ML20212G954
| ML20212G954 | |
| Person / Time | |
|---|---|
| Issue date: | 09/21/1999 |
| From: | Combs F NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Halisey R MASSACHUSETTS, COMMONWEALTH OF |
| References | |
| NUDOCS 9909300165 | |
| Download: ML20212G954 (88) | |
Text
i SEP 2 l iggg
- Mr. Robert M. Halisey, Director Radiation Control Program
, Department of Public Health
' 174 Portland Street,5th Floor Boston, MA 02114
Dear Mr. Hallisey:
- We have reviewed the final Massachusetts regulations which beca ne effective on July 9,1999.
The regulations are contained in Chapter 105, Section 120.001, G e 1eral Provisions; Section 120.100, Licensing of Radioactive Material; Section 120.200, Sta'.Jards for Protection Against Radiation; Section 120.300, Radiation Safety Requirements for Industrial Radiographic Operations; Section 120.500, Use of Radionuclides in the Healing Arts; and Section 120.770, Transportation of Radioactive Material. The request is based on Phillip Allen's e-mail dated August 5,1999. The final regulations.are in response to the eight amendments identified in the enclosed Regulation Assessment Tracking System (RATS) Data Sheet. The regulations were reviewed by comparison t. 5e equivalent NRC regulations in 10 CFR Parts 19,20,30,32,34, 35 and 71. In addition, we reviewed the regulations to determine that our previous oral comments made at the periodic meeting of March 21,1997, on your proposed regulations were incorporated into the final regulations. We also discussed our review of the final regulations with Salifu Dakabu on August 26,1999.
As a result of the NRC review,' we have determined that the Massachusetts regulations, as adopted, meet the compatibility and health and safety categories established in OSP Procedure SA-200. We have also summarized on the RATS Data Sheet our knowledge of the status of other Massachusetts regulations. Please let us know if you note any inaccuracies or have any comments on the information contained in the RATS Data Sheet.
if you have any questions regarding the comment, the compatibility criteria, or any of the NRC regulations used in the review, please contact me or Duncan White at (610) 337-5042 or ADW @ NRC. GOV.
Sincerely, Original signed by:
Frederick C. Combs, Deputy Director Office of State Programs
)
As stated l
\\
Distribution:
i DIR RF(9169)
DCD (SP05) - -
SDroggitis PDR (Yes)
- BUsilton Massichusetts File
- See previous concurrence
. DOCUMENT NAME: G:\\SNS\\MA9169.wpd T* teceive a cop t of this document, Indicate in the bor "C" = Copy without attachmenUenclosure "E" = Copy with attachment / enclosure *N" = No copy OFFICE RSAO:RI lE OSP l
OGC OSP:DD l
l NAME ADWhite SNSalomon:gd STreby FCombs DATE 09/02/99*
09/14/99*
09/17/99*
09/14/* 09#//99 OSP FILE CODE: SP-AG-30 9909300165 990921 T
PDR STPRQ ESGM 1
m.v
_ Mr. R:bart M. H:lisey, Dirgetor
' Radiation Contrtl Progr m Department of Public Health 174 Portland Streat,5th Floor Boston, MA 02114
Dear Mr. Hallisey:
We have reviewed the final Massachusetts regulations whif be::ame effective on July 9,1999.
The regulations are contained in Chapter 105, Section 120s001, General Provisions; Section 120.100, Licensing of Radioactive Material; Section 120.2, Standards for Protection Against Radiation; Section 120.300, Radiation Safety Requireme s for Industrial Radiographic Operations; Section 120.500, Use of Radiunuclides in t Healing Arts; and Section 120.770, Transportation of Radioactive Material. The request is b sed on Phillip Allen's e-mail dated August 5,1999. The final regulations are in response t the eight amendments identified in the enclosed Regulation Assessment Tracking System (
TS) Data Sheet. The regulations were reviewed by comparison to the equivalent NRC regulat ons in 10 CFR Parts 19,20,30,32,34, 35 and 71. In addition, we reviewed the regulations t determine that our previous oral comments made at the periodic meeting of March 21, 997, on your proposed regulations were incorporated into the final regulations. We also discu. sed our review of the final regulations with Salifu Dakabu on August 26,1999.
' As a result of the NRC review, we have determined that the Massachusetts regulations, as j
adopted, meet the compatibility and health and safpty categories established in OSP Procedure SA-200, We have also summarized on the RATS ata Sheet our knowledge of the status of other Massachusetts regulations. Please let us k ow if you note any inaccuracies or have any comments on the information contained in the S Data Sheet.
If you have any questions regarding the comme t, the compatibility criteria, or any of the NRC regulations used in the review, please contact e or Duncan White at (610) 337-5042 or ADW@NRC. GOV.
S' cerely, IFrederick C. Combs, Deputy Director Office of State Programs
Enclosures:
As stated Distribution:
DIR RF(9-169)
DCD (SP05)
SDroggitis PDR (Yes) i BUsilttn M:ssachusetts File
- DOCUMENT NAME
- G:\\SNS\\MA9169.wpd d-f,.p4e L.. ~.~,... ~
~..
OFFICE RSAO:RI c IEf OSP & l6 pGC l
Qlip';GQ l
l NAME ADWhite 3 %(.nSNSalom5n(d STre6y& An#M FCc(mbs[/ /
09/ 7/99 ggg u
DATE 09C /99) #
09//p99
/
q i*
/
l Mr. Robert M; H listy, Dirsctor Radi: tion C ntrol Progr:m.
' Department of Public Health '
174 Portland Street,5th Floor Boston, MA 02114
Dear Mr. Hallisey:
We have reviewed the final Massachusetts. regulations w ch became effective on July 9,1999.
The regulations are contained in Chapter 105, Section 12.001, General Provisions; Section 120.100, Licensing of Radioactive Material; Section 120. 00, Standards for Protection Against Radiation; Section 120.300, Radiation Safety Requirem ts forIndustrial Radiographic Operations; Section 120.500, Use of Radionuclides in t Healing Arts; and Section 120.770, Transportation of Radioactive Material.' The request is ased on Phillip Allen's e-mail dated.
August 5,1999.. The final regulations are in response t the eight amendments identified in the enclosed Regulation Assesrment Tracking System (
S) Data Sheet. The regulations were
. reviewed by comparison to. v equivalent NRC regula ons in 10 CFR Parts 19,20, 30,32,34, 35 and 71. In addition, we ruewed the regulations to etermine that our previous oral incorporated into the final regulations. We also discus /1997, on your pr comments made at the periodic meeting of March 21, sed our review of the final regulations with -
Salifu Dakabu on August 26,1999.
As a result of the NRC review, we have determined jhat the Massachusetts regulations, as
- adopted, meet the compatibility and health and safety categories established in OSP Procedure SA-200. We have also summarized on the RATS Dkta Sheet our knowledge of the status of other Massachusetts regulations. Please let us knfw if you note any inaccuracies or have any comments on the information contained in the RATS Data Sheet /
If you have any questions regarding the comment the compatibility criteria, or any of the NRC' regulations used in the review, please contact m or Duncan White at (610) 337-5042 or ADW@NRC. GOV.
'S!n rely, Fr derick C. Combs, Deputy Director j
ice of State Programs
Enclosures:
As stated Distribution:
DIR RF(9-169)
DCD (SP05)
SDroggitis PDR (Yes)
BUsilton M:ssachusetts File -
DOCUMENT NAME: G:tSNS\\MA9169.wpd Tm receive a cop i of this document, Ind6cato in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE RSAO;RI c l[f OSP M [6 OGC l
QE P:GQ l
l NAME ADWhite > "k( a @NSalomori$/
STreby FCdm )s[/ /
DATE 09g2/99 p#
09//$99 /
09/ /99 Mf99 q (*
L"
[ stephen Salomori!R3A FLview tf Regs
~j Pigri1]
From:
Duncan White To:
Stephen Salomon Date:
Thu, Sep 2,1999 3:57 PM
Subject:
Re: MA Review of Regs Iconcur.
>>> Stephen Salomon 09/02 3:55 PM >>>
- Duncan, Thanks for your response. Attached is what I am sending o Gwen. Do you concur?
For item 1 in your response I added a corresponding sent nce.
For item 2 I used the date when the Commission signed,3/3/97 for the date of Commission review and 3/21/97 for the effective date.
For item 3, I left it blank. We'll see what MA says.
Thanks again.
Steve L
/
/
/
f G
E.
pa aar l
p UNITED STATES i.
j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30e86 4001 September 21, 1999 Mr. Robert M. Hallisey, Director Radiation Control Program Department of Public Health 174 Portland Street,5th Floor Boston, MA 02114 1
Dear Mr. Hallisey:
We have reviewed the final Massachusetts regulations which became effective on July 9,1999.
The regulations are contained in Chapter 105, Section 120.001, General Provisions;Section I
120.100, Licensing of Radioactive Material; Section 120.200, Standards for Protection Against Radiation; Section 120.300, Radiation Safety Requirements for industrial Radiographic Operations; Section 120.500, Use of Radionuclides in the Healing Arts; and Section 120.770, Transportation of Radioactive Material. The request is based on Phillip Allen's e-mail dated August 5,1999. The final regulations are in response to the eight amendments identified in the enclosed Regulation Assessment Tracking System (RATS) Data Sheet. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,32,34, 35 and 71. In addition, we reviewed the regulations to determine that our previous oral comments made at the periodic meeting of March 21,1997, on your proposed regulations were incorporated into the final regulations. We also discussed our review of the final regulations with Salifu Dakabu on August 26,1999.
As a result of the NRC review, we have determined that the Massachusetts regulations, as adopted, meet the compatibility and health and safety categories established in OSP Procedure SA-200. We have also summarized on the RATS Data Sheet our knowledge of the status of other Massachusetts regulations. Please let us know if you note any inaccuracies or have any comments on the information contained in the RATS Data Sheet.
If you have any questions regarding the comment, the compatibility criteria, or any of the NRC regulations used in the review, please contact me or Duncan White at (610) 337-5042 or ADW@NRC. GOV.
Sin re
'Co ~s, ueputyIctor i ' '
Office of State Programs i
Enclosure:
As stated
i REGULATION ASSESSMENT TRACKING SYSTEM i
RATS DATA SHEET l
State: Massachusetts Tracking Ticket Number: 9-169
'8 final amendments (7/9/99) identified by *]
Date: September 21,1999 NRC Chronology identification :
FR Notice RATS ID Proposed /.
.NRCn Final State (State Due Final-Review Regulation Date).
(Y/N)
Date)
Comment ~
Date.
(Effective Standards for Protection Against Radiation-56 FR 23360 1991 3 F-N 3/3/97 3/21/97 Part 20 plus others (1/1/94)
Sifety Requirements for Radiographic 55 FR 843 1991 1 F-N 3/3/97 3/21/97 Equipment-Part 34 (1/10/94)
ASNT Certification of Radiographers-Part 34 56 FR 11504 1991 2 Not j
(none)
Required j
Notification of Incidents-Parts 20, 30, 31, 34, 56 FR 64980 1991 4 F-N 3/3/97 3/21/97 39,40,70 (10/15/94)
Quality Management Program and 56 FR 34104 1992 1 F-N 3/3/97 3/21/97 Misadministrations-Part 35 (1/27/95)
Eliminating the Recordkeeping Requirements 57 FR 45566 1992-2 Not required for Departures from Manufacturer's (none) instructions-Parts 30.35 Licensing and Radiation Safety Requirements 58 FR 7715 1993-2 F-N 3/3/97 3/21/97 for irradiators Part 36 (7/1/96)
D:finition of Land Disposal and Waste Site 58 FR 33886 1993-3 F-N 3/3/97 3/21/97 QA Program-Part 61 (7/22/96)
Decommissioning Recordkeeping and 58 FR 39628 1993-1 F-N 3/3/97 3/21/97 License Termination: Documentation (10/25/96)
Additions [ Restricted areas and spill sites]-
Parts 30, 40 S:lf-Guarantee as an Additional Financial 58 FR 68726 1994 1 F-N 3/3/97 3/21/97 Mechanism-Parts 30,40,70 59 FR 1618 (none)
Uranium Mill Tailings Regulations:
59 FR 28220 1994-2 Not Conforming NRC Requirements to EPA (7/1/97) applicable Standards-Part 40 Timeliness in Decommissioning Material 59 FR 36026 1994 3 Freilities-Parts 30,40, 70 (8/15/97)
- Preparation, Transfer for Commercial 59 FR 61767 1995-1 F-N 9/21/99 7/9/99 Distrioution, and Use of Byproduct Material 59 FR 65243 for Medical Use-Parts 30,32,35 60 FR 322 (1/1/98)
Frequency of Medical Examinations for Use 60 FR 7900 1995-2 of Respiratory Protection Equipment-Part 20 (3/13/98)
Low-Level Waste Shipment Manif est 60 FR 15649 1995-3 Information and Reporting-Parts 20,61 60 FR 25983 (3/1/98)
[NRC Chronologyidentifloation..
1(State Due[
Final f..
Reviewi Regulation) l FR NoticeI
[ RAT 8(ID / Proposed /-.NRCL
' final State?
s'
- m (mDate)j Comment; Date ?
(Effactive; x
-(Y/N)4 Dato)
- Performance Requirements for Radiography 60 FR 28323 1995-4 superced.
Equipment Part 34 (6/30/98) ed by RATSID 1997-5 Radiation Protection Requirements:
60 FR 36038 1995-5 Amended Definitions and Criteria-Parts 19, (8/14/98) 20 Clarification of Decommissioning Funding 60 FR 38235 1995-6 Requirements-Parts 30,40,70 (11/24/98)
- Medical Administration of Radiation and 60 FR 48623 1995-7 F-N 9/21/99 7/9/99 Radioactive Materials-Parts 20,35 (10/20/98)
- 10 CFR Part 71: Compatibility with the 60 FR 50248 1996-1 F-N 9/21/99 7/9/99 Intemational Atomic Energy Agency-Part 71 61 FR 28724 (4/1/99)
One Time Extension of Certain Byproduct, 61 FR 1109 1996-2 Not required Source and Special Nuclear Materials (none)
Licenses-Parts 30,40,70
- Termination or Transfer of Licensed 61 FR 24669 1996-3 FN 9/21/99 7/9/99 Activities: Recordkeeping Requirements.
(6/17/99)
Parts 20, 30, 40, 61, 70
- Resolution of Dual Regulation of Airborne 61 FR 65119 1997-1 F-N 9/21/99 7/9/99 Effluents of Radioactive Materials; Clean Air (1/9/00)
Act-Part 20 Fissile Material Shipments and Exemptions-62 FR 5907 1997-4 Not required Part 71 (none)
Recognition of Agreement State Licenses in 62 FR 1662 1997-2 Areas Under Exclusive Federal Jurisdiction (2/27/00)
Within an Agreement State-Part 150
- Criteria for the Release of Individuals 62 FR 4120 1997-3 F-N 9/21/99 7/9/99 Administered Radioactive Material.
(5/29/00)
Parts 20,35
- Licenses for Industrial Radiography and 62 FR 28948 1997-5 F-N 9/21/99 7/9/99 Radiation Safety Requirements for Industrial (6/27/00)
Radiography Operations-Parts 30,34,71, 150 Radiological Criteria for License Termination-62 FR 39057 1997-6 Parts 20, 30, 40, 70 (8/20/00)
- Exempt Distribution of a Radioactive Drug 62 FR 63634 1997-7 F-N 9/21/99 7/9/99 Containing One Microcurie of Carbon-14 (1/02/01)
Ursa-Part 30 Deliberate Misconduct by Unlicensed 63 FR 1890 1998-1 Persons-Parts 30,40,61,70,150 63 FR 13773 (2/12/01)
Self-Guarantee of Decommissioning Funding 63 FR 29535 1998-2 Not required I
by Nonprofit and Non-Bond-issuing (none) l Licensees-Parts 30, 40. 70 1
- NRC Chronology identification
FR Notice :.
- RATS ID Proposed /.
NRC::
Final State :
i
!.(State Due1 Final '..
Review; Regulation 9
- Date):
Comment; Date.
(EffectiveT (Y/N)'-
' Date):
License Term for Medical Use Licenses-63 FR 31604 1998-3 Not required P*rt 35 (none)
J Licenses for Industrial Radiography and 63 FR 37059 1998-4 Radiation Safety Requirements for Industrial (7/9/01)
Radiographic Operations-Part 34 Minor Corrections, Clarifying Changes, and a 63 FR 39347 1998-5 Minor Policy Change-Parts 20,35,36 63 FR 45393 (10/26/01)
TrInsfer for Disposal and Manifests: Minor 63 FR 50127 1998-6 Technical Conforming Amendment-Part 20 (11/20/01)
R diological Criteria for License Termination 64 FR 17506 1999 1 Not of Uranium Recovery Facilities-Part 40 (6/11/02) applicable l
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Changes to 105 CMR 120.000 which became effective 7/9/99 l
SUMMARY
OF REGULATION L
The amendments are intended to update the Massachusetts regulations to keep them compatible l
and consistent with curmnt NRC's and other national organizations' regulations goveming the use, transportation and disposal of radioactive materials, ard machine produced ionizing radiations. 'Ihe promulgation of these amendments is a necessary con 2quence of Massachusetts being an " Agreement State" and a Licensing State and having the responsibility for the regulation of all soun:es of mdiation, including naturally occumng radioactive material (NARM), byproduct and special nuclear material, and radiation produced by machines. Specifically, the amendments incorporate changes that NRC has made to its regulations since Massachusetts last updated its regulations on February 9,1996. The amendments
~ also make corrdtion oftypographical and editorial errors. The major areas ofrevision include an expansion j
of and/or a clarification of the following: general Definitions (105 CMR 120.005); the Exempt Items Rule (105 CMR 120.104(C)), providing an exemption for Radioactive drug Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans; Radiation Safety Requirements for Industrial Radiography i
regulations (105 CMR 120.300) ; X-Rays in the Healing Arts regulations (105 CMR 120.400) which transfers therapeutic uses to a new section: Therapeutic Radiation Machines (105 CMR 120.430); the Medical Use Rule (105 CMR 120.500), including an expansion of the categories of patients containing radioactive materials who may be released from confinement; and, the Transportation of Radioactive l'
Materials regulations (105 CMR 120.770).
Details of changes L
l In 120.005: Definitions l
insert: A 1 i
l Confinnatory Action Letters means letters, confirming a licensee's, registrant's, or vendor's agreement to take certain actions to remove significant concems about health and ' safety, safeguards, or the emironment.
Constraint (dose constraint) means a value above which specified licensee actions are required.
i Half-value laver (HVD means the thickness of a specified material which attenuates X-radiation or gamma radiation l
to an extent that the air kerma mte, exposure rate, or absorbed dose rate is reduced to one-halforthe value measured l
without the material at the same point.
Irradiation means the exposure of a living being or matter to ionizing radiation.
Kilovolt (kV) Ikilo electron volt (kev 1] means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand vohs in a vacuum. [ Note: curmnt convention is to use kV for photons and kev for electrons.]
1 t
E Chang:s to 105 CMR 120.000 which became effective 7/9/99 Lead Fmivalent means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.
Leakage Radiation means radiation emanating from the diagnostic or therapeutic source assembly except for:
(1)The useful beam; and, (2) Radiation produced when the exposure switch or timer is not activated.
Patient means an individual subjected to healing arts examination, diagnosis, or treatment Phantom means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that oftissue.
> Protective Barrier rneans a barrier of radiation absorbing material (s) used to mduce radiation exposum. The types of protective baniers am as follows:
(1) Prinury protective banier means the material, excluding filters, placed in the useful beam.
(2) Secondary protective barrier means the material which attenuates stray radiation.
Radiation Detector means a device which, in the presence of radiation, pro 5 ides by either direct or indirect means a signal or other indication suitable for use in measurmg one or more quantities ofincident radiation.
Scattered rndiation means ionizing radiation emitted by the interaction ofionizing radiation with matter, the intemction being accompanied by a change in direction of the radiation.
Scattered nrimary radiation means that scattered radiation that has been deviated in direction only by materials irradiated by the useful beam.
Shuller means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
Special form radinactive material means radioactive material which satisfies the following conditions:
(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destmying the capsule; (2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and, (3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in efTect June 30,1983, and constructed prior to July 1,1985, may continue to be used. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on March 31, 1996, and constmeted prior to April 1,1998, may continue to be used. A special form encapsulation 2
7-Changes to 105 CMR 120.000 which bec:me effective 7/9/99 either designed or constructed aller April 1,1998, must meet requirements of tids defmition applicable at the time ofits design or construction.
12 J20.009: Records Replace text with: A 2 (A) Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in 105 CMR 120.000.
(B) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, chall forward the following records to the Agency:
(1) Records ofdisposal oflicensed material made under 105 CMR 120.252 (including burials authorized before January 28,1981),105 CMR 120.253,120.254,120.255; and, (2) Records required by 105 CMR 120.263(B)(4).
4 (C)
Iflicensed activities are transferred or assigned in accordance with 105 CMR 120.131(B), each licensee authorized to possess radioxtive material, with a half-life greater than 120 days, in an unsealed fonn, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is tenninated:
(1) Records ofdisposal oflicensed material made under 105 CMR 120.252 (including burials authorized before January 28,1981),105 CMR 120.253,120.254,120.255; and, 4
(2) Records required by 105 CMR 120.263(B)(4).
(D) Prior to license termination, each licensee shall forward the records required by 105 CMR 120.125(C)(1)(g) to the Agency.-
I: 120.013: Communicatiout i
Replace address with: A 3 l
174 Portland Street, Boston, MA,02114.
In 120.016mWI): Enforcement Procedures 1: sert: A 4 (b)
Confirmatory Action Letters. The Agency may issue Confinnatoiy Action letters confirming a licensce's, registrant's, or vendor's agreement to take certain actions to remove significant concerns about health and safety, safeguards, or the environment.
3
Changes to 105 CMR 120.000 which became effective 7/9/99 In 120.024(A): Plan Revim Add:B1 Additional shielding and design requirements are specified elsewhere in 105 CMR 120.000.
12120.104(B):Exemnt Ouantities Replace (B)(1) with: C 1 (1) Any person is exempt from 105 CMR 120.100 to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in 105 CMR 120.196: Appendix B Table I provided they have been distributed pursuant to a license as described in 105 CMR 120.104(B)(3).
'a 120.104(C): Exempt Items Irsert item (C)(5): C 2 (5) Radioactive drug Capsules containing carbon-14 urea for "in vivo" diwnostie use for humans.
(a) Except as provided in 105 CMR 120.104(C)(5)(b) and ( c ), any person is exempt from the requirements for a license set forth in Section 5P ofM.G.L. c. I11 and from the regulations in 105 CMR 120.100 and 105 CMR 120.500 provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 p Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for in vivo diagnostic use for humans (b) Any persons who desires to use the capsules for research invoMng human subjects shall apply for and receive a specific license pursuant to 105 CMR 120.500.
(c) Any person who desires to manufacture, prepare, process, produce, package, or transfer foi commercial distribution such capsules shall apply, to NRC, for and receive a specific license pursuant to 10 CFR 32.21.
(d) Nothing in 105 CMR 120.104(C)(5) mileves persons fmm complying with applicable FDA, other Federal, and State requirements goveming receipt, administration, and use of drugs.
13120.122(I)(2): General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing i;scrt: C 3 4
i Changes to 105 CMR 120.000 which became effective 7/9/99
, or, has a license that authorizes the medical use of radioactive material that was issued under 105 CMR 120.500.
la 120.128(D)(4):
1 Replace 120.128(D)(4)(c) with: C 4 (e) keep records showing the name, address, and the point ofcontact for each general licensee to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in 105 CMR 120.122(D), or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The records shall show the date of each transfer, the radionuclide and the quantity of radioxtivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of105 CMR 120.128(D)(4)(d). The records required by 105 CMR 120.128(D)(4)(e) shall
{
he maintained for a period of five years from the date of the recorded event.
la 120.128(J): Manufacture. Preparation.orTransfer for Commercial Distribution of Radioactive Drues l
Containine Radioactive Material for Medical Use Under 105 CMR 120.500 R: place.120.128(JV1) with: C 5 (J) Manufacture. Prenaration. or Transfer for Commercial Distribution of Radioactive Dmes Containine Radioactive Material for Medical Use Under 105 CMR 120.500.
(1)
An application for a specific license to manufacture, prepam, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to 105 CMR 120.500 will be approved if:
(a) the applicant satisfies the general requirements specified in 105 CMR 120.125; (b) the applicant submits evidence that the applicant is at least one of the following:
l 1.
registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer; or
- 2. registered or licensed with a state agency as a drug manufacturer, or,
- 3. licensed as a pharmacy by a State Board of Pharmacy; or,
- 4. operating as a nuclear pharmacy pursuant to 247 CMR 13.00.
(c) the applicant submits information on the mdionuclide; chemical and physical fonn; the i
maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for safe handling and storage of the radioactive drugs by medical use licensees; and, (d) 1. a label is aflixed to each transpon radiation shield, whether it is constructed oflead, glass, plastic, or other material of a radioactive drug to be transferred for commemial distributien.
