ML20199F617
| ML20199F617 | |
| Person / Time | |
|---|---|
| Issue date: | 01/04/1999 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, MINNESOTA, STATE OF, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF, WISCONSIN, STATE OF |
| References | |
| SP-99-001, SP-99-1, NUDOCS 9901210374 | |
| Download: ML20199F617 (67) | |
Text
._
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",L January 4, 1999 I
- ALL' AGREEMENT STATES '
- MINNESOTA, OHIO, OKLAHOMA, PENNSYLVANIA, AND WISCONSIN
' TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-99-001)
- l Your attention is invited to the enclosed correspondence which contains:
i
~..
- INCIDENT AND EVENT INFORMATION.........
PROGRAM MANAGEMENT INFORMATION.. XX DRAFT PART 35 COMPATIBILITY CHART TRAINING COURSE INFORMATION..............
l l
TECHNICAL INFORMATION...........................
i OTHER INFORMATION..................................
- Supplementary information
- Enclosed for your information is a draft compatibility chart for the j
proposed revision of 10 CFR Part 35.' This draft chart was developed in accordance with the compatibility categorization criteria detailed in NRC Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs" dated February 27,1998. The compatibility 1
categories in the draft chart reflect revisions, in some cases, to the categories that were I
contained in the proposed rule that was published on August 5,1998.
l We invite your comments and suggestions relative to the compatibility designations detailed in this draft document. The closing date for receipt of comments is February 12,1999.
If you have any questions regarding this correspondence, please contact me or the individual f
~
named below.
l POINT OF CONTACT:
Lloyd A. Bolling i
TELEPHONE:
(301) 415-2327 FAX:
(301) 415-3502 INTERNET:
LABONRC. GOV Original 8igned By:
i PAULH.LOHAUS L-Paul H. Lohaus, Deputy Director 1
Office of State Programs l
l
Enclosure:
\\
l
- As stated
{
Distribution:
l DIR RF.
- DCD (SP03) l. SDroggitis PDR (YES.O i A/S File
[ To fogelue e esp r of Wde desument, in$cete in the bes: "C" = Copy without attachment / enclo "E" = Copy with attachment / enclosure "N" = No copy DOCUMENTNAME: G:\\ LAB \\SP99001.WPD,G:\\ LAB \\35 CHART.WPD
- See previous concurrence.
8 5'
OFFICE ~
OSP l-OSP:DD l
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j NAME-LABolling:gd:kk PHLohaus DCool 5
DATE 12/17/98*
12/17/98 12/22/98*
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9901210374 990104 OSP FILE CODE: SP-A 4 PDR STPRO ES90EN i
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1 ALL AGREEMENT STATES MINNESOTA, OHIO, OKLAHOMA, PENNSYLVANIA, AND WISCONSIN
/
TRANSMITTf.L GF STATE AGREEMENTS PROGRAM INFORMATION (SP )
/
Your attention is invited to the enclosed correspondence whic contains:
INCIDENT AND EVENT INFORMATION.........
PROGRAM MANAGEMENT INFORMATION.. XX pRAFT PART 35 TRAINING COURSE INFORMATION..............
/
TECHNICAL INFORMATION...........................
OTH ER INFORMATION..................................
Supplementary information: Enclosed for your information is a draft compatibility chart for the proposed revision of 10 CFR Part 35. This draft chart'wes developed in accordance with the compatibility categorization criteria detailed in NRC Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs" dated February 27,1998. The compatibility
' categories in the draft chart reflect revisions, in some cases, to the categories that were contained in the proposed rule that was published on August 5,1998.
We invite your comments and suggestions relativ to the compatibility designations detailed in this draft document. The closing date for receipt of comments is February 1,1999.
If you have any questions regarding this corres ndence, please contact me or the individual named below.
/
POINT OF CONTACT:
Lipyd A. Bolling TELEPHONE:
(301) 415-2327 FAX:
(301) 415-3502 INTERNET:
LAB @NRC. GOV
/
/
/
/ Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
/
As stated
! Distribution:
lDIR RF
[
DCD (SP03) lSDroggitis PDR (YES_p '
A/S File
/
pOCUMENT NAME: G:\\ LAB \\SP98med.WPDl 4:\\.n.AB\\35 CHART.
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h,.. e.,r.e mi. e.eum.nt, inee.i. in m. bac cMI Moui cnmenu.neose - copy.un an.cnmenu.ncioaun, w - no copy OFFICE OSR/M l O$4E)/Tl IMlH(:D l
OSP:D /
l NAME LABollingfoPd PHLohbui DCoof# )
RLBan'brt' DATE 12/ / 7 /98 12/ fl/98 12/P/98
_12/ 198 OSP FILE CODE: SP-A-4 i
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4 UNITED STATES j
NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.C. 20566 4001 January 4,1999 ALL AGREEMENT STATES MINNESOTA, OHIO, OKLAHOMA, PENNSYLVANIA, AND WISCONSIN TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-99-001)
Your attention is invited to the enclosed correspondence which contains:
INCIDENT AND EVENT INFORMATION.........
PROGRAM MANAGEMENT INFORMATION., XX DRAFT PART 35 COMPATIBILITY CHART TRAINING COURSE INFORMATION..............
TECHNICAL INFORMATION..........................
OTH ER I N FORMATION..................................
Supplementary information: Enclosed for your information is a draft compatibility chart for the proposed revision of 10 CFR Part 35. This draft chart was developed in accordance with the compatibility categorization criteria detailed in NRC Management Directive 5.9," Adequacy and Compatibility of Agreement State Programs" dated February 27,1998. The compatibility categories in the draft chart reflect revisions, in some cases, to the categories that were contained in the proposed rule that was published on August 5,1998.
We invite your comments and suggestions relative to the compatibility designations detailed in this draft document. The closing date for receipt of comments is February 12,1999.
If you have any questions regarding '.his correspondence, please contact me or the individual named below.
POINT OF CONT ACT:
Lloyd A. Bolling TELEPHONE:
(301) 415-2327 FAX:
(301) 415-3502 INTERNET:
@N C. OV au H.Lohaus, puty Director Office of State Programs
Enclosure:
As stated
12/31h COMPATIBILITY DESIGNATIONS FOR DRAFT 10 CFR PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL '
l.
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
'535.1 Purpose and scope D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
'l
$35.2 Definitions Address of use D
Does not meet any of the criteria of Category A, B,'
C, or D/H&S.
1 i
Agreement State
[B]
This definition also appears in 10 CFR 9150.3(b).
For purposes of compatibility, the language of the
. Part 150 definition should be used and it is assigned to Compatibility Category B.
Area of use D
Does not meet any of the criteria of Category A, B,-
C, or D/H&S.
2
~;
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Authorized medical physicist C
Based upon Handbook 5.9 Part li, " Categorization Criteria," Section (C), paragraph (2)(e), this definition was identified as a Category C because its absence could potentially impair effective communication.
This definition impacts effective commun' cation because it is used to delineate that the individual is legally vested with the authority to function as an authorized medical physicist. This definition is also needed because of its impact on the establishment of a nationwide training and certification program in the medical use area. The essential objective of this definition is to establish that the medical physicist is a person identified on a license issued by the Commission or by an Agreement State, or meets the minimum requirements in 35.59 and 35.961.
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REGULATION SECT 10N TITLE COMPATIBit.ITY COMMENTS SECTION CATEGORY.
^
Authorized nuclear C
Based upon Handbook 5.9 Part 11. " Categorization -
pharmacist Criteria," Section (C), paragraph (2)(e), this definition was identified as a Category C because its absence could potentially impair effective communication.
This definition impacts effective communication because it is used to delineate that the individual is legally vested with the authonty to function as an authorized nuclear pharmacist. This definition is also needed because of its impact on the establishment of a nationwide training and certification program in the medical use area. The essential objective of this definition is to establish that the nuclear pharmacist is a person identified on a license issued by the Commission or by an Agreement State, or meets the minimum requirements in 35.59 and 35.980.
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- REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Authorized user C
Based upon Handbook 5.9 Part 11, " Categorization Criteria," Section (C), paragraph (2)(e), this definition
- was identified as a Category C because its absence could potentially impair effective communication.
