent individual would be h licensee is not required to notify the pet,ent individual without first consulting the referring p the referring physician or petsent individual who 'eceived the misadminis1 ration Cannot be reached within 24 hours, the licensee shall notify the petsent inc evidua as soon as possole thereafter. The licensee shall not delay any appropriate medical care for the pet,ent individual, including any necessary reme as a result of the misadministration, because of any delay in notification; (4) If the petient individual was notified, furnish, within 15 days after discovery of the misad a written report to the peevent inc ividual by sending either a copy of the report that was submitted to the individual, provided a statement is included that the report subm both the event and the consequences as they may effect the pattent the hcensee; (5) Retain a record of each misadministration for 5 years. The record shall contain the names of al individuals involved (including the prescribing physician, allied health personnel, the peevent individu received the rn sadministration, and the petient4 individual's referring physician. if anchcable), the p;;,;nre indivic ual's social security number or identification number if one has been assigned, a brief improvements are needed to prevent recurrence, and the actions (6) Aside from the notification requirement, nothing in Para of licensees and physicians in relation to each other, p;;:;.n;; graph C.8.11(d) affects any rights or duties individuals receivina misadministrations, or that p;;.;n;'; individual's responsible relatives or guardians. C.8.12 Sunaliers for Sealed Sources or Devices for Medical Use. A licensee shall use for me 4; nedkn;.s; m.;;;;M' m.;n fec; ;d. bb;kd, Enkes;.d, end db;i:buted b e;;;;de.;;...:h ; lk;n;e k;ad p. ;an; ;; Fere;;;ph; C.5.5Q, C.S.5 N ;; C.5.5"d ;,7 ;hu;. ;g M;Mn;;; :h; ;;...ekn; ;;.g.b;.ene
- f
- .nc,;h;r A;;;;a.;n; 0:;;;. e Lk;n;b; 0:e;; er :h; U.0. Nak;; n;;.b;;r,- Cen.c.b;Zn, nd
) jg Sealed sources or devices manufactured labeled osekaaed. and distribJted in accordance with a licens}e issued oursuant to Paracrach C.5.5m of Mhese re 3ulacions or the eautva ent reculations of another Acreement State. a Licensina State or the U.S. h uclear F eau atorv Commission and ib! n;;;;n; kh;;h;; h;.se ban m.;nef;;; ;d, Mb;kd, pe;L;;;d, end d%;i:be;;d h neerden;;..shh en
- pp;,s;' b;ad b,
- h; Agen;, pur;an: :; I;;; ;;ph C.5.5N ef :hs; regub;%n;, ;; :h; u,u.s;ka; i
- k;ba; ef ;ne
- h;.. A;
- n n;n; 0;;;;, ; Lk;ne
- n;; 0;;;; er th; U.0, Naker n;;.b;;;,- Cec.c.b;%., fer
- b; p
- ;p;;;;Wa ;f ;;.d4ph;;n.u; ;4;h f;,e m,;dt;; a;.
{g} Telethernov sources or devices manuf actured and distributed in accordance with a license issued et tsuant to Paracrao n C.5 5m o" these reautations or the eautvalent reautations of another Acreement a .tcensino State or the U.S. Nuclear Reculatorv Commission. 0.8.14 Possession. Use. Calibration. and Check of Dose Calibraters (Photon-Emittin instruments to Measure Dosaaes (Aloha and Beta Emittino Radionuclides). (a) Possession and Use. W A m.;d%;; au licensee ;;;her:nd :s ;da.:n%;;.; red %phera.ex.:beb shall possess a dose calibrator and use it to measure the em.; n; ef n;.sh, ;d nib;;;;d activitv of desaaes of choton-emittino radionuclides orier to administration to each patient or human research subiect. g Fer other than unit desnoes of aloha anc beta emittino radionuclides that are obtained from a man;"acturer or orecarer heensed oursuant to 3aracraoh C.5.Em of these reauhtions or the eaurvalent-reau ations of another Aareement State. a Ltcensina State or t,e U.S. Nuclear F ec alatory Commission, a 'scensee sha! Dessess and use instrumentation to "nessure the radioactivity of ato,a-or beta-emittina radionuchdes The beensee shall have crocedures "or use of the Instrumentation. 41
PROPOSED FOR COMMENT-APRIL 1999 ...b) A licensee shall: ( (3) Test each dose calibrator for linearity upon installation and at intervals not to exceed 3 months thereafter over the range of use between
- O m. ;;e; r:;e '070 LO;; 1.11 meaabecouerels (30 ucil and
...the highest dosage that will be administered to a natient or human research subiect; and 3 Perfer n tonts before initial use. ceriodicativ and fotfowino reonir on each instrument used to measure c osaaes of a cha-and beta-emittino radionue ides for accuracv. hnearttv. aeometric c enendence. as g Check each instrument used to measure desaaes of aloha-and beta-emittino radionuclides for constancv and crocer oceration at the beainnino of each dav of use and gj Make adiustment.when necessarv.to each instrument used to measure dosaces of aloha-and beta-emittina radionuclides. (e) A licensee shall retain a record of each check and test required by Section C.8.14 for 3 years. The r.e.c.ords required by Paragraph C.8.14(b) shall include: .o. (2) For Subparagraph C.8.14(b)(2), the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, ;h; :n......... e;;;;nge. end :h; a gne;,.r; ef ;h; Ced:e;bn 0;f;;, Off:;er and the sianature of the individual cerformina the test; (3) For Subparagraph C.8.14(b)(3), the model and serial number of the dose calibrator, the calculated activities,the measured activities,the date of the test, and the signature of the ned:e:ba 0;f;;, Off:;;r individual eerformina the test; and (4) For Subparagraph C.B.14(b)(4),the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured,the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the signature of the ned:e;;en + .. 0;f;;y Off ;;r. individual cerformina the test. C.8.16 ^,un of 9:d:2 hum::n.;:x'O;nen Measurement of Dosaaes of Unsealed Radoactive Materials for Medical Use. A licensen shall: 1 (a) Assey Measure the activity of each red:;pherrne;;u;;;e! dosage :he; cen;dne m.er; : hen 10 r.:;;;,; r:e; '070 kO;; of a photon-emitting radionuclide before medical use; (b) ^ ;n,, hiere m.;d:;;' ec, Measure. bv direct measurement or bv combination o" measurements and calculations. the activity of each red eph;.rm.e;; :.;,;,; dosage..,;n e desa; ee:a.;, of ' O m..;recer.;; (270 LO;; er %ss ;,f a ph;;;n ;m.;;;;ng of an alchs-or beta-emittina radionuclide ;e.;r:fy the; :h; d;,;eg; den ne; ca;;d '.O m.:;recer.es '070 kOqi orier to medical use. exceot for unit dosaces obtained from a manuf acturer or orecarer licensed oursuant to Paraaraoh C.5.5( ) of t 1ese reculations o' the eauivalent reau ations of another Aareement State. a Licensina State or the U S. h uelear Reaulatorv Commission; (c) Retain a record of the assays required by Paragraphs C.8.16(a) and (b) for 3 years. To satisfy this requirement, the record shall contain the: (1) Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide; (2) Patient's or human research subiect's name, and identification number if one has been assigned; (3) Prescribed dosage and activity of the dosage at the time of assay, or a notation that the total activity 42 J
PROPOSED FOR COMMENT APRIL 16:9 ...is less than 49 2Q microcuries (OO kO4 L1RB2); C.B.19 Svrinom Shields. (a) A licensee shall keep syringes that contain radioactive material to be administeredin a ra (b) A licensee shall require each individual who prepares a radiocharmaceutical kit to use a svrin ra diation shield who, creoarino the kit and shall reouire each individualto use a svrince radiation shielcTw ac ministerino a rac tocharmaceutical bv iniection er edn..;..;;;;; sec.eph;;.c.;;;.;.;;;; ;; ;; ; ;,;,n,en r;..;.;.en ;h.;.:: unless the use of the shield is contraindicated for that patient or human research subiect. g; C.8.20 Syringe Labels. A licensee shall conspicuously label each syringe, or syringe radiation s contains a syringe with a radiopharmaceuticaW The labet shall show the radiopharmaceutical name its abbreviation,the ripe of d:esne;;;;. ;;.dr er ;'.;..;p, g,ng procedure to be performed, or the patient's g or human research subiect's name. C.B.24 Release of." ::;n:; Individuals Containino Radionharmaceutlealm or Permanent imolants. l;; A l!;;n;;e ;h;ll ne; e ;he l;e i;.!;;. ; fien. ;enf:.;a,;nt fer.T.edi;;! ;;;; ;rc, p;;;;n; ;d,T.:n:e;;;;d e
- d
- ;phe. ;c.;;;.a;;;; en;;; ;;;her.
(1; Th; d;;; ;;;. f;;.T. ;h; pe;;;n; ;; l;;; ;her. 5.T.::':;;a.e l50 A04; per hear e; ;. d:;;;n;; ef 1.T.;;;;; er l0; The ;;;;..;,.. ;h; pc.;;;n; :; ;;; ; hen 00.T.::::;er:;; l1 11004;.
- h; A lba;n ;hr.'
- n;A eu;her:;; ;;b;; frem. ;;.nf:n;.n.;n; fer a.;d:e;l ;er; en, p;;;;n; ed.T.:n:;;.r d ;
p;;m.c.n;n; :.T.p r.:.n;;l:h; de;e ;;;; frem. :h; pe;.;n;.e be ;h;.n 5 ;.: ::;;a.; ;50 Ov; p;c heur ;; e d:;;;nce of 1.T.;;er. g A licensee may authorire the release from its control of anv individust whe, has been administered radiocharmaceutica s or oerr9anent imolants containino radioacMive materia i t ne tota ef-ective eose eouivalent to any et,er indivic ual from exoosure to the released incividualis not luelv to exceet 5 m5v ' O.5 M g The licensee shall orovide the released in dividual with instructions. includine written instructions. on actions recommended to maintain doses to ot7er ndividuals as low as rea sonab v achievable if the total e"fertive dose eouivalent to anv other individualis li ceiv to exceed 1 mSv (O. rem). If the dose to a breast-feecino inf ant or chi d could exceee 1 mSv 10.1 remi assumino there were no interruotion of breast feedino. ge instructions sha also include: g Guidance on the interruotion or discontinuation of breast feedino; and g Information on the consecuences of failure to follow the cuidance. M The licensee shall maintain a record. for 3 vears after the date of release. of the basis f the release of an individual if tne total effective dose ecuivalent is calculated ov: g Usino the retained activitv rather than the activity administered: Q Usino an occunanev f actor less than 0.25 at 1 meter: 3 Usino the biolooical or effective half-life? or I NRc Raoulatorv Gu'de B 39
- Release of Patients Administered Rad;oactive Materials". describen methods caiculatino denes to o' her indmduais ano contains tab.es at activities not okely to cause doses exceedina 5 m5v (O 5 rem 43
PROPOSED FOR COMMENT-april 1999 . $ Consid;nna_1ha 1hieldina hy_tiABML g The licensee sha i maintain a record. for 3 vears after the date of teiens t thot instructior n were oroviced to a breast-feec ina woman if the ra deation dose to the en ant or chtic coulc resu t in a totale~ ective dose eauiva ent exceedina 5 mSv E5 rem ee. . C.8.28 Use of Redisehermeenwieele Unnealed Radioactive Material for Untake. Dilution. or Excretion Studies. __r__t m_____.._ ___._._t gw, n stw w i s er w w v a r. y as yw wury a upw rwww ts y w su.wnwsswu su s. s wwswye rwu ri swwww gsw us a ws w wwwgurwebsw www wa s y w u y ri ty _1 ._._L_ st..'__ m__ L*_t .L-s= _ _ J __J es _._ a_a_*____*__
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@ A ficensee mav use for imacina and localization studies anv unsealed radioactive material creoared for mec ica use that is either: Q Obtained from a manuf acture or orecarerlicensed oursuant to Daraorneh C 5 5(i) of there reau ations 3r the eautvatent reaulations o~ another Aareement State. a _icensino State or the J.S. N uc ear Reaulatorv Commission; or g Preoared bv an authorized nuclear ohnrma cist. a ohvsician who is an authorized user and who meets the reautrements soecified in Paraarao 1 C. B.76. or an individual under the suoervision of either as soecified in Section C.8.8 of these reau ations. ,L, __J.__L_______s__,_ ____.m_J _m .em,_, _____J m_,, iw, - ruw w. s.w w ..r,, .. swre s wi s s.ww w w.sw.s..rwws. w su, u.i.,i w y.. w..w. r..., ... w s... s te, ri.w w,. w s w... sus. ___J ___?___m _____r___t.._.__es___ _J_?____s __J J_____ y s.w w w, s _ t _ a _ _ _ _ _ e s.w. 1 ____i 3L .t_
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- v. w,i.r u a fet $1 Provided the conditions of Section C.8.32 are met, a licensee shall use radioactive aerosols or 44
p PROPOSED FOR COMMENT-april.1C.9 ga.s.es cnly if specific application is made to and approved by the Agency. C.8.34 Use of Unsealed Radioactive Material ".;d:._;h.:..;;=: f;;.s ns pr;p;;;d red.eph;.n.;;;.;.ee;;. 2 i for Thernov. ?. ':;;n;;.; T,ej ;;. ;b; g fL licensee may use for thernoeutic administration anv unsealed radioactive material orecared for mee sea use that is either: Q Obtained from a manufacture 'or ora carer licensed oursuant to paraorneh C.E.5fB of the! e reo i stisns or the eaulvalent reaulations o" anot 1er Aoreement State. a _icensino State or the J.S. N uc ear Reoulatorv :ommission; or Preoared by an authorized nuclear charms eist. a ohvsician who is an authorized user and who meets t e recuirements scecified m 3araoreo 7 C. 3.76. or an individus soeeMed in Section C.B.8 of these reau ations. under the suoervision of either as ,_t r_;*__ a.g e e aJ_ 1_. ___A L - _ _ m_ __saa__- __aL. .a gwg s ww n.w .ws we rwwsww swa.. w w m.. w w s i n we . n y p,w mi r y s w w wi.. wirw.. s y r www w wi w n sw.. e v, 'b; Ih;,;ph;; ; 02 ;; ;;,l b!e she;ph;;; fer ;;;.;;.T.;n; ef p;lp;i;hern ;. 4;;e, ; ',;n. ;, ;,d bene metestesee; ';; rhe;ph;,; ; 02 ;; ;;;:e:det ehrecc.:e pheeph;;; fer :n;,;;;.hr
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(a) A licensee shall provide oral and written radiation safetyinstruction for all personnel caring for pat or human research subiects undergoing radiopharmaceutical therapy and hospitalized for compliance with Section C.B.24. Refresher training shall be provided at intervals not to exceed 1 year. (b) To satisfy Paragraph C.8.35(a), the instruction shall describe the licensee's procedures for: ..1) Patient or human research subject control; ( (5) Notification of the Radiation Safety Officer or authorized user in case of the patient's or human research subiect's death or medical emergency. C.8.36 Safety Precautions. for compliance with Section C.S.24, a heensee shall:(a) For each patient or human resea (1) Provide a private room with r, private sanitary facility; (2) Post the patient's or human research subject's door with a " Caution: Radioactive Material" sign and note on the door or on the patient's or ... stay in the patient's or human researc 1 subiect's room;numan research subiect's chart where and how lo 45 4
PROPOSED.FOR COMMENT APRIL 1C:9 (5) Either monitor material cnd items remsved frem the patient's or human research subject's room to determine that any contamination cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle these materials and items as radioactive waste; (0) I;;.:de :he p.;;;n;.s:;h red:.; en ;.f;t, i; d. nee :h.:.s::: h; p :: k;;p ;;d:;;;en de;e :s hea;;h;ld r.;r.t;;; end the pub :; ee le'.. ;; ;;.:eas.ht, e;h e J;.L ;. hefer;.a:her ;:n; ri;.; ef :he pe;;;n;, 4 E EEaVAY.Eh (7) Survey the patient's or human research subject's room and private sanitary facility for removable I contamination with a radiation detection survey instrument before assigning another patient or human resenre', subject to the room. The room must not be reassigned until removable contamination is less 4 ...than 2CO disintegrations per minute (3.33 Sq) per 100 square centimeters; and (b) A licensee shall notify the Radiation Safety Officer or the authorized user immediately if the patient or human research subieet dies or has a medical emergency. ( C.8.40 Use of Sources for Brachythernov. A licensee shall use the following sources in accordance with t.h.e. manufacturer's radiation safety and handling instructions: (e) Iridium.192 as seeds encased in nylon ribbon for ins.is.aL interstitial. and intraeavitarv treatment of c.a.n.cer; C.8.41 Safety Instruction. (a) The licensee shall provide oral and written radiation safety instruction to all personnel caring for a patient or human research subieet receiving implant therapy. Refresher training shall be provided at intervals n3t to exceed 1 year. ...b) To satisfy Paragraph C.8.41(a), the instruction shall describe: ( .. 3) Procedures for patient or human research subieet control; ( (5) Procedures for notification of the Radiation Safety Officer or authorized user if the patient g,h,,gg,gg research subieet dies or has a medical emergency. C.8.42 Safety Precautions. 1 (a) For each patient or human research subieet receiving implant therapy and not reieased from licensee control cursuant to Section C.B.24 of these reculations. a licensee shall: (1) Not piece g&ggg,r the patient or human research subieet in the same room with a patient or hpman research subject who is not receivity radiation therapy e.;;;; :h; ::;;n;;; can d;.T.ene;;;;; ;;TG..;nce ...;h ;he res.. ret.en; ef Ce;;;en A..11 ef :h;;; i;;uis;;ene et e d;;;;nce of 1.T.;;;; frern :h; :.T+:en;; (2) Post the patient's or human resnarch subject's door with a " Caution: Radioactive Materials" sign and note on the door or the patient's or numan research subject's chart where and how long visitors may stay ...in the patient's or human research subiect's room; h is, de ib; p.; ;.; ~...;b ii .$ en ;.fCI~y hw.nC;
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PROPOSED - FOR COMMENT-AMtfl.123
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$ M ;;.c..;n;n;'m.p;n. human research subiect dies or has a medical emergency.(b) A licensee shal C.8.43 Brechderew hecen inventerv. (a) O;h ;;...; k;;h,;h;;;&i;;..;;; ;;; ;;.;ned ;; en.;;; ef n;;;ie f;;;..n ;;;. ;.f.;;, ;h; ll;.;...;;;
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- ;c.;;;d:n;;p Promotiv afte removino them from a nattent or a huma,n research subject. a licensee slatl return brachvthernov sources no the storace area. and count or otherwise verify the number returnec to ensure that all sources taken from the storage area have been returned.
(b) A licensee shall make a record of brachytherapy source utilization which includes: (1) The names of the individuals permitted to handle the sources; (2) The number and activity of sources removed from storage, :h; ;;;m ;.. c.h;; :.!.;;. ergs patien or human research subject's name and room number, the time and date they were removed from the number and activity of sources in storage after the removal, and the initials of the individual who removed the sources from storage; and huraan research subiect's name and room number. the time and number and activity of sources in storage after the retum, and the initials of the individual who returned the sources to storage. I (c) Immediately after implanting sources in a patient or human research subjecu d e a er removalof sources from a patient or human research subiect'onfirm that no 4 the Ii ensee shall ma4e a radiation survey of the patient or human research subiect and th f use to c i en misplaced. The licensee shall make a record of each surve (d) A licensee shall maintain the records required in Paragraphs C.8.43(b) and (c) for 3 years. . C.8.44 Release of Patients or Human Research Sublects Treated With Temsorarv Imniants. (a) Immediately after removing the last temporary implant source from a patient or human research autu'ts.t, the licensee shall make a radiation survey of the patient er human research subiect with a radiation detection survey instrument to confirm that all sources have been removed. The licensee shall not release from confinement for medical care a patient or human research subiect treated by temporary implant until all sources have been removed. I (b) A licensee shall maintain a record of patient or human research subject surveys which demonstrate compliance with Paragraph C.8.44(e) for 3 years. Each record shallinclude the date of the survey, the name of the patient or human research subiect, the dose rate from the patient or human research subinet expressed as millirems (microsievertse per hour and measured within 1 meter from the patient, and the initials of the i ' i.nd.ividual who made the survey. i C.S.49 Kafaty Instruction. (a) A licensee shall post vvritten instructions at the teletherapy unit console. These instructions shall inform the operator of: (1) The procedure to be followed to ensure that only the patient or human research subject is in the treatment room before turning the primary beam of radiation "on" to begin a treatment or after a door e.. interlock interruption;. 47 i
r PROPOSED. FOR COMMENT-april 1999 o C. 8 52 Radiation Monitoririg Device. q (d) A radiation monitor shall be checked for proper operation each day before the teletherapy unit is used f.:.r. treatment of patients or human research subjects. C.8.53 Viewing System. A licensee shall construct or equip each teletherapy room to permit continuous cbservation of the patient or human research subinet from the teletherapy unit console during irradiation. Windows, mirror systems, closed-circuit television viewing screens or other equivalent viewing systems shal be so located that the operator may see the patient or human research subject from the treatment control panel. When the primary viewing system is by electronic means (e.g., television), an alternate viewing system, which may be electronic, shall be provided for use in the event of failure of the primary viewing .sys. tem. C. 8 57 Radiation Survevs for Telethernov Facilities. (a)(2) (i) Radiation levels done rates in restricted areas are not likely to cause p;rsena;l ;,, pes.;;s n occuoationallv exoosec indivic ualto receive a dose in excess of the limits specified in Section A.. of these regulations; and - (ii) Radiation levels dese raws in unrestricted areas de n;; ex;;;d are not likelv to enuse anv ic to receive a dose in excess of the limits spectiied in Paragraph individual member of t,e ou a A.2.11(a) of these regulations. C.8.59 Modification of Telethernov Unit or Room Before Beoinnina a Treatment Proaram, if the survey required by Section C.8.57 indicates that en :nd;..d ; ;n en ns;;;;;;;ed er;;.T.;, be exp;;;d ;; l;.;'; cf
- d e;
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- :ted any individual member of the oublic is likelv to receive a dose in excess of the limits soecified by Paragraph A.2.11(a) of these regulations, before beginning the treatment pr.ogram the licensee shall:
C.8.62 Radiation Safetv afficar. Except as provided in Section C.8.63, an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section C.8.5 shall: (a) Be certified by the: (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy er 0;;;nce; or (6) American Osteopathic Board of Radiology or American Osteopathic Board of Nuclear Medicine; or I Q American Board of Medical Physics in radiation encoloov chvsics or (81 Rovat Colleae of Physicians and Suraeons of Canada in nuclear medicinet or eef* C.8.64 Trainino for Untake. Dilation. or Excretion studies. Except as providedin Section C.8.72 and C.8.73, the licenstte shall require the authorized user of a radiopharmaceutical listed in Section C.8.28 to be a physician who: ...a) is certified in: ( 48
PROPOSED FOR COMMENT-APRIL 1C99 g Nuclear medicine bv the Roval Colleoe of Physicians and Suromons of Canada? or (b) Has completed 40 hours of instruction in basic radionuclide handling techniques applicable to th ofjrepared radiopharmaceuticals, and 20 hours of supervised clinical experience. (2) To satisfy the requirement for 20 hours of supervised clinical experience, training must be under the \\ ... supervision of an authorized user at a medicalinstitution and shall include: i (i) - Examining patients or human research subinets and reviewing their case histories to determine their suitability for radionuctice diagnosis, limitations, or contraindications; (ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; (iii) Administering dosages to patients or human research subjects and using syringe radiation shields; (iv) Collaborating with the authorized user in the interpretation of radionuclide test results; and (v) Patient or human research subinet follow.up; or C.8.65 Trainino for Immoina and Localization Studies. Except as provided in Sections C.8.72 or C.8.73, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit specified in Section C.8.30 to be a physician who: ..'.f a) is certified in: g Nuetear medicine bv the Roval Collece of Phvsicians and Suronens of Canada! or - (b) Has completed 200 hours of instructionin basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits,500 hours of supervised work experience, a.n.d 500 hours of supervised clinical experience. i 1 ) (2) To satisfy the requirement for 500 hours of supervised work experience, training shall be under the ,,, supervision of an authorized user at a medicalinstitution and shallinclude: (iii) Calculating and safely preparing patient er human research subinet dosages; (3) To satisfy the requirement for 500 hours of supervised clinical experience, training shall be under the supervision of an authorized user at a medicalinstitution and shallinclude: (i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radionuclide diagnosis, limitations, or contraindications; ,,,iii) Administering dosages to patients or human research subiects and using syringe radiation shields; ( i i ...v) Patient or human rensarch subieet follow up; or ( 49
PROPOSED FOR COMMENT = april 1C39 C.8.66 Trainino for Thermoeutic Use of Unsealed Radioactive Material ti;;*.. u; dc '-. Except as pr;vided in Section C.8.72, the licensee shall require the authorized user of a radiopharmaceuticallisted in Secti:n C 8.34 for therapy to be a physician who: o<.a) is certified by: ( .yyy (2) The American Board of Radiology in radiologyh-J.any or therapeutic radiology; or g Nuclear medicine by the Roval Collece of Phvsicians and Suromons of Canada? or p The American Osteoosthic Board of Radioloov after 1984: or j C.8.67 Trainino for Thernoeutic Use of Brachythernov Sources. Except as provided in Section C.8.72, the ' licensee shall require the authorized user using a brachytherapysource specified in Section C.8.40 for therapy j to be a physician who: ] (a) is certified in: .. 1) Radiology. radiation oncoloav or therapeutic radiology by the American Board of Radiology; ( . C.B.69 Trainino for Use of Sealed Sources for Diaonosis. Except as provided in Section C.8.72, the licensee shall require the authorized user using a sealed source in a device specified in Section C.8.38 to be a physician, dentist, or podiatrist who: ...a) is certified in: ( 15] Nuclear medicine bv the Roval Collece of Physicians and Suroeons of Canada! or .. r C.8.70 Trainino for Telethernov. Except as provided in Section C.8.72, the licensee shall require the authorized user of either a sealed source specified in Section C.8.46 for use in a teletherapy unit to be a physician who: (a) Is certified in: ,,1) Radiology. radiation encoloov or therapeutic radiology by the American Board of Radiology; ( 3 . (b) is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radionuclide techniques applicable to the use of a sealed source in a teletherapy unit,500 hours of supervised work experience, and a minimum of 3 years of supervised clinical experience. (3) To satisfy the requirement for a period of supervised clinical experience, training shall include 1 year in a. formal training program approved by the Residency Review Committee for Radiology of the AccreditationCouncilfor Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional 2 years of clinical experience in therapeutic rediology under the supervision of an authorized user at a medical institution. The supervised clinical experience ...shall include: (iii) Calculating the teletherapy doses and collaborating with the authorized user in the review of 50
PROPOSED -FOR COMMENT APRIL 1%@ 1 prescribed doses as warranted )y patients'or human resea:rch subjects' reaction t siects' progress and c nsid rati:n of the need to modify or .e. C.8.71 Trainino for Telethernov Phvalcist. The licenses shall require the Telethera - (a) Be registered with the Agency, under the provisions of Subpart B cf radiation services in the area of calibration and compliance surveys o.4 of these regulations f teletherapy units. (b) Be certified by the: W American Board of Radiology in: W Q ; Therapeutic radiological physics; g W $ - Roentgen-ray 'and gamma ray physics;g. W E X ray and radium physics; or W M Radiological physics; or f2) e e #" American Boa'rd of Medical Physics in radiation encoloov ohvalent or this Suboart shall have been obtained within the 5 J, years shall have had ;;ntndng ;pgll;;b e related continuino education and experience si ual a.n.d. experience was completed. ee, C.B.76 Trainino for an Authorized Nuclear Pharmacist. i charmacist to be a charmacist who: The licensee shall reouire the authorized nuclear 131 Possesse! lo PEarmaetsts. 3ha'rlacie s anca current licen te as a charmacisti, a ecordance with the Rufer and Ra eufati3ns Perta nino Manufacturers W1o esalers anc Distributors R 5 19-PHAR of the R1 ode stand Denartment o inalt 7!and g Has current board certification as a nuclear charmacist bv the Board of Pharmaceutical S E le)(1) Has comoteted 700 hours in a structured educational orocram consistino of g' Didactic trainino in the followine areas: i' - g Radiation ohvsles and instrumentation? . g Radiation orotection: M Mathematics certainino to the use and measurement of radioactivitv? and g Chemistry of radioactive materlaf for medical uset and g Badiation bioloov and @ Suoervised exoerlence in a nuclear charmaev involvino the followinot l 3 g Shineino.'receivino and nerformino refsted radiation survevs: ' g ' Usino and nerformino checks for done calibrators. survev m eters. and. if soorooriate. instruments used to measure alo,s. or beta emittino radionuchees: 51
PROPOSED - FOR COMMENT april 1C:9 g Calculatino. assavino. and safefv orecarino dosaces for natients or human research subiects g Usino administrative controls to orevent the misadministration of radioactive material: g Usino stocedures to orevent or minimize contamination and usino oroner decontamination crocacures and g Has e btai1ed written cerpfjp.stion. Lioned by a erecentor autt orized nuclear oh arrr acist. that the above trainino nas se en satisfactordv como ete d and that the indivicual has achievec a evel of comnetency suf"tcient to inc enendent v ODerate a nuc ear charmaev. g Trainino for Emnerienced Nuclear Pharmaelsts. A ficensee may anolv for and must receive a license amendment identifveno an exoerienced nuclear charmacist as an authorizec nuclear chstmacist before it allows this individual to work as an autt'orized nuclear charmacist. A charmacist who has comoieted a structured educations orocram as soeci ted in Suboaracraoh C.8.76(bH1) of these reculations before 2 l December 1994. and who is workino in a nuclear charmacy would o Jahfv as an eXDerienced nucleBT oharmacis" An exoerienced nuclear charmacist need not como v wit 1 the recuirements on crecentor statement C.B.76f bH2H and recentness of trainino IC.B.741 to cualiiv as an authorized nuclear charmacist. PART D RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS D.1 PURPOSE AND SCOPE D.1.1 This part establishes procedures for the registration (or licensing) and the use of particle accelerators niended for other than healina arts ute. Recuirements for recistration and use of earticle accelerators for leahno arts use are contained in Part i of these reculations. D.1.2 in addition to the requirements of this part, all registrants are subject to the requirements of Parts A and B. Registrants engagedin industrialradiographic operations are subject to the requirements of Part E-end r;;;;;ren;; ;ng;;;. n ;h; hee :ng er:e er; e bj;;; :e :h; r;;..r;m;n;; ef."er; T ef ;h;;; r;;d;;;ene. Registrants (or licensees) whose operations result in the production of radioactive material are also subject to the requirements of Part C of these regulations. D.2 REGISTRATION PROCEDURE D.2.2 General Recuirements for the issuance of a Reoistration for License) for Particle Accelerators, in addition to the requirement of Part B (or C), a registration (er licensing) application for use of a particle a.c.celerator will be approved only if the Agency determines that: (c) The issuance of tne registration (or license) will not be inimicalto the health and safety of the public-e.n.d. :he eppS;en; ;;;.;f:;; ;c., epp :;ebl; ;p;;1: req..;a,;n; in 0;;;;en 0.2.0 ef ;h:; res.le;:en; b,.) ZC U;G L IL,2 0 $ ACC;!i. !L,1, , Odd i 0,i; ibi i;Q. i;2,;,,1;;;i fe,ih a feil 0, e i;Q[;;isi e. ler S;; nee; fei.;; ef a per;;;le ;;;;;;.;;i :n :h; h;;: c.; er;; wi" b; ;;.;d enli ;f. b; 'A'h;n;s;; d;;m;d n;;;;eer, b :h; ?, ;n;,. ;h; epp!:;en; he; eppe!a;;d e m;d:ee' ce am:;;;; ef ;; k;;; :hr;; me nb;,; ;; ;seh e;; ;ll prep;,;;;l; fer ;;;,;;reh, d:;; nee;;;. end :h;;ep;,;;; ;; ef a per;klc i e;;;kre;e,. M; nb;reh;p ef :h; ;c.,mm:::;;;he d :n;.de ph ;;;;ene ;.,p;r; n :n;;, ne: medk:n;. h;me ebsi.' i th;;;.p;.;k redsbsi, end e p;,;en ;,,p;,in;;d n 0;p;h d;,;; ;;k.M;b,; e,d pre;;;;b. s.g.:,;; sed;;;%n, 52
i PROPOSED FOR COMMENT april.1823 <_._m. .................-__.m__.....rr.~..~..............<..____<___._,.__._.__ dnp ;h.r., ;ahn:; ;; er,..........< _
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- %;%ne.