The label must include the radiation symbol and the words
" CAUTION, RADIOACTIVE MATERIAL", the rame of the radioactive drug or its abbmviation, and the quantity of mdioactivity at a specified date and time. For radioactive 5
r, Changes to 105 CMR 120.000 which became effective 7/9/99 l
drugs with a halflife greater than 100 days the time may be omitted.
- 2. a label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words " CAUTION, RADIOACTIVE MATERIAL" or " DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, sial, or other container can be correlated with the information on the tmnspon radiation shield label.
In 120.142(C)(1): Preparation and Submission of Reports.
Replace initial paragraph with: C 6 (1) Licensees shall make reports required by 105 CMR 120.142(A) and (B) by telephone to the Agency at (617) 727-6214 during normal working hours or the Nuclear Incident Advisory Team (NIAT) (617) 727-9710, at all other times. To the extent that the information is available at the time of notification, the information pmsided in these repons must include:
In 120.196: Appendix B Table 11-Ouantities For Use With 105 CMR 120.125(C)(1) irsert List: C 7 Material Microcuries Iodine-126 1.00 Iodine-129 0.1 lodine-131 1.0 Iodine-132 10.00 lodine-133 1.00
{
Iodine-134 10.00 lodine-135 10.00 Iridium-192 10.00 Iridium-194 100.00 1
Iron-55 100.00 Iron 59 10.00
)
Krypton-85 100.00
)
Krypton-87 10.00 Lanthantun-140 10.00 Lutetium-177 100.00 Manganese-52 10.00 Manganese-54 10.00 l
6 l
-i
m Changes to 105 CMR 120.000 which became effective 7/9/99 Ii Manganese-56 10.00 Mercury-197m 100.00 Mercury-197 100.00 Mercury-203 10.00 l
Molybdenum-99 100.00 Neodymium-147 100.00 Neodymium-149 100.00 Nickel-59 100.00
. Nickel-63 10.00 Nickel-65 100.00 Niobium-93m 10.00 Niobium-95 10.00 Niobium-97 10.00 Osmium-185 10.00 Osmium-191m 100.00 Osmium-191 100.00 Osmium 193 100.00 Palladium-103 100.00 Palladium-109 100.00 Phosphorus-32 10.00 Phosphorus-33 100.00 Platinum-191 100.00 Platinum-193m 100.00 Platinum-193 100.00 Platinum-197m 100.00 Platinum-197 100.00 Plutonium-239 0.01 Polonium-210 0.1 Potassium-42 10.00 Praseodymium-142 100.00 Praseodymium-143 100.00 Promethium-147-10.00 Promethium-149 10.00 Radium-226 0.01 Rhenium-186 100.00 Rhenium-188 -
100.00 Rhodium-103m 100.00 Rhodium-105 100.00 Rubidium-86 10.00 120.1% Table II: > continued 7
I-
Changes to 105 CMR 120.000 which bec me effective 7/9/99 i
Material Microcuries Rubidium-87 10.00 Ruthenium-97 100.00 12 120.210: Radiation Protection Progr==s 11 sert: D1 (D) To implement the ALARA requirements of 105 CMR 120.210(B), and notwithstanding the requirements in 105 CMR 120.221, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees, such that the individual member of the public likely to n:ceive the highest dose will not be expected to receive a total efTective dose equivalent in excess of 0.1 mSv (10 mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in 105 CMR 120.283 and promptly take appropriate corrective action to ensure against recunence.
In 120.283: Reports of Exoosures. Radiation Levels and Concentrations of Radioactive Material Exceeding the Constraints or Limits insert: D 2 (f) the ALARA constraints for air emissions established under 105 CMR 120.210(D); or, in 120.302: Definitions insert: E 1 Annual Refn sher Safety Trainine means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects ofindustrial radiography. The n: view may include, as appropriate, the results
)
ofinternal audits, new procedures or equipment, new or revised regulations, accidents or errors that have been I
observed, and should also provide opportunities for employees to ask safety questions.
Associated Eauioment means equipment that is used in conjunction with a radiogmphic exposure desice to make radiogmphic exposures that drives, guides, or comes in contact with the source, (such as, guide tube, control tube, control cable (drive cable), removable source stop, "J" tube and collimator when it is used as an exposure head)
Cabinet Radiocranhy means. delete redietks !sa and insert: E 2
- doses to individual members of the public I
8 l
l i-
I
. Changes to 105 CMR 120.000 which becune effective 7/9/99 I: sert: E 3 Cenificatinn means the authorization by the Massachusetts Radiation Contml Program (Agency) of an individual to
' perform industrial radiography in the Commonwealth of Massachusetts Cenifie11 InMorial R=iiouranher means an individual who has met prescribed training and experience requirements
? and has passed an approved examination and is authorized by the Agency, pursuant to 105 CMR 120.321(H)(1),
to. perform industrial radiography.
(
Certified Irvinorial Rwiiocranher Trainee means an individual who is authorized by the Agency, pursuant to 105 CMR l
.120.321(H)(2), to be instructed in industrial radiography and who may perform industrial radiography while under the personal supervision of a Certified Industrial Radiographer or an approved Provisionally Cenified Industrial Radiographer.
Control Cable (Drive Cable) means the cable that is connected to the source assembly and used to drive the source from and retum it to the shielded position.
Control Mechanism (Drive Mechanism) means a device that enables the source assembly to be moved from and retumed to the shielded position. A drive mechanism is also known as a crank assembly.
Control tube means a pmtective sheath for guiding the dive cable. The control tube connects the drive mechanism
._ to the radiographic exposure desice.
Exposure Head means a device that locates the gamma mdiography sealed source in the selected working position.
An exposure head is also known as a source stop.
Guide Tube means a flexible or rigid tube, such as a "J" tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.
Add to definition ofIndustrial Rwiiocranhv : E 4 hvisorial R=iiocranhv. For purposes of 105 CMR 120.300, industrial radiography does not include radiogmphy performed with Lixiscopes or cabinet x-ray systems, nor does it_ include computed tomography or computer-based digital radiography in which the useful beam of radiation is collimated to detectors.
Irsert: E 5 hvinorial Rmliocranhv -Rmiiation Machings means the process of performing industrial radiography using mdiation producing machines.
9
Chang:s to 105 CMR 120.000 which becane effective 7/9/99 Industrial Radiocraohv -Radioactive Materials means the process of perfonning industrial radiography using radioactive materials.
Lav-barce Radiocraphy means industrial radiography performed on any water vessel used for lapng pipe.
Offshore Platform Radiocranhv means industrial radiography conducted from a platform over a body of water.
Provisionally Certified Industrial Radiocmpher means an individual who was employed as an industrial radiographer prior to July 1,1999, and who is authorized by the Agency, pursuant to 105 CMR 120.321(H)(3), to perfonn industrial radiography.
Replace definition of Personal Sunervisionwith E 6 Pc rsonal Supervision means supervision provided by a Certified Industrial Radiographer or an approved Provisionally Certified Industrial Radiographer who is physically present at the site where sources of radiation and associated equipment are being used, visually evaluating the perfonnance of the Certified Industrial Radiographer Trainee and in such proximity that inunediate assistance can be given if required.
Dite definition of:
Radiation Symbol Radiocranher Trainer.
In definition of Radiation Safety Officer change 105 CMR 120.370 to:
105 CMR 120.380.
Insert definition: E 7 S-tube means a tube through which the radioactive source travels when inside a radiographic exposure desice.
Underwater Radiocmnhv means industrial radiography performed when the radiographic exposure device and/or related equipment are beneath the surface of the water.
Replice 120.311 with: E 8 120 311: Limits on Extemal Radiation Levels from Storace Containers and Sourte Chancers The maximum exposure rate limits for storage containers and source changers are 2 mSv/hr (200 mrem /hr) at any l
cxterior surface, and 0.1 mSv/hr (10 mrem /hr) at 1 meter from any exterior surface with the sealed source in the l
10 L
Changes to 103 CMR 120.000 which became effective 7/9/99
. shielded position.
Usert in 120312(A): E 9 or radiographer tminee, or an individual specifically authorized by the Agency.
Replace 120312(B) and(C) with: E 10 (B) Each radiographic exposure device, storage container, and source changer shall have a lock or outer lockable container designed to prevent unauthorized or accidental removal or exposure of a sealed source. Each exposure device and souwe changer shall be kept locked and,ifa keyed lock, the key removed at all times except when under the direct visual surveillance of a radiographer or mdiographer tminee, or an indisidnal specifically authorized by the Agency.
(C) Each radiographic exposure device, storage container, and source changer shall be locked and the key removed from any keyed lock prior to being transported from one location to another and also prior to being stored at a given location.
Replace 120313(A) with: E I1 120313: Permanent Storace Precautions (A) Locked radiographic exposure devices, source changers, storage containers, and transport containers that contain sealed sourtes and radiation machines used in industrial radiography shall be physically secured to prevent tampering or removal by unauthorized personnel.
Repl:ce 120314(A)and (B) with: E 12 (A) The licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by 105 CMR 120.300 and 120.225(A). Instrumentation required by 105 CMR 120.300 shall have a range from 0.02 mSv/hr (2 mrem /hr) through 0.01 Sv/hr (I rem /hr).
(B) Each radiation survey instrument shall be calibrated:
(1) By a person licensed or registered by the Agency, another Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission to perfomi such senice; (2) At energies appropriate for the licensee's or registrant's use; (3) At intervals not to exceed six months and after each instrument senicing other than battery replacement; (4) To demonstrate an accuracy within plus or minus 20%; and, (5) At two points located approximately % and % of full-scale on each scale for linear scale 11 L
l Chang:s to 105 CNiR 120.000 which beetme effective 7/9/99 instruments; at midrange ofeach decade, and at two points of at least one decade for logarithmic scale instruments; and for digital instruments, at three points between 0.02 and 10 mSv/hr (2 and 1,000 l
mmm/hr).
Replace 120.315: E 13 i
120.315: Reauirements for Equinment Used in hvinorial lhdiourachic Ooerations (A) Conformance with ANSI Standards.
l Equipnwnt used in industrial radiographic operations shall meet the following minimum criteria:
)
(1) Each radiographic exposure device, source assembly, sealed source, and associated equipment
{
shall meet the criteria set forth by ANSI N432-1980.
I (2) RadiationmachinesmanufactumdafterJanuary10,1992usedinindustrialradiographicoperations I
shall be certified at the time ofmanufacture to meet the criteria set forth by ANSI N537-1976, except accelerators used in industrial radiography.
(3) All radiographic exposure devices and associated equipment in use after January 10,1996, must comply with the requirements of 105 CMR 120.315 '
(4) In lieu of subparagraph 105 CMR 120.315(A)(1), equipment used in industrial radiographic operations need not comply with {8.9.2(c) of the Endurance Test in ANSI N432-1980, if the
{
prototype equipment has been tested using a torque value representative ofthe torque that an individual j
using the radiography equipment can realistically exert on the lever or crankshaft of the drive
{
mechanism.
(5) Engineenng analysis may be submitted by a licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon resiew, the agency may find this an acceptable altemative to actual testing of the component in accordance with 105 CMR 120.315(A)(1).
(B) Labeling.
(1) Each sealed source or soume assembly shall have attached to it or engraved in it a durable, legible, visible label with the words " DANGER. RADIOACTIVE." and a unique serial number. The label shall not interfere with the safe operation of the radiographic exposum device and associated equipment.
(2) Each radiographic exposure device and transport container shall have permanently attached to it a durable, legible, clearly visible label (s) that has, as a minimum, the standard tmfoil radiation caution symbol conventional colors, for example, magenta, purple or black on a yellow background, hasing a minimum diameter of 25 millimeters, and the following wording " CAUTION, RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTIIORITIES (OR NAME OF COMPANY)" or " DANGER.
RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTIIORITIES (OR NAME OF COMPANY).'
(3) Each radiographic exposure device shall have attached to it one or more durable, legible, clearly
. visible labels which show the manufacturer's name, the rated capacity in curies (or becquerels), the 12
s:
Changes so 105 CMR 120.000 which became effective 7/9/99 L
mass of the device without mmovable accessories, and the mass of uranium, if any, used as shielding.
The following information about the sealed source shall also be shown: (A) radionuclide chemical symbol and mass number, (B) activity and the date on which this activity was measured, (C) model number and serial number, (D) manufactumr of the sealed source, and (E) licensee's name, address, and telephone number.
(4) Radiographic exposure devices intended for use as Type B transport containers, shall meet the applicable requirements of 10 CFR Part 71.
. (5) Each vehicle used to transport radioactive material or radiation machines for temporaryjob site use must display durable, clearly visible placards and/or labels showing the licensee's name, and the city or town where the licensee's main business office is located.
j
- (6) Modification of any exposum devices and associated equipment is prohibited, unless the design of any replacement component,- including source holder, source assembly, controls or guide tubes would not compmmise the design safety features of the system.
(C) Performance Reauirements. In addition to the requirements specified in 105 CMR 120.315(A) and (B), 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 routine operations or to source changers:
(1) The coupling between the sourte assembly and the contml cable must be designed in such a manner that the source assembly will not become disconnected ifcranked 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 by means ofa deliberate operation on the exposure desice.
(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 transportation to protect the source assembly fmm water, mud, sand or other foreign matter.
(4): Each sealed source or source assembly must have attached to it or engraved on it, a durable,
' legible, visible label with the wonis:
" DANGER -- RADIOACTIVE."
The label must not interfere with the safe operation of the exposure desice or associated
. equipment.
- (5) - The guide tube must be able to withstand a crushing test that closely approximates the cmshing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely appmximates the kinking forces that are likely to be encountered during use..
(6) Guide tubes must be used when moving the source out of the device.
(7) An exposure head, endcap, or similar device designed to prevent the source assembly from passing out of the end of the guide tube shall be attached to the outermost end of the guide tube during radiographic operations.
(8) ne guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432-1980.
13 4
r
. Changu to 105 CMR 120.000 which became effective 7/9/99
- (9) Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnectmg the drive cable to or from a source assembly.
. (' D) ' Leak Teding (1) Each sealed source shall be tested for leakage at intervals not to exceed six months. In the absence of a certificate from a transferor indicating that a test has been made within the six-month period prior to the tmnsfer, the sealed source shall not be put into use until tested.
. (2) _ The leak test shall be capable of detecting the presence of I85 Bq (0.005 microcuries) of n movable contamination on the sealed source. An acceptable leak test for sealed sources in the possession of a radiography licensee would be to test at the nearest accessible point to the sealed source storage position, or other appropriate measuring point, by a procedure to be approved pursuant to 105 CMR 120.126(A)(5). Records ofleak test results shall be kept in units of becquerels or microcuries and maintamed for inspection by the Agency for five years after it is made.
(3) Any test conducted pursuant to 105 CMR 120.315(D)(1) and (2) which reveals the presence of I85 Bq (0.005 microcuries) or more of removable radioactive material shall be considered evidence
. that the sealed sourte is leaking. The licensee shall immediately withdraw the equipment involved from use and shall cause it to be decontaminated and repaired or to be disposed ofin accordance with regulations of the Agency. Within five days afler 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.
(4) Each exposure device using DU shielding and an "S" tube configuration shall be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 Bq (0.005 micmcurics) of radioactive material on the test sample and must be perfonned by a peson specifically authorized by the Commission or an Agreement State to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed it:m use until an evaluation of the wear of the S-tube has been made. Should the evaluation revnt that the S-tube is wom through, the device may not be used again. DU shielded devices Jo not have to be tested for DU contamination while in storage and not is use. Before using or transferring such a device, however, the device must be tested for DU contamination, if the interval ofstorage exceeds 12 months. Each licensee shall maintain records ofleak testing of sealed sources and devices containing DU. The licensee shall retain each record for agency inspection for five years f
from the date of the leak test..
(5) An applicant or licensee who desires to conduct its own tests for leakage or contamination shall establish procedures to be followed when testing sealed sourtes for leakage or contamination and shall submit a description of such procedures to the Agency for approval. The description shall include the:
(a) Instrumentation to be used; (b) Method of performing the tests; and (c) Pertinent experience of the irxiividual(s) who will perform the test.
1 (G) Limitation. The replacement of any scaled source fastened to or contained in a radiographic exposure desice 14 i
Changes to 103 CMR 120.000 which became effective 7/9/99 and leak testing, repair, tagging, opening, or any other modification of any sealed source shall be performed only by persons specifically authorized to do so by the Agency, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State.
Replace 120.318(A), (H) and (' C) with: E 14
-120.318-Insnection and Maintenance
~
(A) Each' licensee or registrant shall perform visual and operability checks on survey meters, mdiation machines,
- radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability must be performed using check sources or other appropriate means. Ifequipment problems are found, the equipment must be removed fmm service until mpaned.
(B) At least quarterly, each licensee and registmnt shall inspect and repair components affecting safety associated with radiation machines, radiographic exposure devices, transport containers, and source changers. Dese components shall be maintained in accordance with manufacturers' specifications. Records of inspection and maintenance shall be maintained for Agencyinspection for five years from the date of the inspection. His program shall cover, as a minimum, the items listed in 105 CMR 120.396: Appendix B, and inspection and maintenance necessary to maintain the Type B packaging used to transport radioactive materials. He inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.
(C) Records ofequipment problems and ofany maintenance performed in accordance with 105 CMR 120.318(A) or (B) shall be made and maintained for five years.
Replace 120.319(B) and (C) with: E 15 (B) Each entrance that is used for personnel access to the high radiation area shall have both conspicuous visible and audible warning signals to wam of the presence of radiation. De visible signal shall be activated by radiation.
%e audible signal shall be activated when an attempt is made to enter the installation wtile the source is exposed.
(C) The control device or alarm system shall be tested for proper operation with a source of radiation at the beginning ofeach dayofequipment use. The test shall include a check for the visible and/or audible signals. Entrance control devices that reduce the radiation level upon entry as described in 105 CMR 120.227(A)(1) shall be tested
- monthly. If a contml device or alarm system is operating improperly, it shall be immediately labeled as defective and repaired within seven calendar days. De facility may continue to be used during this seven-day period, provided the licensee or registrant implements the continuous surveillance requirements of 105 CMR 120.331, ensures that radiographic personnel use an alarming ratemeter, and complies with the requirements of 105 CMR 120.330(B).
15
O
~
Changes to 105 CMR 120.000 which became effective 7/9/99 e
~
< Records of these tests shall be maintained for Agency inspection for 5 years.
Replace 120.320,120.321,120.322,120.323 and 120.330 with: E l'6
~.
L 120320i Training and Treing (A) HMbaranher Tminee Requirements. The licensee or registrant shall not pemtit any individualto act as a radiographer trainee unless such individual (1) has been certified by the Agency pursuant to 105 CMR 120.321(11)(2) for the class of radiography (i.e., radioactive materials, radiation machines, or both) that the licensee or registrant.
is authorized to perform and such certification has neither expired nor been suspended or revoked l
by the Agency; (2) has received copies of and instructions in the requimments described in the regulations contained in 105 CMR 120.300 and the applicable sections of 105 CMR 120.100,120.200, 120.750, and applicable DOT regulations as referenced in 105 CMR 120.770, a copy of the license or certificate ofregistmtion issued to the licensee or registrant and copies ofand instructions in the licensee's or registmnt's operating and emergency procedures; L
(3)- has been instructed in the use of the licensee's or registrant's sources of radiation, radiographic exposure devices, associated equipment, related handling tools and radiation survey l
instruments that may be employed in industrial radiographic assignments; and, l
(4 ) has demonstrated, to the satisfaction of the licensee or mgistrant, an understanding of the instructions provided pursuant to 105 CMR 120.320(A)(2) and (3) above as evidenced by successful completion of a written or oral test and a field examination on the subjects covered.
(B) RMiouranher Reauirements. The licensee or registrant shall not pemait any individual to act as a radiographer unless such indisidual:
(1) has been certified by the Agency pursuant to 105 CMR 120.321(II)(1) or (3) for the class of radiography (i.e., radioactive materials, radiation machines, or both) that the licensee or mgistrant is authorized to perform and such certification has neither expired nor been suspended or revoked by the Agency;and, (2 ) has met the requirements of 105 CMR 120.320(A) (2) through (4) above.
(C) Tmininn and Testinn Records. Each licensee and registrant shall maintain, for Agency inspection, tmining and testing records which demonstrate that the applicable requirements of 105 CMR 120320(A) and (B) are met for all industrial radiographic personnel. Records shall be kept on fomi MRCP 120.300-1 or on clear, legible reconis containing all the information required by form MRCP i
120.300-1. Records shall be maintained for inspection by the Agency for three years following L
termination'of employment or until the radioactive material license or certificate of registration is tenninated.
16 I
[:
Changes to 105 CMR 120.000 which became efhetive 7/9/99 120321-Anolications and Examinations
' (A) Any individual applying to the Agency for certification to perfonn industrial radiography shall:
- (1) submit a complete and legible application on forms prescribed and fumished by the Agency.
- (2) ~ pay the appropriate non-refundable fee in accordance with 105 CMR 120.321(J).
(3) meet'the examination requirements set forth in 105 CMR 120.321(D) or satisfy the requirements for certification based on reciprocity as set forth in 105 CMR 120.321(K); and, (4) provide evidence that the requirements fer the given category and class for which cenification is sought have been met.
(B) Applicatioit (1) AnyindividualwhoseeksProvisionalCenificationasanindustrialradiographer shall submit an application to the Agency no later than July 1,1999.
'(2) The appropriate fee shall accompany the application when filing with the Agency. An application shall be deemed filed on the date that it is receivea i,y the Agency or on the date that it is postmarked by the United States Postal Sen' ice.
(C) Categories of Certification. (1) The Agency shall certify indisiduals to perfonn industrial radiography in one or more of the following categories:
(a) Cenified Industrial Radiographer,.
(b) Provisionally Certified Industrial Radiographer; or, (c) Cenified Industrial Radiographer Trainee.
(2)
Each certification issued shall include a class endorsement for the type of industrial radiogmphy authorized. Such class endorsements are limited to:
(a) Radioactive Materials; (b) Radiation Mxhines; or
. (c) Radioactive Materials and Radiation Machines.
(D) Examination Requirements (1) An individual who seeks cenification as a Cenified Industrial Radiographer must have passed, prior to application for cenification, a written examination
. appropriate to the category and class of certification sought in accordance with 105 CMR 120.321(E). An individual seeking certification as a Certified Industrial Radiographer after July 1, 1999, must pass, within 12 months prior to application for certification, a written examination appropriate to the category and class of certification sought in accordance hith 105 CMR
- 120.321(G) In the event that this examination is not passed, the indisidual seeking cenification as a Certified Industrial Radiographer may apply, during this 12 month period, for re-examination in accordance with subsection 105 CMR 120.321(D)(4) below.
(2) An individual who holds certification as a Cenified Industrial Radiogmpher Tminee shall take the examination for Certified Industrial Radiographer as prescribed by 105 CMR 120.321(E) within 12 months after certification. In the event that this examination is not passed, the Certified Industrial Radiographer Trainee may apply for re-examination in accordance with subsection 105 17
Changes to 105 CMR 120.000 which became eiTective 7/9/99 CMR 120.321(D)(4) below.
(3)
An individual who is a Provisionally' Certified Industrial Radiographer shall take the examination for Cenified Industrial Radiographer as prescribed by 105 CMR 120.321(E) on or before July 1,1999. In the event that this examination is not passed, the Prosisionally Certified Industrial Radiographer may apply for re-examination in accordance with subsection 105 CMR 120.321(D)(4) below.
[ AGENCY NOTE: In the event the provisionally certified industrial radiographer does not comply with application or testing requirements of 105 CMR 120.321(D)(3) above, certification as Provisionally Certified Industrial Radiographer shall expire on July 1,1999.]
(4) Application for examination or n:-examination shall be on forms pmscribed by the Department and shall include the appmpriate fee specified by 105 CMR 120.321(J). Examination fees shall be non-refundable.
(5) Examinees shall present photogmphic identification (e.g., drivers license) at the time of examination.
(E)
Examuution. (1)
The Agency shall administer exammations in each class of industrial radiography as specified in 105 CMR 120.321(C)(2) at such times and places as the Agency determines necessary.
(a) The examination shall be available through the Conference of Radiation Control Program Directors, Inc.
(b) The scaled passing score shall be 70 percent.
(c) A candidate who fails an examination may apply for re-examination in accordance with 105 CMR 120.321(D).
4 (2) 'lhe Agency shall accept attemative examinations pmvided that such examinations an: found acceptable by the U.S. Nuclear Regulatory Commission.
1 (F) Aporoved Training Procrant industrial radiographer training programs shall be appmved by the Agency. The Agency shall recognize other programs approved by another state orjurisdiction provided that such programs consist of standards and procedures that are the same or comparable to the standards and procedures established by 105 CMR 120.300. The Agency shall base its approval on information provided by the training program tint shall include:
(1) Curriculum infonnation suflicient to assure inclusion of subjects referenced in 105 CMR 120.395: Appendix A; (2) Copies of test que:tions and answers and other evaluation tools and criteria used to demonstrate a participant's comprehension of subject matter in 105 CMP.120.195: Appendix A;
- and, 18
Chenges to 105 CMR 120.000 which became efTective 7/9/99 (3) Resumes ofinstructors.