This definition impacts effective communication because it is used to delineate that the individual is legally vested with the authority to function as an authorized user. This definition is also needed because of its impact on the establishment of a nationwide training and certification program in the medical use area. The essential objective of this definition is to establish that an authorized user is a person identified on a license issued by the i
Commission or by an Agreement State, or meets the minimum requirements in this part.
Brachytherapy source
-D Does not meet any of the criteria of Category A, B, 1
C, or D/H&S.
i Dedicated check source D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
Dentist D
Does not meet any of the criteria of Category A,
. B, C, or D/H&S.
Diagnostic clinical D
Does not meet any of the criteria of Category A, procedures inanual B, C, or D/H&S.
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5 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY High dose-rate remote D
Does not meet any of the criteria of Category A, afterloader B, C, or D/H&S.
Low dose-rate remote D
Does not meet any of the criteria of Category A, afterloader 8, C, or D/H&S.
Management D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
Medical event D
Does not meet any of the criteria of Category A, B, C, or D/H&S since the term was not defined in this section, but is defined in 35.3045(a).
Medicalinstitution D
~ Does not meet any of the criteria of Category A, B, C, or D/H&S.
Medical use C
Based upon Handbook 5.9 Part il," Categorization Criteria," Section (C), paragraph (2)(e), this definition was identified as a Category C. The essential objectives of this definition should be adopted because the lack of it could potentially impair effective communication. The essential objective of
' this definition is to establish a common understanding regarding the application of radioactive materials and the radiation therefrom to humans as directed by an authorized user.
6 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Mobile service D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
Output D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
Pharmacist D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
Physician D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
]
)
Podiatrist D
Does not meet any of the criteria of Category A,
' B, C, or D/H&S.
Prescribed dosage C
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section (C), paragraphs (2)(c) and (2)(e),
this definition was identified as a Category C. The essential objectives of this definition should be adopted because the lack of it could potentially preclude an effective review or evaluation by the Commission and Agreement State programs for
' agreement materials with respect to protection of public health and safety and impair effective communication. The essential objective of this definition is to estat,lish a common understanding regarding the correct quantity of radiopharmaceutical activity prescribed by the authorized user for administration to a patient.
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7 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION.
CATEGORY Prescribed dose' C
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section (C), paragraphs (2)(c) and (2)(e),
this definition was identified as a Category C. The -
essential objective of this definition should be adopted because the lack of it could potentially
.. preclude an effective review or evaluation by the Commission and Agreement State programs for~
agreement materials with respect to protection of public health and safety and impair effective -
communication. The essential objective of this definition is to establish a common understanding ;
regarding the correct quantity of -
radiopharmaceutical activity prescribed by the authorized user for administration to a patient.
m, Pulsed dose-rate remote D
~ Does not meet any of the criteria of Category A, afterloader B, C, or D/H&S.
I
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY t
Radiation safety officer C
Based upon Handbook 5.9 Part II, " Categorization.
p Criteria," Section (C), paragraph (2)(e), this definition j
was identified as a Categor5/C because its absence l
could potentially impair effective communication.
This definition impacts effective communication
' because it is used to delineate that the individual is legally vested with the authority to function as
~
radiation safety officer, especially since there is no lenger a radiation safety committee provision. This definition is also needed because of its impact on '
l the establishment of a nationwide training and
}
certification program in the medical use area. The essential objective of this definition is to establish that the RSO is identified on a license issued by the i
i
. Commission or by an Agreement State, or meets the minimum requirements in 35.59 and 35.900.
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Based upon Handbook 5.9 Part il, " Categorization Sealed source
[B] ~
. Criteria," Section (B), paragraph (2)(c), this definition l
was identified as a Category B because it is a i
definition of a product that licensees routinely f
transport in multiple jurisdictions. This definition also appears in 10 CFR $30.4. For purposes of
. compatibility, the language of the Part 30 definition
. should be used and it is assigned to Compatibility -
[
Category B.
Sealed source and device D
Does not meet any of the criteria of Category A, registry B, C, or D/H&S.
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REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Stereotactic radiosurgery D
Does not meet any of the criteria of Category A, B, C, or DM&S.
Structured educational D
Does not meet any of the criteria of Category A, Program B, C, or DM&S.
Temporary jobsite D
Does not meet any of the criteria of Category A, B, C, or DM&S.
Treatment site C
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section (C), paragraphs (2)(c) and (2)(e),
this definition was identified as a Category C. The essential objective of this definition should be adopted because the lack of it could potentially preclude an effective review or evaluation by the Commission and Agreement State programs for agreement materials with respect to protection of public health and safety and impair effective communication. The essential objective of this definition is to establish a common understanding of the correct anatomical description of the area intended to receive a radiation dose.
Unit dosage D
Does not meet any of the criteria of Category A, B, C, or DM&S.
Written directive D
Does not meet any of the criteria of Category A, B, C, or DM&S since the teim was not defined in this section, but is defined in 35.40.
10 REGULATION SECTION Tm.E COMPATIBluTY COMMENTS SECTION CATEGORY
+
i
$35.5 Maintenance of records D
Does not meet any of the criteria of Category A, B, C, or DM&S.
635.6 Provisions for research C
. Based upon Handbook 5.9 Part II," Categorization involving human subjects.
Criteria," Section (C), paragraph (1), this requirement was designated a Category C. The lack of this requirement could create a gap whereby the-Federal Policy for the Protection of Human Subjects '
would not be applied. The essential objective of this requirement is to assure the consistent application of the Federal Policy.
35.7 FDA, other Federal, and D~
, Does not meet any of the criteria of Category A, State requirements B, C, or DM&S.
$35.8 Information collection
'D Does not meet any of the criteria of Category A, requirements: OMB B, C, or DM&S.
Approval I
'935.10 Implementation D
Does not meet any of the criteria of Category A, B, C, or DM&S.
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11 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 935.11 License required
[C]
Based upon Handbook 5.9 Part II," Categorization Criteria," Section (C), paragraph (2)(f), this requirement was designated a Category C because Agreement States should adopt the Part 30 provision as a minimum requirement for their licensees. The general requirement for activities to be licensed appears in 10 CFR 930.3 which has been designated compatibility category C. If an Agreement State has adopted 10 CFR 930.3, it is not necessary to adopt this section since the requirements aro covered in Part 30.3 and this section would be a duplication of those provisions.
935.12 Application for license, D
. Does not meet any of the criteria of Category A, amendment, or renewal B, C, or D/H&S.
35.13 License amendments D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
35.14 Notifications D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
35.15 Exemptions regarding Type D
Does not meet any of the criteria of Category A, A specific licenses of broad B, C, or D/H&S.
scope 935.18 License issuance D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
12
' REGULATION SECTION TITLE COMPATIBILITY
-=
- COMMENTS SECTION CATEGORY 635.19 Specific exemptions
' D
- Does not meet any of the criteria of Category A,.
B, C, or D/H&S.
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- REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY r
935.24 Authority and D - paragraphs (a) (1), (a)
Paragraphs (a)(1), (a)(2), (a)(3)(b), (d) and (f), do responsibilities for the (2), (a)(3), (b), (d) and (f) not meet any of the criteria of Category A, B, C, radiation protection program or D/H&S. In addition, paragraph (a)(2) was not D/H&S-paragraph (c) and required because the definitions and training of (e) authorized users, authorized nuclear pharmacists, radiation safety officers and authorized medical physicists are required as a matter of compatibility and would prevent an unqualified individual from working in these positions. Based upon Handbook l
5.9 Part II, " Categorization Criteria," Section (E),.
paragraphs (c) and (e) were designated Category D/H&S because they assist in establishing a minimum level of safety for the medical use of agreement materials since they deal with the '
implementation of the radiation protection program.
The essential objective of paragraph (c) is to assure that the RSO agrees to implement the radiation safety program. The essential objective of paragraph (e) is to require that management provides the RSO with sufficient authority, time and resources to identify radiation problems, initiate corrective actions, stop unsafe operations and verify the implementation of corrective actions.