d:n Cu;%n 0.0.11 ef ;ha PART E RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OR WIRELINE SERVICE OPERATIONS AND ANALYTICAL X-RAY EQUIPMENT E.1 PURPOSE The regulationsin this part establish radiation safety requirements for persons utilizing sources of radiation for industrial radiography or wireline service operations (including minerallogging, radioactive markers and X ray equipment. subsurface tracer studies), and provides special requirements for analytical and resea requirements of these regulations.The requirements of this part are in addition to and not in substitution E.2 INDUSTRIAL RADIOGRAPHY E.2.1 Scene and Exemotions. g Senom. Excent as orovided bv Paracrach E 2.1(b). the regulationsin this subpart apply to alllicensees or registrants who use sources of radiation for industnat radiography; provided, however, that nothing in this subpart shall apply to the use of sources of radiation in the healing arts. g Exemotions. Uses of certified and certifiable cabinet x rav systems are exemot from the reouirements oft lis cart excect for the followino: Q For enartified and certifiable cabinet x-rav systems. includino those desianed to aflow admittance of individua s g No reoistrant shall e ermit any individualte' coerate a cabinet x-rav system until the 'ndividual has received a conv co and instruction in 11e coeratre crocedures for t1e unit. Records that emonstrate como innce wlUt this suboaracraoh s c c!sonsal is authertred bv the Acencv. se maintained for Acenev insoection uriti ia g Tests "or oroner coeration c f interlocks must be e 3nducted and recorded at intervals not to exceec six months. Recorc s of these tests shall 3e maintained for Acency intoection until dinnosal is authertred by the Acenev. g The veoistrant shall nerform an evaluotion of the radia~i3n dose imits to determ_ine comr6ance wtt i D.301 a.. b. and c. of these facu ations. and 2' C R 1020.L0. Cabinet X Rav hvstems (39 ~ Federal Reoister 12986. Aoril 10. 974L at intervals not to exceed one vear. Records of these 53
PROPOSED o FOR COMMENT-APRIL 1999 eve.luations shall be maintained for Aaenev insoection for two vears after the evaluation. J Certified cabinet x-rev systems shall be maintoined in comoiiance with 21 CFR 1020.40. Cabinet X. Hav Systems (39 Federal Reaister 12986. April 10.1974). and no modification shall be made to the system unless crior Aaencv accroval has been oranted. l E.2.2 Limits on Extema! Levels of Radiation for 'hd:ssr;;hk Exsc;ura Crike; c.nd from Storace Containers and Source Chanaers. Cedkgreph:c cxpceur; dcekee meesci:ng lcas : hen 4 :nches G O cm; ficm :he a;; cd eevice s:creg; posa;ca :c en, extciki surfecc of :he dcike she:: huic ac red edon cicl ln c,accas cf 50 _ n c. _ _ _. _ _ _ n...% ,m, m.. e m -.. inv w- - & m_u-ne _m m u ....v...,i w ngspn us am ivs u m.w w iaw u s.s . w., u.... _ a _ _ 2.www- - .m m. y un mi sm swi wi u n., w w. n., w. Ced:egrephk exposuic drikes measuring e min lmw-. cf 4 lachea 0 0 cm) ficm :he c,c;kd eeurce a:creg; pcsakn ;s eny cxici:cr surfec of :he dcike, and e" s:crege ccntaincia fc scekd scurece or oc:c ;ca;;;ncre for r:dbg::phk exp::ure devken, ch:!! S:ve n ::d':2r !re:' " :::::: :f 200 "":: r: gen: (5.i S 104 C 'Eg p : Scur :: :ny ex:02: :urf:::, :nd 10 ""::cr: gen: (2.53 10* C/kg) p;r hewi et enc mc;ci ficm any ex:cr:ci surfecc. The redkdca lc.ck spcc'fkd etc viah the scekd scwicc :n the sh:c:dcd U.c., "cff"; pce:dca. The maximum exoosure rate limits for storace containers and sot.ree chanaers are 2 millisieverts (2OO millirem) ear hour at anv exterior surf ace. and O. milksieverts 410 mi hrem) cer 1our at 1 meter from any exterior sur< ace with the sealed source in the shie ded oosition. E.2.3 Lockina of Sources of Radiation. Storaae Containers. and Source ChanU.t2 (a) Each source of red: eden radicarachie exoosure device shall have a lock or outer lccketk hkg container designed to prevent unauthorized c ecc.cca:G; piccw; don of redk::ca er removal c capcawic o" the sealed source from its shielded cosition. The exoosure device and/or its container end shall be kept locked f and if a keved icek. with the kev removed et all times) when not unoer tne direct surveillance of a radiograpner or a radiographer's assistantor es c;hcise;c me, cc autherbcd b, :hk part exceot at oermanent radicarachicinstattations as stated in E.2.13. In addition, during radiographic operations the sealed source assembly shall be secured in the shielded position each time the source is returned to that position. (b) Each sealed source storage container and source changer shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers shall be kept locked.f.a.nd if a keved lock with the key removed at all times) when containing sealed sources except when under the direct surveillance of a raciographer or a radiographer's assistant. k; Cedkgraphk exp;svic dcikes, ecurce changcr;, and ;;cregc ca einers, pr:cc :o bc:ng me.cd from enc b;edca:c engthcr end ;ke pi ei te bcing sc;wicd et a glica lcced i., shell bc kcked end agric,cd :c easwic ;hc::he sca:cd sowice k :n :hc shk'dcd pesaba y The control canet of each radiation machine shall be eauloned with a lock that will orevent the Jnauthorized use of an x-rav system or the accidental oroduction of radiation. The radiation machine shall 3e keot tocked and the key removed at all times exceot when under the direct visual surveillance of a radicaraoner or a radicaracher's assistant. [.2j ClareOE Iie Cout!Ona. Lockcd ied cgr;phk ixp 3Lic dri ccs, scUice changCr2,ied Ldon i echinc; Gad s:cre;c c;r:incts shZ bc ph,;kc", sccercd :; prcica :empcr:ng ;r icmciel by wnesth;rbcd scracracL Q Labelina. Storace. and Transoortation. g The licensee may not use a source chancer or a container to store radioactive material unless the source chanaer or the storace container has secureiv atteched to it a durable. teoible. and clearlv visible label bearina tne standard trefoil radiation caution symbol conventional colors ti,e. maaente. ourole or black on a vellow backaround) havina a minimum diameter of 25 mm. end the wordina: CAUTION 3 RADIOACTIVE N ATERIAL 3e *DANGEA* 54
PROPOSED FOR COMMENT-april It99 NOTIFY CIVIL AUTHORITIES for "NAME OF COMPANY"I g The fica nn ne mav not transoort radioactive material unless the materiali1 oncknoed. and the nacknoe is la belac. mar cec. anc accomoanied with accrocriate shionino Dacers in accore ance with reculations set out in 0C a R 71. g Radiooraoh*e exoosure devices. source chanours. storaan containers. and 'adiation machinen mast be ohvsicanv securec to orevent tamoerino sr remova 3v unaut iorized oersonne. The beensee s nai store racioactive material in a manner which wi I minimize c anoer " rom exolosion or fire. g The licensee sh alllock and chvsicallv nacure the transoort oncknas containino rad"cact ve material in the transoortina vehic e to crevent accidenta loss. tamoerino. or unaut1orized remova of t ie radioactive material from t le vehic e. M The iieensee's or recistrant's name and city or nown where the main business office is located shsti be orominentiv disclaved with a durable. clearfv visible abeHs) on both sides of all vehicles und to transoort radioactive material or radiation machines for temocrarv tob site use. E.2.5 Radiation Survev instruments. (a) The licensee or registrant shall memtem a sufficient calibrated and operable radiation survey instruments at each location where sources of rac iation are cresent to make ph e:;el;g radiation curveys i es required by this subpart and A.3.2 of these regu ations. Instrumentationrequired by t1is pse;; ph section shall 5: : : ::n;; :::S 05:: 2 "":::rt;:n: '.16 10" C/h;I ;;: 5L: tS::U;5 ' :::rt;;r '2.55 : '.T C/Lg! p;i he ;;en b;,T.;;;.;;d be canable of measurino a rance from 0.02 millisieverts (2 millirems) oer hour throuch O.01 sievert (1 rem) cer ,our. (b) The licensee or reoistrant shall have each radiation survey instrument reouired under caracraoh (a) of - this section ;h;S.'.,; cahbrated: (1) Age:ne; epprep;;;;e ;nssi t eneraies ac orcoriate for use and at intervals not to exceed a g months A and after each instrument servicing, exceot "or batterv chances; (2) Such that 7.n en;: a:en.y accuracy within ofus or minus 20 percent of the true radiation dose rate :re;;;b:;;; e d can be demonstrated at each ooint checked; and (3) A: tc.; ;;.T.s;.s:d;!i nps;3d peb;e, 0;hs : hen n;;, en exh ni. Q
- or linear scale instrt ments. at two coints located acoroximatelv one third and two thirds of "un-scale on each sea e:
g For lodrithmic scale instruments. at mid-rance of each decade. and at two coints of at least one decace:and gg
- or dioitalinstruments. at 3 ooints between 0.02 and 10 millisieverts (2 and 1000 millirems) cer Elk i
(c) The licensee or reoistrant shall maintain records of the resutts of these instrument eclibrations sheH t; T.ina.x; fe; ;c.; pa;; ef:s ;n; ed.Rnlen dem fe;.nep;;Len ti ;h; Ag;mi in accordance with M E.2.6 Leak Testinc. ".;;O T;;;'c;;. 0;das. i".;d:!:;=:;. and Reolacement of Sealed Sources. (a) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing, ;;pir, u;ghg, ep;nM;. a ;ny e;h;;.T.ed f ;;;ba of any sealed source shall be performed only by persons specifically authorized to do so by the Agency, the U.S. Nuclear Regulatory Commission, or1my AnQ1tm Agreement State. (b; Cech nid ;;.ru ehell b; ;;;td fe; ; L;;; a; :nn..i ne; ;; ;. Gad 0.T.en;he, b ;h; etxx; ef e n;;;f s= 1 era ; ;;;n;f;;s ;he; e =;; h;; b;;n.T.;d;..;;h:n :h; O.T.en;h p;;.ed p;;s.e :h; ;;enefs, the n c d 'e.;u ; ehe" ne; b; p.: Z u.;;..L: n n;d. 55
PROPOSED - FOR COMMENT-APRIL 1899 g The onenina. renair or modification of anv saa ed source n,att be nerformed entv bv nersons toecr ically authortzed to do so bv the Acencv. the L.S. Nuc ear Reaulaterv Commission. or another Aareement State. ,. m .__.m.,u.._._r_W,.. ....r......,.......m,..,,,...,........,m_, _ _ _ _ __ m,_ >__m__ .m _________,mm ,a ..w- ...w., w......... g............ een;;rn:n; den en ^he ;;id nein. An ;sep';b'e l;;k ;;;; fe; nid ;;.;;e; in he peen;,2, ef e
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- :;;n;n..e. d be ;; ^e;,; e; :h;,;.;n; es;..:b'e pe:n; ;; :h; nid n.;n ;^er;;; p;;,;;.;,n, er e;he. ;pprep;;;^. r.;n.;:n; pe:n^, b, ; pie;;d.;e ;;, b; ;ppie sed p.;;.;.;;; p; ^. C. ".es;d; ef l;;L ;;;;
- .h;;h;ll be kep;',a wn
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______m.__ _.__. m _ __ _____2 .m _2 ._______2 m__2 te rw gr. st t.qwei ww r.wn R. tF t TW y,. I 5. s v e r...s wa s tus Es v. ww w w w us w.wy w. WW tu 451 uw s.r s w as .5 . u w p,. W. w .38 g Testino and record keenino reouirements. Q Each licensee who uses a sealed source shall have t' e source tested for leakase at intervala not to 1 exceed 6 months. he leak testina of the source s hall De cerformed usino a met ioc aoorovec by the Acenev. the U 5. Nuclear Reaulatorv Commission.or another Acreement State. The wioe semole should be taken from the nearest accessible c oint tc, the sealed source where contammation miant accumulete. The wine tamole shal be a nalyzec "or rac tolict ve contamination. The a nalvsis shall be canable of detectina t ie cresence of ' 35 3a ( 3.005 uC o' radioactive ma1erial e n t ie test samole and shall be cerformed bv a cerson soecifical v author red av the Acenev. the J.S. h uc ear Reaulatorv Commission. or another Acreement State to cerform t ie analvsts. Q The licensee shall maintain records of the leak tests in accordance with E.2.26. J Unless a sealed tource is acce moaried bv a certificate from the tran sferor tha t shows that it has been eak tested within 5 months be" ore t 1e trans' er. It mav not se usec
- v the icensee until tested for enkaae. Sealed sources that are in storace and not in use do not reautre en c testina. but shall be tested 3efore use or transfer to another eerson if the interval of storace exceet s 6 months.
(d) Any test conducted pursuant to paragraphs (W W and (c) of this section which reveals the presence of 185 Bq (0.005 pCi) or more of removable radioactive material shall be considered evidence that the sealed source is leaking. The licenses shall immediately withdraw the equipment involved from use and shall cause it to be decontaminated and repaired or to be disposed of, in accordance with regulations of the Agency. Within 5 days after obtaining results of the test, the licensee shall file a report with the Agency describing the equipment involved, the test results, and the corrective action taken. M A e;id n.ru sshkh :s i.e; fesun;d ;; er an;2;d :n ; red:egrephk ;-p;;ere dc.:n she" hrs; ene;hed ;;, ;; e,_d ;eb ; ^;; ;; l;e; en,e N :nch equere beer:.s ;he pren;;b;d red: eden s, den perrnen,e nd r___ __m_ u _ _.. _ _ _, __ __ ________ __ _ __ _ __ _ J,. l a w,. W. h. n g s w w g Ut.s, _2 __ 2 _. ,___..<_u_. __u__. W y a s swwn zu a w w p I..a s t uvi Ipc WWswle, e a I.g b 5 4 b. W3 g,. 3y3b wt5. .5. bs 45 4 Ob.64 bu lb s e E W 68. 6 3 3 56. "Oenge. ".e d:e e e d se ?.".;;e.:e: Oe N;; ';end:e Nedf, OM Aw;he.;dee if Te.nd". g Each exoosure device usino deofeted uranium (DU) shintdino and ai," S" tube confiouration shall be tested for DL contaminat onint intervals not to excead 12 re ont in 'he ana vsis sha le caon 3te of detectina the cresence of 1 35 E a 0.035 uCt) of radioactive ma teriin ont 7e test samole and shall be cerformed bv a oerson soect"icaltv aut nortzec by the Aaenev. the U.S. Muc ear Reaulaterv Commis'tion or another Aareement State to cor"orm the annivsis. Should sue , testina reveal the cresence o"185 Bo (0.005 uCs) e r more of removable 3 J cor tamination. t u exoonure device shall be te moved from use unti en evalJatton o" the wear of the 5-tu 3e has Denn riade. 5 1ould t w evaluation reveal t ist t le 5-tube is worn throua l. the device mav not be used nomin. D Js lielded c evices c o not lave to be tested 'or DU con"ainination while in storace a nd not in use. Be" ore usina or transferrina such a device however the c evic e shall be te sted for DU cont amination. to "he interva of storace exceeds 12 months. A record of the DL leak-test sha i be made in accordance with E. 2. 2 6. E.2.7 Quarteriv Inventerv. W Each licensee shall conduct a quarterly physicat inventory to account for all ;;,id ;;.;ne ;ne.s;d
- p u u. u s b, h
- n The e;u. ;" :h; la^.en;;;;;; ;h;ll b; -^;;n:alne: 's, l. ;;;;;l;n b, :h; li;n;, ;.^
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- he lr.;,n;; y sources of radiation and for devices containino deoleted uranium received and oossessed under-this _ltctn.s.t.
g The licensee or reoistrant shall maintain records of the cuarterlyinventervin accordance with E.2.27. 56
PROPOSED FOR COMMENT-april 1299 i E.2.8' Utilization Logs. .___W E._ach license.e or registrant shall m,aintain ewrent utilization logs,..-t.:;t..t.w': hW w.
- . U; fer m,
_ _ _ _ _,__ __ _ _ _ _. s w.... L _ _.._ _ showing for each source of .t_ m_ ....r w w,. wi. .,.. rw,,, w i rw,,,,, ...w , w w.. .~ --.w w .. ~. w w wr w w.s w.w..., radiation the following information: ie@ A description. includino the for make, and model gQQgig[ number; c' n.;t. ;;.re; of 23 radiation mochine or the radicarachic arcosure device, transoort or storage container in which the sealed source is ocated; iM 2 The identity g,,gigggggs of the radiographer to whom assignedrend fe) Q} Locations where used and dates of use,includino the dates removed and returned to storace: and '4 For oermanent radicarachic instailations. the dates each radiation machine is eneraired. i T1e licensee or recistrant shah retain the loos recuired bv oaracraoh (a) of this section "or 3 vears after i the ao is made. E.2.9 insonetton and Maintenance of Radiation Machines. Radioor^achic E roosure Devices. Transoort and Storace Containers. Associated Eau oment. Source C ianoers. and survev natruments, 1 i (a) Each licensee or registrant shall ;.;..; :P.;; d,ede fe-d..t.s. d;fe;;; in red._:e;;;c, r,.;;t.:,,;;. __ m _ _ ___ __ x ___ a______ _____s __ _._ _ _ n_ s_ s yw s vgi wy s sFw w,tyw w.s3 w ww T ib w e, e twa n.g w w w u s t as us swa e, wasw wwws w te we swu agwg g wt w y og s vi s a nww yltVi .w tree nerform visual and coerability checks on survev meters. radiation ma-hines. racioorachic exoosure w ww a s was y w g devices ten,soort and storace containers associated eautoment. and source c 1ancers be" ore each dav's use. or work s 1Ft. to ensure that: { Q The eouioment is in nood workino condition! Q The sources are adeountelv shielded: and g Reauired labelino is cresent. l g Survev instrument coerabiliev must be cerformed usino check sources or other amoroerinte means. If eouinment oroblems are founc. tie eautoment must be removec from service untet renaired. ,o m________. __,_____e _._n_..___ L.m __,_.u_
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..t _ _ _ _ _ _, x,__ __ twl 5 %s i a i 4 w i i w I a. u wgs a wg u wya si be ,vi se. ns s i te s w s s e _ _ _., rg a s rg s a v w hs s as b,I b# I__ I s es y a s I ts 3 w w.s _,____________;____t _2.. m_ ts q,.,s t y p D hs. T V I.3 4 kB tr w wI bs b I I w b wI . w,,s. w. u _ _... n.. w. w..~w.m_ __ _ _ _ s _,I I % 3_ _ _ _ _ _ _ _ .m_ w,w.... .w... w. .w..,-... m.v., w. .~.b .w... .~ .w.~.....,.rm. w..,..w,s~,s... , e, s,m .,w..._____ L.w_. ?.._____asw__r_w_.._w_._.,_~_a______. m..._ t_.,~.~,t..._._.._.t*.__ c r__t t*_ ____t __f_____L*_ ..,~w.. w. w,,e .w su,,ws.w.- r____et_*__ ._ _ L_t .t_ ___e__ _t_n t__ t_.t _se_ __; _. ste. _t__i_ _s w,.~.....~....,,~,.wr.,~ si s g. as s r gs. Iw 6 a tw V 7 5 IE hr 3 ( 66(3 5 Sww swuI w p.,y e s w g W rwil e sw y w ww t. 5 yspawsw w e rgs w w %s s w w w o yvusasusrg rgisg.sg .V v v t.I AE6 V3 .t_ _s __s_.__ au t _ .t te_ ____t m_ut_ t. __m_s ar t _ __ ste_
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_t_nL_ be sw y e w e b 4 tw ts w4 5 ww4w.iwa s e 5.isw Tistwsw er swis ww u g,.w y g w w wy a ne w s w. s v g a s I sw u nis hs i ws w e r g s s mis e e71 t w 3 4 wb _a ____; m_ 4...____ __a_ __ g ig s a.g_____.e_ ,__._n_ __ mm .t_ y w. I y w. w hs T V 4 # Y.' I 3 E. 4 . tr E I tyu, b 55 g a Iw ww tV 4p 3 a b is a ta #w sI 4 S. s u es.s v 5 I TW W pIIw bI 5w & W wI he w I5 w,5 pur W W1w hs e ,, i au L _ __ _ __ea_.>__ _s___ __ _ _ _ _ _e_et t_ .__.__a1_____________*__ _..L-L__G_*___f ___L ___uJ g e,, eszw ,a w u s t u wl w w w s te in VI.suwua#3 e y y.1., e g s e a o w s s wgs s w e.w gs swi ye wyba w yg,aupbywsses6 e i.w ww g i s.r.s a s a rg w q m____;- _,.._t. g, e. i e y w a rwbs m _. L_ ____m_a wr..~ n,___W.~rw..... .. ww...w..w. s. 4,rm.u _ u.m_ a . _... _ m __ _., c _ u w. .w. .~-.w. ~. .w... ..... ww...w.s..w..~s .w. ~,. d' f,w^ I ,~u e w. .r._ m, iu_____ _____u____e_n .a -...a. -. W _ _ _ _ _ _ _ _ _, ,...,,,, w.. w..,. u,. r m. ~.. r. w..,s...,. s ____ __ __; __._.____ __ _ s. _._. _r _. s w.__ _~___tt__ .w,....s....is.s.. m, . w... w w w. .s,. .......w..w~b __w_____t_ _?___ ___._a_ __a _t______ w w..w.,__.w......s., ..,~,. r.,~ w,,r .w rw.~w., ..w.,,. ,,w...r.,,..., .~ ..,w. w.s..w.. 1. __t_ _1 .w ...s s w ys wyw u v es a sw arwu vii ry wu _s_. an ______ _ ' _ - _ _ _ _ _L_se t_ __'.._ua t wwi g rywu sw s s ne gi u ry gru m uu s h av ewgwgy. ym u s wyys b,ys IW.b _____a____ st _ _ _ .s__. ___e.