(G) Exnerience Reauirements for Cenification. Applicants for certification to perform industrial radiography shall have a nunimum of experience appropriate to each category and class ofindustrial radiography as follows:
(1) Certified Industrial Radiographer (a) Radioactive Materials.......................... 200 hrs (b) Radiation Machines........................ 120 hrs (c) Both Radioactive Materials and Radiation..... 320 hrs Machines of which not less than 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> shall be with radioactive materials and not less than 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> shall be with radiation machines.
(2) Provisionally Certified Industrial Radiogmpher (a) Employment as an industrial mdiographer prior to July 1,1999; and, (b) Compliance with the requirements of 105 CMR 120.320(B).
(3) Certified Industrial Radiographer Trainee. No prior experience required.
(II)
Reanimments for Issuance of Cenificatiort The Agency shall cenify in a category and class of industrial radiography any individual who has satisfied the following mquin ments:
(1) Certified Industrial Radiographer (a) Submitted an application for certification on a form prescribed by the Department; (b) Submitted the application fee specified in 105 CMR 120.321(J)(1);
(c)
Passed an examination as required by 105 CMR 120.321(D)(1) or satisfies the requirements for certificationbased on reciprocity as set fonh in 105 CMR 120.321(K); and, (d) Completed the required hours of experience in industrial radiography as specified in 10.5 CMR 120.321(G) or satisfies the requirements for certification based on reciprocity as set forth in 105 CMR 120.321(K)
(2) Cenified Industrial Radiographer Trainee (a) Submitted an application for certification on a fonn prescribed by the Agency; (b) Submitted the application fee specified in 105 CMR 120.321(J)(1); and, (c) Submitted documentation of successful completion of an approved training progmm as specified in 105 CMR 120.321(F) or satisfies the requirements for certification based on 19
i.
Changes to 105 CMR 120.000 which became effective 7/9/99 i
reciprocity as set forth in 105 CMR'120.321(K)
[ AGENCY NOTE: Tmining includes didactic study incorporating those topics included in 105 CMR l
120.395: Appendix A. Training does not include on-the-job experience.]
~ (3) Provisionally Certified Industrial Radiographer (a) No later than July 1,1999, submitted an application for cenification on a form prescribed by the Agency;
- (b) Submitted the application fee specified in 105 CMR 120.321(J)(1); and,
. (c) Submitted documentation that prior to July 1,1999, the individual was employed as an
~
industrial radiographer and has complied with the requirements of 105 CMR 120.320(B).
[ AGENCY NOTE: Examples ofacceptable documentation are a written statement from an employer that the applicant is or has been employed as an industrial radiographer or a copy of a radioactive materials license, issued by the Agency or by the regulatory agency havingjurisdiction in another state, identifying the applicant as an authorized user ofindustrial radiography sources.]
(I) Duration of Certification. (1) The duration of certification issued by the Agency shall be:
(a) Certified Industrial Radiographer.............. 5 years (b) Certified Industrial Radiographer Trainee..... 2 years (c) Pmvisionally Certified Industrial Radiographer Certification as a Provisionally Cenified Industrial Radiographer, issued pursuant to 105 CMR 120.321(11)(3) shall expire on July 1,1999, provided that the application and testing requirements of 105 CMR 120.321(D)(3) have been met. In the event the provisionally Ecertified industrial radiographer does not comply with application or testing requirements of 105 CMR 120.321(D)(3), certification as Provisionally Certified Industrial Radiographer shall expire on July 1,1999.
(2) Certification ibr Provisionally Cenified Industrial Radiographer and Certified Industrial Radiogmpher Trainee are nonrenewable.
(J).fsss. (1) 'Ihe application fees for examination or certification shall be non-refundable and shall be as follows:
i (a) Each application for examination by the A gency.................................. $ 75.00 (b) Each application for certification:
I i
20 1
l
F 1
s l
Changes to 105 CMR 120.000 which beccme efTective 7/9/99 f
L
{
- 1. Certified Industrial Radiographer................................... $50.00 l
- 2. Certified Industrial Radiographer Trainee.................. $50.00 1
- 3. Provisionally Certified Industrial Radiographer.................. $50.00 f
(
(2)- The appropriate fees shall accompany the application when filing with the Agency.
l (K) Reciorocity. (1) The' Agency shall issue certification to an applicant who has been certifiedin another state orjurisdiction provided that:
(a) The applicant holds a valid certification in tie appropriate category and class issued by anotherstate orjurisdiction; (b) Le standards and procedures for certification in the state orjurisdiction that issued the certification are the same or comparable to the certification standards established by 105 CMR
{
'120.300 J
. (c) He applicant presents a copy of the certification document issued by the other state or j
jurisdiction to the Agency; and (d) _ The applicant submits the application fee in accordance with 105 CMR 120.321(J)(1).
(2) Individuals who are certified by recipmcity shall either:
(a) Maintain the certification upon which the recipmcal certification was issued; or (b)
Satisfy the requirements of 105 CMR 120.321(H) prior to the expiration of the certification upon which reciprocal certification was issued.
(L). Requimments for Renewal ofCertification. (1) Prerequisites:
(a) An individual shall submit an application for re-examination and renewal of certification at least six months prior to the expiration date of certification. De Agency shall waive this requirement if the applicant satisfies the requirements of 105 CMR 120.321(A). An individual may not legally perfonn industrial radiography without valid certification.
(b)
Each applicant shall submit a complete and legible application with the fee for re-examination and renewal ofcertification in accordance with 105 CMR 120.321(A).
(2) Re-examination. ' Applicants for renewal of certification shall meet the requirements of 105 CMR 120.321(H)(1) including re-examination as described in subsection 105 CMR l-120.321(L)(1) above.
t l-(3) Certification as a Provisionally Certified Industrial Radiographer is nonrenewable.
21 l-i
IT L
Changes to 105 CMR 120.000 which became etTective 7/9/99 (4) Certification as a Certified Industrial Radiography Trainee is nonrenewable.
(5) An I.D. card shall be issued to each person who successfully completes the examination prescribed in 105 CMR 120.321(E ).
(6 )
Each person's I.D. card shall contain his/her photograph. The Agency will take the photograph at the time the examination is administered.
(7) The I.D. card remains the property of the Conunonwealth of Massachusetts and may be revoked or suspended under the provisions of 105 CMR 120.322.
(8) A fee of $15,00 shall be paid to the Agency for each replacement of a lost I.D. card.
120.322: Revocation or Susoension of an I.D. Card (A) Any radiographer who violates 105 CMR 120.000 may be required to show cause at a formal hearing why his/her I.D. card should not be revoked or suspended.
(B) When an Agency order has been issued for an industrial radiographer to cease and desist from the use of mdioactive material or revoking or suspending his/her I.D. card, the industrial radiographer shall surrender the I.D. card to the Agency until such time as the order is changed or the suspension expires.
(C) The Agency may act to suspend or revoke an individual's certification for any one or a combination of the following causes:
(1) Knowingly causing a material misstatement or misrepresentation to be made in the application for initial certification or renewal ofcertification if such misstatement or misrepresentation would impair the Agency's ability to assess and evaluate the applicant's qualifications for certification pursuant to 105 CMR 120.321; (2) Knowingly falsifying records ofemployees when such falsification would impair the Agency's ability to assess and evaluate the applicant's qualifications for certification pursuant to 105 CMR l
120.321; (3) Willfully evading the statute or regulations pertaining to certification, or willfully aiding another i
person in evading such statute or regulations pertaining to certification; (4) Exhibiting significant or repeated incompetence in the performance ofindustrial radiography duties; (5) Performing industrial mdiography in such a manner that requirements of 105 CMR 120.300 are violated resulting in a threat to health and safety of the individual, other workers or the public; 22
P; Changes to 105 CMR 120.000 which became efrective 7/9/99 (6) IIaving had a similar certification suspended or revoked if the grounds for that suspension or revocation are the same or equivalent to one or more grounds for suspension or revocation as set forth herein; i
(7) Failure to maintain the out-of-state cenification upon which certification by meiprocity was issued; (D)
If, based upon any of the grounds in subsection (C) of 105 CMR 120.322, the Agency
)
l
' determines that action to suspend or mvoke cenification is warmnted, the Agency shall notify the individual and shall provide an opponunity for a hearing in accordance with 801 CMR 1.01 et seq.
j An opponunity for a hearing shall be provided before the Agency takes action to suspend or revoke an individual's cenificatbn unless the Agencyfinds that an immediate suspension ofcertification is required to protect against immediate danger to the public health or safety, in which case the l
Agency shall suspend an individual's certification pending a heanng.
(E) If the Agency finds that removal ofcertification is warranted, the usual action shall be a suspension of certification for up to one year. He term of suspension may be reduced by the Director of the Radiation Control Pmgmm, upon the n: commendation of the hearing oflicer, ifthe hearing officer finds, based upon evidence presented to him/her during a hearing, that the conditions leading to the l
Preliminary Order for Suspension can be cured in less than one year. Ilowever, if the Agency finds that the causes are of a serious or continuous nature, such as past actions which posed an immediate threat to occupational or public health or safety, deficiencies that cannot be cured within one year, the l
Agency shall revoke the individual's cenification.
(F) When an individual's certification is suspended or revoked, the individual shall sunender his/her certification document to the Agency until the tennination of the suspension period or until reissuance of the certification.
(G) An individual whose certification has been revoked may seek reinstatement of certification by filing with the Agency a petition for reinstatement. Such petition may be filed one year or more aller the beginning of the revocation period.
l 120.323: Personnel Monitorine Control (A) Be personnel monitoring program shall meet the applicable requirements of 105 CMR 120.200.
(B) When performing industrial radiographic operations the following shall apply:
i (1)
The licensee or registrant shall not permit an individual to act as a radiographer, or radiographer trainee unless each individual wears, on the trunk of the body at all times during radiographic operations, a combination of a direct-reading pocket dosimeter or an electronic personal dosimeter, an alarming ratemeter, and either a film badge, a thermoluminescent dosimeter 23
y
' Ch;.nges to 105 CMR 120.000 which become effective 7/9/99 L
(TLD), or an optically stimulated luminescence (OSL) dosimeter. At permanent radiography installations where other appropriate alamiing or warning devices are in routine use, the wearing of an alarming ratemeter is not required.
(2) Pocket dosimeters shall meet the criteria in ANSI N 13.5-1972 and shall have a range ofzero to 200 millimentgens.
(3) ' Pocket dosimeters sha". be recharged at the start of each work shift.
l
~ (4) Exposme indicated by each pocket dosimeter shall be recorded at the beginning ofand at the end ofeach work shift.
l (5) If an individual's pocket dosimeter is discharged beyond its range (i.e., goes "off-scale"),
industrial radiographic operations by that individual shall cease and the indisidual's film badge, TLD or OSL shall be processed immediately. 'Ihe individual shall not retum to work with sources of radiation until a determination of his/her radiation exposure has been made.
(6) Each film badge, TLD or OSL shall be assigned to and wom by only one indisidual.
(7) If a film badge, TLD or OSL is lost or damaged, the worker shall cease work immediately until a replacement film badge, TLD or OSL is provided and the exposure is calculated for the time period from issuance to loss or damage of the film badge, TLD or OSL.
(8) Each alarm dosimeter must:
l (a) Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift (b) Emit an alarm signal at a preset dose rate of 500 mr/hr (5 mSv/hr).
(c) Requim special means to change the preset alami function; and, l
(d) Be tested at periods not to exceed one year for correct response to radiation. Acceptable i
dosimeters must alarm within plus or minus 20% of the tme radiation dose mte.
(C) Records of pocket dosimeter readings ofpersonnel exposures shall be maintained for five years by the licensee or registrant for Agency inspection. If the dosimeter readings were used to determine extemal radiation ~ dose (i.e., no TLD, OSL or film badge exposure records exist), the records shall be maintained until the Agency authorizes disposal.
(D) Pocket dosimeters shall be checked for correct response to radiation at periods not to exceed one year. Acceptable dosimeters shall read within plus or minus 20% of the true radiation exposure.
Records ofpocket dosimeter calibrations shall be maintained for five years by the licensee or registrant for Agency inspection.
(E) Processors of film badge, TLD and OSL devices must be certified by the NVLAP.
120330: Operatine and Intemal Audit Reauirements l
l.
(A) (1) Each licensee and registrant shall conduct an intemal audit program to ensure that the l
regulations in 105 CMR 120.300, the conditions oflicense(s) and/or certificate (s) ofregistration, and the licensee's or registrant's operating and emergency procedures are followed by radiographic per-24
Changes to 105 CMR 120.000 which became efTective 7/9/99 l
l sonnel. 'Ihese intemal audits shall be performed and recorded at intenals not to exceed six months.
(2) Each individual radiographer's performance shall be audited at intervals not to exceed six months, excepting intervals when the radiographer performs no mdiography. Ifa mdiogmpher has not performed radiography during a six month period, hidher performance must be audited immediately upon hidher resumption to radiogmphy. Records ofaudits shall be maintained by the licensee or n=gistrant for Agency inspection for five years from the date of the audit.
(3) The agency may consider altematives in those situations where the individual sen'es as both radiographer and RSO.
(4)
In those operations where a single individual senes as both radiographer and RSO, and perfomis all radiogmphy operations, an inspection program is not required.
(5)
Each licensee shall provide annual refresher safety training for each radiographer and radiographer trainee at inten'als not to exceed 12 months.
(B) Each licensee and registrant shall provide, as a minimum, two radiographic personnel when sources of radiation are used at temporaryjob sites. If one of the personnel is a mdiographer trainee, the other radiographic personnel must be a radiogmpher.
(C) Collimators shall be used in industrial mdiographic operations which use crank-out desices except when physically impossible.
(D) No individual other than a radiographer or a radiographer tminee who is under the personal supervision of a radiographer shall manipulate controls or operate equipment used in industrial radiographic operations.
Insert in 120.331(A): E 17 or radiographer trainee Repl:ee 120.337(C)(1) and (2) with: E 18 (1) 'Ihe registmnt shall comply with the requirements of 105 CMR 120.020 and 120.200..
Insert new 120.340 and 120.350: E 19 120.340: Underwater and I av-barge Radiography (A) Underwater and/or lay-barge mdiography shall not be perfonned unless specifically authorized 25 I
p
- Changes to 105 CMR 120,000 which became efTective 7/9/99 in a license issued by the agency in accordance with 105 CMR 120360.
t (B) - In addition to the other requimments of 105 CMR 120300, the following requirements apply to the perfonnance oflay-barge radiography:
(1) Cobalt-60 sources with activities in excess of 740 GBq (20 Ci) (nominal) and iridium-192 sources with activities in excess of 3.70.TBq (100 Ci) (nominal) shall not be used in the performance of offshore platform or lay-barge radiography.
(2) Collimators shall be used for all industrial radiographic operations performed on lay-barges.
120350: Prohibitions (A) Industrial radiography perfonned with a scaled source that is not fastened to or contained in a radiographic exposure device (fishpole technique)is prohibited unfess specifically authorized in a license issued by the agency.
(B) Retrieval ofdisconnected soumes or sources that cannot be returned by normal means to a fully shielded position or automatically secured in the radiographic exposum device, shall not be performed unless specifically authorized by a license condition.
Irsert in 120.360(C): E 20
' (7) Ifa license application includes offshore platform and/or lay-barge radiography, as a minimum a description of:
(a) transport procedures for radioactive material to be used in industrial radiographic operations; (b) _ storage facilities for radioactive material; and, (c) methods for restricting access to radiation areas.
i (8)
A description of procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification ofindividuals acting as radiographers remains valid.
Del:te 120.370(A)&(B):
l Delete 120.390 (B): E 21 1
i 26
Chinges to 105 CMR 120,000 which became efTective 7/9/99 l
Insert corrections in 120.395:
Replace all OLD 120.400 with:
NEW 120.400: X-RAYS IN TIIE IIEALING ARTS F
and NEW 120.430: TIIERAPEUTIC RADIATION MACIIINFS X
R: place 120.501: Purpose and Scope with: G 1 105 CMR 120.500 establishes requirements and provisions for the production, preparation, compounding and use of mdionuclides in the healing arts and for issuance oflicenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, and patients. The requirements and provisions of 105 CMR 120.500 are in addition to, and not in substitution for, others in 105 CMR 120.000. The requirements and provisions of 105 CMR 120.000 apply to applicants and licensees subject to 105 CMR 120.500 unless specifically exempted. [See exemption in 105 CMR 120.104(C)(5)].
Replace 120.501(B):
with: G 2 (B) (1) Unle:a prohibited by license condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the regulations in 105 CMR 120.500 under the supen'ision of an authorized user as provided in 105 CMR 120.510.
(2)
Unless prohibited by license condition, an individual may prepare unsealed radioactive material for medical use in accordance with the regulations in 105 CMR 120.500 under the supervision of an authorized nuclear pharmacist or an authorized user as provided in 105 CMR 120.510.
Replace 120.504(B):
with: G 3 (B)
Before permitting anyone, except a visiting authorized user or visiting authorized nuclear pharmacist described in 105 CMR 120.511, to work as an authorized user or an authorized nuclear pharmacist, respectively, under the license except an individual who is:
27 l
Changes to 105 CMR 120.000 which became efTective 7/9/99
(!)
an authorized user certified by the organizations specified in 105 CMR 120.567(A),
120.568(A),120.569(A),120.570(A),120.572(A) or 120.573(A);
(2) an authorized nuclear pharmacist certified by the organization specified in 105 CMR 120.580(A);
(3) identified as an authorized user or an authorized nuclear pharmacist on an Agency, or the U.S.
Nuclear Regulatory Commission or Agreement State or Licensing State license that authorizes the use of mdioa tive material in medical use or in the practice of nuclear pharmacy, respectively; or, (4) identified as an authorized user or an authorized nuclear pharmacist on a pennit issued by the Agency, or the U.S. Nuclear Regulatory Commission or Agreement State or Licensing State specific licensee of broad scope that is authorized to permit the use of radioactive material in medical use or the practice of nuclear pharmacy, respectively ;
In 120.505: Notifications insert: G 4 (A)
A licensee shall provide to the Agency a copy of the board certification, the Agency, NRC, Agn=cment State or Licensing State license, or the permit issued by a licensee of broad scope for each individual no later than 30 days after the date that tlie licensee permits the individual to work as an authorized user or an authorized nuclear phannacist pursuant to 105 CMR 120.504(B)(1) through 120.504(B)(4).
(B)
Replace 120.520(A): Authorization for Calibration and Reference Sources with: G 5 (A) Scaled sources manufactured and distributed by persons specifically licensed pursuant to 105 CMR 120.100 or equivalent pmvisions ofthe U.S. Nuclear Regulatory Commission, Agreement State or Licensing State and that do not exceed 1.0 gigabecquerels (27.2 mci) each; Replace 120.527J1 with: G 6 120.527: Release ofindividuals Containing Radionharmaceuticals or Pennanent Imniants (A) Unless otherwise authorized pursuant to 105 CMR 120.527(C), a licensee shall not authorize release from confinement for medical care any individual administered a radiophannaceutical until either:
28 t
I i
Changes to 105 CMR 120.000 which became effective 7/9/99 l
(1) The dose rate from the individual is less than 50 microsieverts (5 mrem) per hour at a distance of one meter; or, (2) The activity in the individual is less than 1.11 gigabecquerel (30 mci).
(B) Unless otherwise authorized pursuant to 105 CMR 120.527(C), a licensee shall not authorize release fmm confinement for medical care any individual administered a permanent implant until the dose rate from the individual is less than 50 microsieverts (5 mrem) per hour at a distance ofone meter.
(C) A licensee may apply to the Agency for approval of proposed procedures, not otherwise authorized in these regulations, to release from its control indisiduals who have been administered radiopharmaceuticals or permanent implants containing radioactive material. Each application shall include:
(1) An analysis and evaluation of pertinent information to show that the total efTective dose equivalent to any other individual from exposure to the released individual is not likely to exceed five millisieverts(0.5 rem);
[ NOTE: NRC Regulatory Guide 8.39, " Release ofPatients Administered Radioactive Materials,"
describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding five millisieverts (0.5 rem).]
(2) A copy of the instructions, including written instructions, to be provided to the released individual on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed one millisievert (0.1 rem).
In 120.569: Trainine for Theraneutic Use of Radiopharmaceuticals replice 120.569(H)(2)(a) to (e) with: G 7 At least five treatment cases for each procedure with radiation safety hazards similar to that use for which the individual is requesting authorized user status.
In 120.675: Personnel Monitoring repl:ce 120.675(A) with : Ql (A) Irradiator operators shall wear either a film badge, a thennoluminescent dosimeter (TLD), or an optically stimulated luminescence (OSL) dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The film badge, TLD or OSL dosimeter processor must be accredited by the National Voluntary Laboratory Accreditation IYogram for high energy photons in the normal and accident dose ranges [see 105 CMR 120.225(C)]. Each film badge, 29
Changis to 105 CMR 120.000 which became effective 7/9/99 TLD or OSL dosimeter must be assigned to and wom by only one individual. Film badges must be processed at least monthly, and TLDs and OSL dosimeters must be processed at least quarterly.
In 120.710: Radiation Monitorine Reauirements i
replace 120.710(A) with : 11 (A) There shall be available at each particle accelerator facility appropriate portable monitoring equipment which is operable and has been appropriately calibrated for the radiations being produced at the facility. Such equipment shall be tested for proper operation before use or once every 3 months, whichever is the lesser.
In 110.753: Instructions to Workers replice 120.753(A) with : J l (A) All individuals who in the course of employment are likely to receive in a year an occupational dose in excess ofimSv(100 mrem)
Replace all OLD 120.770 with:
NEW 120.770: TRANSPORTATION OF RADIOACTIVE MATERI AL T
30
y/h, 7
c
(#
THE COMMONWEALTH OFMASSACHUSETTS Office of the Secretary of the Commonwealth Refation Filing To be completed by filing agency CHAPTER NUMBER:
105 CMR 120.000 CHAPTER TITLE:
Massachusetts Rerulations for Control of Radiation i
AGENCY:
penartment of Public Health
SUMMARY
OF REGULATION State the general requirements and purposes of this regulation:
SEE ATTACHED REGULATORY AUTHORITY: M.G.L. c.111.ss3.5.5M.5N.50 and 5P AGENCY CONTACT: Robert Hallisev PHONE: 617-727-6214 ADDRESS:
Portland Street. Boston. MA
' Compliance with M.G.L. c.30A EMEGENCYADOPTION 1lthis regulation is adopted as an emergency regulation, state the nature of the emergency.
N/A PRIOR NOTIFICATION AND/OR APPROVAL Ifprior notification to and/or approval of the Governor, legislature or others was required, list each notification, approval and date, including notice to the Local Government Advisory Commission:
EOCD - 10/14/98 MMA - 10/14/98 PUBLIC REVIEW Was notice of the hearing or comment period filed with the Secretary of State published in appropriate newspapers and sent to persons to whom specific notice must be given at least 21 days prior to such hearing or comment period?.
Yes l x l Date of public hearing or comment period: November 24.1998 49
1 FISCAL EFFECT -
Estimate the fiscal effect on the public andprivate sectors:
i For thefsrst and secondyears: SEEATTACHED For thefsret fiveyears:
{
Nofincaleffect:
SMALL BUSINESSIMPACT i
State the impen:t of this roulation on small business. Include a description of reporting, record heaping and other compliance twquirements as well as the appropriateness of performance versus design standards and whether this regulation duplicates or conflicts with any other regulation. If the purpose of this rwsulation is to set rates for the suste this section does not apply.
i No additional zwporting or recordkeeping requirements; no performance or design standards are relevant; no duplication or conflict with any other regulation.
CODE OF MASSACHUSETTS REGULATIONS INDEX Lkt key subjects entries that are relevant to this regulation:
' 106 CMR 120.000 PROMULGATION State the action taken by this regulation and its offact on existingprovisions of the Code of Massachusetts Regulations (CMR) to replace or arrand. List by CMR number:
Amends 105 CMR 120.000 ATTESTATION 11se regulation described herein and attached hereto is a true copy of the regulation adopted
'-h-2., b Date: _$ // f/91 ture Publication 1b be compkted by the Regulations Division 873 MASSACHUSETTS REGISTER NUMBER:
DATE:._ 7/'/"
EFFECTIVE DATE:
7/'/89 CODE OF MASSACHUSETTS REGULATIONS ATRUECOPYATTEST M & & h'h4 Remove ehanpaeus:
Inurt these paees:
CMR: Vol.
WILUAMFRANOSGAIMN 5 - 14.2 5 - 14.2 sggggV0FDE(XMONEAL1H 201 - 474.106 201 - 474.122 so
j-3.1&DdARY OF REGULATION The amendments are intended to update the Massachusetts regulations to keep them compatible and consistent with cunent NRC's and other national organizations' regulations governing the use, transportation and disposal of radioactive materials, and
==d:
produced ionizing radiation. h promulgation of these amendments is a necessary consequence of Massachusetts being an " Agreement State" and a Licensing State and having the responsibility for the regulations of all sources of radiation, including naturally occurring radioactive material (NARM), L r45ct and 'special i
nuclear==+-i=1; and radiation produced by machinen S,Wany, the amendments l
incorporate changes that NRC has made to its reguistions since Massachusetts last updated its regulations on February 9,1996. & major areas of revision include an expansion of and/or a clarification of the following: general definitions; the Exempt Items Rule, providing an exemption for radioactive drug capsules containing carbon-14 ures for "in vivo" diagnostic use for humann; Radiation Safety Requirements for Industrial Radiography; X-rays in the Healing Arts which transfer therapeutic uses to a new section: Therapeutic Radiation Machines; the Medical Use Rule, including an expansion of the categories of patients v- *ir.g radioactive materials who may be released from confinement: and, the Transportation of Radioactive Materials.