The H&S two or fewer failure test scenario: If unapproved changes are made to the radiation safety program, or if unsafe operations are not stopped, the public and workers could receive radiation exposures in excess of the limits in Parts 20 and 35 and a medical event could occur.
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14 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY l
935.26 Radiation protection D
D~ ~ not meet any of the criteria of Category A, program changes B, u, or D/H&S.
935.27 Supervision D/H&S Based upon Handbook 5.9 Part II, " Categorization Criteria," Section E, this requirement was designated a D/H&S because it assists in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a worker overexposure and medical event. The essential objectives of this requirement are to assure the instruction of the supervised individuals in radiation safety procedures and policies, and for the supervised individuals to request clarification from authorized users as needed.
The H&S two or fewer failure test scenario: If a licensee fails to instruct supervised individuals in radiation safety procedures, regulations and license conditions and radioactive material is mishandled, the public and workers could receive radiation exposures in excess of limits and a medical event could occur.
- 15 ~
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.40 Written directives D/H&S, except paragraph Based upon Handbook 5.9 Part II, " Categorization (c) is D.
Criteria," Section E, this requirement was designated a D/H&S because it assists in establishing a minimum level of safety for the medical use of
- agreement materials by reducing the likelihood of a medical event. The essential objective of this requirement is to assure that correct information on the prescribed dose is communicated to the' licensee's staff.
The H&S two or fewer failure test scenario: If a t
licensee does not use written directives for therapeutic medical use and a misinterpretation of the authorized users' orders occurs, a medical event could occur.
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16 REGULATION SECTION TITLE COMPATIBILITY COMMENTS.
SECTION CATEGORY
' $35.41 Procedures for D/H&S Based upon Handbook 5.9 Part II, " Categorization administrations requiring a
. Criteria," Section E, this requirement was designated written directive
. a D/H&S because it assists in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event. The essential objective of this requirement is to assure patient identification and dose verification prior to administration to human beings.
The H&S two or fewer failure test scenario: Ifa 4
licensee does not verify patient identity, radioactive material or radiation could be administered to the
, wrong person, and an exposure in excess of limits
- could occur. In addition, if the prescribed dose is not verified before administration, the prescribed dose could be exceeded and a medical event could occur.
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L REGULATION SECTION TITLE COMPATIBILITY COMMENTS CATEGORY SECTION j
or devices for medical use This section is a brackated Category C, because it is
{
$35.49 Suppliers for sealed sources
[C]
already required by 10 CFR $30.32 (g) and g 32.74.
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section (C), paragraph (2)(f),10 CFR $
l
- 30.32 (g) was designated a Category C. This section requires that licensees, authorized to l
possess and use sealed sources or devices for
(
medical use, obtain these products from a licensed vendor. In addition,10 CFR 932.74," Manufacture l
and distribution of sources or devices containing byproduct material for medical use," is designated a L
Category B. This designation was based upon Handbook 5.9 Part II, " Categorization Criteria,"
Section (B), paragraph (b), requirements for approval of products that are distributed nationwide.
If an Agreement State has adopted 10 CFR $30.32 l
(g) and 10 CFR $32.74, it is not necessary to adopt
- t this section since the requirements are covered by i
these provisions.
h 35.50 Training for Radiation Safety C
Based upon Handbook 5.9 Part II, T,ategorization Officer Criteria," Section (C), paragraphs (2) (b) and (2)(f),
- I this requirement was designated a Category C i
^ because they relieve undue burdens on interstate commerce by establishing a minimum level of i
training for the medical use of agreement materials on a nationwide basis. The essential objective of this requirement is to assure that only persons qualified by training and experience shall be authorized as a r
Radiation Safety Officer.
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REGULATION SECTION TITLE COMPATMBlWTY CORNIENTS l
SECTION CATEGORY-1
$35.51 Training for authorized C.
Based upon Handbook 5.9 Part 11 "Categonzation j
medical physicist Criteria," Sechon (C), paragraphs (2)(b) and (2)(f),
this requirement was designated a Category C l
because they. relieve undue burdens on interstate 1
- commerce by estabhshing a minimum level of training for the medical use of agreement materials.
i on a nationwide basis. The. essential objective of this j
.x requirement is to assure that only persons qualified i
by training and experience shall be authorized as a j
b medical physicist.
e
- $35.55 Training for an authorized C'
Based upon Handbook 5.9 Part II, " Categorization i
nuclear pharmacist Criteria," Sechon (C), paragraphs (2)(b) and (2)(f),
, this requirement was designated a Category C because they relieve undue burdens on interstate commerce by establishing a minimum level of '
i training for the medical use of agreement materials on a nationwide basis. The essential objective of this e
requirement is to assure that only persons qualified
)
by training and experience shall be authorized as a nuclear pharmacist.
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19 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 35.57 Training for experienced C
Based upon Handbook 5.9 Part II," Categorization Radiation Safety Officer, Criteria," Section (C), paragraphs (2) (b) and (2)(f),
teletherapy or medical this requirement was designated a Category C physicist, authorized user, because they relieve undue burdens on interstate and nuclear pharmacist commerce by establishing a minimum level of training for the medical use of agreement materials on a nationwide basis. The essential objective of this requirement is to exempt experienced authorized users, including Radiation Safety Officers, who are named on a license from the training requirements in 35.50, Q35.51 and Subparts C through H.
35.59 Recentness of training C
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section (C), paragraphs (2) (b) and (2)(f),
this requirement was designated a Category C because they relieve undue burdens on interstate commerce by establishing a minimum level of training for the medical use of agreement materials on a nationwide basis. The essential objective of this requirement is to assure that applicants requesting authorized user status are familiar with current medical practice in this area.
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REGULATION
- SECTION TITLE COMPATHMUTY CORSRSENTS SECTION CATEGORY.
i 935.60
. Possession, use, calibration,-
D/H&S, except paragraph
' Based upon Handbook 5.9 Part it', T,ategorization and check of instruments to (e) is D.
Criteria," Sectum E, this requirement was designated measure actmty of photon-a D/H&S. This provision assists in establishing a emitting radionuclides
- minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event. The essential objective of this-requirement is to assure the measurement of the
~
dosage with proper instrumentation prior to administration.
The H&S two or fewer failure test scenario: If a j
licensee does not property measure the dosage with the appropriate instrumentation, the administered l
- dose could differ from the prescribed dose and a
~
medical event could occur.
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- REGULATION SECTION TTTLE CORAPATNNUTY CORRISENTS SECTION CATEGORY '
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$35.61 :
- Calibration and check of D/H&S, except paragraph Based upon Han@ook 5.9 Part 11, T,ategorization survey instruments (d) is D.
Criteria," Section E, this requirement was designated a D/H&S. This prowsion assists in estabhshmg a l
minimum level of safety for the medical use of
[
. agreement materials. Without property calibrated survey instruments over exposures could occur.
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The requirement is needed to demonstrate
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~
compliance with Part 20 requirements. The'.
~
essential objective of this requirement is to assure
. the possession of calibrated survey instruments..
i The H&S two or fewer failure test scenario: If a > <
licensee does not calibrate or check survey.
I
. instruments as required by this rule, and a i
contamination event occurs, radiation levels in j
excess of Part 20 limits could occur.
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$35.62 PossessKm, use, calibration, D/H&S, except paragraph Based upon Handbook 5.9 Part 11, Tategorization and check of instrumerts to
_ (d) is D.
Criteria," Sectum E, this requirement was designated measure dosages of alpha-a D/H&S. This provision assists in establishmg a or beta-emitting minimum level of safety for the medmal use of radxmuclides agreement materials by reducmg the likelihood of a j
medcal event. The essential objective of this requirement is to assure the measurement of the l
dosage with proper instrumentation prior to l
administration.
The H&S two or fewer failure test scenario: If a licensee does not properly measure the dosage with -
the appropriate instrumentation, the administered
. dose could differ from the prescribed dose and a medical event could occur.
635.63 Determination of dosages of D/H&S, except paragraph Based upon Handbook 5.9 Part II, Tategorization unsealed byproduct material (e) is D.'
Criteria," Section E, this requirement was designated for medical use a D/H&S because it assists in establishing a minimum level of safety for the medical use of 3
agreement materials by reducing the likelihood of a medcal event. The essential objective of this
. requirement is to assure determination of dosages by proper measurement and/or calculation prior to human use.