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?_ _..t____2 e s a sw u e Ib yIlsw hs .L_. .t_ a____ awi se rpyw w aswe a wy a t # ti r,g 3, a sge y as s a.a u h a s q,as up u eg.,w w w t ge yas.4swa56tew i, y 6 3 rio am y w 3 p,o 7 e ,2, .___2 r, u,._s,,. a,,w,__ m,.__,_ 2_____ __f ..w..-..,r.wr..ww.._ m, ., 7....r. t - .w w..., w.., .s...,b .v ...rW,m.... w...~w. .w __J'--" J_ W 48'48 ' w 6 s w e a ewsb... _L_te L. .J 1. _ ___.*__.. _.*e____*__ L_.-_ L___ __J_ y, ts aw w tr v s be w plrwa wie swuaswww s esvu5a ew a y sw w ga e a t s, awyelesvuvw mr w w e a a u ee wwe M Each licensee or reoistrant shall have written orocedures for and oerform Q Insoection and routine maintenance of radiation machines. radicarachic exoosure devices. source 57
PROPOSED FOR COMMENT-april 1t99 chanoers. associated eauin ment. transoort and storaae containers a nd survev nstruments at intervals not to exceed 3 months or te" ore the first use thereafter to ensure tie o>ocer "unctionina of comoonents imoortan" to safetv. Flen aceme1t comconents shall meet desian soeci"ications. f eautoment oroblems are founc. the eouioment must se removed from service until recaired. (2) Insopctiert and maintenancq necessaryto maintain the Tvon B neckacina used to transoort radiga materials. Ih to assure that Ivne n accor ance witk"tkst inch de orofedure7tance or o pqckaaes are skinso[etthn and maibtenance roaram t e certJicate o como one an maintaine g Records of eauiorr ent orablems and of any maintenance nerformed under this section must be made in accordance with E.2.2 L E.2.10 Trainina and Testing. (a) Tha Ne licensee or registrant shall gg permit any individual to act as a radiographer until such gg individual: 3; llee te;n :n;;;.;;;d in ;h; ;.b;;;;e su;::ned ln Append A ef ;h:; per;; y Has receive d at les at 40 hours of train no in the subjects outlined in Parnaraoh (c) of this section. in ade ition to Sn-t 9e iob "rainin 3 consistino o 1 ands-on exoeria nee under the suoerviston of a radicaract er anc ts certi"le'd t 1rouc 1 a rac ioaracher certit cation crocra m 3v a certifv no e nt tv in accore ance with t le criteria soeci"iec in Anoendix A to Part E. "he Sn-the-to 3 trainino shal ine uc e a minimum of 2 months 320 hours of activer oarticinatter ir the cer' ormance of industria radicaraohv utikrina radioactive ma terial an': /or 1 men"h(160 1ours to" active cartteinstion ir the cerformance of industrial radicaraohv utt zino rac tation Fnac 1ines. Indtvic um s cerformino tnd astria radicaraohv utikrino rac isactive materials anc radiation mac 1ines must comolete both seaments o~ the on the iob trainina (3 mont 1s or 480 moursh SL Q The licens ee or reoistrant rr av. until 27 June 2000. allow an incividual who has mot met tha' reouirement o" carnaraoh (aH1) o' this section. to act as a radicaracher a"ter the individua las receivec at least 40 hours of trainina in the subiects outlined in E.
- 70. and demonstrated an uncerstanc ina e' these sub!ects by successful c Smoletion of a written examination that was oreviousty submitted tc, ancL. '.
accroved bv the Acencv. the \\luclear Reau atorv Commission. or another Aareement State. in ad: ition 7 to on the tob trainino consi stoic of hands-on exoerience under t me suoervision of a radicaracher. T 1e on the sob trainino sha l inc uc e a minitrum of 2 months (320 hourst of active c articioation in t ie cerf ormance of in dustria radicaraohv uti irino rodioactive materia I and/or 1 month (1'50 hours) of active carticioation in t,e cer"ormance o" industria radicaraohv utt iziro radiation machines Indly.ghl3,!,3 3er"ormina industrial rac ioarachv utilizina radioactive materials anc radiation machines must comotete 30t i seaments of the on the sob trainino 13 months or 480 hours). g in addition, the licensee or reaistrant shall not oermit anv individual to act as a radicaracher until the individuah hiS W Has received copies of and instructionin RCA regulations as contained in this part and applicable sections of Parts A and C,in anoticable DOT reouf ations as referencedin 10 CFR 71. in the license (s) and/ or certificate (s)of registration under which the radiographer will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures. (2) Has demonstrated understanding of the ;n;;..;;;;n;;n ;h:; per;;;;ph (;) items in suboarnaraoh (b)(1) of this section by successful completion of a written or oral examination ;;.;;.n; ;h.;.T.;a...;: ;;;; ;n
- L;;; e,,;.T..n.;;;n en ;h; ;;t;;;;; ;;.;ied.
(3) Has d;.T.en;;.;;;d ;;,Tg;;.n;e ;;.;; received trainina in the use of the registrant's radiation machines or gg licensee's radiographic exposure devices,................. ~, sealed sources, ceteted head;.ng ;;;;.,.ad ;.r.;, ne;;..T.;n;;in the dailv insoection of devices and associated eouioment. and in the use of radiation survev instruments; and g Has demonstratect understandino of the use of the eauioment described!n subcaracraoh(b)(3) of this section by successfu como etion of a cractical examination. 58
PROPOSED FOR COMMENT-april 1999 sweh gg;Q3 e licensee or registrant shaligt perrnit any individualto act as a radiographer's assis Mh N inomdual: (1) Has received copies of and instruction in 2.; C;;n;;;*; si i;g;,;n;'s spei.Cn; ;. ;n ;;;; r;, pie;;d.si;; RCA reculations as contained in this cart and acolicable sections of Parts A and C. in acclicable DOT reaulations as re"erenced in 10 CF R 71. HeenseM and/or certificateM o" reaistration unter which the radicaracher's arsistant wil' cer"orm industria radicarachv. and t ie scensee's or reoistrant's coerattna and emeroency crocedures; m______.o ._ m _ .u_ m_ ,_____e__ gg ysys wwr a rvs aggs w aw w w wr e r,yw.w a ww w__ .a .w w erw, wu rww a .x _ __,_. ssw ywpwwssw. s w y wavswrvis wa traw s.rw s wy s wya sw i, nisb __,___w_ __ __,_._ s c_s,__ ..wrw,..y.,~. < _ r. u __ s _ _, _. ~ _ -_._. ..s. m b.,..... -. .......o, ........., ~,,,,, ...r., -r- ..w..~.. .r...,. ___u__. _a ss eg gs wu s sw a see au ru b.saw w w wi e b.ir u 5 6 vv uus e.s g., wr r s m_____ .t_ _______mm_ ______1 ..,.~e~.~o.__,b2-._m..__,___1 .u..... _. _ _ _ _ _ u.. r W... r.. i,,., m
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Q Has demonstrated an understandino of items in suboaraaraoh (b)(1) of this section bv successful j como etion of a written or ora examination: Q Has received trainino in the use of the recistrant's radiat on machines. or the licensee's radicarachie exoosure devices. sealed sources. to the dailv inscection of cevices and associated ecutoment. and in the use of radiation survev instruments: $ Has demonstrated under standina of the use of the eauioment describedin suboaracraoh (b)I1) of this section bv successfu como etion of a oractical examination. , _, ~ _r v_ s_ w e m _a .c_ a__ g ge, iav wa tusw.swwww ts wi. a sag, II u% sww s __s s._,s sg w w y s w as ws vusathwss tw e nS u.fW w.s t b d WE W3 U. E w e7 6 e os s s w e4b1W
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__,u__ .u_ s a s.s k b s s w a as,w s as b vi n I es y s w g s gif 6 5 W .r W 4 I w e b r W I 6 W3fW iib w a a er w w s vi e w g i g 6 s.s a s 6 e _ _ a _ _,b. 8 b Wy b s W 6 3 r ig .,s u f W b8. Bk 3 gb 33b y FI W.r b W W I_ _ _ _ __ s_o__ t_. ___t _____t__ ____t__*_ ___*_m art ___ b@ W8 b I W I r V W v b bd. __m B.Fy bWb83 4 W hs 3 V g I 4.I y 4ib. wB3W 3 5 4.s s V g 4.a y a s b,a p.sggIe,b.5 iib, 3 gaw w I s a a w s i i.ii .m _ o.. m, .d ww I be,y e m ~, o m o,, __ m ,____e_.. r. ~, .m. ~ o yo _n u_ ,,____m. . m.s ..r, m ~ ..~o ..f s ~ -b .~..b. u.____e ....~.s..r v. u_ _*_._*__a s..__ a______1.._,_.m.,.. oo. om .m..... ..f~_...t.~_.. ?_____.__ t.. .t_ -.. ~...... ~. ...ym.~o 7., ~,,,,, ~, s___._ .L_ .a. __.2.. _1 t w, um.~ m.. jg The licensee or rea'strant shall crovide annual refresher safetv trainino for each radicaracher and radicaracher's assistant at interva s not to exceed ' 2 months. the{g}b cerformance o" each ra dioaracher and radicaraoler's assistantExceot as orovida d in carnaraoh feif4). the RSO or dosionee shall conduct an insoectio, crocram of to to enstre that tme Acenev's Fecu ations. heense and/or certi"icate of reaistration reautrements. and the aco icant's coeratina and emercenev orocedures are followed The insoection crocram the I: $ include observation of the oerformance of each radicaracher and radicaracher's assistant durino en actual industrial radicarachic coeration. at intervais not to exceed 6 months: and g Provide that. if a radicaracher or a radicaracher's assista nt has not carticiented in an industrial radicaraonic coeration "or more than 6 months since ' he ast in toection. the radicaraoner must c emonstrate know edoe of tF e trainina reautrements of E.2. ' Of 3lf 3) anc the radicaracher's assistant must re-demonstrate knowledae o" the trainino recuirements of E.2. O(cH2) bv a oractical examination before these incividuals can next carticioate in a radicarachic coeration. Q The Acenev mav consider alternatives in those situations where the individual serves as both radicaracher and R50. 59
PROPOSED. FOR COMMENT-APRIL 1999 g in those coerations where a sinole individual serves as bonh radicaracher and RSO and oerforms all radicaraonv coerations. an insoection crocram is not reouirac g The licensee or reoistrant shall maintair records of the above trainino to include certification documer ts. written and oractical examinations. re res,er saf etv trainino and insoections of iob oerformance in accorcance with E.2.30. g The licensee or reoistrant shallinclude the followino subjects reouired in caraoraoh f a) of this section $ Fundamentats of radiation safetv includina: Q Characteristics of osmma and X-radiation: 3 Units of radiation dose and cuantitv of radioactivitv: g Hazards of exoosure to radiation: gg} Levels of radiation from sources of radiation and M Methods of controllino radiation dose (time. distance. and shieldino): Q Radiation detection instruments includino Q Use. coeration. calibration. and limitations of radiation survev instruments: g Survev techrhues and g Use of cersonnel monitorino eouioment. g Ecuiement to be used includino: Q Ooeration and control of radicarachie exoosure e auioment. remote handlino couloment. and storace containers. includino otetures or models o" source assembhes (oiciails): 3 Doeration and control of radiation machines: @ Storace. control. and discosal of sources of radiation and ~ @ Insoection and maintenance of coulement. g The recoirements of certinent Aaenev and Federal reaulations and g Case histories of accidents in radicaraohv. g} Licensees and reoistrants will have until 27 J ane 2000 to comotv with the certification reouirements soecified in caracraoh taH1) of this nection. Fiecore s of radicaracher certification maintained in accordance with E.2.30ta ' orovide accrooriate a"firmation o" certi"ication reouirements soecified in caracraoh f aH1b of this section. E.2.11 Doeratino and Emeroency Procedures. (a) The licensee's or registrant's operating and emergency procedures shall include as a minimum. instructions in et l;;e; the following: iet (1) Acerooriste %e handling and use of sources of radiation;; b; ;.s';,;d exhis likely to be expos hed in Subpart A.2 tan ards for Protection Against Radiation; 144 Q Methods and occasions for conducting radiation surveys; iet @ Methods for nas.tinsuind controlling access to radiographic arets; 60
PROPOSED FOR COMMENT april.1E 3 (dt 3 Methods and occasions for locking and securing sources of radiation; (e)@ Personnel monitoring and the use of personnel monitoring equipment; (f)foor nohic exoosure devices and storace containers in the vehicles pecting ofacard ra s gbgg needec, and control ot the ecutoment ;; ;;;; et ;;d ;,;;en during transportation (refer to 49 CFR Parts 171 -1 T3); 9121 The inspection,end maintenance and coerability checks of radiographic exposure devices radiation maeTines. survev instruments. alarmino ratemeters. transoort containers, and storage containere;-end
- ten n;,;h.ne;; and fie) 3 Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off scale or an alarm ratemeter alarms unexceetediv.
- The orecedurefs) for identifyino and reoortino defects and noncomofiance as reouired bv Section
- 4. 15 :
th)@ The procedure for notifying proper personnelin the event of an accident gLkgggt; ist M Minimizing exposure of nd:.:d.,;l; cersons in the event of an accident or incident. includino a source disconnect. a transoort accident. or loss of a source of radiation; g Source recoverv erocedure if licensee will eerform source recoverv: and fit M Maintenance of records. g The licensee or reo strant shall main"ain cooies of current coeratino end emeroenev orocedures in accordance with Sections 12.17 and E.2. 3 ' l E.2.12 Personnel Monitorinc C;=;!. ~ (a) 33 Ne licensee or registrant shallgg permit any individuat to act as a radiographer or a radiographer's ast.istant unless, at all times during radiogra;phic operations, each sweh individual wears. on the trunk of g a combination of direct reading pee 4eet dosimeter, an ooeratino alarm ratemeter, and either a film badge or a thermoluminescent dosimeter (TLD)J ;-; ices are in routine use, or durino radicarachie
- p;
- he; fer permanent radiography fe;::;;; installations where other appropriate alarming or warning dev usino radiation machines. the wearing of an alarming ratemeter is not required.
@15 : Pocket dosimeters shall have a range from zero to ;; l;;;; 2 mit isleverts (200 EL'12: n:::ie;n;iico; T-Edeg) and shall be recharged at the start of each shift. E ectronic nersonal e osimeters mav entv be used in oisee of ion chamber cocket dosimeters. 2 Each film badge er ADg TLD shall be assigned to and worn by only one individual. 3 Film badoes and TLDs must be exchanced at oeriods not to exceed one month. g After reofacement. emel film badae or TLD must be returned to the su3olier for crocessino within V en endar davs of the end o" the mor sto~ino oeric c. or as soon as Dractica 3 e. n circumstances that ma(e F tmoossible to return each film Dac ce or T _3 in 14 calene ar days. such erreumstances must 'De c ceumented and availab e for review bv the Acenev. (b)."e;',;; de;:.-,;;;.;;he" b; ;;;d end emp;;.,;;;;;;;;d;d d;y Direct readino dosi,,eters such as oceket dosimeters or electronic nersonal d 3simeters. shall be read and the exoosures recordec at the becinnino and end of each shift. and records sha i be maintained en accordance with E.2.32 (c) Pocket dosimeters. or electronic cersonal dosimeters. shall be checked at periods not to exceed one - Yeer.12 months for correct response to radiation and records must be maintained in accordance with E 2.32. Acceptable dosimeters shall read within plus or minus se gg percent of the true radiation exposure. 61
PROPOSED FOR COMMENT-april 1C99 J'_ _L --J L_ __J
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-__f._. J__*__._ . w u y gy, rus g w us eurw y wesw yse a wu egw, a sie y ase a e e#w w g me wu y en ger gi gw,i yg w w ywwrswg wwyy, s so my s ye . _,s a yI rw s v s,wiss w a______ _. _ _ pas y 5, ...w., .w... .w. v.www.... g if an ir.dividual's oceket losimeter is found to 13e of" scale. or if 1 is or her elec9 tonic cersonal 1 dosimeter reads arente'than 2 mi I sieverts(2OO enremL tie incividual's film andoe or TLD sia I be sent for orocessine within 24 10t. rs.11 me dition. the inc ividual rr av not resume work associated wit 1 the use of sources o' radiation unti ac ete rminat'on c f t e indivic ual's radiation exoosure has been made. This i
- SC or tie 3 50's desionee. The results of this determination shall be f
determinatica must b e made bv t e included in t le recort s maintainec in accordance with E.2.32. g I" a film b doe or TLD is lost or damaaed. the worker sh n!! ces se work immed atefv until a reolacement i . ) s orovided and the exoosure is cateutetee for t1e time oeriod " rom issuance to foss or film bac ce or T pemece e,f ine film reece or TLD The results of the cet uteted evoosure end the time ceriod for which the t film badae er TLD was lost or demaceo shell be included in the recordsmeintainedin ectordance with E.2 3 2 th; A;; ;, i a,e..f yD Reports received from,the film badge or.T, LD processor shall be kep; ier b;p;;;bn b,y__.. _. ____ a_s___ am J m. __m _, m __ a-m _ _ _.__ _ _ _ _ _ _ m _u e_ u_. J t 3w wwe we w5 wwse J ywtw T4 w h w w W u s D Igp tir u u w tr ump.a sg g p u sw i, ww ys w y g ,wu 4 yv v y w w 6 ey as a s a u I sa wasteIwsasw e 5 5 sir u e w u ry.Fw W w 8 u retained in accordance with E.2.32. ifugl Each alarm ratemeter must: (1) Be checked to ensure that the alarm functions properly (i.e. sounds) prior to use at the start of each l shift; j (2) Be set to give an alarm signal at a pre-set dose rate of 5 millisieverta (500 g33 in::Sreen;;;n; M.20
- 47*-gag) per hour. with an accuraev of clus or minus 20 cercent o" the true radiation dose rate; (3) Require special means to change the pre-set alarm function; and (4) Be calibrated at periods not to exceed en; y;;r.12 months for correct response to radiation.
ebr.T...:^h n pie; c:.T.:nw; 20 p;ie;n; ei ;h; ^iw; sedM;bn c'ee; re;; Lhg A;;;p;ebk se^;T,;;;;;.T.w;; i licer see or reoistrant shall maintain records of alarm ratemeter calibrations in accordance with E 2.32. E.2.13 = 'c Surveillance. During each radiographic operation the radiographer, er redbgraph;;'; eteretent shall mee ensure continuous direct yjggj surveillance of the operation to protect against unauthorized entry into a radiation area or a high radiation area, as defined in Part A, except at oermanent radicarachie installations where all entrvwavs are locked and the reouirements of E.2.16 are metet '//h; ; ;h,; high ;;db;bn ei;e b erie:p, ;d...;h ; ;;..;;el d;ib; er ek;.T. 7,;;;.T, e; d;;;i:b;d in b; , wrw. g.wr.,m. .,A w,. L_ ______L d'* 'b' 'A'h;;; ;h; h:;h ;;d: ;,e, er;; k bek;d ;; pre;; ; ege:ne;.,n.u.;heik;d er ;;; den;el ; ;;y. E.2,.14 Postina. Ne;..:;h;;,d:n; en, p;;.hbn; b "_ _e:egreph A.S,.* ',M'_, ;;;e,; ln v.h:;h ;;db;;eph,.; b;: ; .,.,__J. ,u, All areas in which industrial _____J _m_,, ____J J m. y..w....w w. ww...r,w w.., rw..w w .iw..bw W,. e... ,w m...w., "adicaraohvis beino oerformed must be connoicuousiv sosted as reouired by A.3,13(al and (b). Excenttons istec in A.3.14tb) do not anoiv to industna radiocraonic coerations. i E.2.15 Radiation Survevs ;.d C :.;; ". . i, The licensee or reoistrant shall-N' A^ k;;^ en; eeEbre;;d end ep;;ebk sed %^ka ewise, b;^..T; ^. e; ;k;;ibed b e;;;bn E.2.5 .T. b; eve:bbk e; ;h; b;.e;;en of,;;db,;;;phk,e.p;;e;;en,; v..h;n;.;; redb;;ephk ep;ce;ba; er; b;b; p;;'_;;rne._d,_ _au_ _ _ _ __ m. _ _. <_ __J ____ __ m _J m_ m. __ _. _ _ _ -. < _ _ _ _ __ _ s w us s vg i w y n.i ne b rsyw.r w i w w w w r ee w sw wwaafy es W3fw w t tirw e t w a air g w wi ge w us e w w I s i s b us II I tu8b 5 5 w r7. U b y w f u tivi a s v v s sw i n g, w g,i y w;;d iis ^ eieivg;. _ _m. __,m _._J __ J __ __ m,_ _ _, _. _ _ _ __ ___._ __ _ _ _. __._. < _ __m easw38 48 8I h8 w V tr i Ep W i 3 48wI w & 5 w I 5 6wI T&J 88 3 er 43 w' 8 Ib 8 3 4 5 8 8 hl 6 4 wb IIIw w w y a n 1, t u _ w gif 5 4 wi w 4.in tuf__ .t _. .L _ ___,b , o, J_. _~ _J t__ L___ --J _t._iaJ 'Ir L _ Iw m WW5 Y tr { vv itI a e.s u *Iw 8 W W 3 v g 3 w V I I' 4r b as y w air h51 b 6w w my 4 wa B E ii n s ee & I 8 58 h 4I vir ep t, as s m que &wwInr b 5 swe wb er a i a qw 6 w I e #b w bw a6e e a e s w a ims J _____L+_ i w; ;ws w;y;. h; ied ejiehb ; ;isye r=<IC m u_ ___em m_ __ _.__er@w;wie._N;~, ;; iTaw;; en;i ; ; i;w 'O cic r;; ei ib; led ep ep ; _, m m_ _ m. <_ a w wie. g w a as w w b W f b is u u as ey w gwwa ww gwsww a nis 3,ri, g n a s n. pwt T gyy I a a gs ey 4 II B be Iw nd b bIIw 62
5 e PROPOSED - FOR COMMENT
- APRIL 1C:9 n_t
.?L _s*L___J ._J _____Lf_ __J*_.'_ _ __ J?_ ____t'_ wyielwwrw EwwBwbrwu3 _ _ _ *_ _. _ _ _ _ _. _.. L_ ___t- ...L_ ,L l qwg - wwl wwy Tw itt s w w e s t ers es t w tp y s si.s _ L.er W8 WW 3 w y 8.Wis' J_ 8 _t___J ?. ____wwu v w y susetswisyysgg a g gwe t ww U f ewww 45 4 t u s us asi a w U 3wh J_____e__ .L_i .L- ___t_-.8 w I w AVWwwu w wt W 8Ww We y r ww WP W fI u as e & w t w g to us. er w aw tsw a w s e a sus rw E s sus t 68 Uw _s_.____ _A .L_ __a*_____t+ w W W ' _W w e,_ _e;_a au L _ __. __
- w w w w tu8 sw si e ggg yu ssw wwww yw w u n swy y.
I u si, w u s gas w was wws e.s ys w u rbb wu tr.w J_._*__ L-up tats u t u w t '# uwu er W V 8 W 98 EF 3 'n. v _._s____. - _ ___.erwuwysasysyrb w n y w w w. Y, ww y rww a s a ts e b taw _a m__ J___*___ L _._u _ _ _ __. _st_ __J._*__ _.___ __ _- wwi y w y ww, gg s eg y ywws ww ww tsw 6 yv. 6 g up 5.Iw werwIwIeswust W5 .L- ?L .L_ __E_A _I !__._It_J 55 ew I wwsus t#w8 5 wr4Fwww8 w 8wtw tr 4 tu 8se ww t rg g yys Eg vv u tu s 6 5 tWe was E w h y Frwg f u se nwrewesp _.. L_ ._l-E s twW t ww D Wu n w 3.
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- 5. rw wwt
.__Ju __t ,_i ,__t .,__.L_ L_ __ au.__ v us y u ge M ts ss w w us i y ms. usys wyi s gbig s u s.r.ww s u rg ty sw s a e w us er w s w e. sw a. t w a .L_ _...e_.___. .'L .L - w.p. w n,. _ er.w, ' L_ _u_Jf__* _L _.t_ l __i. ._efJ t a rw s w w s u n tw s u g, n y w,,,,s, s,s w wt ...w ...t.. ...b 1__ .._. _ - _ _wwer.ww ww.rwtyw.6, n-.-,.nwet ww o.wn.. wn tw w. w. n -rw w uvo W, .u rt m m sb y j t wi s ww w F W w' w ' 1 s_t _L- _*_ _t-_J'_**_- - -._-. _Ltf L_-J- _f.-- _t -J'_._L?_ __J'_**_- -_L*___ gwg n yu p y w u w Wrd s wws u b swa s wts s v w y w..wss erw. s susww as s t w u wesbu. 5 ww.wg. wys yvw w nywwwg w as wru rg 5 arts uus ttwl 3 s u s ww u u.s rb e .__n______u_ .L_. .t_ __ _ _ L u _ u a _ ms a g ar ww tws s u uss ew ts uwt ts #w s u vuswi ssu rw uw wIIs M Cenduct ett survevs with a celibreted and coerebte redistion curvev instrument that meets the recuirements of E.2.5. g Condo rt a survev of the racioorachic exoosure device and the coide tube after each exoosure when amoroachino t le device or the ouic e tube. T 1e survev must determine than the sea ed source has returned no ns s1:elded oosition before exchanoino films. recositionino the exoosure lead or dismant inc eautoment. Rac iation machines shal e surveyed after each exoosure to determine that the machine is o' f. g Conduct a survev o" the f ac to1ra1 hic exoosure device with a ca ibrated rac iation Turvev instrument any tirne the source es exchanced anc wienever a radicarachic exeosure device is olacec in a storace area (as de"ined in A.0L to gnsure that the sealed source is in its shielded nosition. g Maintain records in accordance with E.2.33. 1 E.2.16 Permanent Rad.icarachic Installations.e.-_.t e n._ _. __Je_.___.. -...~.~.._1.._._ e._~_ t _ _ _ J a _ _e _ _ _ _ _ t.. ... ~.-_ ,_.e ___,___J ,_____L gw( hrye6b aae e v6 =. s g, I w w w hs I.# hs a w g i w y a 4 y-.