FISCAL IMPACT Public Sector: There is no effect on the public sector. The medical community will benefit from the exemption from regulation of radioactive drug capsules containing carbon-14 ures for "in vivo" diagnostic use for humann and the expansion of the patient release rule. There would be a financial benefit associated with these changes.
Private Sector: There is no new overall fiscal effect on fees presently being paid by licensees.
51
105 CMR: DEPARTMIDft OFPUB1JCHEALTH
' Table of Comannes EREli (105 CMR 101.000THROUGH 119.000: RESERVED) 173 105 OdR 120400: MASSAOIUSETTS REOUIADONS POR* DIE COff!ROLOFRADINDON(bGtCR) 201 Section 120.001:
OENERALPROVISIONS 209 Secdon 120.002:
Purpose and Soops 209 Secdas 120.003:
Regulatory Aambority 209 Secebas 120.004:
Otetion 209 Section 120.005:
Defhnmens 209 Seedon 120.006:
Ensumptions 220 Section 120.007:
ProhibisedUess 220 Sendos 120.008:
kapoen&ag 220 Section 12tLOO9:
Raconis 220 Secsion 120.010:
Inspecaioms.
221 Section 120.011:
Teens 221 Section 120.012:
AdditionalRmpaireasons 221 Section 120.013:
c' ---.=landa==
221 Sendes 120.014:
Units cf Raposare and Does 221 Seceos 120.015:
Units of Aatvity 223 ENPrvamsWT Seenom 120A16:
Enforcommet Pohey and Procedians 223 Section 120.017:
Sevemb0ity 229 Seedon 120.018:
Public Disc 1 cease of Emicacement Annons 229 Section 120.019:
Appsadix A-Severity Casagones 229
)
120.020: RBOI57RATIONOFRADINIlONMACHINEFACI12HES ANDSERVICES 234 Seaden 120.021:
Purpose end Scope 234 Sacsion 120.022:
Defhdaions 234 Seccan 120.023:
5= a"Tei==
'234 Section 120.024:
Plan Rrview 234 Section 120.025:
.,, ' - = for Registrados 234
^
Session 120.026:
Applicatica for Registration Services 235 Section 120.027:
Certificens of Regisstansa 235 l
Seedon 120.038:
Pup==*ia= of Nones of Registration 235 Section 120.029:
Ramewelof Notice of Registration 235 Section 120.030:
Report ofOsagne 236 Secsion 120.031:
Approval Not kuplied 236 Seedon 120.032:
Assembler and/or Tsensier Obligatica 236 Seedon 120.033:
Out-of-Stene Radisman Machines 236 Secsion 120.040:
Narine=aan to Ph r, __--
'237 120.100: IK3ENSINO OFRADIOACDVE MATERIAL 237 Secdon 120.101:
Purpose and Scope 237 Secanos 120.102:
Dannidaan 237 Seedon 120.103:
Somos Maamrial 237 Session 120.104:
Radioecdve Material Other Then Sauros Masenal 239 Secdos 120.120:
Types ofIJceases 242 Seceon 120.121:
OsmeralIJoanees -Source Mananal 242 Secdon 120.122:
Genere1 Liesanos - Radsoecove Meannal Other Then Source Maanrial 243 Section 120.124:
Piling Apphcataca for Specific IJoenses 249 Secess 120.125:
Osmond P --;- - - - - for the issuance of Specific IJoenees 249
-l Section 120.126:
Special?, '
= forIsenance of Certain Specific f maan for Radsoective Matenal 253 Seccan 120.127:
Special Recparements for Specafic laosases of Bmed Scope 253
.p 7/9/99 105 CMR -5
105 CMR: DEPAR1MINf OFPUBLJCIEALTH Table of Comesats ERE 105 CMR 120.000: MASSActUSETTS RBOULA110NS PORTHE CON!1t0L OF RADIA1 TON (MRQt) (continued) hetion 120.128:
Special 8 T='==--a= for a SpeciSc Ucause to Mamofman, AasseMs.Rapeir,orDismemes " Products,or r
Devices which Contain Radioecew Maserial 255 Section 120.130:
Issunnos of Spen Sc Uconses.
267 Section 120.131:
Sper.ific Terms and Conditions of Uosenes 267 Section 126.132:
Empiramos andTassensus of Uommons 267 1
Secelom 120.133:
RenewalofUssenes 270 Section 120.134:
Amendesat of ucesses at Raquest of Mosesse 270 Section 120.135:
Agency Aados om f,"
- c to Ramow or Aansed 270 Semien 120.136:
Persons Pa===== int a Unemos fw Somos, Bypenduct, or Special Naciser Maassielle Questidas Not Suf5cimmt to Para a Qatacal Mass on B5mattw Does of 105 CMR 120.000 270 Section 120.137:
7 trees Ptessasing NatureDy rhmmer and Amalernam-Produced Radioactin Masadal(NARM) om Effensive Does of 105 CNR 120.000 270 Sectica 120.140:
Tamsderof M=a= rial 270 Seedon 120.142:
Raponing Raquhaments 271 Session 120.146:
EmerSeacy Plan for Respondlag to a Raleese 272 Secuan 120.130:
uadh and Revocation of Licenses 274 Seonom 120.190:
- =';-- " maaag=Ma= of Uceuses 274 Seance 120.195:
Appendix A-Basept Conosotradoes 277 Semias 120.196:
Appendix B-Tabis1Basept Quantines 282 Seados 120.196:
Table B-Quantined for Use With 105 CMR 120.125(C)(1) 286 Seonom 120.196:
Tabis IB - Quandties of Radiomotive Maandals Ragainng Caesiderados of tis Need for as Basrpsacy Plan for Raspendingto a Raisans 288.2 Secnica 120.197:
Appsodix C-Umbs forBroed uoenses 290 Section 120.198:
Appsodix D rina=ria Relating in Use of Finamem! Tests and Paunt Company Oueressess for Providag m w, Assurance ofPueds forP 296 Seccan 120.199:
Appendix B - Crasria Relating to Ues of Phnancial Tests and Self Guarassess for Providing B-=M Aassumos afl%mds forP+-
298 120.200: STANDARDS POR PROTEC110N AGAINST RADIATION 300 Secdos 120.201:
Purpose 300 Seedon 120.202:
Scope 300 Secelos 120.203:
n.n.wn 300 Seenos 120.204:
M 302 RADEATION PRO 11lC710N PROGRAMS Seedon 120.210:
Rabation Pinesedan Programs 302 OCCUPATIONALDOSB UMirs Secdon 120.211:
naanpaia==8 Does undes ihr Adults 303 Secaca 120.212:
ra== rih with *, '
- for *=====ela= ofExismtal and Internal Domes 304 Secdon 120.213:
Desar'=i==ala=, of Exemanal Does from Airbores Raboective Maamial 304 Secean 120.214:
n s
a= oflueermalE ;-n_
304 Section 120.215:
n=n=, =l=miaa of Priornarny eia==1 Does 305 Sectica 120.216:
Plammed SpecialExpoemes 307 Seccan 120.217:
C-
, ' " Does uudes for Minors 307 Section 120.218:
Does to a BabryoSeeus 307 7MW99 105 CMR-6 i
105 CMR:, DEPARTMENT OF PUBUCHEALTH
'hble of Comesmas i
EISE 105 Oct 120.000: MASSAGUSETT5 REQU1ATIONS PORTHE CONTROL OF RADEATION (hetCR) (conneosd)
RADEATION DOSE IJMITS POR INDIVIDUAL MEMBERS OF11E PUBIJC Section 120.221:
Does IJmits for Individual Members of the Public -
308 Semion 120.222:, ra-pha-withDoesLienksforIndividualMesebers of the Ptedle 309 Section 120.223:
Testing for tankaps or
=*==Anda= of Sealed Sommes r
309 SURVEYS ANDMOlmCRING Semies 120.225:
Genseal 310.
Seceion 120.226:
randMama Respdring bdividual Monisering of External and leseraalW Does 311 CONTROL OF EXPOSURE PROM EXTERNAL SOURCES IN RESnuCIED AREAS Secnon {20.227:
Control of Access to High Radiance Ames 312 Section 120.228:
Connel of Acomes so Very High Radiation Ames 312 Section 120.229:
Control of Amosse to Very HiWi Radiation Areas - Irrednesars 313 RESPIRATORY PROI11C110N AND ColmtOLS 10 RESTRICT DGERNAL EXPOSURE IN RES11LICTED AREAS Section 120.231:
Use of Picomes or Other Begissering Coments 314 Section 120.232:
Ues of OtherControls 314 i
Semion 120.233:
Use of Individual Raspirseory Proension Equipasst 314 STORAGE AND COtmtOL OFIJCENSED OR RBGIS1ERED SOURGS OF RADIA110N
)
hrman 120.235:
Securky and Comaal ofIJeansed or Ragmened Sommes of Ra& dan 316 PRECAUTIONARY PROCEDURES Secnon 120.241:
Caunos Signs 316 Section 120.242:
Postag?,1
~317 Section 120.243:
8=r=gma== to Poenug *,
- 317 Section 120.244:
Imboling Containers sad Radistica Machines 318 Secnos 120.245:
8-=gma== colabeltog Requiremesats 318 Sectics 120.246:
Proce&mes for Receiving sad Opening Pedages 318 WASTEMANAGEMENT Section 120.251:
GemaralRequhassants 319 Section 120.252:
Method for Obtaining Approval of Proposed Disposal Procedures 319 Seenos 120.253:
Discharge by Release into Seminary Sewerage 320 Secnos 120.254:
'Destment byIncineramon 320 Section 120.255:
Disposalof Speci5cWasses 320 Secnon 120.256.
Transfer for Disposal and b8=h*=
320 Seceon 120.257:
r---,'
- with Bavir===*=1 and Henkh Proesenos Regulations 321 RECORDS Secnos 120.261:
Osmeral Provisions 321 Section 120.262:
Recortis of Radiation Pacesssion Programs 321 Section 120.263:
Reconis of Surveys 321 Semien 120.264:
Records of Tests forImakage or n=*==*=d= of Sealed Somoes 322 e
hream 120.265:
ReconisofPrior -
- Dosa 322 r
Section 120.266:
Reconis of Pisamed Special Exposures 322
)
Section 120.267:
Reconis of Indiviesel Monieoring Raoults 322 Secnos 120.268:
Reconis of Does so lodividas1 Members of the Public 323 Section 120.269:
Recortis of Weste Tansfers 323 Secanon 120.270:
Reconie of Testing Entry Connel Devices for Very High P=A=manAreas 323 7/9/99 105 CMR-7
105 CnGt: DEIPARDENT OFPUB1JC HEALDI l
h Zam 105 Chet 120.000:
MASSACHUSETIS RBOUIADONS POItDIE COlGROL OF RADIATION (MRCR) (continued)
Seedon 120.271:
FormofReconis 323 REPORT 3 '
Section 120.281:
Rapons of Sealsa, Imst, or Missang IJoensed or Ragneared l
Somoss ofRadianos 323 Section 1an autP Na*ine=da= ofInoulants 324 Seedon 120.283:
Rayons of R=pa===== Radiatica lavels, and Conosotranons of Radsoective Maassiel Baceeding sin Caesamists or ein IJains 325 Secame 120.284:
Rapons of Pleased SpecialEspoemas 326 Seceon 120.287:
Nanime=*ia=a and Rayons to Individuals 326 Seedon 120.288:
Reports ofImaking or Ph Sealed Souscos 326 ADDmONALREQUIREMENTS Section 120.291:
Vacatheg Plausines 326 Secdon 120.295:
Appendix A - Pteesenom Pactors for Raspirators 327 Seedce 120.296:
Appendix B - AnnualIJaits on Intake (All) and Derrved Air Conosonanons (DAC) of *da==eih for C,'
i Expoems, EfBeast Conosotrusions; Conosotradoes for Reisese so Samitary Semerage 330 W 120.29'1:
Appendix C -()=*6d== ofIJoensed Maanrial Raquidag labelig; 337 Section 120.298:
Appendix D - Requirements for Transfer of Imw-level Radioactive Wases for Duposal at land Disposal Pacilities and Mamiisses 395 Section 120.299:
Appendia B r3 nne.e=a= and Charar*=== dea ofImw-level Radioactive Wases 397 l
120300: RADIATION SAFETY REQUIREMEDCS POR I DUSDLIAL RADIOGRAPIDC OPERADONS 400 Section 120.301:
Purpose and Scope 400 Secoca 120302:
Dennitions 400 Section 120.303:
403 Secuan 120.310:
Records of Recampt, Transfer, and Disposal of Sources of Radistum 403 Sectica 120.311:
IJants on Invols of Radianon for Radiograpinc Exposuse Devices, Source Changers, and hansport Costaianes 403 Secnon 120J12:.
Lacking of Somoss of Radiation 403 Section 120.313:
Storage Precautions 404 Seence 120.314:
- dada = SeveyInstruissets 404 Seedon 120.315:
- ,i
_ for Espupatest Used in Industrial Rachographic Opasunens 405 Secnon 120316:
QuanadyInvemeory 407 Secean 120J17:
Utd sanonImss Secnon 120J18:
W and Mainemaanos 407 Secnos 120.319:
Permanent Radiographic h=tida=5 408 Secnon 120.320:
haining andTestias 408 Sectico 120321:
Apphcances and 8==3ama 409 Section 120.322:
Revocation or Suspension of an LD. Card 412 Secnon 120.323:
Personnel Monitoring Camarol 413 Sectica 120J30:
Operadag out Baternal Audit *
^-
414 Seceos 120.331:
Securnyin Field Operances 414 m 120.332:
Poodag 414 Secdon 120.333:
Pd==da= Surveys and Servey Records 415 Secnon 120.334:
Racords Raquired at Temporary Job Sites 4)6 Secnon 120.337:
Special " -,
and 5 Pa for Enclosed Rahography 416 Seenom 120.340:
Underwaner and Lay herge Radaography 417 Sectioc 120.330:
Prohibinans 417 Section 120.360:
Licensing and Rogueration P a *
^: forIndustnal R%,E Operadoes 417 7MW99 105 CMR - 8
105 CMR: DEPARDENT OFPUBUC HEALTH Table of Comanas ESIE 105 CMR 120.000: MASSACHUSBT13 REGUIATIONS PORTHE CON!ROL OF RADIATION (MRCR) (comnaasd)
Section 120380:
Radiation Sainty OGloer 418 Section 120.385.
Narmaaria= cflacidents 419 Section 120.390:
Resqueciey 419 Sonnen 120.395:
Appendix A - Subjects for Instruence of 8 f Trainess 419 Sectics 120.396:
Appsadam B - Osmeral *, :- - ~ ^ - for I==r= eda = ofIndusinal i
Radiegtuphic Equipenet 421 j
Section 120.397:
Appendet C-Thas *,
for Ranced Eesping 422 Secsion 120.398:
Appendia D - Opasang and N==ry==cy Precedissa 423 i
120A00: X-RAYSINTHEHEAUNG ARTS 423 Secmos 120A01:
Purpoem and Scope 423 i
Semion120A02:
nannieia==
423 i
Seedon 120A03:
Osmeral *,
- 431 Secdon 120A04:
General Raquireessets for All Dugnosoc X-Ray Sysessus 435 Section 120A05:
Pleososcopic X-RaySystems 438 Section 120A06:
Radiographic 3)sessas Other Then Placroscopsc/aag=M Tomography Systems 441 Section 120A07:
Dental Radiossaphac Systems 445 Seceos 120A08:
VesannecyX surSyseems 447 Seedon 120A09:
Compuesd Tomsography X-Ray Systems 448 Semies 120A20:
Appsodix A - Radiation Shiehhng and Sainty *, i 450 Sachon 120.421:
Appsodix B Infhn==ha= to be hl==in=d by Papoes Ptoposing to Conductlimahng Arts Screening 450
)
Sachen 120A22:
Appsahz C - Design Rapmeesses for an Opssasor's Booth 451 heelam 120A23:
Appendet D P===5*ia= ime Shiakhag for Cartain Placeoscope Procednes 452 120A30: THERAPEUDC RADIATION MACHINES 452 Seceos 120.431:
Purpose and Scope 452 Secties 120A32:
nas.sda==
452 Secuen 120A33:
Osseral Administratin*
- forPacilines Using Therapsonc Rahamon Machines 455 Secnos 120A34 Osseral Technical E ; '
- forPacihnes Using 7berspeune Pn=eia= namel====
458 Secanos 120A35:
Quality 18===y====' Progran
, 459 Secnos 120.436:
Therspanne 8a=*ia= Maciuses ofImss 'lhan 500 kV 459 Section 120.437:
lberspoutic *n=ma= brach==, - Photon 1herapy Systems (500 kV sad Above) and Electron Derapy Systems (500 ksV and Above) 463 Section 120.438:
Calibration of SurveyInstnansats 471 Section 120A39:
Sinekhng and Safety Design Raquaemmets 471 Secnom 120.440:
Appendix A: Informanon on Radiance Shi doing Requued for Plan Reviews 472 120.500: USE OF RADIONUCUDES IN THE HEAUNO AR13 474 Secdos 120.501:
Purpose und Scope 474 Section 120.502:
Densitions 474 Section 120.503:
Uomene Raquued 474.3 Sectos 120.504:
Haa== Aha 474.3 Semien 120.505:
Narine=ena=,
474.4 Seceos 120.506:
AIARA Program 474.4 Section 120.507:
am a= Safety OHicer 474.5 Seceos 120.508:
Rad==eia= Safety CMase 474.5 Secton 120.509:
Stan=====' of Authannes sad B==pa==iNhei==
474.6 Secnos 120.510:
Supervisica 474.6 Section 120.511;.
Visiting Authorised User or Visiting Authortand Pharin.cmer 474.7 75/99 105 CMR 9
i 105 CMR: DEPARTMENTOFPURIJC HEA1111f Table dCashets EEE 105 CNR 120.000: MASSACHUSETIE REGULATIONS POR7HE ColGROL OP RADIATION (MRCR) (contimmed)
Section 120.512:
MoldieNuciserMedicies Servios Administrusive ?,
- 474.7*
Section 120.513:
Quelky Ed==ag====a Prognen 474.7 Section 120J14:
Recents,N and Reports of-474.9 Seatica 120J15:
Suppliass 474.10 Seceion 120J16:
Quality Comand otDiagnosec Equipenset 474.10 Section 120J17:
Ptossosion, Uss, C=Hhmeine and Qatk of Does Calbrosors 474.10 Session 120.518:
r=N=ia= and Qeck of Surveylosinumanas 474.11 Section 120.519:
Assayof"W Dossess 474.12 Section 120.520:
Authorisation ist Qlliwation and Rafuumos Seurass 474.12 Section 120J21:
- =T'h""""*= for Pesesseion of Sealed Sommes sad "= ' f'
,2 Scenes 474.12 Section 120522:
Syrings Sidelds 474.13 Section 120J23:
Syrings Labais 474.14 Section 120.524.
Vial awaken 474.14 Sectice 120J25.
VialShield1abels 474.14 Section 120J26:
Surveys for Ambinet Radassion Does Russ and eme==Imaman 474.14 Seenos 120.527:
Raisses of Parisees or Human Rossene Subjects tw=ining Radiophannanseticals or Penmenset kapiasts 474.14 Seedon 120.528:
Mobus NuclearMedicias Servios Techakal Requbensmes 474.15 Section 120.529:
Seurage of Valadies sad Genes 474.15 Section 120.530:
Deosy.h.Storags 474.15 Session 120.531:
Use of 84"la for Uptake, Duunca, or Excsution Studies 474.16 Section 120.532:
Poessasion of Surveyhannumset 474.16 Section 120.533:
Use of Radiopbanamosoticals, e-
. med Reagent Kits for knoging sadia,=u sa= Sembas 474.16 Section 120J34:
Radir==det= came==I===en 474.17 Section 120J35:
Costmlof Aarosals sad Genes 474.17
( dios 120.536:
Posasesion of Surveyhetnansats 474.17 Section 120.537:
Use of Radiophenmaceuticals for Therapy 474.18 Section 120.538:
Safetyhsenanos 474.18 Section 120J39:
Safety Precandoms 474.18 Seedon 120.540:
Posesseios of Survey hatrumsets 474.19 Section 120.541:
- Use of Sealed Sounes forDiagnosis 474.19 Sectica 120.542:
Avensbuky of SurvoyInstrummet 474.19 Section 120.543:
Use of Sommes fori ", f 474.19 Section 120.544:
SaintyInstruction 474.20 Section 120.545:
Safety Pmcensions 474.20 Section 120.546:
BrecbytherapySommes hvastory 474.21 Section 120.547:
Raisons of Patients or Hamma Reararch subjects Tassed With TemporaryImplants 474.21 Secdon 120.548:
Possessica of SurveyInstnanents 474.21 Section 120.549:
Use of a Sealed Seems la a Teletberapy Unit 474.21 Seenos 120.550:
M-and Reper Restricaces 474.21 Secnos 120.551:
Ah 474.22 Section 120.552:
SafetyInstruence 474.22 Section 120.553:
Doors, Interlocks, and Warning Systems 474.22 Section 120.554:
Possession of SurveyInsanansat 474.22 Section 120.555:
Radiana= Maniaoring Devios 474.23 Section 120.556:
Viewing System 474.23 Seceos 120J57:
DesimetryEquipment 474.23 Secnon 120.558:
Pull Calibrados Mansunensees 474.24 Seceos 120.559:
Periodic Spot-Checks 474.25 Secdon 120.560:
Radassion Surveys for Teletberapy Facilities 474.26 Section 120.561:
Saisty Spot-Checks for Teletherapy Facdities 474.26 7MWp9 105 CMR-10
105 Chut: Def/JtTMIDE OFPUBIJC HEALTH Table ofComunes i
U 105 Ch0L 120.000: MASSAQiUSETTS REGULATIONS POR11EE COlGROL OF RADIATION (nGICR) (aaan===d)
Section 120.562:
h8aMie=*ia= of Telsdurupy Unit or Room Befase Begmuung a Theetaset Progress 474.27 Section 120.563:
Repons of Teletherapy Surveys, Checks, Tests and Messunmasses 474.27 Section 120.564:
Pive YearInspessaan 474.27 Section 120.565:
Radsstion Selsey Of5cer 474.27 Seedna 120.566:
Ttaining for RW Radiados Sedsty Of5 car 474.28 Seedos 120.567:
Trainhg for Upsake, DGenon, or Bamation Studies 474.28 Session 120.568:
Tasming for Immaging and IAceksanen Sendus 474.29 Seedom 120.569:
Traishig for1herapeutic Uss of *",'
=?--
47430 Section 120.570:
Tnuming for Therapeutic Use of ?+_ ', ^,, Sources 474.30
{
Section 120J71:
Trainingfor M Use ofStantimeWIO 47431 Secdos 120J72:
T) aiming for Use of Sealed Sonsons for Diagnosis 47431
- Section 120.573:
Tranning forTeletherapy
, 474.32 Section 120374:
Training forTeletbetapy Physirist 47432 Semion 120.575:
Training for Bapedsmead Am:1 arised Users 47433 Seedon 120.576:
Physicina Ttaining in a Times, Month Psograma 47433 Seasson 120.577:
8-of Thaining 47433 Session 120.500:
Trandag for en Authosised Nuclear Phannecast 474.33 Seados 120.581:
Traudog for Rrpen===8 Nuclear Phansacist 474.34 120.600: RADIATION SAPNTY REQUIREhEh40 POR ANALYTICAL,
X-RAYEQUIPMENT 47434 Secdos 120.601:
Purpose and Scope 47434
}
Seonom 120.602:
n.#iminan.
47434 Section 120.603:
Equipment? ;
47434 Sectiez 120.604:
Ases 8 T======*=
47435 Secdos 120.605:
Operatag ?, '
474.36 Secdos 120.606:
PersonnelRequiremmets 474.36 120.620: IJCENSING AND RADIATION SAPETY REQUIREMENTS POR 1RRADIATORS 474.37 Seedon 120.621:
Pusposeand Scope 47437 Section 120.622:
n.#6 inn 47437 Seedon 120.631:
Applicanos foraSpec Scliosass 47438 Seeden 120.633:
Spec ScIJoneses for Enedansers 47438 Seceien 120.635:
Start of Construction 47439 Seados 120.637:
Apphada== for t==gnia==
474A0 s
Section 120.639:
Request forWritsen Stseements 474A0 Design and Perfornunce Requinunsmis for 1rradiaans Secnos 120.641:
Perfonnance Cnteria for Sealed Sources 474A0 Secnos 120.643:
Access Control 474A0 Secdon 120.645:
Shieldag 474Al Seceos 120.647:
Phe Praesceos 474A2 Seccan 120.649:
Raducon Manhors 474A2 hvia= 120.651:
Connel of Source Movannat 474.42 Seedon 120.653:
Irradiasar Pools 474.42 Secace 120.655:
Sousoe Rack Paceschoa 474A3 Seenos 120.657:
Power Paduras 474A3 Secnos 120.659:
Design *,
474.43 Seceon 120.661:
Construction Manhanog and Av Testing 474.44 Operance ofIsradutors Secnos 120.671:
Traimeng 474A5 Semica 120.673:
Operanag, Safety, and Emergemey Procednes 474A6 Secdos 120.6'{5;.