The H&S two or fewer failure test scenario: Ifa licensee does not measure a dosage, and a preparation error occurs, a medmal event could occur.
1
\\
23 REGULATION
- SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY I
35.65 Authorization for calibration D
Does not meet any of the criteria of Category A, and reference sources B, C, or D/H&S.
i 35.67 Requirements for D/H&S, except paragraph
- Based uoon Handbook 5.9 Part II, " Categorization possession of sealed (e) is D.
Criteria," Section E, this requirement was designated sources and brachytherapy a D/H&S. This provision assists in establishing a sources minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event and worker overexposure. The essential objective of this requirement is to assure the safe handling, periodic leak testing, and J
inventory of sealed sources.
' The H&S two or fewer failure test scenario: If the licensee does not follow the manufacturers' instructions, including testing for leakage, and a source is damaged or misplaced, public and worker
.~
exposures in excess of limits and a medical event could occur.
____y m-
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-m w
m
. m-. -
9 3:
24
- ~
~ REGULATION SECTION TITLE COMPATHNUTY COMMENTS SEC110N CATEGORY
$35.69 Labeling and shielding of
. DM&S~
Based upon Handbook 5.9 Part II, T,ategorization vials and syringes -
. Criteria," Section E, this requirement was designated a DM&S. This provision assists in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event and worker overexposure.. The essential objective of this requirement is to make sure that licensees develop, implement and maintain written procedures for labeling synnges, syringe shields, and vial shields that contain -
radiopharmaceuticals.
The H&S two or fewer failure test scenario: If the syringe, syringe shield, or vial shield is not labeled, then the wrong radiopharmaceutical could be administered, and a medical event could occur. If
. syringe and vial shields are not used, then the worker could be overexposed.
l 1
I
25 l
REGULATION SECTION TITLE COMPATIBILITY COMMENTS
- SECTION CATEGORY
$35.70 Surveys for ambient D/H&S, except paragraph Based upon Handbook 5.9 Part II," Categorization radiation exposure rate (c) is D.
Criteria," Section E, this requirement was designated a D/H&S. These provisions assist in establishing a minimum level of safety for the medical use of 1
agreement materials by reducing the likelihood of a medical event and worker overexposure. The essential objective of this requirement is to assure that daily radiation surveys are performed in areas -
where therapeutic radiopharmaceuticals are used.'
4 The H&S two or fewer failure test scenario: Ifa licensee does not conduct surveys for ambient radiation exposure rates, and an unplanned release of radioactive material occurs, contamination could go undetected and cause public and worker exposure in excess of limits in Part 20.
35.75 Release of individuals C, except paragraphs (c)
Based upon Handbook 5.9 Part II," Categorization containing and (d) are D.
Criteria," Section (C), paragraphs (2)(a) and (f), this radiopharmaceuticals or requirement was designated a Category C. This implants provision assists in establishing a minimum level of i
safety for the medical use of agreement materials on a nationwide basis by reducing the likelihood of public overexposures in multiple jurisdictions. The essential objective of this requirement is to assure that 0.5 rem TEDE is not exceeded by any individual, and that instructions are provided to individuals who are breast-feeding an infant / child when the dose to the infant / child could exceed 0.1 6
i l-m m
. m.
26.
~
REGULATION SECTION TITLE
' COMPATIBlWTY COMMENTS -
- SECTION CATEGORY 935.80 Provision of mobile service D - except paragraph (a)is Based upon Handbook 5.9 Part II, " Categorization -
D/H&S for those States Criteria," Section E, paragraph (a) was designated a which authorize this D/H&S those Agreement States which authorize this service.
service. This provision assists in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a -
public exposure. The essential objective of this requirement is to make sure that client management is aware that byproduct material will be used onsite, that instruments are possessed, used, calibrated and checked as described in $35.60 and $35.62, that properly operating survey instruments are used
, and that radiation surveys are performed in areas where therapeutic radiopharmaceuticals are used.
The H&S two or fewer failure test scenario:
Paragraph (a) requires that the requirements in 35.60 and 935.62 be applied to mobile services. If
~a mobile service licensee does not measure dosages with a proper operating instrumentation, then the prescribed dose could be exceeded, causing a medical event. If radiation levels are not measured with properly operating instruments, the radiation protection limits in Part 20 for workers and the public could be exceeded.
27 l
REGULATION SECTION TITLE '-
COMPATIBluTY COMMENTS
. SECTION CATEGORY 35.92 Decay-in-storage D/H&S - for those States Based upon Handbook 5.9 Part 11, " Categorization which authorize this activity.
Criteria," Section E, paragraph (a) and (b) are designated as D/H&S for those Agreement States D - for other States which authorize this activity. This provision assists in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a public overexposure. The essential objective of this requirement is to allow decay in storage for radioactive materials with less than 120 day half-life and to assure that surveys will be performed on the material before disposal in ordinary trash.
The H&S two or fewer failure test scenario: If the radioactive material is not required to decay-in-storage properly before placing in ordinary trash, radioactive material of a high activity could be released into the public domain and overexposure of members of the public could occur. In addition, if the material is not properly surveyed before placing in ordinary trash, workers and members of the public could be overexposed.
i m
=
28 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 35.100 Use of unsealed byproduct D/H&S Based upon Handbook 5.9 Part il," Categorization material for uptake, dilution, Criteria," Section E, this provision was designated a and excretion studies D/H&S. This provision assists in establishing a (written directive not minimum level of safety for the medical use of required) agreement materials by reducing the likelihood of a medical event. The essential objective of this requirement is to assure that radiopharmaceuticals are obtained from a licensed vendor or authorized preparer.
The H&S two or fewer failure test scenario: Ifa licensee does not obtain radiopharmaceuticals from a licensed manufacturer or authorized preparer, a preparation error could occur, and a medical event could occur.
Q35.200 Use of unsealed byproduct D/H&S Based upon Handbook 5.9 Part II," Categorization material for imaging and Criteria," Section E, this section was designated a localization studies D/H&S. This provision assists in establishing a (including any dosages of minimum level of safety for the medical use of sodium I-131 in quantitics agreement materials by reducing the likelihood of a less than or equal to 30 medical event. The essential objective of this microcuries) requirement is to assure that radiopharmaceuticals are obtained from a licensed vendor or authorized preparer.
l The H&S two or fewer failure test scenario: Ifa l
licensee does not obtain radiopharmaceuticals from a licensed manufacturer or authorized preparer, and a preparation error occurs, a patient could receive a radiation exposure and a medical event could occur.
1 29 e
l' REGULATION
' SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.204 -
Permissible molybdenum-99
- D Does not meet any of the criteria of Category A, B, concentration C, or D/H&S.
$35.290 Training for uptake, dilution, C
Based upon Handbook 5.9 Part 11, " Categorization and excretion studies Criteria," Section (C), paragraphs (2) (b) and (2)(f),
i these requirements were designated a Category C because they relieve undue burdens on interstate.
commerce by establishing a minimum level of training for the medical use of agreement materials on a nationwide basis. The essential objective of this requirement is to assure that properly trained physicians use the radioactive material in this
~ section.
35.292 Training for imaging and C
Based upon Handbook 5.9 Part il,'" Categorization localization studies Criteria," Section (C), paragraphs (2) (b) and (2)(f),
these requirements were designated a Category C -
because they relieve undue burdens on interstate ~
commerce by establishing a minimum level of training for the medical use of agreement materials j
on a nationwide basis. The essential objective of this
- requirement is to assure that property trained 1
physicians use the radioactive materialin this
[
section.
l
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30 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION.
CATEGORY 635.300 Use of unsealed byproduct D/H&S '
~ Based upon Handbook 5.9 Part ll. " Categorization material for therapeutic Criteria," Section E, paragraph (a) was designated a administration (including any.
D/H&S for those Agreement States which authorize dosage of sodium I-131 in this activity. This provision assists in establishing a quantities greater than 30 minimum level of safety for the medical use of microcuries)
- agreement materials by reducing the likelihood of a medical event. The essential objective of this requirement is to assure that radiopharmaceuticals are obtained from a licensed vendor or authorized preparer.