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,& 5 i s b be g,.s w a a. b b iT I w y W y & 6be c sp Ib eir i i w 15 ts wi. ly a y vv663I Wyy s4 b w w(b e w hg W 3. b. 5 s ts 4 8 b S w I 6 4 IIS yw3 6.s I e w 5. 5 be. 55 m. w. , m, n.s_ __m b V W i ba . _ a _. ____ 2 _._____t ____v-___ .t .t_ ___,.__t,_ l a. J rb b b he wb I6.bb. y wIs. IV 6 t,. w w n n, w b ba VI Eb y n, w. hw b V i. f y r 44. Ik b yW#6ss
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y y b.. w ws w4 6 yv w y w w. s w s. n, i a i s., is v w s ts.s 6.w e 4 e e _ L u...b...,w,.,,.m...J.._._.*.._._.-_2_. m....a _ ? _ a. t. =w s_. t _. _ _ _ _.- b...r.z..... 6..b _____m_ _, s. sti ,,, w W _.a .L_ .t_ __a iw, m b.... .s.. .,,. r. e _. .byob...b.... ....., rp,. i j I r4t Pt_ _m ____t_ L_ _ _.
- J _ _t
.?L _'.L_ E*I_ L _f _ _ __ _ .L____t ___m J_*__.__ __J br y b. am,b i. i g y b. iiir V. I B s. 4,. gI l a. s w.P h wb yu w v rww w b 6 t s Ib 4 w 5 554 e s V. W ..o,.. v,v i b l E w w W y b. .. s b a i s t w. w i s s u s u. v b b. 4 6 w w.p s. t. b 6 3r 3 w3.W . b y...... e. b .t_....s____a ?.._.._r_w__..__u.. t. b 6 ...,6. wb so.6W...- ..... w, 6. ,,, s...b 1 ,mi _____.____tu,b6 ____m, m..e.. b, t... _ _ _.. t _ n.. y_ b.... ?. __.,. n...a -....J _. v ___ _.. _. _ _.s....t. __t ?._..x_*2.._, t, w_ _ m w... ..w 6 w.s. 6. .r w bo r, .w, r.b... _____.u_____-.,4h__ _s__.t_ ___?. __at__ _a_ _ _ _.. _su_. _.*_ __u.L_ _s_______._~__;______.____ .#, m w.,,,., _a a er b to. V w w w %# w y y w e II 3d 6 I w b 6 5 V..W # 4 5 6 iib V y b..s b II 8 g y s w be b w hs. Ein p 5V4 6s 8b wI 4 6.s B. bs.ewW W to. 4. V e ser bi w.b n.s na w. E r yb ble a. neb u.. _.. _ _ m____J_ L*_t a_____- _____t____ .t .t u ___t________
- _t_e, L_
___._u__s assp ytobeElVI5 Wy .aIb (7 g b 8.b y_ ___..,b2.I v. se 6..s 6 b__ u _ .t__u_a m..L_ . e w a.,ge_ _ _ _ _.r w..s g i.s y.t
- s. W.__
vs e U6W WGbo . E b.* W 3 .hs er_ _ _ _ _ ts w e s u p a s.s 6rne b y v s 6.. t u. r eip s er i..s i. wb g s s w s. s 6.s s s a ge w V W 3 8 5 he e. tr _m WI 8 Lsa gs. eir yw e i 6.w I a sg w w 6 s.w .6 g, gs wy my sb o gb4.b y e , m i.ya _ ___ 1..__ _ _ _ _ _. = _ _ __su__ .r m s..t o t ......,..a__a_ _t __t ,b.6. . r,wrm __t__ r r o b t t _. 7 ___e__ w.w6.... ...s ...-,v, r.......,...,b,b t_ __a ._.__1 __a _ _ _ _ _ u _ _s u _____J____ -,b, ....t w..e Mi e mit t -b .....s m. b ..W .b..- w,. w.s.. m i ,.L. .. u ___. _un ___,___ __ _ _, __. _. u.__._,_ _ _.._ - - - b,2 2_____u_ i i,,. ..b .....s,.. ,... w o r m. w.... w.. ....s..w.., W6 ......w.. 6. ~ 6m ...o ~ ___k- ......n..m a. e..s. t -- ___ t u__ j .t .w........w.~. .....b .b,f....... ,_t r= _ _.
- E
- _ ; _ _ t u _. v _ _. _.. _ __ _. _ t _ v e t _ ___._._?__a
_____e____ e r-m enen an__t___ _a-- a, o w. s...s.. s.b ms.u. g, v,, s yi s u. s b t, y v .L m e. Ibd tw b i 6.. < b w te w & 4. s b 6 s% i w y e y er b b 4 e e t s.s a. wb s
- 6. I a.
i,. a e a y g. v. m v ws..bwa y.8W8 u__ t ___ _____m e e e,_ t___ Wyye w w wa u..s e br w b s I g I.e s e E b W a.a J 65lb D g b I Ib y y hs e W w w a u 6.W me 5 e m. g w # w4 6 8.h er b 8 b, h8. w 6 s w p I @ e M Each entrance that is used for eersonnel access to the hiah radiation area in a nermanent radicarachic ,msta lation shall have either: 63
PROPOSED - FOR COMMENT-april 1999 Q An entrance control of the tvo r describedin Submaracraoh A.3.4 fall 1)that causes the radiation level uoon entry into the area to be ree uced or g Both corsoicuous vis'ble ar.d audible warnino sionals to warn of th! oresence of radiation. The vistle sional must m actua ed av rac iation w ienever the source is exoosec or the rv achine is eneroized. ~ 1e audible siona must 3e actuated when an attemot is made to enter the insta atton whi e the source is ) arcosed or the machine is eneroized. The alarm systerr must be tested for orseer coeration with a radiation source each dav before tre insta. ationis used for rac iocraohic Soerat ons. 'he test munt include a chec ( of both th e visib e and audi 3e sions s. Entrance control devices t ist rec uee the radiation eve uoon entry (desionatec in caraoraoh (a)l I of this sectioni must be tested monthlv. If an entrence r ontrol device or en sterm is coerattne tmoroneriv, i it must be immediatelvlabeled es cefective end reostred within 7 calender devs. The f acility mev continue to be used durino this 7-dev Derted. or Sveded the licensee or reoistrant imolementsthe continuous surveillence recuirements of E.2.13 and uses En a armilo ratemeter. Test records for entrance controls and audible and visual alarm must be maintained in accore ance wit 1 E.2.29. E.2.17 Records Reoulred at Temocrarv Jobsites. Each licensee or registrant ;;nd.;;:n; :nd.;;;;d
- ed;;;;;ph e;
- . ;;.T, pere:i d;; ;h;ll he.; th; fd;;.?ng i;;;rd;isd ;.b ; fer ;n;p;;;;;n b, th; Agenci gbgkl i
maintain et. rrent cooles of the followino doeurr ents and records sufficient to demonstrate comoliance at each monhenble ' ie d station and each temocrarv io 3 site: (a) Appropriatelicense, certificate of registration or equivalent document authorizino the use of sources of radiation. (b) Operating and emergency procedures recuired by E.2.31. (c) App ll;;bl; ;;; e; en; A conv of these reculations. (d) 0.. se, i;;;;d;i;ged p.;;.;n; ;; C.2.15 f;; ;h; p;;;;d of ep;;;;;;n et ;h; eh; Survev records as recuired by E.2.33. for the oeriod of ooeration at the site. (e) OC p;;k;; d;;:.T.;;;, ;;;;;de for ;h; p;;;;d of eper;;;;n ;;;h; eh; Records of dosimeter readinos f ag reouired by E.2.32 'fl Th; le;;;; :n;;. n;n; cd:bre;I;n end l;;k ;;;; i;;eid fer ;;;df;; dei:;;; in.;; ;; ;h; eh;. Ae;;p;;b ; i;; erd; :nd.d; ;eg; er lebd; vsh!;h er; effied ;; th; d;v;;; er ;er.;,.T.;;;;. Q Utilization leo for each source of radiation disentehed from that location as recuired bv E.2.8. g Records of coulement eroblems identified in dailv checks of eauioment as reouired bv E.2.28(a): g Records of starm system and entrance control cheeks reouired bv E.2.29. if neoficable: $ Evidence of the latest calibration of the radiation survev instruments in use at the site. as recuired bv E.2.25: 3 Evidence of the latest calibrations of alarm ratemeters and coerabilitychecks of dosimeters as reouired by E.2.32 g The shiocino nacers for the transoortation of radioactive materlats reouired bv 10 CFR 71.5: and When coeratino under ree oroeitv oursuant to Suboart C.6. a coev of the acolicable State license or certgi sente of recistration. or U 5.Nuclear F ecu atorv Commission heense authorizino the use of sources of LLtA1!.CLrg E.2.18 Performance Reauirements for Radioornehv Eoulement. Equipment used in industrial radiographic operations must meet the following minimum criteria: (a) Each radiographic exposure device. source assembiv or sealed source. and all associated equipment must meet the requirements specified in American National Standards institute (ANSI), N432-1980 64
l PROPOSED. FOR COMMENT-april.1C99 ' Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography"(published NBS Handbook 136, issued January 1981). (b) in addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices. source chanoers. source assemblies and sealed sources end
- d ;&.pa.en;
(1) The licensen shall ensure chat each radiographic exposure device n.;; hrs; gg attached to it tv the weer, a durable, legible, clear y visible label bearing the: (i) Chemical symbol and mass number of the radionuclide in the device; (ii) Activity and the date on which this activity was last measured; (iii) Model n.n.L;; or oroduct code and serial number of the sealed source; (iv) Manufacturerh of the sealed source; and (v) Licensee's name, address and telephone number. (2) Radiographic exposure devices intended for use as Type B transport containers must meet the applicable requirements of 10 CFR 71. (3) Modification of eny exposure devices. source chanoers. source assemblies and associated equi ' is prohibited,unless;h; da:gn ;f sai ;;p;en ;.en;;;m.penen;,.n;: ing ;;.;;e he:d;;, e;.;n ee;;pment n.bl p, an;;;;; e; g. d; ;. bee,..; 'd ne; an.prem.:ee the ds:sn nfri fu;.;;; ef :h; ei;;;c. accroved bv the Aaenev er other acoroval bodv. {c) In addition to the requirements specified in paragraphs (a) and (b) of this section, the following requirements apply to radiographic exposure devices. source assemblies and associated equipment that allow the source to be moved out of the device for ;;.;:n; sp;;;;.en radicarachie coerations or to source chanoers: (1) The coupling between the source assembly and the control cable must be designedin such a manner that the source assembly will not become disconnectedif cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions. (2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released Ly means of a deliberate operation on the exposure device. (3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportationto protect the source assembly from water, mud, sand or other foreign matter. (4) Each sealed source or source assembly must have attached to it or engraved in it, a durable, legible, visible label with the words: " DANGER RADIOACTIVE". The label must not interfere with the safe operation of the exposure device or associated equipment. (5) The guide tube must hrs; ps;;d th; ;;.;h:ng ;;;;; fe; ;h; sn;;;;;.b; a ;pa:f;;d in."NC MO2 end be able to withstand a crushino test that closelv nooroximates the crushina forces that are likelv to be encountered durino use. and be able to wrt1 stand a kinking resistance test that closely approximates i the kmkmg forces likely to be encountered during use. (6) Guide tubes must be used when moving the source out of the device. (7) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during radiographic cperations. (8) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432;.1ER.Q. 65
i PROPOSED. FOR COMMENT. APRIL 1999 (9) Source changers must provide e system for assuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source Cssembly. Mi".Mm -M9-Gi+dt+94E;fM&i"i;"'++":"W=*=== (eg All radiographic exposure devices and associated equipment in use after 10 January 1996 must 1 comply with the requirements of this section. i g Notwithstandino caracraoh f a)(1) e f this section. eouiement used in indt strial radicarachiecoerations 700d not ecmciv with See B.9 2(c) 0" the Endurance Test in American Nationel Standards institute M3219EO. if the orototvoe eautoment les been tested usino e toroue value terresentative of the tercue j 2has an in dividual usino the radicarachv ecutoment can realittical v exert on the lever or crankshaft of the drive mec ianism. i E.2.19 Raoorting Raoulraments, j (a) In addition to the reporting requirements specified under other sections of these regulations, each j licensee shall provide a written report to the Agency within 30 days of the occurrence of any of the following incidents involving radiographic equipment: (1) Unintentional disconnection of the source assembly from the control cable; 1 (2) Inability to retract the source assembly to its fully shielded position and secure it in this position; (3) Failure of any component (critical to safe operation of the device) to properly perform its intended functiong g An irdicator on a radiation machine faiis to show that radiation is beino oroduced. an exoonure switch f ai s to terminat e oroduction of radiation when turned to the off oosition. or a saf etv interlock " ails to terminate x-rav orocuction. paragraph (a) of th,ee gLiggigggi shall include the following information in each report s (b) The licens is section: (1) A description of the equipment problem; (2) Cause of each incident,if known; (3) Name of the manufacturer and model number of equipment involved in the incident; (4) Place, time and date of the incident; (5) Actions taken to establish normal operations; (6) Corrective actions taken or planned to prevent recurrence; ggl (7) ggggg,ggl qualifications of personnel involved in the incident. (c) Reports of overexposure submitted under Section A.5.14 of these regulations which involve failure of safety components of radiography equipment must also include the information specified in paragraph (b) of this section. g Anv licensa!e or "eoistrart conductino radioorachic coerations or storino sources of radiati3n material a? any location not iste: on the scense and/or certificate of reoistra tion for a negod in excess o< 180 cavs in a ca encar year. thal notify the Acenev orier to exceedino the 1 BO davs. I E12g ppnductina industrist Radioarachie ooprations. 1 66 l
PROPOSED FOR COMMENT april 1999 gj W1enever ra,dicaraohvis cerformec at a location other <than a o ermanent radicarachieinstallatic'n.the radicarao ler must 3e accomoanied bv at east cne c'ther ou t ified racioaracher or an individulfl who las at a rr inimum met t 1e recuirements of E.2.10(c '. T:le at ditiona cualified individual sha !! o 3 serve t le coeratiois anc be ca 3a ble of Drovidir c' imme diate assistance to orevent unauthorized entrv. Raciocraohv may not 3e cerformec i~ ontv one cua r ied inc ividual is cresent. gj All radicarachic coeraticrs shall be conducted in a cermanent radicarachie installation. unless l otherwise soecifically autnorizec av the Acenev. l g Exceot when ohvsicallv imoonsible. collimators shafi be used in Industrialracioorachie coerations that use radicarachie exoosure devices t 1st allow the source to be moved out of the c evice. g A licensee or recistrant may conduct lev-barce. effshore of atform. or underwater radiocrachv enly if crocedures hPve been eneroved bv the Acenev the U.S Nuclear Reculatory Commission er enether Aoreement State. g At a job site. the followino shall be sucolied bv the licensee or reoistrant: $ At least one coerable. calibrated survev instrument for each exoosure device or radiation machine in M12J Q A current whole bodv oersonnelmonitor (TLD or film badoe) for each cerson cerformino radiocrachic l M l @ An coerabfe. calibrated ocel<et dosimeter with a rance of zero to 2 millisieverts (200 mrem) for each eerson cerformino radicarachie coerations: $ An coerable. calibrated. alarmino ratemeter for each eerson oerformino radicarachic coerations usino a radiocraonic exoosure device: and g The soorocriate barrier reces and sions. Qf Each radicaracher at a iob site shall have on their eerson a valid certification ID card issued bv a certifvino entitv. g indurtrist radicarachie coerations shall not be cerformed if any of the items in E 2.20fe) and E.2.2O(f) re not avai able at the tob site or are inocerable. Uh Durino en insoection. the Acenev mav terminate an coeration if env of tBe items in E.2.20Ie) and l E.2 20tfi are not available or coerable. or if the r ecuired number o' radiocrachie oei,onnel are not oresent. j Ooerations shall not be resumeo until a i teouitec conditions are met. l @ Radiation Safety Officer for Industrial Radiooraehv. The RSO shell en sure that radiation safetv l activities are beino Derformed in accordance with accroved crocedures anc reau atory recuirements in tne dailv coeration of the licensee's or reoistrant's crocram. g The minimum oualifications.trainino. and exoerience for RSOs for industrialradioaraohv are as follows: $ Comotetion of the trainino and testino recuirements of E.2.10f a): g 2000 hours of hands-on exoerience as a cualified radicaracher in industrial radicarachie coerations: SD$ 3 Formal trainino in the establishment and maintenance of a radiation erotection crocram. gj The Acenev will et,nsider alternatives when the RSO has accrooriste trainino and/or exoerience in the field of ionizino radiation. ano :" addition. has adeounte formal trainino with resoect to the establishment and maintenance of a radiation safety orotection orocram. M The soecific duties and authoritici of the RSO include. but are not limited to: 67 l m
1 i PROPOSED FOR COMMENT-april 1299 i Q Establishina and overseeine all coeratino. erleroenev. and ALARA or 3cedures as reouirec bv Part A of t 1ese reau atio,s. and raviewino t iem reaular v to ensure that thev con' orm to Acency reou ations and to t se license anc lor certi~icate o" reoistration conditions. l g Overseeino ani soorovino all chases of the trainino orooram f 3r radicarachic cersonnel. ensurino that anorooriate anc e"fective radiation orotection oractices are tauc it: I g Ensurino that reouired radiat on survevs and leak testn are eer' rmed and documerted in acco' dance i o with the reaulations. ine udino any corrective measures W1en leve s of rac intion exceae estabicshec limits: g Ensurino that eersonnelmonitorino devicen ere calibrated if moolicable and used orecertv;that records ] are Weot of the monitorino results. and that time v notncations are made as reouired 3v Part A of these reculationst end g Ensurino that coerations are conducted safelv and for imolementino corrective actions includino terminattna coerations. Q L*consees and reoistrants will have until 27 June 2000 to meet the reouirements of onraoraoh (a) or l 3. o~ t iis section. L2,22 Suoervision of Radiocrechers' Assistants. Tie radicaracher's assistant shiilbe under the eersonal suoerv'sion of a radicarac 1er w ien t.sino sot'rces o" radiatier or cor c uctino radiation eurvevs reautred bv E. 2. ' 5' b) to determine that the sealec source las returned tc t le shie ced nosition or thE cadiation machine is of" after an exoosure. The oersonal suoervision must inc ude: g The radiocracher's chvsical oresence at the site where the sources of radiation are beino used: g The availabilitv of the radicaranher to oive immediate assistance if rech l M The radicaracher's direct observat'en of the assistant's cerformance of the coerations referred to in i this section. fM Ree 3rds for Industrial Radioormohv. Each licensee or reoistrant shall maintain a conv of its icense /certi scate o' recistration documents incorocrated bv reference and amendments to each of these tems until suoerseded bv new documents accroved bv the Acenev. or until the Acency terminates the icense and/or certificate of reoistration. L214 Records of Recelot and Transfer of Sources of Radiation. g Each licens+e or reoistrant shall maintain records showino the receints anc transfers of sealed sources. devices usino DU ' or shieldino and radiation machines. and retain each record ' or 3 vears a"ter it ts made. M These records must include the date. the name of the individu n!'makino the re ord. radionuclide. l num ber of becouere s (curies) or mass ' "or 3 J). and manuf acturer. mode. and serial num 3er of each source c" radiation and/or cevice. as anorocriate. gg Records of Radiation Survev Instruments. Each licensee or coistran" shall maintain records of the ci ibrations of its radiation survev instruments that are reouired under E2.5 anc retain each record for 3 vears a"ter it is made. Records of Leak Testino of Ses let Soure as and Devices Cont minino Deoleted Uranium. Each licensee a al mailtain records o" leak test resu ts "or s na ed sources and for cevices conta nino DU. The results must be statec in units of becouerels (microcuries).The licensee shallretain each record "or 3 vears af ter it is maae or until the source in storace is removed. M Records of Quarteriv Inventory. 68
f l PROPOSED
- FOR COMMENT april 1299
' g Each licensee or reoistrant stait maintain records of tFe cuarterly inventerv of sources sf radiation. includino devices containino c eoletec uranium as reouired by E.2.7 and retain each recort "or 2 vaars a"ter it is made. i g T1e record musc include the date of the inventerv. name of the indiv dual conductine the nve,torv. rad onuc ide. num 3er o' becouerels (curi n ) or riass (for DU) in each c evice. oc ition of sources o"raciation anclor devices. and manufacturer, mot e. anc serial number of each source o" radiation and/or device. as g Records of insonetton and Maintenance of Radiation Maelines. Radicaraohle E roosure Devleen. Transson and Storace Containers. Associated Eauioment. Source C ianoers and Survev natru.-..ts. g Each licensee or reoistrant shall maintain records soecified in E 2.8 of eeuioment eroblems found in daily checks and cuarteriv insoections of raoiation rischines. radicarachte exoosure devices transoort end storace containers. asse rvated eouiement. source c ianoers. and survev instruments. Eac 1 record shall be maintained for 3 vaars a"ter it is made. g The record m ust include the d ate of check or insoection. name of inso nctor. eouioment involved. any orobTems found anc what recatr anc lor maintenance. if anv. was nerformec 1 fg Records of Alarrr' Svstem and Ent4ance Controlchecks at Permanent Radicarachicinatallations. Each icen see or rearstrant s na i maintain recore s of a arm syst em and entrance control device tests reautred unc er E. 2. ' 6 and retain each record for 3 vears after it is mace. @. Records of Trainino and Certificatie n. Each licensee or reoistrant shall maintain the followino records (of trainino and certification) for 3 vears a"ter the record ts made: g Records of trainino of each radicaracher and each radicaracher's assistant. "he record must include rad,cara Sher certification documents and verification o' certification statu t. cocies o' written tests. dates o" ora anc oractic al examinations. names of and vidualo conc uctino anc receivino the oral and oractical j examinations. a ist of items tested and the resu ts of t qe era and cractica examinations? and g Records of annualrefresher safetv trainins and semi anntalir soections of iob eerformance for each radicaracher and each radicaracher's assist 1 tnt. T 1e recen as must ist t 1e teoics discussed dur no the refresher saf etv trainino. the dates the annL a refres ler safetv trainino Was condL cted. ind names 3" the instructors anc attendees. For insoect ons 04 iob oerforman ce. n ie records must a so ine ude a list s 10 wino the items checked a,nd any non-como rances observed bv t le F 50 or desionee. Cooies of Ooeratino and Emeroen:v Procedures. Each licensee or racintrant shall maintain a conv e current oceratino and emeroency orotec ures until Mhe Acency t ermiriater t ie scense and/or certificate of reoistration. Suoerseded material must be retatned < or 3 vears a"ter11e c iance is g @ Records of Personnel Moni'torino Procedures. Each licensee or reoistrant shall maintmin the fellowino exoosure records soecified in E.2. ' 2: g Direct readino dosimeterfendinos and vaarly coerabilitv checks reouired bv E.2.12(b) and (c) for 3 veers after the record ts made. g Records of alarm ratemeter calibrations for 3 vears after the record is made. M Reoorts received from the film badoe or TLD orocessor until the Aaenev terminates the license and/or certTscate of recistration. i g Records of estimates of exoostres as a result of off scale eersonal direct readir o dosimeters. or lost or damaced film badoes or TLDs. unti the Aaenev terminates the license and/or certi"icate of recistration. 69
PROPOSED FOR COMMENT APRIL 1M9 g Records of Radiation Suruevs. Each licensee or reaistrant shall maintain a record of each exoosure device survev cond Jcted se"oret le devi:e is olaced in storace as soecified in E.2.15(c). Each record must l se maintained for 2 vears a"ter it is mac e. E.2J.4 Form c f Records. Each reecrd reauired bv this suboart must be leaib e throuohout the s 3ecified retention oerioc. TPe record mav 3e t le oricina or a re stodJCed conv of a micro"orm croVided that t le conv o' microform is aut ienticated bv aut lorized oersonre anc that the rlicroform is caoab e of recroc acina a e ear conv ':hro Jabout "he reauired retention ceriod. 'he r ecord may a so be stored in electronic mec ia wit,
- ,e cacabi lty "or orocucina leaible. accurate. and como ete recorc ; durina the reauired retention oerioc
- ecords. sue 7 as letters. crawinas, and soecifications.mustinclude a' certine nt inf ormation. such as stamos.
inmals. and sienetures The licensee or rea'Strent shell maintain adeauste sa' ecuerds sceinst temDerino wrto anc loss of recores, g Location of Documents and Records. J Each licensee or renistrant shall maim _ n cooies of records reatired by this suboart and other noe icable carts of these reculations at the location soecified in C.5.3(cH1W. g Records shall also be maintained at each nonlicable field station and each temocrarv iobsite. as soecified by E.2.17. E.4 WIRELINE SERVICE OPERATIONS AND SUBSURFACE TRACER STUDIES ) E.4.6 Radiation Survev instruments. (a) The licensee or registrant shall maintain eeff ;,;n: A calibrated and operable radiation survey instruments at each field station and temocrarv iobsite to make phr;;;e radiation surveys as required by this part and by Section A.3.2 of these regulations. Ine:.inen:;;;;n ehe:: b; ;;pebl; cf rn;;;.r:ng 0.1 rn ll:reen:g;n l25.0 nene;; :; cab;/kg; p;; hour :hrough st l;;;; 50 in :::i;;n;;;n; l12.0.T:;rece le.Tbelkg; p;r hour. 0 rver n;;r T.;n;e e;qu;;;d b;fer; 1 A.;;;; 1001 end cepeb ; cf.T;;; r:n; O.1.T:l::re;.n: gen (25.0 nene;;u:;rnba!kg'per hour :hre sh e: ;es: 20.T.::::reen g;no l5.10 in:;re;; :;.T,be/kg; p;r hour ;l;; ee;;sf:;e :his r;qu;r;.T,;n un;;: 1 Aug e: 1000. To satisfv this recuirement.the radiation survev instrument must be cacable of measurino 0.001 mSv (0.1 mrem) Der hour throuah at least 0.5 mSv (50 mrem) oer hour. [ REMAINDER OF PAGE INTENTIONALLY LEFT BLANK) 70
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-s PROPOSED = FOR COMMENT-april 1929 P RADIOGRA .C r 1FICATION I. Renuirements for an indeoenderg Certifyina Ornanization An indeoendent certifvino oroantration shall:
- 1. Be an o'onniranion such a a a toeiety or association. whose members carticioatein. or have an interest in. the "ie da o" ine ustria rac inorachv.