Perscanal Monitonag 474.47 7/9/99 105 CMR.11
105 OGL' DEPARTMENT OF PUB 1JC HEAL 111 Tahim of Comensta EBGE 105 Chet 120.000:
MASSACHUSETT3 REGULATIONSIUR THE CONTROL OF RADIATION (MRCR) (contimmed)
Secean 120.677:
Radiation Surveys 474.47 Seedon 120.679:
Doestice ofIasking Souness 474A8 Section 120.681:
laspection and Malmesmemos 474A8 Section 120.683:
PoolWassr Pu ity 474A9 Secdon 120.685:
Assemdemos During Opasation 474A9 Section 120.687:
Basunng and Imovlug the Radiation Roose 474.49 i
Secmos 120.689:
Erradiation of Explosive er Pl=====hl= h8===l=la 474.50 Section 120.691:
Ranceds and Reemmelon Parlods 474JO Secdon 120.693:
Rapostr 474.51 120.700: RADIATION SAIETY RBQUIREMENI5 POR PARTIC1Ji
- YWf EtB41DRS 47431 Secdon 120.701:
Purpons and Scope 474.51 i
Seedon 120.702:
Ragsstation m.9.a--
474.51 Seedon 120.703:
Onasral Raquinamanes for eks issuamos of a Regismation for Panicis A==I===sar=
474.51 Section 120.704:
36mmen Ues ofPenicis Aconteratoss 474.52 Seedon 120.705:
rJ-inssia==
474.52 Section 120.706:
Shimiding sad SagueyDesige 8 7 a a
47432 Seedon 120."M7:
Panicle ^==l= =aarComerois sad 1===lar* Sysesmas 474.52 Seaden 120.708:
WeningDevious 474.53 Seedon 120.709:
Operating Psoneduses 474.53 he+ian 120.710:
Radiation Monitoring Requhemunes 474.53 Secdon 120.711:
VestDadam Symenes 474.54 120.750: NOTIC2IS, INSTRUCTIONS, AND REPORTS TO WOREERS; INSPflCTIONS 474.54 Secsion 120.751:
Purpons and Soaps 474.54 heelan 120.752:
Posang ofNations to Workers 474.54 Seedon 120.753:
Instruccome to Woders 474.55 Seedon 120.754:
Ndne=an=a and Raports so ledividonis 474.55 Section 120.755:
Pressmos of *
- ofIJoensees or Registrusts sad Weekses During W 474.56 Secdos 120.756:
ra==le=ela= wkb Weekers Dunes 1==p=*la==
474.57 Secnos 120.757:
Requests byWosburs for M 474.57
=
Section 120.758:
Inspeccoms Not Wassamesd; Infanual Review 474.57 l
Section 120.760:
Emergamey Plans 474.58 l
120.770: 11tANSPORTAT10N OF RADIDACITVE MA71ERIAL 474.58 Section 120.771:
Purpons and Soops 474.58 Seedon 120.772:
DeSmitions 474.58 Secanoa 120.773:
Requisessmet forIJoames 474.61 Secdos 120.774:
h== Tela==
474.61 Seedon 120.775:
T-
= of f la====t Material 474.62 Seedon 120.776:
OsmeralIJoensesfor arri=rs 474.62 c
Section 120.777:
OsmeralIlosass: Nuclear Ragulatory ra===l==ian - Approved Packages 474 63 hesian 120.778:
General IJoamas - Pteviously Approved Padcages 47c.63 Secuca 120.779:
Osmeraliia=== U.S.Deparusset ofTransponados I
Sp=e=Ac=*ian Container 474.63 Seedon 120.780:
OsmeralIJosase - Ues of Poseign Approved Padings 474.64 Section 120.781:
Osmaral 1Joense: Plasus Macedal,IJudied Quemnty Per Package 474.64 4
Secdon 120.782:
Osmeral 1Joamas? Plasus Meerial, IJimiend Moderator Per Package 474.65 I
Secdon 120.783:
, = as to Unknown Propernes of Pissils n8=amnal 474.67
)
Secdon 120.784:
Peelheimary W=
474.67 Section 120.785;.
Routies Determi==e===
474.68
]
7/999 105 O4R-12
'105 OdR: DEIPARTMENTOFPUB1JCHEALTH Tahls of Communs Bisa i
105 CMR 120.000: MASSAOIUSET!3 REGULATIONS FORTHE CON 11000F RADIATION OdRCR) (cestimmed)
Section 120.786:
AirliamsportofPistonhan 474.69 Section 120.787A: Opsain8hennetions 474.70 Section 120.787:
ShipmentReconis 474.70 Section 120.788:
Repone 474.70 Section 120.789:
Advanes Nanda=ala= cf Transport of Nuclear Weses 474.70 Semien 120.790:
Quaiky Assuramos Requireusses 474.71 Semien 120.795:
Appsodix A-Dueenminanom of A, and A, 474.72 120.800: IJCENSING AND 095 RATIONAL RBQUIREMBICS FOR EDW-LEVEL RADIDACI1VEWASTE PAGR1BS 474.82 Section 120.801:
Purpoos and Scops 474.82 Session 120.802:
RegulasaryAutharky 474.83 Section 120.803:
De&nitions 474A3 Seedon 120.810:
Gesand Requisuusmas 474A8 Section 120.811:
Ptoescean of ths Osmeral Population tem Reiseems of Radioactivsty 474J8 Section 120.812:
Protection of Indivulmans ham Imedvertent barneion 474.88 Session 120.513:
Pnnection ofindividuals Dunes Operadoms 474.88 Section 120.814:
Stability of the PacGity A$er Oceum 474.88 Seedon 120215:
PacilityDesi a 474.88 8
Semion 120216:
Pacdhy brinneia==8 Control 474.89 Section 120.820:
IJonese Required 474.89 Secdon 120.821:
IJonesing Ptooses 474.89 Secdon 120.822:
Comenet of Appheadon 474.90 I
Semion 120.823:
Osseralbionmenon 474.91 Section 120.824:
Speci5c TechnicalInfonmence 474.91 Secnon 120.825:
Technacal Analyses 474.93 Section 120.826:
hansne===l Infh-= elan 474.94 Section 120.827:
Financial biannanim 474.94 Seceon 120.828:
Ptooperamonal Envun====tal Maalawing 474.94 Secdon 120.829:
Standamis forIssuneen of alleense 474.94 Section 120.830:
Pa=dmiana ofIJoenses 474.95 Section 120.831:
Envuemamanal Monitoring 474.96 Section 120.832:
PacihtyDeensa 474.98 Section 120A33:
Pacility Construction 474.99 Section 120.834:
Opasedag1 Budget Rehnbur====e4 474.100 Section 120.840:
PandkyOpsahs 474.100 Secdon 120.841:
PedlityOperation 474.100 Secnoa 120.842:
Receipt, Handling, and Insparenan of Wases 474.101 Sectica 120.843:
PacintyBoundanes and Markers 474.102 Section 120.844:
Comdspsacy Plans for Pacuity Operanens 474.102 Section 120.845:
Pacdity Ma-474.102 Section 120.850:
Phnding for Pacihty Closure 474.102 Section 120.851:
Appucation forRamswalorClosure 474.103 Section 120.852:
Ptoondens for Review of.*;^= for PacGhy Closure and Clasms Plan 474.104 Section 120.853:
PacintyClosuse 474.104 Section 120.860:
Post <lomas Observatica andwh 474,104 Secnon 120.870:
Transist of1Josase 474.104 Secnica 120.871:
Institunomal Connel 474.105 Section 120.880:
Malmannanan of Reconis, Reports, and Transfers 474.105 Secnon 120.881:
Tests on Pacihties 474.106 l
Sechan 120.882:
Depernaast W of Pacihnes 474.106 Secnon 120.885:
Waivers 474.106 7/W99 105 CMR - 13
105 CMR: DEPAR'm0DfTOFPUBIJCHEALTH Table af Comenmes EREE 105 CnSt 120.000:
MASSACHUSET!3 RBOUIATIONS PORTHE CON!ROL OF RADIATION (hetCR) (condmuod) 120.890:. IDW IJ! VEL RADIDACITVE WAS11 MINIhETATION RBOULATIONS 474.107 Secdos 120.891:
Purpoos and Scops 474.107 Seedon 120.892:
Ragulesary Amihorky 474.107 Seedon 120.693:
DeGakiens 474.107 Seedon 120.895:
Objectives 474.109 Sectism 120.896:
Staessammt and Plas *W 474.109 Seedon 120.897:
Wests hA=8=3=mia= Plan Conoset 474.110 120.900: RADIATION SAPBTY RBQUEtEMENTS ICR WELE1JNE SERVICE OPERATIONS AND SUBSURPAGTRACER $"IUDIES 474.111 Seedon 120.901:
Pmpose andScopo 474.111 Secdos 120.902:
1% Amida==
474.112 Seaden 120.903:
ProhAddos 474.113 Seceos 120.911:
Lindes on1mels of Radiados 474.113 Secelos 120.912:
Stones Puesamtions 474.113 Secdos 120.913:
Trumspost Pascendees 474.113 Sendes 120.914:
Radiados SurwyEssenmasmas 474.113 Secdos 120.915:
KaakTesdag of Sealed Sousass 474.114 Seedos 120.916:
Quartsdyinvumeory 474.114-Section 120.917:
Utuisados Rooseds 474.115 Secdon 120.918:
Deales, Pericanamos, and Comneml= Criseris for Sealed Sounes Usedin Downhois Operadoes 474.115 Seamon 120.919:
Labeling 474.115 Seedon 120.920:
Inspeedom andMalmeseamos 474.116 Secdon 120.931:
Tressing?,
474.116 Section 120.932:
Operating and Essergsacy Procedures 474.117 Secdos 120.933:
Pessommet neonieoring 474.117 Secdon 120.941:
Secadly 474.118 Section 120942:,
HandbagTools 474.118 Secess 120.9c Subsurface"Daser Samlies 474.118 h 120.944:
Particle Acomierators 474.118 Seedon 120.945:
Uranient Simber Bars 474.118 Sectice 120.946:
Use of Sealed Somme in a WeR Without a Surinos Casing 474.118 Section 120.951:
Radiation Surveys 474.118
' eedom 120.952:
h and Reconis Rapased at Pleid Stances 474.119 S
Section 120.953:
nar====*a and Raconis Requimd at Tesaporary Jobsless 474.119 Secnon 120.954:
Namier= dan ofIncidames, Ah===* and Last Sources 474.119 Section 120.960:
Appsodix A - Subjects to be kicluded in'naising Courses for Lagging Supervisons 474.121 Secdon 120.961:
Appendix A - Example of Plaque for Idsstifying Wens raataisier Sealed Sommes a=t=3=lar Radioeceive Maasdal r
Ah=ada==d Downhole 474.122 105 OGt 121.000:
TO CONTROL 7HE RADIATION HAZARDS OPIASERS, LASER SYSTEMS AND OPTICAL PIBER COMMUNI-CATION SYSTEMS IT!1L2 ZING LASER DIODE OR L3 Gift EMIT 11NO D10DE SOURCES 475 Seedon 121.001:
Purpose and Soops 475 Secean 121.002:
ReguissoryAusbority 475 Section 121.003:
Citation 475 Secsion 121.004:
nanalena==
476 Seedon 121.005:
General Requirusasets for A111asers and Laser Sysmans 477 Seceos 121.006:
Special?4_'_
- for Optical Piber Cc==annimetaa Systems Utilizing Laser Diods or IJght Ihmitung Diode ("12D") Sountas 477 Secnon121.007::
Special Raquirsumsmas for Lasers in Henkh Cass PacGities 477 7/999 105 CMR-14 1
l
'105CMR: DIIPAR1)GDfTOFPURIJC HEALTH Tahin af Comamman 1
\\
105 Ch0L 121.000: 1D CON 11t0LTHE RADIA1 ION HAZARDS OF LASERS, LASER SYSI1MS AND OITICAL PIBER COh06UPG-CA110N SYS11M5 II!1UZING IASER DIODE OR UGHT I
EMFITING DIODE SOURGS (comummed)
Sectica 121.008:
Special Requimsnmmes for Emeertainment Laser Pacilities 473 Section 121.009:
r===yl8==a= whh Otherlaws and ang=lseia==
473 Secton 121.010:
Reconis 473 Section 121All:
Waiver 473 Section 121A12:
Pumpose and Scape 479 Section 121A13:
th4=hia==
479 Seedon 121A14:
he 479 Section 121A15:
?;;" ' forRegistration 479 Section 121A16:
Caninoses of Regisannos 479 Section 121A17:
Empiration ofNouns ofRegistramos 479 Section 121A18:
RamewalofNouns of Registrados 400 Section 121.019:
Report of Changes 480 Session 121.020:
AppnwalNotImphed 480 Seedon 121.021:
Vendor Oldignaca 480 Secanos 121.022:
Out-of-Sasse Laser Panilides 480 Section 121.023:
Addidonal *=q=3======e= for lasses Used in Emaartainment
'480 Sennom 121.024:
Inspections 431 Secuan 121.025:
Addidonal
- 431 Seedon 121.026:
r-====ic=sia==
431 Session 121.027:
Enfoscommet Ftdicy sad PN==
481 Seccan 121.028:
Pubbe Disclosum of Enfoscenset Acdoes 432.3
)
Sectica 121.029:
Severubday 432.3 105 Chet 122.000: PDGID PACERIES WHICH OENERATE EUIC10MAGNLTIC PIBIDS IN THE PREQUENCY RANGE OF 300 kHz 10100 Giu AND MICROWAVE OVENS 483 Sectica 122J101:
Purpose and Scope 483 Senhon 122.002:
Authority 484 Soodos in.003:
Catamon 434 Secmon 122.004:
Effective Dune 434 Secnica 122.005:
Pensky for Vioheca 484 h
7MM99 105 CMR - 14.1
I NON-TEXTPAGE 9
l e
I i
i 9
4 e
l l
e h
9 7S 99 105 CMR-14.2
F 1
e.
105 CMR: DEPARTMENT OF PUBLICllEALTil j
MASSACilUSETTS REGULATIONS FOR TIIE CONTROL OF RADIATIO 105 CMR 120.000:
(MRCR)
Section 1
120.001: GENERAL PROVISIONS 120.002: Purpose and Scope
-120.003: Regulatory Autlority 120.004: Citation 120.005: Definitions 120.006: Exemptions 120.007: Prohibited Uses 120.008: Impounding 120.009: Records 120.010: Inspections 120.011: Tests 120.012: Additional Requirements 120.013: Communications 120.014: Units of Exposure and Dose 120.015: Units of Activity ENFORCEMENT 120.016: Enforcement Policy and Procedures 120.017: Severability 1
120.018: Public Disclosure of Enforcement Actions 120.019: Appendix A -- Severity Categories REGJSTRATION OF RADIATION MAClllNE FACILITIES AND SERVICES 120,020:
120.021: Purpose and Scope 120.022: Definitions f
120.023: Exemptions I
120.024: Plan Review
'f 120.025: Application for Registration 120.026: Application for Registration Senices 120.027: Certificate of Registration j
120.028: Expiration of Notice of Registration 120.029: Renewal of Notice of Registration 120.030: Report of Changes 120.031: Approval Notimplied 120.032: Assembler and/or Transfer Obligation f
120.033: Out-of-State Radiation Machines 120 N O: Notification to Fire Department 120.100: LICENSING OF RADIOACTIVE MATERIAL 120.101: Purpose and Scope 120.102: Definitions 120.103: Source Material 120.104: Radioactive Material Other Than Source Material 3
120.120: Types of Licenses General Licenses-Source Material 120.121:
120.122: ' General Licenses - Radioactive Material Other Than Source Material 120.124: Filing Application for Specific Licenses General Requirements for the issuance of Specific Licenses 120.125: Special Requirements for Issuance of Certain Specific Licenses for Radioactive 120.126:
9 Special Requirements for Specific Licenses ofIlroad Scope 120.127: Special Requirements for a Specific License to Manufxture, Assemble, Repair, or 120.128:
Commodities, Products, or Devices which Contain Radioactive Material 120.130: Issuance of Specific Licenses 120.131: Specific Terms and Conditions of Licenses 120.132: Expiration and Tennination of Licenses 105 CMR - 201 7/9/99 l
I i
105 CMR: DEPARTMENT OF PUBLIC IIEAL111 l
- Section: continued 120.133: Renewalof Licenses 120.134: Amendment of Licenses at Request of Licensee 120.135: Agency Action on Applications to Renew or Arnend 120.136: Persons Possessing a License for Source, Hypmduct, or Special Nuclear Material in Quantities Not Suflicient to Form a Critical Mass on EITective Date of 105 CMR 120.000 I
120.137; Persons Possessing Naturally Occurring and Accelerator-Produced Radioactive Material j
(NARM) on Effective Date of 105 CMR 120.000 120.140: Transfer of Material 120.142; Reporting Requirements 120.146: Emergency Plan for Responding to a Release 120.150: Modification and Revocation of Licenses 120.190: Reciprocal Recognition of Licenses 120.195: Appendix A - Exempt Concentrations 120.196: Appendix B - Table 1 Exempt Quantities Table 11 - Quantities for Use With 105 CMR 120.125(C)(1)
Table 111 - Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release Appendix C - Limits for Broad Licenses 120.197:
Appendix D - Criteria Relating to Use of Financial Tests and Parent Company Guarantees for 120.198:
Providing Reasonable Assurance of Funds for Decommissioning Appendix E - Criteria Relating to Use of Financial Tests and Self Guarantees for ihoviding 120.199:
Reasonable Assurance of Funds for Decommissioning 120.200: STANDARDS FOR PROTECTION AGAINST RADIATION 120.201: Purpose 120.202: Scope 120.203: Definitions 120.204: Implementation RADIATION PROTECTION PROGRAMS 120.210; Radiation Protection Prognuns OCCUPATIONAL DOSE LIMITS 120.211: Occupational Dose Limits for Adults 120.212: Compliance with Requirements for Summation of Extemal and Intemal Doses 120.213: Determination of Extemal Dose from Airbome Radioactive Material 120.214: Determination ofInternal Exposure 120.215: Detemiination of Prior Occupational Dose 120.216: Planned Special Exposures 120.217: Occupational Dose Limits for Minors 120.218: Dose ta an Embryo / Fetus RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERS OF Tile PUBLIC 120.221: Dose Lirnits for Individual Members of the Ibblic 120.222: Compliance with Dose Limits for Individual Members of the INblic 120.223: Testing for Lealmge or Contamination of Scaled Sources SURVEYS AND MONITORING 120.225: General 120.226: Conditions Requiring Individual Monitoring of External and Intemal Occupational Dose l
CONTROL OF EXPOSURE FROM EXTERNAL SOURCES IN RESTRICTED AREAS 120.227: Control of Access to Iligh Radiation Areas i
120.228: Control of Access to Very Iligh Radiation Areas 120.229; Control of Access to Very Iligh Radiation Areas - Irradiators RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL I
RESTRICTED AREAS 120.231:- Use of Process or Other Engineering Controls 120.232: Use of Other Controls 120.233: Use of hidividual Respiratory Protection Equipment STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF R 120.235: Security and Control of Licensed or Registered Sources of Radiation 105 CMR - 202 7/9'99
7-f 105 CMR: DEPARTMENT OF PUBLIC HEAL 111 Section: continued i
PRECAUTIONARY PROCEDURES 120.241: Caution Signs 120.242: Posting Requirements 120.243: Exceptions to Posting Requirements 120.244: Labeling Containers and Radiation Macidnes 120.245: Exemptions to Labeling Requirements 120.246: Procedures for Receiving and Opening Packages WASTE MANAGEMENT 120.251: General Requirements 120.252: Method for Obtaining Approval of Proposed Disposal Procedures 120253: Discharge by Release into Sanitary Sewrage 120.254: Treatment by Inciaeration 120.255: Disposal of Specific Wastes 120.256: Transfer for Disposal and Manifests 121.257: Compliance with Environmental and llealth Protection Regtdations RECORDS 120.261: General Provisions i
120.262: Records of Radiation Protection Programs 120.263: Records of Surveys 120.264: Records of Tests for Leakage or Contamination of Scaled Sources 120.265: Records of Prior Occupational Dose 120.266: Records of Planned Special Exposures 120.267: Records ofIndividual Monitoring Results j
120.268: Records of Dose to Individual Members of the Public 120.269: Records of Waste Transfers l
Records of Testing Entry Control Devices for Very liigh Radiation Areas 120.270:
l 120.271: Form of Records REPORTS 120.281: Reports of Stolen, Lost, or Missing Licensed or Registered Sources of Radiation 120.282: Notification ofincidents Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding 120.283:
the Constraints or the Limits 120.284: Reports of Planned Special Exposures 120.287: Notifications and Reports to Individuals 120.288: Reports of Leaking or Contaminated Scaled Sources ADDITIONAL REQUIREMENTS 120.291: Vacating Premises l
120.295: Appendix A -- Protection Factors for Respirators 120.296: Appendix B - Annual Limits on Intake (ali) and Derived Air Concentrations (dac) of Radionuclides for Occupational Exposure; Efiluent Concentrations; Concentrations for Release to Sanitary Sewerage j
120.297:
Appendix C - Quantities of Licensed Material Requiring 1.abeling Appendix D - Requirements for Transfer of Low-level Radioactive Waste for Disposal at Land 120.298:
Disposal Facilities and Manifests 120.299: Appendix E - Classification and Characteristics of Low-level Radioactive Waste
)
120.300: RADIATION SAFETY REQUIREMENTS FOR INDUSTIUAL RADIOGRAPillC j
OPERATIONS 120.301: Purpose and Scope 120.302: Definitions 120.303: Exemptions 120.310: Records of Receipt, Transfer, and Disposal of Sources ofIbdiation l
1 120.311: Limits on Levels of Radiation for Radiographic Exposure Devices, Source Changers, und Transport Containers 120.312: Locking of Sources of Radiation 120.313: Storage Precautions 105 CMR - 203 7/9/99
l t
105 CMR: DEPARTMENT OF PUl3LIC llEALTil Section: continued 120314: Radiation Survey Instruments j
120315: Requirements Ibr Equipment Used in Industrial Radiographic Operations
]
120316: Quarterly Inventory 120317: Utilization logs 120318: Inspection and Maintenance j
120319: Permanent Radiographic Installations 120320: Training and Testing
{
120321: Applications and Examinations 120322: Revocation or Suspension of an I.D. Card 120323: Personnel Monitoring Control 120330: Operating and Internal Audit Requirements 120331: Security in Field Operations 120332: Posting 120333: Radiation Surveys and Survey Records 120334: Records Required at Temporary Job Sites 120337: Special Requirements and Exemptions for Enclosed Radiography 120340: Underwater and Lay-barge Radiography 120350: Prohibitions 120360: Licensing and Registration Requirements for Industrial Radiographic Operations 120380: Radiation Safety Oflicer 120385: Notification ofincidents 120390: Reciprocity 120395: Appendix A - Subjects for Instruction of Radiographer Trainees 120396: Appendix 11 - General Requirements for inspection of Industrial Radiographic Equipment 120397: Appendix C - Time Requirements for Record Keeping 120398: Appendix D - Operating and Emergency Procedures 120.400: X-RAYS IN TIIE ilEALING ARTS 120.401: Purpose and Scope 120.402: Defmitions 120.403: General Requirements 120.404: General Requirements for All Diagnostic X-Ray Systems 120.405: Fluoroscopic X-Ray Systems 120.406: Radiographic Systems Other han Fluoroscopic, Computed Tomography Systems 120.407: Dental Radiographic Systems 120.408: Veterinary X-ray Systems 120.409: Computed Tomegraphy X-Ray Systems 120.420: Appendix A - Radbtion Shielding and Safety Requirements 120.421: Appendix B - Informadon to be Submitted by Persons Proposing to Conduct Ilealing Arts Screening 120.422: Appendix C - Design Requireirnts for an Operator's llooth l
l 120.423: Appendix D - Exemption from Shielding for Certain Fluoroscope Procedures 1
120A30: TilERAPEUTIC RADIATION MACIllNES 120.431: Purpose and Scope 120.432: Ikfinitions 120.433: General Administrative Requirements for Facilities Using Therapeutic Radiation Machines 120.434 General Technical Requirements for Facilities Using nerapeutic Radiation Machines I
120.435: Quality Management Program 120.436: nerapeutic Radiation Machines ofless han 500 kV 120.437: Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron herapy Systems (500 kev and Above) 120.438: Calibration of Survey Instrtunents 120.439: Shielding and Safety Design Requirements 120.440: Appendix A: Information on Radiation Shielding Required for Plan Reviews 120.500: USE OF RADIONUCLIDES IN THE IIEALING ARTS 120.501: Purpose and Scope 120.502: Definitions 120.503: License Required 105 CMR - 204 7/9/99
E i
f 105 CMR: DEPARTMENT OF PUllLIC llEALTil Section: continued 120.504: License Amendments 120.505: Notifications 120.506: ALARA Program 120.507: Radiation Safety Ollicer 120.508: Radiation Safety Committee 120.509. Statement of Authorities and Responsibilities 120.510: Supervision 120.511: Visiting Authorized User 120.512: Mobile Nuclear Medicine Service Administrative Requirements 120.513: Quality Management Program 120.514: Records, Notifications, and Reports of Misadministiations 120.515: Supplies 120.516: Quality Control of Diagnostic Equipment 120.517: Possession, Use, Calibration, and Check of Dose Calibrators 120.518: Calibration and Check of Survey Instruments 120.519: Assay of Radiopharmaceutical Dosages 120.520: Authorization for Calibration and Reference Sources 120.521: Requirements for Possession of Scaled Sources and Brachytherapy Sources 120.522: Syringe Shields 120.523: Syringe Labels 120.524: Vial Shicids 120.525: Vial Shield Labels 120.526: Surveys for Ambient Radiation Dose Pate and Contamination 120.527: Release of Patients Containing Radiophannaceuticals or Permanent implants 120.528: Mobile Nuclear Medicine Service Technical Requirements 120.529: Storage of Volatiles and Gases l
120.530: Decay-In-Storage l
120.531: Use of Radiophannaceuticals for Uptake, Dilution, or Excretion Studies 120.532: Possession of Survey Instrument 120.533: Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies l
120.534: Radionuclide Contaminants l
120.535: Control of Aerosols and Gases l
120.536: Possession of Survey Instruments l
120.537: Use of Radiopharmaceuticals for Therapy 120.538: Safety Instruction l
120.539: Safety Precautions l
120.540: Possession of Survey Instruments 120.541: Use of Scaled Sources for Diagnosis 120.542: Availability of Survey Instrument 120.543: Use of Sources for Brachytherapy 120.544: Safety Instruction 120.545: Safety Precautions 120.546: llrachytherapy Sources Inventory
{
120.547: Release of Patients or l hunan Research Subjects Treated With Temporary implants 120.548: Possession of Survey Instruments 120.549: Use of a Scaled Source in a Teletherapy Unit 120.550: Maintenance and Repair Restrictions 120.551: Amendments 120.552: Safety Instruction 120.553: Doors, Interlocks, and Waming Systems 120.554: Possession of Survey Instrument 120.555: Radiation Monitoring Device 120.556: Viewing System 120.557: Dosimetry Equipment 120.558: Full Calibration Measurements 120.559: Periodic Spot-Checks j
4 120.560: Radiation Surveys for Teletherapy Facilities 120.561: Safety Spot-Checks for Teletherapy Facilities 120.562: Modification of Teletherapy Unit or Room Befbre Beginning a Treatment Program s
7/9/99 105 CMR - 205 l
a l
s
f 105 CMR: DEPARTMINT OF PUllLIC IIEAlllI Section: continued 120.563: Reports of Teletherapy Surveys, Checks, Tests and Measurements 120.564: Five Year Inspection
)
120.565: Radiation Safety Oflicer j
120.566: Training for Experienced Radiation Safety OtTicer I
120.567: Training for Uptake, Dilution, or Excretion Studies f
120.568: Training for Imaging and Localization Studies 120.569: Training for 'lherapeutic Use of Radiopharmaceuticals 120.570: Training for lherapeutic Use of Brachytherapy Sources 120.571: Training for Ophthalmic Use of Strontium-90
-120.572: Training for Use of Scaled Sources for Diagnosis 120.573: Training for Teletherapy 120.574: Training for Teletherapy Physicist 120.075: Training for Experienced Authorized Users 120.576: Physician Training in a Three-Month Program 120.577; Recentness ofTraining 120.580: Training for an Authorized Nuclear Pharmacist 120.581: Training for Experienced Nuclear Phannacist 120.600: RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT I
120.601: Purpose and Scope
{
120.602: Definitions
)
120.603: Equipment Requirements
{
120.604: Area Requirements 120.605: Operating Requirements j
120.606: Personnel Requirements g'
)
120.620: LICENSING AND RADIATION SAFETY REQUIREMENTS FOR 1RRADIATORS f
120.621: Purpose and Scope 120.622: Dermitions 120.631: Application for a Specific License 120.633: Specific Licenses for Irradiators 120.635: Start of Construction 120.637: Appliations for Exemptions 120.639: Request for Written Statements Design and Perfomtance Requirements for Irradiators 120.641: Performance Criteria for Scaled Sources 120.643: Access Control 120.645: Shielding 120.647: Fire Protection 120.649: Radiation Monitors 120.651: Control of Source Movement 120.653: Irradiator Pools 120.655: Source Rack Protection 120.657: Power Failures 120 659: Design Requirements 120.661: Construction Monitoring and Acceptance Testing i