The H&S two or fewer failure test scenario: Ifa
. licensee does not obtain radiopharmaceuticals from
~
a licensed manufacturer or authorized preparer, a preparation error or medical event could occur.
i
31
- REGULATION SECTION TITLE COMPATIBluTY COMMENTS SECTION CATEGORY f35.310 Safety instruction D/H&S, except (b)is D.
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section E, paragraph (a) was designated a D/H&S. These provision assist in establishing a
~ minimum level of safety for the medical use of agreement materials by reducing the likelihood of exposure to members of the public. The essential objective of this requirement is to assure that personnel caring for patients receive initial and annual radiation safety instruction.
The H&S two or fewer failure test scenario: If the personnel. caring for patients are not properly
. instructed, then personnel could be overexposed and persons visiting the patient could be overexposed. In addition, contaminated material could be released into the public domain, and a public overexposure could occur.
6 i
i 6
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j
-l REGULATION SECTION TITLE COMPATIBIUTY COMMENTS SECTION CATEGORY j
i
$35.315 Safety precautions D/H&S _
Based upon Handbook 5.9 Part il," Categorization' Criteria," Sectx>n E, paragraph (a) was designated a
~ D/H&S. This provision assists in establishing a
. minimum level of safety for the medical use of l
agreement materials by reducing the likelihood of l
worker and put4ic exposure. -The essential objectrve l
of this requirement is to limit unnecessary patient contact with members of the public, and to assure that proper notifications are made if the patient dies.
t l
The H&S two or fewer failure test scenario: If the
, safety precautions are not taken, then hospital
[
personnel could be overexposed and persons
}
visiting the patient could be overexposed.
- Contaminated material could also be released into the public domain, and public overexposures could occur. In addition, if the proper persons are not notified if a patient dies or, if a medical emergency
[
1 occurs, other personnel could be overexposed.
p
$35.390 Training for therapeutic use C
Based upon Handbook 5.9 Part 11, " Categorization -
of unsealed byproduct Criteria," Section (C), paragraphs (2) (b) and (2)(f),
f material (including any this requirement was designated a Category C dosages of sodium l-131 in because they relieve undue burdens on interstate j
quantities greater than 30 commerce by establishing a minimum level of
[
microcuries) training for the medical use of agreement materials l
on a nationwide basis. The essential objective of this requirement is to assure that properly trained physicians use the radioactive material in this
[
j section.
i I
I
33 REGULATION SECTION TITLE COMPATIBILITY
' COMMENTS SECTION CATEGORY
$35.400.
Use of sources for manual (C]
This section is a bracketed Category C, because it is brachytherapy already required by 10 CFR s30.32 (g) and $32.74.
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section (C), paragraph (2)(f),10 CFR 630.32 (g) was designated a Category C. This section requires the use of sealed sources in the SS&D Registry by all specific licensees. In addition, 10 CFR 532.74, " Manufacture and distribution of sources or devices containing byproduct material for medical use,"is designated a Category B. This designation was based upon Handbook 5.9 Part 11 Categorization Criteria," Section (B), paragraph (b),
requirements for approval of products that are distributed nationwide. If an Agreement State has adopted 10 CFR 30.32 (g) and 10 CFR 32.74, it is not necessary to adopt this section since the requirements are covered by these provisions.
b
1 svq v
Ti 34-
=
REGULATION SECTION TITLE COMPATIBIUTY COMMENTS
. SECTION CATEGORY-i
$35.404 -
Radiation surveys of D/H&S, except (c) is D.
Based upon Handbook 5.9 Part II," Categorization i
individuals with therapy -
~ ~
Criteria," Section E, paragraph (a) and (b) were t
implants designated D/H&S. These pic/A.5 assist in
[
establishing a minimum level of safety for the medical use of agreement materials by reducing the :
likelihood of a medical event and overexposures in excess of Part 20 limits. The essential objective of.
this requirement is to assure that patient arid area j
surveys are performed immediately after removal of sources from the patient or human research subject.
- The H&S two or fewer failure test scenario: If a i
licensee does not perform a patient radiation survey.
after implanting sources, sources could be misp!sced c.d the public and workers could be exposed to radiation in excess of basic radiation protection limits in Parts 20 and a medical event could occur.
-i i
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. -m m
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m
...m.m '
e-35
. REGULATION SECTION TITLE COMPATIBILITY '
COMMENTS SECTION CATEGORY -
$35.406 Brachytherapy sources D/H&S, except (c) is D.
Based upon Handbook 5.9 Part II, " Categorization inventory Criteria," Section E, paragraph (a) and (b) were designated D/H&S. These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a lost source, medical event, public and.
worker overexposure. The essential objective of this i
requirement is to assure the accountability of sources after use.
The H&S two or fewer failure test scenario: Ifa
. licensee does not maintain source accountability a source may be misplaced and the public and workers could be overexposed and a medical event could occur.
i
$35.410 Safety instruction D/H&S, except (b) is D.
Based upon Handbook 5.9 Part 11, " Categorization Criteria," Secticn E, paragraph (a) was designated a D/H&S. These provisions assist in establishing a '
minimum level of safety for the medical use of
, agreement materials by reducing the likelihood of exposure to members of the public. The essential objective of this requirement is to assure that personnel caring for a patient receive proper radiation safety instruction.
The H&S two or fewer failure test scenario: If the personnel caring for patients are not properly instructed, then the personnel could be overexposed and persons visiting the patient could be overexposed.
s w.
36 P
REGLN.ATION SECTION TITLE COMPATIBIUTY COMMENTS SECTION
' CATEGORY-
$35A15 Safety precautions D/H&S Based upon Handbook 5.9 Part 11, " Categorization.
Criteria," Section E, these provisions were E
designated D/H&S.' These provisions assistin establishing a minimum level of safety for the '
medical use of agreement materials by _ reducing the likelihood of worker and public exposure. The essential objective of these requirements is to limit patient contact with members of the public, to assure i
. the availability of emergency response equipment -
and to assure that proper notifications are made if T
the patient dies.
The H&S two or fewer failure test scenario: If the safety precautions are not taken, then hospital
. personnel could be overexposed and persons
~
visiting the patient could be overexposed.- In addition, if the proper persons are not notified if a
' patient dies or, if a medical emergency occurs, other j
hospital personnel could be overexposed and 1
material could be released into the pubhc domain, and public overexposures could occur.
j
.i i
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............ - -... -.. -.. ~..
37 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.432 Full calibration D/H&S, except (g) is D.
Based upon Handbook 5.9 Part il," Categorization measurements of Criteria," Section E, these provisions were brachytherapy sources designated DiH&S. These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event. The essential objective of this requirement is to assure that full calibration measurements on sources are performed before the first use of the source or source / applicator configuration.
~ The H&S two or fewer failure test scenario: Ifa licensee does not perform full calibration measurements of brachytherapy sources, a medical event could occur.
35.490 Training for use of manual C
Based upon Handbook 5.9 Part il," Categorization brachytherapy sources Criteria," Section (C), paragraphs (2)(b) and (2)(f),
these requirements were designated a Category C.
by relieving an undue burden on interstate commerce by establishing a minimum level of training for the medical use of agreement materials.
The essential objective of this requirement is to assure that properfy trained physicians handle sealed sources for human use in this section.
l l
l l
I 38 I
REGULATION SECTION TITLE COMPATMBILITY COMMENTS SECTION CATEGORY-i
$35.500 Use of sealed sources for
[C]
This secten is a bracketed Category C, because it is
[
diagnosis already required by 10 CFR $30.32 (g) and $32.74.