- 2. Make its membershin available te the eeneral oublic nationwide that is not restricted because of race.
color. relioion. sex. ace nations orioin or disabilitv.
- 3. H' ave a certification crocrem coen to nenmembers. as well as members.
- 4. B e an incorocrated. nationalh' recoonized oroanization. that is involved in settino national standards o' oractice within its fields o" exoertise.
- 5. Have ar adeounte staff a viabic system for financinoits ooerations and a ooliev and decision-makino review soard.
- 6. Havo a set of written c roanintional bv. laws and oolicie i that orovide ad ecoate assurance of lack of cent ict of interest anc a system for monitorino and en' orcino those bv. aws and coltetes.
- 7. Have a committee. whose members can carry out their resoonsibilities imoartiallv. to review anef
. acorove the certif! cation ouicelines and erotecures. and to advise the oroantration's staff in imolementino the certification orocram.
- 8. Have a committee. wl'ose mem bers can carrv out their renconsibilities imoartiallv.- to review comelaints soainst certi~ied indivic uals and to determine nocrooriate sanctions.
- 9. Have written crocedures describino all asoects of its certification eroarim. maintain records of the current status of each individua
's certification and t ne administration o' its certification orcoram.
- 10. Have orecedures to ensure that certified individuals are orovided du e crocess with reso eet to the acministration of its certr # cation crocram. 'ncludino t ne orocess o becomino certifiec and any sanctions imoosed moninst certifiac individus s.
- 11. Have orocedures for oroetorino examinations. includinn cualifications for oroetors. These orocedures must ensure that t le inoividuals croctorino each ex'imina tion are not emo oved bv th e same comoanv or corocration (or a whollv-owned subsidiarv o' suc 1 comoany or corooration
. as any of the R.E. RED 1D. CAL
- 12. Ex thance information about certified indiv' duals with the U.S. Nuclear Raoufatorv Ce mmission other
, inc ecendent certifvino oroontrations anc /or Aareement States. and allow cerioc ic review of its certification crooram and te sted records. __L13. Provide a descriotion no the U.S. Nuclear Reculatorv Commission of its orocedures for choosing examination sites and "or orovidino an noorooriate examination environment.
- 11. Reauirements for Certification Proorams All certification 'orocramsyg
- 1. ' Reouire anoticants for certification to:
(a) Receive trainino in the teoics set forth in E.2.10foi or eouivalent reculations of the U.S. Nuclear
- Reculatorv Commission or another Aoreement State: and 72
)
PROPOSED - FOR COMMENT april.1999 ib) Satisf actoriiv remolete a written examir ation coverino uhes e tooles. 2. F eauire ano icant s "or certificationto orovide c ocumentationt 1st c emonstrates that the nonlit. ant has: (a) Received trainino in the tenies set forth in E.2.10fo) or mouivalent Aareement State reaulations: (b) Satisf actorifv comoteted a minimum neriod of on the-iob trainina soecified in E.2.10fa ); and (c) Received verificationbv a State lic ensee or reaistrant or a U.S. Nuclear Reaulatorv Commission icensee t ist the anolicant 1as c emonstrated the canabt itv of inc emendentiv workina as a radicarao ler.
- 3. Include crocedures to ensure that aff examination cuestions are orotected from_ disclosure.
- 4. Include crocedures for denvino an acetication. revokino. susoendina. and reinstatino a certificatien.
- 5. Provide a certification eeriod of not less than 3 vaars nor more than 5 vears.
- 6. Include crocedures for renewine certifientions and. If the orecedure r allow renewats without examination. reouire evidence of recent fu time emolovment anc annua refresher trainino.
- 7. Provide a timelv resoonse to inouiries. bv tefechone or letter. from members of the oublic. about an individuars certi-ication status.
til. Reauirements for Written Examinations All examinations must be:
- 1. Desianed t 3 test an individuaf's knowledae and understandina of the tooics fisted in E.2.10(al or soutvalent 'J.5. Nuclear Reaulatorv Commission and/or State reouirements.
- 2. Written in a multiole choice format.
- 3. Have test iteme drawn from a nuestion bank containina osvchometricallvvalid ouestions based on the rnaterial in E.2.10(o).
eee [ REMAINDER OF PAGE INTENTIONALLY,LEFT BLANK) 73
f pnoPosED - FoM COMMENT-april 1299 .PART F X-RAYS IN THE HEALING ARTS me. ee. I F.2 GENERAL REQUIREMENTS FOR ALL HEALING ARTS FACILITIES I F.2.3 (a) Individuals who will be operating the X-ray systems shall non ses i a eu rent lica ine in necordance wit 1 the RJtes and RoSulati3 a f r t1e Licensu'e sf Radicorachers. Muc ear V edicine ~echno ooists aind Hac satior' ~ lersoints 15 6 i EAE ' o" the Rhoc e sland Eenartlient of Hea i1. Jn est the individua is soecifica tv exemoted ' re'm icensure 3v Section 6.0 of saic reou atio ns. Indivic us s who wi I 3e coeratina the X rav systems and wie are nc,1 subrect to licensure under R5 68. RAD shall be adequately unstructed in j i the sete operating procedures ena be compartent in the safe use of the equipment. As a minimum, such i.n.st.ruction shall consist of subjects outlined in Appendix B of this part. j i F.2.10 Procedures and auxiliary equipment designed to minimize patient and personnet exposure commensurate with the needed diagnosticinformation shall be utilized. This is interpreted to include but is 1 n.o.t. limited to: (e) X rav Film Develoolno Raoulrements. Compliance with this paragraph is required of all healing arts registrants and is designed to ensure that the patient and operator exposure is minimized and to produce o.pt.imum image quality and diagnostic information. j2; ". t n. d "; x d.; ef ""n.;. T; n,; ;h;:: b; p;;;;;;;d ;n ;.;h ;
- na;;
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j d;.;;;pn.;;.;.e ;h; ;;n.; ;;..e d b; e;h:;.;d bi prep;; edheren ; te 0 bs;;egieph M l ;be.; ln en.e p;e;;e; ns'.." e ;.T.:n'T. m., ;h; e ;;c.;;.; p;;;;;;;; ;h;!: b; ep;;;..;;;d ;; pree;;; f;:a.; in e;;;; den;; i ..:;h ;h; ;-.;n fe;; rei ; ep;;;f;;;;:ene. i (2) Automatic Processors and Other Closed Processino Svstama. (i) Films shall be stocassed in accordance with 1he time temoerature relationshios recommended bv i the film manu"acturer commensurate with tle automatic orocessor and chemistrv in use and fii) The noecifie develoner temocrature and imrrersion time shall b4 nosted on the automatic crocessor.
- or automatic orocessors canable o" two or more ore se ectab e settinos. the costino gh ticiude both a descriotion of each orocessor evele settino (e.o. standard. extended ract d cr evcM in seconds) and the noecific develooet temoerature and immerston time associated wit int orocessor evele settino.
1 t if; P;;;;; ;;f; :;ht; ln ;;;.;;d;n;e..th !Ha, n.;n fe;;.;,'; ;;en.a.;nd;;:ene.;hei: b; ;;d. if t IRESERV.ED1 (h) Other Reautrements: (1) Pass b 3xes if crovided. shall be no constructed as to exclude lioht from the tiarkroomwhen cas settes - are o acec in or removed from the bries. and shal incorocrate adeounte shie dino from strav taciation to orevent exoosure of undevelooed 'i m. (2) The darkroom shall be liebt tioht and use oroner safelichtino such that anv film tvoe in use exe in a cassette to x radiation su"ficient to oroduce an ootical densitv from to 2 w1en crocessed shal not "fer an incre nse in densttv cre ite' than 0.05 when exoosed in the c su arkroo T) for 2 minutes with all s a' e lohts on. f used davitoht fi m inndlino systems 11all creclude focaino e' the film. (3) Darktc> oms tvolcativ used bv more than one in dividualshall be orovided a method to orevent accidental entry who e undevelooed films are beino handiec or crocessed. (4) Film shall be stored in e cool. drv clace and shall be orotected from exoosure to strav radiation. Film 74
NOPOSEO FOR COMMENT april.19L9 in noen nackaces shall be stored in a licht tioht contamer. l f5) Film eassettes and intensifvino scree ns siall b e insoected oeriodically and shall be cleaned and ~ reolaced as necessarv to assure radicaran is o' ococ c iannostic ouality. (8) Outdated x rav fi m shall not be used for dia anostic radicaraohs unless a samole of the film nasses . a sensitometric test ' or norma rances of base o us foo. contrast anc somed. l f71 Film develonino n utions shall be nremaree in accordance with the directions niven bv the manuf acttrer anc at la ne riaintained in s"renoth Sv re 5 enishment or renewal so that ful develooment l is accomo inhed wit iin t se time soecified 3v the manu"acturer. eee l l e#4 idy~ i;isi bei ;wnie is Og iIr; nQ iNwiiTsci ; e. U. A.$ 4 w;I. w; iy~ ebe IT,w ie! e ; ^s r r w w w.. ,_t __J _ _. _, m_ gwg w wwu f tw g wg w p Wp s tw WWn WU turw y wtTwufte ilk M_a_ _,V -..-_'__A' gwg asr u n w wi n s w y WMw3 4 uus sw erwe io I j f_t 9"..__'__i'__f_t A.__A___Af_t _'- -- L. __..A' t___t A*AE_ J___m.J AL_ m_ _L_'_
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t_ l gwg t M y n s si 's ts t r w p E g e g ws sawwguyswasagel gu r wp I wy a ww nsu aw ws sww.s giggw we ww aw aww win ag rw nw wi ya seqww wsswl 6. ru 3 _ __ v ___ _, .m ,___m _,m_ ..aw;r[w ....n.I . _ _ f_ v e w__ ___.h,h 3 5 y[w wwu weerwy y g __..a rw u s o, _ _w[ 5 w w u wh_s w y a r es s tw w t u u syg wa rw re fi e w ws sg wy w was suu r swg twv aswwoustws36 wn838634rg n Ewy5 wt tw w s 418w35 WW8w evem u p t u rv sw p rg t u s v a ts aw w rsy w w wa w p s wa 5:w w tu s swa rt w arvi6 tg ry hww h rh w ryhp ;,h,, w;ryw gIphy. num b hyyu wy 5 hr hwwwwp a E se 6 IIT r s v v w w ur n s u y fJ1 A_.. J_ .*_a*__ aL_ _a-_J-_J _____J ____?,?_J AL_ A__L_' _ L _ _a ?_ _f..J'_ _tt ___ __i gwg mu s y wtvuwnsvis si ws s u t u rw s teu m sw w s w yuwwwwwsw we eywws s ew w wiu tsyw aw w e ri uring ww bi rus be es swswwst ry wII #wywwt f_t t a dL _ _ ___l'__Ll_ .L_ %./ _ _. _. _ _
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L.-___ L_tJ ?, ___J agg siessesw WI El sw sswisawis v svawws g su mu ww w e 'h' '.'em; ef :h; :;;.;;d rie;;;,:en;; e' ;h; h;;':n; er:e eider:ng :h; ;,,;,:ne;;;a. _J m____J_ W 1;;r. fe:;..ing :h; ; em:n;;;;n ;; re;;;u u; eg re; erd; ehe" b;.T.;:n;; n;d fer ; m:n:m.,T, e' '?v;.___ ____. .L, w_..rw....___J mm _____,3,sw_,1.. r w.r w s.. _ .w...w u .wu w .....w w,.r. w. w. w wu .uw ..rw... w. .. B r. r w.. ...u. t. _ _ _ _ _ m __J m_ ..w.. .ww. ..w... v w usnuusiszwiss we narw gwg y wwi e ww y we sw bu sw w y n, ws a s s esJ wa s n y e F.2.14 X Rav Utilization Loa. fa) Excent for veterinarv f acilities. each facility shall maintain a record containino the natient's name. Lhe tvoe of examinations. and the dates the exammations were oerformed. The record shall also melude the glowino information: fil Name of the licensed oractitioner of the healine arts orderino the examination. l I (2) Namels) of individuals who nerformed the examination. f31 Anv deviation from the standard crocedure as soecified on the technioue chart. includino all recent SEEEA&imb (4) When anoticable. the cumulative fluoro on-time. \\ l f5) When anoticable. the X-rav system used. l '6) When the entient or film must be orovided with human auxiliarv sunoort. the name of the human l 491$E (b) X rav utilir stien loos shall be maintained for a minimum of five f 5' vears fo!!owine the examination or l treatment of adu t natients. Recorc8s of examination or treatment el minors shall be maintained for a 75
PROPOSED. FOR COMMENT-APRIL 1999 minimum of five (El vaars bevond the noe of maioritv. (c) If X-rav utilirationloos are stored electronicallv. records shall be maintained in a manner that will retrieval of records for anv sneerfied time ceriod. F.4 FLUOROSCOPlc X-RAY SYSTEMS F.4.6 EXPOSURE Rate Limits. The entrance EXPOSURE rate allowable limits are as follows: (a) For uncertified fluerescooic eouiement. the EXPOSURE rate at the point where the center of the usefut beam enters tne patient shall not exceeo 10 roentgens (2.58 mC/kg) per minute, except during recording of fluorescopic images, or when provided with an optional high level control. (b) For uncertified fluorosecole ecoloment. when provided with optional high level control, the equipment shall not be operab'e at eny combination of tube potential and current which will result in an EXPOSURE rate in excess of 5 ;;;n^;;ne C.20 ;,0.'k;; 10 roentoens (2.58 mC/ko) per minute at the point where the center of the useful beam enters the patient unless the high level controlis activated. . (1) Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. (2) A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed. i k; ln ;dd:::en ;; :h; e;h;; ;;4. ;;a.;n;e ef 0 bper; 5.0, cer;;id ;ie;;.T.e v.h:;h de ne; :ncerper;;; en
- u ;,T,e;;. EXPOOUCC re;; ;en.re
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fel Certified Fluoroscoole Eouinment: (1) Fluorescooie eauioment manufactured before 19 Mav 1995 must meet the reovirements of 21 CFR 1020. Section 1020.32. Paracraoh (d). J2) clacroscooic coulomen" manufactured on or after 19 May 1995 must meet the reouirements of 21 CFF 020. Section 1020.'! 2. Paracraoh (el (d) Compliance with the requirements of this section for both certified and uncertified fluoroseenie eouiement. shall be determined as follows: (3) if the source is above the table, the EXPOSURE rate shall be measured at 30 centimeters above the tabletop with the end of the beam limiting device or spece agag,gt positioned as closely as possible to the ... oint of measurement. p (5) in a stationary C-arm type of fluoroscope where an integral patient support device (tabielis provided, the entran._ce EXPOSURE._ rate sh,a,ll b,e measu. red nd;; eend:::ene of,a;;, ish;;e ;he :,,b,; he.,e:n; .m .m _mm e____ .m ........,....... m m.... , m,.. m....................,...............,.........,....,._.._._.._.2
- n;
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- ep. at 30 es ntimeters from the inout surface of the fluoroscooie imnoino assembiv. with the source cositioned at t ne minimum avai able 5 D. crovided that t le end of the beam
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c PROPOSED FOR COMMENT april 1t99 timitina device c>r soneer is no closer than 30 centimeters from the inout surface of the fluoresconie immoino assemb v. F.4.7 Periodic Measurement of Entrance EXPOSURE Rate. Periodic measurement of entrance EXPOSURE rate shall be performed by, or under the direction of, a person registered with the Agency to provide Diagnostic X-ray Physics Services. These measurements shall be performed for both maximum and typical valu:s and shall be made at least annually or after any maintenance of the system which might affect the EXPOSURE rate. Results of these measurements shall be posted where any fluoroscopist may have ready access to such results while using the fluoroscope and in the record required in F.2.13(e). Results of the measurements shall include the toentgens per minute, as well as the technique factors used to determine j such results. The name of the person, registered with the Agency to provide Diagnostic X-ray Physics Services, performing the measurements and the date the measurements were performed shall be included i.n.t.he results. J (b) Conditions of periodic measurement of typical entrance EXPOSURE rate are as follows: ) (1) The measurements shall be made under conditions that satisfy the requirements of F.4.6(d)(2)-(d)M) W and are typical of clinical use of the X ray system; .. P F.4.8 Barrier Transmitted Radiation Rate Limits. The EXPOSU RE rate due to transmission throuaF the - orimary orotective barrier with the attenuation block in the usefu beam. combined with the radiation " rom "he imace intensi mr. If erovideo shad not exceed 2 mdhroentaens (0.5 uCluo) c er 1our at 10 centimeters ' rom any necessab e surf ace of the f uoroscooic immoina assembiv bevond the o ane of the imace recentor or each Foentaeni mC/ka) Der minute of entrance exoosure rate. The EXPOSURE rate due to transmission through the primary protective barrier combined with radiation from the image b;n;$;d intensifier shall be determined by measurements averaged over en area of.100 square centimeters with no linear dimension greater than 20 centimeters, if the source is below the tabletop, the measurement shall be made with the input surf ace of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the bram limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters. Movable grids and compression devices shall be removed from the usefulbeam during the measurement. If the entrance EXPOSURE rate and the barrier transmission are measured at the same time during one activation of the fluoroscopic tube, the attenuation block shall be positioned in the useful ~ b.e.am at least 10 centimeters from the point of measurement of entrance EXPOSURE rate. T.7 Tn nAPCUT:0 X RAY OYSTraiO OT L:00 THAN ON: ai;V f.7 IRESERVEDI r.0 X nAv AN: L:OTncN Tn: nary OYSTraiO :: ai;v AN: A0cyc l 1 F.B IRESERVEDI Public Hearina Note: Subparts F.7 (existing pages F 18 through F 25) and F.8 (existing pages F 26 1 through F 41) are intended to be deleted in their entitety and Reserved. However, because of the large number of text pages involved in this deletion, only the Subpart titles actually appear in this document. ...The materialpreviously containedin these Subparts is included with the proposed addition of Part H. F.11 MAMMOGRAPHY F.11.1 Anotienbilitv. (b) In addition to the requirements contained in these regulations, all aspects of Mammography services l shall be managed in accordance with the provisions of the Rules & Regulations related to Quality Assurance Standards for Mammography (R23-1 MAM) of the Rhode Island Department of Health and acolicable U.S. l l 77 1
PROPOSED.FOR COMMENT april 1C:9 Food and Drun Mammearaohv Qualitv Standards Act (FDA/MOSA) reouirements. F.11.2 Technical Reanteements. .e (b) X-rav Svstem Renotrementa. All X ray systems used for mammographic imaging shall comply wit a.s..a minimum, the following technical specifications: e (3) The X-ray system shall be equipped with a Molybdenum target / Molybdenum filtration combination for all film / screen modalities, or Tungsten target / Aluminum filtration for xerography. Any other target / filtration combination must be ; pr;.;d in...;; ng t, ;h; Agency consistent with ecolicable FDA/ MOSA teouirements. (4) The X-ray system focal spot size shall be maintainedin accordance with the most current FDA/ MOSA reauirements. Am;r;;;n 0;";;; ef P,;d:;.lc;y lA0r.; 0:;nderde fer M;rr,megr; phi Th; X ;;y ;y;;;m ;he; ,,,hav; e fe;;: f;lm d:;;en;; ef et l;;;; 1;f;i l50; ;;n;;m;;;re. [ REMAINDER OF PAGE INTENTIONALLY LEFT BLANK) t I L l l i 78
l PROPOSED - FOR COMMENT-april 1C99 PART H THERAPEUTIC RADIATION MACHINES H.1 SCOPE AND APPLICABILITY l H.1.1 ' Purt,ose. Seone. Provisions for Research involvino Human Sublects and FDA. Other Federal and Etate Raou ramer.is. (a) Senee. This Part establistes reouirements. for which the reoistrant is resoonsible. f Sr use of j theraceutic radiation machines. "he orovisions of this Part are in addition to. and not in su 3stitution for. other ecolicable provisions o" these reculetions. (b) The use of thernoeutic radiation machines shall be bv. or under the suoervisier of. a licensed oractitioner of the 1ealino arts w10 meets the trainina/axnerience criteria establishec av H.3.3. (c) Provisions for Research involvino Human Subinets. A r noistrait mav conduct research involvira j human subiects usino trefaceutic ra diation machines orovider that t ie research is cond jete1. funcec sunoorted. or reculated Sv a Federa Acenev wh th ha s imolerr ented the Federal Poliev "or t le Protection of Human Subiects. Otherw se. a reoistrant sha ano v for anc receive ac oroval of a scecific amendmer.t to its Acenev reaistration be" ore co1ductilo sue l researc i. Bot, tvoes o" reoistrants s 1all. at a minimum. obtain informed consent " rom tie ht man subiects anc obtain orior review anc a Soroval of the research activities by an "Institutior al Feview Board" in accorda nce with the meanine o"t 1ese terms as cefined and c escribed in the Federa Do-icv for the Protection of - uman Subiects. fdl FDA. Other Federal and State Reauirements. Nothina in this Part relieves the reaistrant from com 3 vino with soolicable F JA. other ederal. and State recuirements covernino theraceutic rac tation mac 1 nes or auxiliarv devices. H.2 DEFINITIONS - Whenever used in this Part. the follovwino terms shall be construed as follows: Absorbed dose (D) means the mean enerov ir carted bv ionizino radiation to matter. Absorbed dose is determined as the cuotient 31 dE bv d VI. where c E ts the mean enerov iTinarted bv tonizino radiation to matter of mass dVI The SI unit 0" abnorbec dose is toule Der kilocram anc t ie name of the unit of absorbed dose is the crav (Gv). The orevious v used soecial unit of absorbed dose (rad) is berno reolaced bv tne orav. Absorbed dote rate means absorbed dose oer unit time. for machines with timers. or dose monitor unit oer unit time f or inear accelerators. Accessible surface means surface of eautoment or of an eouiement cart that can be easilv or accidentally touched bv Dersons without the use of a tool. Added filtration means anv filtration which is in addition to the inherent filtration. Air kerma (K) men u the kinetic enerov released in air bv ionizino radiation. Kerma is determined as the luotient of dE bv d V. where dE is the sum o" the initial kinet c enerates of al the charae d iontrina carticles iberated bv uncharaed io nizino Dartie es in air of mass dM. T 1e SI unit of air cerma is iou e oer kilooram and Mhe name for the unit of (erma is the crav (Gvl Barrier (See " Protective barrier"). Beam axis means the axis of rotation of the beam limitino device. Beam-fimitino device means a field definina co limator. 'n"earnt to the thernoeutic radiation machine which ' I Drovides a means to restrict the dimensions 01 the use"u beam. j 1 l 79
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- 'duf?;~y).