Operation ofIrradiators 120.671: Training 120.673: Operating, Safety, and Emergency Procedures 120.675: Personnel Monitoring 120.677: Radiation Surveys 120.679: Detection of Leaking Sources 120.681: Inspection and Maintenance 120.683: Pool Water Purity 120.685: Attendance During Operation 120.687: Entering and Leaving the Radiation Room 120.689: Irradiation of Explosive or Flanunable Materials 120.691: Records and Retention Periods 120.693: Reports 7/9/99 105 CMR. 206
f 105 CMR: DEPARTMENT OF PUBLIC llEALTil
)
Section: continued 120.700: RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS 120.701: Purpose and Scope 120.702:' Registration Requirements 120.703: General Requirements for the issuance of a Registration for Particle Accelerators 120.704: lluman Use of Particle Accelerators 120.705: Limitations 120.706: Shielding and Safety Design Requirements 120.707: Particle Accelerator Controls and Interlock Systems 120.708: WamingDevices 120.709: Operating Procedures i
120.710: Radiation Monitoring Requirements 120.711: Ventilation Systems 120.750: NO flCES, INSTRUCTIONS, AND REPORTS TO WORKERS; INSPECTIONS 120.751: Purpose and Scope i
120.752: Posting of Notices to Workers
]
120.753: Instructions to Workers 120.754: Notifications and Reports to Individuals 120.755: Presence of Representatives of Licensees or Registrants and Workers During Inspection 120.756: Consultation with Workers During inspections 120.757: Requests by Workers for Inspections 120.758: Inspections Not Warranted; Informal Review
)
120.760: Emergency Plans
]
120.770: TRANSPORTATION OF RADIOACTIVE MATERIAL 120.771: Purpose and Scope 120.772: Definitions 120.773: Requirement for License 120.774: Exemptions 120.775: Transportation of Licensed Material
(
120.776: General Licenses for Carriers 120.777: General License: Nuclear Regulatory Commission - Approved Packages j
120.778: General License Previously Approved Packages 120.779: General License: U.S. Department of Transportation Specification Container 120.780: General License - Use of Foreign Approved Package 120.781: General License: Fissile Material, Limited Quantity Per Package 120.782: General License: Fissile Material, Limited Moderator Per Package 120.783: Assumptions as to Unknown Properties of Fissile Material j
120.784: Pn:liminary Detemunations 120.785: Routine Detenninations 120.786: Air Transport of Plutonium 120.787A: Opening Instructions 120.787: Shipment Records 120.788: Reports 120.789: Advance Notification of Transport of Nuclear Waste 120.790: Quality Assurance Requirements 120.795: Appendix A - Determination of A, and A2 120.800: LICENSING AND OPERATIONAL REQUIREMENTS FOR LOW-LEVEL RADIOACTIVE WASTE FACILITIES l
120.801: Purpose and Scope
[
120.802: Regulatory Authority 120.803: Defmitions 120.810: General Requirements 120.811: Protection of the General Population from Releases of Radioactivity j
120.812: Protection ofIndividuals from inadvertent intrusion 120.813: Protection ofIndividuals During Operations 120.814: Stability of the Facility Aller Closure 120.815: Facility Design 120.816 Facility Institutional C(mtrol 7/9/99 105 CMR - 207
t 105 CMR: DEPARTMENT OF PUBLIC llEALTil Section: continued 120.820: License Required 120.821: Licensing Process 120.822: Content of Application 120.823: GeneralInformation 120.824: Specific TechnicalInfomiation 120.825: Technical Analyses 120.826: InststutionalInformation 120.827: FinancialInfamiation 120.828: Preoperational Environmental Monitoring 120.829: Standards for issuance of a License 120.830: Conditions of Licenses 120.831: Emironmental Monitoring 120.832: Facility Design 120.833: Facility Construction 120.834: Operating Budget Reimbursements 120.840: Facility Opening 120.841: Facility Operation 120.842: Receipt,1landling, and Inspection of Waste 120.843: Facility Boundaries and Markers 120.844: Contingency Plans for Facility Operations 120.845: Facility Maintenance 120.850: Funding for Facility Closure 120.851: Application for Renewal or Closure 120.852: Procedures for Resiew of Application for Facility Closure and Closure Plan 120.853: Facility Closure 120.860: Post-Closure Observation and Maintenance 120.870: Transfer of License 120.871: Institutional Control 120.880: Maintenance of Records, Reports, and Transfers 120.881: Tests on Facilities 120.882: Department inspection of Facilities 120.885: Waivers 120.890: LOW-LEVEL RADIOACTIVE WASTE MINIMIZATION REGULATIONS 120.891: Purpose and Scope 120.892: Regulatory Authority j
120.893: Definitions 120.895: Objectives J
120.896: Statement and Plan Requirements 120.897: Waste Minimization Plan Content I
120.900: RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUBSURFACE TRACER STUDIES 120.901: Purpose and Scope i
120.902: Definitions 1
120.903: Prohibition 120.911: Limits on Levels of Radiation 120.912: Storage Precautiens l
120.913: Transport Precautions 120.914: Radiation Survey Instruments j
120.915: Leak Testing of Scaled Sources 1
120.916: Quarterly Inventory j
120.917: Utilization Records 4
120.918: Design, Performance, and Certification Criteria for Scaled Sources Used in Ikmidiole Operations 120.919: Labeling 120.920: Inspection and Maintenance 120.931: Training Requirements l
120.932: Operating and Emergency Procedures i
120.933: Personnel Monitoring 120.941: Security 7/9/99 105 CMR - 208
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105 CMR: DEPARTMENT OF PUBLIC IIEALTIi Sectiore continued 120.942: llandling Tools 120.943: Subsurface Tracer Studies 120.944: Particle Accelerators 120.945: Uranium Sinkerllars 120.946: Use of Sealed Source in a Well Without a Surface Casing 120.95I: Radiation Surveys 120.952: Documents and Records Required at Field Stations 120.953: Documents and Records Required at Temporary Jobsites 120.954: Notification ofincidents, Ahuidonment, and Lost Sources 120.960: Appendix A - Subjects to be included in Training Courses for logging Supen'isors 120.961: Appendix A - Example of Plaque for identifying Wells Containiag Sealed Sources Containing Radioactive Material Ahudoned Downtole l
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7/9/99 105 CMR - 209
l 105 CMR: DEPARTMENT OF PUBLIC IIEAL111 120 001: GENERAI PROVISIONS 120.002: Purnose and Scopg Except as otherwise specifically provided,105 CMR 120.000 apply to all persons who receive, possess, use, transfer, own, or acquire any source ofradiation; provided, however, that nothing in 105 CMR 120.000 shall apply to any person to the extent such person is subject to regulation by the U.S.
Nuclear Regulatory Commission (NRC). Regulation by the Commonwealth of source material, byproduct material, and special nuclear material in quantities not suflicient to fbrm a critical mass is subject to the provisions of the agreement between the State and the NRC and to 10 CFR Part 150 of the NRC's regulations.
120.003: Retndatory Authority f
lhe authority for the Department of Public Ilealth to promulgate 105 CMR 120.000 is found in:
M.G.L. c. I11, {6 3, SM, SN,50, SP.
j 120.004: Citation 105 CMR 120.000 shall be known and may be cited as the Massachusetts Regulations ihr the Control of Radiation (MRCR).
120 005: Definitions As used in 105 CMR 120.000, these terms have the definitions set forth below. Additional definitions used only in a certain Section will be found in that Section.
Ai means the maximum activity of special form radioactive material pennitted in a Type A package.
A means the maximum activity of radioactive material, other than special form mdioactive material, 2
pennitted in a Type A package. These values are either listed in 120.795: Tame 1, or may be derived in accordance with the procedure prescribed in 120.795: Appendix A.
Absorbed dosc means the energy imparted by ionizing radiation per unit mass ofirraliated material.
The units of absorbed dose are the gray (Gy) and the rad.
A ccelerator means any machine capable ofaccelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant paniculate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, " particle accelerator" is an equivalent term.
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Accelerator-Produced Material means any material made radioactive by a particle accelerator.
Act means M.G.L. c. III {Q,3,5M, SN,50,SP.
Actirity rneans the rate ofdisintegration or transformation or decay of radioactive material, lhe units of activity are the becquerel (Bq) and tle curie (Ci).
120.005: continued 7/9/99 105 CMR - 209 L __
f 105 CMR: DEPARTMENT OF PUBLIC llEAL111 120.005: continued Mull mcans an individual 18 or more years of age.
Auency means the Radiation Control Program of the Massachusetts Department of Public IIcalth.
Agreement State sneans any State with which the U.S. Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agn:ement under l 274b of the Atom Energy Act of 1954, as amended (St.1973, c. 689).
Ahme Radioactive Material means any radioactive material dispersed in the air in the fumes, particulates, mists, vapors, or gases.
Ahme radioactivity area means a room, enclosure, or area in which airbome radioactive mate exist inconcentrations:
(a) in excess of the derived air concentrations (DACs) specified in 105 CMR
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120.200: Appendix B Table 1; or (b) To such a degree that an individual present in the area without respiratory protectiv equipment could exceed, during the hours an individual is present in a week, an intake of 0.6%
the annual limit on intake (ALI) or 12 DAC-hours.
As low as is reasonably achievaNe (Al ARA) means making every reasonable efibrt to ma!n exposures to radiation as far below the dose limits in 105 CMR 120.000 as is practical, consistent w the purpose for which the licensed or registered activity is undertaken, taking into account t technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioccanomic considerations, and U1 relation to utilization of ionizing radiation and licensed o registered sources of radiation in the public interest.
Backcround radiation means radiation from cosmic sources; non-technologically en occurring radioactive material, induding radon, except as a decay product of source or spe material, and including global fallout as it exists in the environment from the testing ofnuc devices. " Background radiation" does not include sources of radiation from radioactive materia regulated by the Agency.
Becouerel mal means the SI unit of activity. One becquerel is equal to one disintegration transformation per second (dps or tps).
Bioassav means the detemiination of kinds, quantities, or concentrations, and, in some cases locations ofradioactive material in the human lxxty, whether by direct measurement (in or by analysis and evaluation of materials excreted or removed from the human body.
of 105 CMR 120.000, "radiobioassay" is an equivalent term.
Brachytherapy means a method ofradiation therapy in which scaled sources are utilized to delive radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.
Hypnxluct materialmeans:
(1) Any radioactive material, except special nuclear material, yielded in or mikle nulioac exposure to the radiation incident to the process ofproducing or utilizing special nuclear material and (2) 1he tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resu from uranium or thorium solution extraction processes. Underground ore bodies depleted b solution extraction operations do not constitute " byproduct material" within this definition.
Calendarcuarter means not less than 12 consecutive weeks nor more than 14 co first calendar quaner ofeach year shall begin in January and subsequent calendar quarters shal arranged such that no day is included in more than one calendar quarter and no day in any one is omined fmm inclusion within a calendar quarter. He method observed by the licensee or r for detennining calendar quarters shall only le changed at the beginning of a year.
7/9/99 105 CMR - 210
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105 CMR: DEPARTMENT OF PUBLIC IIEALTil 120.005: continued CahbratiOD means the determination of; (1) the response or reading of an instrunx nt relative to a series of known radiation values over the range of the instmment; or
- (2) the strength of a source of radiation relative to a standard.
CMR means Code of Massachusetts Regulations.
UE meam Code of Federal Regulations.
Chelatine acent means aminc polycarboxyhc acids, hydroxy-carboxylic acids, gluconic acid, and polycarboxylic acids.
Collective dose means the sum of the individual doses received in a given period oftime by a s population from exposure to a specified source of radiation.
Committed dose couh alent G Ir.so) means the dose equivalent to organs or tissues ofreference j will be received from an intake of radioactive material by an individual during die 50-year perio
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following the intake.
Commissioner means the Commissioner, Massachusetts Department of Public Ilealth.
i Committed efibetive dose couivalent dis,3a) means the sum of the products of the weighting factoj applicable to each of the body organs or tissues that are irradiated and the committed dose equivaj to each of these organs or tissues (IIc,,o = [ w lir.so).
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Confirmatorv Action f etters means letters, confuming a licensce's, registrant's,or vendor's agreem to take certain actions to remove significant concems about health and safety, safeguards, or the emironment.
Constraint fdose constraint) means a value above which specified licensee actions are required.
Curie means a unit of quantity of activity. One curie (Ci) is that quantity ofradioactive material which decays at the rate of 3.7 x 10 " disintegrations or transformations per second (dps or tps). Com used submultiples of the curie are the millicurie and the microcurie. One millicurie (mci) = 1 x 10 4
curie = 3.7 x 10' tps. One microcurie ( Ci) = 1 x 10+ curie = 3.7 x 10 tps. One nanocurie (nCi) =
4 1 x 10* curie = 3.7 x 10' tps. One picoeurie (pCi) = 1 x 10 curie = 102 gp3, Dmu> Aion means to remove safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and/or termination oflicense.
Deen dose eouivalent GIA means the dose equivalent at a tissue depth of I centimeter (1000 mg and applies to external whole body exposure.
Denanmtnt means the Department of Public IIca!th.
Ihnleted I tnusum meam the source material uranium in which the isotope uranium-235 is less lluut 0.71 I weight percent of the total uranium present. Depleted uranium does not include special nuclear i material.
i Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed efTective dose equivalent, total organ dose equivalent, or tota!
l effective dose equivalent. For purposes of 105 CMR 120.000, "ntdiation dose" is an equivalent term.
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Dose couivalent al ) means the product of the absorbed dose in tissue, quity factor, and all other t
necessary modifying factors at the location ofinterest. De units ofdose equivalent are the sievert (Sv) and rem.
7/9/99 105 CMR - 211 l
f 103 CMR: DEPARTMENT OF PUBLIC llEALTil 120.005: continued Dose limits means the permissible uppen bounds ofradiation doses established in accordance with CMR 120.000. For purposes of 105 CMR 120.000," limits"is an equivalent term.
EfTective dose eouivalent 0IJ means the sum of the products ofthe dose equivalent to e tissue (lir) and the weighting factor (w1) applicable to each of the body organs or tissues that are irradiated (11, = E w lIc).
i Embrvdfi tus means the devekiping human organism from conception until the time of birth.
Entrance or access noint means any opening through which an individual or extremity of an indiv could gain access to radiation areas or to licensed or negistered radioactive materials. This includes entry or exit portah of sufficient size to permit human entry, inespective of their in: ended use.
Exntosive materialmcans any chemical compound, nixture, or device which pnxiuces a substantia instantaneous release of gas and heat spontaneously or by contact with sparks or flame.
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Exposure means being exposed to ionizing radiation or to radioactive material.
Exposure means the quotient of dQ by dm where "dQ" is the absolute value of the total charg ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exp the coulomb per kilogram (C/kg). Sae 105 CMR 120.013 Units of Exposure arxl Dose for the s unit.
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Exnosure Rate means the exposure per unit of time, such as roentgen per minute and milliroj hour.
Exiemal Dose means that portion ofthe dose equivalent received from any source ofr the body.
Extrenuty means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.
Eve Dose Fouivalent means the extemal dose equivalent to the lens of the eye at a tissue dept centimeter (300 mg/enf).
Former U.S. Atomic Encrev Commission (AEC) or UX Nuclear Reculatory Commission (NRC)
Licensed Facilities means nuclear reactors. nuclear fuci reprocessing plants. uranium enrichm or critical mass experimental facilides where AEC or NRC licenses have been terminated.
Genemlly Anplicable Environmental Radiation Standards means standards issued by the U.S.
Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radicactive material,in the general environment outside the boundaries oflocations under the control of persons possessing or using radioactive material.
Gay (Gy) means the Si unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule p kilogram (100 rad).
Ilatf-value laver OlV13 means the thickness of a specified material which attenuates X-radiation or gamma radiation to an extent that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-half of the value measured without the material at the same point.
Ilazardous Wasig means those wastes designated as hazardous by U.S. Environmental Protection Agency regulations in 40 CFR Part 261.
7/9/99 105 CMR - 212 d
t 105 CMR: DEPARTMENT OF PUBLIC IIEALTIi 120.005: continued Ilealine Arts means any discipline which involves the diagnosts or treatment ofpersons by a practitioner or animals by a veterinarian, and who is licensed for that purpose by the Commonwealth of Massachusetts, and which disciplineincludes the intentional exposure ofpersons and animals to sources of radiation for diagnosis or treatment.
Ilieh Radiation Area means an area, accessible to individuals, in which radiation levels could result in an indisidual receiving a dose equivalent in excess of1 mSv (0.1 rem) in I hour at 30 centimeters from any source of radiation or fmm any surface that the radiation penetrates.
I himan Use means the internal or extemal administration of radiation or radioactive material to human beings.
Indmdualmeans any human being.
Individual monitorine means the assessment of:
(1) Doseequivalent.
(a) by the use ofindividual monitoring desices; or (b) by the use ofsurvey data;or (2) Committed efTective dose equivalent.
(a) bybioassay;or (b) by detennination of the time-weighted air concentrations to which an indisidual ins been exposed, that is, DAC-hours. (See the defmition of DAC-hours in 105 CMR 120.200).
Individtal monitorine devices means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of 105 CMR 120.000, " personnel dosimeter" and
" dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thetynoluminescent dosimeters ('!LDs), pocket ionization chambers, and personal air sampling desices.
Insnection means an official examination or observation including but not limited to, tests, surveys, and.
monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.
Instrument Traceability means the ability to show that an instmment has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at laboratory accredited by a program which requires continuing participation in e
measurement quality assurance with the National Institute of Standards and Technology or other equivalent national or international program.
Intemal dose means that portion of the dose equivalent received from radioactive material taken into the body.
Interlod means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
lonizine Radiation (See Radiation).
Irradiatigo rneans the exposure of a living being or matter to ionizing radiation.
Kilovolt (kV)Ikilo electron volt (lev)] means the energy equal to that acquired by a particle with one electron charge in passing through a potential difTerence of one thousand vohs in a vacuum. [ Note:
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current convention is to use kV for photons and kev for electrons.]
Lead Eouivalent means the thickness of the rnateria: in question afTording the same attenuation, taler specified conditions, as lead.
7/9/99 105 CMR - 213 l
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105 CMR: DEPARTMENT OF PUBLIC IIEALTil
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120.005: continued
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1 i
Lenkage Radiation means radiation emanating from the diagnostic or therapeutic source assembly except for:
l (1) 'lhe useful beam; and, (2) Radiation produced when the exposure switch or timer is not activated.
I Ixense means a license issued by the Agency in accordance with the regulations adopted by the Agency.
Ligensed (or recistered) material means radioactive matent received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.
Licensee means any penon who is licensed by the Agency in accordance with 105 CMR 120.000 and M.G.L. c. Ii1, fi 3, SM,5N,50 and SP.
Iicensine State means any State with regulations equivalent to the Suggested State Regulations for l
Control of Radiation relating to, and an c1Tective program for, the argulatory control of NARM and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.
Limits (See Dose limits).
I.ost or missing sourte of radiation means licensed [or registered] source of radiation whose location is unknown. 'lhis definition includes, but is not limited to, licensed (or registered) material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
Maior Processor means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four times Type B quantities as scaled sources, but does not include nuclear medicine pmgrams, universities, industrial radiographers, or small.
industrial programs. Type A and B quantities are defined in 105 CMR 120.772.
Manifest means a detailed record of the characteristics and quantities of packaged waste as presented for transportation, treatment, storage, or disposal which usually accompanies waste transfers for these purposes.
Member of the nublic means an individual except when that individual is receiving an occupational dose.
Minor means an individual less than 18 years of age.
Monitonng means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to l
evaluate potential exposures and doses. For purposes of 105 CMR 120.000," radiation monitoring" and " radiation protection monitoring" are equivalent terms.
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NARM means any natumily occurring or accelerator-produced radioactive material. It does not i
include byproduct, source, or special nuclear material.
1 Natural Radioacthity means radioactivity of natumlly occurring nuclides.
l Non-ionizine Radiation (See Badiation).
Nuclear Reculatory Commission (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
7/9/99 105 CMR - 214 i'
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105 CMR: DEPARTMfiNT OF PUllLIC IIEALTil 120.005: continued Occunational dose means the dose received by an individual ia the course of employment in which the individuafs assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources ofradiation are in the possession of the licensee, registrant, or other person.
i Occupational dose does not include dose received: from background radiation, or as a patient from medical practices, or from voluntary participation in medical research program, or as a member of th public.
f Package means the packaging together with its radioactive contents as presented for transport.
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Particle accelerator (Sce Accelerator).
f Patient means an individual subjected to healing arts examination, diagnosis, or treatment
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Person means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency of the commonwealth other than the department, any political subdivision the commonwealth, any other state or politicalsubdivision or agency thereof, and any legal successor, typresentative, agent, or agercy of the foregoing, but not including federal govemment agencies.