.j Based upon Handbook 5.9 Part 11, ' Categorization Criteria," Secten (C), paragraph (2)(f),10 CFR
$30.32 (g) was designated a Category C. This I
section requires the use of sealed sources in the SS&D Registry by all specific licensees. In additen, 10 CFR 9 32.74, " Manufacture and distribution of sources or devices containing byproduct material for j
medical use,"is designated a Category B. This i
designation was based upon Handbook 5.9 Part li,
" Categorization Criteria," Section (B), paragraph (b),
requirements for approval of products that are l
distnbuted nationwide. -If an Agreement State has i
adopted 10 CFR 930.32 (g) and 10 CFR 532.74, it is i
not necessary to adopt this secten since the i
requirements are covered by these provisions.
l
$35.590 Training for use of sealed C
Based upon Handbook 5.9 Part 11, " Categorization.
sources for diagnosis Criteria," Section (C), paragraphs (2) (b) and (2)(f),
l
- this requirement was designated a Category C because they relieve undue burdens on interstate commerce by establishing a minimum level of l
l training for the medical use of agreement materials i
on a nationwide basis. The essential objective of this requirement is to assure that property trained physicians handle sealed sources for human use in this section.
l t
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1
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39 REGULATION SECTION TITLE COMPATIBlWTY COMMENTS L SECTION CATEGORY
- $35.600 Use of a sealed source in a
[C).
- This sectx>n is a bracketed Category C, because it is device for therapeutic
. already required by 10 CFR 630.32 (g) and $32.74.
medical uses Based upon Handbook 5.9 Part II, " Categorization Criteria," Sectx>n (C), paragraph (2)(f),10 CFR
. 930.32 (g) was designated a Ca'agory C. This section requires the use of sealad sources in the SS&D Registry by all specific licensees. In addition,'-
10 CFR $32.74 " Manufacture and distribution of.
sources or devices containing byproduct material for l
medical use,"is designated a Category B. This designation was based upon Handbook 5.9 Part II,
" Categorization Criteria," Section (B), paragraph (b),
requirements for approval of products that are distributed nationwide. If an Agreement State has adopted 10 CFR 30.32 (g) and 10 CFR 932.74, it is
{
not necessary to adopt this section since the.
l requirements are covered by these provisions.
.i t
f i-t e
m
M-p 9
REGULATION SECTION TITLE COMPATIBluTV COMMENTS SECTION CATEGORY -
' $35.604' Radiation Surveys of D/H&S, except'(b) is D.
. Based upon Handbook 5.9 Past II, "Categonzation -
~
-individuals treated with -
Criteria," Section E, paragraph (a) was designated remote afterloaders.
D/H&S. This provision assists in estabhshing a ~
minimum level of safety for the medical use of.
agreement materials on a nationwide basis by -
reducing the likelihood of a lost source, medical.
- event, and. pubhc/ worker overexposure. The '
essential objective of this requirement is to assure that a survey is conducted on the patient and the.
device after source (s) removal from the patient or human research subject.
The H&S.two or fewer failure test scenario: If a licensee does not perform a patient radiation survey.
after implanting sources, sources could be misplaced and the public and workers could be exposed to radiation in excess of radiation protection
. limits in Parts 20 and 35 and a medical event could occur.
a
41 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.605 Installation, maintenance D/H&S, except (d) is D.
Based upon Handbook 5.9 Part il, " Categorization and repair Criteria," Section E, these provisions were designated D/H&S. These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the i
likelihood of a medical event and public and worker overexposure. The essential objective of these requirements is to assure that installation, maintenance, and adjustments are performed by a person specifically licensed by the Commission or an Agreement State.
The H&S two or fewer failure test scenario: Ifa licensee does not use a person who is specifically I
licensed to install and service devices and an equipment failure occurs, the person servicing the device could ber 9 overexposed. In addition, the public and --
,ould receive exposures in l
excess of the, aviation protection limits in Part 20, if I
. the device is not serviced properly.
-42
~
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY -
$35.610 Safety procedures and D/H&S except (e) is D.
Based upon Handbook 5.9 Part il, " Categorization instructions for remote Criteria," Sectum E, these provisions were afterloaders, teletherapy designated D/H&S. These provisions assist in units, and gamma establishing a minimum level of safety for agreement.
stereotactic radiosurgery materials by reducing the likelihood of a medical units
. event and public and worker overexposure. The essential objective of these requirements is to assure the establishment and use of safety procedures and instructens for remote afterloaders, teletherapy units and gamma stereotactic
' radiosurgery units.
t The H&S two or fewer failure test scenario: If a licensee does not develop and implement safety procedures and instructions, and radioactive material is misharidled, workers and the public could receive radiation exposures in excess of the radiation protection limits in Part 20 and a medical event could occur.
e h
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43 REGULATION
' SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 635.615
' Safety precautions for D/H&S Based upon Handbook 5.9 Part 11," Categorization remote afterloaders, Criteria," Section E, these provisions were teletherapy units, and designated D/H&S. These provisions assist in gamma stereotactic establishing a minimum level of safety for the radiosurgery units medical use of agreement materials by reducing the likelihood of a medical event, worker and public exposure. The essential objective of these requirements is to assure that controls are implemented, to require the physical presence of the.
authorized user and/or authorized medical physicist
' during the use of the device, and to assure the accessibility of emergency equipment.
The H&S two or fewer failure test scenario: Ifa licensee does not control access to therapy equipment and treatment rooms, and an equipment failure occurs, the public and workers could receive exposures in excess of the radiation protection limits in Part 20 and a medical event could occur.
i
... ~
~
44 REGULATION SECTION TITLE
. COMPATHNUTY COMMENTS
' SECTION CATEGORY
~
' $35.630 -
Dosimetry equipment
~ D/H&S except (c) is D.
Based upon Handbook 5.9 Part 11, T,ategorization Criteria," Secten E, paragraphs (a) and (b) were designated D/H&S. These provisions assist in estabhshing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event. The essential -
objective of this requirement is to assure the use of a dosimetry system that has been calibrated in accordance with national standards.
The H&S two or fewer failure test scenario: If a -
~. licensee does not calibrate and check dosimetry -
equipment in acceidance with industry standards, and an equipment failure occurs, the public and
,. workers could be exposed to radation in excess of radiation limits in Part 20 and a medical event could occur.
~
45 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY i
1 35.632 Full calibration D/H&S, except (g) is D.
Based upon Handbook 5.9 Part II, " Categorization.
measurements on Criteria," Section E, paragraphs (a) through (f) were teletherapy units designated D/H&S. These provisions assist in establishing a minimum level of safety basis by t
reducing the likelihood of a medical event. The essential objective of this requirement is to assure that the medical device is performing properly.
The H&S two or fewer failure test scenario: If a l
~ Iicensee does not perform full calibration '
measurements on teletherapy units in accordance -
with industry standards, and an equipment failure occurs, the public and workers could be exposed to radiation in excess of radiation limits in Part 20 and a medical event could occur.
P 1
n q.
i REGULATION SECTION TTTLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.633 Full calibration D/H&S, except (h) is D '
Based upon Handbook 5.9 Part li, T,ategorization measurements on remote Criteria," Section E, paragraphs (a) through (f) were afterloaders designated D/H&S. These provisions assist in establishing a minimum level of safety for the.
i medical use of agreement materials by reducing the likelihood of a medK:al event. The essential objective of this requirement is to assure that the medical device is performing properly.
' The H&S two or fewer failure test scenario: Ifa licensee does not perform full calibration measurements on remote afterloaders in -
accordance with industry standards, and an equipment failure occurs, the public and workers
- could be exposed to radiation in excess of radiation limits in Part 20 and a medical event could occur.
.. m
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_g m-fr-www-a r
- aw A-m-
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+
~,
~
- F REGULATION
. SECTION TITLE COMPATNHLITY COMMENTS SECTION CATEGORY -
~
.j r
$35.635 Full calibration DM&S, except (g) is D.
. Based upon Handbook 5.9.Part 11, " Categorization measurements on gamma.
Criteria," Sechon E, paragraphs (a) through (f) were stereotactic rachosurgery designated DM&S. These provisions assist in-i units establishing a minimum level of safety for the medmal use of agreement materials by reducmg the e
likelihood of a medmal event.' The essential '
i 3
. objective of this requirement is to assure that the.
n medmal device is performing properly.
[
i
' The H&S two or fewer failure tesi scenario: If a
~i licensee does not perform full calibration ~,
measurements on gamma stereotactic radiosurgery units in accordance with industry standards, and an -
1 equipment failure occurs, the public and workers L
.e could be exposed to radiation in excess of radiation :
limits in Part 20 and a medmal event could occur.