. r.x.:.u.a. . Y* Mt0 POSED - FOR COMMENT-april.1U9 g n,. t.. Ga e; W 'l E eam monitorino system means a svatem desianed and installed in the radiation head to deinet and measure t le radiation Dresent in the useful beam, B nam acatterino foil means a thin elece of mater al fusua'Iv metallie) clalced in th'a EEEm to scatter a beam o" electrons in order to orovide a more uniform e actron c istribution in t se usefu haam. Bent beam linear accelerator means a linear accelerator oeometrv in whichMin.p&h. Electron be -.. 3accelerateif. ~ must chance airection by oassino throua i a bendino maanet. .g@g.:.w.a &~:19dt.,-~: - - e s..., Chanoenble Citters means any filte' exclusive of inherent filtration. svhich enribiremoved from the useful ?eem throua, env electronic. mec ienical. or chvsicel crocess. Contnet thernov system means a thernoeutic radiation machine with a short tarcet to skin distance (TSD). usua v less than 5 centimeters. ,,j.... .y. ,f., ~~ r.. +1 ;.u;.- t w... .w Detector (See " Radiation detector"). -- ~ Dos e Eouivaient (H,1 rr enns the oroduct of the absorbed de se in tissue. crualitv f actor. and all other necessarv moc ifvino f actors at t 7e location of interest. The units o" dose eauiva ent are the Sievert (Sv) anc rem. Dese monitor unit (DMJ) means a unit resconse from the' beam monitorino system from which the absorbed pose can be ca culatec lxternal t eam radiation thernov means thernoeutieltradiationin which the source of radiationis at a distance rom the Sodv. Field-flattenino filter means a filter used to homooenire the absorbed dose rate over the radiation field. Filner means material olaced in the useful beam to chance beam ouality in thernoeutic radiation machines - su 3:ect g5u snart H.6. '3antrv means that eart of a radiation thernov svstem succortino and allowine movements of the radiation * * ' inad about a center of rotation. l3rav (Gv1 means the SI unit ef absorbed dose. kerma. and soecific enerov imoarted een at to 1 ioule oer - ci ocram. 'he orevious soecia unit of a 3 sorbed dose (radl is beino reolaced by the crav. 1 Gv ' 00 radl. Half value laver (HVL) mear s the thickness of a soecified material whic, art +nuates X radiation or onmma ta diation lo an extent such t,at the att kerma rate. exoosure rate or a 3sor Sec c ose rate is reduced to one-haff Q' the va ue measured without the material at the same Dotnt. Interlock means a device oreventino the start or continued coeration of mouiement unless certain credetermined conditions orevail. e Interruotion of irradiation means the stocoira of irraclistion with the oossibility of continuino irradiation without resettino of ooeratino conditions at t ie contro Danet. .g frradiation means the eroosure of a livino beino or matter to ionizine radiation. . y :;.. 4.. Isocenoer means the center of the schere throuch which the useful beam axis nasses while the cantrv moves throuci its full rance of motions. -... ~... -. a,.- Kilo electron volt (kev) maar n the enerov eo Jat to that scouired bv a ca rticle with one electron charoe in oasmna t,rouah a notentia dP erence ef one t lousand vo is in a vacuum. Note: current convention is to use kV' or e,otons and kev for electrons. Lead mouivalent means the thickness of the material in cuestion affordino the same attenuation. under. soecified conditions. as lead. 4 80
PROPOSED FOR COMMENT-april K99 Ms2n Leakaos radiation means radiation emanatino from the radiation thernov system exceot for the useful beam. Licht field means the area illuminated by licht. simulatino the radiation field. mA means milliammere. Meca eleetron volt (MeV) means the enecov enunt to tha t acouired bv a r a ticle with one electron charoe in oassino tirouch a oo"entia diff erence o" one mi lion vo ts in a vacuum. h ote: current convention is to use My for c lotons and VieV ' or e metrons. Monitor unit (MU) (See "Dese monitor unit"). Movino beam f adiatien thern ov means radiation theraov with any elannet disolecement of raciation field or natie nt/ human research su sitet relat ve to each other. c r with any e anned chance of a 3 sorbed dose distri 3ution. It inelades are. s on. con"ormal. intensitv moc ulation and rotational thernov. Nominal treatment distance means: f'l1 For electron irradiation. the distance from the scatterino feit. virtual source. or exit winde.w of the e ectron beam to the entrance surf ace of the irradiated obieet alona the central Exis of the use' ut beam. (2) tor X rav l' radiation. the virtual source or tarcet to isocenwr distance alone the central axis of the ul beam. or non-tsocentric couvoment. this distance shal 3e that soectied bv the manufacturer. use Patient means an individual subjected to machte oroduced external beam radiation for the ourcose(s) of medical theraov. Peak tube notential means the maximum value of the notential difference across the X rav tube durino an REQ 2 EEL Periodic ouali"v assurance check means a orocedure which is nerformed to ensure that a orevious calibratio continues to se valid. Phantom means an obieet behavino in essentia!!v the same manner as tissue. with resoect to abscretion or scatterino of the ionizino radiation in cuestion. Practica!rance of electron corresoonds to clasticalelectron rance where che ontv remainino contributic.n to 50se is from bremnstrah uno X ravs. A f urt ier erolana tion mav be "c Jnd in "Chnical Beetron E eam Josimetry: Re sort o" AAP VI Radiation Thernov Committee Disk Gro Jo 25"I Viedical Physics ' 8(1): 73-109. J,in/Feb 199' andI :RUF enort 35. ' Radiation Dosimetrv: E ectron Beams with Eneroies Eetween 1 and 5 3 N eV" International Commission on F adiation Units and Measurements. Seotember 15. ' 984. Primarv dose monitorino system means a svstem wbich will monitor the useful beam durino irrediation and which will terminate irradiation when a ore-selectec number of dose monitor units have been c e ivered. Primarv erotective barrier (See " Protective barrier"). Protective barrier means a barrier of rndiation absorbino materialis) used to reduce radiation exoosure The tvoes of erotective barriers are as to ows: f'il "Primarv orotective barrier" means the material. excludino filters. ofaced in the useful beam. (2) "Secondarv erotective barrier" means the material which attenuates strav radiation. Radiation detector means a device which. in the eresence of radiation orovides bv either direct or indirect means a sional or_ other indication suitable fer use in measurina one or more crocerties or cuantities 0" incident radiation. i { 81 i I
PROPOSED - FOR COMMENT-april st99 del Radiation field (See useful beam) Radiation head means the structure from which the useful beam amerapy. l padiothernov Physicist means an individual cualified in accordance with H.3.4. Redundpnt beam rponitorino svqtert) means a comhination gf two doge monitoripe svptpms in which myh pvstem is desioned to terminate irradiationin accordance with a ore selected number of dose monitor tmgs Seattered radiation means lon*rino radiation emitted bv interaction of ionizine radiation with matter. the interaction beino accomoanied av e chance in direction of the radiation. Scattered crimarv radiation merns that scattered f ac iation which has been deviated in direction on v by materials irradiated by tne useful beam. S neondarv dose monitorino system means a avstem which will terminate irradiation in the event of failure o' the crimarv dose monitorino system. I Secondarv orotective barrier (See " Protective barrier"). Shadow trav means a device attached to the radiation head to nunoort auxiliary beam blockino material. ~ Shutter means a device attached to the tube housino assembiv which can totally intercent the useful beam and which has a lead ecuivalency not essthant 1st of the tube housino assembiv. Sievert fSv) means the SI unit of dose eouivalent. The unit of dose eauivalent is the ioule ner kilooram. The crevious soecia unit of isose ecutvalent em) is beino reolaced bv the sievert. M Sv = ' 00 rerg Simulator frad'atientherpv simulation system) means anv X-rav system intended for localizino the volume no be exo%ec durino rsciatiop iernov anc recroducino the cosition and size of the thernoeutie irradiation olIU ~ Source means the recion and/or material from which the radiation emanates. Source-skin distance (SSD) ISee Tarcet skin distance) Statierurv beam radiation thernov means radiacion th ernov without disolacement of one or more mechanical axeste ative to the natient/ human reseach su 3inct c urino irradiation. gggggg gyp means the sum of leakaoe and scattered radiation. 'Tarcet means that Dart of an X rav tube or accelerator onto which is directed a beam of accelerated earticles to eroduce sont2ino radiation or other carticles. Tarset skin distance (TSD) means the distance measured alone the beam axis from the center of the front sur ace of tie X rav tatoet and/or electron virtual source to the surf ace o' the irradiated obiect or natient/ human research subiect. Tenth-value laver (TVL1 means the thickness of a soecified material which attenuate 1 X-radiation or onmma radiatior to a n ext ent such that the air cerma rate, exoosure rate or absorbed cose rate is reduced to one tent, of t ne va ue measured wit,out Mhe material at the same coint. lermination of irradiat on means the stoneino of irradiation in a fashion whicF will not oermit continuance ci irradiation without t ie resettino of ooeratino conditions at the control cane Theranettie radiation machine means X-rav er electron-eroducino couloment desioned and used for external beam rac intion thernov. ._ Tube means an X rav tube. unless otherwise snacified. 1 2 j 82
PROPOSEO - FOR COMMENT-april 1699 E2 Tube housino assemb!v means the tube housino with tulie installed. It neludes hich voltaae and/or filament transformers and ot1er acerooriate elements when suc1 are containec wit iin the tu 3e housino. Useful beam means the r ediation emanatino from tFe tuta housino nort or the radiation head and massin n irouch the acerture of t ie beam limitino device w1en t1e exoosure controls are in a moc e to cause tie M1eraceutic radiation mac 1:ne to oroduce ractation. Virtual source means a noint from which radiation anoents to orioinate. Wedoe filter means a filter which effects continuous chance in transmission over all or a cart beam. Wrav tube means any electron tube which is desioned to be used crimarily for the oroduction of X-rays. H.3 GENEIRA1. AD VI NIST RATIVE REC UlF Ef/ EFS FDR FACILITIES JS h G' } EF AF EUTIC RAD AT O \\ IV ACH h ES H.3.1 Administrative Controis. The rocistrant shall be resoonsible for directino the coeration of t theraceutic radiation machines which lave been recistered with the Ar,enev. The recistrant or t ie i teoistrant's a sent s 1all ensure that the reouirements o" Part H are met in the coeration of t ionef sL ie t ieraceutic I radiation mac H.3.2 A thernoeotic radiation machine which does not meet the orovisions of these reculations shall not be useo f or irraciation o' catientsthuman research subiects. H.9.3 Trainira for External I!aam Radiation Thernov Authorized Users. The reoistrant for anv the radiation mac1ine sub!ect to 4.6 or H.7 shall reouire the authorized user to be a ohvsician who: (a) is certified in: (1) Radioloov or thernoeutic radioloov bv the American Board of Radioloov: or (2) Radiation encoloov bv the American Ostecoathie Board of Radiofoovi or (3) Radiotsov. with soeeinfirst e n in radiothernov as a British " Fellow of the Faculty of Radioloov" or "Fe low of the Roval Ce leoe o1 Radioloov" or (4) Thernoeutic radioloov bv the Canadian Roval Colleoe of Phvsicians and'Suroeons or (b) is in the active oractice of thernoeu"ic radioloov and has comoteted 200 hours of instruction in basic i radiation technsoues anchenble to the use o" an external beam raclation theraov unit. 500 hours of suoervis work exoerience. and a minimum o" 3 vears of suoervised clinica eroerience. M) To satisfv the reouirement for instruction. the classroom and laboratorv trainino shall include: fi) Radiation obvsics and instrumentation (ii) Radiation erotectioni (iii) Mathematies certainino to the use and measurement of ionization radiation and (iv) Radiation biofoov. i (2) To satisiv the reau'rennt fc r suoervised work ernerience. trainino shall be under the suoervision of an authorized user anc s,a I ine ude: 83
PROPOSEO FOR COMMENT-april 1t9] M fil Review of the full calibration measurements and eeriodic oualitv assurance checks: fill Evalua" ion of orecared treatment olans and calculation of treatment times and natient/ human research mu 3iect treatment settinos: filil Usino administrative controls to orevent misadministrations: fivi imolementino emeroenev orecedures to bo followed in the event of the abnormal ooeration of a external beam radiation theraov unit or conto etand (v) Checkino end usino radietion survey meters. (3) Tc natisiv the reouirement for a ceriod of suoervisec clinical exeerience. trainin a shaft include 1 veer in a "ormal trainino 3rocram ano'c'ved be the Resicencv Review Committee "or R ac ioloov of 1 1e . Accreditati 3n Coun :il ' or Graduate V edical E ducati3n or the Co mmitnee on Postdoctora ~rainino of t ie American C'steocat nic Associationand an ac c itions 2 vears o": inicn excertenceiit 1 era 3eutic radioloov under the suoervision of an authorized user. T 1e suoervised c inica exoerience s Tallinc ude: 'il Examinino individuals and reviewino their case histories to determine their suitability for external seam radiation thernov treatment. and any limitations / contraindications: fiil Selectino oroner dose and how it is to be administered! j fiill Calculatino the external beam radiation thernov doses and collaboratino witl the auth 3rized u ter j in the r eview of natients'thurr an research su :tects;oroaress end consideration o" the neec to moc ry l oriainal v orescribed dose s anc lor treatment o ans as warranted av natients'/humanresearch subiects' reaction to radiation: anc fiv) Post administration follow-uo & review of case histories. f:) Notwithstandiro the reauirements of H.3.3f a) and H.3.3fb).the reoistrant for anv t,ernoeut c radiation mac 1ine subiect to 4.'5 mav a so submit the trainino of the crosoective authorized user c ivsician "or Acencv review on a case-bv case basis. 1 y (d) A chvsician shall not act as an authorized user for any thernoeutic radiation machine until such time as said chvsician's trainino has been reviewed and anoroved by the Aaencv. .3.4 Trainine for Radiothernov Physicist. The reoistrant for anv thernoeutic radiation machine subiect to .6 or H.7 sha i reouire the Radiothernov Physicist to: fal Be reoistered with the Acerev. under the ore, visions of Part 3 of these reaulations. as a orovider of rad ation services in t me area of cali station and como lance survevs o' external beam rac intion thernov units. S3G. (b) Be certified bv the American Board of Radioloov in: fil Thermoeutic radioloolcal chvalent or (21 Roenteen-rav and camma-rav chvsics! or (3) X rav and radium chvmics! or 1 (4) Radiolooical chvsics? or (c) Be certified bv the American Board of Medical Physics in Radiation Oncoloov Physics: or (d) Be certified by the Canadian Collene of Medical Physics! or 84
prop 0 SED. FOR COMMENT april 1999 M have comoleted 1 va er of full time traininoin t ieraceutic ra diolooica ohvsics anc also 1 vear o' "o itime wor cfe) Hold a master's er doctor's decre hvsics. biochusies. radiolooicalchvsics. or heeft 5 civsics an1 exoerience under
- 1e suoervision of a Radiothernov P 1vsietst at a m edica
'nstitution. ~o Tieet thi s recuirement. the inc evidual n ia under the suoervision of a Fac rotheraov Physicist durino the vear of workI have cerformed th isted in H.4.1. F.6.16/ H.7.20. and H.6. 7/H.7.2' ff) Notwithstandino the orovis ons of K5 ofe). certidication ournuant to H.3.4fb).
- 1. 3.4(c ) s ial be reouired on or 3efore 3' Jecember 999 for al H.3.4'c) and/or Radiothernov 3hvsicist oursuant to F.3.4(el.
cersons currentiv cualrvino as a H.3 5 Qualifications of Ooerators. fa) Individuals who will be coeratino a theraceutic radiatiorimachine "3r rredical use shalf oossess a
- urrent license is a Radiation Thermo st in accordance with the Rules and
- eau ations for the Licensure o~
Radicarachers. V uclear Medicir'e Tec1nolociists and Raciation Theraoists IR5-68-RA 31 of the Rhode isla d Jeonttment of -esith. un ess tie individua ts scecifica lv exemoted from heensure 3v Section 6a3 of said n reau ations. (b) The names and trainino of all oerse,nnel currentiv ooerat no a thermoeotic radiation machi (not on file at the f acihtv information on " ne shall be ormer coerators shal be retained for a ceriod o" at east 2 vears 3evond the ast date thev were authortzec to ocerate a theraceutic radiation machine at t ist "acil tv. i I H.3.6 Written safetv erocedures and rules shall be devetooed bv a Radiothernov Physicist available en the control area of a thernoeutic radiation machine. includino any restr etions reouirec for t1e safe and that! be Doeration of the carticular theraceutic radiation machine. "amiliarity with these ru The coerator sha I be able to demonstrate es. H.3.7 Individuals shall not be exoosed to the useful beam exceot for medien identified sn the Certificate ofsuch exoosure has been ordere s in writino bv a icensed cractitioner of the heahno arts who is soecifical v Reoistration. individual "or trainino. demonstration or other non-heahno-arts ournoses.This oro H.3.8 Visitino Authorized User. Notwithstandino the orovisions of H.3.7. a reoistrant rr av oermit anv chvsician to act as a visitino authorized user t.r' der the term of the recistrant's Cert un to 60 davs ner calencar vear under the to lowino conditions: fa) The visitino authorized user has the orior written oermission of the reoistran 9he use occurs on behalf of an institution. the institution's Radiation Safety Committee (b) The visitino authorized user meets the reouirements established for authorized H.3.3(bL and and fe) The reoistrant maintains cooies of all records soecified by H.3.8 for 5 vents from the date of the la X!!1 H.3.9 Allindividuals associated with the coeration of a thernoeutic radiation mac aad shad como v with the orovisions of the recistrant's cuahtv manacement crocram. recuirements of Part H. these individuals are also subiect to the recuirements of A.2.3. A.2.7 In addition to the I.3.10 inicirmation and Maintenan:e Record and Associatec'information. The recistra "obowinc in"ormation en a secarate 'i e or oncknoe for each tieraceutic radiation machine for insoection bv - the Acenev: 85
PROPOSED FOR COMMENT-april 1999 M fa) Reoort of accentance testina. I3) Records of all survevs. calibrations and neriodi: cuality assurance cheeks of the thernoeutic radiation mac 1ine reouired by Part F. as we I as the name(s) o" oerson(s) who nerformed such activities. (c) Records of maintenance and/or rredifications nerformed on the thernoeutic radiation machine after 1 Auoust 1978 as well as the name(s) o" cerson(s) who cerformed such services. (d) Sionature of norson authorizino the return of thermoeutie radiation machine to cliniceluse after service. gooir. or unarade. H191 Records Retention. All records recuired bv Part H shell be retained until d'sooselis authorized bv the Acencv unless another 'etentio1 ceriod is soecifically authoriz tc in Part H. A 6 teoutred records shall be retainied in an active fi e< rom at east the time of ceneration unti t le next Acency insoect on. Anv recuired recore cenerated orior to t ie ast Acencvinsoection mav 3e microfi med or otherwise arc itved as lona as a comolete coov of said recore can be retrieved until such time as the Acenev authorizes i ina disoosal. H.4 GENERAL TECHNICAL REQUIREf/ ENTS FOI :ACILITIES USING THERAPEUTIC RADIA' ON MAC I WES H 4.1 Protection Survevs. f a) The reoistrant shalt ensure that radiation erote etion 3urvevs of all new f acilities. and existito f i rilities 1ot oreviousiv surveyed are oerformed with an ooera 3fe rac iation measurement survev instrument ca i 3ra"ed n accc'rdance with H.8. The radiation erotection survey shal be cerformed bv. or tinder the directio'r o" a Radict ieraov P1v!,cist or a C ertified Health Phvsteist and s 1all verifv that. with t ie theraceutic ractation rr achine in a "B E A VI O N" conc ition. with the f aroest clinicallv available tteatment fie c and wit 1 a scatterg c lantom in the useful 3eam o" radiation (1) Radiationlevels in restricted areas are not liketv to cause eersonnel exoosures in excess of the limits soecified in A.2.3(al: and (2) Radiation levels in unrestricted areas do not exceed the limits soecified in A.2.11(a) and A.2.11(b). (b) In addition to the re nuirements of H.4.1(a). a radiation erotection survev shall also be oerformed orier to any subsecuent medica use and: (1) After makino any chance in the treatment room shieldino: (2) After makino anv chance in the location of the thernoeutic radiation machine within the treatment GEE (3) After relocatino the thernoeutic radiation machine! or !4) Before usino the thernoeutic ra c'intion m nehine in a manner that could result in increased radiation evels in areas outside the externa 3eam rac iation thernov treatment room. fe) The survev reec rd n F all indicate all instances where the "acilitv. In the c oinion of the Ra lioth<!rsov i Physictst or a Cert lfia d lea t 1 Physicist. ii in violation of acolicab e reculations. he ' survey secore shal a so une ude the date & t le meast rements. t le reason the survev is reautred. the rr anu' acturer's name.11odel lumber and ser a number of t le thernoeutic radiation machine. the instrument (s. used to measu'e rac iation d evels. a clan o" the areas surroundina the treatment room that were surveved the m easured c ose ra"e at several coints in each are i excressac il microsieverts or milkrems Der 1our. the calcJ ated maximum evel J of radiation over a cerioc of ' week "or each restricted and unrestricted area. anc the sionature of the - i individual resconsible for conductino the survev. B6 i
PROPOSEO - FOR COMMENT APRIL 1999 E4 lMI i (d) If the re mults of the survevs resuirec by H.4.1(a) or H.4.1(b) indicate any ra dattienjevels in excess of the resoective imit soecified in H.L. ' (a). tle recistrant shall ock the control in t le "OFF" cosition and not j use the unit: >1) Excent as may be necessarv to reonir. roolace. or test the thernoeutic radiation machine. the thernoeutic radiation machine shieldino. or the treatment room thieldinot or (2) Until the reoistrant has received a soecific exemotion from the Aaenev. H 4.2 Modification of Radiation Thernov Unit or Room Before Beoinnino a Treatment Procram. If the survev reovireo bv H 4.1 anoicates that an individualin an unrestricteo area may be exooseo to levels of realetion creater than " hose oermitted by A.2.11(an and A.2.111b). before becinnino tne treatment.orocram the teoistrant sha 1: i fa) Either eau o the urit w'th beam direction interlocks or add additional radiation shieldino to ensug i comoliance with A.2. lia anc A.2. 1(b). (b) Perform the survev teouired bv H.4.1 aonin. and c) include in the re oort reouired by H.4.4 the results of the initial survev. a descriotion of the modification i mace to comolv with 4.4.2(a) and the resu i ts of the second survev. or (d) Reauest and receive. a recistration amendment under A.2.11(c) that authorizes radiation unrestricted areas creater t1an those oermitted bv A.2.11(a) and A.2.11(b H.4.3 Desimetrv Eaulement. fa) Tre reoistrant shall 1 ave a calibrated dos ~metrv uvstem avails ble for un e. The systemshall have been lalibratec bv the National.n ititute for Standare s and ~ 'echnoloov (NIST) or 3v on Amertran Association of Phvsiststs in Medicine (A AP VI) Accredited Dostmetrv Calibration Laboratorv (A 3CL). T 1e calibration shall I lave 3een eerformed within the orevious 24 months and after anv servicino that may have affected svstem calibration.
- 1) For b<tams with eneraies creater than 1 MV (1 MeV). the dosimettv svstemshall have been calibrate or Ccba t-60:
(21 For beams with enerales ecual to or less than 1 MV (1 MeV). the dosimetrv svstem shall h ca ibrated at an enerov tenerov rance) accroorlate for the radiation betno measured: (b) The reoistrant shall have available for use a dosimetrv system for cuality assurance check measurements. To meet this r eautrem ent. the system mav be comoared with a system that has be en calibrated in accorc ance with 4.L.3(a). Thn comoorison shall have been cerformed within the orevious 2 months and after eac1 servierno that mav lave af ected system calibration. The cuality assurance check system mav be the same system used to meet the recuirement in H.4.3(a). i (c) The r.eoistrant shall ma ntain a record of each dosimetrv svstem calibration. intercomoarison.and comoartson '3r the duration o" the license and/or recistration. For eacP calttration. tntercomoarison. or comoaru nn. t 9e recort sha Iinc ude the date. "he model numbers and neria n Jr1 3ert of the instruments that were ca i3 rated. inter.comoarec. or comoarec as recoired by .4.3(a ' anc F A3(b the correction f actors 2 hat were determined. the nam es of the individuals who cer"ormec the calibration. Intercomoarison. or comoarison and evicence tha" t ie intercomoarison was cerformed bv. or under the direct suoervision and in 2he ohvsical oresence of. a Radiothernov Physicist. H,4.4 Resorts of Extemal Beam Radiation Thernov Survevs and Measurements. The reoistrant for anv. fheraceutic radiatiori machine subiect t 3 F.6 or H.7 nhall furnt sh a conv of the records recurred in H.4.1 and ti 4.2 to the Acency within 30 davs to lowino como etton of t 1e action that initiatec the record reouvrement. i 87
R i PROPOSED - FOR COMMENT APRIL 1299 Ea5 H.5 QUAUTY MANAGEMENT PROGRAM i H.5.1 in addition to the definitions in H.2. the followine definitions are neolicable to a cualitv manacement M fa) Prescribed dose means the total done and dose ner fraction as documented in the written directive. j (b) Misadministration means the administration of an external beam radiation thernov done: (1) Involvino the wrono natient/ human research subiect. wrono mode of treatment. or wrono treatment 1!1EE (2) When the treatment consists of three (3) or fewer fractions anc the calet'tated total administered dose differs from the tota cresenbed dose bv more t,an 10 oercent o" the tota crescribec dose or (3) When the calculated weekiv administered dose differs from the weekiv orescribed dose bv more than 30 cercent: or (4) When the cateu"ated total ad ninistered dose differs from the total orescribed dose bv more than 20 cercent of the tota crescribed c one. ft) Recordabfe event means the shiinistrat on of an external team radiation thernov dose when the l calculated weeklv administered dose c r fers bv ' 5 oercent or more " rom the weektv orescri 3ed dose. i (d) Written directive means an order in writino for a soucific catient/ human research subject. dated and j sioned 3v an author:2ed user ortor to the administration o~ radiation, containino the followino inf ormation: total dose. dose oer traction. treatment site and overall treatment oeriod. i 1 i H.5.2 Seone and Aeolicability. Each acoliennt or recistrant st biect to H.6 or H.7 shaft es"ablish and maintain a written cua itv mannaement orocram to orovide hich con"idence that rac iation will 3e administered as directed bv t7e authorized user. The. cuality manaaement orocram shal incluce written oolicies and crocedures to meet the followino soeci"It obtectives: (a) Prior to administration. a written directive is orecared for anv external beam radiation thernov dose. (1) Notwithstandina H.5.2(a). a written revision to an existino vvritten directive may be made orovided that the revision is dated and sioned by ar authorized user orier to administration o" the external beam raosation thernov dose or the next externa beam radiation thernov fractional dose: (2) Notwithstandino H 5.2(a). if. because of the eatient's/humanreseare b subiect's condition. a delav in order to orovide a written revision to an extstino Written directive woule ieosardize the ont ent's/ human research su siect's healt i. nn oral revision to an exirtino written directive s 1all be acceota 3le. orovided that the ora revaion is c ocumented immediatelv en t ie natient's!"uman research subiect's record anc a revisec written c irective is sioned bv an authorized user within L 3 hours of the oral revision: f 3) Notwithstandino F.5.2(a). if. because of the emeroent nature of the natient's/ human research subiect's ce ndition. a cef av in ore er to Drovie e 0 written directive wou d ieocardize the cattent's/humar research susiect's hea t i. an era c irective s ial be acceotable. orovided that it e in"ormation contain ec in t le or al directive is documen' ec immodiate v iri the natient's/ human ta searc i st. siect'a record anc a written cirective is orecared anc sioned av an aut 1orized user within 24 1ours of t ie ora directive. (b) Prior to the administration of s ach course of radiation treatments. the natient's/ human research subiect's identitv is verified. bv more t ian one method. as the individual nameo in the written directive. (c) External beam radiation thernov final clans of treatment and related calculations are in accordance with the resoective written directives. ' fdl Each administration is in accordance with the written directive. and 88
l PROPOSED - FOR COMMENT-april 1C99 E.L2ffd (e) Anv unintended deviation from the written directive is identified and evaluated is taken. c on l-.5.3 Develooment of Quality Manaaement Naram. Each nor>lic ation for reoistration subieet tc' H.6 or H 7 s1allinc ude a cuality man.noament crooram that so scifies staf" c uties and retoonsibiits es. anc eautoment and crocedures as cart o"t ie sentication recu rec by part B of these reau attons. T 1e reoistrant shall molement the crocram uoon issuance of a Certi"icate of Recistration bv the Acencv. H.5.4 Imolementation of Quality Manacement Prooram. As e cart of the cuality menacement orocrem the rocistrent shall: a) Devetoo oroced ares for. and conduct a review of. the cualitv manaoemenn orocram irciudino. s f the ast rev ew. an eva untion c f a reoresentative same e of satient/h3 man researc 1 subiect ac rainistrations. all recorda 5 e events. and a misadmtnistrations to veri"v como innee with all asoects o" the cuaktv manaaement croaram. ib) Conduct these reviews at intervals not to exceed 12 months. (c) Evaluat e each of these reviews to determine the effective ness of the cualitv mannaement orocram and. If reoutrec. make modifications to meet the reouvrements of j 4.5.2. and i (d) Maintain records of each review. includino the evaluations and findinos of the review form. for 3 vears. H.5.5 The re cistrant shall evaluate and resoond. within 30 davs after discoverv of the recordab each recorda 3 e event bv: (a) Assembline the relevant facts includino the cause. (b) Identifvino what. If anv. corrective action is recuired to orevent recurrence and (c) Retainino a record. in an auditable form. for 3 vears. of the relevant facts and what co if anv. was ta (en. H.5.6 The recistrant shall retain (a) Each written directive. and (b) A record of each administered radiation dose. in an auditabte form. for 3 vears after the administration. H.5.7 The recistrant may make mod'fications to the cuality manaoement orocram to increase the orocram's ef ficienev orovided the crocram's ef ectiveness ts not decreased. H.5.8 The reoistrant shall evaluate each misadministration and shall take the followine actio to a misadministration: (a) Notify the Acenev bv telechone5 no later than the next calendar dav after discoverv of the misadministration. 5 During normal businese hours, the Agency may be contacted at (401) 222 2438. At other times, this number immediately contact the Agency, utilize the R1 Department of Health 24 hout numbe indicate the nature of your emergency. FAX communication may be sent 24 hours a day to (4011222-2456. 89
PROPOSEO FOR COMMENT-april 1[99
- d. 1.6 M l
(b) Submit a written recort to the Aaenev within 15 devs after discoverv of the misadministration. T1e written recort shallinclude: the r eaistrant's name: nhe crescribina ohvsician's name: a brief descriotion of t-1e event: why the event 0:currec : t ie effect on t ie individual who received the misadministration: what imorov ements are ne edet to orevent 'ecurrence: alctions taken to orevent recurrence:whether the r eaistrant notiftec t le ind vidus or t le individus 's resconsib e relative or ou ardian. and i4 not. whv not, and if t 1ere w as ~ l notification. w ist in< ormation was orov'ded no the individual. 'h e recod i 1all not include the inc ividua 's name or other infe rmatienthat could teac to _icentificationof the incividus '~o rneet the recuiremems of t1is Section. the noti", cation of the individus receivino t'he misodministration may be made insteac to that I individual's resoonsible relative or cuardian. When accrocriate. (c) Notify the referrino chysicien and afso notify the individualwho received the misadministrationno later then 24 ht*urs ef ter its ciscoverv. uWess the referrino envsician eersonally informs the rec'strent either tnet 1ershe willinf orm the mdiviousi or that. based on medicel tudament. tellina the inervidual would be harmf ul. The recistrant is not reauired to notify the individual vJithout first consultina the referrina ohvsicien if the ~ referrina ohysician or individual.who received the misadministration cannot be reached with 124 hours. the recistrant shall not fv the individual as soon as nossible thereafter. The recistrant sha not delev anv acoroortate medica care for the indtvic ual, includina any necessary remedTa care as a result of the misseministration. 3ecause of any delev in notification. (d) If the individust was notified. furnish, within 15 davs after discoverv of the misadministration. a written recort to the individual bv sendino either a cooy of the recort that was submittec to the Acencv or a bnef descriotion of both the event and the consecuences as they may effect the inc ividual, orovided a statement is included that _the recort submitted to the Acency can be obtained " rom the reaistrant. and (e) Retsin a record of each misadministration for 5 vears. The record shall contain the names of al' individu als invo ved (incluc'ina the crescribina ohvsician. allied See th oersonnel. the individus who receivec the misadministr stion. anc the individual's referrina ohvsician. if 800 ica Sle). the individual's social security number or identncation number if one has been assionec. a brief descriotion of the event, whv it occurred. jhe effect on the individual, what imorovements are neeced to crevent recurrence. and the actions taken to orevent recurrence. H.5.9 Aside from the notification reauirement. nothina in H.5.8 affects any riahts or duties of reaistrants and chvsicians in relation to each other. individuais receivino misadministrations. or the individual's resconsible relatives or cuerdians. H.6 THERAPEUTIC RADIATION MACHINES OF LESS THAN 500 kV H.6.1 Leakace R sdiatfor). When the X rav tube is coersted at its maximum rated tube current for the maximum kV. the eakaae air kerma rate shall not exceed the value soecified at the distance soecified for that classification of theraceutic radiation machtne: (a) 5 50 kV Systems. The leakmoe air kerma rate measured at any oosition 5 centimeters from the tube housino assembiv shall not exceed 1 mGv (100 mrad) in any one hour. (b) > 50 and < 500 kV Systems. Th e leakaae air kerms ra te measured at a distance of 1 meter from the tatoet in any direction shall not exceed ' cGv (1 rad) in anv 1our. ~his air (erma rate measurement may be averaaed over areas no larcer than 100 sauare centimeters. In addition. the air kerma rate at a distance o" 5 centimeters from the surf ace of the tube housino assembiv shall not exceed 30 cGv (30 rad > oer hour. (c) For each thermoeutic radiation machine. the reoistrant shall determine. or obtain from the manuf acturer. the leakaae radiation existina at the cositions soecified in 4.6.1(at and F.6.1(b) f or the soecified oceratino conditions.