Personnel monitorine cauinment (See Individual monitorine devices).
Phantom means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic numtcr (Z) and the density of the material be similar to that of tissue.
Pharmacist means an individual certified as such under M.G.L. c. I 12, { 24 to compound and dispense drugs, prescriptions, and poisons.
Ph{sician means an individual certified as a physician under M.G.L. c. I12, { 2 or corresponding citation of earlier laws.
1 Principal Acthities means activities authorized by the license which are essential to achieving thf purpose (s) for which the license was issued or amended. Storage during which no licens is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.
Protective Anton means an apron made of radiation-attenuating rnaterials used to reduce exposure to radiation.
Protective flarrier means a barrier ofradiation absorbing material (s) used to reduce radiation exposure.
j The types of protective barriers are as follows:
(1) Primary protective banier means the material, excluding filters, placed in the usefu! beam.
(2) Secondary protective banier means the material which attenuates stray radiation.
Public doss means the dose received by a member of the public from sources of radiation licensed registered operations. Public dose does not inchide occupational dose, or dose received from background radiation, or dose received as a patient from medical practice, or dose from volunt participation in medical research programs.
Pyronhoric Material means any liquid that ignites spontaneously in dry or moist air at or telow 130* F (54.4*C) or any solid material, other than one classed as an explosive, which under normal is liable to cause fires through friction, retained heat from manufacturing or pnwessing, or which can be ignited readily and, when ignited, bums so vigorously and persistently as to create a se transportation, handling, or disposal hazard. Included are spontaneously combustible and w reactive materials.
t 105 CMR - 215 7/9/99 l-
e 105 CMR: DEPARTMENT OF PUBLIC llEALTil 120.005: continued Oualified exocrt means an individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board ofIlealth Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an indisidual ha in addition to the above qualifications, training and experience in the clinical applications of radiation physics to radiation thempy, for example, individuals certified in Therapeutic Radiological Phys X-Ray and Radium Physics by the American Board of Radiology, or those having equivalent qualifications.
Ouality factor (0) means the modifying factor, listed in 105 CMR 120.014: Tables I and 11, that is used to derive dose equivalent from absorbed dose.
l lhd means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.0I joule per kilogram (0.01 gray).
Radiation means alpha particles, beta particles, gamma rays, x rays, neutrons, high-speed electrons high-speed protons, and other particles capable of producing ions. For purposes of 105 CMR 120.000, ionizing radiation is an equivalent term. Radiation, as used in 105 CMR 120.000, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultrasiolet l Hmb6on area means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
Radiation dose (See Dgs).
Ra"diation Detector means a device which, in the presence of radiation, provides by either direct or indirect means a signal or other indication suitable for use in measuring one or more quantities incident radiatiort Radiation machinc means any device capable of producing radiation except, those devices with radioactive material as the only source of radiation.
Radiation Safety Officer means an individual who has the knowledge end responsibility to apply appropriate radiation protection regulations, and who is idendfied on a certificate of regist radioactive material license as the Radiation Safety Officer.
Radioactive Material means any solid, liquid, or gas which emits radiation spontaneously.
i Radioactivity means the transfonnation of unstable atomic nuclei with the emission of radiation.
Radiabionssay (See Bioassav).
Repstmnt means any person who is registered with the Agency and is legally obligated to r the Agency pursuant to 105 CMR 120.000 and M.G.L c.111, {s 3, SM, SN,50, and 5P.
Registration means registration with the Agency in accordance with the regulations adop Agency.
Regulations of the U S. Denartment ofTransnortation(U.S. DOT), means the regulations Parts 100-189.
Ihm means the special unit of any of the quantities expressed as dose equivalent. he do in tem is equal to the absorbed dose in rad multiplied by the quality factor (I rem = 0.01 Sv).
105 CMR - 216 7/9/99
t 105 CMR: DEPARTMENT OF PUBLIC IIEALTil 120.005: continued Research and Develonment means:
(1) theoretical analysis, exploration, or experimentation; or the extension of investigative fmdings and theories of a scientific or technical nature into (2) practical api cation for experimental and demonstration purposes, including the experim di production and testing of models, devices, equipment, materials, and processes. Res development does not incluae the intemal or extemal administration of ra diation or radioac material to human beings.
I Restricted area means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restric does not include areas used as residential quarters, but separate rooms in a residential building may set apart as a restricted area.
B9Calgc0means the special unit ofexposure. One roentgen (R) equals 2.58 x 10 coulombstile 4
of air (see Dposure).
Scattered mdiatios means ionizing radiation emitted by the interaction ofionizing radiation with matter, the interaction being accompanied by a change in direction of the mdiation.
Seattered nrimary radiation means that scattered radiation that has been deviated in direction only b materials irradiated by the useftd beam.
Scaled Source means any radioactive material that is used as a source of radiation and is enc a capsule designed to prevent leakage or escape of the radioactive material.
Shallowdose eouivalent M1 which applies to the external exposure of the skin or an extremity, means the slose equivalent at a tissue depth of 0.007 centimeter (7 mg/eni) averaged over an area centimeter.
Shutter means a device attached to the tube housing assembly which can totally intercept thi beam and which has a lead equivalency not less than that of the tube housing assembly.
S1 means the abbreviation for the Intemational System of Units.
Sieserl means the SI unit of any of the quantities expressed as dose equivalent. The dose in sievert is equal to the absorbed dose in gray multiplied by the quality factor (I Sv = 100 rem Site boundary means that line beyond which the land or property is not owned, leased, or other controlled by the licensee or registmnt.
Source Material means:
(1) uranium or thorium, or any combination thereof, in any physical or chemical form; or (2) ores which contain by weight 1/20 of 0.05% or more of:
(a) uran'um; (b) thorium;or (c) any combination thereof.
Source material does not include special nuclear material.
Soutse Material Milling means any activity that resuhs in the pnxtuction of byprodu l
defined by definition (2) of byproduct material.
Source of Radiatiori means any radioactive material or any device or equipment emitting, o of producing, radiation.
105 CMR - 217 1
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1 105 CMR: DEPARTMENT OF PUBLICllEALTil 120.005: continued
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Sourre Traceability means the ability to show that a radioactive source has been calibrated eithe the national standards laboratory of the National!nstitute of Standar6 and Technology (NIST a laboratory which participates in a continuing measurement quality assumnce program w other equivalent national or intemational program.
Snecial fonn radioactive material means radioactive material which satisfies the following conditio (1) It is either a single solid piece or is contained in a sealed capsule that can be op destroying the capsule; (2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 (3) It satisfies the test requirements specilled by the Nuclear Regulatory Commiss fonn encapsulation designed in accordance with the Nuclear Regulatory Commission require in effect June 30,1983, and constructed prior to July 1,1985, may continue to be used. j form encapsulation designed in accordance with the Nuclear Regulatory Cormnission req in effect on March 31,1996, and constructed prior to April 1,1998, may continue to be use A special form encapsulation either designed or constmeted after April 1,1998, must me requirements of this definition applicable at the time of its design or construction.
Special nuclear materialmeans:
(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope other material that the U.S. Nuclear Regulatory Commission, pursuant to the prosisions o 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear mate does not include source material;or (2) Any material artificially enriched by any of the foregoing but does not inchide s Special Nuclear Material in Ouantities not Sufficient to Fonn a Critical Mass mea in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; urardu quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; combination of them in accordance with the following formula: For each kind of special nu material, detennine the ratio between the quantity of that special nuclear material and the specified above for the same kind of special nuclear material. The sum of such of special nuclear material in combination shall not exceed I. For example, the combination would not exceed the limitation and are within the formula:
175 (crams U-235) + 50 (crams U-233) + 50 (erams Pu) = 1 350 200 200 SurVeV means an evaluation of the radiological conditions and potential hazards inciden l
When i
production, use, transfer, release, disposal, and/or presence of sources of radiation appropriate, such evaluation includes, but is not lunited to, tests, physical ex measurements oflevels of radiation or concentrations of radioactive material present.
I Inst means the process of verifying compliance with an applicable regulation.
105 CMR 120.000 means all Sections of the Massachusetts Regulations for the Control N'
Total effective dose eauivalent (TEDE) means the sum of the deep dose equivalent fo exposures and the committed effective dose equivalent for intemal exposures Total orcan dose couivalent (TODE) means the sum of the deep dose equivalent and dose equivalent to the organ receiving the highest dose as described in 105 CM 105 CMR - 218 7/9/99
f 105 CMR: DEPARTMENT OF PUBLIC llEALTil 120.005: continued Traceable to National Standard (See Instrument Traceability or Source Traceability]
ILS. Denartment of Enercy means the Departmentof Energy established by Public Law 95-91, Au 4,1977,91 Stat. 565,42 U.S.C. 7101 et seq., to the extent that the Department exercis famierly vested in the U.S. Atomic Energy Commission, its Chairman, members, components and transfened to the U.S. Energy Research and Development Adm Administrator thereof pursuant to sections 104(b),(c) and (d) of the Energy Reorganiz 1974 (Public Law 93-438, October 11,1974,88 Stat.1233 at 1237,elTective January retransferred to the Secretary of Energy pursuant to section 301(a) of the Department oj Organization Act(Public Law 95-91, August 4,1977,91 Stat. 565 at 577-578,42 U effective October 1,1977.)
Unrefined and Uncrocessed Ore means ore in its natural fann prior to any processing, suc roasting, beneficiating, or refming.
Unrestricted Area (Uncontrolled Area) means area access to which is neither limited n the licensee or registrant. For purposes of 105 CMR 120.000,uncontmiled area is an eq f
Vendor means a supplier of products or senices to be used by a licensee or regis 4
or registered facility or actisity.
Waste means those low-level radioactive wastes that are acceptable for disposal in !
facility. For the purposes of this defmition, low-level waste has the same mea Radioactive Waste Policy Act, P.L.96-573, as amended by P.L 99-240, effective Jan that is, radioactive waste (a) not classified as high-level radioactive waste, spent nu byproduct material as defmed in Section Ile.(2) of the Atomic Energy Act (ura) and waste) and (b) classified as low-level radioactive waste consistent with exist accordance with(a)by the NRC.
i
_ aste 1landline Licensees means persons licensed to receive and store radioact W
disposal and/or persons licensed to dispose of radioactive waste.
,Wssh means seven consecutive days starting on Sunday.
Whole body means, for purpases of external exposure, head, trunk including male the elbow, or legs above the knee.
Worker means anindividual engaged in work under a license or registration issu controlled by a licensee or registrant, but does not include the licensee or registrant.
li d d d ht s in oneliter of air that will
_ orkine level (WL)means any combination ofshort-ve ra on aug er re. alt in the ultimate emission of 1.3E+5 MeV ofpotential alpha particle energy W
daughters are - for radon-222: polonium-218, lead-214, bismuth-214, and radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.
ki
_ orkine level month (WI.hD means an exposure to one workinglevel for i70 hou Whours per year divided by 12 months per year is approximately equal to 170 Ysm rneans the period of time beginning in January used to detennine c The licensee or registrant may change the staning date of the year used of 105 CMR 120.000.
determine compliance by the licensee or registrant provided that the chang of the year and that no day is omitted or duplicated in consecutive years.
1 105 CMR - 219 l
7/9/99
t 105 CMR: DEPARTMENT OF PUBLIC IIEALTil 120_006: Exemntions (A) General Provisiort 'lhe Agency may, upon applicatiN m xfore or upon its own initiative, grant such exemptions or exceptions from the requirements ot H. CMR 120.000 as it determines are authorized by law ar J will not result in undue hazard to public health and safety or property.
(B)
ILS. Denartment of Enerev Contractors and U S Nuclear Regulatory Commission Contractors. Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this Commonwealthis exempt from 105 CMR 120.000 to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers or acquires sotu.es of radiation:
(1)
Prime contractors performing work for the U.S. Department of Energy at U.S.
Govemment-owned or Govemment controlled sites, including the transportation of sources of radiation to or from such sites and the performancs of contract sersices during temporary interruptions of such transportation; (2) Prime contractors of the U.S. Department of Energy performing research in,or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof; (3) Prime contractors of the U.S. Department of Energy using or operating nuclear reactors or other nuclear desices in a United States Govemment-owned vehicle or vessel; and, (4) Any other prime contractor or subcontractor of the U.S. Department of Energy or of the U.S.
Nuclear Regulatory Commission when the State and the U.S. Nuclear Regulatory Commission jointly determine-(a) That the exemption of the prime ccnt actor or subcontractor is aut}mrized by law; and, (b) "Ihat under the terms of the contract 6r subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public lealth and safety.
120 007: Prohibited Usc,3 (A) A hand-held fluoroscopic screen shall not be used with x-ray equipment unless it has been listed j
in the Registry of Scaled Source and Devices or accepted for certification by the U.S. Food and Drug i
Administration, Center for Devices and Radiological lleahh.
(B) A Shoe-fitting fluoroscopic desice shall not be used.
120.008: Imnoundine Sources of radiation shall be subject to impounding pursuant to M.G.L. c. I11, (( 50 and SP.
120 009: Records (A) Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in 105 CMR 120.000.
(B) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days,in an unsealed form, shall forward the following records to the Agency:
(1) Records of disposal oflicensed material made under 105 CMR 120.252 (including burials authorized before January 28,1981),105 CMR 120.253,120.254,120.255; and, (2) Records required by 105 CMR 120.263(B)(4).
(C) Iflicensed activitic are transferred or assigned in accordance with 105 CMR 120.131(B), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is temunated i
105 CMR - 220 7/9/99 l
f 105 CMR: DEPARTMENT OF PUBLIC llEALTil 120.009: continued (1) Records of disposal oflicensed material made under 105 CMR 120.252 (including burials authorized before January 28,1981),105 CMR 120.253,120.254,120.255; and, (2) Records required by 105 CMR 120.263(B)(4).
(D) Prior to license termination, each licensee shall forward the records required by 105 CMR 120.125(C)(1)(g) to the Agency.
120.010: Insnections (A) Eachlicensee and registrant shall afTord the Agency at all rea:,onable times opportunity to inspect 1
sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.
(B) Each licensee and registrant shall make available to the Agency for inspection, upon reasonable notice, records maintained pursuant to 105 CMR 120.000.
J.20.011: Tests Each licensee and registrant shall perfomi upon instructions from the Agency, or shall permit the Agency to perform, such reasonable tests as the Agency deems appropriate or necessary including, but not limited to, tests of:
(A) Sourcesofradiation; (B) Facilities wherein sources of radiation are used or stored; i
(Cl Radiation detection and monitoring instruments; and, 1
(D) Other equipment and devices used in connection with utilization or storage oflicensed or-registered soun;es of radiation.
120.012: Additional Reauirements The Agency may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in 105 CMR 120.000 as it deems appropriate or necessary to minimize danger to public health and safety or property.
j 120.013: Communications All communications and reports conceming 105 CMR 120,000, and applications filed thereunder, should be addressed to the Agency at its office located at 174 Portland Street, Boston, MA,02114.
120.014: Units of Exnosure and Dose (A) As used in 105 CMR 120.000, the unit of I'xposure is the couk>mb per kilogram (C/kg) of air.
One roentgen is equal to 2.58 x 10dcoulomb per kilogram of air.
(B) As used in 105 CMR 120.000, the units of dose are:
Rad is the special unit of absorbed dose. One tad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 gray).
Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of I joule per kilogram (100 rads).
l Rem is the special unit ofany of the quantities expressed as dose equivalent. 'Ihe dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (I rem = 0.01 sievert).
Sievert is the SI unit of any of the quantities expressed as dose equivalent. ~1h: dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 sievert = 100 rems).
105 CMR - 221 7/9/99 i
t 105 CMR: DEPARTMENT OF PUBLIC IIEALTil 120.014: continued As used in 105 CMR 120.000, the quality factors for converting absorbed dose to dose (C) equivalent are shown inTable 1.
TABLEI OUAIITY FACTORS AND ABSORBED DOSE FOUlVAl ENCIES Quality Factor Absorbed Dose Equal to TYPE OF RADIATION (Q) a Unit Dose Equhulent*
i 1
X, gamma, or beta radiation and high-speed electrons Alpha particles, multiple-charged particles, fission fragments and 20 0.05 heavy particles of unknown charge 10 0.1 Neutrons ofunknown energy 10 0.1 IIigh-energy protons (N) Ifit is more convenient to measure the neutron fluence rate t 1
equivalent rate in sievert per hour or rem per hour, as provided in 105 CMR 120 (I rem) of neutron radiation of unknown energies may, for purposes of 105 CMR assumed to result from a total fluence of25 million neutrons per square centimeter incid body. If suflicient information exists to estimate the approximate energy distribution o the licensee or registrant may use the fluence rate per unit dose equivalent or the app from Table 11 to convert a measured tissue dose in gray or rad to dose equivalent in sievert o I
i l
- Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to I rem.
j 105 CMR - 222 7/9/99 t
r.
105 CMR: DEPARTMEMT OF PUBLIC llEALTil 120.014: continued '
I
/
TABI Ell MEAN OUA1.lTY FACTORS O. AND Fl.UENCE PER UNIT DOSE EOUIVAI ENT FOR MONOENERGETIC NEUTRONS Neutron Quality Fluence per Unit Fluence per Unit Energy Factor Dose Equivalent
- Dose Equivalent *
(MeV)
(Q)
(neutrons (neutrons ent' rent')
cm'2 Sv')
(thermal) 2.5 x 10 '
2 980 x 10' 980 x 10' l.0 x 10 2
980 x 10' 980 x 10' 4
l.0 x 104 2
810 x 10' 810 x 10' 8
l.0 x 10
2 810 x 10' 810 x 10 1.0 x 10d 2
840 x 10 840 x 10 8
6 8
1.0 x 10^2 2
980 x 10' 980 x 10 l.0 x 10 2 2.5 1010 x 10' 1010 x 10' l.0 x 10-'
7.5 170 x 10' 170 x 10' 5.0 x 10 11 39 x 10' 39 x 10' 4
I 11 27 x 10' 27 x 10' 2.5 9
29 x 10 29 x 10' 6
5 8
23 x 10' 23 x 10' 8
7 7
24 x 10' 24 x 10 8
10 6.5 24 x 10' 24 x 10 14 7.5 17 x 10' 17 x 10' 8
20 8
16 x 10 16 x 10 6
40 7
14 x 10' 14 x 10' 60 5.5 16 x 106 16 x 10' l.0 x 10 4
20 x 10' 20 x 10' 2
2 3.5 19 x 10' 19 x 10' 2.0 x 10 3.0 x 10 3.5 16 x 10' 16 x 10' 2
8 4.0 x 10 3.5 14 x 106 14 x 10 2
120.015: Units of Activity For purposes of 105 CMR 120.000, activity is expressed in the SI unit of special unit of curie (Ci), or their multiples, or disintegrations or transforma (A) One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps (B) One curie (Ci) = 3.7 x 10 disintegrations or transformations per secon 10' becquerel (Bq) = 2.22 x 10'2 disintegrations or transformations per minute i
- Value of quality factor (Q) at the point where the dose equivalent is maxim cylinder tissue-equivalent phantom.
- Moncenergetic neutrons incident normally on a 30<entimeter diameter cylin 105 CMR - 223 7/9/99 L
h i
105 CMR: DEPARTMENT OF PUBLIC llEALTil l
120.01fe Fnforcement Policy and Procedures (A) Enforcement Poliev. The purpose of the enforcement program ofthe Agency is to
(
protect the radiological health and safety ofthe public, including employees' health environment by:
(1) Ensuring compliance with regulations and conditions oflicense; (2) Obtaining prompt correction of violations and adverse quality conditions which may safety; (3) Deterring future violations and occurrences ofconditions adverse to quality; and, (4) Entouraging improvement of licensee, registrant and vendor performance, and by that ofindustry, including the prompt identification and reporting of potential safety problems.
Consistent with the purpose of this program, prompt and vigorous enforcement action will when dealing with all persons who do not comply with regulations. In no case will license not achieve and maintain adequate levels of protection be permitted to coaduct licensed aethiti (B) Grounds for Susnension of a lhw or Certificate of Reaistration or lu Iws.' viv Cease Activity, in accordance with M.GL c. Ill, Q 50, the Commissioner may_
l summarily suspend a license or certificate of registration v order immediate cessation without a prior hearing, whenever the Department fmds that public health, safety or the em would be threatened by delay in issuance of an order. A faci'ity or person may not operate durin period of a suspension of his/its license or certificate of registration and may not c activity after notification of an order requiring the immediate cessation of an acthity. Ifoweve request by the licensee or registrant, a hearing shall be provided prorWy after the is suspension order.
(C) Gmunds for Denial. Modification. I imitation. Revocation or Refus Certificate of Rwistration, (I) Specific Grounds.1he Department may issue an order denying, revoking, modi
,or refusing to renew a license or certificate of registration sought or issued under 105 120.000 for any one of the following reasons:
The applicant, licensee or registrant has failed to submit the infonnation require i
(a) l licensure or registration under 105 CMR 120.000.
(b) The applicant failed to meet the n:quirements for licensure or registration as s 105 CMR 120.000.
(c) The applicant, licensee or registrant is not suitable and responsible to operate required or provide the service as licensed or registered.
(d) The applicant, licensee or registrant has obtained or attempted to obtain or m cenificate of registration or license by fraud, misrepresentation, or by the submissio incorrect, false or mislead ng information.
(e) 1he applicant, licensee or registrant has failed to pay licensure and'or registrat (f) 1he applicant, licensee or registrant has failed to pay chil penalties or criminal f in accordance with of M.GL c. Ii1,5 50 or 6 5P and/or 105 CMR 120.000.
(g) 1he applicant, licensee or registrant has:
- 1. failed to allow duly authorized agents of the Agency to conduct inspections; or
- 2. attempted to impede the work of duly authorized representatives of the Age enforcement of any provisions of M.GL c. Ii1 (( 5N through P or 105 CMR 120.000.
(h) The applicant, licensee or registrant has been convicted of, pleaded guilty to, judicial proceeding, admitted facts sullicient for a fuxling that he/she is guihy violation relating directly or indirectly to his/her fitness to be licensed or registered CMR 120.000.
(i) The applicant, licensee or registrant has been the subject of proceedings wh the suspension, denial, mod'fication, limitation, or revocation of a similar license of registration or refusal of renewal of a similar license.
1he applicant, licensee or registrant has been the subject of proceedings whi (j) ultimately resolved by settlement agreement but which were initiated to suspend limit,or revoke or refuse renewal of a license, unless the Settlement Agreement c provisions whicheither:a. stated that the licensee, applicant or registran was charged with or provided that the charges or violations that were the subject of the Settlem b,
Agreement or the Settlement Agreement itself cannot be used in whole or in basis for any future licensing, registration or enforcement action by the Departnwnt.
105 CMR - 224 7/9/99
t 105 CMR: DEPARTMENT OF PUllLIC l&G i 120.016: continued t
(k) De applicant, licensee or registrant has been disciplined in anotherjurisdic by a licensing authority for reasons substantially the same as those set forth heJ (1) The applicant or licensee operated a facility aller the expiration of the license.
I (m) %e applicant, licensee or registrant has failed to remedy or correct a cit the date specified in the u",en notice from the Departme
(
Trection accepted or modified by the Department, unless the the date specified in the plan applicant, licensee or registrant demonstrates to the satisfaction of the D failure was not due to neglect of duty and occurred despite his/her good faith att corrections by the specified time.
(n) He applicant or licensee has engaged in or aided in the falsification of tes (o) Heapplicant,licenseeorregistrantreceives, possesses,uses, transfers,ownsor or uses radioactive materials or machines which emit ionizing radiation in a man endangers public health, safety, or the emironment.
(2) Other Grounds %e Department reserves the right to deny, modify, limit r review a license or certificate of n gistration for any other suflicient reason notlis 120.016(C)(1) if it reasonably considers such action necessary to protect the p or the emironment, in addition, nothing herein shall be deemed to limit the Dep to establish or recognize funher general or specific grounds for discipline throu
]
adjudication, the issuance of polices or advisories or other similar means.
(D) Sgyerity of Violations.
Regulatory requirements have varying degrees of safety or emironmen (1)
Derefore, the relative importance of each violation must be identified as the firs enforcement process. Violations are categorized in tenns of five levels of se relative importance within each of the following five activity areas:
(a) llealth Physics; (b) Transportation; (c) MaterialsOperations; (d) Miscellaneous Matters;and, (e) Emergency Preparedness.
(2) Within each activity area, Severity LevelI has been assigned to viola signi6 cant and Severity Level V to those that are the least significant violations are of very significant regulatory concem. In general, violations that categories involve actual or high potential impact on the public. Severity L cause for significant concem Severity Irvel IV violations are less serious bu minor concem;i.e. ifleft uncorrected, they could lead to a more serious con V violations are of minor safety or emironmental concem.
Comparisons of significance between activity areas are inappropriate.
immediacy of any hazard to the public associated with Severity level I sio O) is not directly comparable to that associated with Severity Level I siolations in E Preparedness.