I I
h l
L
. I
.7_
n-m
" REGULATION
. SECTION TITLE COMPATNNUTY COMMENTS
.SECTION
- CATEGORY -
~
i
$35.642
- Periodic spot-checks for D/H&S,' except (f) is D.
Based upon Haneook 5.9 Part 11, T,ategorization
- teletherapy units Criteria," Section E, paragraphs (a) through (e) were -
designated D/H&S. These provisions assist in -
p establishing a minimum level of safety for the medical use of agreement material by reducing tt e ;
likelihood of a medical event. The essential' objectna of this requirement is to assure that the
}
medical device is performing properly.
i
^
? The H&S two or fewer failure test scenario: If a '
i licensee does not perform periodic spot checks of -
teletherapy units, and an equipment failure occurs, l
the pubhc and workers could receive exposures in L medical event could occur.'
' [
excess of radiation protection limits in Part 20 and 'a h
+
3 ef i
__,-._.--_,____-,-,e<.,w.
o
.<e
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V
-49 REGULATION SECTION TITLE COMPATMBIUTY COMMENTS SECTION CATEGORY h
$35.643 Periodic spot-checks for.
DM&S, except (h) is D.
Based upon Handbook 5.9 Part II, "Categonzation high dose-rate and pulsed Critena," Sechon E, paragraphs (a) through (g) were dose-rate remote designated DM&S. These provisions assist in afterloaders estabbshmg a minimum level of safety for the medical use of agreement materials by reducmg the j
likehhood of a medical event. The essential objective of this requirement is to assure that the medical
~
device is performing properly.
' The H&S two or fewer failure test scenario:. lf a. i licensee does not perform penodic spot checks of high dose-rate and pulsed dose-rate remote afterloaders, and an equipment failure occurs, the public and workers could receive exposures in.
excess of radiation protection lirr.its in Part 20 and a -
7 medical event could occur.
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50 REGULATION SECTION TITLE-COMPATIBILITY COMMENTS SECTION CATEGORY
$35.644 Periodic spot-check forlow 0/H&S, except (e)is D.
Based upon Handbook 5.9 Part II," Categorization dose-rate remote Criteria," Section E, paragraphs (a) through (d) were afterloaders designated D/H&S. These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a medical event by requiring the checking of instrument performance between maintenance and full calibrations are performed.
The essential objective of this requirement is to
' assure that the medical device is performing properly.
The H&S two or fewer failure test scenario: If a licensee does not perform periodic spot checks of low dose-rate remote afterloaders, and an equipment failure occurs, the public and workers '
. could receive exposures in excess of radiation protection limits in Part 20 and a medical event could
. occur.
_ _ _ _.. ~.,__
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51 REGULATION
- SECTION TITLE COMPATNNUTY COMMENTS SECTION CATEGORY s
z $35.645
_ Periodic spot-checks for
. D/H&S, except (g) is D.
Based upon Handbook 5.9 Part II, T,ategorization gamma stereotactic Criteria," Section E, paragraphs (a) through (f) were y
radiosurgery units designated D/H&S. These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the.
likelihood of a medical event by checking instrument :
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performance between maintenance and full
. calibrations. The essential objective of this
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requirement is to assure that the medical device is
' performing properly.
y The H&S two or fewer failure test scenario: If a
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licensee does not perform penodic spot checks of
.h gamma stereotactic radiosurgery units, and an.
equipment failure occurs, then the public and
=!
workers could receive exposures in excess of j
radiation protection limits in Part 20 and a medical '
i event could occur.
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.52 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.647 Additional technical D - except paragraphs (a)
Based upon Handbook 5.9 Part il, " Categorization requirements for mobile '
through (d) are a D/H&S Criteria," Section E, paragraph (a) was designated a remote afterloaders those States which D/H&S those Agreement States which authorize this authorize this service.
service. This provision assists in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood of a public exposure. The essential objective of this requirement is to assure that the appropriate radiation surveys are performed and that the proper
~ administrative controls are utilized.
The H&S two or fewer failure test scenario: If these rcquirements are not adopted, a mobile remote afterloader licensee would not be required to check survey instruments and verify sources after use, then sources could be misplaced and the public and workers could be exposed to radiation in excess of radiation protection limits in Part 20 and a medical
- event could occur.
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D 53 REGULATION SECTION TITLE
' COMPATIBILITY COMMENTS SECTION CATEGORY
$35.652 Radiation surveys D/H&S, except (c) is D.
Based upon Handbook 5.9 Part II, " Categorization Criteria," Section E, paragraphs (a) and (b) were designated D/H&S. These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the -
likelihood of public and worker overexposures.- The essential objective of this requirement is to assure that exposure to the source (s) in the shielded
. position does not exceed the levels stated in the SS&D registry.
The H&S two or fewer failure test scenario: Ifa licensee does not perform these radiation surveys, and the radiation safety of the device is compromised, then the public and workers could receive exposures in excess of radiation protection limits in Part 20.
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- e 54 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.655 Five-year inspection for D/H&S, except (c) is D.
Based upon Handbook 5.9 Part II, " Categorization teletherapy and gamma.
. Criteria," Section E, paragraphs (a) and (b) were stereotactic radiosurgery designated D/H&S. These prowsions assist in.
units establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood a medical event, and public and worker
~
exposure. The essential objective of this requirement is to assure that the inspection and
. servicing of teletherapy and gamma stereotactic :
radiosurgery units during source replacements or at
- intervals not to exceed 5 years and this inspection and servicing is performed by a person specifically licensed by the Commission or an Agreement State.
t The H&S two or fewer failure test scenario: If a licensee does not have their teletherapy and gamma stereotactic radiosurgery units inspected and serviced at 5-year intervals and an equipment failure occurs, the public and workers could receive radiation exposures in excess of radiation protection limits in Part 20 and a medical event could occur.
l 55 i
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.657.
Therapy-related computer D/H&S Based upon Handbook 5.9 Part paragraphs (a) and systems (b) was designated 11, " Categorization Criteria,"
Section E, this provision was designated D/H&S.
These provisions assist in establishing a minimum level of safety for the medical use of agreement materials by reducing the likelihood a medical event.
The essential objective of this requirement is to assure that therapy related computer systems are functioning properly and testing is done in accordance with national protocols.
The H&S two or fewer failure test scenario: Ifa licensee does not verify that computerized treatment planning systems are operating properly, a medical event could occur.
$35.690 Training for use of C
Based upon Handbook 5.9 Part 11 " Categorization therapeutic medical devices Criteria," Section (C), paragraphs (2) (b) and (2)(f),
' this requirement was designated a Category C because they relieve undue burdens on interstate commerce by establishing a minimum level of i
training for the medical use of agreement materials on a nationwide basis. The essential objective of this requirement is to assure that properly trained physicians use therapeutic medical devices.
l Q35.900 Radiation safety officer
[C]
This section is a bracketed Category C, because it is already required by 10 CFR 35.50. If an Agreement State has adopted 10 CFR 535.50, the State should not adopt this section.
i 56 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.910 Training for uptake, dilution,
[C]
This section is a bracketed Category C, because it is and excretion studies already required by 10 CFR $35.290. If an Agreement State has adopted 10 CFR Q35.290, the State should not adopt this section.
$35.920 Training for imaging and
[C]
This section is a bracketed Category C, because it is localization studies already required by 10 CFR 35.292. If an Agreement State has adopted 10 CFR $35.292, the
' State should not adopt this section.
Q35.930 Training for therapeutic use
[C]
This section is a bracketed Category C, because it is of unsealed byproduct already required by 10 CFR 35.390. If an material Agreement State has adopted 10 CFR 35.390, the State should not adopt this section.
935.932 Training for treatment of
[C]
This section is a bracketed Category C, because it is hyperthyroidism
_ already required by 10 CFR 935.390. If an Agreement State has adopted 10 CFR 935.390, the State should not adopt this section.
935.934 Training for treatment of
[C]
This section is a bracketed Category C, because it is thyroid carcinoma already required by 10 CFR 35.390. If an Agreement State has adopted 10 CFR 535.390, the State should not adopt this section.