- ecords on leakaae radiation measurements shall be maintained at the installation for insoection by the Acency.
90
PROPOSED FOR COMMENT-APRIL 1i99 H.B.2 i F .6.2 Perrmanent Beam Um:iino Devices. Permanent dinohraom3 or s1all orovic e at least the same decree of attenuation as recuirstfor the tu 3e housino assem siv. useful beam H.B 3 Adiostable or Romavable Bearn Umit;no D= vices. fa) All adjustable or rememable beam limitino devleen. dinohraoms. cones or blocks s than 5 Dercent of the usefu seam for the most eenetratino beam used. smit more Ib) When adiostable beam limitino devices are used the oositien and indicated by a icht beam. shall be H.6.4 Filter Svstem. The filter svstem shall be so desioned that: (a) Filters can not be accidenta!!v disolaced at anv consible tube orientation. (b) For couloment installed after 1 Auoust 1978. an interlock system oreve t fdter is not in o ace. n s irradiation if the crocer _ fe) The air kerma rate escanino from the filter slot shall not excee under anv oneratino conditions. and fd) Each filter shafi be marked as to its material of construction and its thickn H.B.5 Tube Immobilization. fa) The X rav tube shall be so mounted that it can not accidentally turn or sfide with res housino acerture. and i o the (b) The tube housino assembiv shall be canable of beino immobilized for stati onarv nortal treatments. 4.6.6 Source Markine. The tube housino assembiv shall be so mark te' that it s nossible to determi ocation of the source to witnin 5 millimeters. and such markino sha ne the calibration oroceoures. 3e readi v accessible for use durino H.B.7 Beam Block. eouivalent in attenuation to 0.5 mithmeters o' Contact thernov tube 33us no assemblies shall have a removable shield of material i beam exit oort durino oeriods when the beam is not in use.est at 100 (V. which can be positionec over t le entire useful H.B.B Time-time interva. A suitable irradiation control device shall be orovided to terminate th fa) A timer which has a ditefav shall be orovided at the treatment control canel nre-set time selector and an e ansed time or time remainino indicator. The timer shall have a (b) The timer shall be a cumulative timer which activates with an indication of ON" can be reinitiated. it s1all be necessarv to reset the elanted tim on is terminated and 3efore irradiat o and retains in fe) The timer shall terminate irradiation when a ore selected time has etansed. If anv dose monitorine system cresent has not oreviousiv terminated irrac tation. fd) The timer shall cermit accurate ore-settino and determination of exoosu fe) The timer shaff not oermit an eroosure if set at zero. 91
PROPOSED - FOR COMMENT-APRIL 1899 M fil The tirrer shall not activate until the shutter is ooened when irradiatie n is co1 trolled bv a shutter j mec,anism un ens calibration includes a timer error correction to comoensate "or mec ianical lao. and fa) Timer shall be accurate to within 1 cercent of the selected value or i second. whichever is creater. I
'4.6.9 Con usino assembiv. In ac c ition. aft er the unit is at coeratino . Darameters. the slutter shall be co ntrollec bv t ie coerator from the control cane . An indication of shutter oosition shall acoear at the contro onnel. 4.6.13 Low Filtration X-rnv Tu ses. Es ch thernoeutic radiation riachine coulooed with a bervLiam or other ow filtration window shal be e early la 3eled as such uoon the tu 3e housino a!sembly and a la ' :e orovided with a cermanent warnino device on t ie contrcl canel that is activated w1en no additional deltration is cresent. to indicate that the dose rate is verv hio 1. 4.6.14 Facil tv Denton Raoulrements f sr Thermoeutic Radiation Machines Canobla of Ooeratino in the Ranoe 50 kV to 50C' kV. n ac c ition to s hielc ino adeounte to meet reouirements of H.9. the treatment room sha I meet the followino desian reautrements: (a) Aural Communication. Provision sP all be made for continuoun two-way aurai communication between the cattent/ human research subsect and t ie coerator at the control onnel. 92 PROPOSED - FOR COMMENT-april 1999 E$mE (b) Vievrino Systems. Provision shall be made to cerrvit continu3us observati3n of the natient/1uman r esearch su 3lect durino irra dist on anc the viewino system s11111 be so ocatec that t le coerator can o 3 serve t ie olitienttiuman researc i su 3tect from t ne control o snel. ~he theraceutic radiation machine shall not be used "or natient/ human research subiect irradiation un ess at least one viewino system is coerationa H.6.15 AdditionalRooui4ementu. Treatment 'coms which contain a thernoeutic radiation machine caoable of ooeratino above 150 (V sha meet the foi owine additional recuirements: (a) All orotective barriers shall be fixed exceot for entrance doors or beam intercentors. (b) The control cenel shell be located outside the tre?tment room. k) Interlocks shall be orovided such that all entrance doors. includine doors to anv interior booths. shall be c osed before treatment can be initiated or continuec. If the radia" ion beam is siterruoted bv anv door ocenino. it shall not be oossib e to restore the m schine to coeration wit 1out closino t le ccor and reinitiatino ivradiation bv manual action at the control cane.and (d) When anv door referred to in H.6.15(c)is ooened while the X-rav tube is activated. the air kerma rate at a distance of 1 meter from the source shall be reduced to less than 1 mGv (100 mrad) Der hour. H.6.16 Full Calibration Measurements. (a) Full calibration of a theraceutic radiation machine subieet to H.6 shall be'oerformed bv. or under the cirect sucervision of. a Raciotheraov Phvsicist: (1) Before the first medical use fellowine installation or reinstallation of the theraceutic radiation machine: M (2) At intervals not exceedino 1 vear: and (b) The Radiothernov Phvnicist shall eerform or directiv sucervise all elements of a full calibration necessarv to determine that al carameters are within accentable -imit s: (1) Whenever cuality assurance check measurements indicate that the radiation outout differs bv more than 5 oercent from the value obtained a t the last ful calibration and the difference cannot be reconciled. Theraceutic radiation machines with mu ti-enerov caeabilicies shall oniv recuire measurements for those moces ar.d/or eneroies that are not within their acceotab e rance: and (2) Fellowino a nv comoonent reolacement. maior reoair. or modification of comoonents that could sionificantiv af' ect the characteristics of the radiauion beam, if the reoair reolacement or modification does not affect all eneraies. measurements shall De cerformed on the effected enerov that is in most "recuent clinicaluse at the f actittv. The remainino eneroies may be valic sted with ouality assurance check crocedures acainst the criteria in H.6.16(bif1). (c) To satisiv the recuirement of H.6.16(a) and H.6.16f b). full calibration shall include all mearurements mcommended for annual calibration bv NCRP Recort 69. " Josimettv of X-Rav and Gamma Rav Beams for Radiation Thernov m the Enerov Rance 10 kev to 50 MeV' (1981l. (d) The reoistrant shall m aintain a record of each colibration for the duration of the recistration. The Pecord shallinclude the date o" the calibration. the manu"acturer's name, model number. and serial number "07 both the theraceutic radiation machine and the X rav tube. the model numbers and serial numbers of the nstruments used to calibrate the theraceutic radiation rr.achine. and the stonature of the Radiothernov anvsicist resoonsible for oerformance of the calibration. 93 PROPOSED o FOR COMMENTo AMEK 1999 Os0 H.6.17 Periodic Qualltv Assurance Checks. (a 1 Periodic o uali"v assurance checks shall be nerforried o n thernoeutic radiation machines subinet to H.B. whic i are caeab eo" oneration at creater than or sous to 6 3 [V. (b) To satisfy the reauirement of H.6.17(a). cuality assurance checks shall meet.the followino til The racistrant shall Serform ouality assurance checks in accordance with written erecedures eatablished 3v the Radtot iernov Physicist. anc (2) The cuality essuran ?e check crocedures shall soetNv the frecuen ev et which tests or measurements n 'e to be 3erf orm ed. '~he cuahtv assurance e leck 3rocec t res that soecifv that 1he cuahtv essurance .6.1 5(a). 'he accenta sie tole 'ance f or each cTeck sha ibe ner' ormed durina nhe calibration soeci~ied in narameter measured in t ie cua itv assur ince chec c. w ien comcarec to the va'Je for t 1at carameter determined in the calibration soecified in -.6.16(al shal be stated. (c) The caule for a carameter exceedino a tola rance set bv the Radiothara ov Phvsicist shall be investtosted anc corrected before the system is used "or natient/ human researc 1 su stect irradiation. (d) Whenever a cuality asturancicheck indicates a sionificant chance 11 the coeratino characteristics of l a sysMe
- 1. as soecified ir the Radict ieraov Physicists c ua itv assurance cieck crocedures. t1ose e ements I
o"a "u calibration shal se oerformed. au teouiret in -i.i.16(s). that are necesse rv to determine tha't all s' fected carameters are wit mn acceoteb e imits. Otaer cua ity assurance c iec ( orocedures s icule be recented. as necessarv. to ensure that all system carameters are within accentable limits. (a') The reoistrant shall use the dosimetrv svstem described in H.4.3(b) to make the cuality assurance chec ( reautred in H.6.17( D). (f) The reaistrant sha!! have the Radiothernov Phvsicist revia'w and sion the r'rsuits of each radiation ou2 cut cuality assurance chee ( within 1 month o" the date that t le check was cer' ormed. (a) The 'eoistrant shall ensure that safety cuality as'surane e cheeks of thernoeutic radiation machines subiect to F.6 are cer< ormed at intervals not to exceed mont i. (h) Notwithstandino the reauirements of H.6.17(f) and H.6.17(o). the reaistrant shall ensure tFat no t_hevace Jtic i'adia" ion mac mine is used to administer radiat on to humans unless the cualttv assurance ciecks l re suivec bv H.6. ' 7(f) and H.6.17(a) have been oerf ormec within the 30 dav cened immadiatelv orsor to said ac ministration. (i) To satisfy the recuirement of H.6.17(a). safetv auality assurance checks shall ensure crocer coeraticr1 l Sdi 1 (1) Eieetricalinterlocks at each external beam radiation thersov room entrance: (2) Procer cocration of the " BEAM-ON" and termination switchey ~ (3) Beam condition indicator lichts on the access doorfs). control console. and in the radiation thernov l M j l f4) Viewina avstems: i l (5) If nonficable. elettricallv ooerated treatment room doors from inside and outside the treatment room: (. l ' fit Tha reaistrant shall maintain a record of each at altv ascarance check re'auired by H.6.17(a) and H.6. ' 710) "or 3 vears. 7he record shallinclude the date o" t ie oua itv assur ance c iec c. the manuf acturer's narT e. moc el number a nd serial number for the thernoe atic radiation mac vne. tlie manu"acturer's name.. j moc el num be ' and ser a number of the instrurrent(s 'asec to measure the radiation outout of the thernoeutic j radiation mac 1 ne. anc the sianature of the inc ividua w1o cer"ormed the ceriodic auality assurance check. j 1 94 1 1 i PROPOSED - FOR COMMENT. april 1t99 M H.6.18 Doeratina precadurae. (a) The thernoeutierad'a tion machine s 1a I not be used for irradiation of unless the recuirements o< natients/ human research subjects i.6.16 and H.15. 7 1 ave 3een met. (b) Theracautic rad' iation machinen shall not be left unattended unless moeured oursuant to H.6.9fel. fe) When a natient/ human research subject must be held in oosition for radiatio succortino or restraintna c evices s 1all be used. c anical (d) The tube housino assembiv shaft not be held bv an individust durino coe desioned to recoire such holdino end the ceak tube notentet of the system coes not exce cases. the holder shell weer orotective cloves and acron of not less th 100 kV. . In suet, i fe) A coov of the current ooeratins and emeroenev orecedures shal j radiation machine control conso e.anc eraceutic ff) . exoosures from thernoeutec radiation machines coeratino a atment room durino 150 kV. a ny individual. Other than the oatynt/ human research sutlect At e,erales ess than or e 3uut to 50 (V. crotected 3v a barrier sufficient to meet the recuirements o" A.2.3 o~ these reculations. in ie treatment room s ia be H 6.19 Possession of Survev !rntrament(s). machine in accordance with b.45 niall oossess accroonatelv cali3ratec nortable monitorino ecutomentEach f acility n autt orized to use a thernoeutic radiation a minimum. such ecutoment shal incluce a certable radiation measureme1t survev natrument :anable o" . At measurino de se ra"es over the rance 10 u5v l' mrem ner hour to 10 mSv 11000 mrem oer hour instrumentis ' shal be coerable and calibrated in accordance with H.8. .he survev H.7 "HERAPEUTIC R ADIAT C)h' IV ACHlh EP - PHOTO V THERA SY SYSTEN 9 (500 kV A ND ABOVE) Ah D ELEC"F C V 'HEF'A 'Y SYSTE VIS ( 500 ceV AND A ! OVE) ^ H.7.1 Possession of Survev Instrument (s). machme m accordance with F.7 nhall oossess accrocriately ca ibrated nortable monitorino eautomentEach a mmimum, such ecutoment shal include a cortable radiation measurement survev nstrument :anable of . As measunno dose rates over the rance 10 aSv (' instrumentis) shall be coerable and cal 3 rated en accordance with H Bmrem) cet hour to 10 r15 ' oer hour. 'he survev ' H.7.2 Leakace Radiation Outside the Maximum Useful Beam in Photon a o es. (a) The absorbed done due to leakaoe radiacion (excludino neutrors) at a 'stzed useful seam. but within a circular olane o" racius 2 meters whici es ceroendicular to and cent the central axis of the useful beam at the nominal treatment distance 16 e catient/P on the centra arts of the beam at the nominaltreatment dis 1ance. M 3" th uman researc i tubsect e absorbec cose on not exceedino 100 souare centimeters at a minimum o 16 noints uni"ormiv c averaced over an area (b) Exceot for the area defined in H.7.2(a). the absorbed dose due to l shall not exceed 0.5 cercent ci the absorbed dose on the central axis of the treatm ntneutronsl at 1 meter from the a ectron oath between the electron source and the tarcet or e ectron windoweakace rad distance. Measurements sha i be avermoed over en area not exceedino 130 souare centimeters. e (c) F 3r eculoment manufactured after flNSERT EFFECTIVE DATE OF THESE RE Absor Sec dose outside the usefu beam shall be ti comotiance with international E ectrotechni NS). the neutron. dEC) Jocument 60121 (most current revtsion ' and calCommission 95 PROPOSED - FOR COMMENT-april 1C99 UnbE fd) For each tieraneutic radiation machine. the reoistrant shall determine. or obnain from the manuf acturer. the enkaae radiati:n existino at t ie cositions soecified in 4.7.2(a) throuch F.7.2 f cl "or t ie soect"ted coerattna condi1 tont.
- ecords on en cace rac iation measurements shall be maintained at t ie instal ation for insoection 3v t,e Acenev.
H.7.3 Lankane Radiation Throuch Beam Limitino Devices. fa) Photon Radiation. All adiustable or interchanoesble beam limitino devices shall attenuate the useful beam such that at the nominal treatment distance. t ie maximum absorbed dose anywhere in t ie area shielced bv the beam limitino device (s) shall not exceed 2 cercent of the meximum absorbed dose on the centret exis of the useful beam measured in a 10 centimeters by 10 centtmeters radiation field. (b) Ela etron R idiation. A I adiusta 3(e or interchanacable efectron acclicators shalf attenuate the radiation. ir ciudino Sut not imited to c loton rac intion cenerated av e actrons incident on ';1e beam lit 11tino device and e ectron soolicator and other c arts of the radiation helid. suc 1 that the a 3sorbeddose in a o ane oeroendicu ar to the central axis of the use ut beam at t1e nomina treatment distance shall not exceed: (1) A riaximum of 2 eeree nt and avernoe of 0.5 3erc ent of thn absor ned do se on the central axis of the use' ul Deam at "hn nomina "reatment distance. ~ hts imit sha acolv 3evonc a ine 7 centimeters outside the oericherv o"t le usefu 3eam: anc (2) A maximum of 10 cercent of th e ab sorbed dose on the central axis of the useful beam at the nomina ureatment distance This limit sha soo v bevond a line 2 centimeters outside the oerloherv o" the useful 1AAL (c) Measurement of Lanknoe Radiation. (1) Photon Radiation. N ensurerr ents of leaksee radiation throuer the be im limi"ina devices shatlbe made with the 3eam limitino cevicer c 3se d and any residual acer"ure Slockec bv at east 2 t enth va ue avers of suitab e absorbinc materia nt ie case of overlaooina 3eam limitina devices. the eakaae rac iation chrouch eac 1 set sha i be m easured trdeoendentiv at t 1e death of maximum dose. Measurements shall 3e made usino a radiation c etector o' area not exceec ino 10 sauare centimeters (2) Eltetron Radiation. Measurement:t of leaka se radiation throuch the electron soolicanors shall be made with tle electron beam directed into t"e air anc usina a rac istioidetector of area un to Sut not exceedino 1 sauare centimeter suitablv orotectec saain s" radiation w 1ich 1as seen scattered from material bev3nd the radiation detector. Measurements shal 3e made usina 1 centimeter of water eauivalent builc uo malanaL H.7.4 Filterg fa) Each wedoe filter which s removable from the tvstem shall se clearfv m.nrked with an identification number. For removable wedae i itters. the nomina l wecae anale shal accear on t ie we doe or wedae trav (if cermanentiv mounte d to the trav). If t ie wecce or wedae trav is sianificantiv c amaced. the wedae transmission f actor s ia i be redetermined. (b) If t1e absorbed dose rate ir format'on recuired bv H.7.1 relate s exclusivelv to coeracion with a field flattenino "ilter or beam scatterina "oilin o ace.such" oil or filter shall 3e removable oniv by t 1e use of too s. (c) F3r eauioment manufactured after 1 Januarv 1985 which utilre a system of wedae filters. inter. chanceable fie d flattenina filters. or interchanceable beam scatterino " oils: J11 Irradiation shall not be oossible entil a selection of a filter or a cositive telection to use "no filter" has been made at the treatment contro cane. either manually or automatica v: (2) An interlock system shall be orovided to orevent irradiation if the filter selected is not in the correct D.O.i!ED.m 96 PROPOSED FOR COMMENT april 1C99 M '3) A disclav shall be orovic'ed at the treatment control onnel showir o the wedae filter (s). Interchanoeable "ielo t attenino filterts). anc lor interchancea sle beam scatterino "oi (s) in use:-snd (4) An interlock shall be trovided to orevent irradiation if any filter and/c r beam scatterino foil selectior ooeration carried out in the treatment room does not moree wit 1 the ti ter and/or beam scatterinct f6i selection ooeration carried out at the treatment control onnet. 4,,. ;,., ,, ~, a,., H.7.5 Strav Padiation in the Useful Beam. For eouiement manufactured after flNSERT Ere THES E REGU.AT ONS the reoistrant shall determine durina acceotence nestino_ or obtain from the manu< acturer. data sufficient to ensure that X-rav strav raciation m the useful e eetron beam ebsorbec cose 27 She surf 8ce durino X-rev Irracletion end str2V neutrCn redletion in the usef ul X-r2V beam are with international Electrotechnical Commission <lECl Document 6012-1 tmost current revisioni. f.7.6 Beam Monitors. All thermoeotic radiat en machines subieet to H.7 shall be orovided w!"h redundant t seam monitorino systems. The detectors "or these systems shall be fixed in the usefu 3eam durino treatment to indicate the dose monitor unit rate. (a) Eouiement minufactured after 1 Januarv 1985 thall be orov ded with a' leasn 2 indeoendentiv cowered intecratino c ose meters. Alternativ elv. common e ements mav 3e used if the croc uction o" radiation i3 terminated uoon failure of any common e ement. (b) Ecoloment manufactured on or before 1 Januarv 1985 shall be orovided with at least 1 de?ector. " hts oetector shall be mcorocrated into a useful 3eam monitorino system. fel The detector and the system into which that detector is incorocrated shall meet the followino recuirements: (1) Each detector shall be removable only with tools and. if movable. shall be interlocked to orevent incorrect eositionino: (2) Each detector shalf form cart of a beam monitorino system from whose readinos in dose monitor units the absorbed dose at a reference noint can be calculated (3) Each beam monitorino system shall be caoable of indeoendentiv monitorino. interruotina. and terminatino irradiation: and (4) For eouioment manufactured after 1 January 1985. the desion of the beam monitorino systems shall ensure that the: (i) Malfunctionina of one system shall not affect the correct functionino of the other svstem(s) and (ii) Failure of either system shall terminate irradiation or orevent the initiation of radiation. (5) Each beam monitorino system shall have a leoible c'isolav at the treatment control ennel For ecuroment manuf actured after 1 Januarv 1985. each disc av shal fi) Maintain a readino untilintentionally reset fii) Have only one scate and no efectrical or mechanical scale multiolvino factors: fiii) Utilire a desion such that increasino dose is disotaved bv increasino numbers and fiv) in the event of oower f ailure. the 3eam meninorino information recuired in H.7.6(eH5Hiii) disclaved at the control canel at the time 0" f ailure sha i be retrievable in at east one system for a 20 minute ceriod of time. 97 I PROPOSED - FOR COMMENT-april 1C99 Un2n1 H.7.7 Beam Symmetry. fa) Bent-beam linear accelerators subject to H.7 shall be orovided with auxiliarv devicef si t'o monitor beam AY.mmalfL (b) The devicefs) referenced in H.7.7(a) shall be able to detect field anvmmetrv ornater than 10 nercent. (c) The device (sh refererced in H.7.7(a) shall be confieured to terminate irradiation if the soecifig, tag in H.7.7(b. can not se mainMained. H 7.8 Selection and Disolav of Dose Monitor Units. fa) Irradiation shall not be nossible until a new selection of a number of done monitor unitshas been made at the treatment control onnel. (b) The ore selected number of dose monitor units shall be disclaved at the treatment control canel until reset manually for the next irradiation. (c) After te'mination c f irra diation. it shall be necessary to reset the dosimeter disolav before subsecuent treatment can 3e initiatec. anc fdl For eau:oment manufacturec after 1 January 1985. after termination of irradiatior. it shall be necessarv for t 7e coerator to reset t ie ore selected dose monitor units before irradiatton can 3e initiatec F.7. !! Air Kerma Rate /A 3 sorbed Dose Rate. For eautoment manufactured after 1 Januarv 1985. a system _.. s i nli 3e orovided from w,ose readinos the air kerma rate or a bsorbed dose rate at a reference coint can 3e ca eu ated. [The radiation detectors soecified in H.7.6 mav "orm cart of this system.' n addition: fa) The dose monitor unit rate shall be disolaved at the treatment control onnel. (b) "f the couloment can deliver under any conditions an air ker'na ' ate or abso' bed dose rate at thm ~ nomina tre atment distance more than twice the maximum value soecined 3v the manu"acturer. a devicaucha
- a orovidec which termin ites irradiation wh.en nhe air kerma rate or absorbed dose rat e exceeds a value twice nie soecifiec maximum. he dose rate at w lic 1 the irradiation will be terminated shal be a record maintained 3v the reoistrant.