(4) While examples are provided in 105 CMR 120.019: Appendix A fo appropriate severity level for violations in each of the five activity are exhaustive nor controlling. nese examples do not create new requirements is predicated on a violation of an existing regulatory requirement. Eal significaner which the Departnxnt places on a particular type of violatio requirements.In each case, the severity of a violation will be characterized at (5) significance of the particular violation. In some cases, violations may be and a single seveiity level assigned for a group of siolations.
l 105 CMR - 225 7/9/99
F i
105 CMR: DEPARTMENT OF PUBLIC llEALTil 120.016: continued (6) %e severity level of a violation may be increased if the circumstances s involve careless disregard of requirements, deception, or other indication of willful "willfalness" includes, but is not limited to, the deliberate siolation of any prosision 111, (( 3, SM, SN,50, and $P or careless disregard of the requirements of 3, SM, SN,50, and 5P. Willfulness does not include acts which do not ri e tj disregard,' r.g. inadvertent clerical errors in a document submitted to the A the specific severity level of a violation involving willfulness, consideration factors as the position of the person involved in the violation (e.g., first-line sup manager), the significance or any underlying violation, the intent of the viola amounting to careless disregard, careless disregard, or deliberateness), an advantage,if any, gained as a result of the violation. He relative weight givel j
factors in aniving at the appropriate severity level will be dependent on the circu he Agency expects licensees to provide complete, timely, and accurate violation.
Appendix A the (7) reports. Accordingly, unless otherwise categorized in 105 CMR 120.019:
severity level of a violation invohing the failure to make a required report based upon the significance of and the circumstances surrounding the mat reported. A licensee will not nonnally be cited for a failure to report a the licensee was actually aware of the condition or event which it failed to rep severity level of an untimely report, in contrast to no report, may be redu circumstances surrounding the matter.
(E) Fnforcement Procedures.
(1)(a) Notice of Violation Whenever the Agency not in compliance with provisions of M.G.L. c. Ii1, f} SN through $P or a promulgated thereunder, the Agency shall notify the applicant, lice violation or deficiency. The notice shall include a statement of the violations found, the provision of the law relied upon, and a reasonable period of t violationor deficiency may result in denial, suspension, revocation or refusal i
or certificate of registration; a modification or limitation of a license or certif a cease and desist order; and'or the imposition of a chil penahy and/or crim Confinnatory Action I etters. De Agency may issue Confumatory Action Letter (b) confuming a licensee's, registrant's, or vendor's agreement to take certain ac significant concems about health and safety, safeguards, or the environment.
(2) BanofCorrection(a) he applicant, licensee or registrant shall w the Agency a written plan ofcorrection. He plan shall clearly identify state the date, reference the violation or deficiency cited, state specific timetable (s) and date(s) for completion for each deficiency cited, and the applicant, licensee or registrant or hidher designee.
(b) The Agency may re-inspect a fxility in order to determine whethe been made. If upon review of plan ofcorrection and'or reinspection the A applicant, licensee or registrant is in compliance with 105 CMR 1 applicant, licensee or registrant has submitted acceptance or modification of the plan of correction.
If upon review of plan of correction and'or reinspection the Age correction is unacceptable, the Agency may request that the applicant, (c) amend and resubmit the plan of correction within five days of the date time as the Agency may specify for resubmission.
(d) If upon review of the plan of correction and'or reinspection the an applicant, licensee or registrant remains norecompliant with a regarding licensure, the Department may initiate enforcement pro 105 CMR - 226 7/9/99
p t
105 CMR: DEPARTMENT OF PUBLIC llEALTil 120.016: continued (3) Notice ofIknanment's Intent to Issue an Order.
(a) Prior to the Department issuing an order to modify,lin it, deny, revoke or re a license, anNor to require a person to cease and desist any activity, anNor to im penalties, the applicant, licensee or registrant shall be notified in writing o Department's action, the provision (s) of law relied upon, the amount of a his/her right to request an adjudicatory proceeding anNor judicial review.
If a license or certificate of registration is to be denied, modified, limited, revoke (b) refused reuewal or if an activity is to be ceased or a citil penalty imposed by the Dep then the aggrieved applicant, licensee or registrant may request un adjudica 21 days of receipt of notification of the Depanment's Intent to Issue an Orde
' ocedures,801 shallbe filed in accordance with Standard Adjudicatory Rules of Practice an CMR 1.01 et seq.
Procedure.
(4) AdministrativeIIcarines: Suspension of a License or Certificate o (a)
Immediately Cease an Activity:
- 1. The Department shall give the licensee or registraat written notiec stating for the suspension or issuance of an order to immediately cease an activity provisions oflaw relied upon. The suspension or oder to immediately shall take efTect immediately upon issuance of the notice.
The Department shall provide for a hearing pursuant to 801 CMR 1.01 es 2.
promptly after the issuance of an order of suspension or an order to imm actisity.
- 3. In cases of suspension of a license or certificate of registration or issua to immediately cease an activity, the IIearing Oflicer shall detennine wheth Department has proved by a preponderance of the evidence that the immediately prior to or at the time of the suspension or cease and desist or public health, safety or the environment.4. In the event that the D CMR 120.000 which posed a threat is corrected prior to the decision of th OfTicer, the Department may lift the suspension by giving written notice to th registrant.
(b) Denial, Modification, Limitation, Revocation,orRefusaltoRenewaL No of Registration Based on Failure to File Reports or Pay Fees or Maintam I heanng shall be afTorded where denial, modification, limitation, revoca j
j refusal to review is basal solely upon failure of the licensee or registrant to file schedules or applications or to pay lawfully prescribed fees, or to maintain insur as required by any law or regulation.
(c) Denial, Modification, Limitation, Revocation or Refusal to Renew of Registration; Orders to Cease an Activity; Civil Pen and the Standard Adjudicatory Rules of Practice and Procedure,80) CMR 1
- 2. Except for circumstances specified in 105 CMR 120.016(E)(4)(b),if th determines that a license or certificate of registration should be denie l
revoked, or refused renewal, and/or that a facility should cease an activ civil penalty should he imposed,and if the Department notifies the appi registmnt ofits intended action, upon receipt of a Notice of Claim fo Proceeding, the Department shall initiate a hearing pursuant to 801 CMRi The ficating Ollicer shall determine whether the Department has provl preponderance of the esidence that the licen 3.
and'or that a civil penalty be imposed based on relevant facts as the to the time the Department initiated the hearing procedure.
I I
105 CMR - 227 7/9/99
I l
l 4
1 105 CMR: DEPARTMENT OF PUBLIC llEALTII i
120.016: continued I
If the llearing OtTicer finds any single ground for denial, nudification, limitation, 4,
revocation, suspension, or refusal to renew a license or certificate of registration; for cessation of an activity; and/or for imposition of a civil penalty, then the Hearing Officer
' Order.
, shall render a recommended decision aflirming the issuance of the Departmen: s (d) Public 1lealth Council and.fudicial Review:
1, he recommended decision of a llearing Oflicer in any adjudicatory proceeding conducted under 105 CMR 120.000 shall be reviewed by the Commissioner and the Public Ilealth Council. %eir decision upon this resiew shall constitute a fmal agency decision in an adjudicatory proceeding subject to judicial review pursuant to M.G.L c.
30A)14,
- 2. Any applicant, licensee or registrant that fails to exercise its right to an adjudicato proceeding under 105 CMR 120.000 waives both its right to administrative r Cornmissioner and the Public llealth Council and its right to judicial raiew pursuant to M.G.L. c. 30A $ 14 i
(F) CivilPenalties.
(1) If the Depanmentdetermines,af eranoticehasbeenissuedandanopportunity fo has beert provided, that a licensee, registrant or vendor has not complied with a pursuartt to M.G.L c. I116 50 or with siny provision of M.G.L.c. Ii1 il SN thro any applicable rule, regulation, license or cenificate of registration adopted or iss the Department, in lieu of, or in addition to suspending, denying, modifying, limiti refusing renewal of a license or certificate of registration, may assess civil penalties not exceeding $100,000 per violation. Such civil penalty may be assessed whethe violatiott was willful.
Generally, civil penahics are imposed for Severity Level I violations and if mit (2) circumstances are absent, for Severity Level !! violations. Civil penalties are consid
. Severity Level 111 violations, aM may be imposed for Severity Level IV violatio to previous violations for which the licerisce did not take effective corrective action (3) In applying this guidance for Severity LevelIV violations,the Agency norm penalties only for similar Severity LeveliV violations that occur after the da or within two years, whichever peiiod is greater.
(4) Civil penalties will normally be assessed for known and conscious violation requirements of 105 CMR 120.000 and for any willful violation of any Agency r including those at any severity level.
(5) Payment of civil penalties imposed under M.G.L c.111,6 50 shall be mad Radiation j
or money order payable to the Commonweahh of Massachusetts, and mailed to:
Control Program,174 Portland Street, Boston. MA 02114.
(6) Factors in Determinine the Amount ofPenahv. In determining the annunt i
tle Department shall consider the fo'llowing:
(a) De willfulness of the violation; (b) Inc actual and potential danger to the public health or the environment; (c) %e actual or potential costs of such danger to the public health or the emir (d) %c actual or potential damage or injury to the public health or emironment; (e) %c actual and potential cost of such damage or injury; (f) ne actual or potential cost to the Commonwealth of enfbrcing provisions
(
120.000; (g) Whether the person being assessed the civil penahy did everything rea failun: to,to come into compliance promptly, and to remedy and mitigate what have been done as a result of de failure to comply; (h) Whether the person being assessed the civil penalty has previously any order issued pursuant to M.G.L c.111, il SN through SP or any rule adopted hereunder; (i) Whether imposition of a civil penalty is likely to deter future non-compliance; l
(.
(j) We financial condition of the person being assessed the chil penahy; and j
(k) %e public interest.
105 CMR 228 7/9/99
r 1
f 105 CMR: DEPARTMENT OF PUBLIC IIEAL111 120.016: continued (G) Escalation of Enforcement Sanctions.
(1) The Department considers violations of Severity Levels I,11 or lit to be of significant regulatory concem. Ifserious violations occur, the Department will, where necessary, issue orders in ec,njunction with civil penalties to achieve immediate corrective actions and to deter furtlwr recurrence of serious violations. The Department carefully considers the circumstances of each case in selecting and applying the sanction (s) appropriate to the case in accordance with the criteria described in 105 CMR 120.016(D).
(2) Nonnally, the progression ofenforcement actions for similar violations will be based on similar violations at an individual facility and not on similar violations under the same license. Ilowever, it should be noted that under some circumstances e.g, where there is common control over some facet of facility operations, similar violations may be charged even though the second violation occurred at a different facility or under a different license. For example, a health physics violation at one division of a dual unit hospital that repeats an earlier violation of the other division might be considered similar.
(II) Criminal Enforcement. The Depertment may elect to enforce any section of the regulations or provision of M.G.L. c. I I1, i SP by seeking to have criminal sanctions imposed. Any person who violates M.G.L. c. I11,6 5N or i 50 or any rule, regulation, license, registration, or order adopted or issued under said M.G.L. c. I11,9 $N or 150 shall be fined not less than $100 nor more than
$2,000, or be imprisoned for a period ofnot more than two years, or both. Any person who continues to violate the provisions of the aforementioned laws afler due notice by tie Dqiartment shall be fined not less than $1,000 nor more than $20,000 or be imprisoned for a period of not more than 20 years, or both. After due roi? has been issued by the De[xutment,each day ofsuch violation shall constitute a separate offense.
(1) JtKbcial Enfon:ement The Department may apply directly to the Supreme Judicial Court or Superior Coun L enforce any provision of M.G.L. c. I11, (( 5N through SP and'or any rule or regulation, license, registration, or order adopted and issued thereunder by the Department. When a person is engaged in or about to engage in any act or practice which constitutes or will constitute a.
violation of such provision, rule, regulation, license, registration, or order, the Department may seek to restrain such act or practice or the use or occupation of premises or parts thereof or such other equitable relief as public health and safety requires.
(J) Nonexclusivity of Enfbreement Procedures. None of the enforcement procedures contained in 105 CMR 120.000 are mutually exclusive. Any enforcement procedures rnay be invoked simultaneously if the situation so requires.
120.017: Severability The provisions of 105 CMR 120.000 are severable. If any section, subsection, paragraph or provision is declared unconstitutional or invalid by a court of competent jurisdiction, the validity of the remaining provisions shall not be so afTected.
12001R: Public Disclosure of Enforcement Actions in accordance with M.G.L. c. 30A, the Administrative Procedures Act, all enfbreement actions and licensees' responses are publicly available for inspection. In addition, press releases are generally issued for civil penalties related to violations at Severity Level 1,11, or 111. Press releases are issued at the time of the order or the proposed imposition of the civil penalty.
120.019: Annendix A - Severity Categories
'lhe following examples of severity levels are neither exhaustive nor controlling. They reflect only the seriousness of the violation and not the intent of the violator, the history of the violator,the amount necessary to deter future violations, or efTorts to correct the violation.
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120.019: continued (A) Severity I evel 1 - Most Sienificant Violatiom.
(1) 1Icahh Physics.
(a) Single exposure of a worker in excess of 25 rems of radiation to the whole Exx!y,150 rems to the skin of the whole body, or 375 rems to the feet, ankles, hands or foreamis; (b) Annual whole body exposure of a member of the public in excess of 2.5 rems ofradiation; (c) Release of radioactive material to an unrestricted area in excess of ten times the limits 105 CMR 120.253; (d) Disposal oflicensed material in quantities or concentrations in excess of ten times tie limits of 105 CMR 120.253; (e) Exposure of a worker in restricted areas of ten times the limits of 105 CMR 120.212.
(2) Transmrtation.
(a) Annual whole body radiation exposure of a mernber of the public in excess of 0.5 rems of radiation; or, (b) Breach of package integrity resulting in surface contamination or extemal radiation levels in excess of ten times the Agency limits.
(3) Materials Onerations.
(a) Radiation levels, contammation levels, or releases that exceed ten times the limits specified in the license; (b) A system designed to prevent or mitigate a serious safety event not being operable when actually required to perform its design function.
(4) Miscellaneous Matters.
(a) A Material False Statement (MFS)' in which the statement made was deliberately false; (b) Falsification of records which the Agency requires be kept of significant infonnation in which the records were deliberately falsified by or with the knowledge of management; or, (c) A knowing and intectional failure to provide any notice required by 105 CMR 120.000.
(d) Possession of licensable quantities of radioactive material without a license, or loss of control of a source of radiation.
(c) Refusing authorized Agency personrel access to facilities, records and'or equipment to conduct inspections or investigations.
(5) Emercency Prenaredness. In an emergency, licensee failure to promptly:
(a) correctly identify the event; (b) make required notifications to responsible Federal, State, and local agencies; or (c) respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response facilities, and augment shift stafl).
(B) Severity I evel II - Verv Sienificant Violations.
(1) _Ilealth Physics.
(a) Single exposure of a worker in excess of 5 rems of radiation to the whole txidy,30 rems to the skin of the whole body or 75 rems to the feet, ankles, hands or foreamis; (b) Annual whole body exposure of a member of the public in excess of 0.5 rems ofradiation; (c) Release of radioactive material to an unrestricted area in excess of five times the l 105 CMR 120.222; (d) Failure to make an immediate notification as required by 105 CMR 120.282(A), and (D);
In essence, a Material False Statement is a statement that is false by omission or commission and is relevant to the regulatory process. As can be seen in the examples, in determining the specific severity level of a violation involving material false statements or falsification of records, consideration will be given to such factors as the position of the person involved in the violation (e.g., first line supervisor or senior manager), the significance of tie infonnation involved, and the intent of the violator (i.e., negligence not amounting to careless disregard or deliberateness). The relative weight given to exh of these factors will be dependent on the circumstances of the violation.
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l 105 CMR: DEPARTMENT OF PUBLIC llEALTil 120.019: continued (e) Disposal of license material in quantities or concentmtions in excess of five times the limits ]
l of 105 CMR 120.253; (f) Exposure of a worker in restricted areas in excess of five times the limits of 105 CMR j
120.212.
(g) An x-ray system having a malfunction such that inadvertent exposures could occur e.g.,
a system such that when the exposure switch is activated, not one but repeated exposures occur, or the timer fails to terminate exposure, or exposure initiated without utilizing the exposure switch.
(h) A fluoroscopic x-ray system with a tabletop entrance exposure rate of greater than or equal to 25 R/ min. at the point where the center of the useful beam enters the patient, except:
- a. During recording of fluoroscopic images; or,
- b. When an optional high level control is activated.
(i) A fluoroscopic system such that the entire x-ray beam is not intercepted by the primary protective barrier, or, (j) Therapy systems which exhibit excessive leakage and/or inoperable door interlocks, shutters, timers, e/c.
(k) 'Iherapy system, with improper operator / patient communication / observation.
1 (2) Transnortatiert (a) Breach of package integrity resulting in surface contaminationor extemal radiation levels in excess of Agency requin:ments; (b) Surfacecontaminationorextemalradiationlevelsinexcessoffivetimes Agencylimitsthat did not result from a breach of package integrity; or, (c) Failure to make required initial notifications associated with Severity Ixvel I or II violations.
(3) MaterialOncrations.
(a) Radiationlevels,contaminationlevels,orreleasesthatexceedfivetimesthelimitsspecified in the license; or, (b) A system designed to prevent or mitigate a serious safety event being inoperable.
(4) Miscellaneous Matters.
(a) A MFS, or a reporting failure, invohing information which, had it been available to the Agency and accurate at the time the information should have been submitted, would have resulted in regulatory action or would likely have resulted in the Agency seeking further information; (b) A MFS in which the false statement was made with careless disregard.
(c) Deliberate falsification of records which the Agency requires be kept invohing significant information; or, (d) A failure to provide the notice required.
(e) Failure to register sources of radiation or services as required by 105 CMR 120.000.
(f) Action by management to discriminate against an employee for attempting to communicat or for actually communicating with the Agency.
(5) Emereency Prenaredness. Licensee failure to meet or implement more than one emergency planning standard involving assessment or notification.
(C) Severity I.evel til - Sienificant Violations.
(1) !!cahh Physics.
(a) Single exposure of a worker in excess of 3 rems of radiation to the whole body,7.5 rem to the skin of the whole body, or 18.75 rems to the feet, ankles, hands or forearms; (b) A radiation level in an unrestricted area such that an individual could receive greater 100 millirem in a one hour period or 500 millirem in a seven consecutive days; (c) Failure to make a 24-hour notification as required by 105 CMR 120.281 or an immedia notification required by 105 CMR 120.282; (d) Substantial potential for an exposure or release in excess of 105 CHIR 120.200, wir or not such exposure or release occurs (e g., entry into high radiation areas, such as und reactor vessels or in the vicinity of exposed radiographic sources, without having performed an adequate survey, operation of a radiation facility with a nonfunctioning interlock system)
(e) Release of radioactive material to an unrestricted area in excess o 120.222; 105 CMR - 231 7/9/99-
t 103 CMR: DEPARTMENT OF PUBLIC llEAllll 120.019: continued (f) Improper disposal oflicensed material not covered in Severity Level I or 11; (g) Exposure of worker in restricted areas in excess of the limits of 105 CMR 120.212; (h) Release for unrestricted use of contammated or radioactive material or equipment which poses a realistic potential for significant exposure 40 members of the public, or which reflects a programmatic (rather than isolated) weakness in the radiation control program; (i) Cumulative worker exposure above regulatory limits when such cumulative exposure reflects a programmatic, rather than an isolated weakness in radiation protection; (j) Conduct oflicensee activities by a technically unqualified person; (k) Significant failure to control licensed material; (1) Failure to use exposure reduction devices properly (e.g., collimators, filtration);
(m) For a fluoroscopic system where the maximum allowable tabletop exposure rate is 5 R/ min., test values of greater than or equal to 7 R/ min. (uncorrected), but less than 25 R/mir Correspondingly, for a maximum allowable rate of 10 R/ min., test values of greater than vs equal to 14 R/ min. (uncorrected) but less than 25 R/ min. are included.
(n) A radiographic x-ray system having positive beam limitation where the x-ray field size in the plane of the image receptor, whether automatically or manually adjusted,is such that either the length or the width of the x-ray field ditTers from that of the image receptor by greater than 10% of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor.
(o) Intraoral dental systems capable of operations in the above 50 kVp range for which the fieki size at the cone tin is greater than or equal to nine centimeters or which exhibit a minimum SSD less than 16 centimeters.
(p) Dental radiographic systems in which it is possible to, m!uce x-rays with the timer in the zero or ofTposition.
(q) Mammographic x-ray systems in which the edge of the x-ray field at the chest wall extends beyond the edges of the image receptor by more than 5% of the source to image receptor distance.
(r) lherapy systems which fail to maintain proper surveys, calibrations, spot checks or operating procedures.
(2) Transnortation (a) Breachofpackageintegrity; (b) Surface contamination or extemal radiation levels in excess of, but less than a factor of five above Agency requirements that did not result from a breach of package integrity; (c) Anynoncompliancewithlabeling, placarding,shippingpaper,packagingloading,orother requirements that could reasonably result in the following:
- a. Improper identification of the type, quantity, or form of material;
- b. Failure of the canier or recipient to exercise adequate controls;or,
- c. Substantial potential for personnel exposure or contamination, or improper transfer of material; or, (d) Failure to make required initial notification associated with Severity Level til violations.
(3) Materials Oncrations.
(a) Failure to control access to licensed materials for adiation purposes as specified by Agency requirements; (b) Possession or use of unauthorized equipment or materials in the conduct oflicensee activities which degrades safety; (c) Use of radioactive material on humans where such um is not authoriml; (d) Conduct oflicensed activities by a technically unqualified person; (e) Radiation levels, contamination levels, or releases that exceed the limits specified in the license; or, j
(f) Medicaltherapeutic misadmmistrations.
(g) Failure to obtain appropriate Agency approval before moving to a new use anNor storage location.
(4) Miscellaneous Matters.
(a) An MFS not amounting to a Severity Level I or 11 violation; or, (b) Deliberatefalsification,orfalsificationbyorwiththeknowledgeofmanagementofrecords which the Agency requires be kept that did not imolve signification information.
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l 120.019: continued (5) Emercency Precaredness. Violations oflesser severity than Severity level 11 violations.
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(D) Severity I evelIV - Violations.
(1) IIcalth Physics.
(a) Exposures in excess of the limits of 105 CMR 120.211 notconstituting Severity Level 1,
!!, or 111 violations; (b) A radiation level in an unrestricted area such that an indi,idual could receive greater tha two millirem in a one-hour period or 100 millirem in any seven consecutive days; (c) Failure to make a 30-day notification required by 105 CMR 120.283; (d) Failure to make a follow-up written report as required by 105 CMR 120.281,120.287 and 120.750; or, (e) Any other matter that has more than minor safety or environmental significance.
(f) A capacitor storage radiographic system such that the standby radiation is greater than mR/hr,but less than 25 mR/hr.
(g) Systems equipped with positive beam limiting devices which do not allow the field size be reduced to a size less than that of the inuge receptor.
(h) Systems equipped with positive beam limiting devices which do not provide for an automatic retum to PBL from a reduced field size.
(i) Mobile radiographic systems for which the minimum sourte to skin distance is less than 27.5 centimeters.
Mammographic systems manufactured aller October 1977 for which the edges of the (j) x-ray field on the right or left sides extend beyond the edges of the image receptor. If manufactured prior to November 1977 and the edges of the x-ray field on either side extenl beyond the edge of the image receptor by more than 5% of the SID.
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(2) Transnortation.
(a) Package selection ofpreparation requirements which do not result in a breach of packag integrity or surface contamination or extemal radiation levels in excess of Agency requirem or, (b) Other violations that have more than minor safety or emironmental significance.
(3) MaterialOnerations.
(a) Failure to maintain patients hospitalized who have cobalt-60, cesium-137, or iridium implants or to conduct required leakage or contamination tests, or to use properly cali equipment; (b) Other violations that have more than minor safety or emironmental significance; or, (c) Failure to report medical diagnostic misadnunistrations.
1 (4) Miscellaneous Matters.
(a) A false statement caused by an inadvertent clerical or similar error involving inform which, had it been available to the Agency and accurate at the time the information should ha been submitted, would probably not have resulted in regulatory action or the Agency seeking additionalinformation.
Unless specified in a more severe category, changes in procedures or other conditio 1
(b) of a license or certificate of registration of which the Agency was not informed (e.g., change of address, expiration of certificate of registration); or, (5) Emergency renaredness. Violauons oflesser severity than Severity LevelIll violation p
(E) Severity t.evel V - Minor Violations.
(1) JIcalth Physics.
(a) For a fluoroscopic x-ray system where the maximum allowable tabletop exposu 5 R/ min., test values of greater than 5.0 R/ min. (uncorrected), but less than 7.0 R/ min.
Corcespondingly, if the maximum allowable tabletop exposure rate is 10 R/ min., te greater thsn 10.0 R/ min. (uncorrected) but less than 14.0 R/ min. are included.
(b) Other violations that have minor safety or emironmental significance.
(2) Transnortation. Other violations that have minor safety or environmental significance (3) Materials Onerations. Other violations that have minor safety or emironmental sig (4) Miscellaneous Matters. Other violations that have minor safety or emironmental sign f
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105 CMR: DEPARTMENT OF PUllLIC llEALTil 120.019: continued (5) Emereency Prenaredness. Other violations that have minor safety or environme significance.
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