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$35.940 Training for use of
[C]
. This section is a bracketed Category C, because it is brachytherapy sources already required by 10 CFR @35.490. If an Agreement State has adopted 10 CFR 35.490, the State should not adopt this section.
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i 57 REGULATION SECTION TITLE COMPATMHLITV COMMENTS
'f SECTION CATEGORY d
$35.941 Training for ophthalmic use
[C]
This secton is a bracketed Category C, because it is of strontium-90
' already required by 10 CFR $35.490. If an
' Agreement State has adopted 10 CFR $35.490, the l
State should not adopt this section.
$35.950 Training for use'of sealed
[C]
This secton is a bracketed Category C, because it is sources for diagnosis already required by 10 CFR 935.590. If an
, Agreement State has adopted 10 CFR $35.590, the.
,j State should not adopt this secton 935.960 Training for use of
[C]
This section is a bracketed Category C, because it is l
therapeutic medical devices already required by 10 CFR 935.690. If an Agreement State has adopted 10 CFR $35.690, the State should not adopt this section.
j i
$35.961 Training for authorized
[C]
This section is a bracketed Category C, because it is medical physicist
. already required by 10 CFR 635.51. If an Agreement State has adopted 10 CFR 935.51, the l
State should not adopt this section.
i 635.980 Training for an authorized
[C]
This section is a bracketed Category C, because it is nuclear pharmacist already required by 10 CFR 935.55. If an Agreement State has adopted 10 CFR $35.55, the
-State should not adopt this secton.
l
$35.981 Training for experienced
'[C]
. This section is a bracketed Category C, because it is nuclear pharmacists already required by 10 CFR $35.57. If an l
Agreement State has adopted 10 CFR $35.57, the State should not adopt this section.
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58 REGULATION SECTION TITLE COMPADBILITY COMMENTS SECTION CATEGORY 635.1000 Other medical uses of D
Does not meet any of the criteria of Category A, byptoduct material or B, C, or DM&S.
radiation therefrom
$35.2024 Records of authority and D
Does not meet any of the criteria of Category A, responsibilities for radiation B, C, or DM&S.
protection programs Q35.2026 Records of radiation D
Does not meet any of the criteria of Category A, protection program safety B, C, or D/H&S.
changes 935.2040 Records of written directives D
Does not meet any of the criteria of Category A, B, C, or D/H&S.
535.2045 Records of medical events D
Does not meet any of the criteria of Category A, B, C, or DM&S.
635.2060 Records of instrument D
Does not meet any of the criteria of Category A, calibrations B, C, or DM&S.
$35.2061 Records of radiation survey D
Does not meet any of the criteria of Category A, instrument calibrations B, C, or DM&S.
35.2063 Records of dosage of D
~ Does not meet any of the criteria of Category A, unsealed byproduct material B, C, or DM&S.
for medical use
0 59 REGULATION SECTION TITLE COMPATIBluTY COMMENTS SECTION CATEGORY 935.2067 Records of possession of D
Does not meet any of the criteria of Category A, sealed sources and B, C, or DM&S.
brachytherapy sources j
935.2070 Records of surveys for D
Does not meet any of the criteria of Category A, ambient radiation exposure B, C, or DM&S.
rate
'I
$35.2075 Records of the release of D
Does not meet any of the criteria of Category A, individuals containing B, C, or DM&S.
radiopharmaceuticals or l
implants i
'535.2080 Records of administrative D
Does not meet any of the criteria of Category A, and technical requirements B, C, or DM&S.
l that apply to the provision of mobile services
?
$35.2092 Records of waste disposal D
Does not meet any of the criteria of Category A, i
B, C, or D/H&S.
635.2204 Records of molybdenum-93 D
Does not meet any of the criteria of Category A, concentration B, C, or DM&S.
$35.2310 Records of instruction and D
. Does not meet any of the criteria of Category A, training B, C, or DM&S.
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60 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.2404 Records of radiation surveys D
Does not meet any of the criteria of Category A, of patients and human B, C, or DM&S.
research subjects
$35.2406 Records of brachytherapy D
Does not meet any of the criteria of Category A, source inventory B, C, or DM&S.
935.2432 Records of full calibrations D
Does not meet any of the criteria of Category A, on brachytherapy sources B, C, or D/H&S.
@35.2605 Records of installation, D
Does not meet any of the criteria of Category A, maintenance, and repair B, C, or D/H&S.
35.2630 Records of dosimetry D
Does not meet any of the criteria of Category A, equipment B, C, or DM&S.
35.2632 Records of teletherapy full D
Does not meet any of the criteria of Category A, calibrations B, C, or DM&S.
635.2633 Records of remote D
Does not meet any of the criteria of Category A, afterloader full calibrations B, C, or DM&S.
35.2635 Records of gamma D
Does not meet any of the criteria of Category A, stereotactic radiosurgery B, C, or DM&S.
unit full calibrations
E 61 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.2642 Records of periodic spot-D Does not meet any of the criteria of Category A, checks for teletherapy units B, C, or DM&S.
$35.2643 Records of periodic spot-D Does not meet any of the criteria of Category A, checks for remote B, C, or DM&S.
afterloaders 935.2645 Records of periodic spot-D Does not meet any of the criteria of Category A, checks for gamma B, C, or DM&S.
stereotactic radiosurgery units t
35.2647 Records of additional D
Does not meet any of the criteria of Category A, technical requirements for B, C, or DM&S.
mobile remote afterloaders 935.2652 Records of surveys of D
Does not meet any of the criteria of Category A, therapeutic treatment units B, C, or DM&S.
35.2655 Records of five-year D
Does not meet any of the criteria of Category A, inspection of teletherapy B, C, or DM&S.
and gamma stereotactic radiosurgery units
.. ~.
62 REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
'$35.3045 Reports of medical events C, except paragraphs (b)
Based upon Handbook 5.9 Part 11, " Categorization and (f) are D.
Criteria," Section (C), paragraphs (2)(c), this requirement was designated a Category C because absent this provision there could be a potential preclusion of an effective review or evaluation by the Commission and Agreement State programs for
. agreement material with respect to protection of public health and safety. The essential objective of this requirement is to assure that medical events are reported to the radiation control program.
35.3047 Reports of a dose to an C, except paragraph (c)is Based upon Handbook 5.9 Part II, " Categorization t
embryo / fetus or a nursing D.
Criteria," Section (C), paragraphs (2)(c), this child requirement was designated a Category C because
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absent this provision there could be a potential
, preclusion of an effective review or evaluation by the Commission and Agreement State programs for i
agreement material with respect to protection of public health and safety. The essential objective of this requirement is to assure that doses to the embryo / fetus or nursing child are reported to the radiation control program.
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63 '.
t 4
REGULATION SECTION TITLE COMPATIBILITY COMMENTS
~ SECTION CATEGORY I
- 35.3069 Reports of leaking sources C
Based upon Handbook 5.9 Part II, " Categorization I
Criteria," SectK>n (C), paragraphs (2)(c), this' requirement was designated a Category C because 4
absent this provision there could be a potential preclusion of an effective review or evaluation by the Commissx>n and Agreement State programs for -
.j
. agreement material with respect to protectKm of public health and safety. The essential objective of s
this requirement is to assure that leaking sources
[
are reported to the radiation control program.
935.4001 Violations D
Does not meet any of the criteria of Category A, j
B, C, or D/H&S.
$35.4002 Criminal penalties D
Does not meet any of the criteria of Category. A, l
B, C, or D/H&S.
t
. Appendix A Examining Organization or B
Based upon Handbook 5.9 Part 11. " Categorization l
Entity Criteria," Section (B), paragraph (2)(c), this definition was identified as a Category B because it provides 1
the requirements for the establishment of a J
nationwide training program in the area of medical
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use of agreement materials, which would have direct j
and significant effects in multiple jurisdiction.
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$20.1301 (a)(3)
Dose limits for individual A
members of the public I
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REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 632.72 (b)(1) and Manufacture, preparation, or B
(b)(2)(ii) -
transfer for commercial distribution of radioactive drugs containing byproduct material for medmal use under Part 35 632.74 (a) and Manufacture and distribution B
(a)(3) of sources or devices I
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