(c) ff the eouiomen" can deliver under anv "ault condition (s) an air kerma rate or absorbed dose rate at the nominal treatment ristance more t ian ten P O) times the maximum value soecif ed by the manuf acturer. a device sha I be orovic ed to orevent t le air kerma rate or absorbed dose rate anyw1ere in the radiation field from exceedino twice the soecified maxirr um value and to termnate irradiation i" the excess absorbed dose at the nominal treatment distance exceec s 4 Gv (400 rad). anc id For each thernoeutic radiation rnachine. the reoist'an" a5all determine. or obtain from the 11anu' acturer. the maximum value(s i soeci" led in H.7.9( 3)anc F.7.3tc l for tt e soecified coeratino conditions. Records of these maximum value(s) shall be maintained at t 1e installation "or insoection bv t 7e Acencv. I.7.10 Termination of irradiation by the Beam Monitorina System or Systems Durina Stationarv Beam itadiation Thernov. fa) Each orimarv svntem shall terminate irradiation when the ore-selected number of done monitor units has been detected bv t ie system. (b) If the orieinaldesion of t ne coulement included a secondarv dose monitorino system. that system sF al be caoable of terminatino irraciation when not more than 15 eercent or 40 dose monit 3r units above t ie ore-selected number of dose monitor units set at 11e control canel 1as been detected by t 1e secondarv dose monitorino system. and 98 i ) PROPOSED - FOR COMMENT-APRIL 1999 i fel For eautome st manuf actured after 1 January 1985. an indicator on the control onnel shall show which monitorina system ,as terminated irradiation. H.7.11 Termination of Irradiation. It shall be nossible to terminate irrad ation and eouiement movement or oc from an interruotior' condition to termination condition at any time " rom the coerator's cosition at the treatment control cane H.7.12 Interruotion of Irradiation. If a thernoeutic radiation machine has an interruot mode. it shall be ?cssible to interruct irrediatten end ecuirment movements at any time from the treatment controi cenei.
- olloweno en interruottonit theil be oossible to restert irractation bv coerator action without any reseiection j
of coeratino conditions. f sinv chance is made of a ore selected value durino an interruotion. trradiation and eouiement movements s,a i be automatica lv terminated. H.7.13 Timer. A suitable irradiation control device shall be orovided to terminate the irradiation after a ore set time interval. (a) A timer shall be orovided which has a disolav at the treatment control onnel. The timer shall have a n-igitime se ector and an e ansed time indicator. (b) The timer shall be a cumulative timer which a:tivates with an indication of " BEAM ON" and retains its roadino af ter irradistic'n is interruoted or terminatec. A' ter irradiation is terminated and before irradiation g Se reinitiated. it sia I be necessarv to reset the elaosed time Indicator. fel The timer shall terminate irradiation when a ore-selected time has elaosed. if the dose monitorino systems have not creviousiv terminated irradiation. H.7.14 Saluetion of Radiatic n Tvoe. Eouioment caoable of both X-rav thernov and electron thernov shall 1 meet the ' o lowino additiona reoutrements: (a) Irradiation shall not be oossible until a selection of radiation tvoe (X-ravs or electrons) has been made i at the treatment control canel, (b) The radiation tvoe selected shall be disofaved at the treatment control onnel before and durino irradiation. fc) An inter'ock svstem shall be orovided to ensure that the eauioment can erincioally emit ontv the radiation tvoe w,ien has been selected. I fd) An interlock system shall be orovided to orevent irradiation with X ravs. exceot to obtain an imace. when electron anolicators are fitted. fe) Ar. interlock system shall be orovided to orevent irradiation with electrons when accessories soecific for X rav t-,ernov are fitted. and (f) An interlock system shall be orovided to or event irradiation if env selected coerations carried out in the treatment room do not moree wit 7 the selectec coerations carriec out at the treatment control canel, i H.7.15 Selection of Enerov. Eouioment caeable of ceneratino radiation beams of different eneroies shall meet the followino reouirements: (a) Irradiation shall not be nossible until a selection of enerov has been made at the trestrnent control M 99 i 1 l PROPOSED - FOR COMMENT-april 1C99 Us11Ed$ (b) The nominal enerov value selected shall be disolived at the treatment control canet until reset manually "or the next irradiation. After termination of irrac iation. it shall be necessarv to reset the nomina enerov value selected before subseouent treatment can be initiated. i - fc) frradiation shaff not be nossible until the anorooriate flattenino filter or scatterino foil for the selected i enerov is in its oroner ocation. and l (d) For mod oment manu actured a"ter flNSERT EFFECTIVE DATE OF THESE REG JLAT ONS1 the seie tion d of enerov sha be in como lance wit 1 ntemational Electrotechnical Commission EC) Jocument 60' -21 (most current revision). H.7.16 Selection of Stationa v Beam Radiation Theriov or Movina Beam Radiation Thernov. Thernoeutic radiation r1achines caeab e of 30th stationarv beam rac intion thernov and movino beam radiation theranv shall meet the "ollowino reouirements: fa) Irradiation shall not be oossible until a selection of stationarv beam radiation thernov or movino beam radiation thernov has been made at t ie treatment contro canel. (b) The mode of ooeration shall be disclaved at the treatment control onnel. (c) An Fnterlock system shaft be orovided to ensure that the eaulement can ooerste ontv in the mode which has 3een selected. fd) An interlock system shall be orovidedto orevent irradiation if any selected carameter in the treatment room does not moree with the selected carameter at the treatment contro canel. fe) Movino beam radiation thernov shall be controlled to obtain the selected relationshios between incremental dose monitor units and incremental movement. (1) For couiement manuf actured after 1 January 1985: f1 Where anale verminates t,e irradiationin movino beam radiation thernov. the dose monitor units celivered shall dif' er bv esst,an 5 oercent from the dose monitor unit value selected: fii) An interlock shall be orovided to stevent motion of more than 5 decrees or 1 cm bevond the selected limits durino movino Seam rac iation thernov: fili) An inter ock ahail be orovided to recuire that a s election of d:rection be made at the treatment control cane in a i units which are canable of both e ockwise anc counter clockwise movino beam radiation thernov. (2) For eauioment manpf actured after flNSERT EFFECTIVE DATE OF THESE REGULATIONSh f~) - An interlock system shall be orovided to terminateirradiation f the number of done monitor units celivered in anv 10 decrees of rotation or 1 cm of inear motion di"fers bv more than 20 cercent from t le selected value! fii) Movino beam radiation thersv shall be co',treilled with toth crimarv cosition sensors and secondarv cosition sensors to obtain the selectee re ationshios Setween incremental c ose monitor units and incrementa movement. (f) Where the beam monit'or avstem terrinates the irradiation in movino beam radiation thernov. the termination of irradiation shall 3e as recuitec 3v H.7.10. anc fo) For eouioment manuf actured afteri Januarv 1985. an interlock system shall be orovided to terminate irradiation if movement: (1) Occurs durino stationarv beam radiation thernov or 100 PROPOSED. FOR COMMENT-april 1939 RL1fdall21 '2) Does not start or stoon durino movino beam radiation thernov unless such stenoane is a ore-olann unction. H.7.17 Faellity Deslan Reauirements for Theraneutic Radiarlon fylachines Oneratino above 500 kV. In addition to s1ieldino adeounte to meet recutrements of H.9. tie fo lowino desion recutrements are made: fa) Protec1Lre Barriers. All orotective barriers shall be fixed. exceot for access doors to the treatment room or mova 3le beam intercentors. (b) Control Panel, in addition to other reovirements soecified in this Pert. the centrol cenet shall etso: (1) Be located outside the treatment room: (2) Provide an indication of whether electrical oower is available at the control onnel and if activation of the radiation is nossible: i (3) Provide an indication of whether radiation is beino oroduced: and (4) include ar, access control flockino) device which will orevent unauthorized use of the thernoeutic radiation mac 1lne: (c) Viewino Systems. Windows. mirrors. closed-circuit television or an ecuivalent viewino system shall te orovic ed to oermh continuous observation of the cattentthumairesearch su 3iect followino nositionino and d urino tiradiation anc shall 3e so loca ted that the ocerator may o nerve the entient/ human research rubiect " rom the treatment contro cane Te theraceutic radiation mac1:ne shall not be usec for eatienttluman research su 3tect trradiation unless at east one viewano system is coerational. fdl Aural Communications. Provicion shall me made for cantinuous two wa v aural communication between the oatientthumairesearc 1-subiect and t le coerator at t:1e contro canel. 'he tieraceutic rac iation mine shall not be usec for trraciation of oatients/ human research subiects unless continuous two-way mac aura communtention is consible. fe) Reiom Ertrances. Treatment room entrances sha I t e ersvided with warnino lichts in a readily observab e cosit on near the outside of all access doors. w1ic1 wel Indicate when the useful beam is "ON" and when it is "OFF" (f) Entrance Interlocks. Interlocks shall be orovided such that all access controls are activated befer e treatment can be initiated or continued if the radiation beam is interruoted bv any accesu control. it sha i not be oossible to restore the rnachine t 3 coeration without resettino the access contro and reinitiatino irradiation bv manua action at t le contro canel. (c) Beam intercenter interlocks. If the shield'no ma"erial in any eret ective barrier recuir es the cresence of a 3eam Intercector to ensure comoitance wit i A.2. 1(a) and A.2. ' (b). interlocks s ial be orovided to crevent the oroduction of 'adiation. unless the beam intercentor is in olace. whenever the useful beam is c irected at the desionated 3arrier(sL (h) Emereenev Cutoff Swinches. At least i emercenev oower eutoff switch shall be located in the radiation"hernov room and s la I terminate al eouioment electricaloower includino radiation and mechanica motion. This switch is in adcition to the termination switch reoutred bv H.7.11. All emeroenev oower cutofi switches shal incluc e a manual reset so t 1st the theraceutic 'adiation machine cannot be restarted from the unit's control conso e without resettino t 1e emercenev cuto"f switch. fi) SafetyInterlocks. All safety interlocks shall be desioned so that anv defect or comoonent failure in the safety interlock system orevents or terminates coeration of the theraceutic radiation machtne and fi) Surveys for Residual F adiation. Survevs for res dual activitv shall be conducted on all theraioeutic ' radiation machines canab e o' oeneratino choton and electron eneroies above 10 IV V orior to mac ilitna. removino. or workina on theraceutic radiation machine comoonents which mav have accome activatec due to choto neutron oroduction. 101 1 i PROPOSEO - FOR COMMENT-APRIL 1999 ILllI l H.7.18 Radiothernov Physicist $unnori. (a) The sa.rvices of a Radiothernov Physicist sha 't be reouired in facilities havino thernoeutic radiation - machines wit i eneraies o' 500 kV and above. The
- .ac iothernov Physicist shall be resoonsible "or
(1) Full calibration (s) reouir'ed bv H.7.20 and orotection survevsNouired bv H.4:1: (2) Suoervision and review of donimetrvi (3) Beam data seaufsition and transfer for comeuterized dosimetrv. and sueervision of its use: (4) Quality assurance. includina auslity assurance check review reovired bv H.7.21fe) of there reaulations 1 I (5) Consultation with the authorized user in treatment ofannino. as needed: and (6) Performina calculations / assessments reoardina misadministrations. j i (b) 14 the Radiotheramv Dhvsicist is r et a full-tirr e emeifovee of the reoistrant. the coerat:no orocedures reoJree bv H.7.19 sha a so s oecifica v address low t ie Rac iot ieraov Physicist is to be contacted for cro s ems or emeroencies. as we I as the soecific actions. i< anv. to be taken until the Radiothernov Phvsicist can be contacted. i H 7.19 Doeratina Procedures. (a) No individual. ether than the natient/ human research subiect. shall be in the treatment room durino i treavment or durina any irradiation for testina or calibration ourooses. (b' "hmaceutic rac'intion machines shall not be made available for medical use unless the reauirements .7.20 and -i.7.21 have been met. of H.L.' (c) Thermoeutic radiation machines. when not in ooeration. shall be secured to orevent unauthorized use. (d) When adit stable beam limitino devices are used. the nomition and shaos of the radiation field shall be indicated bv a lio it fim d. (e) If a natient/ human 'esearch subieet must be held in oosition durina treatment. mechanical succortino or restrainina devices sha i be usec.and (f) A conv of the current oceratino and emeroenev orocedures shall be maintained at the thernoeutic radiation machine control conso e. H.7.20 Accentance Testina. Commissignlna pnd Full Calibration Measurements. (ah Accentance testina. commissic nina and full calibration of a thernoeutic radiation machine subject to H.7 s 1all be cerformed bv. or under t ie direct suoervision of. a Radiothernov Physicist. 's) Accentance testino and c'3mmissionino sha'l be nerformedin a teordance w'th "AAPM Code of Practice "or
- .adiothernov Accelerators F eoort of AAPM F adiation T ieraov ask Grouc (5" and shall be conducted 3efore the first medica use followino installation or reinstal ation ei the theraceutic radiation machine.
(:) Full calibration shall include measureme nt of all carameters reauired by Tab e II of "Comorehennive QA"or Radiation Oncoloav: Reoort of AAPM
- ac iation T iers ov Committee Task Grouc 40" and shal se ce r"ormed ti accore an te with " AAPM Code o" F racutce "c.r Radiothernov Acceleratora
- Reoort of AAFM Rac iation T Sernov ~ ~as c Grouc 45" Althou
- h it liha I not se ne:s starv to como ete a ie ements of a full cali 3 ration at the same time. all carameters i "or a' a,nerates) s "a i se corroleted at interva s not exceedina '
12 ca endar months. un ens a more frecuent interva is reauitec in ~able i 102 PROPOSED - FOR COMMENT-APRIL 109 ELE (d) The Radiothernov Phvnicist shall eerform or directiv sur,ervise all elements of a full calibratio necessarv to determine that al carameters are within accentable imits: 'il Whenever cuality assuranco check measuremen"s indicate that the radiation outout differs bv rr ore than 5 cercent" rom the value o stained at t le est "ul calibration and the differs nee cannot be reconci ed. Theraceutic radiation machmes with mu ti-ener av and/or muhi moc e cana siities shall en v reouire measurements for those moc es anc /or enercies tist are not witiin their accentab e rance: and (2) Followtna any e smosnent reolacerrer t. maior reonir. or modification of comoonents that could sionificant v affect t,e c laracteristics o" t 1e radiation beam. If the reosir. reolacement or modification does not affect all modes end/or eneraies. measurements shall be nerformed on the effe enerov thet is in meet frecuent chnical use et the f ecihtv with ouality assurance check crocedures aosinst the criteria in FThe rem 9tnino eneroies < modes may be ve!icated .7.2O(al(1 L (e) The reoistrant shalluse the dosimetrv system described in Section H.4.3fa) to measure the raciation outout for one set of exoosure conditions. '~he remainno radiation measurements reouitet in H.7.201 3L (c) and (d) may then be made usino a dosimetrv svstem t 1st indicates te ative dose rates. and (f) The reo strant shall mnintain a record of each caliEration in an auditable form for the duration of reo stratic n. T1e record sha include t1e date of the rali3 ration. the rnanu"acturer's name. model number. anc seria number for the flieraneutic radiation rqac1:ne. the mode num 3ers and seria numbers of t1e nstruments used to cabbrace the thera Deutic rac iation machine. and the sionature o" the Radiotheraov Dhvsicist resoonsible "or cer"ormance 0" the cahbration. H.7.21 Periodic Quality Assurance Checks. (a) Periodic ouality assurance checks shall be oerformed on all theraceutic rad'ation maetnines subiect "c 4.7 at intervals not to exceed those soecified in "Comorehensive Q A "or Radiation 4 Onc oloov: Reoort of A APV i
- Iadiation Thernov Committee Task Grouc 40" All ner 3dic ouahty assurance c 1ecks with an annual "recuenev do not have to be cerformed at the same time. '3ut shall be comoleted durino an exceed 12 consecutive calendar months.
(b) The reoistrant shall use a dosimetrv syster, which has been inter-comoared within the orevious 12 months with the dosimetrv system described in i.L.3la) to make the oeriodic ouaktv assurance checks reouvred in H.7.21(al i fe) The reoistrant shall oerform 3er' odic ouality assurance checks recuired bv H.7.21(a) in accordance with crocedures estabhshed bv the Rac iothernov Phvsicist. (d) The recistrant shall review the results of each neriodic radiation outout check accordino t followine crocedures: (1) The authorized t ser or Radiothernov Physicist shall be immediatelv notified if anv earameter s not within its accentab e tolerance. 'he theracet.t c radiat on machine shall not be made availab e for subsecuent medical use until the Radiothernov P 1vsicist ins determined that all carameters are within their acceotab e to erances: (2) If all radiation outout oustity i ssurance check oarameters nonear to be within their aceeotable rance
- 1e cuaktv assurance check sha be reviewed and stoned bv either the authorized user or Radiothernov
- hvsicist within 14 calendar days; and (3) The Radiothernov Physicist shall review and sion the results of each radiation outout cuality assurance check at intervals not to exceed 1 month.
(e) Thernoeutic radiation machines subiect to H.7 shall have the followino safetv auslity assurance checks cerformeo at intervals not to exceed 1 week: (1) Prooer coeration of the " BEAM-ON" interruet and termination switches: 103 l PROPOSED - FOR COMMENT-april 1999 M (2) Beam condition Indientor lichts on the access doors. control console. and in the radiation thernov IESEi (3) Electricallv coerated treatment room doorfs) from inside and outside the treatment room; ffl The reoistrant shall oromotiv renair any system identified in H.7.21(a) and H.7.21(a) that is not coera?ino oronariv: and (c) The recistrant shalf maintain o record of each cuality assurance check recuired by H.7.21(a) and h7.214e) for 3 veers. The record she Iinclude the date of the cuehty assurance check. the manUfecterer's neme, model number, end serial number for the thereceutic racistion machine. the manuf ecturer3 name. model number and ser al number of the instrument's) Jsed to measure the radiation outout of the theraceutic radiation machine. anc the sionature of the indivicus who nerformed the ceriodic oualttv assurance check. i H.8 CAllBRATION OF SURVEY INSTRUMENTS 4 B.1 The reoirtrant s nafl ensure that the survev instrurre nts usec to show comoliance with Part H g 3een calibrated 3efore1 irst use, at intervals not to exceec 2 mont is. and followino reonir. H.B.2 To satisfv the reouirements of H.B.1. the reoistrant shall: fa) Calibrate all recuired sea e readirie s un to 10 mSv (1000 mr em) cer hour with in acerooriate radiation source that is traceab e to the Wattona nstitute of Standards anc Technoloov (N157. (b) Calibrate at least two (2) ooints on each scale to be calibrated. These coints should be at j accroximatelv 1/3 and 2/3 of ful -scale. j H.B.3 To satisfv the reouirements of H.B.2. the reoistrant shall: fa) Consider a noint as calibrated if the indicated dose rate differs from the calculated dose rate bv not more than 10 cercent. and r (b) Consider a noint as calibrated f the indicated dose rate diffe s from the calculated dose rate bv not more than 20 cercent if a correction " actor or oraoh is consoicuous v attached to the instrument. HA4 The recistrant shall retain a record of each entibration reouired in H.B.1 for 3 vears. The record shall inc ode fa) A descriotion of the calibration orocedure. and tb) A descriotion of the source used and the certified dose rates from the source and uhe rates indicated by the instrument 3eino cahbrated the correction f actors deduced " rom the cahbration c ata.t 7e sionature c" the individual wie nerformed the calibration. and the date of calibration. '4.8.5 The reoistrant may obtain the services of individuals licensed bv the Amenev. the U.S. Nuclear Reculatorv Commtssion. af Acreement State. or a Licensino State to oerform ca hbrations of survev ins?vuments. Records of cali brations which centain information reouired bv H.B.4 sha i Se maintained by the EEE1[d@a 104 s PROPOSED - FOR COMMENT APRIL 1999 U H.9 SHIELDING AND SAFETY DESIGN REQUIREMENTS H.9.1 - Each theraceutic radiation machine subieet to H.6 or H.7 s secondary barriers as are necessarv to ensure comoliance with A 2.3 and A.2. 1. of a theraceutic radiation mac1lne o" hioler enerov into a room not orevious v sooroved for that enerov s 1alH.9.2 Facility desion informs new installations of a theraceutic radiation machine or installa be submitted for Acenev accroval orier to actual instaHetion of the thereceu minimum fecthtv cesion information that must be submitted is contained in ADDe ~he { REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] l l l 105 l PROPOSED - FOR COMMENT-april 1999 M INFORMATION ON RADIATION SHIELDING L ALL THERAPEUTIC RADIATION MACHINES RED FOR PLAN REVIEWS 1. Basic facility information includino? name t yidividual resoonsible "or orecaration of the s i e . e eoisne number and Aeonev reo suoerviser! and the street address linelJdino room c ino olan name and teechone num 3er o" th n facilitv. ~~he olan should also indicate wiethe th atructureisy is is a new structure or a e facii r e jx 2. All wall floor. and ceiline areas struck b v the useful beam shall have crimary barri 3. Secondarv barriers shall be orovided in all ers.
- 11. THERAPEUTIC RADIATION MACHIN arriers in addition to che recuirements listed in S kV (PHOTONS ONLY)
Droduce oniv D 10 tons wit 7 a maximum enerov fess tha.n or soual to 15 Which contain. as a minimum the foll ne facilities which Eaulement soee'fications. includino the maowino additions informationj shall submit shieldino olans 1. rnachine. as we.1 as the maximum technioue fac ^ 2. Vlaximum desion workload f 3r the facility i ors. u e radiation trad) or air kerma at 1 metertotal beam-on time oer dav or wncludino to ~ Datient/ human research subiect M \\ . alono with the anticiosted number of oa eek. the averace. essed in orav treatment time oer 3. A facilitv blueerint/drawine indicatino; scal e treated eer da] normal location of the thera seutic radiation e (0.25 inch = 1 foot 's "voicaflt directi amitst ceneral direction (s) o" the uteful beam loc machine's radiation cort (s it t ne cort's trave a nd t of the theraceutic radiation mac vne control canel on of North thersoeutic radiation machine trettme ations o" any windows and doors! and t1e l raverse 5.ufficient to ensure comoliance with Aon the olan nt room, the location of the coerator's booththe ocation i e the The structuraleom sosition and t ntrol ennel shall be benind a orotecti .2.3 s qall be notel 4. arrie]r Lloor. and ceilino o" the room (s) hickness or lead / concrete eoui concerned. 5. The tvoe of occomanev of all adiacent of all walls. doors. eartitions. concerned. individuals may be oresent.If there is an exterior wall areas inclusive of soace above and belo . show distance to the closest arents) wh w the room (s) skelv that lli. THERAPEUTIC RADIATION MACHINES OVER 15 ~ 0 kV In addition to the reouirements listed in S Dreduce ohotons with a maximum s'e rovn excess of 150 kV and/or e actr D_lans which contain. as a minimum "S ne facilitien which e foi owino additional informationj _ 9. Ecuiement soecifications includino the m shall submit s ateldino nhoton. electront. machine. and orav frad) at the tsocenter The taroet to isocenter distance shall be enerov(s) and tvoe( ' of radiation orodunoeutic ra 2. Maximum desion workload for the facilitvin l di e soecified. cedt ie! -1radi at 1 meterl. total beam-on time oer day or we kno total cu e the aversoe treatment time oer eat orav ient. alono 106 L PROPOSED FOR COMMENT-april 1999 with the anticioated number of natients to be treated eer dav er week. 3. F4icility blueorint/drawinolincludina both floor olan and elevati on viewsl indicatina relati'te orientation o' the theraceutic radtation machine. sea e 10.25 inc i=1"oc
- 1tekness and 3rth. the.
't is tvoicall tvoe(s). rninimt m de nsinv of shleidina m9terial(s), c rection of h ocations and size of a i neneurations tiroua l eac 1s ateldina barrier Iceilina. wa is and floor as we I as details of the door (s) anc mare. 4. The structuralcomoosition and thickness or concrete eauivalent of all walls. doors. martitions. floor. and car ina of the roomls) concerned. 5. The tvoe of occuonnev of all adiacent areas inclusive of sonee above and below the room (s) concerned if there is an exterior wall, show distance to the closest aree(s) where it ts hkelv that individuais mev ba c* resent. 6. Descrio" ion of all assumotions that were in shieldina calculations inel;dina. but not limited to. desian enero*r iet room may be desicned "or 6 MV unit althouc 1 onlv a 4 VIV urit is currentiv orocosedl. work-cad. oresence of intears beam-stoo in unit. ocet cancv and usds) o" a diacent areas < ' action of lime that use"ul bea m will intercent en th cermanen't Darrier Iwalls. ' loor anc cethnal and "a owed" ractation exoosure in 30t 1 restricted anc unrestrictec areas. 7. At feast one examole calculation which shows the methodoloav used to catermine the amount o_f shieldina reauired for each or vsteal condition lie: orimarv a nd seconeorv/leakao e barriers. restrict ed ind unrestricted aree s. uma I anale scatter. entrv c oor(s ' and maze and ! hie dina material in t le 'acihtv. f commercia so"tware is used to aenerate s 1teldina reautrements, a so identifv the software used anc the versionirevision date. IV. NEUTRON SHIELDING In addition to the recuirements listec n Section 'll above thernoeutic radiation machine f acilities which i tr's cacable of ooeratina above 10 V V shall su 3mit shieldina clans whic 1 contain. as a minimum. t 1e "o lowina additionalinformation: i 1. The structuralcomoosition. thickness. minimum density and loca' ion of all neutron shieldina material. 2. ')escriotion of all assumotions that were tsed in neutron shii!!dina calculations includina. but not imitet to. n eutron soectra as a function o' enerav. rieutron f uence rate. a 3 sorbed dose and dose ecuivalent (cue to neutrons) in both restricted and unrestricted areas. 3. At least one examole calculation which shows the methodoloav used to determine the amount of reutron shieldina reautred for each chvsical conditic n lt e: restritted and unrestricted are as. entrv coor(s) and mazel and neutron shieldina material uti tzec in tF e "acilitv. If commercial so' tware is used to aenerate shieldina reautrements. also identi"v the so"tware used and the version / revision $11 4. The methodfs) and 'nstrumentation which will be used to verifv the adeousev of all neutron shieldina installed in the f act itv. V. REFERENCES 1. 4CRP Re cort 49. "StructuralShieldina Desian and Evaluation for Medical Use of X Ravs and Gamma Ravs of Enerales Uo to 10 MeV" (1976). 2. VCRP Recor" 51. " Radiation Protection Desian Guidelines for O.1-100 MeV Particle Accelerator
- acihties" (1 377l.
3. NCRP Recort 79. " Neutron Contamination from Medic.at Electron Accelerators" (1984). [END OF DOCUMENT) 107}}